2163

2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, "Written Description" Requirement [R-5]

I. GENERAL PRINCIPLES GOVERNING COMPLIANCE WITH THE "WRITTEN DESCRIPTION" REQUIREMENT FOR APPLICATIONS

AMGEN

"Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required." Ans. 6 ( citing Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., ... [927 F.2d 1200 (Fed. Cir. 1991))]." 

ARIAD

"[T]he purpose of the written description requirement is to 'ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification."' Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)).

That a person skilled in the art might realize from reading the disclosure that such a feature is possible is not a sufficient indication that the feature is a part of the invention. In re Barker and Pehl

559 F.2d 588 (CCPA 1977). 

BARKER

“That a person skilled in the art might realize from reading the disclosure that such a step is possible is not a sufficient indication to that person that that step is part of appellants' invention. Such an indication is the least that is required for a description of the invention under the first paragraph of §112.” In re Barker, 559 F.2d 588, 593 (CCPA 1977). 

That a person skilled in the art might realize from reading the disclosure that such a feature is possible is not a sufficient indication that the feature is a part of the invention. In re Barker and Pehl, 559 F.2d 588 (CCPA 1977). 

CURTIS

Whether written description adequately supports claims is an issue of fact. See In re Curtis, 354 F.3d 1347, 1352 (Fed. Cir. 2004).

ENZO

Drawings may be relied upon to satisfy the written description requirement.  See Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002) (stating that the "written description requirement is satisfied by the [patent applicant's] disclosure of  'such descriptive means as words, structures, diagrams, formulas, etc., that fully set forth the claimed invention.'" (quoting Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997)).

However, “[t]he disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.” Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002) (citation omitted).

NEW RAILHEAD

For a claim in a non-provisional application to be entitled to the filing date of an earlier-filed provisional application, the provisional application must, inter alia, provide a written description of the claimed invention. New Railhead Mfg. LLC v. Vermeer Mfg. Co., 298 F.3d 1290, 1296 (Fed. Cir. 2002).

"In other words, the specification of the provisional must 'contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms,' 35 U.S.C. § 112 (1), to enable an ordinarily skilled artisan to practice the invention claimed in the non-provisional application." Dynamic Drinkware, LLC v. Nat'! Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (quoting New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed.Cir.2002)) (emphasis added). 

 

ROCHESTER

 

The written description requirement “serves a teaching function, as a "quid pro quo" in which the public is given "meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time."” Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed. Cir. 2004).

“Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004).  

 

TRONZO

“In order for a disclosure to be inherent, however, the missing descriptive matter must necessarily be present in the ... specification such that one skilled in the art would recognize such a disclosure.” Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998)

WRIGHT

The claimed subject matter need not be described “in haec verba” in the original specification in order to satisfy the written description requirement. In re Wright, 866 F.2d 422, 425 (Fed. Cir. 1989). 

A. Original Claims

 

PURDUE

 

"In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue." Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). However, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. See id.

see also Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1326-27 (Fed. Cir. 2000) (“one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say [‘]here is my invention.[’] In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”).

These facts are similar to those in Purdue Pharma L.P. v. Faulding, Inc., where “a characteristic that is not discussed even in passing in the disclosure” was claimed and then made the characteristic the basis of claims that cover any formulation having that characteristic.  230 F.3d 1320, 1327 (Fed. Cir. 2000).  According to the court, “this is exactly the type of overreaching the written description requirement was designed to guard against.”  Id.

RUSCHIG

The Specification must contain some guideposts, akin to “blaze marks” on trees that mark a trail that would establish the claimed invention “as something appellants actually invented.” In re Ruschig, 379 F.2d 990, 995 (CCPA 1967).

Ruschig explained this standard in the written description context by analogizing a genus and its constituent species to a forest and its trees, noting that, 

It is an old custom in the woods to mark trails by making blaze marks on the trees. It is no help in finding a trail . . . to be confronted simply by a large number of unmarked trees. Appellants are pointing to trees. We are looking for blaze marks which single out particular trees. We see none.

In re Ruschig, 379 F.2d 990, 994–95 (1967). 

SMITH

The disclosure of a genus does not necessarily implicitly describe every subgenus encompassed by that  genus. In re Smith, 458 F.2d 1389, 1395 (CCPA 1972). 

WERTHEIM

 

"[T]he PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.” In re Wertheim, 541 F.2d 257, 263-64 (CCPA 1976).

Based on these facts, we determine that the preamble breathes life and meaning into the claim that

provides completeness to the claim and thus must be considered a limitation of the claim. In re Wertheim, 541 F.2d 257, 269 (CCPA 1976) (citing Kropa v. Robie, 187 F.2d 150, 152 (CCPA 1951)).

    B. New or Amended Claims

 

BENNO

See In re Benno, 768 F.2d 1340, 1346 (Fed. Cir. 1985) (“The scope of a patent's claims determines what infringes the patent; it is no measure of what it discloses. A patent discloses only that which it describes, whether specifically or in general terms, so as to convey intelligence to one capable of understanding.”).

LUKACH

Application of Lukach, 442 F.2d 967, 969-70 (CCPA 1971) (later-filed broad range claim not supported by earlier grandparent disclosure of point in the range and anticipated by a similar disclosure in a related British patent)

New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 968-69 (CCPA 1971)

A prior art reference that enables a single embodiment within the scope of a claim anticipates that claim, even if the same embodiment would not enable the full scope of the later-claimed invention. Cf In re Lukach, 442 F.2d 967, 970 ( CCPA 1971) (" [T]he description of a single embodiment of broadly described subject matter constitutes a description of the invention for anticipation purposes ... , whereas the same information in a specification might not alone be enough to provide a description of that invention for purposes of adequate disclosure.").

MAYHEW

 

In Mayhew, the rejected claim omitted reference to an element (use of a specially-located cooling bath) that the Specification made clear was an essential element of the invention. Mayhew, 527 F.2d at 1233.

 

JOHNSON

“[The] specification, having described the whole, necessarily described the part remaining.” In re Johnson, 558 F.2d 1008, 1019 (CCPA 1977).

The notion that one who fully discloses, and teaches those skilled in the art how to make and use, a genus and numerous species therewithin, has somehow failed to disclose, and teach those skilled in the art how to make and use, that genus minus two of those species, and has thus failed to satisfy the requirement of s [sic] 112, first paragraph, appears to result from a hypertechnical application of legalistic prose relating to that provision of the statute. Id.

An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of the error in the specification but would also recognize the appropriate correction.  In re Oda, 443 F.2d 1200 (CCPA 1971).

 

II. METHODOLOGY FOR DETERMINING ADEQUACY OF WRITTEN DESCRIPTION

    

    A. Read and Analyze the Specification for Compliance with 35 U.S.C. 112, para. 1

        1. For Each Claim, Determine What the Claim as a Whole Covers

 

De Lajarte

 

In re De Lajarte, 337 F.2d 870, 873-74 (CCPA 1964);   

GENENTECH

Claim 1 is a method “comprising” certain steps.  The Federal Circuit has held “the open-ended term ‘comprising’ . . . . means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.”  Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997); David Netzer Consulting Eng’r LLC v. Shell Oil Co., 824 F.3d 989, 998 (Fed. Cir. 2016).  Thus, the claims as presently written do not preclude tracking and displaying additional information.

KATZ

A claim that recites both a system (or apparatus) and a method of using that system (or apparatus) does not apprise one of ordinary skill in the art of its scope, and thus, is invalid under 35 U.S.C. 1 12, second paragraph. see IPXL Holdings, LLC v. Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005). ...

Stated differently, one of ordinary skill in the art could reasonably consider the  "placed in an initial operating state" limitation as "directed to user actions, not system capabilities." In re Katz Interactive Call Processing Patent Litig., 639 F.3d 1303, 1318 (Fed. Cir. 2011), quoted in UltimatePointer,L.L.C. v. Nintendo Co., No. 2015-1297, 2016 WL 798354, at *9 (Fed. Cir. Mar. l , 2016). Thus, we reject claim I as invalid under 35 U.S.C. 112, second paragraph.

 

MORRIS

"[T]he PTO applies to the verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant's specification." In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).

 

See also In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997) ("[I]t would be unreasonable for the PTO to ignore any interpretative guidance afforded by applicant’s written description."). 

PPG

see also PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354-57 (Fed. Cir. 1998) (Patentees “could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention. The question for our decision is whether PPG did so.”).  

 

        2. Review the Entire Application to Understand How Applicant Provides Support for the Claimed Invention Including Each Element and/or Step

 

Under proper circumstances, drawings alone may provide a written description of an invention as required by 35 U.S.C. § 112, first paragraph. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991); see also Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 866 (Fed. Cir. 1993) (drawings provided substantial evidence of disclosure of leadless SIMMs).

 

 

        3. Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Applicant was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed

            (a) Original claims

WOLFENSPERGER

When assessing whether a drawing provides descriptive support for a claim feature the "legitimate enquiry in each case ... is what the drawing in fact discloses to one skilled in the art. Whatever it does disclose may be added to the specification in words without violation of the statute and rule which prohibit 'new matter."' In re Wolfensperger, 302 F.2d 950, 955 (CCPA 1962).

See, e.g., In re Wolfensperger, 302 F. 2d 950 (CCPA 1962) (A disclosure should not be considered lacking due to speculation that one skilled in the art might interpret the teaching of the inventor in a remote and equivocal manner). 

UMC

"[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim." UMC Elecs. Co. v. United States, 816 F.2d 647, 652 (Fed. Cir. 1987).

ENZO 

Appearance of a claim in the specification in ipsis verbis does not guarentee that the written description requirement is satisfied, see, e.g. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002)

 

FALKNER

For example, in Falkner v. Inglis, the court affirmed the conclusion of the Board of Patent Appeals and Interferences that claims to a modified pox virus vaccine were enabled, despite the fact that the specification focused on viruses other than pox virus, provided no examples directed to pox virus, and discussed pox virus only in general terms relating to the inventive disclosure. Falkner v. Inglis, 448 F.3d 1357, 1365 (Fed. Cir. 2006).

HERSCHLER

 

The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language. In re Herschler, 591 F.2d 693, 700 (CCPA 1979); In re Edwards, 568 F.2d 1349, 1351-52 (CCPA 1978).

MARTIN

In response to the Examiner’s position that “nowhere in the present application specification has cited the phrases ‘the suction nozzle is not melted by arc heat,’” (Ans. 5) (emphasis omitted), the Specification need not describe the invention ipsis verbis in order to meet the written description requirement (see Martin v. Johnson, 454 F.2d 746, 751 (CCPA 1972)). We agree with Appellant that at least paragraphs 25, 59, and 61 provide sufficient written description support. 

NOLL

see also In re Noll, 545 F.2d 141, 148 (CCPA 1976) (holding that a "programmed machine is structurally different from a machine without that program.")

 

VAS-CATH

 

“[D]rawings alone may be sufficient to provide the written description of the invention required by § 112, first paragraph.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1565 (Fed. Cir. 1991).

 

CAPON

 

“[T]he determination of what is needed to support generic claims to biological subject matter depends on a variety of factors, such as the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, the predictability of the aspect at issue, and other considerations appropriate to the subject matter.” Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).

 

“It is not necessary that every permutation within a generally operable invention be effective in order for an inventor to obtain a generic claim, provided that the effect is sufficiently demonstrated to characterize a generic invention.” Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).

NOELLE, ENZO

 

For antibody claims, which are defined by their function rather than the structure of the antibody per se, the Court of Appeals for the Federal Circuit, our reviewing court, has adopted the USPTO Written Description Guidelines:

[A]s persuasive authority for the proposition that a claim directed to “any antibody which is capable of binding to antigen X” would have sufficient support in a written description that disclosed “fully characterized antigens.” Synopsis of Application of Written Description Guidelines, at 60, available at http://www.uspto.gov.web.menu.written.pdf (last visited Jan. 16, 2003) (emphasis added).

Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004); see also Enzo Biochem Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002).

For each claim drawn to a genus:

ABBVIE

When a patent claims a genus using functional language to define a desired result, “the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1299 (Fed. Cir. 2014) (quoting Ariad, 598 F.3d at 1349).

"One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus." AbbVie Deutsch/and GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014).

LIZARDTECH

 

Thus, a patentee cannot always satisfy the requirements of section 112, in supporting expansive claim language, merely by clearly describing one embodiment of the thing claimed. For that reason, we hold that the description of one method for creating a seamless DWT does not entitle the inventor of the ′835 patent to claim any and all means for achieving that objective. See, LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1344-1346 (Fed. Cir. 2005).

LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346 (Fed. Cir. 2005) (a description of a single embodiment "does not entitle the inventor" to broad claims).

 

RASMUSSON

 

A disclosure lacking a teaching of how to use a fully disclosed invention for a specific, substantial utility is, under the present state of the law, entirely adequate to anticipate a claim. See Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir. 2005).

 

            (b) New Claims, Amended Claims, or Claims Asserting Entitlement to the Benefit of an Earlier Priority Date or Filing Date under 35 U.S.C. 119, 120, or 365(c)

CURTIS

 

For a claim in a later filed application to be entitled to the benefit of an earlier filing date of a previously filed application under 35 U.S.C. § 120, the previously filed application must comply with the written description requirement of 35 U.S.C. § 112, ¶1. In re Curtis, 354 F.3d 1347, 1351-52 (Fed. Cir. 2004). “This requires the disclosure in the earlier application to reasonably convey to one of ordinary skill in the art that the inventors possessed the later-claimed subject matter when they filed the earlier application.” Id. at 1351.

 

HYATT

 

When an explicit limitation in a claim is not present in the written description, it must be shown that a person of ordinary skill would have understood that the description requires that limitation. Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed. Cir. 1998).

see also Hyatt v. Boone, 146 F.3d 1348, 1354–55 (Fed. Cir. 1998) (“[T]he written description must include all of the limitations . . ., or the applicant must show that any absent text is necessarily comprehended in the description provided and would have been so understood at the time the patent application was filed.”) (emphasis added). 

ROBINS

Cf. In re Robins, 429 F.2d 452, 458 (CCPA 1970) (“Giving the language its broadest possible meaning, as we are bound to do in the absence of special definitions by appellant, the breadth of the claims insofar as the catalyst is concerned is indeed immense.  However, ‘Breadth is not indefiniteness.’  In re Gardner, 427 F.2d 786 [, 788], 57 CCPA [1207] (1970).”)  

 

WERTHEIM

 

"[T]he PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.” In re Wertheim, 541 F.2d 257, 263-64 (CCPA 1976).

 

WRIGHT

 

“In deciding the issue [of written description], the specification as a whole must be considered.” In re Wright, 866 F.2d 422, 425 (Fed. Cir. 1989).

III. COMPLETE PATENTABILITY DETERMINATION UNDER ALL STATUTORY REQUIREMENTS AND CLEARLY COMMUNICATE FINDINGS, CONCLUSIONS, AND THEIR BASES

        

        A. For Each Claim Lacking Written Description Support, Reject the Claim Under 35 U.S.C. 112, para. 1, for Lack of Adequate Written Description

 

MARZOCCHI

 

Assuming there is sufficient reason to think undue experimentation would be needed to use an invention, a rejection for failure to teach how to use would be proper. In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971). 

        

        B. Upon Reply by Applicant, Again Determine the Patentability of the Claimed Invention, Including Whether the Written Description Requirement Is Satisfied by Reperforming the Analysis Described Above in View of the Whole Record

 

2163.01 Support for the Claimed Subject Matter in Disclosure

 

RASMUSSEN

 

When the original written description describes something within the scope of the claim, the Examiner must do more than point out the difference in scope. This is so because "that a claim may be broader than the specific embodiment disclosed in a specification is in itself of no moment." In re Rasmussen, 650 F.2d 1212, 1215 (CCPA 1981). There are instances in which a narrower disclosure can support broader claims. Id.

 

2163.02 Standard for Determining Compliance With the Written Description Requirement

 

ARIAD  VAS-CATH RALSTON

 

Thus, “the description must ‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.’” Ariad Pharmas. v. Eli Lilly and Co., --- F.3d ----, 2010 WL 1007369, at *12 (Fed. Cir. 2010) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Id.

“[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad, --- F.3d ----, 2010 WL 1007369 at *12 (citing Vas-Cath, 935 F.2d at 1563.)

 

... 

Recently, the Court of Appeals for the Federal Circuit decided en banc the scope and purpose of the written description requirement within the first paragraph of 35 U.S.C. § 112. The court reaffirmed that the written description requirement found in the first paragraph of 35 U.S.C. § 112 is separate and distinct from the enablement requirement of that provision. Ariad Pharms., Inc. v. Eli Lilly and Co. , --- F.3d ----, 2010 WL 1007369, at *12 (Fed. Cir. 2010) (citing Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-1563 (Fed. Cir. 1991)). Further, the purpose of the written description requirement in 35 U.S.C. § 112, first paragraph, is to “clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Ariad, 2010 WL 1007369, at *12.

Accordingly, “the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. (citing Ralston Purina Co. v. FarMar-Co, Inc. , 772 F.2d 1570, 1575 (Fed. Cir. 1985)). The hallmark of the written description is disclosure. Ariad, 2010 WL 1007369, at *12. As such, not just possession, but “‘possession as shown in the disclosure’ is a more complete formulation.” Id. Thus, the test for whether the claims are adequately described “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. “Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id. This inquiry is a question of fact. Id. (citing Ralston Purina, 772 F.2d at 1575). “[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Ariad, 2010 WL 1007369, at *12 (citing Capon v. Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005)).

The purpose of the written description requirement in 35 U.S.C. § 112, first paragraph, is to “‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”’  Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) (citing Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991)).  “[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.”  Id.  This test “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.”  Id.  “Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.”  Id.  This inquiry is a question of fact.  Id. (citing Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985)). 

 

GOSTELI

 

“Although [the applicant] does not have to describe exactly the subject matter claimed, . . . the description must clearly allow persons of ordinary skill in the art to recognize that [the applicant] invented what is claimed” as of the filing date of the application. In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (discussing the written description requirement in the context of a claim of foreign priority).

 

KASLOW

“The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language.” In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983)

It is well established that the content of the drawings may also be considered in determining compliance with the written description requirement. See, e.g., In re Kaslow, 707 F. 2d 1366, 1375 (Fed. Cir. 1983).

ELI LILLY

An adequate written description of a chemical invention "requires a precise definition, such as by structure, formula, chemical name, or physical properties." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir. 2004); Regents of the Univ. of Cal. v. Eli Lilly & Co., Inc., 119 F.3d 1559, 1566 (Fed. Cir. 1997); Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993). "A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F.3d at 923; Eli Lilly, 119 F.3d at 1568. Instead, the "disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Id. In addition, possession of a genus "may be achieved by means of a recitation of a representative number of [compounds] … falling within the scope of the genus." Eli Lilly, 119 F.3d at 1569. "Possession may not be shown by merely describing how to obtain possession of members of the claimed genus." Ex parte Kubin, 83 USPQ2d 1410, 1417 (BPAI 2007) (citing Rochester, 358 F.3d at 927).

 

FIERS

"Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required." Ans. 6 ( citing Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., ... [927 F.2d 1200 (Fed. Cir. 1991))]." 

LOCKWOOD

 

"One shows that one is 'in possession' of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious." Lockwood v. American Airlines Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997).

Where a textual description of an embodiment is absent, a showing that the missing description would have been obvious does not suffice. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997) (“Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. It extends only to that which is disclosed.”).

2163.03 Typical Circumstances Where Adequate Written Description Issue Arises

 

I.    AMENDMENT AFFECTING A CLAIM

 

WRIGHT

 

“When the scope of a claim has been changed by amendment in such a way as to justify an assertion that it is directed to a different invention than was the original claim, it is proper to inquire whether the newly claimed subject matter was described in the patent application when filed as the invention of the applicant.” In re Wright, 866 F.2d 422, 424 (Fed. Cir. 1989).

 

II.    RELIANCE ON FILING DATE OF PARENT APPLICATION UNDER 35 U.S.C. 120

 

SCHEIBER

 

In re Scheiber, 587 F.2d 59, 62 (CCPA 1978) (to be entitled to benefit under § 120, claimed invention must be described in parent application; "Stempel" rationale does not apply to issues under § 120).

 

III.    RELIANCE ON PRIORITY UNDER 35 U.S.C.

 

IV.    SUPPORT FOR A CLAIM CORRESPONDING TO A COUNT IN AN INTERFERENCE

 

2163.04 Burden on the Examiner with Regard to the Written Description Requirement [R-6]

 

ALTON

 

The Examiner “‘bears the initial burden . . . of presenting a prima facie case of unpatentability.’ Insofar as the written description requirement is concerned, that burden is discharged by ‘presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.’” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996), quoting In re Oetiker, 977 F.2d 1443, 1445 “If . . . the specification contains a description of the claimed invention, albeit not in ipsis verbis (in the identical words), then the examiner . . . , in order to meet the burden of proof, must provide reasons why one of ordinary skill in the art would not consider the description sufficient.” Alton, 76 F.3d at 1175.

 

HYATT

 

See Hyatt v. Dudas, 551 F.3d 1307, 1313-14 (Fed. Cir. 2008) (the Board may treat arguments appellant failed to make for a given ground of rejection as waived);

The Federal Circuit has outlined how the prima facie case burden for anticipation is met, and its purpose. Specifically, “the prima facie case is merely a procedural device that enables an appropriate shift of the burden of production.” Hyatt v. Dudas, 492 F.3d 1365, 1369 (Fed. Cir. 2007). This burden is met by “adequately explain[ing] the shortcomings it perceives so that the applicant is properly notified and able to respond.” Id, at 1370. It is only “when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection” that the prima facie burden has not been met and the rejection violates the minimal requirements of 35 U.S.C. §132. Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir. 1990).

 

MARZOCCHI

 

Assuming there is sufficient reason to think undue experimentation would be needed to use an invention, a rejection for failure to teach how to use would be proper. In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971).

 

[A] disclosure which contains a teaching of the manner and process of making and using the invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support. In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971).

 

WERTHEIM

 

"[T]he PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims.” In re Wertheim, 541 F.2d 257, 263-64 (CCPA 1976).

In re Wertheim, 541 F.2d 257, 263— 264 (CCPA 1976)  "By pointing to the fact that claim I reads on embodiments outside the scope of the description, the PTO has satisfied its burden."

 

I.    STATEMENT OF REJECTION REQUIREMENTS

 

RASMUSSEN

 

When the original written description describes something within the scope of the claim, the Examiner must do more than point out the difference in scope. This is so because "that a claim may be broader than the specific embodiment disclosed in a specification is in itself of no moment." In re Rasmussen, 650 F.2d 1212, 1215 (CCPA 1981). There are instances in which a narrower disclosure can support broader claims. Id.

 

II.    RESPONSE TO APPLICANT'S REPLY

I.    BROADENING CLAIM

        Omission of a Limitation

GENTRY

The "omitted element" test, sometimes called the "essential element" test has been broadly criticized. It is instructive that one of the most widely vilified decisions in this context, Gentry Gallery, Inc. v. Berkline Corp., which affirmed an invalidity based on the absence of a key element, has never been overturned. How can this apparent paradox be explained? The key lies in the caution repeated in our decision: written description determinations are so fact-specific that it is hazardous to read too much into any precedent. The Gentry Gallery court had to determine whether a finding that the specification as a whole conveyed a requirement for a specific element was clearly erroneous. In determining it was not, the court expressly rejected an over-reading of its holding:

It is a truism that a claim need not be limited to a preferred embodiment. However, in a given case, the scope of the right to exclude may be limited by a narrow disclosure.

 

Critics of Gentry Gallery have often converted the decision into a straw-man for criticism. Any opinion when so caricatured can be made to seem foolish. When the opinion is read narrowly, in light of the specific facts of the case, as the court intended, it remains a viable (albeit limited) opinion.

JOHNSON

Johnson Worldwide Associates, Inc. v. Zebco Corp., 175 F.3d 985, 992 (Fed. Cir. 1999) (stating the infringer “recognizes that the unmodified term ‘coupled’ generically describes a connection, and does not require a mechanical or physical coupling”).

The Examiner points out that the description requirement necessitates "a description of an invention, not an indication of a result that one might achieve if one made that invention." Id. (citing In re Wilder, 736 F.2d 1516, 1521 (Fed. Cir. 1984)).

        Addition of Generic Claim

GOSTELI

In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989) (later-filed claims containing subject matter, a genus, not disclosed in foreign priority application, disclosing a subgenus of the genus claimed, not entitled to foreign priority)

II.    NARROWING OR SUBGENERIC CLAIM

FUJIKAWA

 

This is a situation where the word "parallel" is used ipsis verbis in the Specification (FF 8), even though ipsis verbis support is not required. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996). We think Appellant has the better argument here, since any person of ordinary skill would recognize that one embodiment of "substantially parallel" is "parallel" itself.

"[I]psis verbis disclosure is not necessary to satisfy the written description requirement of Section 112." Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996). 

 

LUKACH

 

In re Lukach, 442 F.2d 967 (CCPA 1971) (to be entitled to  § 120 benefit, subject matter claimed in later application must be described in parent in manner required by § 112);

When an Applicant claims a class, the Applicant “must describe that class in order to meet the description requirement of the statute.” In re Lukach, 442 F.2d 967, 968 (CCPA 1971).

III.    RANGE LIMITATIONS

However, it has been established that the claim need not use the same words as the specification, but rather it is enough that one of ordinary skill in the art would recognize that the inventor invented what is claimed. Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000).

 

2163.06 Relationship of Written Description Requirement to New Matter

 

I.    TREATMENT OF NEW MATTER

 

RASMUSSEN, CHIRON

 

(“a rejection of an amended claim under § 132 is equivalent to a rejection under § 112, first paragraph”) (quoting In re Rasmussen, 650 F.2d 1212, 1214 (CCPA 1981)); see also Chiron Corp. v. Genentech, Inc. , 363 F.3d 1247, 1255 (Fed. Cir. 2004) (“The written description requirement prevents applicants from . . . . add[ing] new matter to their disclosures . . . defeating an accurate accounting of the priority of invention. See 35 U.S.C. 132.”)

II.    REVIEW OF NEW MATTER OBJECTIONS AND/OR REJECTIONS

 

III.    CLAIMED SUBJECT MATTER NOT DISCLOSED IN REMAINDER OF SPECIFICATION

BENNO

See In re Benno, 768 F.2d 1340, 1346 (Fed. Cir. 1985) (“The scope of a patent's claims determines what infringes the patent; it is no measure of what it discloses. A patent discloses only that which it describes, whether specifically or in general terms, so as to convey intelligence to one capable of understanding.”).

I.    REPHRASING

ANDERSON

See Application of Anderson, 471 F.2d 1237, 1244 (CCPA 1973) (“The question . . . is not whether ‘carrying’ was a word used in the specification as filed but whether there is support in the specification for employment of the term in a claim; is the concept of carrying present in the original disclosure?”)

See In re Anderson, 471 F.2d 1237, 1242 (CCPA 1973) ("It is always possible to put something into a combination to render it inoperative. It is not the function of the claims to exclude all such matters but to point out what the combination is."). 

II.    OBVIOUS ERRORS

2163.07(a) Inherent Function, Theory, or Advantage

 

ROBERTSON

 

Under principles of inherency, when a reference is silent about an asserted inherent characteristic, it ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’ In re Robertson, 169 F.3d 743, 745 (Fed. Cir.1999).

“To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.’” In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949, 1950-51 (Fed. Cir. 1999).

2163.07(b) Incorporation by Reference [R-3]