Connecting the Dots or Swiss Cheese: Does Your Patent Application Have Holes? Written Description and Enablement Requirements Unchanged by Patent Reform

Abstract

With enactment of the America Invents Act (“Patent Reform”) in September 2011, the US patent system entered an 18-month transition from a first-to-invent system to a “first inventor to file” system for new patent applications filed on or after March 2013.¹ The change is significant not only for what it does change, but also for what it does not change. Patent Reform changes the rules for determining patentability over prior information, but leaves unchanged the requirements for determining the technical information for adequate disclosure to support an invention claimed in a patent. Under Patent Reform, in response to a perceived pressure to be the ‘first to file,’ a US patent applicant may file a patent application before taking time to obtain the information needed for adequate disclosure of an invention. The result is a potential trap for the unwary patent applicant who files an application quickly, only to learn (possibly years later) that they are unable to obtain or defend a patent on their invention.

This article provides guidance to patent applicants for evaluating the risk of filing their patent application too early, and thereby losing a patent on their invention despite winning the perceived “race” to file. The examples provided relate to inventions in the so-called “unpredictable” life science technologies.

“A patent is not a hunting license.”² To obtain a valid US patent, a patent applicant still must provide a written description of the claimed invention and enough information to allow a person of ordinary skill in the art to make and use the entire claimed invention as of the priority date.³ In exchange for awarding a right to exclude others from infringing a claimed invention for a limited time, US patent law requires patent applicants to demonstrate that the inventor(s) had possession of the full scope of the patent claims at the time of filing (written description) with sufficient information to enable a person with the relevant technical skill set to reproduce the claimed invention (enablement).⁴

On first impression, the written description is rather unassuming, and perhaps deceptively simple: the patent applicant is required to disclose the claimed invention with enough detail for others in the relevant technical field(s) to (objectively) demonstrate that he or she was “in possession of the invention.”⁵ The written description requirement separates patentable inventions from claims to a “mere wish or plan” for obtaining an invention.⁶ The enablement requirement also prevents patenting of a research proposal or claims describing an object for further research (i.e., “fishing expeditions”).⁷ To comply with the enablement requirement, the claims of a patent application cannot cover subject matter that would require “undue experimentation” to make or use the invention.⁸ This does not mean that valid patent claims cannot include some examples of the invention that do not work (“inoperable embodiments”) or subject matter that would require some amount of experimentation to make and use given the disclosure of the patent application at the time of filing.⁹ In addition, a patent application need not disclose information that is well known in relevant technology areas.¹⁰ In short, the recent Patent Reform does not change the written description or enablement requirements for US patent applications. Nor does Patent Reform change the requirement of maintaining US patent applications in confidence for 18 months after the application is first filed.

What the new “first inventor to file” system has the potential to create, however, is a tailwind pressing some patent applicants toward filing their applications with the United States Patent and Trademark Office (USPTO) sooner rather than later. Without recourse to proving an earlier date of invention against others, a misconception of the new US patent system as being a ‘first to file’ system (rather than a ‘first inventor to file’ system) tempts inventors to file their patent applications before assembling a disclosure adequate to support the full scope of their invention. For example, a patent applicant may hesitate to delay the filing of a patent application to obtain additional data or examples for fear that another patent applicant may file a competing patent covering a similar invention during the delay. However, the decision to file a patent application “too early” (i.e., before adequate supporting disclosure for the claimed invention can be obtained, or with claims broader than the scope of support in an existing patent application) can have lasting consequences. A patent applicant can change the scope of the patent claims or submit additional information (e.g., declarations and additional data) while the patent application is pending. However, the rest of the disclosure of the patent application (specification) typically cannot be changed after the original filing date to fix a failure to provide adequate support for the patent claims.

Recent US patent case law provides cautionary tales of patents invalidated for failing to meet the written description or enablement requirements. This same case law will apply to patents filed after Patent Reform as well.

When “Eureka!” is Not Enough

A good idea is not necessarily enough to obtain a valid patent. In one case, a US patent covering a method of treatment with a previously known drug was later found invalid, because the patent specification “merely state[d] a scientific hypothesis or a proposed testing to determine the accuracy of that hypothesis.”¹¹ In 1986, a researcher had a good idea while reviewing scientific literature about the activity of the drug galantamine. After reviewing reports that galantamine inhibits an enzyme that breaks down the neurotransmitter acetylcholine in the brain and separate studies noting cognitive improvement upon administration of the drug to healthy animals, she “connected the dots” between certain neuroreceptors and a model for Alzheimer's therapy and identified galantamine as a possible treatment for Alzheimer's disease.¹² Colleagues would later refer to this insight as exhibiting “scientifically reasonable judgment,” a “proposal…worth the effort to check it out …” and a “scientifically grounded” discovery.¹³ The researcher filed a patent application to methods of treating Alzheimer's disease with galantamine, without the benefit of data demonstrating activity of galantamine in an animal model of the disease state. The inventor later stated, “[w]hen I submitted this patent, I certainly wasn't sure, and a lot of other people weren't sure…that [the invention] would ever work.”¹⁴ While the patent application was pending, the researcher successfully pursued animal studies requiring several months and “considerable effort” to obtain results supporting the further development of galantamine as a promising Alzheimer's disease treatment.¹⁵ The data were obtained after the patent issued, confirming her earlier insights into the scientific literature and relevant science but never submitted to the USPTO.¹⁶

Nearly 22 years later, a court held this patent invalid for failing to provide an enabling disclosure for the claimed methods of treating Alzheimer's disease.¹⁷ Absent test results of galantamine in an Alzheimer animal model, the patent applicant could not rely purely on inferences about prior art references cited in the patent disclosure to provide an enabling disclosure. “At the end of the day,” the court concluded on appeal, “the specification…does no more than state a hypothesis and proposes testing to determine the accuracy of that hypothesis. That is not sufficient.”¹⁸

This case illustrates the potential harm of filing a patent application too early. While the patentee had discovered a novel scientific insight, she filed her patent application before she obtained the data needed to support a patent covering the resulting method of treatment. In the end, she may have been the first to file, but not the first inventor to file, because the court held that she had not described a complete invention, only a hypothesis.

Winning the Race, but Losing the Patent

In another case, dueling patents covering genetic tests for detection of genetic mutations linked to a certain hereditary iron absorption disorder were filed by competing firms.¹⁹ In December 1994, Billups filed a patent application that disclosed a general location for the relevant genetic mutation (within a 300 base pair region of a known multi-gene family), but did not disclose the location or sequence of this mutation.²⁰ In 1995, the inventor of the Billups patent unsuccessfully pursued research to identify and isolate the mutations responsible for the disorder.²¹ The Billups patent was issued with only claims to methods of detecting the mutations responsible for the disorder.²² The following year, however, another group of scientists independently identified the exact genetic sequences for three relevant genetic mutations linked to the disorder, and later obtained their own patent on this technology.²³ This second patent was assigned to Bio-Rad.²⁴

About 16 years later, Billups asserted its patent against a Bio-Rad product embodying the methods of detecting the genetic mutation.²⁵ The court invalidated the Billups patent on summary judgment.²⁶ Despite being earlier to file for patent protection, the Billups patent was held invalid for failing to provide an adequate written description of the invention.²⁷ Instead, the court found Billups filed a patent that “merely represents Billups's research plan” when the relevant DNA sequences at issue were otherwise unknown.²⁸ This case illustrates that filing a patent application too early can increase the risk of losing out to a competitor who files a more complete patent application on similar technology after you.

A Tale of Two Chimeric Antibodies: No Pardon for Overreaching

Centocor researchers had a problem: their A2 mouse antibody still possessed the desirable properties of binding to and neutralizing activity of the desired biological target for treatment of arthritis, but produced an undesirable immune response in humans.²⁹ To solve the immunogenicity problem without losing the desirable properties, Centocor researchers exchanged a murine portion of the antibody with a portion of a known corresponding human antibody to form a mouse-human chimeric therapeutic antibody.³⁰ Centocor filed a US patent application disclosing the chimeric antibody, eventually leading to Centocor's US Patent 7,070,775.³¹

Meanwhile, Abbott independently developed a therapeutic antibody for the same biological target as the Centocor chimeric antibody. Abbott pursued a very different approach based on assembling various portions of human antibodies, without including murine or other animal antibodies. Abbott developed a research technique to identify variable regions from a library of human antibodies to the biological target.³² By 1995, having selected and combined regions of multiple human antibodies, Abbott created the therapeutic antibody approved as the drug Humira^® and filed a patent on the human antibody.³³ The patent application was later issued as an Abbott patent covering the Humira^® product.³⁴

After FDA approval of Humira^® in 2000 and the 2002 USPTO grant of the Abbott patent covering the human antibody in Humira^®, Centocor amended the claims in its pending US patent application to cover the human antibody from Abbott.³⁵ Shortly after the Centocor patent issued, Centocor successfully asserted the human antibody claims of the patent against the Humira^® product sold by Abbott, and obtained a favorable jury verdict of infringement and $6.7 billion in damages.³⁶ Abbott appealed the verdict, arguing that the Centocor patent did not even disclose a single all-human antibody, and that Centocor was in effect “attempting to claim as its own the fruit of Abbott's innovative work.”³⁷ The appeals court reversed the trial court verdict, holding the Centocor patent to be invalid for failing to meet the written description requirement with respect to the human antibody claims.³⁸ According to the appeals court, the Centocor patent “merely disclosed tools that might be used in an attempt to make the claimed invention—essentially,…Centocor's disclosure is no more than a mere wish or plan for how one might search for a fully-human antibody.”³⁹

This case illustrates a role of the written description requirement in policing “overreaching” by patent applicants. The Centocor patent provided adequate disclosure to cover claims to the chimeric antibodies disclosed in the patent. But Centocor attempted to write patent claims covering later-developed human-only antibody technology in a patent application that disclosed only human-animal chimeric antibodies. Centocor's efforts to ensnare the Abbott human-antibody product were ultimately unsuccessful, because the court found that the Centocor patent specification did not demonstrate possession of this invention.

So Now What …

So when is “enough, enough” when it comes to a patent application disclosure? How can inventors and other patent applicants evaluate when a patent application has adequate disclosure? When does a patent application need additional data, examples, embodiments or disclosure? When are the patent claims commensurate with the scope of the rest of the specification?

Written description requires that one of skill in the relevant technical art “visualize or recognize” the claimed technology based on the disclosure of the specification.⁴⁰ In general, the written description and enablement requirements for patent applications do not require examples or actual reduction to practice.⁴¹ These determinations are fact-laden and subject to change as knowledge in a relevant technology progresses.⁴²

For biological inventions, such as gene or protein sequences, courts have held invalid generic claims to coding sequences defined only by function without commensurate disclosure of a representative number of structural sequences. Similarly, patent claims to human genome coding sequences have been held invalid when supported only by allegedly corresponding animal sequences and analogous biological function.⁴³ In general, a biological genus cannot be adequately disclosed by a biological function alone; the written description requires disclosure of a representative number of species within a claimed genus in unpredictable technologies. The number of species constituting a “representative” sample of a genus depends on the degree of variability within the genus and the relevant identifying functional characteristics disclosed for the species in the genus.⁴⁴ Fewer species may be required to support a generic claim when a correlation is known or described between the structure and function and the patent disclosure is sufficient to show the patent applicant possesses the entire claimed genus based on the species disclosed.⁴⁵ Conversely, a sufficiently wide variety of species can be required in a patent disclosure to support claims covering a genus of more highly variable species. In any case, one of the relevant technical skill must recognize the applicant possesses the common attributes (e.g., shared structural features) of the genus based on the representative examples provided in the patent specification.⁴⁶ Factors courts consider in evaluating how much support is required in the specification for claims to generic biological subject matter include: the level of existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.⁴⁷

For chemical inventions, written description can be provided for claims to a species or sub-genus of chemical compounds when the patent specification includes “reasonably specific supporting disclosure” narrowing a broader chemical formula (e.g., “blaze marks”).⁴⁸ A patent application that merely recites a “laundry list” of chemical moieties in a broad chemical formula does not necessarily provide adequate support for patent claims to each and every species or subgenus formed by selecting specific combinations of chemical moieties from the “laundry list” in the specification. The patent applicant must provide adequate support for any claimed compound or groups of compounds, including support for amendments to pending patent claims to demonstrate possession of the claimed invention at the time of filing.⁴⁹

The enablement requirement can be met where some experimentation (e.g., “routine screening”) is required to make and use a claimed invention.⁵⁰ But the scope and degree of experimentation to practice the invention cannot be “undue.”⁵¹ Whether undue experimentation is required is a conclusion reached by weighing a series of one or more applicable factors from In re Wands: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure.⁵² For some types of biological inventions, such as microorganisms, the enablement requirement can be met by depositing living materials required to make and use the invention in a cell depository for public access in circumstances where the biological organisms would not otherwise be publicly available.⁵³

As the various provisions of the US Patent Reform act take effect, the written description and enablement requirements remain unchanged. Considerations about when to file a patent application must properly balance both the new “first inventor to file” provisions with the existing and continuing standards for adequacy of supporting disclosure in a patent application. The new system still awards valid patents only to inventors. Patent applicants should not be the first to file a patent application without adequate supporting disclosure, as that may cost them the patent years later.

References

“Leahy-Smith America Invents Act” (Public Law 112 - 29), 125 Stat 284 - 125 Stat. 341signed into law by President Barack Obama onSeptember 16, 2011.

Brenner v. Manson, 383 US 519, 535 [86 S.Ct. 1033, 16 L.Ed. 2d 69]. 1966(“[A] patent is not a hunting license, it is not a reward for the search but compensation for its successful conclusion.”)

35 U.S.C. §112, first paragraph provides. “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.”

See, e.g., Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 922 (Fed. Cir. 2004)(“The written description serves a quid pro quo function ‘in which the public is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.’”); Reiffen v. Microsoft Corp., 214 F.3d 1343, 1345-1346 (“The purpose of the [written description requirement] is to ensure that the scope of the right to exclude…does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.”).

The written description requirement requires “the [patent] applicant must ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,’, demonstrate that by disclosure in the specification of the patent.”Carnegie Mellon Univ. v. Hoffmann-LaRoche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008).

Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1566 (Fed. Cir. 1997)cert. denied, 523 U.S. 1089 (1998).

Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed Cir 1997)(“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.. Tossing out the mere germ of an idea does not constitute enabling disclosure”).

In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)(reversing the PTO's determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement).

As summarized in section 2164.08(b) of the USPTO Manual of Patent Examining Procedure“[t]he presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art.” (citing Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (prophetic examples do not make the disclosure nonenabling).

10.

As summarized in section 2164.05(a) of the USPTO Manual of Patent Examining Procedure“[t]he specification need not disclose what is well-known to those skilled in the art, preferably omits that which is well-known to those skilled, already available to the public.” (citing In re Buchner, 929 F.2d 660, 661 [18 USPQ2d 1331] (Fed. Cir. 1991), Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 [231 USPQ 81] (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1463 [221 USPQ 481] (Fed. Cir. 1984)).

11.

In re ‘318 Patent Litigation583 F.3d 1317 (Fed. Cir. 2009).

12.

Id.at 1326.

13.

Id.at 1327.

14.

Id.

15.

Id.at 1322.

16.

Id.

17.

U.S. Patent 4,663,318 was held invalid in a bench trial for lack of enablementIn re ‘318 Patent Infringement Litig., 578 F. Supp.2d 711, 737 (D.Del. 2008) aff'd 583 F.3d 1317 (Fed. Cir. 2009).

18.

In re ‘318 Patent Litigation583 F.3d 1317, 1327 (Fed. Cir. 2009).

19.

Billups-Rothenberg, Inc. v. ARUP.642 F.3d 1031 (Fed. Cir. 2011).

20.

Id.at 1033.

21.

Id.at 1034.

22.

U.S. Patent 5,674,681 (filed December 6, 1994) issued October 7, 1997Billups later obtained another US Patent 6,355,425 (issued March 12, 2002) held invalid in this case, based on the 6,025,130 patent as prior art.

23.

Billups-Rothenberg, Inc. v. ARUP.642 F.3d 1031, 1034 (Fed. Cir. 2011).

24.

U.S. Patent 6,025,130 issued February 15, 2000to Winston J. Thomas et al.

25.

Billups-Rothenberg, Inc. v. Associated Reg'l & Univ. Pathologists, Inc.08-CV-21349 (C.D. Cal. May 26, 2010), aff'd Billups-Rothenberg, Inc. v. ARUP. 642 F.3d 1031, 1034 (Fed. Cir. 2011).

26.

Summary judgment is appropriate if the movant can show both the absence of genuine issues of material fact and entitlement to judgment as a matter of lawFed. R. Civ. P. 56(c).

27.

Billups-Rothenberg, Inc. v. ARUP.642 F.3d 1031, 1038 (Fed. Cir. 2011).

28.

Id.at 1037.

29.

Centocor Ortho Biotech Inc. v. Abbott Lab.636 F.3d 1341, 1345 (Fed. Cir. 2011)

30.

Id.

31.

Centocor filed U.S. Patent application 07/670,827 on March 18, 1991 (later abandoned)This application became the earliest claimed priority date in a series of 12 subsequently filed patent applications (including 9 continuation-in-part patent applications) culminating in the filing of the patent application granted as the US Patent asserted against the Humira^® product (U.S. Patent 7,070,775). In asserting the 7,070,775 patent, Centocor relied patent applications patent filings filed in 1994 in this chain of priority (these priority patent filings had issued as US Patents 5,656,272, 5,919,452, and 6,284,471).

32.

Centocor Ortho Biotech Inc. v. Abbott Lab.636 F.3d 1341, 1346 (Fed. Cir. 2011)

33.

Id.at 1346–1347.

34.

U.S. Patent 6,090,382 entitled “Human antibodies that bind human TNFα,”issued July 18, 2000 (filed February 9, 1996).

35.

Centocor Ortho Biotech Inc. v. Abbott Lab.636 F.3d 1341, 1346-1347 (Fed. Cir. 2011).

36.

Id.at 1343–1344.

37.

Id.at 1348–1349.

38.

Id.at 1349.

39.

Id.

40.

See, e.g., Carnegie Mellon Univ. v. Hoffmann La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008)(“To satisfy the written description requirement, ‘the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.”)

41.

Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006)(“(1) examples are not necessary to support the adequacy of a written description; (2) the written description standard may be met even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure”); see also “Guidelines for the Examination of Patent Applications Under the 35 U.S.C. - 2100 Patentability,” USPTO Manual of Patent Examining Procedure, Section 2163.

42.

Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc)(“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”); Carnegie Mellon Univ. v. Hoffmann La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) (“Whether the written description requirement is satisfied is a fact-based inquiry that will depend on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.”)

43.

See, e.g., Carnegie Mellon University v. Hoffmann La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008)(holding invalid patent claims covering a genus of recombinant plasmids that contain coding sequences for certain activity obtained from any bacterial source, based on a narrow specification disclosing only one species within the claimed genus); Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed. Cir. 2004); Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) (holding generic claims directed to recombinant prokaryotic microorganisms comprising any vertebrate and mammalian cDNA were not adequately supported by the specification that only disclosed rat insulin cDNA); see also, “Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues,” 76 Fed. Reg. 7162 (February 9, 2011).

44.

“Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues,”76 Fed. Reg. 7162 (February 9, 2011); “Guidelines for Examination of Patent Applications under 35 USC 112, P1, “Written Description” Requirement, 66 Fed. Reg. 10-99 (Jan. 5, 2001).

45.

See, e.g., “Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues,”76 Fed. Reg. 7162 (February 9, 2011) and “Guidelines for Examination of Patent Applications under 35 USC 112, P1, “Written Description” Requirement, 66 Fed. Reg. 10-99 (Jan. 5, 2001).

46.

Id.

47.

Capon v Eschar418 F.3d 1349, 1358 (Fed. Cir. 2005)

48.

In re Ruschig 54 C.C.P.A. 1551, 379 F.2d 990, 994-995 [1967](“Specific claims to single compounds require reasonably specific supporting disclosure and while…naming [each species] is not essential, something more than the disclosure of a class of 1000, or 100, or even 48 compounds is required.”)

49.

Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed Cir 1996)(“Clearly, however, just because a moiety is listed as one possible choice for one position does not mean ther is ipsis verbis support for every species or sub-genus that chooses that moiety. Were this the case, a ‘laundry list’ disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus. This cannot be because such a disclosure would not ‘reasonably lead’ those skilled in the art to any particular species.”).

50.

As summarized by the USPTO Manual of Patent Examining ProcedureSection 2164.06: “[t]he quantity of experimentation needed to be performed by one skilled in the art is only one factor involved in determining whether “undue experimentation” is required to make, use the invention. ‘[A]n extended period of experimentation may not be undue if the skilled artisan is given sufficient direction or guidance.’ In re Colianni, 561 F.2d 220, 224, 195 USPQ 150, 153 (CCPA 1977). ‘The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed.’” In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (citing In re Angstadt, 537 F.2d 489, 502-04, 190 USPQ 214, 217-19 (CCPA 1976)).”

51.

See, e.g., USPTO Manual of Patent Examining ProcedureSection 2164.06.

52.

In re Wands858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).

53.

As noted in the USPTO Manual of Patent Examining ProcedureSection 2163: “[a]n application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 965, 63 USPQ2d 1609, 1614 (Fed. Cir. 2002) (“reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material”); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 FR 34,864 (August 22, 1989).”