Ex parte Prichard

Decision Date28 October 2020
Docket Number164,Appeal 2020-001001,Application 15/887
PartiesEx parte ROGER K. PRICHARD, CATHERINE BOURGUINAT, and TIMOTHY G. GEARY Technology Center 1600
CourtPatent Trial and Appeal Board

Ex parte ROGER K. PRICHARD, CATHERINE BOURGUINAT, and TIMOTHY G. GEARY Technology Center 1600

Appeal 2020-001001

Application 15/887, 164

United States Patent and Trademark Office, Patent Trial and Appeal Board

October 28, 2020


FILING DATE: 02/02/2018

Before ULRIKE W. JENKS, AMEE A. SHAH, and RACHEL H. TOWNSEND, Administrative Patent Judges.

DECISION ON APPEAL [1]

SHAH, Administrative Patent Judge.

Pursuant to 35 U.S.C. § 134(a), the Appellant[2] appeals from the Examiner's final decision to reject claims 13 and 17-24.[3] We have jurisdiction under 35 U.S.C. § 6(b).

We AFFIRM.

CLAIMED SUBJECT MATTER

The Appellant's invention relates to "genetics related to macrocyclic lactone (ML) endectocide resistance in nematode parasites (e.g., Dirofilaria immitis)," "[s]ingle nucleotide polymorphisms within the genome of D. immitis . . . that, singly or in combination, correlate with reduced responsiveness of the parasites to MLs," "methods for detection of these parasites, methods for treatment of these parasites, and methods and kits for determination of responsiveness of these parasites to MLs." Spec. 1, ll. 14-20.

Claims 13 and 20 are the independent claims on appeal. Claim 13, reproduced below, is illustrative of the claimed subject matter.

13. An isolated nucleic acid molecule comprising 5 - 300 nucleotides of SEQ ID NO: 118, or a reverse complement thereof
wherein the isolated nucleic acid molecule includes a disclosed polymorphic site that correlates with resistance to a macrocyclic lactone; and wherein the isolated nucleic acid molecule further includes a detectable label

Appeal Br. 19 (Claims App.). Claim 20 recites a "kit for determining a genotype of a Dirofilariaspp. nematode, the kit comprising at least" the elements of claim 13. See id at 19-20.

REFERENCES

The prior art relied upon by the Examiner is:

Name

Reference

Date

Brennan

US 5, 474, 796

Dec. 12, 1995

Prichard et al. (“Prichard”)

US 10, 000, 811 B2

June 19, 2018

Jeffrey D. Rothstein et al., “Chronic inhibition of superoxide dismutase produces apoptotic death of spinal neurons, ” 91 Proc. Natl. Acad. Sci. USA, 4155-4159 (May 1994) (“Rothstein”)

Author unknown, “1998/99 Catalog, ” pp. 121, 284, New England BioLabs (1998) (“NEB Catalog”)

Christelle Godel et al., “The genome of the heartworm, Dirofilaria immitis, reveals drug and vaccine targets, ” 26 The FASEB Journal, 4650-4661 (Aug. 15, 2012) (“Godel”)

REJECTIONS

I. Claims 13 and 17-24 stand rejected under 35 U.S.C. § 101 as being directed to a judicial exception without significantly more.

II. Claims 13 and 17-24 stand rejected under 35 U.S.C. § 112(a) as fa ilin g to comply with the written description requirement.

III. Claims 13 and 17-24 stand rejected under 35 U.S.C. § 112(b) as being indefinite.

IV. Claims 13, 17, and 20-24 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Brennan.

V. Claims 13, 17, and 20-24 are rejected under 35 U.S.C. § 102(a)(1)[4] as being anticipated by NEB Catalog.

VI . Claims 13 and 17-24 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Godel.

VII. Claims 13, 17, and 20-24 stand rejected under pre-AI A 35 U.S.C. § 103 as being unpatentable over NEB Catalog and Rothstein.

VIII. Claims 13 and 17-24 stand rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-5 of Prichard.

OPINION

Preliminary Matter

The Appellant argues that the Examiner's decision to withdraw claim 37 should be reversed because "there is no reasonable, logical, or legal basis for Examiner to conclude Claim 37 should be withdrawn from consideration separately from Claim 20." Appeal Br. 9. The Examiner maintains the withdrawal. See Ans. 22-23.

As the Examiner notes (see id.), matters regarding restriction requirements are to be resolved via petition to the technology center Director. See 37 C.F.R. § 1.144; Manual of Patent Examining Procedure § 1002.02(c) ("MPEP"). Thus, we consider claim 37 withdrawn and not pending on appeal.

Rejection I - 35 U.S.C. § 101 - Statutory Subject Matter

The Appellant presents arguments for the claims together. See Appeal Br. 9-10. We thus group all the claims together and select claim 13 as representative of the group, with the rejection of the remaining claims standing or falling therewith. See 37 C.F.R. § 41.37(c)(1)(iv).

35 U.S.C. § 101 Framework

Section 101

An invention is patent-eligible if it claims a "new and useful process, machine, manufacture, or composition of matter." 35 U.S.C. § 101. However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: "[l]aws of nature, natural phenomena, and abstract ideas" are not patentable. E.g., Alice Corp. v. CLS Bank Int'l, 573 U.S. 208, 216 (2014).

In determining whether a claim falls within an excluded category, we are guided by the Court's two-part framework, described in Mayo and Alice, Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework, we first determine what concept the claim is "directed to." See Alice, 573 U.S. at 219. If the claim is "directed to" an implicit exception, we turn to the second step of the Alice and Mayo framework, where "we must examine the elements of the claim to determine whether it contains an 'inventive concept' sufficient to 'transform' the claimed [exception] into a patent-eligible application." Alice, 573 U.S. at 221 (quotation marks omitted); see also Mayo, 565 U.S. at 78-79. Specifically, the Supreme Court considered this second step as determining whether the claim recites an element or combination of elements that is "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself." Mayo, 566 U.S. at 72-73. "If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. '" Id. at 77.

USPTO Section 101 Guidance

We are also guided by U.S. Patent and Trademark Office ("USPTO") Guidance, as set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) ("Guidance"), incorporated into the MP EP § § 2104-06, Rev. 10. 2019, in June 2020. "T he guidance sets out agency policy with respect to the USPTO's interpretation of the subject matter eligibility requirements of 35 U.S.C. § 101 in view of decisions by the Supreme Court and the Federal Circuit." Guidance, 84 Fed. Reg. at 51. Although "[a]ll USPTO personnel are, as a matter of internal agency management, expected to follow the guidance," the guidance "does not create any right or benefit, substantive or procedural, enforceable by any party against the USPTO." Id. The Guidance, by its terms, applies to all applications, and to all patents resulting from applications, filed before, on, or after January 7, 2019. Id. at 50.

Under USPTO Guidance, we first look to whether the claim recites: (1) any judicial exceptions, including laws of nature, natural phenomena, and products of nature (see MPEP §§ 2106.04(II)(A)(1), 2106.04(b)) ("Step 2A, Prong One"); and (2) additional elements that integrate the judicial exception into a practical application (see id. §§ 2106.04(II)(A)(2), 2106.04(d)) ("Step 2A, Prong Two").[5]

Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look, under Step 2B, to whether the additional elements, individually or in combination, provide an inventive concept. See MPEP §§ 2106(III), 2106.05. "An inventive concept 'cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.'" Id. at § 2106.05 (quoting Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, (Fed. Cir. 2016)). Among the considerations in determining whether the additional elements, individually or in combination, amount to significantly more than the exception itself, we look to whether they add a specific limitation beyond the judicial exception that is not "well-understood, routine, conventional" in the f ie ld or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. MPEP § 2106.05(II); Guidance, 84 Fed. Reg. at 56.

Step One of the Mayo/Alice Framework

Under the first step of the Mayo/Alice framework and Step 1 of USPTO guidance, we determine that claim 13 recites an isolated nucleic acid molecule, i.e., a composition of matter.

Under the first step of the Mayo/Alice framework and Step 2A, Prongs One and Two of USPTO guidance, the Examiner determines that claim 13 is "directed to nucleic acid fragments from the Dirofilaria genome, i.e. known naturally occurring nucleic acids. Such isolated nucleic acid molecules, that are identical to fragments of naturally occurring nucleic acid molecules[, ] are not patent eligible subject matter." Final Act. 4. The Examiner further finds that "[t]he broadest reasonable interpretation of detectable label encompasses additional nucleotides . . . [that] may be detected using hybridization and sandwich assays." Id. "Thus, these oligonucleotides may comprise naturally occurring nucleotides that may be detected by hybridization and sandwich type assays. Probes with nucleotides would be [sic ] therefore be labeled with detectable nucleotides." Id. The Examiner also finds that claim 13 "embrace[s] probes and primers that are identical to naturally occurring gene fragments and clearly read on nature-based products that themselves do not exhibit markedly different...

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