Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Clams 1-20 are under consideration in the instant Office Action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to o a judicial exception, a natural product without significantly more. The claims recite a natural product which reads on the naturally occurring COL20A1 protein and its fragments. This judicial exception is not integrated into a practical application because they read on a naturally occurring protein. This judicial exception is not integrated into a practical application because these are naturally occurring products that are not significantly different from what is found in nature even when in a composition with an adjuvant. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the composition does not add anything that is considered significantly different from the natural products except add more naturally occurring product or solutions.
Guidance effective December 16, 2014 and in 2019 revised patent subject matter eligibility guidance sets out a series of steps and factors for determining subject eligibility in light of recent court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., Mayo Collaborative Services v. Prometheus Laboratories, Inc., and Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
The first step under this guidance is determining if the claim is directed to one of the four statutory categories (process, machine, manufacture, or composition of matter). In this case, the claims are directed to a composition of matter. The second step, first prong of 2A, 2A1, is determining if the claims recite or involve judicial exceptions, such as laws of nature, natural phenomena, or natural products. In this case, the claims involve natural products, the COL20A1 protein (collagen, Type XX, alpha 1) and a peptide derived from this naturally occurring protein and an adjuvant. In the second prong of 2A, 2A2, it is required to determine if the claims recites additional elements that integrates the judicial exception into a practical application. The claims again fail this second prong of 2A since the composition fails to integrate in a practical application since the peptides are known. In the final step it must be determined if the claim as a whole amounts to something significantly more than the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception except claims 16-19. Claims 1-15 and 20 fail to include any limitations which would distinguish the claimed peptides from those which occur in nature since they still encompass embodiments that read on a natural product. In the absence of the hand of man, naturally occurring products are considered non-statutory subject matter. Specifically, the claims, as written, do not sufficiently distinguish over the polypeptides that exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed products and the naturally occurring products.
The instant claim 1 calls for a peptide that consists of SEQ ID NO: 28 wherein the peptide is in a composition. Dependent claims 2-15 and 20 only call for other products that do not structurally change the instantly claimed peptide. The instant specification does not teach anything beyond peptides that encompass the naturally occurring COL20A1 protein. Therefore, the broadest claim 1 reads on the disclosed COL20A1 protein taught by Grifantini et al., WO2011/051278 (IDS 3/3/203). The instant claims only require the naturally occurring polypeptide characteristics and their intended use which does not further limit or distinguish the peptides from those found in nature. The composition with an adjuvant also reads on a natural product because it is still a naturally occurring peptide that is not markedly different from the naturally occurring protein. Isolating the protein does not significantly change it structure or function. The instant claims do not recite any elements in addition to the natural products that impose meaningful limits on the claim scope and would substantially foreclose others from using these natural products. The intended use of this composition does not further limit or change the basic structure of these naturally occurring products. The composition does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. See Myriad, 133 S. Ct. at 2117.
Therefore, claims 1-15 and 20 are not patent eligible.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,946,064. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘064 claims the same peptide, SEQ ID NO: 28, and the use of it as a vaccine. The instant claims claim the same sequence with adjuvants to produce an immunogenic response and reads on a vaccine and medicament.
Conclusion
No claims are allowed.
Advisory Information
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675