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 .
Restriction/Election
Applicant’s election without traverse of Group II, claims 10, 12, 21-23 and 28-38, and the species SEQ ID NO: 24, without the His tag, in the reply filed on 01/12/26 is acknowledged.
Claims 1, 3, 4, 6, 8, 9, 24, 25 and 39 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/12/26.
Objections
Claims 12, 28-30, 35 and 36 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Although the naturally occurring peptide of SEQ ID NO: 3 (free of the prior art) contains only one substitution to separate it from the naturally occurring protein, there is no teaching or motivation to suggest the claimed substitution in SEQ ID NO: 124, or the other sequences of these claims, at the specific locations in the polypeptides isolated from Mattirolomyces terfezioides, as this sequence was not previously art recognized. Therefore, the claimed sequences are novel, unobvious, and drawn to non-naturally occurring products.
Claim 22 is objected to because of the following informalities: the does not have a period at to mark the end of the claims. Appropriate correction is required.
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 10, 37 and 38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more.
The MPEP states: “When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature.”
The analysis is as follows:
Step 1: Is the claim directed to a statutory category (e.g., process, machine, manufacture, or composition of matter)? Yes, it is a drawn to a composition.
Step 2A: Is the claim drawn to a judicial exception? Yes. The claim is drawn to a natural product.
Step 2A of the eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature." For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116-17, 106 USPQ2d 1972, 1979 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Therefore, although the specific peptides isolated from these naturally occurring species were not known at the time of the invention, they are still drawn to the naturally occurring peptides and nucleotides
Step 2B: Do the claims recite something that amounts to significantly more? No. The claims recite naturally occurring peptides isolated from Mattirolomyces terfezioides, as evidenced by Aman et al. (Studies in Fungi 5(1): 452–461, 2020)
The limitation “not a naturally occurring Myd polypeptide” does not structurally or functionally include additional elements that are sufficient to amount to significantly more than the judicial exception because it does not provide a markedly different characteristic from the naturally occurring protein. Similarly, claim 37 is drawn to a product by process, but there is nothing about the process that distinguishes the product from the naturally occurring polypeptide. As such, the claims are drawn to a judicial exception to patentability. Finally, claim 38 is drawn generically to additional sweeteners, which can encompass more than one of the same or other claimed naturally occurring polypeptides, which fall within the sweetener scope, resulting in a combination of natural products with the same characteristics.
Non-Statutory 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 10, 21-23, 31-33, 37 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,297,861. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘861 teaches a polynucleotide encoding a polypeptide comprising an amino acid sequence having at least 95% sequence identity to the amino acid sequence of SEQ ID NO: 3, operably linked to a heterologous regulatory element, and claim 8 teaches a composition, comprising a combination of a product for oral administration, wherein the product is not Mattirolomyces terfezioides truffle, and a sweetening composition comprising the isolated protein of claim 1. This meets the limitations of instant claim 10 by teaching a polypeptide that is over 90% identical to the elected species, SEQ ID NO: 124. Additionally, claim 18 of ‘861 teaches SEQ ID NO: 21, which aligns with over 90% identity to SEQ ID NO: 124:
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As such, claims 1 and 8 of ‘861 meet the limitations of instant claim 1. Instant claim 21 is met because claim 8 teaches the same product for oral administration, with the same polypeptide, for oral administration to enhance sweet taste. Claim 22 is met because one of ordinary skill in the art would recognize that there would be more than one polypeptide in a composition comprising said peptides of claim 1, as the process of isolating peptides results in more than one of the same peptide, and the claim does not require two different peptides, only a plurality of peptides. Instant claim 23 is met because claims 11-15 of ‘861 teach the same food product embodiments to which the peptide can be added. Instant claim 31 is met because SEQ ID NO: 4 is PDLSSFITIKNNSNHVFTRT, which is at the N-Terminus of SEQ ID NO: 21. Instant claims 32 and 33 are met because claims 2 and 3 of ‘861 teach protein and histidine tags. Instant claim 37 is met because the claims teach the same polypeptides of instant claim 10, having the same sweet modulating activity (claims 8-15 of ‘861), and claims 4-7 teach a method of using a host cell and vector to produce the same peptides. As such, method by which the polypeptide is produced does not markedly change the claimed product from the polypeptide of instant claim 1, requiring 90% identity to SEQ ID NO: 124. Instant claim 38 is met because claims claim 11 teaches adding the peptides to already sweetened food products to enhance flavor, and the claim only requires nutritional or non-nutritional sweeteners, which would encompass any type of sweetened food product to which the peptide is added.
As such, the claims are rejected over those of ‘861.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654