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 .
Detailed Action
Claims 1-16 (dated 12/06/2024) are pending in this application and is now under consideration for examination.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a is DIV of 18/301,460 filed on 04/17/2023 now US 12,146,122, which is a DIV of 16/305,259 filed on 11/28/2018 now US 11,661,567, which is a 371 of PCT/US2017/035217 filed on 05/31/2017, which claims benefit of Provisional application 62/343,618 filed on 05/31/2016.
Information disclosure statement
The information disclosure statement (IDS) submitted on 10/14/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
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.
Non-Statutory Subject Matter
Claims 1-2 and 5-13 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, claims 1-2 and 5-13 do not recite something significantly different than a judicial exception as per the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc (June 13, 2013) and in light of the Interim Guidance on Subject Matter Eligibility of December 16, 2014. The rationale for this determination is explained below.
Claims 1-2 and 5-13 are directed to naturally-occurring protein(s), or composition thereof, whether isolated, synthetic or recombinant or man-made mutation or not, that are not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (June 13, 2013), as they are not markedly different than the naturally-occurring protein(s) or composition thereof protein variants corresponding to amino acid residue positions of SEQ ID NO: 2 and having 86.3% and having protease activity (see UniProtKB/TrEMBL database Accession# A0A0T6BNC6 see provided sequence alignment); the occurrence of mutations within naturally occurring proteins is well known in the art and the encoded polypeptide (naturally occurring variant(s)) has the following mutations T77I-N184Q and T77I-N184Q-A202V, … corresponding to SEQ ID NO: 2 of the instant application (see provided sequence alignment), thus the proteins of claims 1-2 and 5-13 are directed to natural products (see, the recent Office Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products, available from http://www.uspto.gov/patents/law/exam/examguide.jsp). Although claims 5-13 are directed to inherent properties of the variant/mutant as structure and function are inseparable and detergent compositions and recite that the composition is “a detergent, a detergent additive” alone without anything else clearly meets the recitation of “a detergent, a detergent additive”. The terms surfactant and detergent also encompasses naturally occurring products (see Surfactants: the ubiquitous amphiphiles, and Saponins, provided in DIV application 18/301,460 Non-Final rejection 02/16/2024) and recite compositions additionally comprising ions and additional enzymes, ions and enzymes are also naturally occurring. Compositions that are mere aggregation of naturally occurring products, wherein upon aggregation the products are not markedly different, are also not patent eligible (see particularly Examples D and E of the recent “Guidance for Determining Subject Matter Eligibility of claims reciting or involving Laws of Nature, Natural Phenomena, & Natural Products” http://www.uspto.gov/patents/law/exam/examguide.jsp). Also see Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), which held that a facially trivial implementation of a natural principle or phenomenon of nature is not eligible for a patent and Example 6 “Bacterial Mixtures” as the relevant “Nature Based Product Example” set forth by the USPTO at http://www.uspto.gov/patent/laws-and-regulations/examination-policy/2014-interim-guidance-subject-matter-eligibility. There is no evidence that either the protein of SEQ ID NO: 2 and corresponding variant, a surfactant/detergent, an ion, or an enzyme, in the composition, is markedly different than the naturally occurring products. As such, the claims recite patent ineligible subject matter for the reasons stated.
A “product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product’s naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘product of nature' exception.” 79 FR, page 74623, right column. A change in biological activity, chemical or physical properties, and structure and form are given as non-limiting examples of possible “markedly different characteristics.” 79 FR, page 74623, right column. Here, as stated, the rejected claims encompass naturally-occurring proteases having the same structure, and therefore biological activity, chemical and physical properties, as a naturally-occurring product. As such, the claims appear to be directed towards nothing more than a judicial exception for the reasons stated. The claims recite ineligible subject matter for the reasons stated.
Claim Rejections: 35 USC § 102 (AIA )
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5 and 8 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Kim et al., (Int. J. Syst. Evol. Microbiol., 2015. Vol. 65: 3586-3590) discloses variant/mutant of the subtilisin/serine protease, said reference protease having 86.3% and having protease activity (see UniProtKB/TrEMBL database Accession# A0A0T6BNC6 see provided sequence alignment); naturally occurring variant(s) reference polypeptide has the following mutation T77I-N184Q and T77I-N184Q-A202V, corresponding to SEQ ID NO: 2 of the instant application (see provided sequence alignment). Said variant also has at least one of the structural limitation recited in each of claims 1-2, 5 and 8.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kim et al., (Int. J. Syst. Evol. Microbiol., 2015. Vol. 65: 3586-3590) as applied to claims 1-2, 5 and 8 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and in view of Estell et al., (WO 2016/183509 A1; priority 05/13/2015, in IDS).
The disclosure of Kim et al., (Int. J. Syst. Evol. Microbiol., 2015. Vol. 65: 3586-3590) as applied to claims 1-2, 5 and 8 is described above in 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above. However, Kim et al., is silent regarding parent comprising the amino acid sequence of SEQ ID NO: 2 (as in claims 3-4); …improved cleaning performance in detergent … (as in claims 5-7 and 9) ; the composition further comprises one or more calcium ion… additional enzymes and a method of use/cleaning (as in claims 10-16).
Regarding claims 3-16, the following reference teaches the structural and functional elements of the instant invention: priority 05/13/2015, in IDS).
Regarding claims 3-16, Estell et al., (WO 2016/183509 A1; priority 05/13/2015, in IDS) discloses variants of the subtilisin/serine protease of SEQ ID NO: 2 therein (having 100% identity with SEQ ID NO: 2 herein), said variants having any amino acid at the position corresponding to one or more of the following residues A1Q, T3Q/V, P9E, L10M, K15I, A24Q, V26Q A29S, I35A, V45Q/R, A52R, A68S, V71A, N76K, T77D/E/H/N/Q, T78I, S86H/R, V87S/T, L95A, N96S, S98R, G99Q, S100G, S102, Y103, S108H, M123I, G127S/T/V, A128P/R/S, S129H/R, V147L, S115N, S158D, N160C/D, T161D/Q, G165A/E/Q, N184E/Q, S187E/P, A193D, A202V, G203E/N/QT210E/I, N217S, N239S/T, A242G/N, S258D/E/P, F260W, K264H/Q … (see Abstract; ¶ [01-07]; [0134-0145]; ¶ [03] clearly suggests “some embodiments are directed to an AprL-clade variant subtilisin enzyme or an active fragment thereof comprising one or more amino acid modification to a parent AprL-clade subtilisin enzyme”; (¶ [0155-0160]); Assays and Productive Positions and Combinable Mutations, (¶ [0294-0329]); and entire document) and the use of said reference protease variants in detergent compositions and additionally comprising enzymes such as amylases, cellulases … (¶ [0211-0224]and entire document). Said variants also have at least one of the structural limitation recited in each of claims 1-3. Estell et al., (WO 2016/183509 A1; priority 05/13/2015, in IDS) are silent regarding said subtilisin variant having specific combination of mutations in SEQ ID NO: 2; i.e., combinations of Claim 1; T77N-G165Q, T77N-S258P, N184Q-S258P, and T781-N1 84Q; and Claim 2: combinations T77N-G165Q-N184Q, T77N-G165Q-A202V; T77N-G165Q-S258P and T77N-N184Q-S258P. The many advantages of specific amino acid residue changes including the following substitutions in SEQ ID NO: 2, as claimed in the instant invention are disclosed in Estell et al., T77D/E/H/N/Q, T78I, N184E/Q, and S258D/E/P; said reference also in ¶ [03] clearly suggests “some embodiments are directed to an AprL-clade variant subtilisin enzyme or an active fragment thereof comprising one or more amino acid modification to a parent AprL-clade subtilisin enzyme”; Assays and Productive Positions and Combinable Mutations (¶ [0294-0329]).
As such, disclosure of a polypeptide annotated as subtilisin, said polypeptide having 100% identity to SEQ ID NO: 2 of the instant application including the claimed substitutions in SEQ ID NO: 2 as claimed in the instant invention T77D/E/H/N/Q, T78I, N184E/Q, and S258D/E/P, clearly suggests to a skilled artisan to modify the teachings of Estell et al., i.e., specific combinable mutations and the biochemical advantages of the claimed combination of substitutions as claimed in claims 1-2 of the instant invention: i.e., combinations Claim 1; T77N-G165Q, T77N-S258P, N184Q-S258P, and T781-N1 84Q; and Claim 2: combinations T77N-G165Q-N184Q, T77N-G165Q-A202V; T77N-G165Q-S258P and T77N-N184Q-S258P. In addition, examiner holds the position that the cited reference Estell et al., (WO 2016/183509 A1; priority 05/13/2015, in IDS) has taught with “sufficient specificity” and “predictable variables” clearly envisaging i.e., including “finite number and specific amino acid residue changes” as claimed in the instant invention; for details see the rejection above.
Therefore, it would have been obvious to a person of ordinary skill in the art to combine and modify the teachings of Kim et al., and employ the reference variant protease polypeptide of Kim et al., in a detergent composition and methods of use as disclosed in the reference of Estell et al. Motivation to generate such a detergent composition comprising the variant/mutant protease derives from the fact that such detergent compositions are commercial product of importance (Estell et al.,). The expectation of success is high, because the combined teachings of Kim et al., and Estell et al., teach the structural and functional elements of the instant invention including detergent compositions (Teaching, Suggestion and Motivation).
Therefore, claims 1-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kim et al., (Int. J. Syst. Evol. Microbiol., 2015. Vol. 65: 3586-3590) as applied to claims 1-2, 5 and 8 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and in view of Estell et al., (WO 2016/183509 A1; priority 05/13/2015, in IDS).
Double Patenting rejection
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-16 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over allowed patents: (i) Claims 1-15 of Marquez et al., (US 11,661,567 B2); and (ii) Claims 1-13 of Basler et al., (US 12,146,122). An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claims are not patentably distinct from the reference claims, because the examined claims are either anticipated by, or would have been obvious over reference claims. 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claims 1-16 of the instant application cannot be considered patentably distinct over allowed patents: (i) Claims 1-15 of Marquez et al., (US 11,661,567 B2); and (ii) Claims 1-13 of Basler et al., (US 12,146,122), when there is specifically disclosed embodiments and falls within the scope of the claims 1-16 herein. In the instant case, the allowed patent specifications and allowed patents: (i) Claims 1-15 of Marquez et al., (US 11,661,567 B2); and (ii) Claims 1-13 of Basler et al., (US 12,146,122) discloses as a preferred embodiment and reproduced below: said reference polypeptides have 100% sequence identity to SEQ ID NO: 2 of the instant invention.
ODP: US 11,661, 567
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ODP: US 12,146,122
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Therefore, claims 1-16 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over allowed patents: (i) Claims 1-15 of Marquez et al., (US 11,661,567 B2); and (ii) Claims 1-13 of Basler et al., (US 12,146,122).
Allowable Subject Matter
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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