DETAILED ACTION
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 . 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 (i.e., changing from AIA to pre-AIA ) 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 Status
Claims 1-18 are pending.
Claim Objections
first objection
Claims 12, 13, and 15-17 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 12, 13, and 15-17 not been further treated on the merits.
second objection
Claims 1-18 are objected to because of the following informalities: the claims have been amended compared to the previous amended claim set, yet there are no status indicators and no markup of changes. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 14, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The rejected claims discuss using a non-polar solvent, but claims 2 and 14 specify that the non-polar solvent contain an alcohol, which will make the solvent polar. This makes it unclear what applicants mean by a non-polar solvent, as the way they are using the term is different than how it is used in the art. For purpose of examination, this will be interpreted as a solvent containing a non-polar compound, consistent with the solvent systems used in the disclosure.
Claim Rejections - 35 USC § 102
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.
Claims 1-11, 14, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kakiuchi et al (US 20120253012).
Kakiuchi et al describes the synthesis of
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by reacting a compound with a structure
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with a compound of structure
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(all variables defined identically with that of examined claim 1) in the presence of a base and within a solvent containing a non-polar organic solvent (paragraphs 16 and 17). The examples discuss mixing the two ingredients in cyclohexane, then adding methanol (paragraph 164), anticipating claim 1. This solvent also contains an alcohol (paragraph 18), anticipating claim 2. n can be between 1 and 4, X can be an amino group, a guanidino group, or a -COHN2 group, or n can be 1, and X is a pyrrole group, an imidazole group, a pyrazole group, or an imidazole group (paragraph 19), anticipating claim 3. The R1 group can be a C11-21 aliphatic group with a linear structure, with optionally up to two unsaturated bonds (paragraph 20), anticipating claim 4. R2 can be a hydrogen or a C1-3 alkyl group, possibly having a C1 branch (paragraph 21), anticipating claim 5. Paragraph 22 describes R2 and R4 identically with examined claim 6, anticipating it. Likewise, paragraph 23 describes the identical embodiments as examined claim 7, anticipating it. Paragraphs 24-27 describe the identical embodiments as claims 8-11, anticipating them. Toluene is a preferred non-polar solvent (paragraph 80), and methanol and ethanol are described as some of the alcohols that can be used (paragraph 82), anticipating claim 14. The starting lipidated amino acid can be made by reacting an acid halide, ester, or anhydride of the lipid with a protected amino acid (paragraph 36), anticipating claim 18. After reaction, the base is neutralized with a hydrogen halide solution (paragraph 88), precipitating out the product (paragraph 95).
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.
first rejection
Claims 1-11, 14, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-11, 14, and 18 of copending Application No. 18/269,725 (US 20240067675) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the claims.
Competing claim 1 is identical with examined claim 1, save the competing claim has a further extraction step. Competing claims 2-7 appear to be identical with the same examined claim, as does claims 9-11 and 14. Competing claim 18 is likewise almost identical to competing claim 17, save that the competing claim has an additional extraction step. Examined claim 8 is a subgenus of the genus of competing claim 1, and is small enough to be immediately envisioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
second rejection
Claims 1, 3-11, 14, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12, and 13 of U.S. Patent No. 9,180,201. Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 is identical with examined claim 2, and differs from examined claim 1 in that it specifies the solvent contains an alcohol. Competing claim 2 is worded identically with examined claim 3, as is competing claim 3 and examined claim 4. Competing claim 5 is identical with examined claim 6, anticipating both that claim and examined claim 5. Competing claims 6-10 are identical with examined claims 7-11, anticipating them. Competing claim 12 lists a Markush group of solvents, including toluene, while competing claim 13 specifies methanol or ethanol as the alcohol, rendering obvious examined claim 14.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 2 and 18 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 17 of prior U.S. Patent No. 9,180,201. This is a statutory double patenting rejection.
Examiner’s Note
The only significant difference between the invention of Kakiuchi et al and applicant’s invention appears to be the purification step. Kakiuchi et al neutralize the base with acid to precipitate the peptide. Applicants adjust the pH to the isoelectric point to accomplish the same thing. However, this is an obvious variant, as the isoelectric point is typically the pH where solubility is at a minimum (Grossmann et al, Food Res. Int. (2019) 116 p283-290, p284, 1st column, 1st paragraph). A person of skill in the art would thus reasonably be motivated to maximize the amount of product collected by minimizing solubility, which is at the isoelectric point.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658