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
1. This application is a 371 of PCT/EP2023/059771 04/14/2023, PCT/EP2023/059771 is a CON of 17/721,421 04/15/2022 ABN.
Claims 1-11, 14-18 are pending.
Response to Restriction Election
2. Applicant’s election of group I and the species, C16LeuGABA, in the reply filed on September 10, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). According to applicants’ representative claims 1-4, 14, 18 read on the elected species. Applicant has miscounted the number of carbons in the alkyl at least for claim 3, which has an even number of carbons in the R group, however the carbonyl is part of the C16 since it is derived from palmitic acid, requiring an R1 that is C15 since the carbonyl supplies 1 carbon with C(=O). Applicant explains this on page 8 of the specification. This means that claim 9 reads on the elected species but claim 3 does not. As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. The search and examination was continued until prior art was found that anticipated or rendered obvious a non-elected species that falls within the scope of the generic Markush claim reading on the elected species. As per MPEP 803.02 II. C. “[T]he examiner must continue to search the species of the claim unless the claim has been found to be unpatentable over prior art.” The examiner “need not continue to search the claim if the claim is rejected over prior art”. [ibid. D.] Therefore, the search and examination is restricted to the claims reading on the elected species, and claims not reading on the elected species are held withdrawn. Accordingly, claims 3, 6-8, which do not read on the elected species are withdrawn.
Information Disclosure Statements
3. The information disclosure statement fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the NPL document 42 is cited without a date. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
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.
4. Claim 18 is 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. Claim 18 is said to be “a compound for use according to claim 16”. Claim 16 is a method dependent upon claim 11, which is also a method claim. Claim 11 defines a method with the compound of claim 1, making claim 18 a constructive impossibility. A compound cannot depend from a defined method claim since the claim is a process comprising steps. A description of compound by use does not define the scope of the claim. It is not clear what statutory class of invention claim 18 is drawn to.
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.
5. Claim(s) 1-2, 4, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN database entry for compound 4-[[2-[(3,3-dimethyl-1-oxobutyl)amino]-1-oxopropyl]amino]- Butanoic acid, in the database Registry RN 2037849-81-1 Entered STN: 25 Nov 2016 supplied by FCH Group. This compound anticipates claim 1 where Xaa is alanine, Y is OH, and R is a C5 alkyl.
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6. Claim(s) 1-2, 4-5, 14, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PETITFILS ET AL: "Abstract", NEUROGASTROENTEROLOGY AND MOTILITY, vol. 33, no. S2, 1 September 2021 (2021-09-01), Abstract Code: NGS15384-93 –Poster of Distinction | Impact of prenatal stress on visceral hypersensitivity and gut microbiota in adulthood (cited on the IDS). “This bacterium produces two lipopeptides, C14asnGABAOH and C16PheGABAOH.” The later is a compound of claim 1 where Xaa is phenylalanine, Y is OH, and R is a C15 alkyl. Some experiments were performed with the compounds.
7. Claim(s) 1-2, 4, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
WO 2008102127 A2 (cited on the IDS). Page 37 has the compound
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This is a compound of claim 1 where Xaa is leucine, Y is OH, and R is a C11 alkyl.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over STN database entry for compound 4-[[2-[(3,3-dimethyl-1-oxobutyl)amino]-1-oxopropyl]amino]- Butanoic acid, in the database Registry RN 2037849-81-1 Entered STN: 25 Nov 2016 supplied by FCH Group as applied to claim(s) 1-2, 4, 18 above. This compound is a commercial compound offered for sale by a suppliers as a biological assay screening compound as disclosed in the citation above. The compound was a “Premium Screening Compounds “ according to Online: “http://web.archive.org/web/20120301075525/http://www.fchgroup.net/products.php” dated March 1, 2012 accessed October 12, 2016.
Since this compound was sold for high throughput screening purposes it would be obvious to place it in solution, since otherwise it could not be screened. Typically such compounds are even sold as solutions in DMSO for cell screening purposes, however no evidence of a solution offered for sale for FCH has been obtained before the effective filing date. It would be obvious to place the compound in DMSO or other appropriate solvent to facilitate screening.
Ex parte Douros et al. (POBA 1968) 163 USPQ 667; “It is clearly obvious to add a carrier or solvent to an unpatentable compound. This combination does not become new and patentable because of the presence of the solvent or carrier, Ex parte Billman, 71 USPQ 253 ; In re Riden et al., 50 CCPA 1411, 318 F.2d 760, 1963 C.D. 794, 796 O.G. 863, 138 USPQ 112 ; In re Pieroh et al., 50 CCPA 1471, 319 F.2d 248, 797 O.G. 6, 138 USPQ 238 ; In re Rosicky, 47 CCPA 859, 276 F.2d 656, 755 O.G. 929, 125 USPQ 341 , 1960 C.D. 197.”
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.
8. Claims 1-2, 4-5, 9, 14, 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed toa nature based product without significantly more. The claim(s) recite(s) compounds from nature. The gut microorganism made the compounds as discussed on page 3 of the specification:
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This is the elected species.
Page 8 explains all the claimed compounds come from nature:
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PETITFILS ET Al also disclose natural products of the instant claims as discussed above. This judicial exception is not integrated into a practical application because the compound is simply itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 14 which adds excipients such as a solvent. Merely placing the product of nature into a solvent does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (solvents, sugar excipients mannitol, etc.) when considered separately and in combination, do not add significantly more (also known as an “inventive concept”) to the exception. The additional limitations only dissolve the compounds, and these are well-understood, routine, conventional materials added. The claimed compound and composition does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. Accordingly, the claim is directed to a judicial exception. Because the claim does not include any additional features that could add significantly more to the exception, the claim does not qualify as eligible subject matter, and is appropriately rejected under 35 U.S.C. § 101. The composition may also be viewed as a combination of natural products since many are also natural products.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID K O'DELL/Primary Examiner, Art Unit 1621
