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
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 29, 2025 has been entered.
Response to Amendment
2. Claims 1, 6, 10, 12, 14, 18, 22 and 114-116 have been amended and claims 117-119 added as requested in the amendment filed on October 29, 2025. Following the amendment, claims 1, 4, 6, 10, 12, 14, 16, 18, 19, 22 and 114-119 are pending in the instant application.
3. Claim 16 stands withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in Papers filed March 15, 2024 and September 17, 2024.
4. Claims 1, 4, 6, 10, 12, 14, 18, 19, 22 and 114-119 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
Claim Objections
6. Claims 1, 6, 19, 114, 116-119 are objected to because of the following informalities:
The claims recite acronyms without first providing the full name of the terms. It is suggested that the terms be spelled out at their first use and in all independent claims so that it is clearly understood what they stands for. Appropriate correction is suggested.
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.
7. Claims 1, 4, 6, 10, 12, 14, 16, 18, 19, 22 and 114-119 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.
8. Claim 1 is vague and ambiguous for reasons that follow. The claim encompasses a method of modulating an immune response by administration of factors recited within a) and b); however, it is not obvious what immune response is intended by the claim. Thus, claim 1 is limited to one step of administration of active ingredient of choice from the list in a) or b), which is claimed to suppress “the immune response in the subject as compared to an immune response in a second subject who has not been treated with the agent,” without any indication whether a first or a second subject even experience any form of an immune response so that it is properly modulated or suppressed. Moreover, it is not even clear whether the “immune response” of the first and second subjects are the same, so to be used as a proper control for comparing the results. Finally, the claim encompasses a method of modulating an immune response while the final step recites suppression of the immune response, thus making the final step of the claim effectively in conflict with the claim’s preamble.
9. Claims 1, 116, 117 and 118 are indefinite wherein they recite functional language. The Office has issued new guidance May and September 2016, which has been incorporated into the current MPEP rewrite dated August 2017, at section 2173.05(g), wherein it states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” The claims recite an antibody or antigen binding fragment but then define the products by functional language—“a means for binding to one or more OLFR in an animal cell.” While a functional limitation can provide a patentable distinction (limit the claim scope) by imposing limits on the function of a structure, material or action, in the instant case it is unclear what material/structural or manipulative differences are encompassed by a limitation “a means for binding.” Since the claims fail to meet the criteria set forth in MPEP 2173.05(g), then the claims are rejected as being indefinite.
10. Applicant is advised that one of the purposes of the 112, second paragraph is to provide a clear warning to others as to what constitutes infringement of the patent (see, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The test for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d 1565 (Fed. Cir. 1986) (citations omitted).
In precedential decision Ex parte Kenichi Miyazaki, Appeal 2007-330, BPAI stated “In particular, rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amendable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph.”
Further, the federal Circuit stated in Halliburton Energy Servs.:
When a claim limitation is defined in purely functional terms, the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiner demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs. V. M-ILLC 514 F .3d 1244, 1255 (Fed. Cir. 2008) (emphasis added).
11. Claim 6 limits the subject matter of claim 1 to a reduction in expression of certain factors without providing a clear and unambiguous understanding where exactly these factors are expressed. Is it a whole-body expression or expression within a certain population of cells? One skilled in the art would not know how to meet the limitations of the claim without precise knowledge of what to measure and compare.
12. Claim 12 is vague and indefinite insofar as it employs the term “an aberrant immune response” as a limitation. This term is not known in the relevant prior art of record as being associated with well-defined genus of immune responses. Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of an “aberrant immune response”, an artisan cannot determine if a response which meets all of the other limitations of a claim would then be included or excluded from the claimed subject matter by the presence of this limitation.
13. Claims 119 is indefinite for being dependent from itself.
14. Claims 4, 10, 14, 16, 18, 19, 22, 114 and 115 are indefinite for being dependent from indefinite claim(s).
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
15. Claims 1, 4, 6, 10, 12, 14, 16, 18, 19, 22 and 114-119 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement for reasons of record in section 11 of Paper mailed on November 08, 2024. The claim(s) contains subject matter which was not described in the specification in such a was to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 4, 6, 10, 12, 14, 16, 18, 19, 22 and 114-119 specifically require possession of antibodies and antigen binding fragments comprising a means for binding to one or more OLFRs in an animal cell. The claims do not require that these antibodies and fragments possess any particular conserved structure or other disclosed distinguishing feature to satisfy the limitation “a means for binding.” Thus, the claims are drawn to a genus of antibodies and antigen binding fragments that is defined only by reference to a functional limitation “a means for.” However, the instant specification fails to describe the entire genus of molecular embodiments, which are encompassed by these claims.
MPEP §2163(I)(A) states:
“The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim "A gene comprising SEQ ID NO:1." The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements).”
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. For example, the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein, but the same information would not place the inventor in possession of the naturally-occurring DNA or mRNA encoding the protein. See In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C 103).”
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the claims is a recitation, currently rejected as vague and ambiguous, see section earlier, of “a means for binding.” There is not even identification of any particular portion of the structure that must be conserved. Moreover, it is not even clear if an antibody and antigen binding fragment have any common structure. The specification does not provide a complete structure of those antibodies and antigen binding fragments comprising a means for binding to one or more OLFRs in an animal cell, and fails to provide a representative number of species for the recited genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of antibodies and antigen binding fragments, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 102
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.
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.
16. Claim(s) 1, 4, 6, 10, 12, 14, 18, 22, 114, 115, 117 and 118 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herzmann, Acta biol. Med. German, 1966, 17, 550-2.
Claim(s) 1, 4, 6, 10, 12, 14, 18, 22, 114, 115, 117 and 118 are broadly drawn to a method of treating atherosclerosis by administration of citral. The publication of Herzmann teaches the effect of citral on experimental atherosclerosis, see title, methods and the whole paper. Thus, Herzmann fully anticipates the instant claimed invention.
Conclusion
17. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
December 23, 2025