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
This Office Action is a response to Applicant’s Election filed April 27, 2026 and Applicant’s Response to Rule 105 Communication filed May 28, 2026.
Claims 1-5 and 7-11 are pending in the instant application.
Election/Restrictions
Applicant’s election of Group III (claims 7-9) (without traverse) in the reply filed on April 27, 2026 is acknowledged. Applicants’ further species election (with traverse) of OR51E2 as the odorant receptor in the reply filed on April 27, 2026 is also acknowledged.
The traversal is on the grounds that Gpr132 is a binding partner of OR51E2 and therefore should not be treated as a separate electable species.
This traversal has been fully considered by the Examiner and is found persuasive. The Examiner will consider the elected species to read on OR51E2 and Gpr132. In other words, an OR51E2-Gpr132 binding interaction.
Claims 1-5, 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention there being no allowable generic or linking claim.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 the reply filed on April 27, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-9 have been examined on the merits as detailed below:
Information Disclosure Statement
Applicant's information disclosure statement (IDS) filed October 16, 2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant's IDS filed April 5, 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant's IDS filed June 4, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Priority
Acknowledgment is made of Applicant's claim for foreign priority based on KR 10-2021-0049718 filed April 16, 2021. The certified copy has been placed in the file.
Drawings
The Drawings filed May 28, 2026 are objected to because the Figures of the instant application lack legible features. The Figures submitted with this application do not meet the required technical standards due to Legibility: The text, lines, and numbers in Figures are blurry and indistinct; and Clarity: The X and Y axis of the Figures are faint or bleeding together, making it impossible to clearly see the details of the invention.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the Drawings will not be held in abeyance.
Response to Amendment
Applicant’s Response to Rule 105 Communication filed May 28, 2026 is acknowledged, however it is not found persuasive because the Replacement Drawings submitted with the Communication do not meet the required technical standards due to legibility and clarity as discussed supra.
Claim Rejections - 35 USC § 112
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.
Claims 7-9 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. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims are drawn to a method of screening an anticancer drug, the method comprising: (1) contacting test substances with isolated macrophages; (2) measuring a degree of binding of odorant receptor Olfr78 or OR51E2 and Gpr132 in the macrophages contacted with the test substances; and (3) selecting a test substance with a reduced degree of the binding of Olfr78 or OR51E2 and Gpr132 compared to a control sample. NOTE: In Applicant’s Election filed April 27, 2026, OR51E2 and Gpr132 were elected as the odorant species for examination. The claims require several method steps including measuring a degree of binding of odorant receptor Olfr78 or OR51E2 and Gpr132 in the macrophages contacted with the test substances. However, the present Specification does not provide a single example wherein the binding of OR51E2 and Gpr132 is measured in macrophages. In other words, evidence of an OR51E2-Gpr132 binding interaction is absent.
In the present invention, it was found that Olfr78 forms a heterodimer with Gpr132 to mediate lactate-induced M2 polarization in macrophages. See Figure 6 and Example 3. The art of Poongkavithai Vadevoo et al. (Proc Natl Acad Sci. 2021 Sep 9;118(37), pages 1-11, plus Supplementary Information) also teach Olfr78/GPR132 interacts as a physical heterodimer and binds to lactic acid to differentiate into cancer-friendly M2 type macrophages. Neither the present Specification nor Poongkavithai Vadevoo et al. teach OR51E2 forms a functional heterodimer with Gpr132.
To provide 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. Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement.
The specification provides examples wherein a method comprising: (1) contacting test substances with isolated macrophages; (2) measuring a degree of binding of odorant receptor OR51E2 in the macrophages contacted with the test substances; and (3) selecting a test substance with a reduced degree of binding of OR51E2 compared to a control sample. See Figure 3. However, the specification does not provide any example wherein a method of screening an anticancer drug, the method comprising: (1) contacting test substances with isolated macrophages; (2) measuring a degree of binding of odorant receptor OR51E2 and Gpr132 in the macrophages contacted with the test substances; and (3) selecting a test substance with a reduced degree of the binding of OR51E2 and Gpr132 compared to a control sample. Therefore, it cannot be said that the specification describes a method of screening an anticancer drug as claimed.
The structure of the full genus of test substances that reduce the degree of biding of OR51E2 and Gpr132 responsible for each of the functions claimed is lacking and fails to provide a structure/function correlation. Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of test substances that reduce the degree of biding of OR51E2 and Gpr132 nor guidance as to which of the myriad of test substances (e.g. anticancer drugs) encompassed by the claims would meet the limitations of the invention.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that “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).
The skilled artisan cannot envision the detailed chemical structure of the genus of claimed agents, and therefore conception of the method of screening is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. 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 (Fed. Cir. 1991). Therefore, the instant claims do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
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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 7-9 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 pre-AIA the applicant regards as the invention.
Claim 7 is missing a conclusion step that relates the body of the claim back to the preamble. For example, the preamble of the claims is drawn to a method of screening an anticancer drug, however, the last step recites, “selecting a test substance with a reduced degree of the binding of Olfr78 compared to a control sample”. As written and interpreted, the claims do not recite any conclusion steps that relate them back to the preamble.
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 therefore, subject to the conditions and requirements of this title.
Claims 7-9 stand rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to a judicial exception (i.e. observing a natural relationship) binding of Olfr78 or OR51E2 and Gpr132 in macrophages and then “selecting” based on that observation. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Furthermore, “selecting” is a mental step that can be performed entirely within the practitioner’s mind. Mental steps are themselves judicial exceptions. None of the method steps, (1), (2) or (3) add significantly more to the different judicial exception.
These judicial exceptions are not integrated into a practical application because the end result of the method is simply acknowledging the natural correlation; i.e. there is no explicitly recited practical application. This is similar to the fact pattern in the Mayo v Prometheus case. In Mayo, a drug was administered, the natural metabolites were measured, and the metabolite "indicates" a need to alter therapy. This was deemed ineligible by the Supreme Court. In particular, the Court indicated that the “wherein” clause in which the correlation was recited simply informs a relevant audience about the correlation, at most suggesting the correlation should be applied in some way. The methods of screening an anticancer drug as encompassed by the claims do not add significantly more to the natural correlation itself, as the method steps amount to no more than informing a relevant audience about the correlation with a vague suggestion that one should "apply it".
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the step of measuring a degree of binding of odorant receptor Olfr78 or OR51E2 and Gpr132 in the macrophages contacted with the test substances would have been routinely used by those of ordinary skill in the art to apply the correlation. The method for measuring OR51E2 is performed with routine assays and reagents well-established in the art. See Lee et al. (Journal of Crohn’s and Colitis, 2019 Vol. 13: Supplement 1, pages S118-S119) (submitted and made of record on the IDS filed June 4, 2025).
Further, there is nothing done with the selected test substance. For example, it is not administered. The individual steps (contacting, measure binding, selecting) are well-understood, routine, and conventional in drug screening, so no inventive concept is added. Looking to the claims as a whole, none of the method steps considered individually or in combination include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims are therefore not patent eligible.
Closest Prior Art
The closest prior art is Lee et al. (Journal of Crohn’s and Colitis, 2019 Vol. 13: Supplement 1, pages S118-S119) (submitted and made of record on the IDS filed June 4, 2025). Lee et al. teach the method steps (1) and (2) as claimed. For example, regarding claim 7, Lee teaches step (1), contacting test substances with isolated macrophages. In this example, SCFAs (butylate, b-ionone, propionate) is the test substance and the isolated macrophages are the Phorbol 12-myristate 13-acetate (PMA) treated THP-1 cells which were differentiated to macrophage and polarized to M1 or M2 phenotypes. Further regarding claim 7, Lee et al. teach step (2), measuring a degree of binding of odorant receptor OR51E2 in the macrophages contacted with the test substance. For example, Lee et al. teach following THP-1 cell treatment with SCFA, OR51E2 was analyzed by qPCR and immunocytochemistry. Concerning step (3) of claim 7, Lee et al. teach selecting a test substance with a reduced degree of biding of OR51E2. For example, Lee et al. teach SCFA as a ligand for OR51E2 which modulates colonic macrophage polarization. However, Lee et al. do not teach measuring any degree of binding of odorant receptor OR51E2 and Gpr132 in macrophages.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635
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