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 .
Claims 1-20 are pending.
Election/Restrictions
Applicant’s election of Group I, claims 1-14, and the species of a coumarinic tonality in the reply filed on 04/22/2025 is re-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 § 818.01(a)).
Claims 4 and 6-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups/inventions and/or nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/22/2025.
Claims 1, 5, and 11 are currently amended.
Claims 1-3 and 5 are under examination on the merits.
Priority
This application is a U.S. National Phase Application of International Patent Application No. PCT/EP2020/077711, filed October 2, 2020, which claims priority to U.S. Provisional Application No. 62/911,096, filed October 4, 2019, and European Patent Application No. 19212031.9, filed November 28, 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS submission filed on 11/14/2025 has been considered by the Examiner.
Withdrawn Objections/Rejections
The objection to the specification is withdrawn as addressed by the corrective amendments dated 11/14/2025. The rejections of the claims under 35 § 102 and 103 as presented in the office action dated 07/15/2025 are withdrawn and replaced with the rejections of the claims under 35 USC §103 as they appear in this Office Action to better account for the altered claim scope resulting from the claim amendments dated 11/14/2025.
Claim Interpretation
Note that "olfactory tonality" or "tonality" means a specific olfactory perception and relates to the activation of an olfactory receptor (OR) by a compound. Non-limiting examples of an olfactory tonality include citrus, coconut, patchouli, etc. Compounds may have greater than one tonality. For example, as shown in Figure 1, Compound (1) (beta ionone) has violet and blonde woody tonalities arising from the activation of OR5A1 and OR7A17, respectively, as supported by paragraph 0051 of the specification.
Maintained-Claim Rejections - 35 USC § 112
Maintained-35 USC § 112(a)
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.
Claim 5 is 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B. V. v. Dianwnd Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
With respect to claim 5, the instant Application teaches that the receptor comprises SEQ ID NO: 13 (OR8B3), but does not teach which residue(s) of the receptor may be mutated (substituted/deleted) while retaining the claimed function of being associated with a coumarinic tonality. Therefore, in view of this disclosure, Applicant is claiming a broad genus of molecules that would be expected to encompass multiple receptors having diverse sequences because the claims allow for up to 5% of the receptor sequence to be mutated/varied. Even though Applicant has disclosed species within said genus, specifically the species having 100% homology to the claimed sequence, the specification does not provide adequate written description for the entire claimed genus of species having variation/mutation(s), because in the absence of empirical determination, one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genus claimed, specifically, which receptor sequence variations encompassed by the genus would retain association with a coumarinic tonality.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Applicant has disclosed species having 100% homology to the claimed SEQ ID NO:13, but has not disclosed which species having the claimed sequence with up to 5% mutated/varied residues retain association with a coumarinic tonality. Thus, given the substantial structure variation within the genus as well as the high level of unpredictability in the art, the disclosure of species having 100% homology to the claimed SEQ ID NO: 13 comprised within the claimed genus is not sufficiently representative of the entire genus.
Furthermore, Applicant has not disclosed relevant, identifying characteristics of olfactory receptor sequences that confer upon the receptor an association with a coumarinic tonality, because the instant specification does not provide structural features that correlate with a functional ability to respond to a coumarinic tonality/coumarinic compound. To elaborate on why the claimed receptor genus lacks adequate written description, Franco et al (Neural Regen Res. 2025 Sep 1;20(9):2480-2494. doi: 10.4103/NRR) teach that characterization of olfactory receptors is difficult due to lack of tools and that activation of olfactory receptors to assess functionality is often achieved by testing solutions of odorants or of mixtures of odorants (see for example the first paragraph of the Specific ligands for ectopically expressed olfactory receptors section). This indicates the unpredictability of predicting/assigning olfactory tonalities based upon sequence alone. Further underscoring this point, Jimenez et al (The mutational landscape of human olfactory G protein-coupled receptors. BMC Biol. 2021 Feb 5;19(1):21. doi: 10.1186/s12915-021-00962-0) teach that even single amino acid variants in human olfactory receptors can alter the resulting phenotype, for example, by altering the odorant perception (see for example the first paragraph in the Mutability landscapes of amino acids changes section).
Absent a description of the at least minimal structural features correlating with a functional ability to respond to coumarinic compounds/tonalities which are shared by members of a genus commonly sharing this function, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish which receptor sequences may be mutated/varied such that the resultant sequence(s) confer the ability to respond to coumarinic compounds/tonalities.
Furthermore, while the prior art teaches some understanding of the structural basis of receptor-odorant recognition, it is noted that the art is characterized by a high level of unpredictability, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the olfactory receptor sequences. The general knowledge and level of skill in the art does not adequately supplement the omitted description, because specific, not general guidance is needed. Since the disclosure fails to describe relevant, identifying structural characteristics, in the form of conserved sequences/residues, that correlate with the ability to respond to coumarinic compounds/tonalities, and because the one disclosed species detailed above is not sufficient to describe the claimed genus, it is submitted that the written description requirement of 35 U.S.C. 112(a) has not been met.
The claims require the use of a receptor comprising a sequence having at least 95% identity to instant SEQ ID NO: 13 to screen for at least one compound having a coumarinic tonality. The specification does not describe which amino acid residues of the polypeptide are responsible for the functions claimed. Rather, the specification implies that these potential agents must first be screened in an assay to ascertain if the agents have the functions required by the instant claims. Although the specification provides the species having 100% identity to SEQ ID NO: 13, it fails to disclose the structures common to all members of the genus of polypeptides encompassed by the broad definition provided by applicant. The specification does not disclose the structure of all of the claimed variant agents and fails to disclose which regions of the agents are responsible for the functions claimed. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described.
Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement. Here, applicant has not described a reasonable number of members of the genus of receptors that responds to (so as to screen for) a coumarinic tonality as claimed, but rather has presented the public with an idea of how to perform an assay that might identify some peptides that fall within the scope of the claim. Of course, depending on what agents are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face.
Although screening techniques can be used to isolate receptor variants that possess the ability to responds to (so as to screen for) a coumarinic tonality, Applicant is reminded that the written description requirement of 35 U.S.C. 112 is severable from the enablement provision. As stated in Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555, “The purpose of the 'written description' requirement is broader than to merely explain how to 'make and use'; the applicant must also 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.”
Maintained-Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Warr et al; as cited on the 02/15/2022 IDS) and De March et al (Structure-odour relationships reviewed in the postgenomic era: Olfactory receptors and odorants, DOI: 10.1002/ffj.3249, (May 2015)) as evidenced by Nature News (Beauty is in the nose of the beholder, obtained from: https://www.nature.com/news/2007/070910/full/news070910-15.html#:~:text=Gene%20found%20that%20determines%20if,Smell%20that? (published online 09/16/2007)) and BaseNotes (Terranol, BaseNotes, obtained from: https://basenotes.com/community/threads/terranol.307242/ (posted on 08/02/2012)).
Regarding claim 1, Warr et al teach providing an olfactory receptor (OR11A1) (step a of instant claim 1) which is contacted with a compound A (Androstenone presumed to have at least one tonality such as floral, vanilla, sweat, or urine tonalities as evidenced by Nature News (Beauty is in the nose of the beholder, obtained from: https://www.nature.com/news/2007/070910/full/news070910-15.html#:~:text=Gene%20found%20that%20determines%20if,Smell%20that? (published online 09/16/2007); step b of instant claim 1) and measuring the response of the OR11A1 receptor to the test compound and the response of the OR11A1 receptor to the assay buffer (baseline), and calculating a first fold of change (FOC1: response OR11A1 to test compound/response OR11A1 to baseline) (step c of instant claim 1). Note that, here, the baseline/reference comparison is a buffer, not an odorant having at least one known tonality. However, claim 11 of Warr et al teaches comparison of a test compound and a sample containing a known tonality (patchouli oil) and comparing the activation/response of the receptor between the sample of only the test compound and the sample containing the compound with a known tonality (this is also taught in examples 3-5 wherein the OR11A1 receptor is contact with compounds such as androstenone and Patcho 315, each with a different, but known tonality whereupon activation of the receptor is measured). Warr et al also teach testing a plurality (65) of olfactory receptors with different compounds having olfactory tonalities wherein the OR11A1 receptor was found to respond to compounds having a patchouli tonality and was thereby associated with responding to a patchouli tonality (see for example, Examples 1 and 2 of Warr et al). The OR11A1 receptor was then tested with patchouli alcohol, Patcho 315, terranol, andrane, pogostone, and norpatchouli alcohol at carious concentrations. The OR11A1 receptor was found to respond to patchouli alcohol, Patcho 315, pogostone, and norpatchouli alcohol (which one of ordinary skill in the art would understand to have a tonality in common in light of their shared ability to activate the OR411A1 receptor [a patchouli tonality]) whereas terranol and andrane did not (note that these compounds are characterized by warm, woody/green fragrance that are patchouli adjacent, but which one of ordinary skill in the art would classify as lacking a patchouli tonality in light of the results of Example 4 of Warr et al (as evidenced by BaseNotes (Terranol, BaseNotes, obtained from: https://basenotes.com/community/threads/terranol.307242/ (posted on 08/02/2012))(see for example, Examples 3-5 of Warr et al). Contacting the receptor(s) with the patchouli oil and Patcho 315 and then measuring the receptor’s activation/response is considered to be encompassed by step d of instant claim 1. With respect to steps e and f of instant claim 1, the specification proves categorizing compounds into a subset of compounds that activate the receptor and then identifying one or more tonalities shared by the compounds withing that subset (see for example paragraph 067). Here, Warr et al categorize patchouli oil, patchouli alcohol, Patcho 315, pogostone, and norpatchouli alcohol as compounds that activate the OR11A1 receptor and identify them as sharing the patchouli tonality (see for example, Examples 1-5 of Warr et al). Note that Warr et al, after testing the receptors (a plurality of 65 receptors) assign the responsive (activated) OR11A1 receptor with the patchouli tonality (see for example, Examples 1-3 of Warr et al), which is held to read upon step g of instant claim 1.
Warr et al, as evidenced by Base Notes and Nature News, does not teach identifying the olfactory receptor (deorphanization) with a compound having a known coumarin tonality.
However, De March et al teach compounds (such as coumarin and 4-hydroxycoumarin) and ORs (such as OR1C1 and OR2B11) which are associated in the art with a coumarinic tonality (see for example, pages 28-29).
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of the combined references. The artisan would have been motivated to make and use the invention as claimed because Warr et al teach a method which is obvious to adapt for associating ORs with one or more tonalities by altering the test compounds (each having a known tonality) against which the OR is tested in order to associate the OR with the one or more tonalities of the test compound based upon the OR’s responsiveness/activation after being contacted with the one or more test compounds according to the method steps of Warr et al. The artisan who desires to find ORs associated with a coumarinic tonality would have found it obvious to look to the art for compounds with a known coumarinic tonality against which to test ORs for potential association with said tonality would have found it obvious to use one or more of the compounds taught by De March et al as being associated with a coumarinic tonality for use in the method of Warr et al to associate ORs with a coumarinic tonality. The artisan would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Regarding claim 2, as discussed above, Warr et al teach testing and identifying the OR11A1 receptor as responding to (being associated with) the patchouli/woody tonality (see for example, Examples 1-3 of Warr et al), which is held to read upon step a of instant claim 2. Warr et al then teach contacting a number of compounds with the OR11A1 receptor to determine if they activate the receptor and then associating/assigning compounds which activate the receptor with a given tonality (the patchouli/woody tonality) (see for example, Examples 4-5 of Warr et al), which is held to read upon steps b-d of instant claim 2.
Warr et al, as evidenced by Base Notes and Nature News, does not teach identifying/associating the olfactory receptor (deorphanization) with a compound having a known coumarin tonality.
However, De March et al teach compounds (such as coumarin and 4-hydroxycoumarin) and ORs (such as OR1C1 and OR2B11) which are associated in the art with a coumarinic tonality (see for example, pages 28-29).
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of the combined references. The artisan would have been motivated to make and use the invention as claimed because Warr et al teach a method which is obvious to adapt for associating one or more test compounds with one or more tonalities by using one or more receptors with one or more known tonalities and associating the one or more test compounds with the one or more tonalities associated with the one or more ORs having a known tonality which are activated in response to contacting the OR(s) with the test compound(s). The artisan who desires to find compounds associated with a coumarinic tonality would have found it obvious to look to the art for compounds with a known coumarinic tonality against which to test ORs for potential association with said tonality would have found it obvious to use one or more of the ORs taught by De March et al as being associated with a coumarinic tonality for use in the method of Warr et al to associate compounds with a coumarinic tonality. The artisan would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Regarding claim 3, as discussed above, Warr et al teach providing a receptor with a known/identified tonality (OR11A1 having an identified patchouli tonality). Warr et al fail to explicitly teach a list of different olfactory receptors associated with different, identified tonalities..
However, De March et al teach that patchouli, more broadly, has a woody tonality as taught by De March et al (Structure-odor relationships reviewed in the postgenomic era (see for example tables 3 and 4). De March et al further teach a number receptors with different, identified odors/tonalities (see for example tables 3 and 4), any one or more of which would have been obvious to use in the method of Warr et al for screening/associating ORs for association/responsiveness to known tonalities (coumarinic, balsamic, etc) such as those taught by De March et al (see for example, Table 3 at pages 28-32).
The inclusion of the receptors of De March et al into the method of Warr for screening a compound for multiple tonalities in a single assay/screening procedure would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosure of Warr et al and De March et al. The artisan would have been motivated to make and use the invention as claimed because Warr et al teach this method is useful to obtain receptors responsive to known tonalities which may then be used to assess for compounds possessing that known tonality, thereby enabling the artisan to screen for synthetic compounds having the desired tonality which may also be cheaper and/or easier to source/obtain for a variety of purposes such as the manufacture of perfume(s) (see for example the abstract, paragraph 0008, and Examples 1-5 of Warr et al). The artisan would have found it obvious to select a plurality of olfactory receptors having known tonalities (such as those taught by De March et al in, for example Tables 3-4) in order to screen/associate a test compound (or test composition comprising one or more compounds) as being positive or negative for a number of different tonalities in order to effectively screen test compounds for tonalities in a time and cost efficient assay (simplified in that the compound needs to only be run through the process 1 time). The artisan would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Applicant’s Arguments and Responses
A. At pages 1-2 of the remarks dated 11/14/2025, Applicant argues that the single example of SEQ ID NO: 13 is sufficient to describe variants comprising only 95% sequence identity because the specification generally states that the invention encompasses variants with as little as 75% sequence identity and because the artisan could have screened for portions of the 7 transmembrane-domain GPRC superfamily encoded by a single, approximately 1kb long exon exhibiting the required functions/properties.
As iterated above, 1 species is not a representative number of species and no conserved structure is indicated as supporting description by a demonstrated structure/function correlation.
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP 2145 (I).
As noted in the rejection under 35 USC § 112(a) reproduced above and in the notice section of the conclusion reproduced below, citing to Jimenez et al (The mutational landscape of human olfactory G protein-coupled receptors. BMC Biol. 2021 Feb 5;19(1):21. doi: 10.1186/s12915-021-00962-0) and Franco et al (Neural Regen Res. 2025 Sep 1;20(9):2480-2494. doi: 10.4103/NRR)), the unpredictability of associating an OR with a tonality requires full description of any allegedly novel/non-obvious OR sequence associated with a particular tonality.
Applicant has not articulated a convincing, evidenced argument to support withdrawal of the rejection by showing that association of variant ORs would be obvious.
Note that while the application teaches screening methods, this is insufficient to meet the written description requirement (see for example the cited portion of University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004) , in the rejection under USC § 112(a) above).
B. Applicant argues that the rejections over Warr et al and De March et al did not account for the claim amendments dated 11/14/2025 which add a list of tonalities to claim 1, including the elected species of a coumarinic tonality.
Response: The Examiner agrees that the rejections under 35 USC §103 presented in the office action dated 07/15/2025, being responsive to the 04/22/2025 claim set, did not account for the amendments to the claims dated 11/14/2025. The Examiner has amended the rejections under 35 USC §103 as presented in this Office Action to account for the amendments to the claims dated 11/14/2025, including the recitation the at least one tonality is a coumarinic tonality. Moreover, arguments that the artisan would not find it obvious to use the method of Warr et al for non-patchouli tonalities are unpersuasive/ for two reasons. First, the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP 2145 (I). Second, Note that, the MPEP provides that,
“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.”KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.”Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.”Id. at 418, 82 USPQ2d at 1396,”
(see MPEP § 2141 (II)(c)). It is considered within the scope of the average artisan to adapt known methods for screening to use a different tonality OR/compound pair for the shared goal of screening or deorphanizing ORs and/or associated compounds. The claims are deemed obvious for the reasons set forth in the rejections presented above.
Conclusion
No claim is allowed.
Applicant is advised that, regarding claim 5, as discussed above, Warr et al teach providing a receptor, contacting the receptor with at least 1 compound, determining if the compound activates the receptor, and associating the compound with the tonality of the receptor if the compound activates the receptor. However, Warr et al does not teach that the receptor has 90% of more identity to instantly claimed SEQ ID NO: 13 or that the receptor is associated with a coumarinic tonality and is used to screen for a coumarinic tonality.
However, De March et al teach that OR8B3 receptor is associated with a mint tonality (see for example table 3). De March et al does not explicitly teach that the OR8B3 receptor comprises a sequence identical to instant SEQ ID NO: 13, but this is evidenced by NCBI Blast (NP_001005467.1; available as of 10/06/2004).
The prior art does not appear to clearly teach that the OR8B3 receptor (also called the OR11-311 receptor) is associated with a coumarinic tonality.
Given the difficulty and unpredictability of associating an olfactory receptor with an olfactory tonality and the unpredictability of mutating an olfactory receptor sequence (as discussed in the rejection of claim 5 under 35 USC §112(a), above citing Jimenez et al (The mutational landscape of human olfactory G protein-coupled receptors. BMC Biol. 2021 Feb 5;19(1):21. doi: 10.1186/s12915-021-00962-0) and Franco et al (Neural Regen Res. 2025 Sep 1;20(9):2480-2494. doi: 10.4103/NRR)), the discovery of such an association is deemed to be free from the prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The written opinion by the ISA for PCT/EP2020/077711, WO 2019/101812 A2, WO 2019/110630 A1 (all of which are as cited on the 02/15/2022 IDS), WO 2018081588 A1 (as cited on the 02/21/2025 IDS) are deemed to contain prior art and arguments relevant to the claimed subject matter.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to ASHLEY GAO whose telephone number is (571) 272-5695. The
examiner can normally be reached on M-F 9:00 am - 6:00 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Gregory Emch can be reached on (571) 272-8149. The fax phone number for the
organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent
Application Information Retrieval (PAIR) system. Status information for published applications
may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
applications is available through Private PAIR only. For more information about the PAIR
system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
like assistance from a USPTO Customer Service Representative or access to the automated
information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678