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
Status of 17/932,200
Claims 1-2 and 32-48 are currently pending.
Priority
Instant application 17/932,200, filed 9/14/2022, claims priority as follows:
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The provisional application 62/560,077 provides support for the instant claims and thus, the instant claims are granted the priority date of 9/18/2017.
Information Disclosure Statement
All references from the IDS’s submitted on 10/3/2023, 3/29/2024, and 10/30/2025 have been considered unless marked with a strikethrough.
Response to Applicants Arguments/Amendments
The amendment filed 10/30/2025 has been entered. Claims 1 and 2 have been amended. Claims 3-8 have been cancelled. Claims 32-48 have been added, but are not considered new matter as support is present in the parent application.
The abstract was objected to in the Non-Final Rejection dated 7/3/2025 for insufficient length. In response, Applicant has submitted a corrected abstract with the reply filed 10/30/2025 to overcome the objection. Thus, the objection is withdrawn.
Claims 1-8 were rejected under 35 U.S.C. 102(a)(2) in the Non-Final Rejection dated 7/3/2025. Upon the amendment of claim 1 to recite compounds of Formula I, and the cancellation of claims 3-8, the rejection has been overcome and therefore withdrawn.
In the Non-Final Rejection dated 7/3/2025, claims 1-8 were rejected on the grounds of nonstatutory double patenting. In response, Applicant has filed a terminal disclaimer to overcome the rejection. Thus, the rejection is withdrawn. However, Applicants amendment’s have presented new ground(s) of rejection that are the subject of this Office Action.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 32-48 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by NeRRe Therapeutics Limited (US 2017/0326141 A1, cited in the IDS of 10/30/2025, herein after “NeRRe”), as evidenced by Garceau (Garceau, D. & Chauret, N. Pulmonary Pharmacology & Therapeutics, 2019, 56, 56-62). The Examiner notes the reference was published on November 16th, 2017, but was filed August 2nd, 2017, thus permitting the document as prior art under 35 U.S.C. 102(a)(2). The instant claims are drawn to a method of treating a chronic cough patient while avoiding a loss of taste the method comprising administering a selective P2X3 antagonist of Formula (I). Further, the Examiner notes the use of “comprising” as the transitional phrase in claim 1, indicating that the claim is open-ended and does not exclude additional unrecited components or steps.
The reference NeRRe discloses methods of treating chronic cough by the administration of therapeutically effective amounts of orvepitant in combination with other therapeutic agents (abstract). The other therapeutics agents include a P2X3 purinergic receptor agonist (page 16, claim 1), which is further specified as compounds of formula (I) (page 16, claim 11):
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Which maps to the compounds of instant Formula I. NeRRe further discloses the method with compound BLU-5937:
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Which maps to instant Formula I when R1 is methyl, R2 is hydrogen, R3 is halogen, R4 is halogen at the ortho position, R5 is hydrogen, R6 is C1 alkyl, R7 is hydrogen, R8 is hydrogen, R9 is C1 alkyl, and X is O, in the method of treatment (page 16, claim 11).
With respect to the “avoiding taste loss response” limitation listed in instant claim 1, the instant specification discloses P2X3 receptors have a primary role in the cough reflex, but P2X2/3 receptors have a major role in taste function (page 10, para [0021]). And as such, this present invention is directed to selectively antagonizing the P2X3 receptor versus the P2X2/3 heterodimer in an effort to treat chronic cough without losing taste sensation. Evidentiary reference Garceau supports the instant specification by disclosing a compound, BLU-5937, that did not cause taste loss at concentrations known to block P2X3 receptors but not P2X2/3 receptors, while a non-selective P2X3 antagonist affected taste in models (Page 59, section 4). Thus, though not explicitly stated, according to Applicants own arguments, the compound BLU-5937 of NeRRe inherently avoids the loss of taste response while treating a chronic cough patient because it does not target the P2X2/3 receptors. This is considered a characteristic or property of a material.
Furthermore, with respect to the limitation in claim 1, “at least 10-fold selective for P2X3 homomeric receptor antagonism versus P2X2/3 heteromeric receptor antagonism”, and the limitations up to 2700-fold selective recited in claim 2, Garceau further discloses the hP2X3 versus hP2X2/3 selectivity of BLU-5937 is over 960-fold (Page 58, Table 1), and the broadest reasonable interpretation of the values includes even higher selectivity. Similar to the argument above, though not explicitly stated, the compound BLU-5937 of NeRRe inherently has this selectivity because it is considered a characteristic or property of the material.
Given the identical genus of the method of treating chronic cough in patients of NeRRe, and the preferred embodiment BLU-5937, in addition to evidentiary reference Garceau, a skilled artisan could at once envisage the method of treating chronic cough of the instant claims. Thus, NeRRe anticipates the instant claims as evidenced by Garceau.
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.
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.
Claims 1-2 and 32-48 are rejected under 35 U.S.C. 103 as being unpatentable NeRRe Therapeutics Limited (US 2017/0326141 A1, cited in the IDS of 10/30/2025, herein after “NeRRe”) as evidenced by Garceau (Garceau, D. & Chauret, N. Pulmonary Pharmacology & Therapeutics, 2019, 56, 56-62., as applied to claims 1-2 and 32-48 above.
Determining the scope and contents of the prior art
The references NeRRe and Garceau teach as disclosed above, and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
The reference NeRRe fails to teach an anticipatory example of treating a chronic cough patient with a compound of Formula I.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of selective P2X3 modulators. An artisan possess the technical knowledge necessary to make adjustments to the modulators to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said selective P2X3 modulators and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Above, the Examiner took the position that a skilled artisan could at one envisage the method of treatment in chronic cough patients because the genus, in addition to the compounds of the genus, is identical to the instant claims and the limitations recited to differentiate the instant claims are merely inherent characteristics of the compound. In the alternative, it would have been prima facie obvious for one of ordinary skill in the art to arrive at the instant methods of treating chronic cough given the identical genus of the disclosure and the example BLU-5937. One of ordinary skill in the art would be motivated before the effective filing date to arrive at the claims of the instant disclosure because the method of using compounds of formula (I) to treat chronic cough patients is known in the art, and is thus expected to have similar results. A skilled artisan would have readily predicted that applying the methods of treatment of chronic cough of NeRRe would be successful in light of the teachings of NeRRe as evidenced by Garceau.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 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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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621