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 .
Priority
Applicant claims priority benefit as follows:
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Election/Restriction
Applicants’ election without traverse of Group IV, claims 24-26, 28, 30 and 34-37, drawn to crystalline Form E1 of Gefapixant citrate, in the reply filed September 9, 2025 is acknowledged.
Accordingly, claims 1-11, 17-19 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 24-26, 28, 30 and 34-37 are the subject of this Office action.
Specification Objections
The disclosure is objected to because of the following informalities:
The amendment filed on March 14, 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “the entire disclosures of each of which are incorporated by reference herein”. See paragraph [0001].
MPEP 211.02(a) states that “When a benefit claim is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement specifying of the prior application unless an incorporation by reference statement specifying of the prior application was presented upon filing of the application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ).”
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The instant application is a 371 application which has an International filing date of September 16, 2021. The incorporation by reference statement is being added by way of a Preliminary Amendment filed on 03/14/2023, which is after the instant application’s International filing date. Therefore, the “incorporation by reference” statement being added is deemed new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Duplicate Claims, Warning
Applicant is advised that should claim 24 be found allowable, claim 28 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k). Claims 24 and 28 encompass the same exact subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
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 30 and 34 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 30 recites the broad recitation “chronic cough, asthma, interstitial cystitis, etc.”, and the claim also recites “and particularly chronic cough,” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In claim 34, the phrase “substantially as depicted in figure 5” makes the claim unclear because one of ordinary skill would not be able to determine what the critical (characteristic) peaks are.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 37 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 37 provides for Crystalline Form E1 of Gefapixant citrate according to claim 34
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Claim 34 recites that the Crystalline Form E1 of Gefapixant citrate is characterized by data selected from one or more of the following:
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Claim 37 is dependent of and limited by claim 34. However, claim 37 would appear to contain crystalline and amorphous forms not embraced by the parent claim, such as Gefapixant maleate. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
To overcome this rejection, claim 37 may be written as a pharmaceutical composition comprising the particular ingredients.
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 24-26, 28, 30 and 34-37 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 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.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, 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 courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The rejected claims lack written description for the full scope claimed therein. The scope of the claims is that of a crystalline form E1 of Gefapixant citrate according to claim 34 -comprising
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.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.
In Regents of the University of California v. Eli Lilly & Co. the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The instant disclosure at paragraph [0087] discloses that crystalline form E1 is an ethanol solvate. Additionally, a molar ratio of higher than 1:1 with a larger citric acid amount favors a hydrate form, as evidenced by WO2018/118668 in at least Table 2 and example 5. This reference was cited by applicant in the IDS of 03/14/2023.
The art knows that generation of polymorphs is unpredictable. It is not obvious from the disclosure of one species if any other crystal structure can be made and how to make it. The art knows that disclosure of one crystal form cannot represent other crystal forms. The one process taught in the specification that makes the hydrated ethanol solvate Form E1 with the XRPD claimed cannot possibly work for making diverse crystalline solvates with the same XRPD. There were no other solvents added to make Form E1, thus, this cannot support other solvate forms with the X-ray powder diffraction pattern as in claim 34. The XRDP of claim 34 doesn’t represent diverse crystalline forms; the scope of claim 34 is not limited to any particular solvate form and the specification does not teach how to make other solvate forms with the same peak characteristics.
Accordingly, it is deemed that the specification does not describe in sufficient detail the invention in the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
This rejection could be overcome by reciting “Crystalline Form E1 of Gefapixant citrate hydrated ethanol solvate”.
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.
Claim(s) 24, 28, 30 and 34-37 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Maloney (WO 2019/209607-cited by applicant in the IDS of 03/14/2023).
The prior art teaches a crystalline form of Gefapixant citrate with similar X-ray powder diffraction pattern having peaks around 7.2, 10.9, 13.1, 14.5, 14.9, 16.8, 17.1, 17.5 and 25.5
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, as recited in claims 34-36. The X-ray powder diffraction pattern of Gefapixant citrate of Figure 10 of the prior art is also similar to the one in Figure 5 of the instant disclosure. See Figure 10 of the prior art and Figure 5 of the instant disclosure below:
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The prior art teaches that this compound is to be used in the treatment of respiratory and pain-related diseases. The prior art also describes the form at Fig. 10 as only one form; containing no other crystalline forms.
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.
Claim(s) 24-26, 28, 30 and 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Maloney (WO 2019/209607) as above, in view of Ibrahim (WO2018/118668-cited by applicant in the IDS of 03/14/2023).
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of prior art Maloney were discussed above.
Ibrahim taught that crystal forms of Gefapixant citrate are to be used in pharmaceutical compositions, with pharmaceutically acceptable excipients, for the treatment of pain and chronic cough.
Ascertainment of the Difference Between Scope the Prior Art and the Claims (MPEP §2141.012)
The difference between the prior art Maloney and claims 25-26 is that Maloney is silent about a combination with pharmaceutical acceptable excipients.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
A person of ordinary skill in the art is a medical practitioner/professional who knows what the drug Gefapixant citrate is used for and who is aware of the commonly used inert excipients, carriers and adjuvants for making pharmaceutical compositions of active medicaments. It would have been prima facie obvious to prepare a pharmaceutical composition comprising the crystalline form of Gefapixant citrate of Maloney with pharmaceutically acceptable excipients because this is what is done in the art. The artisan would have followed the teachings of Ibrahim since it described the same compound for the same use.
Conclusion
Claims 24-26, 28, 30 and 34-37 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph K McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621