DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification, drawings and claims as well as applicant arguments/remarks, filed 03/24/2026, is acknowledged. Amendments to the specification and/or drawings have been entered.
Applicant's statement that the subject matter disclosed in the references by Couch et al., US 2023/0167113 A1 and the claimed invention not later than the effective filing date of the claimed invention were either owned by GlaxoSmithKline Intellectual Property Development Limited or subject to an obligation of assignment to GlaxoSmithKline Intellectual Property Development Limited is acknowledged.
Claims 1-21 are pending in this action. Claims 22-23 have been cancelled previously. Claims 5-6, 13, 15-16, 17 have been amended. Claims 1-21 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments and/or arguments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a 371 of PCT/EP2022/052564, filed February 3, 2022, which claims benefit of provisional U.S. Application No. 63/146,106, filed February 5, 2021.
Claim Objections
Claims 1-3, 7-9, 13, 20-21 are objected to because of the following informalities:
As stated previously, claim 1 comprises the typographic error “comprises about 45% to 75%” that needs to be corrected to “comprises from about 45% to 75%”. Similar is applied to claims 7-9, 13.
In response to applicant’s argument that the meaning of said limitation is clear, it is noted that the boundaries of the recited range should be clearly delineated. Correction is required.
Claim 2 comprises the typographic error “the gepotidacin” that needs to be corrected to “gepotidacin”.
As stated previously, claim 1 recites the limitation “by weight of gepotidacin (measured as free base)” that needs to be corrected to “by weight of gepotidacin free base” or as needed for clarity. Similar is applied to claims 20-21.
In response to applicant’s argument that one skilled in the art would understand this limitation, it is noted that the main purpose of definiteness of claim language is to ensure that the scope of the claims is clear and to provide a clear measure of what the applicant regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability. MPEP 2173. Further, it is noted that parenthetical expressions are not permissible, which do not contribute to clearness or exactness in stating applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). Correction is required.
As stated previously, claim 3 recites the limitation “the crystalline form is gepotidacin mesylate dihydrate, gepotidacin mesylate anhydrate or gepotidacin anhydrate” that needs to be corrected to “the crystalline form is gepotidacin mesylate dihydrate, or gepotidacin mesylate anhydrate, or gepotidacin anhydrate” or clarified.
In response to applicant’s argument that said limitation is clear, it is noted that said claim language does not clearly defines the alternatives that can be included into the claimed composition. Correction is required.
Claim 13 comprises the typographic error “weight of a lubricant” that needs to be corrected to “weight of the lubricant”.
Appropriate correction is required.
Claim Rejections - 35 USC § 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 1-21 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 1 recites the term "about” that is a relative term, which renders the claim indefinite. As stated previously, this term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 7-9, 13, 15. Clarification is required.
In response to applicant’s argument that one skilled in the art would understand that the term “about” reflects analytical measurement error, it is noted that said term does not clearly define the metes and bounds of the patent protection desired. Can it be ±20%, ±10%, ±5%, or ±1.0%? Clarification is required.
Claim 2 (dependent on claim 1) discloses pharmaceutical compositions, wherein gepotidacin is in a crystalline form. In the present case, it is unclear what compositions are disclosed. Can it be a liquid composition comprising said crystalline form of the claimed active ingredient, OR the instant claims disclose solid pharmaceutical compositions? To this point, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, it is noted that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Similar is applied to claims 3-16. Clarification is required.
Claim 3 recites the limitation “the crystalline form is gepotidacin mesylate dihydrate, gepotidacin mesylate anhydrate or gepotidacin anhydrate” that is not reasonably clear. Does this limitation disclose two constituents/alternatives (i.e., gepotidacin mesylate dihydrate, gepotidacin mesylate anhydrate) OR a single compound, (i.e., gepotidacin anhydrate)? Clarification is required.
Claim 4 recites the limitation “the crystalline form is gepotidacin mesylate dihydrate” that is not reasonably clear, because the structure/crystalline form is defined as a compound. Similar is applied to claims 3, 14. Clarification is required.
As stated previously, claim 6 recites the limitation “characterized by an X-ray powder diffraction pattern substantially in accordance with FIG. 1”. First, it is noted that the term "substantially” is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Second, it is noted that claims are to be complete in themselves, and incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). MPEP 2173.05(s). Third, it is well known in the filed that X-ray powder diffraction intensity depends on the crystal structure, atomic scattering factors, sample characteristics, and instrumental parameters (see Wikipedia and references cited therein). Therefore, said claim is not sufficiently definite, because it refers to a variable (i.e., instrumental parameters). MPEP 2173.05(b)(ll). Similar is applied to claim 16. Clarification is required.
Claim 8 (dependent on claims 1, 4) recites the limitation “wherein the one or more excipients comprise a diluent, a disintegrant, and a glidant” that is not reasonably clear. First, it is unclear what is defined as recited “one or more excipients” – a mixture that may include other compounds even in large amounts (i.e., comprising), OR a mixture of recited functional agents. Second, the instant specification teaches that the same compound (e.g., magnesium stearate) can be used as different functional agents, e.g., as a glidant and as a lubricant (Page 9). Therefore, the structure of the claimed compositions is not clearly delineated. Similar is applied to claims 9-12. Clarification is required.
Claim 19 recites the limitation “the bacterial infection is uncomplicated urinary tract infection” that is not reasonably clear, because neither the claims nor the specification clarifies what is understood as “uncomplicated urinary tract infection”. Similar is applied to claim 20. Clarification is required.
In response to applicant’s argument that one skilled in the art would understand/recognize said conditions, it is noted that neither the claims nor the instant specification provide a definition for said conditions, the specification does not provide a standard for ascertaining the requisite degree. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claims 17-18, 21 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al., US 2010/0137282A1.
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Davies teaches tricyclic nitrogen containing compounds, e.g., (2R)-2-({4-[(3,4-Dihydro-2H-pyrano[2,3-c]pyridin-6-ylmethyl)amino]-1-piperidinyl}methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione hydrochloride (also known as gepotidacin; shown on the right) as antibacterial agents and pharmaceutical compositions comprising said compounds, wherein said compounds can be present/used in a crystalline form (Title, Abstract; Para. 0144, Example 32; as applied to claims 1, 2).
Davies teaches that said compositions may include/contain conventional excipients such as lactose, sorbitol (i.e., diluents), starch, carboxymethyl cellulose (i.e., disintegrants), magnesium stearate, talc (i.e., glidants, lubricants; Para. 0184), and said compositions can be in the form of a tablet (Para. 0181 as applied to claim 17).
Davies teaches that said compositions can be used for treating a bacterial infection in humans, e.g., urinary tract infection (Para. 0179, 0180, 0189-0191 as applied to claims 18-20).
Therefore, it is the examiner’s position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, because every element of the invention has been taught by the teaching of the reference cited. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare pharmaceutical compositions comprising crystalline forms of gepotidacin as instantly claimed to be used for treatment of urinary infection. With regard to the concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Claim 3-16, 21 are rejected as being dependent on rejected claim 1.
Response to Arguments
Applicant's arguments, filed 03/24/2026, have been fully considered, and they were found to be partially persuasive. Any rejection or objection not reiterated in this action is withdrawn. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments (see above). Applicant is advised to clarify the claims language and scope, the structure of the claimed compositions and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the reference cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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