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
Applicant’s election without traverse of claims 1-4 and 7 in the reply filed on 04/17/2026 is acknowledged. Claims 1-4 and 7 are currently under examination and the subject of the present Office Action. Claims 10-11, 14-15, 17, 19-20, 22, 24, and 25 are withdrawn from consideration without traverse. Claims 5-6, 8-9, 12-13, 16, 18, 21, and 23 are cancelled.
As such, the restriction is made final.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 03/27/2024, 01/21/2026, 04/17/2026 have been considered here.
Claim Rejections - 35 USC § 112
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.
Claim 4 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 depends on claim 1, which recites that “a compound of Chemical Formula 1…which serves as an active ingredient, an excipient, a disintegrant, and a binder…”. Claim 4 then recites that the amounts of the excipient, binder, and disintegrant are different. The limitation of claim 1 requires that the compound of Chemical Formula 1 fulfills the rolls of the active ingredient, binder, excipient, and disintegrant and as such it is not clear how it can be present in differing amounts, as required by claim 4. As such one with ordinary skill in the art would not understand the metes and bounds of the claim as written and is indefinite. For purposes of search and consideration, claim 1 is understood as reading “a compound of Chemical Formula 1…which serves as an active ingredient; wherein the pharmaceutical composition further comprises an excipient, a disintegrant, and a binder;…” in order to remedy the issue.
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.
Claims 1-4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022051321 A1 (Cook, 2022; filing date of 09/01/2021) in view of US PGPUB 202303270718 A1 (Melnick, 2023; filing date of 04/12/2021).
In regards to claim 1, Cook teaches a composition in the form of a tablet with granules (see Cook, page 28, lines 29-30; page 29, lines 1-14) wherein the composition comprises SGLT-2 particles with a size of about 2µm to about 10µm (see Cook, page 35, lines 1-29). The composition is taught to comprise excipients such as sorbitol, microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium crospovidone, starch, polyvinylpyrrolidone, among others (see Cook, page 13, lines 19-26; pages 22-28). These are listed in the instant specification as filed as acceptable binders, excipients, and disintegrants (see instant specification as filed, page 6, paragraphs 3-6).
In regards to claim 7, it is taught that about 50 to about 99 wt% of the total amount of the SGLT-2 inhibitor is released after about 15 minutes and after about 20 minutes (see Cook, page 39, lines 16-30). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Further in regards to the limitation of the dissolution rate releasing 85% or more of the total content of the active ingredient after 30 minutes, it is noted that dissolution rate is a variable that can be modified, among others, by adjusting the amount of water, type of buffer, pH, and paddle speed (i.e., conditions), the dissolution rate changing as the conditions are changed, the dissolution rate would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed dissolution rate cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the conditions in Cook to obtain the desired balance between the dissolution rate as taught by Cook (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here 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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Cook is silent on the composition comprising a compound of the chemical formula I in any amount and the amounts of excipient, binder, and disintegrant.
In regards to claim 1, Melnick teaches a tablet comprising SGLT-2 inhibitors such as enavogliflozin (a compound of chemical formula I), canagliflozin, bexagloflozin, empagliflozin, ertugliflozin, ipragliflozin, remogliflozin, tofogliflozin, among others (see Melnick, paragraphs 0043-0044).
In regards to claims 2-3, it is taught that the composition comprises the active compounds in an amount from 0.1 mg to about 2 mg (see Melnick, paragraph 0188). It is also taught that the dosage form of the composition is a tablet that has a weight from about 50mg to about 750 mg or even about 100 mg to about 230 mg (see Melnick, paragraph 0345). Using these numbers, for example a 100 mg tablet with 0.1 mg of active compound such as the enavogliflozin would meet the requirements of claim 2. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 4, it is taught that the composition comprises lactose, which is taught as an acceptable excipient in the instant specification as filed (see instant specification, page 6, third paragraph), in an amount from about 70 weight percent to about 99 weight percent (see Melnick, paragraph 0213). Further, it is taught that the composition comprises a binder in an amount of about 1.0 weight percent to about 10.0 weight percent (see Melnick, paragraph 0215) and a disintegrant in an amount from about 1.0 weight percent to about 10.0 weight percent (see Melnick, paragraph 0218). There is also overlap with the materials listed as acceptable binders and disintegrants as Cook (see Melnick, paragraphs 0214-0219). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 1-4 and 7, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Cook and Melnick to formulate the instant composition as both references teach similar compositions comprising similar compounds (i.e., SGLT-2 inhibitors, binders, excipients, and disintegrants). Further, while Cook is silent on the use of a compound of chemical formula I, the list of SGLT-2 inhibitors of Melnick has significant overlap with the list of SGLT-2 inhibitors in Cook (see Cook, paragraph bridging pages 12-13). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would be motivated to combine the SGLT-2 inhibitor and tablet of Melnick with the composition of Cook according to the known method of formulating tablets comprising SLGT-2 inhibitors (see Cook, pages 75-76) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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