DETAILED ACTION
Status of the Application
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, 4, 9, 11-14, 17, 20, 22, 31-32, 34-35, 41-42, and 47-48 are pending and represent all claims currently under consideration.
Priority
This application is a 371 of PCT/US2022/080335, which claims priority to PRO 63/282,540.
Claims 1, 4, 9, 11-14, 17, 20, 22, 31-32, 34-35, 41-42, and 47-48 are considered to have an effective filing date of 11/23/2021.
Election/Restrictions
Applicant’s election without traverse of Group I and of the species “disintegrant, dispersion polymer, diluent, glidant, and lubricant” in the reply filed on 07/08/2026 is acknowledged.
Claims 55 and 64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/08/2026.
Information Disclosure Statement
The information disclosure statements filed 11/12/2024 and 12/01/2025 have been considered.
Claim Objections
Claims 1, 9, 22, and 47 are objected to because of the following informalities. Appropriate correction is required. Regarding claims 1 and 9, an article such as “a” or “an” should precede each individually listed ingredient (i.e., “crystalline” should read “a crystalline”).
Regarding claim 22, “of the of the” should read “of the”.
Regarding claim 47, “pH 7” should read “a pH of 7”.
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.
Claims 9, 11-13, and 34-35 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the phrase “selected from the group comprising” renders the claims indefinite, because a Markush grouping is a closed list of alternatives and “comprising” is open-ended. It is unclear what other alternatives are intended to be encompassed by the claim. See MPEP § 2173.05(h)(I).
Claims 11-13 are dependent on the rejected claim 9 and does not cure its deficiencies, and therefore is deficient for the same reason as above.
Regarding claim 34, the claim recites the limitation "the anti-adherent". There is insufficient antecedent basis for this limitation in the claim.
Claim 35 is dependent on the rejected claim 34 and does not cure its deficiencies, and therefore is deficient for the same reason as above.
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, 9, 11-14, 17, 20, 22, 31-32, 34-35, 41-42, and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (WO 2021007172 A1; IDS reference, 11/12/2024). Lin was cited previously by the Examiner.
Regarding claim 1, Lin teaches a pharmaceutical composition comprising a compound of formula (I), as claimed, and a dispersion polymer (Lin, claim 1) in the form of a tablet (Lin, claim 38), and teaches the composition can comprise an a disintegrant, a glidant, a lubricant, and a filler (Lin, claim 24). Lin further teaches a filler to be microcrystalline cellulose (i.e., a diluent as defined by the instant claim 32; Lin, page 85, paragraph 00234).
Lin is considered to be analogous to the claimed invention, because both Lin and the instant invention are in the same field of RBP4 inhibitors. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Lin under the meaning of 35 U.S.C. 103.
Regarding claim 4, Lin teaches all of the elements of the current invention as applied to claim 1. Lin teaches a compound having the structure as claimed (Lin, page 3, paragraph 0007).
Regarding claim 9, Lin teaches all of the elements of the current invention as applied to claim 1. Lin teaches a disintegrant which can be croscarmellose sodium (Lin, page 88, paragraph 00242).
Regarding claim 11, Lin teaches all of the elements of the current invention as applied to claim 1. Lin teaches a disintegrant which can be croscarmellose sodium (i.e., CCNa; Lin, page 88, paragraph 00242).
Regarding claim 12, Lin teaches all of the elements of the current invention as applied to claim 11. Lin teaches a disintegrant in about 1-99% by weight of the pharmaceutical composition (Lin, page 88, paragraph 00243), which lies within the claimed range.
Regarding claim 13, Lin teaches all of the elements of the current invention as applied to claim 11. Lin teaches a disintegrant which can be croscarmellose sodium (i.e., CCNa; Lin, page 88, paragraph 00242). Lin teaches the disintegrant in up to about 10% by weight of the pharmaceutical composition (Lin, page 89, paragraph 00244), which encompasses the claimed amount, and teaches optimal doses are generally determined using experimental models or clinical trials (Lin, page 108, paragraph 00311). Therefore, it would have been prima facie obvious for one of ordinary skill in the art to optimize within the range taught by Lin, and it would be reasonable to expect optimization within the range of up to 10% would result in the claimed amount of 0.75% or 3%.
Regarding claim 14, Lin teaches all of the elements of the current invention as applied to claim 1. As above, Lin teaches a pharmaceutical composition comprising a dispersion polymer (Lin, claim 1).
Regarding claim 17, Lin teaches all of the elements of the current invention as applied to claim 14. Lin teaches the dispersion polymer can comprise HPC (Lin, claim 9).
Regarding claim 20, Lin teaches all of the elements of the current invention as applied to claim 17. As above, Lin teaches the dispersion polymer can comprise HPC (Lin, claim 9). Lin further teaches the dispersion polymer comprises up to about 10% by weight of the solid dispersion (Lin, page 79, paragraph 00217), which encompasses the claimed amount, and teaches optimal doses are generally determined using experimental models or clinical trials (Lin, page 108, paragraph 00311). Therefore, it would have been prima facie obvious for one of ordinary skill in the art to optimize within the range taught by Lin, and it would be reasonable to expect optimization within the range of up to 10% would result in the claimed amount of 6%.
Regarding claim 22, Lin teaches all of the elements of the current invention as applied to claim 1. As above, Lin teaches a disintegrant which can be croscarmellose sodium (i.e., CCNa; Lin, page 88, paragraph 00242) and that the dispersion polymer can comprise HPC (Lin, claim 9). Lin teaches the disintegrant in up to about 10% by weight of the pharmaceutical composition (Lin, page 89, paragraph 00244) and the dispersion polymer comprises up to about 10% (Lin, page 79, paragraph 00217), which each encompasses the claimed amounts. Lin teaches optimal doses are generally determined using experimental models or clinical trials (Lin, page 108, paragraph 00311). Therefore, it would have been prima facie obvious for one of ordinary skill in the art to optimize within the ranges taught by Lin, and it would be reasonable to expect optimization within those ranges of up to 10% would result in the claimed amounts.
Regarding claim 31, Lin teaches all of the elements of the current invention as applied to claim 1. As above, Lin teaches the composition can comprise a filler (Lin, claim 24), and teaches a filler to be microcrystalline cellulose (i.e., a diluent as defined by the instant claim 32; Lin, page 85, paragraph 00234). Lin further teaches the filler comprises about 1-99% by weight of the pharmaceutical composition (Lin, page 86, paragraph 00235), which lies within the claimed range. Therefore, it would be prima facie obvious to one of ordinary skill in the art to utilize microcrystalline cellulose (i.e., a diluent) in the claimed amount.
Regarding claim 32, Lin teaches all of the elements of the current invention as applied to claim 31. As above, Lin teaches the composition can comprise a filler (Lin, claim 24), and teaches a filler to be microcrystalline cellulose (i.e., MCC; Lin, page 85, paragraph 00234).
Regarding claim 34, Lin teaches all of the elements of the current invention as applied to claim 1. Lin teaches the composition can comprise a lubricant (Lin, claim 24), and teaches a lubricant to be magnesium stearate (i.e., an anti-adherent as defined by the instant claim; Lin, page 92, paragraph 00254).
Regarding claim 35, Lin teaches all of the elements of the current invention as applied to claim 34. As above, Lin teaches the composition can comprise a lubricant (Lin, claim 24), and teaches a lubricant to be magnesium stearate (i.e., an anti-adherent as defined by the instant claim; Lin, page 92, paragraph 00254). Lin further teaches the lubricant in up to about 10% by weight (Lin, page 92, paragraph 00255), which encompasses the claimed amount, and teaches optimal doses are generally determined using experimental models or clinical trials (Lin, page 108, paragraph 00311). Therefore, it would have been prima facie obvious for one of ordinary skill in the art to optimize within the range taught by Lin, and it would be reasonable to expect optimization within a range of up to 10% would result in an amount of 1% as claimed.
Regarding claim 41, Lin teaches all of the elements of the current invention as applied to claim 1. Lin teaches a pharmaceutical composition in the form of a tablet (Lin, claim 38), and teaches the pharmaceutical composition is administered in an amount of about 10 mg (Lin, claim 57), which lies within the claimed range.
Regarding claim 42, Lin teaches all of the elements of the current invention as applied to claim 1. Lin teaches the compound of formula (I) comprises about 5% by weight of a solid dispersion (Lin, page 80, paragraph 00221), and teaches the solid dispersion can comprise 100% of the pharmaceutical composition (Lin, page 84, paragraph 00230), suggesting the compound of formula (I) would result in a total of 5% by weight of the pharmaceutical composition.
Regarding claim 47, Lin teaches all of the elements of the current invention as applied to claim 1. While Lin does not specifically measure a dissociation or dissolution in a specific aqueous medium as claimed, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Regarding claim 48, Lin teaches all of the elements of the current invention as applied to claim 1. Lin teaches a dispersion (i.e., pharmaceutical composition) of a compound of formula (I) to be suspended in a 0.1N HCl simulated gastric fluid media in a bath at 37°C for 30 minutes and measured to have a final concentration of 473.8 out of a possible 500 µg/mL (i.e., about 95% dissolves after 30 minutes; Lin, page 133, paragraph 00373, tables 11-12).
Claims 1, 4, 9, 14, 31, 34-35, 41-42 and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Petrukhin (US 20180354957 A1; IDS reference, 11/12/2024), as evidenced by The Spruce Eats.
Regarding claim 1, Petrukhin teaches a compound of formula (I) as shown in the instant claim 4 (Petrukhin, page 79, compound 82) and teaches the compound can be administered in an oral dosage form of a tablet (i.e., a tablet pharmaceutical composition; Petrukhin, page 33, paragraph 0215). Petrukhin teaches the compound can be coadministered with excipients, and specifies that the tablet may contain disintegrating agents (i.e., disintegrants), diluents, or lubricants (Petrukhin, page 33, paragraph 0216).
Petrukhin is considered to be analogous to the claimed invention, because both Petrukhin and the instant invention are in the same field of RBP4 targeting compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Petrukhin under the meaning of 35 U.S.C. 103.
Regarding claim 4, Petrukhin teaches all of the elements of the current invention according to claim 1. As above, Petrukhin teaches a compound of formula (I) (Petrukhin, page 79, compound 82).
Regarding claim 9, Petrukhin teaches all of the elements of the current invention according to claim 1. Petrukhin teaches the tablet may contain disintegrants such as agar (i.e., agar agar as evidenced by The Spruce Eats; Petrukhin, page 33, paragraph 0218).
Regarding claim 14, Petrukhin teaches all of the elements of the current invention according to claim 1. Petrukhin teaches the tablet may contain a carrier such as methyl cellulose (i.e., a dispersion polymer as defined by the instant specification, page 10, paragraph 0006; Petrukhin, page 33, paragraph 0218).
Regarding claim 31, Petrukhin teaches all of the elements of the current invention according to claim 1. As above, Petrukhin teaches the compound can be coadministered with diluents (Petrukhin, page 33, paragraph 0216). Petrukhin further teaches that the dosage of the compounds administered varies depending upon several factors, and that techniques for making dosage forms are known in the art (Petrukhin, pages 32-33, paragraph 0214-0217). Based on the teachings of Petrukhin, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of the diluent in order to be properly formulated as a easy to swallow or chew tablet (Petrukhin, page 33, paragraph 0216).
Regarding claim 34, Petrukhin teaches all of the elements of the current invention according to claim 1. Petrukhin teaches the tablet may contain a carrier such as magnesium stearate (i.e., an anti-adherent as defined by the instant claim; Petrukhin, page 33, paragraph 0218).
Regarding claim 35, Petrukhin teaches all of the elements of the current invention according to claim 34. As above, Petrukhin teaches the tablet may contain a carrier such as magnesium stearate (i.e., an anti-adherent as defined by the instant claim; Petrukhin, page 33, paragraph 0218). Petrukhin further teaches that the dosage of the compounds administered varies depending upon several factors, and that techniques for making dosage forms are known in the art (Petrukhin, pages 32-33, paragraph 0214-0217). Based on the teachings of Petrukhin, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of the carrier in order to be properly formulated as a easy to swallow or chew tablet (Petrukhin, page 33, paragraph 0216).
Regarding claim 41, Petrukhin teaches all of the elements of the current invention according to claim 1. As above, Petrukhin teaches the compound can be administered in an oral dosage form of a tablet (Petrukhin, page 33, paragraph 0215). Petrukhin further teaches that the dosage of the compounds administered varies depending upon several factors, and that techniques for making dosage forms are known in the art (Petrukhin, pages 32-33, paragraph 0214-0217). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to optimize the dosage of the composition being administered depending on the specific patient and symptoms (Petrukhin, page 33, paragraph 0215).
Regarding claim 42, Petrukhin teaches all of the elements of the current invention according to claim 1. As above, Petrukhin teaches a compound of formula (I) as shown in the instant claim 4 (Petrukhin, page 79, compound 82) administered in an oral dosage form of a tablet (Petrukhin, page 33, paragraph 0215). Petrukhin further teaches that the dosage of the compounds administered varies depending upon several factors, and that techniques for making dosage forms are known in the art (Petrukhin, pages 32-33, paragraph 0214-0217). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to optimize the dosage of the active compound being administered depending on the specific patient and symptoms (Petrukhin, page 33, paragraph 0215).
Regarding claim 47, Petrukhin teaches all of the elements of the current invention according to claim 1. While Petrukhin does not specifically measure a dissociation or dissolution in a specific aqueous medium as claimed, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Regarding claim 48, Petrukhin teaches all of the elements of the current invention according to claim 1. While Petrukhin does not specifically measure a dissociation or dissolution in a gastric fluid as claimed, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Claims 11-13, 17, 20, 22, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Petrukhin (US 20180354957 A1; IDS reference, 11/12/2024) as applied to claims 1, 4, 9, 14, 31, 34-35, 41-42 and 47-48, and further in view of Monia (US 20110123521 A1; IDS reference, 11/12/2024).
Regarding claim 11, Petrukhin teaches all of the elements of the current invention according to claim 9. Petrukhin teaches the tablet may contain a carrier such as lactose, gelatin, and the like (Petrukhin, page 33, paragraph 0218). Monia teaches compositions for modulating RBP4 (Monia, page 1, paragraph 0011), and teaches carriers such as lactose, gelatin, and microcrystalline cellulose (i.e., MCC; Monia, page 36, paragraph 0505).
Petrukhin and Monia are both considered to be analogous to the claimed invention, because Petrukhin, Monia, and the instant invention are in the same field of pharmaceutical compositions targeting RBP4. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Petrukhin to comprise microcrystalline cellulose, because Petrukhin teaches lactose, gelatin, and the like (Petrukhin, page 33, paragraph 0218), while Monia teaches lactose, gelatin, and microcrystalline cellulose as alternative carriers (Monia, page 36, paragraph 0505). It is prima facie obvious to substitute equivalents taught by the prior art to be useful for the same purpose. See MPEP 2144.06(I).
Regarding claim 12, Petrukhin and Monia together teach all of the elements of the current invention according to claim 11. As above, Petrukhin teaches the tablet may contain disintegrants (Petrukhin, page 33, paragraph 0218). Petrukhin further teaches that the dosage of the compounds administered varies depending upon several factors, and that techniques for making dosage forms are known in the art (Petrukhin, pages 32-33, paragraph 0214-0217). Based on the teachings of Petrukhin, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of the disintegrating agent in order to be properly formulated as a easy to swallow or chew tablet (Petrukhin, page 33, paragraph 0216).
Regarding claim 13, Petrukhin and Monia together teach all of the elements of the current invention according to claim 11. As above, Petrukhin teaches the tablet may contain a carrier such as lactose, gelatin, and the like (Petrukhin, page 33, paragraph 0218). Monia teaches compositions for modulating RBP4 (Monia, page 1, paragraph 0011), and teaches carriers such as lactose, gelatin, and microcrystalline cellulose (i.e., MCC; Monia, page 36, paragraph 0505). As above, it would have been prima facie obvious to one of ordinary skill in the art to substitute the lactose or gelatin of Petrukhin with microcrystalline cellulose as taught by Monia, because Monia teaches the carriers to be art recognized equivalents. Petrukhin further teaches that the dosage of the compounds administered varies depending upon several factors, and that techniques for making dosage forms are known in the art (Petrukhin, pages 32-33, paragraph 0214-0217). Based on the teachings of Petrukhin, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of the carrier in order to be properly formulated as a easy to swallow or chew tablet (Petrukhin, page 33, paragraph 0216).
Regarding claim 17, Petrukhin teaches all of the elements of the current invention according to claim 14. Petrukhin teaches the tablet may contain a binder such as starch (Petrukhin, page 33, paragraph 0218). Monia teaches binding agents such as a starch or hydroxypropyl methyl cellulose (i.e., HPMC; Monia, page 36, paragraph 0505). It would have been prima facie obvious to one of ordinary skill in the art to substitute the starch of Petrukhin with HPMC as taught by Monia, because Monia teaches the two binders to be art recognized equivalents.
Regarding claim 20, Petrukhin and Monia together teach all of the elements of the current invention according to claim 17. As above, Petrukhin teaches the tablet may contain a binder such as starch (Petrukhin, page 33, paragraph 0218). Monia teaches binding agents such as a starch or hydroxypropyl methyl cellulose (i.e., HPMC; Monia, page 36, paragraph 0505). It would have been prima facie obvious to one of ordinary skill in the art to substitute the starch of Petrukhin with HPMC as taught by Monia, because Monia teaches the two binders to be art recognized equivalents. Petrukhin further teaches that the dosage of the compounds administered varies depending upon several factors, and that techniques for making dosage forms are known in the art (Petrukhin, pages 32-33, paragraph 0214-0217). Based on the teachings of Petrukhin, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of the binder in order to be properly formulated as a easy to swallow or chew tablet (Petrukhin, page 33, paragraph 0216).
Regarding claim 22, Petrukhin teaches all of the elements of the current invention according to claim 1. As above, Petrukhin teaches the tablet may contain a carrier such as lactose, gelatin, and the like (Petrukhin, page 33, paragraph 0218). Monia teaches compositions for modulating RBP4 (Monia, page 1, paragraph 0011), and teaches carriers such as lactose, gelatin, and microcrystalline cellulose (i.e., MCC; Monia, page 36, paragraph 0505). As above, it would have been prima facie obvious to one of ordinary skill in the art to substitute the lactose or gelatin of Petrukhin with microcrystalline cellulose as taught by Monia, because Monia teaches the carriers to be art recognized equivalents. Petrukhin teaches the tablet may contain a binder such as starch (Petrukhin, page 33, paragraph 0218). Monia teaches binding agents such as a starch or hydroxypropyl methyl cellulose (i.e., HPMC; Monia, page 36, paragraph 0505). It would have been prima facie obvious to one of ordinary skill in the art to substitute the starch of Petrukhin with HPMC as taught by Monia, because Monia teaches the two binders to be art recognized equivalents. Petrukhin further teaches that the dosage of the compounds administered varies depending upon several factors, and that techniques for making dosage forms are known in the art (Petrukhin, pages 32-33, paragraph 0214-0217). Based on the teachings of Petrukhin, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of the carrier and the binder in order to be properly formulated as a easy to swallow or chew tablet (Petrukhin, page 33, paragraph 0216).
Regarding claim 32, Petrukhin and Monia together teach all of the elements of the current invention according to claim 31. Petrukhin teaches the tablet may contain a carrier such as lactose, gelatin, and the like (Petrukhin, page 33, paragraph 0218). Monia teaches compositions for modulating RBP4 (Monia, page 1, paragraph 0011), and teaches carriers such as lactose, gelatin, and microcrystalline cellulose (i.e., MCC; Monia, page 36, paragraph 0505). As above, it would have been prima facie obvious to one of ordinary skill in the art to substitute the lactose or gelatin of Petrukhin with microcrystalline cellulose as taught by Monia, because Monia teaches the carriers to be art recognized equivalents.
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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