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
Claims 1-10 and 21-28 are pending in the application. Claims 1-10 and 21-28 are rejected.
Response to Amendment / Argument
On pages 10 and 11 of the response filed March 2nd, 2026, Applicant traverses the rejections under 35 USC 112(b) based on amendments. Applicant’s traversal is not found persuasive regarding the references to “Method D,” “Method B” and “Type A” since the claims still rely upon the specification for claim limitations that could otherwise be recited in the claims themselves.
Beginning on page 5 of the response filed March 2nd, 2026, Applicant traverses the rejections of claims under 35 USC 102(a)(1) and 102(a)(2) over WO 2021/055807 A1 by Ericsson et al. Applicant first disqualifies the reference as it applies to 35 USC 102(a)(2). Regarding 102(a)(1), Applicant discusses different solid forms of a compound having different properties and that the prior art fails to teach properties instantly claimed. The instantly claimed properties are discussed in the rejection. The products produced by the prior art contain the same components as required by the instant claims.
Beginning on page 7 of the response filed March 2nd, 2026, Applicant traverses the rejections of claims under 35 USC 102(a)(1) and 102(a)(2) over WO 2021/055863 A1 by Babu et al. Applicant first disqualifies the reference as it applies to 35 USC 102(a)(2). Regarding 102(a)(1), Applicant asserts that the reference does not qualify under 102(a)(1) since “the disclosure of WO’863 was made by the joint inventor Suresh BABU.” This is not found persuasive since the prior art names inventor George Luke, who is not an inventor on the instant application. See MPEP 2153.01(a): “If, however, the application names fewer joint inventors than a publication (e.g., the application names as joint inventors A and B, and the publication names as authors A, B and C), it would not be readily apparent from the publication that it is an inventor-originated disclosure and the publication would be treated as prior art under AIA 35 U.S.C. 102(a)(1) unless there is evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies.”
On page 8 of the response filed March 2nd, 2026, Applicant traverses the rejections of claims under 102(a)(2) over U.S. PGPub No. 2022/0087983 A1 by Ericsson et al., which is withdrawn based on Applicant’s statement regarding 35 USC 102(b)(2)(C).
Beginning on page 8 of the response filed March 2nd, 2026, Applicant traverses the rejections of claims under 102(a)(2) over U.S. PGPub No. 2022/0304987 A1 by Ericsson et al., which is withdrawn based on Applicant’s statement regarding 35 USC 102(b)(2)(C).
On page 9 of the response filed March 2nd, 2026, Applicant traverses the rejections of claims under 102(a)(2) over U.S. Patent No. 12,128,035 A1 by Ericsson et al., which is withdrawn based on Applicant’s statement regarding 35 USC 102(b)(2)(C).
Beginning on page 9 of the response filed March 2nd, 2026, Applicant traverses the rejections of claims under 102(a)(2) over U.S. PGPub No. 2022/0378755 A1 by Luke et al., which is withdrawn based on Applicant’s statement regarding 35 USC 102(b)(2)(C).
On page 10 of the response, Applicant traverses the rejection of claims under 35 USC 103 over WO 2021/055807 A1 for the same reasons as under 35 USC 102, which arguments are not found persuasive.
On page 11 of the response, Applicant traverses the double patenting rejections and states they will attend to the rejections “upon an indication of allowable subject matter in the instant application.” Until such time, the rejections are maintained.
All other rejections made in the previous Office Action that do not appear below have been overcome by Applicant's amendments to the claims.
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 1-10 and 21-28 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.
The references to “Method D,” and “Method B,” in claims 1, 2 and 21 are rejected as indefinite since they rely upon the specification when the limitations being relied upon could otherwise be recited in the instant claims. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. 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)”. In this situation, it is unclear which of the all the parameters are required to perform the methods, e.g. identical instrumentation, identical amounts, etc. Dependent claims are rejected as indefinite for the same reason.
The same rationale above in view of MPEP 2173.05(s) applies to the reference to “Type A of Compound 1” where the specification purports that “Type A” is novel (paragraph [0010]) but does not provide a clear delineation on which properties must be observed to consider a material as “Type A”. For instance, the specification recites properties in paragraph [0082]-[0089] but where the specification only recites that properties apply in “some embodiments” rather than setting forth which minimum properties must be observed. Regardless, the reference is considered indefinite for the same reason discussed above as relying on subject matter found in the specification that could otherwise be recited in the claims.
The limitations above are recited in instant claims 1, 2, 21, 26 and 27 and dependent claims are rejected as indefinite for the same reasons.
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.
(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.
Claim(s) 1-9, 21 and 23-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Application Publication No. WO 2021/055807 A1 by Ericsson et al.
The prior art teaches the preparation of a spray dried dispersion of a compound 1 (defined on page 3, paragraph [0009] of the prior art) with a polymer hydroxypropylmethyl cellulose AS-MG (as recited in instant claims 29 and 30) beginning on page 83, paragraph [00295]-[00297]. The prior art further teaches in paragraph [00295] that the material was spray dried to obtain an amorphous drug substance. Since claim 1 does not require any particular amount or formulation, the preamble “oral dosage form” is considered an intended use that does not distinguish from the prior art sample prepared in paragraph [00297].
Regarding the limitations of instant claims 1, 2, 26 and 27 involving crystallinity or DSC properties, MPEP 2112.01(II) states: ‘"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.’
Regarding instant claim 25, if the exterior and interior of the tablet are uniform and identical, it would be arbitrary to consider any portion to represent the core and/or to even consider a uniform interior layer to contain a “minitablet” core such that even the smallest amount at the center could be considered the “core” having the claimed range.
Accordingly, the prior art anticipates instant claims 1, 2, 29 and 30.
Further regarding instant claims 1-9, the prior art teaches a tablet comprising a spray dried intermediate and where paragraph [0001] on page 47 discloses an amorphous solid dispersion. The prior art teaches on page 47: “Table 1 provides an example of a tablet comprising a SDD obtained by the method of Example 1 and other components.” The prior art teaches 10-40% by weight of the amorphous compound. The prior art teaches an embodiment where “a tablet contains 200 mg of Compound 1 in a tablet weight that is less than about 800 mg” as embraced by instant claims 3, 4, 5, 6, 7, 8 and 9 (teaching a ratio of 1:3).
The tablet embodiment discussed above is further deemed to anticipate instant claims 21, 23, 24 and 28 based on the same rationale in view of MPEP 2112.01(II) and where the prior art teaches coated tablets in paragraph [00181] on page 47.
Claim(s) 1-10 and 21-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Application Publication No. WO 2021/055863 A1 by Babu et al.
The prior art teaches claims 1-10 on pages 223-224 that correspond, respectively, to the limitations of instant claims 1-10. Regarding instant claims 21-24 and 28-30, the prior art teaches analogous embodiments on pages 152-154 as embodiments 235, 237, 238, 239, 252 and 253.
Regarding instant claim 25, if the exterior and interior of the tablet are uniform and identical, it would be arbitrary to consider any portion to represent the core and/or to even consider a uniform interior layer to contain a “minitablet” core such that even the smallest amount at the center could be considered the “core” having the claimed range. Regarding instant claims 26 and 27, the prior art recites analogous embodiments on pages 153 and 154 as embodiments 249 and 246.
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.
Claim(s) 1-9 and 21-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over International Application Publication No. WO 2021/055807 A1 by Ericsson et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches the preparation of a spray dried dispersion of a compound 1 (defined on page 3, paragraph [0009] of the prior art) with a polymer hydroxypropylmethyl cellulose AS-MG beginning on page 83, paragraph [00295]-[00297]. The prior art further teaches in paragraph [00295] that the material was spray dried to obtain an amorphous drug substance. Since claim 1 does not require any particular amount or formulation, the preamble “oral dosage form” is considered an intended use that does not distinguish from the prior art sample prepared in paragraph [00297].
Regarding the limitations of instant claims 1, 2, 26 and 27 involving crystallinity or DSC properties, MPEP 2112.01(II) states: ‘"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.’
Regarding instant claim 25, if the exterior and interior of the tablet are uniform and identical, it would be arbitrary to consider any portion to represent the core and/or to even consider a uniform interior layer to contain a “minitablet” core such that even the smallest amount at the center could be considered the “core” having the claimed range.
Accordingly, the prior art anticipates instant claims 1 and 2.
Further regarding instant claims 1-9, the prior art teaches a tablet comprising a spray dried intermediate and where paragraph [0001] on page 47 discloses an amorphous solid dispersion. The prior art teaches on page 47: “Table 1 provides an example of a tablet comprising a SDD obtained by the method of Example 1 and other components.” The prior art teaches 10-40% by weight of the amorphous compound. The prior art teaches an embodiment where “a tablet contains 200 mg of Compound 1 in a tablet weight that is less than about 800 mg” as embraced by instant claims 3, 4, 5, 6, 7, 8 and 9 (teaching a ratio of 1:3).
The tablet embodiment discussed above is further deemed to anticipate instant claims 21, 23, 24 and 28 based on the same rationale in view of MPEP 2112.01(II) and where the prior art teaches coated tablets in paragraph [00181] on page 47.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1-9, 21 and 23-28 where anticipation is the epitome of obviousness. The instant claims 25-27 additionally encompass an embodiment where the tablet core is a minitablet comprising about 1-4 mg of Compound 1 but where material outside said core does not contain Compound 1. Instant claim 22 encompasses a tablet where the core comprises at least 30 weight % of Compound 1.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
The general disclosure does not limit the amount of Compound 1 and the prior art further teaches administration of 25 mg – 1,500 mg of Compound 1 each day, in single or divided doses where dividing 25 mg into multiple dosages would correspond to dosages approaching and overlapping with the instant range of claim 25. Accordingly, the prior art teaches a range that either overlaps and/or is close the amounts instantly claimed and the instantly claimed tablets are considered obvious in view of MPEP 2144.05(I). Regarding the limitation of “minitablet,” there do not appear to be any unique characteristics other than size where a person using a relatively low dosage would have been motivated to minimize excipients to reduce cost.
Regarding instant claims 26 and 27, the same rationale above in view of MPEP 2112.01(II) would apply regarding, for instance, a scaled down version of the explicit formulation example cited above.
Regarding instant claim 22, the same rationale regarding rationale in view of MPEP 2144.05(I) where the prior art teaches a range of 10-40% weight of the compound 1 in tablets in, for instance, paragraph [0001] on page 47. The recitation of a “core” does not appear to demand or imply any exterior layer lacking the compound of Compound 1.
Claim(s) 1-10 and 21-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over International Application Publication No. WO 2021/055863 A1 by Babu et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches claims 1-10 on pages 223-224 that correspond, respectively, to the limitations of instant claims 1-10. Regarding instant claims 21-24 and 28, the prior art teaches analogous embodiments on pages 152-154 as embodiments 235, 237, 238, 239, 252 and 253.
Regarding instant claim 25, if the exterior and interior of the tablet are uniform and identical, it would be arbitrary to consider any portion to represent the core and/or to even consider a uniform interior layer to contain a “minitablet” core such that even the smallest amount at the center could be considered the “core” having the claimed range. Regarding instant claims 26 and 27, the prior art recites analogous embodiments on pages 153 and 154 as embodiments 249 and 246.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1-10 and 21-28 where anticipation is the epitome of obviousness. The instant claims encompass an embodiment according to instant claims 25-27 where the tablet core is a minitablet comprising about 1-4 mg of Compound 1 but where the tablet does not contain additional Compound 1 outside the core.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
The general disclosure does not limit the amount of Compound 1 and the prior art further teaches embodiments having about 10 mg of Compound 1 (page 61, paragraph [0176]). Accordingly, the prior art teaches a range that either overlaps and/or is close the amounts instantly claimed and the instantly claimed tablets are considered obvious in view of MPEP 2144.05(I). Regarding the limitation of “minitablet,” there do not appear to be any unique characteristics other than size where a person using a relatively low dosage would have been motivated to minimize excipients to reduce cost.
Regarding instant claims 26 and 27, the prior art teaches analogous properties generally in embodiments 249 on pages 154 and embodiment 246 on page 153.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5 and 21-27 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-21 of U.S. Patent No. 12,128,035. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite methods of using overlapping materials. Claim 9 of the patent recites a method of administering a compound 1 as instantly claimed “as a non-crystalline solid form” and where dependent claim 18 recites the use of a tablet. Claim 16 of the patent recites the oral unit dosage comprising up to about 15% by weight of Compound 1 overlapping with the range of instant claim 1. Regarding the limitation of “a tablet core,” this limitation would not appear to demand the presence of, for instance, a coating. For instance, a uniform a tablet would still have some type of core, i.e. portion not directly exposed to surroundings. Regarding the limitation of “Type A of Compound 1” not being observable, at least since claim 10 of the patent recites a non-crystalline solid, a person having ordinary skill in the art would have been motivated to minimize crystalline forms. Regarding instant claim 22, claim 20 of the patent recites amounts of Compound 1 ranging from 200 mg to 600 mg and claims 13-15 of the patent recite total weights ranging from 200 mg to 1000 mg such that permuting the disclosed ranges to optimize a formulation would have overlapped with instant claim 30. The same rationale applies to instant claims 23 and 24. Regarding instant claim 25, the discussion above regarding the difference between a “tablet core” and exterior would apply where if the exterior and interior of the tablet are uniform and identical, it would be arbitrary to consider any portion to represent the core and even the smallest amount at the center could be considered the “core” having the claimed range. Regarding instant claims 26 and 27, as noted above the prior art teaches the use of a non-crystalline solid and where claim 12 of the patent recites the use of a denucleating agent such that a person having ordinary skill in the art would have been motivated to prepare tablets that do not result in crystalline forms. The same analysis above applies to instant claims 1-5 and the recited properties, amounts and tablet.
Claims 1-10 and 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-21 of U.S. Patent No. 12,128,035 in view of Tanno et al. Drug. Development and Industrial Pharmacy 2004, 30, 9-17. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite methods of using overlapping materials. Claim 9 of the patent recites a method of administering a compound 1 as instantly claimed “as a non-crystalline solid form” and where dependent claim 18 recites the use of a tablet. Claim 16 of the patent recites the oral unit dosage comprising up to about 15% by weight of Compound 1 overlapping with the range of instant claim 1. Regarding the limitation of “a tablet core,” this limitation would not appear to demand the presence of, for instance, a coating. For instance, a uniform a tablet would still have some type of core, i.e. portion not directly exposed to surroundings. Regarding the limitation of “Type A of Compound 1” not being observable, at least since claim 10 of the patent recites a non-crystalline solid, a person having ordinary skill in the art would have been motivated to minimize crystalline forms. Regarding instant claim 22, claim 20 of the patent recites amounts of Compound 1 ranging from 200 mg to 600 mg and claims 13-15 of the patent recite total weights ranging from 200 mg to 1000 mg such that permuting the disclosed ranges to optimize a formulation would have overlapped with instant claim 30. The same rationale applies to instant claims 23 and 24. Regarding instant claim 25, the discussion above regarding the difference between a “tablet core” and exterior would apply where if the exterior and interior of the tablet are uniform and identical, it would be arbitrary to consider any portion to represent the core and even the smallest amount at the center could be considered the “core” having the claimed range. Regarding instant claims 26 and 27, as noted above the prior art teaches the use of a non-crystalline solid and where claim 12 of the patent recites the use of a denucleating agent such that a person having ordinary skill in the art would have been motivated to prepare tablets that do not result in crystalline forms. The same analysis above applies to instant claims 1-5 and the recited properties, amounts and tablet.
Regarding instant claims 6-10, the claims of the patent recite a non-crystalline formulation and a denucleating agent but do not teach specific examples of a dunucleating agent. A person having ordinary skill in the art, however, would have at least been motivated to apply agents that have been similarly used to prevent crystallization. As an example, Tanno et al. teach HPMCAS (recited in instant claims 7-10) a carrier in solid dispersions as well as testing relative to HPMC, HPMCP and PVP (each recited in claim 7). Regarding the ranges of claims 9 and 10, Tanno et al. teach a comparison of of 1:1 and 1:2 (API:polymer) on page 16. Accordingly, a person having ordinary skill in the art in applying agents to perform the function of a denucleating agent would have at least been motivated to test similar ratios for the API of the claims of the patent.
Conclusion
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 MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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