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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/15/2026 has been entered.
Amended claims 1, 3-9, 11-13, 15-20 are pending.
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.
Previously presented rejection of claims 1, 3-9, 11-13, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tachibana US 20230128162 = US 12559474= US Application 17790358; Unoh, bioRxiv (2022), 1-52 and Sun Int J Nanomedicine 2012 Nov 12;7:5733–5744, Zhao, Rev Bras Farmacogn 24(2014): 584-590; Wang, Pharmaceutics 2022, 14, 1901 is maintained for reasons of record.
Amendments to claims are noted. Response to Applicants arguments are at the bottom of the following rejection of record.
The references of Tachibana and Unoh predates the instant priority date as explained below:
The priority date for 17790358 is
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Unoh date of
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The priority date for instant case is
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Tachibana teach at published application 20230128162 page 362 column B
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At sheet 3 of 15 Tachibana crystal shows the diffraction pattern
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At sheet 3 of 4 of instant claim crystal shows the diffraction pattern
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Unoh also teach fumaric crystal of the compound at page 16 just below the Figures.
Given the error rate and peak positions, the crystal of Tachibana is the same as the instant crystal. s
The properties of the compound of Tachibana and Unoh (co-author Tachibana) and its disclosed property and use is the same as the instantly pictured compound and its intended use are the same.
The difference is the limitation with respect to particle size of the compound and method of making it (by pulverizing the crystal).
The teachings of Sun, Zhao and Wang are invoked to cure the deficiency of Tachibana and Unoh. Sun teaches the effect of particle size on solubility, dissolution rate, and oral bioavailability.
Zhao, teaches the effect of superfine pulverization on physicochemical and medicinal properties of Qili Powder;
Wang Review (state of the art) teaches Particle Engineering Methods of pulverizing APIs.
Taken together, Sun, Zhao and Wang teach that in the pharmaceutical industry, controlling the D90 particle size—the size below which 90% of the crystal population exists—is critical for ensuring consistent bioavailability, dissolution rates, and manufacturability, particularly for poorly soluble drugs. Size reduction, or pulverization (comminution), is used to achieve target API (Active Pharmaceutical Ingredient) particle sizes, with techniques often resulting in D90 values in the low micrometer or even nanometer range.
Position taken is that pulverizing to desired size claims 1-16, dosing claims 17 and use of known excipients claims 18-20 are routinely used methods known to one of skill in the art of pharmaceutical art. For example, not in the rejection statement references (to avoid clutter) Marriott, Pharmaceutical Compound and Dispensing, Second Edition, 2010, 1-288 and Ansel, Pharmaceutical Dosage Forms and Drug Delivery Systems, 1999 and . it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The limitations of the crystal with respect to crystallinity and the intended method of its are known in the teachings of Tachibana and Unoh; optimization of paratactical properties such as bioavailability by arriving at desired particle sizes by pulverization are known in the art.
It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Response to Applicants Remarks:
Applicants arguments focus on the (smaller) particle sizes of the composition. According to Applicant, cited prior art has a wide range for the particle size. See Remarks bottom of page 7 onto page 8. Further Applicants argues that the smaller D90 and D50 produces superior and unexpected improvements.
The instant base claim particle size limitation(s) is/are still in the prior art range noted by the Applicant. Further the difference between the prior art range and instant range; is not different from differences the range of base claim 1 ranges and the ranges in dependent claims 3, 4. In addition, it is unclear what amount of the two different (sized) particles in the composition provides for the alleged superior and unexpected improvements. For example the amount of D90 particles could be 99.9% such that the amount of D50 particles may not make a different. The significance of the smaller particle size as taught by the references is noted. This is not different from one of skill in the art of pharmaceutical art. That said, It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-9, 11-13, 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11655240, further in view of Tachibana US 20230128162 = US 12559474= US Application 17790358; Unoh, bioRxiv (2022), 1-52 and Sun Int J Nanomedicine 2012 Nov 12;7:5733–5744, Zhao, Rev Bras Farmacogn 24(2014): 584-590; Wang, Pharmaceutics 2022, 14, 1901. And further Morissette, Advanced Drug Delivery Reviews 56 (2004) 275-300 and Rodriguez, Advanced Drug Delivery Reviews 56 (2004) 241-274.. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Note that the entirety of the disclosure in the secondary references here was discussed under Claim Rejections - 35 USC § 103 and is/are invoked here in the obviousness analysis.
The difference is the presence of language for the particle size in the instant claim. The intended use of the base claim of 11655240 crystal (which has the same physical diffraction parameter) is the same as the instant claim 1 and 11655240 claim 7.
Claims 1, 3-9, 11-13, 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of US Application No. 18132120 further in view of Tachibana US 20230128162 = US 12559474= US Application 17790358; Unoh, bioRxiv (2022), 1-52 and Sun Int J Nanomedicine 2012 Nov 12;7:5733–5744, Zhao, Rev Bras Farmacogn 24(2014): 584-590; Wang, Pharmaceutics 2022, 14, 1901 and Morissette, Advanced Drug Delivery Reviews 56 (2004) 275-300 and Rodriguez, Advanced Drug Delivery Reviews 56 (2004) 241-274. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Note that the entirety of the disclosure in the secondary references here was discussed under Claim Rejections - 35 USC § 103 and is/are invoked here in the obviousness analysis.
The difference is the presence of language for the particle size in the instant claim. The intended use of the base claim of 18132120 crystal (which has the same physical diffraction parameter) is the same as the instant claim 1 and 18132120 claim 12-15.
Morissette and Rodriguez summarize the impetus of and the benefit of synthesizing as many polymorphs as possible of any active pharmaceutical ingredient of interest, the traditional difficulties, and technological means of overcoming these difficulties. Even if the prior art polymorphs are not identical to Applicant’s claimed/recited polymorphs, it would have nonetheless been obvious to the person of ordinary skill in the art to follow the teachings of Morissette and Rodriguez, and obtain Applicant’s claimed/recited polymorphs. The person of ordinary skill in the art would have had a reasonable expectation of successfully obtaining instantly claimed/recited polymorphs by using high throughput technology which permits the person of ordinary skill in the art to evaluate thousands of crystallization experiments in parallel and identify all polymorphs of a particular active agent.
There is common ground that the biological activity of a compound depends primarily on its molecular structure. To reach its target it will at some point be in solution, e.g. in body fluids, where all differences among polymorphs disappear. The skilled person would thus expect that all polymorphs of the compound display the same pharmacodynamic profile. In addition, the methods to screen for polymorphs are well known in the art as taught by Morissette and Rodriguez. The skilled person being investigating the therapeutic application of the compound would thus routinely screen for polymorphs thereof. If such routine work yields other polymorphs, e.g. the presently claimed ones, then their provision is an obvious.
Likewise (for the same rationale as discussed above),
Claims 1, 3-9, 11-13, 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of US Application No. 19364877 further in view of Tachibana US 20230128162 = US 12559474= US Application 17790358; Unoh, bioRxiv (2022), 1-52 and Sun Int J Nanomedicine 2012 Nov 12;7:5733–5744, Zhao, Rev Bras Farmacogn 24(2014): 584-590; Wang, Pharmaceutics 2022, 14, 1901, Morissette, Advanced Drug Delivery Reviews 56 (2004) 275-300 and Rodriguez, Advanced Drug Delivery Reviews 56 (2004) 241-274. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Note that the entirety of the disclosure in the secondary references here was discussed under Claim Rejections - 35 USC § 103 and is/are invoked here in the obviousness analysis.
Note:
There is an Approved Terminal Disclaimer filed for claims of 19364877 in 18132120 which has a Notice allowance filed on 04/22/2026.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 11840526 same compound/composition without diffraction data.
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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