Prosecution Insights
Last updated: April 19, 2026
Application No. 18/265,317

SOLID PREPARATION

Non-Final OA §103§DP
Filed
Jun 05, 2023
Examiner
CHANDRAKUMAR, NIZAL S
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Aska Pharmaceutical Co. Ltd.
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
2y 4m
To Grant
91%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
1273 granted / 1752 resolved
+12.7% vs TC avg
Strong +18% interview lift
Without
With
+17.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 4m
Avg Prosecution
76 currently pending
Career history
1828
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
30.0%
-10.0% vs TC avg
§102
12.0%
-28.0% vs TC avg
§112
35.3%
-4.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1752 resolved cases

Office Action

§103 §DP
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. Am ended claims 1-17 are pending. Election/Restrictions 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) 1-7, 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakagawa WO2017195804 , Thoorens, WO2011056785 , Kahn Chapter 13 in Amjad , Calcium Phosphate in Biological Systems, 1988 ; Kataoka , US 6861071 . The elected species is so lid pr eparation containing a combination of the active ingredient A, the excipients first carrier B and second carrier C. Nakagawa at t op of page 17 and subsequent Tables teach A. The fo cus of Nakagawa is so lid pr eparation of A. Though other preparation are included, as highlighted below, Nakagawa invention is a so lid pr eparation: See section under Use and pharmaceutical composition in English Machine Translation : Also s ee Nakagawa section above Example 1 for dosage information (for claim 15). Nakagawa disclosure does not explicitly include the el ected sp ecies B and C as carriers, rather Nakagawa teachings include these B and C in the so lid pr eparation in generic functional language such as ‘ dis integrant ”. Further though B and C are noted as ca rriers , Nakagawa does not use the language ‘first ca rriers ’, ‘second ca rrier ’. The species B and C are well-known in the prior art for making pharmaceutical solid dosage forms. For example, Thoorens teaches, “ microcrystalline cellulose and calcium phosphate compositions useful as pharmaceutical excipients ”; Thoorens Abstracts reads ‘ Compositions containing calcium phosphate and microcrystalline cellulose are useful as excipients in the preparation of solid dosage forms containing active pharmaceutical ingredients, particularly those prepared by processes involving multiple compaction steps. The recompactibility performance of such compositions is improved through the use of calcium phosphate having a relatively small particle size . The science behind the routine use B and C is also well-known in the art. See the following Text Book teachings: As taught in Chapter 13 by Khan in the cited T ext B ook of Amjad , in pharmaceutical development, (B) and (C) are inactive excipients routinely used in solid formulation s : Calcium phosphate (CaP) is a wi dely us ed, biocompatible, and chemically stable excipient in so lid pr eparations , primarily functioning as a filler and binder in tablets and capsules due to its excellent flowability and compressibility. Common forms include anhydrous/dihydrate dibasic calcium phosphate. Calcium phosphate is especially valuable for direct compression, facilitating the manufacturing of tablets without wet granulation techniques. Micro cryst alline cel lulose (MCC) is a widely used excipient in solid pharmaceuticals, acting as a binder, filler, and dis integrant due to its high crystallinity and compressibility. Derived from purified cellulose, it enables direct compression of tablets without granulation, offering excellent tensile strength and fast disintegration. According to opening statement in K han , Chapter 13 Calcium phosphate is a widely used pharmaceutical excipient as binder and filler in solid oral dosage forms which include compressed tablets and hard gelatin capsules. A review of the marketed tablets and capsules indicated that several of them contain calcium phosphate. Some of the commonly used dosage forms are Benadryl®, Sudafed®, Decadron®, Norvasc®, Ex-Lax®, and Gas-~. The wide acceptance of calcium phosphate is primarily due to its excellent flowability and compressibility characteristics. Applicant is encouraged to use word search technique to locate the teaching B at 19 locations in Khan and C 48 times in Khan. The limi tations of with regards to B and C in generic functional language in claim s 4-7 and 16 . 17 , are in Thoorens teachings as highlighted and discussed above. The routine use of B and C as taught by Khan, in the preparation of pharmaceutical so lid pr eparation is exemplified in Kataoka titled “ Highly Absorptive so lid pr eparation ” at c olumn 3, line 62 onto column 4 line 11 and working example-2 column 5 section onto column 6 . As such nothing unobvious is seen in the claims of 1-7, 15-17. The prior art made of record and not relied upon considered pertinent to applicant's disclosure include US7557123; US6872732; US20040132756;US6589963. . 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 1-17 rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-7 of U.S. Patent No. 12458650 , further in view of Nakagawa WO2017195804 , Thoorens, WO2011056785 , Amjad , Calcium Phosphate in Biological Systems, 1988; Kataoka , US 6861071 . Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter , a s explained below: The elected species is so lid pr eparation containing a combination of the active ingredient A, the first carrier B and second carrier C. Claim 1 of 12458650 is drawn to the use of A for treatment of urination disorder ( as per instant claims 9-14) . Claims of 12458650 is silent with respect to what so lid pr eparation of A is dosed in the dosage of claim 7 of 12458650 . The teachings of Nakagawa, Amjad and Kataoka cure this deficiency of 12458650 , because these secondary references teach why and how for making pr eparation of (A). The fo cus of Nakagawa is so lid pr eparation of A. Though other preparation are included, as highlighted below, Nakagawa invention is a so lid pr eparation: See section under Use and pharmaceutical composition in English Machine Translation: Also see Nakagawa section above Example 1 for dosage information (for claim 15). Nakagawa disclosure does not explicitly include the el ected sp ecies B and C as carriers, rather Nakagawa teachings include these B and C in the so lid pr eparation in generic functional language such ‘ dis integrant ”. Further though B and C are noted as ca rriers, Nakagawa does not use the language ‘first ca rriers’, ‘second ca rrier’. B and C are well-known in the prior art for making pharmaceutical solid dosage forms. For example, Thoorens teaches, “ microcrystalline cellulose and calcium phosphate compositions useful as pharmaceutical excipients”; Abstracts reads ‘ Compositions containing calcium phosphate and microcrystalline cellulose are useful as excipients in the preparation of solid dosage forms containing active pharmaceutical ingredients, particularly those prepared by processes involving multiple compaction steps. The recompactibility performance of such compositions is improved through the use of calcium phosphate having a relatively small particle size . The science behind the routine use B and C is also well-known in the art. See the following Text Book teachings: As taught in Chapter 13 by Khan in the cited T ext B ook of Amjad , in pharmaceutical development, (B) and (C) are inactive excipients routinely used in solid formulations: Calcium phosphate (CaP) is a wi dely us ed, biocompatible, and chemically stable excipient in so lid pr eparations , primarily functioning as a filler and binder in tablets and capsules due to its excellent flowability and compressibility. Common forms include anhydrous/dihydrate dibasic calcium phosphate. Calcium phosphate is especially valuable for direct compression, facilitating the manufacturing of tablets without wet granulation techniques. Micro cryst alline cel lulose (MCC) is a widely used excipient in solid pharmaceuticals, acting as a binder, filler, and dis integrant due to its high crystallinity and compressibility. Derived from purified cellulose, it enables direct compression of tablets without granulation, offering excellent tensile strength and fast disintegration. According to opening statement in K han , Chapter 13 Calcium phosphate is a widely used pharmaceutical excipient as binder and filler in solid oral dosage forms which include compressed tablets and hard gelatin capsules. A review of the marketed tablets and capsules indicated that several of them contain calcium phosphate. Some of the commonly used dosage forms are Benadryl®, Sudafed®, Decadron®, Norvasc®, Ex-Lax®, and Gas-~. The wide acceptance of calcium phosphate is primarily due to its excellent flowability and compressibility characteristics. Applicant is encouraged to use word search technique to locate the teaching B at 19 locations in Khan and C 48 times in Khan. The limi tations of with regards to B and C in generic functional language in claims 4-7 and 16. 17, are in Thoorens teachings as highlighted and discussed above. The routine use of B and C as taught by Khan, in the preparation of pharmaceutical so lid pr eparation is exemplified in Kataoka titled “ Highly Absorptive so lid pr eparation” at column 3, line 62 onto column 4 line 11 and working example-2 column 5 section onto column 6. With the teachings of Nakagawa, Amjad and Kataoka one of skill in the art would have reasonable expectation of success in the arriving at solid preparation for use of A as per claims of 12458650 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NIZAL S CHANDRAKUMAR whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6202 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8-5 EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Andrew Kosar can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-0913 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NIZAL S CHANDRAKUMAR/ Primary Examiner, Art Unit 1625
Read full office action

Prosecution Timeline

Jun 05, 2023
Application Filed
Mar 29, 2026
Non-Final Rejection — §103, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
73%
Grant Probability
91%
With Interview (+17.9%)
2y 4m
Median Time to Grant
Low
PTA Risk
Based on 1752 resolved cases by this examiner. Grant probability derived from career allow rate.

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