DETAILED ACTION
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 .
Amendments & Claim Status
The amendments to the claims filed 04 June 2026 is acknowledged and entered.
Claims 1, 6-8, 13-14, 16-17, and 21-32 are pending.
Claims 1 is amended.
Claims 21-32 are newly added.
Claims 2-5, 9-12, 15, and 18-20 are cancelled.
Claims 13-14 remain withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 04 June 2026 is acknowledged and has been considered. Any lined-through references have not been considered and must be submitted or resubmitted in proper format for consideration. Specifically, the IDS appears to contain a typo, as the listed foreign patent document is “CN 111511355 A”, but the submitted document is labelled “CN 111511365 A”.
Response to Arguments
Applicant arguments, filed 04 June 2026, with respect to the objections and rejections under 112(a), 112(b), 103, and on the ground of nonstatutory double patenting have been fully considered.
With respect to the objection to the abstract of the disclosure because it contains legal phraseology, Applicant’s arguments have been fully considered and are persuasive. Amendments moot the objection, as the abstract has been amended to remove legal phraseology.
The objection to the abstract of the disclosure of 26 February 2026 is withdrawn.
With respect to the objection of claim 3 due to informalities, Applicant’s arguments have been fully considered and are persuasive. Amendments moot the objections, as claim 3 has been cancelled by Applicant.
The objection of claim 3 of 26 February 2026 been withdrawn.
With respect to the rejection of claim 1 under 112(a) as failing to comply with the written description requirement, Applicant’s arguments have been fully considered and are persuasive.
Applicant argues amendments to claim 1 narrow the scope of claim 1 to include only active pharmaceutical ingredients and cellulose derivatives which are supported by the disclosure. Examiner agrees with Applicant’s assertion.
The rejection of claim 1 under 112(a) of 26 February 2026 been withdrawn.
With respect to the rejection of claims 4-5 under 112(b) on the basis that these claims contain improper Markush groups, Applicant’s arguments have been fully considered and are persuasive. Amendments moot the rejection, as claims 4-5 have been cancelled by Applicant.
The rejection of claims 4-5 under 112(b) of 26 February 2026 been withdrawn.
With respect to the rejection of claims 1-2, 4, 6-12, and 16-19 under 103 as being unpatentable over Mori (JP 2016014019 A) in view of Kesteleyn (WO 2016180696 A1; IDS dated 03 May 2023, Cite No. 12), Applicant’s arguments have been fully considered and are partially persuasive.
Amendments moot the rejection of claims 2, 4, 9-12, and 18-19, as claims 2, 4, 9-12, and 18-19 have been cancelled by Applicant.
Note the claims have been amended and therefore require new grounds of rejection. Accordingly, the previous rejection under 35 USC 103 is mooted by the amendments and is withdrawn. The responses herein are with respect to Applicant’s arguments in view of the amendments and are intended to clarify the record and support the new grounds of rejection.
Regarding Mori, Applicant argues Mori’s disclosure provides only general guidance regarding preparing pharmaceutical formulations, lacking any specific examples (Arguments, p. 10). Applicant asserts Mori lacks suggestions which would direct a person having ordinary skill in the art (PHOSITA) toward the instantly claimed invention, as Mori lacks teachings related to gastric fluid solubility, storage stability, and pharmacokinetic properties (Arguments, p. 11, ¶ 1). Furthermore, Applicant argues Kesteleyn fails to remedy Mori’s deficiency since, like Mori, Kesteleyn also provides a general disclosure, lacking guidance on preparing a pharmaceutical formulation containing a dengue viral replication inhibitor, stating the link connecting Mori and Kesteleyn can only be made using hindsight. Additionally, Applicant argues the combination of Kesteleyn and Mori lacks a clear teaching, suggestion, or motivation to combine the additives disclosed by Mori with the dengue inhibitor disclosed by Kesteleyn, as said dengue inhibitors are structurally unrelated to the antiviral compounds disclosed by Mori.
In response to Applicant’s argument that Examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may 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. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, while Applicant is correct in stating the compounds disclosed by Mori are structurally dissimilar to the dengue inhibitors disclosed by Kesteleyn, Mori’s and Kesteleyn’s compounds are analogous since said compounds are all viral replication inhibitors. Thus, a PHOSITA would have been motivated to substitute the hepatitis E viral replication inhibitor disclosed by Mori with another viral replication inhibitor used for other virus infections, such as dengue virus infections using a dengue viral replication inhibitor disclosed by Kesteleyn.
In response to Applicant’s argument that Mori and Kesteleyn have general disclosures which lack particular guidance on preparing a pharmaceutical formulation comprising a dengue viral replication inhibitor, specifically in relation to its gastric fluid solubility, storage stability, and pharmacokinetic properties, it is not necessary for Mori to expressly recognize the role certain additives (i.e. HPMC and/or methyacrylic acid copolymer) serve in pharmaceutical compositions, as a PHOSITA would understand the impact such excipients have on a composition’s pharmaceutical characteristics.
With respect to the rejection of claim 3 as being unpatentable over Mori (JP 2016014019 A) in view of Kesteleyn (WO 2016180696 A1; IDS dated 03 May 2023, Cite No. 12) and further in view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11) as evidenced by Bardiot (Bardiot et al., Journal of Medicinal Chemistry, 2018, 61(18), p. 8390-8401), Applicant’s arguments have been fully considered and are persuasive. Amendments moot the rejection, as claimed 3 has been cancelled by Applicant.
The rejections of claim 3 under 103 of 26 February 2026 has been withdrawn.
With respect to the rejection of claim 5 as being unpatentable over Mori (JP 2016014019 A) in view of Kesteleyn (WO 2016180696 A1; IDS dated 03 May 2023, Cite No. 12) and further in view of Cai (WO 2016161990 A2), Applicant’s arguments have been fully considered and are persuasive. Amendments moot the rejection, as claim 5 has been cancelled by Applicant.
The rejections of claim 5 under 103 of 26 February 2026 has been withdrawn.
With respect to the rejections on the ground of double patenting of:
Claims 1 and 9-10 as being unpatentable over:
Claim 2 of U.S. Patent No. 10,696,632 B2,
Claim 3 of U.S. Patent No. 10,919,854 B2, and
Claims 1-27 of U.S. Patent No. 12,172,959 B2;
Claim 1 as being unpatentable over:
Claims 3, 8, and 16-17 of U.S. Patent No. 9,944,598,
Claim 3 of U.S. Patent No. 10,765,662 B2,
Claims 2 and 4 of U.S. Patent No. 10,689,340 B2,
Claim 3 of U.S. Patent No. 10,029,984 B2,
Claim 3 of U.S. Patent No. 11,773,126 B2,
Claim 3 of U.S. Patent No. 10,786,484 B2,
Claims 3 and 5 of U.S. Patent No. 10,646,469 B2,
Claim 5 of U.S. Patent No. 11,179,368 B2,
Claim 6 of U.S. Patent No. 11,053,196 B2,
Claim 3 of U.S. Patent No. 11,702,387 B2,
Claim 5 of U.S. Patent No. 11,083,707 B2,
Claims 2 and 10 of U.S. Patent No. 10,913,716 B2,
Claim 3 of U.S. Patent No. 10,730,884 B2, and
Claim 10 of U.S. Patent No. 11,407,715 B2; and
Claims 1-8, 11-12, and 16-19 as being unpatentable over:
Claims 3 and 8 of U.S. Patent No. 10,206,902 B2.
In view of Huang (WO 2015103230 A9; IDS dated 03 May 2023, Cite No. 11).
Applicant’s arguments have been fully considered and are partially persuasive.
Amendments moot the rejections of claims 2-5, 9-12, and 18-19, as claims 2-5, 9-12, and 18-19 have been cancelled by Applicant.
The rejections of claims 2-5, 9-12, and 18-19 on the ground of double patenting of 26 February 2026 have been withdrawn.
Note claims have been amended and therefore require new grounds of rejection. Accordingly, the previous double patenting rejections are withdrawn.
Claim Objections
Claim 32 is objected to because of the following informalities:
A period is missing immediately following the number “32” in claim 32.
Appropriate correction is requested.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-8, 16-17, 21-23, 26-27, and 30-32, rejected under 35 U.S.C. 103 as being unpatentable over Mori (JP 2016014019 A) in view of Kesteleyn (WO 2016180696 A1; IDS dated 03 May 2023, Cite No. 12) and further in view of Cai (WO 2016161990 A2).
Regarding claims 1, 21-23, 26-27, and 30-32, Mori teaches a pharmaceutical composition comprising a plus-strand RNA viral replication inhibitor (p. 1, Technical Field) used in treating and/or preventing infectious diseases caused by viruses that express a superfamily 1 (SF1) helicase, which includes the hepatitis E virus (p. 5, Paragraphs 4-5). Other viruses, like dengue and hepatitis C, express SF2 helicases (p. 2, Paragraph 5, Sentence 1). Mori discloses a pharmaceutical composition containing an active ingredient, which is an RNA virus replication inhibitor (p. 6, Paragraph 3; p. 5, Paragraph 3), and a pharmaceutical additive, which may include substances such as sodium carboxymethyl cellulose (NaCMC), hydroxypropyl methylcellulose (HPMC), methyl cellulose (MC), and carboxymethyl cellulose (CMC) (p. 6, Last Paragraph). Furthermore, Mori discloses a solid preparation can be produced for oral administration which includes the active ingredient, a binder like HPMC, and a disintegrant like CMC or calcium carboxymethyl cellulose (CaCMC) (p. 7, First Paragraph). The solid preparation is granulated, and the resultant granules may receive an enteric coating such as hydroxypropylmethylcellulose phthalate, methacrylic acid-methyl methacrylate polymer, or ethylcellulose (EC) (p. 7, First Paragraph).
Mori does not explicitly teach the active ingredient is a dengue viral replication inhibitor or a pharmaceutical formulation wherein the cellulose derivative has a viscosity between 3-5,000 mPa·s in 2 wt% solution in H2O at 25°C and is HPMC E5, HPMC E6, HPMC E15, HPMC E50, HPMC K4M, or HPMC-AS..
Kesteleyn teaches dengue viral replication inhibitors (Title; p. 3, Lines 9-11), including the instantly claimed active pharmaceutical ingredient which is a dengue viral replication inhibitor (p. 5, Col. 1, Compound 4), shown below:
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Kesteleyn does not explicitly teach a formulation containing a cellulose derivative or a methacrylic acid copolymer a pharmaceutical formulation wherein the cellulose derivative has a viscosity between 3-5,000 mPa·s in 2 wt% solution in H2O at 25°C and is HPMC E5, HPMC E6, HPMC E15, HPMC E50, HPMC K4M, or HPMC-AS.
Cai teaches a coating method wherein the coating is HPMC having a viscosity between 30-60 mPa·s like HPMC E50 or 2.2-10 mPa·s like HPMC E5 or HPMC E6 (p. 3, Paragraph 3, Middle). Furthermore, Cai discloses HMPC is dissolved in H2O (p. 5, Paragraph 2, Sentence 1), the mass percentage HPMC is 5-10% (p. 5, Paragraph 3, Last Sentence), and the coating process occurs at between 35-60°C (p. 5, Paragraph 3).
Cai does not explicitly teach a 2 wt% solution at 25°C or an API which is a viral replication inhibitor.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Mori would have found it prima facie obvious to prepare a pharmaceutical formulation comprising the instantly recited dengue viral replication inhibitor, a methacrylic acid copolymer, and a cellulose derivative based on the teachings of Kesteleyn and Cai because a PHOSITA would have expected success in substituting Mori’s hepatitis E viral replication inhibitor for Kesteleyn’s dengue viral replication inhibitor because these active pharmaceutical ingredients (APIs) exhibit similar properties in a pharmaceutical composition by inhibiting viral replication and Mori discloses it is favorable to administer an API in a pharmaceutical composition containing one or more pharmaceutical additives (p. 6, Paragraph 3). A PHOSITA would have understood solid formulations which allow pharmaceutical compositions to be administered orally are desirable, but often require an enteric coating to attenuate disintegration in a gastric environment. Furthermore, Kesteleyn discloses an oral dosage composition containing a dengue viral replication inhibitor would be advantageous due to the ease with which capsules and tablets can be administered (p. 7, Lines 31-34). Thus, a PHOSITA would have been motivated to replace the API in the pharmaceutical composition disclosed by Mori with an API disclosed by Kesteleyn to treat a dengue virus infection instead of or in addition to a hepatitis E virus infection.
Furthermore, a PHOSITA would have had a reasonable expectation of success in modifying the teachings of Mori to incorporate the teachings of Kesteleyn and Cai and prepare a pharmaceutical formulation comprising the API compounds of Formula (I) described by Kesteleyn in combination with the cellulose derivatives as disclosed by Mori in the amounts and under the conditions described by Cai. A skilled artisan would have expected the cellulose derivative to become more viscous at lower temperatures and less viscous at higher temperatures. Thus, a PHOSITA would have known to optimize the HPMC concentration to via routine experimentation to achieve the desired viscosity (MPEP 2144.05(II)). In addition, Cai indicates too much HPMC results in a coating which is to too viscous to be sprayed whereas too little HPMC causes the coating efficiency to be poor (p. 5, Paragraph 2).
Regarding claims 6 and 16-17, the combination of Mori, Kesteleyn, and Cai teaches all of the claimed elements as stated above. Furthermore, Mori suggests a skilled artisan can determine the ideal ratio between the API and any additives in the pharmaceutical composition and indicates the composition may be blended in an amount 1-90% by weight based on the API’s weight (p. 6, Last Paragraph). Kesteleyn suggests the appropriate pharmaceutical composition depends on the route by which it is administered (p. 7, Lines 16-34) and artisans skilled in treating infectious diseases will be able to determine the appropriate API amount, but this will depend on the specific compound of Formula (I) used in the composition and the individual receiving the composition (p. 8, Lines 8-20).
With respect to claims 6 and 16-17, the combination of Mori, Kesteleyn, and Cai fails to explicitly disclose a pharmaceutical formulation containing ≤ 40 wt% API.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Mori would have found it prima facie obvious to prepare pharmaceutical formulation containing ≤ 40 wt% API based on the teachings of Kesteleyn and Cai. A PHOSITA would have known to optimize the API amount necessary in the pharmaceutical formulation through routine experimentation to achieve the desired inhibitory effect on viral replication (MPEP 2144.05(II)). Furthermore, both Mori and Kesteleyn indicate a skilled artisan could determine the ideal API amount in the formulation.
Regarding claim 7, the combination of Mori, Kesteleyn, and Cai teaches all of the claimed elements as stated above. Furthermore, Mori indicates a lubricant like magnesium stearate or talc may also be included in a solid preparation (p. 7, First Paragraph). In addition, Kesteleyn suggests any “usual pharmaceutical media” may be utilized in when preparing an oral dosage preparation and broadly lists disintegrating agents, binders, diluents, and lubricants as media which may be included (p. 7, Lines 25-31). Kesteleyn indicates choosing appropriate excipients depends on the particular administration method being utilized, as the excipient used in the formulation may have an impact on its solubility and stability (p. 7, Lines 11-15).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Mori would have found it prima facie obvious to prepare a pharmaceutical formulation comprising one or more pharmaceutically acceptable excipients based on the teachings of Kesteleyn and Cai because a PHOSITA would understand excipients help modulate pharmaceutical properties and Mori and Kesteleyn both teach the use of excipients.
Regarding claim 8, Mori in view of Kesteleyn teaches all of the elements of the claimed invention as stated above. Furthermore, Mori teaches an API and pharmaceutically acceptable excipients can be mixed to create a powder, to which a binder like HPC or a disintegrant like CMC may be added in combination with a granulate. Then, a lubricant like magnesium stearate can be added prior to forming the granules into tablets. Mori suggests the resultant tablets should receive an enteric or EC coating and indicates the powder or granules may also be packaged into capsules (p. 7, First Paragraph).
Mori does not explicitly use the terms “intragranular phase” and “extragranular phase.”
The instant specification defines the term “intragranular phase” as, “…those components of a formulation that are with granules and/or within granules,” (p. 31, Lines 29-30) and the term “extragranular phase” as, “…those components of a formulation that are outside of the granules” (p. 31, Lines 31-32). The intragranular phase may contain a lubricant, such as magnesium stearate (p. 37, Lines 22-24).
Because Mori indicates granules containing an API and magnesium stearate should receive a coating, the granules and coating are equivalent to the “intragranular phase” and the “extragranular phase,” respectively. Thus, it would have been prima facie obvious to a PHOSITA before the effective filing date of the claimed invention to have modified Mori to incorporate the teachings of Kesteleyn and prepare a pharmaceutical formulation comprising granules containing inner and outer layers (i.e. an intragranular and extragranular phase).
Claims 24-25 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Mori (JP 2016014019 A) in view of Kesteleyn (WO 2016180696 A1; IDS dated 03 May 2023, Cite No. 12) and further in view of Cai (WO 2016161990 A2) and Ellenberg (CN 111511365 A; IDS dated 04 June 2026, Cite No. 1).
Regarding claims 24-25 and 28-29, the combination of Mori, Kesteleyn, and Cai teaches all of the claimed elements as stated above.
With respect to claims 24-25 and 28-29, the combination of Mori, Kesteleyn, and Cai fails to explicitly disclose a pharmaceutical formulation wherein the API and either the methacrylic acid copolymer or cellulose derivative are present in a ratio from 4:1 w/w to 1:9 w/w or 2:1 w/w to 1:3 w/w.
Ellenberg teaches pharmaceutical compositions comprising an API and one or more pharmaceutically acceptable excipients (p. 2, Claim 1). The excipient can be hydroxypropyl cellulose, ethyl cellulose, or methacrylate-methacrylic acid copolymer (p. 2, Claims 6-7). Ellenberg indicates, “…the ratio of the active pharmaceutical ingredient to the pharmaceutical excipient is approximately 2:3.” (p. 5, Claim 28). Additionally, Ellenberg suggests the API to excipient ratio may also be 3:27 (p. 4, Claim 27).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Mori, Kesteleyn, and Cai would have found it prima facie obvious to prepare a pharmaceutical formulation wherein the API and either the methacrylic acid copolymer or cellulose derivative are present in a ratio from 4:1 w/w to 1:9 w/w or 2:1 w/w to 1:3 w/w based on the teachings of Ellenberg because Ellenberg suggests ratios of API to excipient which are within the instantly claimed ratio ranges. Thus, a PHOSITA would have been motivated to optimize the ratio of the API to either the methacrylic acid copolymer or cellulose derivative to achieve the desired antiviral effect guided by Ellenberg’s teachings.
Non-Statutory 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, 7-8, 22-23, 26-27, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 10,696,632 B2, claims 1-2 and 23-27 of U.S. Patent No. 12,172,959 B2, and claims 1-3 of U.S. Patent 10,029,984 B2 in view of Mori (JP 2016014019 A) and Cai (WO 2016161990 A2).
Patent ‘632 claims a pharmaceutical composition comprising the instantly recited compound as well as one or more pharmaceutically acceptable excipients, diluents, or carriers (Claim 2).
Patent ‘632 does not expressly claim a methacrylic acid copolymer or a cellulose derivative.
Patent ‘959 claims a pharmaceutical composition comprising the instantly recited compound as well as one or more pharmaceutically acceptable excipients, diluents, or carriers (Claim 1)
Patent ‘854 does not expressly claim a methacrylic acid copolymer or a cellulose derivative.
Patent ‘984 claims a pharmaceutical composition comprising a compound which is similar to the instantly recited compound (i.e., Cl is F) as well as one or more pharmaceutically acceptable excipients, diluents or carriers.
Patent ‘984 does not expressly claim a methacrylic acid copolymer or a cellulose derivative.
See rejections under 103 supra for rationale which applies in equal or greater force to the issued claims.
Because claims 1, 7-8, 22-23, 26-27, and 30-31 in the instant application would have been obvious over claim 2 of U.S. Patent No. 10,696,632 B2, claims 1-2 and 23-27 of U.S. Patent No. 12,172,959 B2, and claims 1-3 of U.S. Patent 10,029,984 B2 in view of Mori and Cai, claims 1, 7-8, 22-23, 26-27, and 30-31 in the instant application are not patentable distinct from claim 2 of U.S. Patent No. 10,696,632 B2 and claims 1-2 and 23-27 of U.S. Patent No. 12,172,959 B2.
Conclusion
Claims 1, 6-8, 16-17, and 21-32 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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