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 .
Amended claims 1, 11, 14-15, 17, 18 and withdrawn claim 20 are pending.
Upon further considerations product claims 1, 11, 14-15, 17, 18 and method claim 20 are examined together.
Amendments overcome the previously presented rejection under Claim Rejections - 35 USC § 102.
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, 11, 14-15, 17, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Desai WO2014102818, Cai WO2016049097, Deng WO 2007115315 and Haley US8426368.
pharmaceutical composition comprising 40 %w/w of compound of formula Ia (hereinafter active ingredient or Desidustat) ;44 % w/w microcrystalline cellulose;5 % w/w croscarmellose sodium;5 % w/w lactose monohydrate;4 % w/w hypermellose:1 % w/w talc; and1 % w/w maqnesium stearate;wherein the pharmaceutical composition is in the form of a tablet, caplet, or capsule core or an uncoated tablet, caplet or capsule, and method of using (claim 20) the composition.
The active ingredient is well-known commercially available anemia drug Desidustat or ZYAN1 or Oxemia. The specification is silent with regards to the commercial name of the active ingredient.
The biological property of the compound as well as its poor aqueous solubility are also known to one of skill in the art.
Desai teaches pharmaceutical compositions comprising the Desidustat or its pharmaceutically acceptable salts and one or more pharmaceutically acceptable carriers, diluents, or excipients (see claims 9-12). It also discloses a method for the treatment of anemia in a patient which comprises administering to a patient in need thereof an effective amount of composition through the inhibition of HIF prolyl hydroxylase.
While Desai disclosure includes excipients in the composition in generic terms, Desai is silent with respect to the excipients as limited by the claim (microcrystalline cellulose) AND (Croscarmellose sodium) AND (lactose monohydrate) AND (Hypermellose) and Talc AND (magnesium stearate) or the amounts of active and inactive ingredients.
The teachings of Cai, Deng and Haley are invoked to cure the deficiency of Desai.
The teachings of Cai and Deng in the same area of endeavor with structurally similar compounds with same biological properties are shown below:
Cai discloses pharmaceutical compositions for treating anemia comprising inhibitors of HIF prolyl hydroxylase wherein the composition further includes colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, starch, and lactose.
Deng discloses the HIF inhibitors and compositions comprising thereof. The composition comprises pharmaceutical excipients such as a binder, disintegrant, coating aid, lubricant, sweetener or flavoring, suspending/gelling agent, or wet granulation agent. Binders include, e.g., carbopol, povidone, xanthan gum, etc.; coatings include, e.g., cellulose acetate phthalate, ethylcellulose, gellan gum, maltodextrin, etc.; compression/encapsulation aids include, e.g., calcium carbonate, dextrose, fructose, honey, lactose (anhydrate or monohydrate; optionally in combination with aspartame, cellulose, or microcrystalline cellulose), starch de, sucrose, etc.; disintegrants include, e.g., croscarmellose sodium, gellan gum, sodium starch glycolate, etc.; creams and lotions include, e.g., maltodextrin, carrageenans, etc.; lubricants include, e.g., magnesium stearate, stearic acid, sodium stearyl fumarate. See paragraph [0112]
The use of all excipients of the instant claim are known in the same area of research as the instant case. Further, the use of such excipients in the pharmaceutical also well-known in related pharmaceutical art. For example, pharmaceutical compositions consisting of all the instant excipients are found in the claims 31 and 32 of Haley and column 22, Table 9-1.
Therefore the issue here is the selective combination of w/w ratio of the active and individual inactive ingredients as per the claims. 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).
Response to Applicant’s argument:
Applicant argues (see page 9 Figure 1 onwards) that significant increase in hemoglobin and RBC levels are obtained with the claimed composition. However as noted in above, as per examination guidelines, routine optimization of routinely used result effective variables is obvious to one of skill in the art. Given this acknowledged methods of improving desired properties, Applicant pointed out results are expected. For discussion of Examination guidelines regarding this, see MPEP 716.02(a) Evidence Must Show Unexpected Results [R-07.2022].
As such nothing unobvious is seen in the claims.
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.
Claim(s) 1, 11, 14-15, 17, 18 and 20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 62 of copending Application No. 18688677 (reference application), further in view of Desai WO2014102818, Cai WO2016049097, Deng WO 2007115315, Haley US8426368 and Wang, Pharmaceutics 2022, 14, 1901. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claim contain overlapping subject matter as explained below.
Active and inactive ingredient in the composition in conflicting claims are the same. The difference is that claims of 18688677 are drawn to the active ingredient (with art acknowledged nomenclature) in specific particle sizes and the amount of inactive ingredients are defined in ranges. The teachings of Desai, Cai and Deng and Haley discussed under section 103 is invoked here for the use of the components in the composition in conflicting claims. Further the Review article of Wang is invoked here for the limitation of particle size in the claims of 18688677. According to Wang, article size plays a crucial role in the performance of pharmaceutical products. For example, the dissolution behavior of an active pharmaceutical ingredient (API) depends on particle size, where larger specific surface area of smaller API particles yields faster dissolution. Note Wang is post-filing date Review providing state of the prior art references for ‘Size Specifications as a Result of Particle Engineering Methods’ for optimizing properties of pharmaceutical compositions.
The above is reformatted version (in view of amendments to claims) of previously presented NSDP. It is noted that Applicant is non-responsive to the rejection of record.
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.
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.
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, 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.
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
Prosecution Insights