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 .
Election/Restrictions
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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.
Claims 143, 155-159, and 170-183 are rejected under 35 U.S.C. 103 as being unpatentable over Sage, WO2014169833; Sage,WO2019051264 and Sage WO2019241442 and US 11236121, further in view of Mittal WO2010134965
‘833 describes pharmaceutical compositions (see page 70 L.6-p.71 L.16, in claim 43) comprising GABA receptor modulator such as present compound (page 122, SA-4)
for the treatment of CNS-related disorders (in claims 44,45, p. 71-81). Tablets and capsules comprising present compound is described in Exemplary formulations 1,4,6-10 (see p.70-71).
The difference between the compositions of ‘833 and the instant base claim 143 is in the % amount of active ingredient and % excipients mannitol and microcrystalline cellulose and croscarmellose and silicon dioxide and stearyl fumarate (more on excipients below). Thus while ‘833 teaches pharmaceutical compositions containing the active ingredient and at least some of the excipients and how to make with different amounts. Also acknowledged here is that ‘833 does not teach the specific crystalline form of the instant active SA-4.
Disclosure in 11236121 is invoked here with regards to crystalline form(s). Compare instant claim 180 XPRD peak numbers with the corresponding numbers of claim 8 of 11236121.
‘264 and ‘442 teach also teach pharmaceutical compositions containing crystalline versions of the active ingredient. For example, reference to crystal forms (including conversion of one crystal form to a different crystal form at Fig 6) are taught about 70 times in ‘264. Thus making crystalline forms and recording diffraction pattern or finding out physical properties such DSC is explicitly taught in the prior art. The role of polymorphism in pharmaceutical composition is of paramount importance in the art (and to arrive at alternate versions of prior art active ingredients). For examples see Brittain, Polymorphism in pharmaceutical solids. Applicant is encouraged to use routine ‘word’ search for ‘crystal’ in the is art. The term ‘crystal’ occurs 148 in Brittain’s teaching DRUGS AND THE PHARMACEUTICAL SCIENCES VOLUME 192, 2nd Edition, 2009. This reference is not in the rejection statement because the area of polymorphism in the pharmaceutical art is one of elementary knowledge. Also see https://www.intechopen.com/chapters/82182# Available online.Pharmaceutical Crystals: Development, Optimization, Characterization and Biopharmaceutical Aspects. As such from common general knowledge, it is known that the systematic investigation of a compound to determine whether it is prone to polymorphism is routine practice in the pharmaceutical industry. It is also known that most substances when investigated for a sufficiently long time will reveal more than one polymorph and methods to screen for polymorphs are well known in the art. The skilled person being interested in the therapeutic application of the compound of formula (I) would thus routinely screen for polymorphs of this compound. The crystalline forms disclosed in the present application do not present a substantiated unexpected property which is relevant for its application as a medicament when the person skilled in the art starts from the cited reference. ‘833teaches that the compound of formula (I) is a solid, so that the person skilled in the art would expect with a very high degree of certainty to find one or more crystalline forms of the compound of formula (I). This is work routinely done in the pharmaceutical art and, thus, would have been within the level of skill of the ordinary artisan in the art at the time of the present invention.
‘264 Abstract:
‘264 describes on p.30 L.14-p.31 L.12 solid dosage forms comprising a binding agent, a filler (for example lactose, sugar, maize-starch, calcium phosphate, sorbitol and glycine); a tabletting lubricant (for example magnesium stearate); a glidant (e.g., magnesium trisilicate, powdered cellulose, starch, talc and tribasic calcium phosphate) and a disintegrants (for example starch, sodium starch glycollate and microcrystalline cellulose) etc...
‘442 Abstract:
‘442 describes on p.49 L.10-15 capsules comprising zuranolone, croscarmellose sodium, mannitol, silicified microcrystalline cellulose (SMCC), colloidal silicon dioxide and sodium stearyl fumarate as excipients.
‘264 and ‘442 describe zuranolone (also called SAGE-217), a 19-nor C3,3- disubstituted C21-pyrazolyl neuroactive steroid. Zuranolone differs from present compound only with the carbonitrile group of the position 4 of the pyrazole, which is a methyl in present case.
‘264 describes on p.30 L.14-p.31 L.12 solid dosage forms comprising a binding agent, a filler (for example lactose, sugar, maize-starch, calcium phosphate, sorbitol and glycine); a tabletting lubricant (for example magnesium stearate); a glidant (e.g., magnesium trisilicate, powdered cellulose, starch, talc and tribasic calcium phosphate) and a disintegrants (for example starch, sodium starch glycollate and microcrystalline cellulose) etc...
‘442 describes on p.49 L.10-15 capsules comprising zuranolone, croscarmellose sodium, mannitol, silicified microcrystalline cellulose (SMCC), colloidal silicon dioxide and sodium stearyl fumarate as excipients.
‘965 is invoked here for the routine use of inactive ingredients (excipients) in different amounts in pharmaceutical compositons. See for example, ‘965 in claims
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While ‘965 does not teach the instant active ingredient, ‘965 is invoked here for the knowledge of one skill in the art for use of instant inactive ingredients and for arriving at optimum amounts of these in pharmaceutical compositions. Therefore, the invention is a selective combination of previously known ingredients (active and inactive) 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). Further as to the limitations of claims wt% amounts, 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).
Therefore, there is 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.
Claims 143, 155-157, and 170-183 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US 11236121 further in view of Sage, WO2014169833; Sage,WO2019051264 and Sage WO2019241442 and US 11236121, further in view of Mittal WO2010134965 Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to overlapping subject matter.
The difference is that the instant claim language with respect to ‘composition’. Note that the entirety of the discussions under section 35 USC § 103 is invoked here as subject matter known to one of skill in the art, in the obviousness analysis as per Graham v. John Deere Co..
Further, note that reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application.
The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are:
1. The disclosure can be used as a dictionary for claim terminology; and
2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804).
The MPEP further notes:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”)
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
Likewise, (Likewise means, for same rationale presented above)
Claims 143, 155-157, and 170-183 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 18-20 of U.S. Patent No. US 12122804 .
Claims 143, 155-157, and 170-183 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of US 12358942.
Likewise, (Likewise means, for same rationale presented above)
claims 143, 155-157, and 170-183 are rejected on the ground of nonstatutory double patenting as being unpatentable over 29-32, 35-37, 39, 40, 42 and 48-51 of copending Application No. 18006141 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following is consistent with Remarks filed
Copending Applications
Applicant is encouraged to check for additional copending applications and issued patents for overlapping subject matter in the claims and file terminal disclaimers.
MPEP 2001.06(b) Information Relating to or From Copending United States Patent Applications [R-08.2012]: The individuals covered by 37 CFR 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are “material to patentability” of the application in question. As set forth by the court in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972):
[W]e think that it is unfair to the busy examiner, no matter how diligent and well informed he may be, to assume that he retains details of every pending file in his mind when he is reviewing a particular application . . . [T]he applicant has the burden of presenting the examiner with a complete and accurate record to support the allowance of letters patent.
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