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 .
The claims are filed with Remarks filed 04/24/2026
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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.
Previously presented rejection of claims 143, 155-159, and 170-183 rejected under 35 U.S.C. 103 as being unpatentable over Sage, WO2014169833; Sage, WO2018039378; Sage,WO2019051264 and Sage WO2019241442 and US 11236121, further in view of Mittal WO2010134965. Brittain’s teaching DRUGS AND THE PHARMACEUTICAL SCIENCES VOLUME 192, 2nd Edition, 2009 is maintained for reasons of record.
WO2018039378 and Brittain’s Text book are now in rejection statement.
Applicants arguments are not persuasive.
The arguments focus on the following:
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Response:
The rejection is not under 102.
The active ingredient and the included excipients are previously known the art. Arriving at optimum range of the ingredients is within the routine skill in the art engaged in arriving at alternate formulations/combinations of previously known agents. The term ‘crystalline form’ is an umbrella term. For example WO2018039378 describes many crystalline forms of the prior art active ingredient.
The position taken is that the w/w optimization of the agents is routine in the art. 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.
MPEP guidance with regards to selective combination of prior art elements and routine optimization of workable range are elaborated in the previous action.
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). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). see MPEP § 2144.05 part II A. Although the prior art did not specifically disclose the amounts of each constituent, it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of components because concentrations of the claimed components are art-recognized result effective variables because they have the ability for controlling parasites, which would have been routinely determined and optimized in the pharmaceutical art.
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. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). KSR Int. Co. v. Teleflex Inc, 550 U.S. 82 USPQ2d 1385 (2007), instructs courts to take a more “expansive and flexible approach” in determining whether a patented invention was obvious at the time it was made. 550 U.S. at 415. In particular, the Court emphasized the role of “common sense”. “Rigid preventative rules that deny fact finders recourse to common sense … are neither necessary under our case law nor consistent with it.” Id. at 421. See also, Wyers v. Master Lock Co, 95 USPQ2d 1525, (Fed. Cir. 2010).
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
With respect to Applicant argument
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Response:
Optional use of mannitol and dicalcium phosphate, see claims of US11197896 (claims 5, 7 and in particular 20) and US5232704 (claims, claim 6).
In the comparative data, other factors are present in the different samples. At 75 minutes composition 33 is similar to that of composition and 35 and composition and 34 which have pregelatinized Starch and silicified microcrystalline cellulose respectively, not as limited by the claim 1.
The very purpose of routine optimization of using previously known agents is to arrive better results in this case, desirable dissolution properties.
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.
From previous action:
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).
Suggestion:
Amend base claim limiting to compositions 34 and 35 as per Table 39, including the micronized compound 1 (that is micronized crystalline Form C with diffraction data)
and File Terminal Disclaimers as per rejections of record.
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.
Previously presented rejection of claims 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 is held in abeyance as requested by the Applicant. .
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.”)
Likewise, (Likewise means, for same rationale presented above)
Previously presented rejection of 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 is held in abeyance as requested by the Applicant. .
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The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US11884696 Crystalline 19-nor C3,3-disubstituted C21-n-pyrazolyl Steroid.
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.
THIS ACTION IS MADE FINAL. 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