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 .
Priority
The present Application, filed April 27, 2023, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/CN2021/128402, which claims priority to Chinese Patent Application No. CN202011206371, filed November 3, 2020.
Status of the Claims
In the amendment filed January 21, 2026, new claims 1-13, 15, 16, and 20 are amended. Claims 1-20 are currently pending.
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn.
Response to Arguments and Amendments
Rejections for anticipation/obviousness:
Addressing the rejections for anticipation, Applicant asserts (pg. 17 of Applicant’s Remarks of January 21, 2026, fourth paragraph) that, while a pharmaceutical tablet can include a solid dispersion, the tablet of Wang does not necessarily include a solid dispersion, and solid dispersion is not expressly mentioned in Wang. It is noted that the term “solid dispersion” has a qualitatively understood meaning in the art, but it is amenable to multiple definitions. See, for example, the non-patent publication, Fundamental aspects of solid dispersion technology for poorly soluble drugs, Acta Pharm. Sinica B, 4, pgs. 18-25 (2014) by Huang et al. (hereinafter, “Huang”) which distinguishes a broad historical descriptor of “solid dispersion” from a narrower definition that only includes amorphous molecular dispersions, or “glass solutions” (pg. 19, left column, third paragraph). Huang discusses various techniques that can be used to characterize a composition as being a “solid dispersion” according to the narrower definition, techniques that include DSC and solid-state NMR (pgs. 20-21). Alternatively, the non-patent publication, Solid Dispersion- A Review, PharmaTutor, 5, pgs. 24-29 (2017) by Kumar (hereinafter, “Kumar”) defines solid dispersion substantially according to methods of forming it (pg. 24, right column, Solid Dispersion, first paragraph), and teaches a list of methods that can be used to form a solid dispersion. Meanwhile, the non-patent publication, Use of the Co-grinding Method to Enhance the Dissolution Behavior of a Poorly Water-Soluble Drug: Generation of Solvent-Free Drug–Polymer Solid Dispersions, Chem. & Pharm Bulletin (Tokyo), 60, pgs. 837-845 (2012) by Yang et al. (hereinafter, “Yang”) teaches that co-grinding active ingredient and excipient, a method not listed in Kumar, can form a pharmaceutical solid dispersion (Abstract). Yang notes that, unlike the more stringent current definition of Huang, the active ingredient in a solid dispersion can be either microcrystalline or amorphous (pg. 837, left column, first paragraph). As such, the criteria for what constitutes a “solid dispersion” in the art are somewhat fluid and variable, depending on source.
In contrast to the varying definitions of “solid dispersion” in pharmaceutical formulations, relating frequently to physical properties and/or methods of formation, the instant specification provides a very generic and broad definition of the term at pg. 21, second full paragraph. It states that a “solid dispersion” of the disclosure refers to any solid composition with at least two components, comprising and active ingredient dispersed in at least one other component (such as the carrier of instant claim 1). According to this very broad definition, which is not tied to any physical characteristics (aside from “dispersion”), analytical techniques, or methods of formation, it appears that essentially any tablet of Wang in which active ingredient and excipient are co-ground, would include such a two-component, “dispersed” solid composition. As such, Applicant’s argument that Wang does not necessarily teach a solid dispersion, as defined in the instant specification, is unpersuasive. Even still, it is noted that amended claim 1 is largely the same as previous claim 3, and similarly rejected for obviousness over Wang and Lomuscio. Even according to a more stringent definition of “solid dispersion,” Lomuscio plainly teaches this element.
Applicant notes (pg. 17 of Applicant’s Remarks, fifth paragraph) that Wang by itself does not teach the weight ratios of amended claim 1, previously of claim 3. This is addressed by the fact that amended claim 1 is rejected for obviousness over Wang and Lomuscio, as previous claim 3 was.
Turning to the previous rejections for obviousness, Applicant next argues (paragraph spanning the bottom of pg. 17 to the top of pg. 18 of Applicant’s Remarks) that a person of ordinary skill in the art would not have been motivated to look at the teaching of Lomuscio to develop a solid dispersion of the compound of formula (I). This argument is based on the fact that Compound A of Lomuscio is a somewhat different compound than Compound 8 of Wang. As noted, however, Compound A of Lomuscio and Compound 8 of Wang are structurally similar molecules with identical biopharmaceutical targets and mechanisms of action. Moreover, Lomuscio teaches that solid dispersions enhance the aqueous solubility and bioavailability of the low solubility MDM2 inhibitor, Compound A (e.g. Abstract, Example 11). As such, one would have been motivated to apply the approach of Lomuscio, and would have had a reasonable expectation of success in doing so, to the mechanically prepared compositions of Wang.
Finally, Applicant argues that the claimed solid dispersion has unexpected effects, namely that incorporation of the compound of Formula (I) substantially improves dissolution (aqueous solubility) which can improve bioavailability. Applicant points to the examples and Figure 1 in support of this contention. However, such a result is not unexpected; rather it is the expected outcome and indeed the purpose of incorporating an active ingredient such as Compound A of Lomuscio or Compound 8 of Wang into a solid dispersion. For example, the Abstract of Lomuscio extols exactly these benefits, while references such as Huang, Kumar, and Yang note that improved solubility and bioavailability are the primary purpose of using solid dispersions in pharmaceutical formulations. As such, this is not regarded as an unexpected effect in the instant case.
The rejections, as modified in view of the amendments, are maintained in substance.
Rejections for nonstatutory double patenting:
With respect to the three rejections for nonstatutory (“obviousness type”) double patenting, Applicant notes that none of the reference patents claims a solid dispersion of APG-115, and asserts that a solid dispersion is not an obvious variation of the APG-115-containing pharmaceutical compositions claimed in the reference patents. This argument has been fully considered, but is not found persuasive. As demonstrated by Lomuscio, at minimum, incorporation of an MDM2 inhibitor like APG-115 into a solid dispersion, for the purpose of increasing solubility and bioavailability, was known in the art. As such, this combination is an obvious variation of the pharmaceutical compositions of the reference patents. The secondary references are applied to the nonstatutory double patenting rejections as in the rejections for obviousness under 35 U.S.C. § 103, and the rejections for nonstatutory double patenting are maintained.
Claim Rejections - 35 USC § 103 – Modified in View of Rejection, Substantially Maintained
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.
Claims 1-4, 6-7, 11, and 14 are obvious over Wang and Lomuscio:
Claims 1-4, 6-7, 11, and 1 are rejected under 35 U.S.C. § 103 as being unpatentable over U.S. Patent No. 9,745,314 to Wang et al. (hereinafter, “Wang”), in view of U.S. Patent No. 9,427,427 to Lomuscio et al. (hereinafter, “Lomuscio”).
Claim 1 recites a solid dispersion comprising a carrier and an active ingredient of formula (I)
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or a pharmaceutically acceptable salt, crystal form, or hydrate thereof. It is understood that a tablet, formed by conventional methods, can constitute or comprise a solid dispersion of instant claim 1, if the tablet includes a carrier and active ingredient of formula (I). See, for example, the instant specification at pg. 10, final paragraph through pg. 11, fourth paragraph; the paragraph spanning the bottom of pg. 10 to the top of pg. 11; and pg. 15, second full paragraph). Claim 1, as amended, further recites that the carrier is selected from among a list of specified carriers, and that the active ingredient and carrier are at a weight ratio in a range of from 1:1.2 to about 1:8.
Wang teaches compositions comprising (i) an excipient and/or pharmaceutically acceptable carrier, and (ii) an MDM2 inhibitor of generic formula (I)
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where the variable moieties are as defined (col 4, lines 25-38; and col. 2, lines 33-50). Wang teaches the composition can be a tablet (col. 38, lines 42-63), and that such a tablet can be formed by combining a disclosed MDM inhibitor with a solid excipient, and optionally grinding the resulting mixture (col. 39, lines 47-54). Wang teaches that the excipient can be selected from a variety of conventional excipients, including polyvinyl pyrrolidone (povidone, col 39, lines 55-67) Wang further teaches compound 8:
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as the most potent working example of the disclosed MDM2 inhibitors of formula (I), having the lowest IC50 for MDM2 binding to a p53 peptidomimetic and for limiting cancerous cell growth (col. 48, line 5 through col. 50, line 5; and Table 2). Compound 8 of Wang is the active ingredient of formula (I) of instant claim 1. Wang thus expressly teaches tablets comprising a carrier/excipient (e.g. a solid excipient) and an active ingredient of instant formula (I).
As noted above, the tablets of Wang, formed by co-grinding carrier and active ingredient (Compound 8), includes a “solid dispersion” of claim 1, with the exception that Wang does not expressly teach the weight ratio range of active ingredient to carrier recited in amended claim 1. It would have been obvious to utilize a weight ratio within this range, however, because weight ratios within this range were known in the art for highly similar solid dispersions. See, for example, Lomuscio.
Lomuscio teaches a solid dispersion that includes Compound A and a polymer (col. 9, lines 1-2), Compound A being an inhibitor of the p53-MDM2 interaction (col. 1, lines 25-56).
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Compound A of Lomuscio thus has a similar structure, the same cellular target, and the same mechanism of action as does Compound 8 of Wang. Lomuscio further teaches the solid dispersion comprises from about 10% to about 90% (wt/wt), and varying narrower ranges, of Compound A dispersed in a matrix formed by the polymer, and teaches that the polymer can be povidone, among other alternatives (col. 9, lines 14-20). It would have been obvious to utilize the weight percentages disclosed for the solid dispersion of Lomuscio in the tablet or composition of Wang, given the near identity of the compositions and the high degree of similarity of the active ingredients. Moreover, the weight percentages of Lomuscio encompass and overlap with those of instant claim 3. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257 (CCPA 1976).
Claim 2 specifies various specific polymers within the broader categories recited in claim 1; for example claim 2 recites that the povidone is selected from a list of specific povidone products, such as PVP VA64. Lomuscio teaches the solid dispersion can utilize PVP VA 64 as the povidone carrier (col. 9, lines 1-13). Claim 2 further recites that the solid dispersion include an antisticking agent. Wang teaches the tablet can include an auxiliary that is a flow-regulating agent, such as magnesium or calcium stearate (i.e. a metal stearate antisticking agent; col. 39, line 67 through col. 40, line 3). Claim 2 also recites a list of salt types and hydrate types that the active ingredient must be, if it is a salt or hydrate; but claim 2 does not require that the active ingredient be a salt or hydrate.
Claim 3 recites various alternative combinations of specific carrier identity and/or narrower weight ratio ranges of active ingredient to carrier. For example, in the first recited alternative, the active ingredient and the carrier are at a weight ratio in a range of from 1:2 to about 1:4. As noted above, Lomuscio teaches that the solid dispersion can contain anywhere from 10% to 90% of active ingredient dispersed in matrix (carrier); i.e. a weight ratio within a range of 1:9 to 9:1. Lomuscio also teaches various intermediate ratios, such as 20% to 50% active ingredient (i.e. a weight ratio of 1:4 to 1:1. The weight ratios of Lomuscio overlap and encompass the various alternative ratios of claim 3 (such as the 1:2 to 1:4 cited above) and where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257 (CCPA 1976).
Claim 4 recites a method for preparing [the] solid dispersion of claim 2, comprising a step of mixing one or more carrier and the active ingredient with a solvent to obtain a mixed liquid; and drying the mixed liquid. An optional step of mixing the dried composition with the antisticking agent of claim 2, is not required.
Lomuscio further teaches a method for preparing a solid dispersion of a compound, and an ionic polymer, the method comprising forming a solution of the compound and the polymer in a suitable solvent, and spray drying the compound with the polymer (col. 12, lines 20-29). Lomuscio teaches that preferably the compound is Compound A and the polymer is Povidone (col. 12, lines 20-29). It would have been obvious to apply this method of forming a solid dispersion to the compositionally and functionally highly similar solid dispersion of Wang, thereby arriving at the method of instant claim 4.
Claim 6 recites a pharmaceutical composition comprising [the] solid dispersion of claim 2 and excipients (construed as meaning at least one excipient), while claim 7 specifies a number of excipients. With respect to claims 6 and 7, Lomuscio teaches that the solid dispersion can be combined with additives/excipients for various routes of administration, where the additive/excipient includes compounds such as xylitol and various salts of stearic acid.
With respect to claim 14, Lomuscio teaches a coated tablet having the solid dispersion in combination with the disclosed excipients (the working example of Table 6, as well as a general approach to manufacturing the tablet in col. 17, line 38 through col. 18, line 28).
Claim 5 is obvious over Wang, Lomuscio, and Memmert:
Claim 5 is rejected under 35 U.S.C. § 103 as being unpatentable over Wang, in view of Lomuscio, further in view of the non-patent publication, Heating and Drying Ovens, Memmert GMBH catalog, 32 pgs. (2017) obtained at the url: www.hettichlabinstrument.se/wp-content/uploads/2017/05/BR-Heating-Ovens-english-D13646.pdf (referred to hereinafter as “Memmert”).
Claim 5 recites the method for preparing the solid dispersion of claim 4, where the mass-to-volume ratio of active ingredient to solvent is within a range of about 5:1 to about 30:1; where the solvent is one of several enumerated, such as acetone; and where the drying step includes first and second drying steps as specified.
With respect to claim 5, Lomuscio teaches the solvent can be acetone (col. 12, lines 20-24), and teaches a working example in with compound A and copovidone, at a weight ratio of 1:1, are dissolved in acetone at a solid concentration of 5% (w/w) – col. 17, lines 38-41). Thus it is approximately 2.5 mg of compound A (active ingredient) to 95 mg of acetone. Given an acetone density of about 790 mg/mL, this corresponds to about 20 mg compound A per mL of acetone, within the recited range. Lomuscio further teaches in this working example a first drying, that is spray drying, and a second drying in a tray dryer. Thus, Wang and Lomuscio teach all elements of claim 5, except that neither explicitly states that the second drying step is performed by vacuum decompression drying (i.e. drying accelerated by vacuum) or by electric blast drying (i.e. in an electric heated oven with forced air circulation. The tray drying of Lomuscio could be performed in such an oven, but this is not explicitly stated. Nonetheless, it would have been obvious to use an electric blast dryer to perform the second drying step of Wang/Lomuscio, because electrically heated ovens with forced air circulation were well-known in the art for the drying of pharmaceutical compositions. See, for example, Memmert.
Memmert is a product catalog describing a variety of ovens for drying pharmaceutical compositions (pg. 2). For example, the Universal Oven has both natural convection and forced convection (i.e. “Blast” capability – pg. 4), the forced convection model having adjustable fan for high air exchange and reduced drying times (pg. 5). Like other ovens in the catalog, the Universal Oven is electrically powered (see the specs on pg. 6), and has multiple shelves (trays). Thus, in forced convection versions, this is an electric blast dryer and also a tray dryer. It would have been obvious to use such an electric blast oven as the tray dryer of Lomuscio, to obtain reduced drying times via high air exchange, as taught by Memmert.
Claims 8-10 are obvious over Wang, Lomuscio, and Fernández:
Claims 8-10 are rejected under 35 U.S.C. § 103 as being unpatentable over Wang, in view of Lomuscio, and further in view of the non-patent publication, Rapid Development and Optimization of Tablet Manufacturing Using Statistical Tools, AAAPS PharmSciTech, 9, pgs. 620-627 (2018) by Fernández et al. (hereinafter, “Fernández”).
Claim 8 recites mass ratios of various excipients (diluent, disintegrating agent, lubricant, etc.) to solid dispersion, and also recites specific selections (or Markush groups for selecting) the various excipients, however only one is required, per the terms of claim 7, as well as the optionality of the additional excipients of the preamble of claim 8.
Wang and Lomuscio are applied to claim 8 as to claim 7, above. Lomuscio further teaches a working example of a tablet (Table 6, col. 17, lines 1-30) in which mannitol, a filler/diluent, is present relative to the solid dispersion at a mass ratio of 0.085:1. This is adjacent to the recited mass ratio, and a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985). See also MPEP 2144.05(I). This is particularly so where there is no evidence of criticality of the recited range.
Furthermore, it would have been obvious to optimize the amount of this excipient, or of any other excipient, as excipient amounts are known to be a result-effective variable for the pharmaceutical performance of tablets. See, for example, Fernández.
Fernández teaches a statistical methodology to optimize tablet manufacturing, largely through optimization of excipient amounts (Abstract). Fernandez identifies the problem, noting that manufacturers of generic tablets are usually focused on the optimization of the excipient mixture composition to obtain a product that meets established standards. Fernandez further notes that pharmaceutical literature abounds with statistical methods considering mixture design to optimize excipient proportions. As such, it would have been obvious to optimize the excipient proportions of tablets having the solid dispersion of Wang and Lomuscio, in order to obtain a product that meets established standards, in conjunction with the manufacturing methods employed.
With respect to claim 9, the amounts taught by Lomuscio in Table 6 are within or adjacent to the recited ranges. For example, as noted, the example includes 0.085:1 diluent:solid dispersion. The example also includes 0.1375:1 disintegrating agent:solid dispersion, and ~0.009:1 lubricant:solid dispersion. While these are lower than the recited weight ratios, as with claim 8, it would have been obvious to optimize the result-effective variables of these excipient proportions, according to the teachings of Fernandez.
With respect to claim 10, Lomuscio teaches the recited components (e.g. microcrystalline cellulose col. 11, line 29, crospovidone col. 16, line 1, and magnesium stearate col. 11, line 31) and teaches amounts of the different functional components (filler/diluent, lubricant, etc.) that are within or adjacent to the recited ranges. As with claims 8 and 9, it would have been obvious to optimize the result-effective variables of these excipient proportions, according to the teachings of Fernandez.
Claims 12-13 and 18-20 are obvious over Wang, Lomuscio, and Ofori-Kwakye:
Claims 12-13 and 18-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Wang, in view of Lomuscio, and further in view of the non-patent publication, Formulation And Quality Evaluation Of Two Conventional Release Tablet Formulations, Int. J. Pharm. Sci. Rev. Res., 4, pgs. 94-99 (2010) by a Ofori-Kwakye et al. (hereinafter, “Ofori-Kwakye”).
Claim 12 recites a method for preparing tablets, comprising steps of (i) mixing a solid dispersion of claim 2, a diluent, and a disintegrating agent to obtain a mixture; sieving and granulating the mixture to obtain particles; and (ii) mixing the particles with the lubricant and pressing the particles to obtain a tablet.
Wang and Lomuscio are applied to claim 12 as to claim 4, above, but they do not expressly teach the precise order of steps recited in claim 12, including sieving and granulating prior to addition of lubricant, followed by pressing the tablets. This arrangement of steps would have been obvious, however, because this was known in the art as a conventional methodology for tablet manufacture. See, for example, Ofori-Kwakye.
Ofori-Kwakye teaches a study of the formulation optimization of metformin and paracetamol tablets (Abstract). Ofori-Kwakye teaches that the tablets in the study were formed by, in order, weighing and premixing the components, wet granulating the mixed components, sifting the granulated mixture, drying the wet granulated and sifted mixture, and then mixing in lubricant (pg. 95, paragraph spanning bottom of the left column to top of the right column). Ofori-Kwakye further teaches that the processed granulates were compressed into tablets in a final manufacturing step (pg. 96, left column, first paragraph). It would have been obvious to employ this conventional sequence of steps, taught by Ofori-Kwakye, for manufacturing a tablet of Wang and Lomuscio.
With respect to claim 13, it appears that the addition of antisticking agent/glidant and lubricant remain optional, as recited in claim 12. Notwithstanding this, the working example in Table 6 of Lomuscio includes glidant and lubricant at about 1.5% and 0.7%, respectively, which are within the weight percentage ranges recited in claim 13. Furthermore, Lomuscio teaches a method for manufacturing a tablet that utilizes dry granulation rather than wet granulation (col. 18, lines 1-4). It would have been obvious to use dry granulation in the method of Wang, Lomuscio, and Ofori-Kwakye.
With respect to claim 18, Lomuscio teaches mannitol as a filler/diluent (Table 6). With respect to claim 19, Lomuscio teaches the glidant/antisticking agent is colloidal silica (and also teaches the glidant/antisticking agent in to coating is talc). With respect to claim 20, Lomuscio (Table 6) teaches that the disintegrating agent is both croscarmellose sodium and crospovidone.
Claim 15 is obvious over Wang, Lomuscio, and Franz:
Claim 15 is rejected under 35 U.S.C. § 103 as being unpatentable over Wang, in view of Lomuscio, and further in view of U.S. Patent No. 4,880,636 to Franz (hereinafter, “Franz”).
Claim 15 recites the coated tablet of claim 14 where the mass ratio of coating to pharmaceutical composition is 0.02:1 to 0.2:1 and the coating includes polyvinyl alcohol, titanium dioxide, talc powder, triacetin, and hydroxypropyl methyl cellulose. In the working example (Table 6) of Lomuscio, the mass ratio of coating to pharmaceutical composition is 0.03:1, and the coating contains polyvinyl alcohol, titanium dioxide, and talc. It does not contain triacetin or HPMC, but it would have been obvious to include these, because they were well-known in the art to be conventional components of tablet coatings. See, for example, Franz.
Franz teaches polymeric film coatings for a pharmaceutical tablet based on an HPMC polymer, and using triacetin as a plasticizer (claim 1). Franz teaches that triacetin, in combination with HPMC, minimizes discoloration of the coating and minimizes drug migration into the coating, being thus a preferred plasticizer with HPMC (col. 2, line 62 through col. 3, line 5). It thus would have been obvious to include HPMC as a conventional polymer into the tablet coating of Wang/Lomuscio, and to further include triacetin to minimize discoloration and drug migration into the coating.
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 1-15 and 18-20 are rejected for nonstatutory double patenting over the ’716 patent, in view of Wang, Lomuscio, Memmert, Fernández, Ofori-Kwakye, and Franz:
Claims 1-15 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11,452,716 (hereinafter, “the ’716 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of the ’716 patent recites a pharmaceutical composition having the active ingredient of instant claim 1 in combination with a CDK inhibitor. The solid dispersions, pharmaceutical compositions, and tablets of the instant claims are obvious variations of the composition of claim 12 of the ’716 patent, as the dispersions, compositions, and tablets of the instant claims are arrived at by merely incorporating conventional excipients into the composition of claim 12 of the ’716 patent. The conventionality of these excipients, and of the methods for incorporating them, is described above in the rejections for obviousness, with reliance on the secondary references.
Claims 1-15 and 18-20 are rejected for nonstatutory double patenting over the ’469 patent, in view of Wang, Lomuscio, Memmert, Fernández, Ofori-Kwakye, and Franz:
Claims 1-15 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,478,469 (hereinafter, “the ’469 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ’469 patent recites a combination having the active ingredient of instant claim 1 in combination with a Bcl-2 inhibitor. The solid dispersions, pharmaceutical compositions, and tablets of the instant claims are obvious variations of the composition of claim 1 of the ’469 patent as the dispersions, compositions, and tablets of the instant claims are arrived at by merely incorporating conventional excipients into the composition of claim 1 of the ’469 patent. The conventionality of these excipients, and of the methods for incorporating them, is described above in the rejections for obviousness, with reliance on the secondary references.
Claims 1-15 and 18-20 are rejected for nonstatutory double patenting over the ’024 patent, in view of Wang, Lomuscio, Memmert, Fernández, Ofori-Kwakye, and Franz:
Claims 1-15 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,194,024 (hereinafter, “the ’024 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ’024 patent recites a pharmaceutical composition having the active ingredient of instant claim 1 in combination with an anticancer agent. The solid dispersions, pharmaceutical compositions, and tablets of the instant claims are obvious variations of the composition of claim 1 of the ’024 patent as the dispersions, compositions, and tablets of the instant claims are arrived at by merely incorporating conventional excipients into the composition of claim 1 of the ’024 patent. The conventionality of these excipients, and of the methods for incorporating them, is described above in the rejections for obviousness, with reliance on the secondary references.
Conclusion
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 extension fee 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 ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on (571) 272-5541. 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.
/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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