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 .
DETAILED ACTION
The preliminary amendment filed 09/09/2025, amended claims 1-2, 4, 5, 7, 9, 15-21, 24, 26, cancelled claims 3, 6, 8, 11-14, 22-23, 25, and 27-30, and added claims 31-34.
Claims 1-2, 4-5, 7, 9-10, 15-21, 24, 26 and 31-34 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim Objections
Claims 5, 9, 17, 19-20, and 26 are objected to because of the following informalities:
-In claim 5, the comma following “b1)” should be deleted, and the term - -or- -should be inserted. And a comma should be inserted following “b2).”
-In claim 9, line 9, prior to “step b2)” the term “and” should be replaced with - -or- -.
-In claims 17 and 20, the parenthetical recitation “equivalent to 30 mg of the free base” should be deleted.
-In claims 19 and 20, since hypromellose and HPMC are synonyms, either hypromellose or HPMC should be recited in the claims. If HPMC is chosen to be recited in the claims, the first time it appears in the claims it should recite “hydroxypropyl methyl cellulose (HPMC).”
-In claim 26, line 2, the phrase “having such a cancer” should be replaced with - -in need thereof- -.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4-5, 7, 9-10 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-In claim 2, line, the parenthetical recitation “free base” renders the claim indefinite, as it is not clear if “free base” is describing the compound preceding or if it is an optional, exemplified form of the compound.
-In claim 2, “b1)” and “b2),” it is not clear which solution is at 15-30 C, i.e., the solution of “step a)” or the “solution of tartaric acid and organic solvent,” or if the combined solution is at 15-30 C.
-In claim 20,
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renders the claim indefinite. It is not clear what “Target Capsule Fill Weight” is referencing. It is not clear if it is additional components of the composition or a combination of some or all of the recited active, fillers, disintegrant, or lubricant recited prior to this recitation.
It is not clear what “size 3” is referencing in “HPMC Capsule size 3.” It is not clear if this is referencing a range of particle sizes or length or width or dimension of the capsule, or if it is something else entirely.
Additionally, it is not clear what makes up the “Total Capsule Weight” since adding together all the mg amounts prior to “Total Capsule Weight” does not result in 122.000mg.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/245974 to Hoffman (published 2019, IDS of 12/18/2025) in view of Kumar (Particle Size Reduction Techniques of Pharmaceutical Compounds for the Enhancement of Their Dissolution Rate and Bioavailability, published 2021, PTO-892) and Variankaval (From Form to Function: Crystallization of Active Pharmaceutical Ingredients, published 2008, PTO-892).
Hoffman teaches the instantly claimed compound of formula (I) having XRPD peaks at 11.49, 12.54. 19.16, 19.42, or 24.67 ([0013], “a crystal form of Compound B”).
Hoffman teaches its Compound B as having the following particle size distribution:
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([0036]).
Hoffman differs from that of instant claim 1 in that it does not teach the instantly claimed particle size distribution.
Kumar teaches particle size reduction techniques of pharmaceutical compounds for the enhancement of their dissolution rate and bioavailability (title, abstract).
Kumar teaches that conventional processes such as milling, high pressure homogenization, and spray drying are well established and widely used for particle size reduction. Non-conventional processes such as liquid anti-solvent crystallization, supercritical anti-solvent process, rapid expansion of supercritical solutions, particles from gas saturated solutions, and pulsed laser ablation are emerging as potential alternatives to overcome the disadvantages of conventional processes (abstract).
Kumar teaches that wet milling produces nano particle sizes and that dry milling produces micron particle sizes. Kumar teaches that the selection of milling equipment also results in different particle sizes:
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(pgs. 335-336, “Milling).
Kumar teaches that high-pressure homogenization produces a range of 5-20 um particle sizes (pg. 336). Kumar teaches high pressure homogenization as producing a range of 5-20 um particle sizes (pg. 336). Kumar teaches spray drying as producing a range of 20-100 um particle sizes (pg. 336). Kumar teaches liquid anti-solvent crystallization processes as producing nanoparticles with improved controllability, reduced batch to batch variation, narrow particle size distribution, reduced reagent consumption, and high reproducibility (pg. 339). Kumar teaches supercritical anti-solvent processes as resulting in average particle sizes that are tuned by varying the vibration intensity of the deflecting surface (pg. 344).
Variankaval teaches the crystallization of active pharmaceutical ingredients (title, Introduction).
Variankaval teaches that it is well known that crystals grow in a variety of shapes in response to both internal (i.e., crystal structure) and external factors. Some of these factors can be manipulated (e.g., solvent type, impurity or additive concentrations, solution temperature and supersaturation, etc.) by crystal engineers to steer crystals toward a target shape or away from undesired shapes. Variankaval teaches that it is well-known that different polymorphs may exhibit substantially different crystal morphologies (pg. 1684, “Crystal Shape and Size).
Variankaval teaches that dramatic changes to crystal shape can be induced by changes in solvent or solvent mixture and by the presence of quite small amounts of surface active impurities in solution that act as growth inhibitors for certain crystal planes. Growth inhibitors may be added deliberately to modify the crystal shape, or may be present as a result of the manufacturing conditions. Variankaval teaches that the potential for engineering changes in crystal shape is enormous. Variankaval further teaches that particle-size distribution (PSD) may determine the rate of plasma uptake of an active pharmaceutic ingredient (API). “The PSD may also affect API processing parameters, such as filtration and drying rates and product formulation parameters, such as filtration and drying rates and product formulation parameters, such as flow, compactability, sticking, and segregation, which ultimately affect key product/process attributes, such as content uniformity, tablet strength, and productivity. From the bioavailability perspective, small particles are preferred as they provide faster dissolution. . .As a general rule, broad or bimodal particle size distributions are to be avoided as they have a higher tendency to yield slow filtration rates and often have poor flow properties. In most cases, narrow distributions about an optimal mean size are desired. Typically, for both seeded and unseeded crystallizations, the particle-size distribution is set by the balance between crystal growth and nucleation, which is ultimately controlled by the level of supersaturation prevailing during the course of the crystallization. This is true whether the supersaturation is created by cooling, antisolvent addition, evaporation, or chemical reaction. Ward et al. present an example of a seeded batch crystallization operated in cooling mode, for which a significant degree of control over the PSD could be obtained by selecting an appropriate cooling policy. The cooling profile determines whether nucleation or growth processes dominate at each instant of time during the crystallization. If the system nucleates early, these crystals have a chance to grow, and relatively large particles are produced. If the system nucleates late, they do not, so one is likely to generate a PSD rich in fines. Current practices of API particle-size control often involve some type of size reduction subsequent to crystallization,” wherein API particles, for example, can be reduced from an initial size of 100-200 microns to particles smaller than 20 microns (last paragraph beginning on pg. 1684-last paragraph ending in Col. 2 of pg. 1685).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the particle size distribution of the compounds of Compound B of Hoffman, which is the compound of instant formula (I), to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Hoffman teaches a mono modal particle size distribution of instant formula (I),
-Kumar teaches that conventional processes are known in the art to modify particle size, and
-Variankaval teaches that it is known in the art how to modify the size of crystals and it is known in the art that particle size distribution determines the rate of plasma uptake of an active pharmaceutical ingredient.
As such, an ordinary skilled artisan would have been motivated to make such a modification, to predictably arrive at a particle size distribution of crystalline formula (I) that is optimized for plasma uptake.
Claims 2, 4-5, 7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/245974 to Hoffman (published 2019, IDS of 12/18/2025) in view of Kumar (Particle Size Reduction Techniques of Pharmaceutical Compounds for the Enhancement of Their Dissolution Rate and Bioavailability, published 2021, PTO-892) and Variankaval (From Form to Function: Crystallization of Active Pharmaceutical Ingredients, published 2008, PTO-892), as applied to claim 1, and further in view of Tung (Industrial Perspectives of Pharmaceutical Crystallization, published 2013, PTO-892).
Hoffman, Kumar, and Variankaval are applied as discussed above and incorporated herein.
Regarding claims 2, 4-5, 7, and 9-10, Hoffman teaches a process for preparing a crystalline compound by contacting a compound of:
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(claims 102, 104) with tartaric acid in the presence of an organic solvent (claim 102, 106, 176-178).
Hoffman teaches that the reaction mixture may be heated with agitation to a reaction temperature, typically a temperature of from 2 C to about 30 C and held for a time sufficient to essentially complete the reaction such as determined by chromatography ([0183], [0199], [). Hoffman teaches cooling the temperature of about 20 C, 25 C, or 30 C ([0212]-[0213]).
Hoffman teaches seeding the solution with the crystalline compound ([0555]). Hoffman teaches compound B seeds were added to the solution and the rest of compound B was transferred into the 20 L reactor over 1 hour, aged at 70 C for 30 minutes, cooled to 20 C over 5 hours, aged at 20 C for a minimum of 2 hours, filtered and washed, to provide compound B ([0556]-[0559]).
See examples 7, 8, and 10A.
Though the combination of Hoffman, Variankaval, and Kumar, does not explicitly teach the methods of instant claims 2, 4-5, 7, and 9-10, it generally teaches the same methods of combining a free base compound of instant formula (I) with a solution of tartaric acid and an organic solvent, that includes, mixing for periods of time, temperature fluctuation, and seeding.
Tung teaches industrial perspectives of pharmaceutical crystallization (title, abstract).
Tung teaches that various factors can affect the crystal morphology, such as crystal structure, solvents, additives, impurities, and supersaturation or desupersaturation rates during crystal growth and dissolution periods. Additionally, it is shown that multiple heat/cool cycles coupled with wet milling at each cool cycle with or without wet milling can be employed to modify crystal morphology (paragraphs spanning pgs. 447-448).
Tung teaches that given the first key mixing factor is mixing time. The mixing time is loosely defined as the time required to reach 95% homogeneity. Mixing time can be affect by multiple factors, such as mixing intensity, scale, mixer geometry, etc. (pg. 45, 3.3).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of making instant formula (I), i.e., Compound B of Hoffman, as taught by the combination of Hoffman, Kumar, and Variankaval, to arrive at instant claim 2, 4-5, 7, and 9-10. One of ordinary skill in the art would have been motivated to make such modifications, with a reasonable expectation of success, because:
-Hoffman generally teaches the same methods of combining a free base compound of instant formula (I) with a solution of tartaric acid and an organic solvent, that includes, mixing for periods of time, temperature fluctuation, and seeding,
-Kumar, Variankaval, and Tung teach that it is known in the art to modify different steps of crystallization to arrive at crystals with distinct properties,
-Tung teaches that various factors affect crystal morphology, such as crystal structure, solvents, additives, impurities, supersaturation rates during crystal growth, desupersaturation rates during crystal growth, dissolution periods, multiple heat/cool cycles coupled with wet milling or without wet milling, and mixing time, and
- "[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,” MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such modifications to predictably arrive at the most stable product with a particle size distribution optimized for plasma uptake.
Claims 15-18, 26, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/245974 to Hoffman (published 2019, IDS of 12/18/2025) in view of Kumar (Particle Size Reduction Techniques of Pharmaceutical Compounds for the Enhancement of Their Dissolution Rate and Bioavailability, published 2021, PTO-892) and Variankaval (From Form to Function: Crystallization of Active Pharmaceutical Ingredients, published 2008, PTO-892), as applied to claim 1, and further in view of US2022/0380348 to Siddiqui-Jain (effectively filed 2019, PTO-892).
Hoffman, Kumar, and Variankaval, are applied as discussed above and incorporated herein.
Regarding claim 15, the combination of Hoffman, Kumar, and Variankaval differs from that of instant claim 15 in that it does not teach pharmaceutical compositions comprising microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate.
Siddiqui-Jain teaches capsules comprising an API, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate ([0074]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the capsule formulation of Siddiqui-Jain as the capsule formulation of Hoffman, to arrive at instant claim 15. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Hoffman teaches is pharmaceutical compositions in the form of capsules comprising 1-150mg of Compound B, which is instant formula (I) ([0357], [0361], [0363], [0393])),
-Siddiqui-Jain teaches that capsule formulations comprising API and microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate, are known in the art.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predicably arrive at a pharmaceutical composition optimized for capsule formulation.
Regarding claim 16, Siddiqui-Jain teaches embodiments wherein the microcrystalline cellulose comprises about 10-30 wt. % microcrystalline cellulose, about 50-80% lactose monohydrate, about 1-5 wt.% croscarmellose sodium, about 0.5-2 wt.% magnesium stearate ([0077]-[0081]), and wherein the API comprises about 0.1 wt.% to about 50 wt. % of the formulation ([0055]).
While Siddiqui-Jane does not teach the instantly claimed %weight of lactose monohydrate, "[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." MPEP 2144.05(II)
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 17, Siddiqui-Jaine teaches the active ingredient as comprising 1-100mg of the API [0057]).
Regarding claim 17, in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists, see MPEP 2144.05.
Regarding claim 18, the composition of the combination of Hoffman, Kumar, and Variankaval is in the form of a capsule, wherein a capsule is for oral administration.
Regarding claims 26 and 31, Hoffman teaches a method of treating breast cancer, such as HER2-positive breast cancer or triple negative breast cancer by administering its compounds or a pharmaceutical composition comprising its compounds (claims 36-37).
Regarding claim 32, Hoffman teaches its compounds as a component of adjuvant therapy (claim 39).
Regarding claims 33-34, Hoffman teaches its compounds as administered in combination with anti-cancer agents, such as abemaciclib, ribociclib, or palbociclib (claims 45, 47 and 48).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/245974 to Hoffman (published 2019, IDS of 12/18/2025), Kumar (Particle Size Reduction Techniques of Pharmaceutical Compounds for the Enhancement of Their Dissolution Rate and Bioavailability, published 2021, PTO-892), Variankaval (From Form to Function: Crystallization of Active Pharmaceutical Ingredients, published 2008, PTO-892), and US2022/0380348 to Siddiqui-Jain (effectively filed 2019, PTO-892), as applied to claim 1, 15-18, 26, 3-34, and further in view of Kubiak (published 2011, PTO-892).
Hoffman, Kumar, Variankaval, and Siddiqui-Jain are applied as discussed above and incorporated herein.
Regarding claim 19, the combination of Hoffman, Kumar, Variankaval, and Siddiqui-Jain differs in that it does not teach the capsule as made of hypromellose.
Kubiak teaches that the main advantages of hypromellose, i.e., hydroxypropyl methylcellulose (HPMC), capsules is low moisture, non-susceptibility to proteolytic degradation, and non-animal source (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the capsule as made of hypromellose, to arrive at instant claim 19. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-the combination of Hoffman, Kumar, Variankaval, and Siddiqui-Jain teach capsule formulations, and
-Kumar teaches hypromellose capsules as having low moisture, as non-susceptible to proteolytic degradation, and as a non-animal source.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a capsule that is stable and acceptable to be administered to a patient population that includes vegetarians and vegans.
Regarding the mg amounts of microcrystalline cellulose, lactose monohydrate, magnesium stearate, and hypromellose (HPMC) in claim 20, Siddiqui-Jaine teaches the active ingredient as comprising 1-100mg of the API [0057]), about 30-40mg microcrystalline cellulose, about 100-150mg lactose monohydrate, about 4-6mg croscarmellose sodium, and about 1-2.5mg magnesium stearate ([0096]-[0099]), and "[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," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Claims 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/245974 to Hoffman (published 2019, IDS of 12/18/2025), Kumar (Particle Size Reduction Techniques of Pharmaceutical Compounds for the Enhancement of Their Dissolution Rate and Bioavailability, published 2021, PTO-892), Variankaval (From Form to Function: Crystallization of Active Pharmaceutical Ingredients, published 2008, PTO-892), and US2022/0380348 to Siddiqui-Jain (effectively filed 2019, PTO-892), as applied to claim 1, 15-18, 26, 31-34, and further in view of Machtech (All About Conical Mill, published 2020, PTO-892).
Hoffman, Kumar, Variankaval, and Siddiqui-Jain are applied as discussed above and incorporated herein.
While the combination of Hoffman, Kumar, Variankaval, and Siddiqui-Jain teaches the composition of claim 15, it differs from that of claims 21 and 24 in that it does not teach the instantly claimed method of making the composition.
Siddiqui-Jain teaches methods of making a capsule by blending components, sifting, and filling capsule shells ([0226]-[0251]).
Machtech teaches that conical mills are known in the art for use in making pharmaceutical formulations, wherein conical mills grind and reduce the size of material uniformly (pg. 1). Machtech teaches that conical mills contain blades that reduce the size of the particles and contain sieves which reduce the particle size even further (pg. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the conical mills of Machtech in the methods of making the capsules in Siddiqui-Jain, to arrive at instant claims 21 and 24. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because Machtech teaches that it is known in the art to utilize conical mills in pharmaceuticals to produce formulations of uniform particle size.
Regarding the mesh size of 0.5-1mm recited in claim 21, Machtech teaches that “Both knife and sieve impact the size of the particle and can be changed based on the required size”; and "[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," MPEP 2144.05(II).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-46 of U.S. Patent No. 10,954,234 (IDS of 02/18/2025) in view of in view of Kumar (Particle Size Reduction Techniques of Pharmaceutical Compounds for the Enhancement of Their Dissolution Rate and Bioavailability, published 2021) and Variankaval (From Form to Function: Crystallization of Active Pharmaceutical Ingredients, published 2008, PTO-892).
‘234 claims a compound of instant formula (I) with the XRPD pattern recited in instant claim 1 (claims 11-46).
Kumar and Variankaval are applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the particle size distribution of the compounds of Compound B of ‘234, which is instant formula (I), to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Hoffman teaches a mono modal particle size distribution of instant formula (I),
-Kumar teaches that conventional processes are known in the art to modify particle size, and
-Variankaval teaches that it is known in the art how to modify the size of crystals and it is known in the art that particle size distribution determines the rate of plasma uptake of an active pharmaceutical ingredient.
As such, an ordinary skilled artisan would have been motivated to make such a modification, to predictably arrive at a particle size distribution of crystalline formula (I) that is optimized for plasma uptake.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622
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