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
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, 11 and 12, drawn to a particle composition, in the reply filed on 16 Jan 2026 is acknowledged.
Claim 10 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-9, 11 and 12 are under consideration.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 15 Aug 2023 and 23 Aug 2023 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3, 5, 9, 11 and 12 are objected to because of the following informalities:
In claim 3, the HPC should be in parenthesis for consistent formatting, as done for the abbreviations in claim 4.
In claim 5, there should be a space between the “5” and “wt%” as was done for the other weight percentage amounts.
In claim 9, Laser does not need to be capitalized.
Claims 11 and 12 are objected to for improperly referring to a withdrawn claim (i.e. claim 10).
Claim 11 and 12 list the limitation “at least one anionic surfactant” twice in the third bullet.
Appropriate correction is required.
Specification
The abstract of the disclosure is objected to because it exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Rejections - 35 USC § 112
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 1-9, 11 and 12 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.
The limitation "non-ionic surfactant" is recited in the fifth bullet of claims 1, 11 and 12 and in claims 6 and 8. There is insufficient antecedent basis for this limitation in the claims as base claim 1 at the fourth bullet recites “at least one non-ionic surfactant”, which encompasses multiple non-ionic surfactants, and it is unclear whether the “non-ionic surfactant” includes just one or more than one non-ionic surfactant. Claims 2-5, 7, and 9 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 1.
The limitation "the cellulose based polymer" is recited in claim 3. There is insufficient antecedent basis for this limitation in the claims as base claim 1 recites “at least one cellulose based polymer”, which encompasses multiple cellulose based polymer, and it is unclear whether the “cellulose based polymer” includes just one or more than one cellulose based polymer.
The limitation "the anionic surfactant" is recited in claim 4. There is insufficient antecedent basis for this limitation in the claims as base claim 1 recites “at least one anionic surfactant”, which encompasses multiple anionic surfactants, and it is unclear whether the “anionic surfactant” includes just one or more than one cell anionic surfactant.
The limitation "low molecular weight non-ionic surfactant" and “high molecular weight non-ionic surfactant" is recited in claim 5. It is unclear if these surfactants are intended to refer to the to the at least one non-ionic surfactant of claim 1 or to some other non-ionic surfactant.
The limitation "the low molecular weight non-ionic surfactant" is recited in claim 7. There is insufficient antecedent basis for this limitation in the claims as base claim 1 recites “at least one non-ionic surfactant”, and it is unclear if the low molecular weight non-ionic surfactant is intended to refer to the at least one non-ionic surfactant or to some other non-ionic surfactant.
Claim 9 recites “HPC as cellulose based polymer,” “SDS as anionic surfactant,” and “PVP12 as low molecular weight non-ionic surfactant. It is unclear if these are intended to refer to the “at least one cellulose based polymer”, “at least one anionic surfactant” and the “at least one non-ionic surfactant” of claim 1 or if these refer to alternative cellulose based polymers, anionic surfactant and non-ionic surfactant.
Claim 9 recites “at least one active ingredient” and also recites “the substance.” It is unclear if the “at least one active ingredient” and “the substance” are intended to refer to the same component of the composition or if these are separate components.
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.
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.
Claims 1-9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ostendorf et al. (WO 2021/069350, published 15 Apr 2021, listed on IDS filed 15 Aug 2023) as evidenced by Cayman Chemical (Product Information Indomethacin).
Ostendorf teaches that higher dissolution of a pharmaceutical active substance usually results in increased bioavailability and that this can be achieved by increasing the specific surface area of the active substance particle and that active substance nanosuspensions have an appreciably higher rate of dissolution than a micronized suspension (page 1 lines 7-10). Ostendorf teaches suspending a pharmaceutical active substance in an aqueous solution of a polymer (page 3 lines 1-7) and that the d90 particle size is ≥10 nm to ≤ 1μm (page 4 lines 15-18). This range includes the 1 μm of the range in claim 1 and the 1 nm to 999 nm size of claims 11 and 12, rendering obvious these particle sizes. 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, 191 USPQ 90 (CCPA 1976). Ostendorf teaches measuring with laser diffraction (page 4 line 17). Ostendorf does not teach the dynamic light scattering method as in claims 11 and 12 but this is not necessary to render the claim obvious as the measurement method does not change the product with particle sizes in the range of the instant claims, as taught by Ostendorf. Ostendorf teaches pharmaceutical actives such as indometacin (page 5 lines 2-4). As evidenced by Cayman Chemical, indomethacin has an aqueous buffer solubility of approximately 0.05 mg/mL (i.e. 0.05 g/L) (page 1), meeting the solubility limitation for the substance of the instant claims.
Ostendorf teaches a mixture of at least two polymers for the suspensions including polyvinylpyrrolidone PVP K12 (page 10 line 9) and hydroxyalkyl celluloses (page 3 lines 22-28) such as hydroxypropyl cellulose (page 5 line 21), rendering obvious the at least one cellulose based polymer of HPC and the at least one non-ionic surfactant of polyvinylpyrrolidone of the instant claims. Ostendorf teaches the inclusion of a surfactant (page 1 line 1, page 4 lines 19-24) such as sodium dodecyl sulfate (SDS) (page 7 lines 4-5), rendering obvious the at least one anionic surfactant of the instant claims. Ostendorf teaches that the active substance and polymer are present in a weight ratio ≥1:1 to ≤2:1 (page 7 lines 11-13). As Ostendorf teaches polyvinylpyrrolidone and HPC, this ratio of active to polymer renders obvious the cellulose + non ionic surfactant to substance between 2:1 to 1:2 (claims 1, 11 and 12) and 1:1 (claim 9). Ostendorf teaches examples where the active indomethacin is at 10 wt% (page 10 line 8). With regard to the claimed amount of substance from 10.1 to 15 wt% (claims 1, 11 and 12 and 10.1 to 12 wt% (claim 9), the examiner notes that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. In the instant case, the difference between the 10 wt% taught by Ostendorf and the claimed 10.1% is very small and the amounts are expected to have the same properties. Ostendorf teaches that the polymer content is ≥ 0.1% to ≤ 40% by weight (page 4 lines 25-26) and teaches examples where the PVPK12 is at 6% (page 9 line 9) and 9 wt% (page 12 line 22) rendering obvious the 0.01 to 10 wt% of low molecular weight non-ionic surfactant of claim 5.
Claims 11 and 12 are directed to a composition manufactured by the method of claim 10. Claim 10 recites the formation of nano-particles by comminution of the micron sized composition for a time span until the particle size stays constant in a temperature range between 253K and 323K. Ostendorf teaches milling (i.e. a type of comminution) to form the particles and that the milling is done for a preferred milling time (page 7 lines 16-30). Ostendorf does not teach comminution until the particle size is constant and done at the temperature range between 253K and 323K, but these method limitations are product-by-process limitations that do not distinguish the claimed composition from what is obvious in the art. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In the instant case, the nanoparticles of Ostendorf, having the same polymer and surfactant components, appears to be the same product claimed.
Ostendorf does not expressly teach selecting the active substance, PVPK12, HPC, and SDS discussed above as part of the particle suspension with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed a composition comprising an active substance at 10 wt% and ≤1μm, PVPK12, HPC and SDS where the PVP is at amounts such as 6% and 9% and the active to PVP12+HPC ratio is 1:1 to 2:1. One of ordinary skill in the art would have been motivated to do so as each of these components and amounts are taught by Ostendorf as suitable in a formulation comprising nanoparticles, polymer and surfactant. One of ordinary skill in the art would have a reasonable expectation of forming a composition with these components as taught by Ostendorf since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Regarding the limitation that the cellulose polymer (e.g. HPC) is present in at least 2 wt% (claims 1, 9, 11 and 12) and 2-3 wt% (claim 3) and that the non-ionic surfactant to cellulose polymer is from 10:1 to 1:10 (claims 1, 11 and 12) or 1:4 to 4:1 (claims 8 and 9), these parameters are obvious as a matter of routine experimentation. As noted above, Ostendorf teaches the mixtures of polymers such as PVP and HPC and teaches PVPK12 at various amounts (e.g. 6% and 9%) and teaches that the polymer content is ≥ 0.1% to ≤ 40% by weight and that the active substance and polymer are present in a weight ratio ≥1:1 to ≤2:1, thus indicating that the amount of polymer is an art-recognized result effective variable such that determining that the HPC is between 2-3% and the ratio of PVP to HPC is 1:4 to 4:1 would be a matter of optimization through routine experimentation. "[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). Ostendorf teaches combinations of polymers such as HPC and PVP and one of ordinary skill would recognize the need to determine the optimal values for these components in a given system. A wide range of polymers is suitable for the compositions (0.1-40%), rendering it obvious to vary the polymer content in this range. Further, a preferred range of active to polymer is from 1:1 to 2:1 and PVPK12 is known to be used at amounts such as 6 and 9% and the active is known at amounts such as 10%. This provides one of ordinary skill a reasonable starting point for determining the appropriate HPC amount to add in order to maintain the active to polymer ratio from 1:1 to 2:1. Thus, determining the amount of HPC and the ratio of HPC to PVP is clearly an optimizable variable which one of ordinary skill in the art would recognize.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Ostendorf.
The claims were rejected above as obvious over the teachings of Ostendorf. An alternative rejection is presented below where the amount of HPC is explicitly taught and obvious from the art.
Claims 1-9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ostendorf et al. (WO 2021/069350, published 15 Apr 2021, listed on IDS filed 15 Aug 2023) in view of Li et al. (Asian Journal of Pharmaceutical Sciences 14 (2019) 649–657, listed on IDS filed 15 Aug 2023) as evidenced by Cayman Chemical (Product Information Indomethacin).
Ostendorf teaches that higher dissolution of a pharmaceutical active substance usually results in increased bioavailability and that this can be achieved by increasing the specific surface area of the active substance particle and that active substance nanosuspensions have an appreciably higher rate of dissolution than a micronized suspension (page 1 lines 7-10). Ostendorf teaches suspending a pharmaceutical active substance in an aqueous solution of a polymer (page 3 lines 1-7) and that the d90 particle size is ≥10 nm to ≤ 1μm (page 4 lines 15-18). This range includes the 1 μm of the range in claim 1 and the 1 nm to 999 nm size of claims 11 and 12, rendering obvious these particle sizes. 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, 191 USPQ 90 (CCPA 1976). Ostendorf teaches measuring with laser diffraction (page 4 line 17). Ostendorf does not teach the dynamic light scattering method as in claims 11 and 12 but this is not necessary to render the claim obvious as the measurement method does not change the product with particle sizes in the range of the instant claims, as taught by Ostendorf. Ostendorf teaches pharmaceutical actives such as indometacin (page 5 lines 2-4). As evidenced by Cayman Chemical, indomethacin has an aqueous buffer solubility of approximately 0.05 mg/mL (i.e. 0.05 g/L) (page 1), meeting the solubility limitation for the substance of the instant claims.
Ostendorf teaches a mixture of at least two polymers for the suspensions including polyvinylpyrrolidone PVP K12 (page 10 line 9) and hydroxyalkyl celluloses (page 3 lines 22-28) such as hydroxypropyl cellulose (page 5 line 21), rendering obvious the at least one cellulose based polymer of HPC and the at least one non-ionic surfactant of polyvinylpyrrolidone of the instant claims. Ostendorf teaches the inclusion of a surfactant (page 1 line 1, page 4 lines 19-24) such as sodium dodecyl sulfate (SDS) (page 7 lines 4-5), rendering obvious the at least one anionic surfactant of the instant claims. Ostendorf teaches that the active substance and polymer are present in a weight ratio ≥1:1 to ≤2:1 (page 7 lines 11-13). As Ostendorf teaches polyvinylpyrrolidone and HPC, this ratio of active to polymer renders obvious the cellulose + non ionic surfactant to substance between 2:1 to 1:2 (claims 1, 11 and 12) and 1:1 (claim 9). Ostendorf teaches examples where the active indomethacin is at 10 wt% (page 10 line 8). With regard to the claimed amount of substance from 10.1 to 15 wt% (claims 1, 11 and 12 and 10.1 to 12 wt% (claim 9), the examiner notes that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. In the instant case, the difference between the 10 wt% taught by Ostendorf and the claimed 10.1% is very small and the amounts are expected to have the same properties. Ostendorf teaches that the polymer content is ≥ 0.1% to ≤ 40% by weight (page 4 lines 25-26) and teaches examples where the PVPK12 is at 6% (page 9 line 9) and 9 wt% (page 12 line 22) rendering obvious the 0.01 to 10 wt% of low molecular weight non-ionic surfactant of claim 5.
Claims 11 and 12 are directed to a composition manufactured by the method of claim 10. Claim 10 recites the formation of nano-particles by comminution of the micron sized composition for a time span until the particle size stays constant in a temperature range between 253K and 323K. Ostendorf teaches milling (i.e. a type of comminution) to form the particles and that the milling is done for a preferred milling time (page 7 lines 16-30). Ostendorf does not teach comminution until the particle size is constant and done at the temperature range between 253K and 323K, but these method limitations are product-by-process limitations that do not distinguish the claimed composition from what is obvious in the art. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In the instant case, the nanoparticles of Ostendorf, having the same polymer and surfactant components, appears to be the same product claimed.
Ostendorf does explicitly teach the amount of cellulose polymer HPC. This deficiency is made up for in the teachings of Li.
Li teaches improved dissolution by co-grinding active drug probucol and ternary stabilizers with planetary beads milling method (title). Li teaches constructing nanosuspension drug delivery systems using wet milling (abstract). Li teaches ternary stabilizer systems composed of a primary stabilizer such as HPC, a nonionic surfactant of Pluronic F68 and an anionic surfactant of SDS (abstract). Li teaches formation of stable nanosuspension with improved dissolution when the ternary stabilizer system included HPC at 2% (page 653 left column).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed a composition comprising an active substance at 10 wt% and ≤1μm, PVPK12, HPC and SDS where the PVP is at amounts such as 6% and 9%, HPC is at 2% and the active to PVP12+HPC ratio is 1:1 to 2:1. Forming nanoparticle compositions comprising 10% active, PVPK12, HPC and SDS is known from the teachings of Ostendorf. It would have been obvious to included the HPC at 2% as this amount is known from Li as suitable for ternary stabilizer systems for nanoparticle suspensions. One would have had a reasonable expectation of success as similar compositions of nanoparticle suspensions comprising components such as HPC and SDS are known from both Ostendorf and Li. The amount of 2% HPC is known from Li to produce stable nanosuspensions, rendering this as an obvious amount to include in the compositions of Ostendorf. Regarding the ratio of 1:4 to 4:1 for PVPK12 to HPC as in the instant claims, it is known from Ostendorf to include the PVPK12 in an amount such as 6% and it is known from Li to include the HPC at 2%. This results in a ratio 3:1, rendering obvious the claimed ratio.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 1-8, 11 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 17/759,958 in view of Ostendorf et al. (WO 2021/069350, published 15 Apr 2021) and Li et al. (Asian Journal of Pharmaceutical Sciences 14 (2019) 649–657) as evidenced by CDER (verquvo (vericiguat) tablets, Chapter VI Biopharmaceutics).
The ‘958 application recites a stable nanosuspension of a compound of formula (I) with one or more stabilizers such as PVP, SDS, and HPC and a dispersing agent, where the particles have a d50 of 500 nm or less (claim 1). The PVP may be K10-K50 (claim 2), rendering obvious PVPK12. The ratio of the compound to the stabilizer(s) is 16:1 to 1:2 (claim 3). The compound of formula (I) in the ‘958 application is vericiguat which, as evidenced by CDER, has a solubility in phosphate buffers of about 0.001 mg/mL (0.001 g/L) (see page 3 table 2), meeting the solubility requirement of the instant claims.
The ’958 application does not teach the amount of the PVPK12, HPC and active substance or the particles in micrometer sizes. These deficiencies are made up for in the teachings of Ostendorf and Li.
The teachings of Ostendorf and Li are described supra. Ostendorf further teaches vericiguate-PVPK12-SDS nanosuspensions where the vericiguate is at 10 wt% and the PVPK12 is at 5.8 wt% (page 11 lines 9-19).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the nanosuspension of the compound of formula (I) (i.e. vericiguat) at 10% and with PVPK12 at amounts such as 5.8%, HPC at 2% and with SDS. These components are recited in the reference claims and their amounts are obvious from Ostendorf and Li as Ostendorf teaches 10% vericiguat nanoparticulate compositions with 5.8 PVPK12, HPC, and SDS and Li teaches that 2% is a suitable amount for HPC in nanosuspension compositions. Thus, these amounts are known to be suitable for such compositions, providing a reasonable expectation of success in using these amounts. Regarding the micrometer sized particles of claim 1, Ostendorf teaches compositions with particulates of 1μm, rendering this an obvious alternative size for forming drug suspensions.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner Art Unit 1600