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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 22 May 2026 has been entered.
Claims 1 and 10 remain pending in the application.
Claims 1- and 10 are amended.
Claims 2-9, 11 and 12 are cancelled.
Claim 10 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim 1 is under consideration.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Non-Final Office Action mailed 24 Feb 2026 are hereby withdrawn in light of applicant’s amendments of the specification.
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 24 Feb 2026 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 24 Feb 2026 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Pursuant to 35 USC § 103
The rejection of claims 1-9, 11, and 12 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15 Apr 2021, listed on IDS filed 15 Aug 2023) as evidenced by Cayman Chemical (Product Information Indomethacin) is withdrawn in light of applicant’s amendment of the claims, and the art is reapplied in the new grounds of rejection set forth below.
The rejection of claims 1-9, 11, and 12 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(2019) 649–657, listed on IDS filed 15 Aug 2023) as evidenced by Cayman Chemical (Product Information Indomethacin) is withdrawn in light of applicant’s amendment of the claims, and the art is reapplied in the new grounds of rejection set forth below.
Rejections Pursuant to Double Patenting
The rejection under Double Patenting is withdrawn in light of applicant’s amendment of the claims, and is reapplied in the new grounds of rejection set forth below.
New Grounds of Objectins/Rejections
Specification
The abstract of the disclosure is objected to because of the use of implied phraseology of “the disclosure provides.” 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 language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “hydroxypropylceullulose HPC.” The claim would be improved by placing the “HPC” into parenthesis to identify it as the abbreviation for hydroxypropylcellulose.
Claim 1 recites “at least one non-ionic surfactant comprising polyvinylpyrrolidone PVP K12.” The language of the claim would be improved by placing the PVP into parenthesis to identify it as the abbreviation for polyvinylpyrrolidone or to use alternative phrasing such as “comprising polyvinylpyrrolidone wherein the polyvinylpyrrolidone is PVP K12.”
Appropriate correction is required.
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.
Claim 1 is 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). Ostendorf teaches measuring with laser diffraction (page 4 line 17). Ostendorf teaches that the particles are attained by means of milling (page 7 lines 16-27) thus indicating that the particles are first at a size greater than their final ≥10 nm to ≤ 1μm particle size. Ostendorf provides a comparative example not comprising a surfactant where the particles did not retain their nanometer dimensions but redispersed into micrometer dimensions (page 11 lines 21-30, fig 8). Thus it is obvious to have the particle size of the active component greater than 1μm before milling as the particles of Ostendorf are milled to their nanometer dimensions, thereby rendering obvious the claimed particle size. 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 comprising PVP K12 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 PVP K12 and HPC, this ratio of active to polymer renders obvious the cellulose + non ionic surfactant to substance between 2:1 to 1:2 as recited in the instant claim. 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). The active to polymer ratio of 1:1 to 2:1 and the polymer content between 0.1 and 40 wt% render obvious the instantly claimed range of 10.5-12 wt% for the substance. For example, a ratio of 1:1 renders obvious a range of active substance from 0.1-40 wt%.
Ostendorf does not expressly teach selecting the active substance, PVPK12, HPC, and SDS in the amounts 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 with particle size greater than 1μm, PVPK12, HPC and SDS where the PVP is at amounts such as 6% and 9% and the active to PVPK12+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 HPC is present in at least 2 wt% and in a ratio from 10:1 to 1:10, 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 the HPC is between at least 2 wt% and the ratio of HPC to PVP K12 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 (e.g. 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%. 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.
Response to Arguments
Applicant's arguments filed 22 May 2026 have been fully considered but they are not persuasive. Applicant argues that Ostendorf does not teach a PVP K12 to HCP ratio of 10:1 to 1:10 (page 6 part (i) of remarks). Applicant argues that Ostendorf does not teach a ratio of the cellulose based polymer and the non-ionic surfactant together to the substance of 2:1 to 1:2 (page 6 part (ii) of remarks). Applicant argues that Ostendorf does not teach a substance concentration of 10.5 to 12% (page 7 part (iii) of remarks). The applicant argues that the technical problem solved by the present invention is a process for generating a composition of nanoparticles and that the claimed triple stabilizer system of HPC, SDS and PVP K12 at the specific ratios reduces viscosity, enabling higher active ingredient concentrations and resulting in fewer milling batches (page 7 part B of remarks). Applicant argues that one would not have a reasonable expectation of success as Ostendorf does not combine HPC with PVP K12 and that to combine them from Ostendorf is improper hindsight reconstruction (page 7 part C(i) of remarks). Applicant argues for unexpected results with the PVPK12 lowering viscosity as contrary to the expectation in the art (pages 7-8 part C(ii) of the remarks). Applicant argues that there is no suggestion to increase the concentration above 10 wt% (page 8 part (iii) of remarks).
The examiner does not find these arguments persuasive to overcome the prima facie case of obviousness as presented. It is obvious from the teachings of Ostendorf to form a composition comprising an active substance with particle size greater than 1μm, PVPK12, HPC and SDS where the PVP is at amounts such as 6% and 9% and the active to PVPK12+HPC ratio is 1:1 to 2:1. Even though Ostendorf does not embody the combination of HCP and PVP K12 in a single composition, Ostendorf clearly teaches mixtures of polymers for the invention and teaches HPC and PVP K12 (e.g. page 3 lines 22-28). The rejection was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Ostendorf may not provide a specific embodiment of the instantly claimed invention, the examiner maintains that the invention as claimed is nonetheless made obvious from the teachings of art. Mixtures of polymers are taught and there is nothing to indicate that one of ordinary skill would not combine the HCP and PVP K12 polymers taught by Ostendorf. Ostendorf clearly teaches that the active substance and polymer are present in a weight ratio ≥1:1 to ≤2:1 (page 7 lines 11-13) rendering this an obvious ratio for the combination of the polymers and the active components in the composition. While Ostendorf does not specify a particular value for the HPC and that the substance is between 10.5-12%, the claimed amounts would have nonetheless been obvious to one of ordinary skill as a matter of routine optimization. It is known that the amount of polymer is a variable parameter from 0.1-40% and Ostendorf provides examples of PVP K12 at concentrations including 6 and 9% and Ostendorf teaches that the active to polymer ratio of 1:1 to 2:1. Even though Ostendorf does not embody or specifically teach the active and HPC amounts, the claimed parameters would be obvious to one of ordinary skill in the art through the ratios that are taught and through routine experimentation of varying the polymer concentrations as described in the rejection above. Additionally, although Ostendorf does not teach the lower viscosity with PVP K12 leading to fewer milling batches, the examiner notes that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). In KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court cautioned that, "[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103." Id. at 419. Ostendorf teaches compositions with high dissolution of active substance and teaches each of the claimed components for such compositions as described above and it would have thus been obvious to form a composition with such components in the amounts as described. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Each of the HPC, PVPK12 and SDS components are taught for such compositions, including mixtures of polymers and thus the teachings of Ostendorf render obvious such compositions as described.
Regarding the argument for unexpected results of lower viscosity, the examiner does not find this persuasive as the results are not commensurate in scope with the claims. The applicant has demonstrated viscosity decreasing as PVPK12 was varied from 0 to 8% in a composition of 2 wt% HPC and 0.2 wt% SDS (e.g. example 3, fig 2). The examiner notes that this is more specific than what the breadth of the current claims. For example, the percentage of PVP K12 and SDS are not limited and may included at any amount and the HPC is may be any amount above 2%, with the only limitations being that the components are present in certain ratios. The applicant has not demonstrated the same improvement in viscosity across this percentage range for these components and the applicants data actually suggests that the results would not be expected across the entire range. For example, table 2 and fig 2 of the specification indicates that in a composition with PVP above 8% that the compositions had a higher viscosity than when the PVPK12 was not present. Thus, the claim limitations are broader than what is supported by the results provided.
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.
Claim 1 is 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). Ostendorf teaches measuring with laser diffraction (page 4 line 17). Ostendorf teaches that the particles are attained by means of milling (page 7 lines 16-27) thus indicating that the particles are first at a size greater than their final ≥10 nm to ≤ 1μm particle size. Ostendorf provides a comparative example not comprising a surfactant where the particles did not retain their nanometer dimensions but redispersed into micrometer dimensions (page 11 lines 21-30, fig 8). Thus it is obvious to have the particle size of the active component greater than 1μm before milling as the particles of Ostendorf are milled to their nanometer dimensions, thereby rendering obvious the claimed particle size. 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 comprising PVP K12 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 PVP K12 and HPC, this ratio of active to polymer renders obvious the cellulose + non ionic surfactant to substance between 2:1 to 1:2 as recited in the instant claim. 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). The active to polymer ratio of 1:1 to 2:1 and the polymer content between 0.1 and 40 wt% render obvious the instantly claimed range of 10.5-12 wt% for the substance. For example, a ratio of 1:1 renders obvious a range of active substance from 0.1-40 wt%.
Ostendorf does not 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 with particle size greater than 1μm, PVPK12, HPC and SDS where the PVP is at amounts such as 6% and 9% and the active to PVPK12+HPC ratio is 1:1 to 2:1, and where the HPC is at 2%. Forming nanoparticle compositions comprising PVPK12, HPC and SDS where the PVP is at amounts such as 6% and 9% and the active to PVPK12+HPC ratio is 1:1 to 2:1 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 1:10 to 10:1 for PVPK12 to HPC as in the instant claims, it is known from Li to include the HPC at 2% and it is known from Ostendorf to include the PVPK12 in an amount such as 6%. This results in a ratio 1:3, 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.
Response to Arguments
Applicant's arguments filed 22 May 2026 have been fully considered but they are not persuasive. Applicant argues that Li teaches probucol at 16.7 wt% which is above the claimed 10.5-12% and that Li uses different surfactant-to-polymer ratios (page 9 part (i) of remarks). Applicant argues that Li does not address the viscosity reduction and that Li’s objective was to reduce particle size and improve dissolution rate and not to address the viscosity problem (page 9 part (ii) of remarks). The applicant argues that the technical problem solved by the present invention is providing a more economic process by enabling higher substance concentrations through viscosity reduction (page 9 part B of remarks). Applicant argues for unexpected results with the PVPK12 lowering viscosity as contrary to the expectation in the art (page 9 part C of the remarks).
The examiner does not find these arguments persuasive to overcome the prima facie case of obviousness as presented. It is obvious from the teachings of Ostendorf to form a composition comprising an active substance with particle size greater than 1μm, PVPK12, HPC and SDS where the PVP is at amounts such as 6% and 9% and the active to PVPK12+HPC ratio is 1:1 to 2:1. Even though Ostendorf does not embody the combination of HCP and PVP K12 in a single composition, Ostendorf clearly teaches mixtures of polymers for the invention and teaches HPC and PVP K12 (e.g. page 3 lines 22-28). Li was merely used for the teaching that HPC is known to be present at amounts such as 2% and not for the percentage probucol. As Ostendorf does not explicitly state the HPC concentration is would have been obvious to use it at 2% as this is known to be a suitable concentration for HPC in nanosuspension drug delivery systems. The rejection was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Ostendorf and Li may not provide a specific embodiment of the instantly claimed invention, the examiner maintains that the invention as claimed is nonetheless made obvious from the combined teachings of the art. Mixtures of polymers are taught and there is nothing to indicate that one of ordinary skill would not combine the HCP and PVP K12 polymers taught by Ostendorf with the HPC at 2% as is known from Li.
Additionally, although Ostendorf does not teach the lower viscosity with PVP K12 providing a more economic process, the examiner notes that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). In KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court cautioned that, "[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103." Id. at 419. Ostendorf teaches compositions with high dissolution of active substance and teaches each of the claimed components for such compositions as described above and Li indicates 2% as a suitable value for HPC and it would have thus been obvious to form a composition with such components in the amounts as described.
Regarding the argument for unexpected results of lower viscosity, the examiner does not find this persuasive as the results are not commensurate in scope with the claims. The applicant has demonstrated viscosity decreasing as PVPK12 was varied from 0 to 8% in a composition of 2 wt% HPC and 0.2 wt% SDS (e.g. example 3, fig 2). The examiner notes that this is more specific than what the breadth of the current claims. For example, the percentage of PVP K12 and SDS are not limited and may included at any amount and the HPC is may be any amount above 2%, with the only limitations being that the components are present in certain ratios. The applicant has not demonstrated the same improvement in viscosity across this percentage range for these components and the applicants data actually suggests that the results would not be expected across the entire range. For example, table 2 and fig 2 of the specification indicates that in a composition with PVP above 8% that the compositions had a higher viscosity than when the PVPK12 was not present. Thus, the claim limitations are broader than what is supported by the results provided.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 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. The PVP may be K10-K50, rendering obvious PVPK12. The ratio of the compound to the stabilizer(s) is 16:1 to 1:2. 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 a composition comprising vericiguat with particle size greater than 1μm, PVPK12, 2% HPC and SDS where the PVP is at amounts such as 6% and 9% and the active to PVPK12+HPC ratio is 1:1 to 2:1. Regarding the micrometer dimensions of the instant claims, it is known from Ostendorf that nanosuspensions, including suspensions of vericiguat are formed by ball milling methods, thus rendering it obvious to have compositions with micrometer dimensions before milling and thus it would be obvious to have the particles of nanosuspensions first with micorometer dimensions before milling. The amount of 2% HPC is known from Li to produce stable nanosuspensions, rendering this as an obvious amount to include it at. Regarding the ratio of 1:10 to 10:1 for PVPK12 to HPC as in the instant claims, it is known from Li to include the HPC at 2% and it is known from Ostendorf to include the PVPK12 in an amount such as 6%. This results in a ratio 1:3, rendering obvious the claimed ratio. Regarding the percentage of substance from 10.5-12 wt%, it is known from Ostendorf that polymer content from ≥ 0.1% to ≤ 40% by weight and the active substance and polymer are present in a weight ratio ≥1:1 to ≤2:1 are suitable parameters for such suspensions. The active to polymer ratio of 1:1 to 2:1 and the polymer content between 0.1 and 40 wt% render obvious the instantly claimed range of 10.5-12 wt% for the substance. For example, a ratio of 1:1 renders obvious a range of active substance from 0.1-40 wt%.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 22 May 2026 have been fully considered but they are not persuasive. Applicant argues that claim 9 was excluded from the previous rejection and the limitations have been incorporated in the current claim. The examiner notes that claim nine was inadvertently left off in the statement of rejection but the limitations were addressed in the rejection. The examiner maintains that claim 1 is obvious over the copending application in view of Ostendorf and Li for the reasons given in the rejection above. The applicant argues that the solubility of vericiguat is approximately 0.0009 mg/mL at pH 6.8 as evidenced by the CDEER article. The examiner is not persuaded by this and notes that the solubility of vericiguat is 0.001 mg/mL at pH 6.0 (Table 2) and there is no pH limitation on the solubility of the instant claim.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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