DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments, filed 02/23/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1, 2, 8, 13, 20, 21, 25, 28, 33, 34, 37, 40, 46, 50, 58, 59, 63, 68, 73, 74, 77, 80, 82, 99, 100, 103, 108, 112, 121, 139, 141, 168, 210, and 211, are pending.
Claims 33, 99, 100, 103, 108, 112, 121, 139, 141, 210, and 211, are withdrawn.
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 34, 50, 58, 59, 63, 68, 73, 74, 77, 80, 82, and 103, stand 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.
Claim 34, as newly amended, recites “wherein the second active pharmaceutical ingredient is for the treatment of the same disease or disorder, for the treatment of a different disease or disorder, or confers an additional physiological effect,” and it is still unclear what component the second active agent is being compared to. For example, is the second active pharmaceutical ingredient compared to the active pharmaceutical ingredient of claim 1, or something else?
Claims 50, 58, 59, 68, and 103, recite “the composition” and it is unclear if “the composition” is referring to the composition containing the co-crystal and co-former or if it is referring to the pharmaceutical composition. The claims are interpreted in light of specification, and the instant specification recites that the terms “compositions” and “pharmaceutical compositions” are used synonymously and interchangeably herein (see ¶ 110 of the instant specification). For purposes of examination, the composition is interpreted as the composition containing the co-crystal and co-former from step (A).
Claims 63, 73, 74, 77, 80, and 82 also stand rejected for the same reasons for depending upon rejected claim 68.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 2, 8, 13, 20, 21, 25, 28, 34, 37, 40, 46, 50, 58, 59, and 63, stand rejected under 35 U.S.C. 103 as being unpatentable over Salmoria et al (Rhematol Orthop Med, 2017, 2(3), pp. 1-7), in view of Gautam et al (AAPS PharmSciTech, 2019, 20:149, pp. 148-149), as evidenced by PubChem (2,5-Dihydroxybenzoic acid, 2025).
Salmoria et al teach polycaprolactone/fluorouracil tablets that were additively manufactured by selective laser sintering (abs). As evidenced by Gautam et al, fluorouracil is a chemotherapy agent (intro 1st ¶). The tablets were prepared in the open air with a powder bed temperature of 45 deg C, the laser scanning speed was 350 mm/s, and the spacing between laser cans was 125 microns (pg. 2 4th ¶).
Salmoria et al do not teach a composition comprising a co-crystal and co-former, the claimed limitations directed to the co-crystal formulations, nor the inclusion of an excipient.
Gautam et al teach co-crystal formulations comprising 5-flourouracil (active pharmaceutical agent) with co-formers including gentisic acid, 3,4-dihydroxybenzoic acid, etc., were known (abs). Gautam et al teach 3,4-dihydroxybenzoic acid comprises a carboxylic group and is bound via hydrogen bonds to the fluorouracil (non-covalent interaction) (fig. 6). As evidenced by PubChem, gentisic acid comprises a carboxyl functional group. Pharmaceutical co-crystallization offers enhanced solubility, dissolution, bioavailability, permeability, and stabilization of unstable compounds (intro 1st ¶). Co-crystals of 5-fluorouracil were specifically shown to improve permeability and antitumor efficacy compared to free drug (abs, pg. 148 1st col 2nd ¶, conclusion). Both 3,4-dihydroxybenzoic acid and gentisic acid have a variety of physiological activities which are of great benefit to health, including antioxidant and free radical scavenging activities, and exerts pro-apoptotic as well as antiproliferative effects in various cancer tissues (pg. 149 1st ¶). 5-flourouracil and the co-formers were included in equimolar quantities (pg. 149 1st col 4th ¶). The particle size of the co-crystal composition was in the range of 0.175-0.177 mm (175-177 microns) (pg. 149 1st ¶). The co-crystals have a pKa difference of less than 1 between the co-formers, where a pKa greater than 3 results in salt formation and less than 1 will almost exclusively result in co-crystal formation (pg. 149 2nd col last ¶). The melting point peak of the co-crystal formulations were 233.28 deg C and 221.49 deg C for the co-crystal formulations comprising gentisic acid and 3,4-dihydroxybenzoic acid, respectively (pg. 149 last ¶).
Regarding claim 1, it would have been obvious to modify the method of formulating fluorouracil tablets via selective laser sintering of Salmoria et al by substituting a co-crystal formulation of fluorouracil with co-formers, such as gentisic acid or 3,4-dihyroxybenzoic acid, as taught by Gautam et al, for the free fluorouracil used by Salmoria et al, where co-crystal fluorouracil compositions were known to have enhanced solubility, dissolution, bioavailability, permeability, stabilization, permeability, and increased antitumor efficacy compared to the free drug, as taught by Gautam et al.
The examiner notes that selective laser sintering (species elected by Applicant) appears to be a type of powder-bed fusion, thereby meeting the claimed limitation.
Regarding claim 2, it would have been obvious to formulate the co-crystal composition with at least 50% by weight of the active pharmaceutical ingredient and the co-former as a co-crystal, where the co-crystals were known to offer enhanced solubility, dissolution, bioavailability, permeability, stabilization, permeability, and increased antitumor efficacy compared to the free drug, as taught by Gautam et al. The skilled artisan would have a reasonable expectation of success in formulation the co-crystal formulations with at least 50% by weight of the active as a co-crystal where pKa differences between the active and the co-former were known to result in formulations that are almost exclusively co-crystals. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 8, it would have been obvious to include fluorouracil and the co-former made obvious above in equimolar ratios (i.e., 1:1), as taught by Gautam et al, falling within the claimed range.
Regarding claim 13, it appears that the composition comprising the co-crystal reads on a granule, where the particle sizes are taught to be 0.175-0.177 mm (175-177 microns). The instant specification does not define granule, but recites that the powders have an average particle size less than 50 microns (see ¶ 31 of the instant specification), and it would be expected that granules would be larger than the powders. Therefore, where the particle sizes of the co-crystal composition is greater than those of the powders, it appears to read on a granule.
Regarding claims 20 and 21, fluorouracil is a chemotherapy drug as taught by Gautam et al.
Regarding claim 25, the co-former interacts with the fluorouracil via hydrogen bonds (non-covalent interactions), as taught by Gautam et al.
Regarding claim 28, co-crystallization with active pharmaceutical agents and co-formers were taught by Gautam et al to enhance solubility of the active compounds, thereby reading on a co-former that modifies the solubility of the active agent.
Regarding claim 34, the co-formers made obvious above were taught by Gautam et al to have beneficial physiological effects including antioxidant and free radical scavenging activities, as well as pro-apoptotic and antiproliferative effects in various cancer tissues.
Regarding claim 37, gentisic acid and 3,4-dihydroxybenzoic acid comprise carboxyl functional groups, as discussed above by Gautam et al and evidenced by PubChem.
Regarding claim 40, gentisic acid and 3,4-dihydroxybenzoic acid, both being acids having carboxyl functional groups, are carboxylic acids.
Regarding claim 46, it would have been obvious to formulate the co-crystal composition made obvious above with a pKa difference between the active pharmaceutical ingredient and the co-former is less than 1, resulting in almost exclusively co-crystal formation, as taught by Gautam et al.
Regarding claim 50, where the composition made obvious above by Salmoria et al and Gautam et al comprise a co-crystal composition in combination with polycaprolactone, it appears that polycaprolactone reads on an excipient, where the instant specification lists polymeric carriers and thermoplastic polymers as suitable excipients (see ¶ 81 of the instant specification).
Regarding claim 58, where method made obvious by the combination above uses a laser to direct energy at the composition to form tablets with specific spacing between laser scans, it appears that the formation of the tablets read on forming a pattern.
Regarding claim 59, the pattern is prepared with a print speed of 350 mm/s, as taught by Salmoria et al, falling within the claimed range.
Regarding claim 63, the spacing between laser scans was 125 microns, as taught by Salmoria et al, falling within the claimed range. Note, the distance between laser scans appears to read on hatch spacing as instantly claimed where the instant specification defines hatch spacing as the distance between each successive laser pass (see ¶ 101 of the instant specification).
Response to Arguments
Applicants assert the Action has failed to establish obviousness as there is no suggestion that a co-crystal could be processed through an additive manufacturing process as presently claimed. Applicants assert Gautam et al notes that co-crystals possess different physical properties from their respective compound, and there is no evidence to suggest that these compounds could be subjected to additive manufacturing to obtain a co-crystal composition that retains its crystallization. Applicants cite Chettri et al (cited on IDS dated 02/23/2026), Patel and Mali (cited on IDS dated 02/23/2026), and Wong (cited on IDS dated 02/23/2026) for teachings of co-crystal properties for support.
Respectfully, this argument is not persuasive. Regarding the additional references cited by Applicants that were not included in the prior art rejection, nor previously made of record, the examiner notes that these references appear to be published after the effective filing date of the claimed invention, and any teachings or knowledge gleaned from these references would not have been available to the skilled artisan at the effective filing date of the instant claims. Therefore, the examiner will rely upon the teachings of the prior art of record to address Applicants’ arguments concerning the reasonable expectation of success in subjecting the co-crystals of Gautam et al to the additive manufacturing technique of Salmoria et al.
Salmoria et al was cited for teaching that selective laser sintering was known to be used to produce polycapralactone/fluorouracil tablets; Gautam et al was cited for teaching co-crystal formulations comprising fluorouracil with co-formers were known, and have enhanced solubility, dissolution, bioavailability, permeably, stabilization, and antitumor efficacy compared to free drug. Following these teachings, the skilled artisan would have motivation to modify the active agent of Salmoria et al by instead using co-crystals, for the above mentioned benefits.
Obviousness requires only a reasonable expectation of success, not absolute expectation of success; at least some degree of predictability is all that is required. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See MPEP 2143.02. Gautam et al was also cited for teaching the melting point peak of the co-crystal formulations were 233.29 and 221.49 deg C. Additionally, Salmoria et al teaches the melting point peak of the polymer used in the selective laser sintering process was 60 deg C and fourouracil showed a melting point peak in DSC of about 284 deg C in the tablets prepared by laser sintering using different wattage lasers. The processing parameters suggests that the sintering temperature was designed to be greater than the melting temperature of the polymer, and less than the melting temperature of the active. From this, it appears that the skilled artisan would recognize from Salmoria et al that the sintering temperature was below the melting point of the active, and the skilled artisan could reasonably adjust the processing parameters accordingly for the co-crystal formulations, where the melting point peaks of the co-crystals were known. Therefore, the skilled artisan would reasonably expect that the co-crystal drug, having a melting point of 233.29 and 221.49 deg C, could reasonably undergo the selective laser sintering process of Salmoria et al, while still retaining its crystallinity, thereby resulting in a formulation having the improved properties resulting from the co-crystal drug form.
Claim 13 stands rejected under 35 U.S.C. 103 as being unpatentable over Salmoria et al (Rhematol Orthop Med, 2017, 2(3), pp. 1-7) and Gautam et al (AAPS PharmSciTech, 2019, 20:149, pp. 148-149) as applied to claims 1, 2, 8, 13, 20, 21, 25, 28, 34, 37, 40, 46, 50, 58, 59, and 63 above, and further in view of Dhumal et al (Pharm Res, 2010, 27:2725-2733, cited on IDS dated 12/01/2024).
Salmoria et al and Gautam et al are discussed above, and while appearing to teach granules, for the sake of argument, if the co-crystal composition does not read on granules, then the following applies.
Dhumal et al teach it was known to formulate co-crystal compositions comprising ibuprofen (active pharmaceutical agent) and nicotinamide (co-former) in the form of granules, where the morphology of the granules were particularly advantageous for pharmaceuticals and improved downstream processing (abs, pg. 2731 1st col last full ¶).
Regarding claim 13, it would have been obvious to formulate the composition comprising co-crystals made obvious above in the form of granules, which were known forms suitable for co-crystal formulations, as taught by Dhumal et al.
Response to Arguments
Applicants have not provided argument with respect to the combination of Salmoria et al, Gautam et al, and Dhumal et al. Accordingly, the claim stands rejected for the same reasons above and of record.
Claims 68, 73, 74, 77, 80, 82, and 168, stand rejected under 35 U.S.C. 103 as being unpatentable over Salmoria et al (Rhematol Orthop Med, 2017, 2(3), pp. 1-7) and Gautam et al (AAPS PharmSciTech, 2019, 20:149, pp. 148-149) as applied to claims 1, 2, 8, 13, 20, 21, 25, 28, 34, 37, 40, 46, 50, 58, 59, and 63 above, and further in view of Allahham et al (Pharm, 2020, 12, 110, pp. 1-13).
Salmoria et al and Gautam et al are discussed above but do not specifically teach wherein the selective laser sintering device has a chamber, nor wherein the pharmaceutical composition further comprises a filler.
Allahham et al teach selective laser sintering of oral printlets comprising a drug, where it was known to include fillers such as mannitol for its taste masking properties (abs, pg. 2 last ¶). It was known to use selective laser sintering devices with a chamber that has a chamber temperature that is lower than the surface temperature (pg. 3 2.3 2nd ¶). The mixture of drug and excipient was transferred to the building platform of the printer (pg. 3 2.3 2nd ¶).
Regarding claim 68, it would have been obvious to modify the combination of Salmoria et al and Gautam et al, by using other known selective sintering devices for 3D printing oral dosage forms, such as a device comprising a chamber with a surface, as taught by Allahham et al.
Further, it would have been obvious to deposit a layer of the composition onto the surface in the chamber for selective laser sintering, as taught by Allahham et al.
Regarding claims 73, 74, and 77, where the selective laser sintering of Salmoria et al uses a surface temperature of 45 deg C in an open air environment (i.e., room temperature), it would have been obvious to use a surface temperature of 45 deg C with room temperature in the chamber made obvious above, where these temperatures were known to be suitable for selective laser sintering pharmaceutical formulations comprising a chemotherapy agent.
Regarding claim 80, where the co-crystal has a peak melting point of 233.28 deg C and 221.49 deg C for the co-crystal formulations comprising gentisic acid and 3,4-dihydroxybenzoic acid, respectively, as taught by Gautam et al, and the surface temperature made obvious above is 45 deg C, as taught by Salmoria et al, the surface temperature is greater than 5 deg C less than the melting point of the co-crystal as instantly claimed.
Regarding claim 82, where a layer is made obvious above, it would have been obvious to expose the layer to the laser in the selective laser sintering method made obvious above, thereby meeting the claimed limitation.
Regarding claim 168, it would have been obvious to further include known fillers suitable for formulations prepared by selective laser sintering, such as mannitol, in order to provide the tablet made obvious above with taste masking, as taught by Allahham et al.
Response to Arguments
Applicants have not provided argument with respect to the combination of Salmoria et al, Gautam et al, and Allahham et al. Accordingly, the claims stand rejected for the same reasons above and of record.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 8, 13, 20, 21, 25, 28, 34, 37, 40, 46, 50, 58, 59, 63, 68, 73, 74, 77, 80, 82, and 168, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/041,475 (reference application), hereinafter ‘475, in view of Salmoria et al (Rhematol Orthop Med, 2017, 2(3), pp. 1-7), Gautam et al (AAPS PharmSciTech, 2019, 20:149, pp. 148-149), Dhumal et al (Pharm Res, 2010, 27:2725-2733, cited on IDS dated 12/01/2024), and Allahham et al (Pharm, 2020, 12, 110, pp. 1-13).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims disclose a composition comprising a co-crystal, wherein the co-crystal comprises an active pharmaceutical ingredient and a co-former, wherein the active agent is a chemotherapy agent, etc. (claim 1). The composition comprises at least 50% of the active and the co-former as a co-crystal (claims 2, 65). The co-former interacts with the active agent through one or more non-covalent interactions (claim 20). The co-former modifies the solubility of the active (claims 23, 86). The co-former is a second active agent for the same disease or disorder as the first active agent or is for a different disease (claims 28, 92). The co-former comprises carboxyl functional groups, etc. (claims 32, 95), and is a carboxylic acid, etc. (claim 35). The pKa of the active and co-former have a difference of less than 3 (claims 45, 105). The composition further comprises an excipient (claims 48, 108). The active agent and the co-former comprises a molar ratio of about 0.1 to about 10 (claims 52, 113). Also recited is a method of preparing the composition using additive manufacturing techniques (claims 64, 154). The additive manufacturing technique is powder bed fusion, etc. (claim 154). Also recited is a method of treating or preventing a disease or disorder by administering the composition to a subject in need thereof (claim 177).
The claims of ‘475 do not disclose wherein the composition is present as a granule, the presence of a filler, nor the processing steps and parameters of claims 1, 58, 59, 63, 68, 73, 74, 77, 80, and 82.
The references are discussed above.
Regarding the granule, it would have been obvious to formulate the co-crystal compression in the form of a granule, as taught by Gautam et al and Dhumal et al above and for the same reasons.
Regarding the filler, it would have been obvious to include a filler, for the same reasons discussed above by Allahham et al.
Regarding the processing steps of claims 1, 58, 59, 63, 68, 73, 74, 77, 80, and 82, it would have been obvious to modify the method of ‘475 by using known powder bed fusion techniques, such as selective laser sintering, as taught by Salmoria et al above and for the same reasons. It would have been further obvious to use known processing steps for selective laser sintering, such as those discussed above, thereby arriving at the claimed invention.
Regarding the presence of a chamber, it would have been obvious to use a known selective laser sintering device that comprises a chamber, as taught by Allahham et al for the same reasons discussed above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants request the nonstatutory double patenting rejection be held in abeyance as the reference application is subject to a restriction requirement that may materially alter the claims and their scope.
The examiner acknowledges Applicants’ request. The claims stand rejected for the same reasons above and of record.
Claims 1, 2, 8, 13, 20, 21, 25, 28, 34, 37, 40, 46, 50, 58, 59, 63, 68, 73, 74, 77, 80, 82, and 168, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/256,897 (reference application), hereinafter ‘897, in view of Salmoria et al (Rhematol Orthop Med, 2017, 2(3), pp. 1-7), Gautam et al (AAPS PharmSciTech, 2019, 20:149, pp. 148-149), Dhumal et al (Pharm Res, 2010, 27:2725-2733, cited on IDS dated 12/01/2024), and Allahham et al (Pharm, 2020, 12, 110, pp. 1-13).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims disclose a method of preparing a composition comprising an active pharmaceutical ingredient (API) and a co-former, wherein the pharmaceutical composition comprises at least 50% of the API and the co-former present as a co-crystal (claims 1, 100). The composition is further processed by extrusion, etc. (claim 28). The API is selected from chemotherapeutic drugs, etc. (claims 53, 138, 139). The co-former interacts with the API through non-covalent interactions (claims 69, 154, 155). The co-former modifies the solubility of the API (claims 70, 155). The mixture further comprises an excipient (claim 95). The co-former comprises functional groups selected from carboxyl, etc. (claim 166). The API and co-former have a pKa difference of less than 3 (claim 167). The claims also recite a method of treating or preventing a disease or disorder comprising administering the composition to a subject in need thereof (claim 185).
The claims of ‘897 do not disclose the additive manufacturing technique of selective laser sintering, the ratio of claim 8, wherein the composition is in the form of a granule, the presence of a filler, wherein the co-former is a second active ingredient, nor the processing steps and parameters of claims 1, 58, 59, 63, 68, 73, 74, 77, 80, and 82.
The references are discussed above.
Regarding the additive manufacturing technique, it would have been obvious to use known manufacturing techniques suitable for co-crystal pharmaceutical compositions, such as selective laser sintering, as taught by Salmoria et al.
Regarding the ratio of claim 8, it would have been obvious to use known API to co-former ratios for co-crystal compositions, such as a 1:1 molar ratio, as taught by Gautam et al above and for the same reasons.
Regarding the granules, it would have been obvious to formulate the co-crystal compression in the form of a granule, as taught by Gautam et al and Dhumal et al above and for the same reasons.
Regarding the filler, it would have been obvious to include a filler, for the same reasons discussed above by Allahham et al.
Regarding wherein the co-former is a second active ingredient, it would have been obvious to use a co-former that acts as a second active ingredient, which were known from Gautam et al.
Regarding the processing steps of claims 1, 58, 59, 63, 68, 73, 74, 77, 80, and 82, it would have been obvious to modify the method of ‘897 by using known powder bed fusion techniques, such as selective laser sintering, as taught by Salmoria et al above and for the same reasons. It would have been further obvious to use known processing steps for selective laser sintering, such as those discussed above, thereby arriving at the claimed invention.
Regarding the presence of a chamber, it would have been obvious to use a known selective laser sintering device that comprises a chamber, as taught by Allahham et al for the same reasons discussed above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants note that the present application is the earlier filed application and thus if in condition for allowance, the double patenting rejection should be withdrawn in accordance with MPEP 804(I)(B)(1)(b)(i).
The examiner acknowledges Applicants’ assertion. Currently, as the nonstatutory double patenting rejection is not the only remaining rejection, the claims stand rejected for the same reasons above and of record.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights