DETAILED ACTION
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
Previous Rejections
Applicants' arguments, filed 11/14/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 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, 3-8 and 17-19 are rejected under 35 U.S.C. 103 as being as being obvious over De Miguel et al. (EP 3260114 A1) in view of Geyer et al. (US 5,466,865).
Regarding claims 1 and 19, De Miguel discloses a dosage form [Abstract] with surface-reacted calcium carbonate as a carrier [0001]-[0002], wherein the surface-reacted calcium carbonate is a reaction product of natural ground calcium carbonate with carbon dioxide and one or more H3O+ ion donors, wherein the carbon dioxide is formed in-situ by the H3O+ ion donor treatment and further includes at least one active ingredient [Claim 1], which can be a pharmaceutical active agent [Claim 4] such as ibuprofen [0119] [0236]-[0242]. De Miguel does not require the use of polymers in the dosage form (full document).
De Miguel does not disclose the active ingredients are at least partially X-ray amorphous with a crystallinity of less than 40 wt.% (as recited in claim 1) or less than 50 wt.% (as recited in claim 19).
Geyer discloses amorphous ibuprofen to be given in dosage form where at least 95 wt.% is in the amorphous form based on the total amount of active (i.e., a crystallinity of at least less than 5 wt.%) (Col 5, lines 19-42; Col 2, lines 15-17; Col 8, lines 53-62). Geyer does not require the use of polymers to prepare amorphous form ibuprofen (full document). Geyer teaches that the drug in the amorphous form has less bitter taste, causes less burning sensation upon swallowing, and leads to better patient compliance (abstract; Col 8, lines 2-10, lines 53-62).
Since De Miguel generally teaches a dosage form with a pharmaceutical active agent, such as ibuprofen, it would have been prima facie obvious to one of ordinary skill in the art to include an at least partially X-ray amorphous active ingredient with a crystallinity less than at least 5 wt.%, within the teachings of De Miguel, because Geyer teaches the amorphous form of ibuprofen where the crystallinity is less than at least 5 wt.% can be given in dosage form (Col 5, lines 19-42; Col 2, lines 15-17; Col 8, lines 53-62). An ordinarily skilled artisan would be motivated to use the amorphous form of the active ingredient, such as ibuprofen, because Geyer teaches that the drug in the amorphous form has less bitter taste, causes less burning sensation upon swallowing, and leads to better patient compliance (abstract; Col 8, lines 2-10, lines 53-62).
In regards to the wt.% of the crystallinity, 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 A.
Further regarding claims 1 and 19, the limitations of “co-ground” and “rendered at least partially X-ray amorphous during co-grinding” are interpreted as a product-by-process limitations. Even though the 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, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the amorphous form of a pharmaceutically active substance of Geyer, reads on “an at least partially X-ray amorphous active”. As such, the patentability of the instant product does not depend on its method of production, and the Applicant' s limitation regarding the active being co-ground and rendered at least partially X-ray amorphous by co-grinding is not patentable, in view of De Miguel and Geyer.
Further regarding the claim 19 transitional phrase “consisting essentially of”, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" is construed as equivalent to "comprising”. See MPEP 2111.03.
De Miguel in view of Geyer reads on claims 1 and 17-19.
Claim 3 is rendered prima facie obvious because De Miguel discloses the natural ground calcium carbonate is selected from marble [0016].
Claim 4 is rendered prima facie obvious because De Miguel discloses the surface-reacted calcium carbonate is a reaction product of natural ground calcium carbonate with carbon dioxide and one or more acids, wherein the carbon dioxide is formed in-situ by the acid treatment [0003] and the acid can be phosphoric acid [0056].
Claim 5 is rendered prima facie obvious because it would have been prima facie obvious to use at least partially amorphous active(s), as previously discussed, and De Miguel discloses the use of active ingredients which have a melting temperature from 20 to 100°C [0131]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 6 is rendered prima facie obvious because it would have been prima facie obvious to use at least partially amorphous active(s), as previously discussed, and De Miguel discloses the pharmaceutically active substance can be used in an amount of 10 wt.% or 40 wt.% [0236] [0108]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 7 is rendered prima facie obvious because De Miguel discloses the surface-reacted calcium carbonate is a suitable carrier material and other components are not required [0002] [0010].
Regarding claim 8, the limitations of the claim are interpreted as product-by-process limitations. Even though the 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, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the dosage form of De Miguel, containing surface-reacted calcium carbonate as a carrier, and the amorphous form of a pharmaceutically active substance of Geyer, reads on the co-ground active comprising product according to claim 1. As such, the patentability of the instant product does not depend on its method of production, and the Applicant' s limitation regarding the process of preparation is not patentable, in view of De Miguel and Geyer.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive and will be addressed insofar as they apply to the new ground of rejection.
Applicant argues at pg. 9 that comparative examples prepared by the method of De Miguel exhibit a crystallinity of 50 wt.%, thus the examples of the present application show that the process of De Miguel results in products having different degrees of crystallinity to that of the present process which requires a crystallinity of less that 40 wt.%. Applicant argues that the process of De Miguel is distinct from the process used to obtain the co-ground actives of claim 1 and yields a dosage form that is distinct and non-obvious over the co-ground actives of claim 1.
Applicant also argues (pg. 11) that the milling of De Miguel results in a particle size decrease of the compacted material only, without major amorphization of the active ingredient, therefore, the process of De Miguel yields a product that is significantly less amorphized than the co-ground actives of claim 1.
The Examiner agrees that De Miguel does not disclose the active ingredients are at least partially X-ray amorphous with a crystallinity of less than 40 wt.% and that De Miguel does not teach major amorphization of the active ingredient. However, it would have been prima facie obvious to one of ordinary skill in the art to include an at least partially X-ray amorphous active ingredient with a crystallinity of at least less than 5 wt.%, within the teachings of De Miguel, as taught by Geyer, as discussed above.
As discussed above, the limitation of “rendered at least partially X-ray amorphous during co-grinding” is interpreted as a product-by-process limitation. The product of the combined teachings of the prior art (De Miguel and Geyer) meets the limitations of claim 1, as amended, because one of ordinary skill in the art would include the actives of Geyer (produced by a polymer free method and which have a crystallinity of less than 40 wt.%) within the teachings of De Miguel (as the active ingredient) with a reasonable expectation of success to produce the product as claimed.
Claim 19 is rejected under 35 U.S.C. 103 as being as being obvious over De Miguel et al. (EP 3260114 A1) in view of Higgins et al. (US 2014/0206717 A1).
Regarding claim 19, De Miguel discloses a dosage form [Abstract] with surface-reacted calcium carbonate as a carrier [0001]-[0002], wherein the surface-reacted calcium carbonate is a reaction product of natural ground calcium carbonate with carbon dioxide and one or more H3O+ ion donors, wherein the carbon dioxide is formed in-situ by the H3O+ ion donor treatment and further includes at least one active ingredient [Claim 1], which can be a pharmaceutical active agent [Claim 4].
De Miguel does not disclose the active ingredients are at least partially X-ray amorphous with a crystallinity of less than 50 wt.%.
Higgins discloses a pharmaceutically active substance to be given in dosage form [Abstract] [0015] where an active pharmaceutical ingredient is processed (milled/ground [0020]; Claim 2) in the presence of an inorganic matrix (such as calcium carbonate [0025]), converting the pharmaceutically active substance to substantially amorphous form, where the crystallinity is less than 5% [Abstract]. Higgins discloses the amorphous forms of a substance shows a higher solubility and/or dissolution rate than crystalline forms of the same substance. The higher dissolution rate/solubility of an amorphous form can result in better bioavailability as compared to an associated crystalline form [0004].
Since De Miguel generally teaches a dosage form with a pharmaceutical active agent, it would have been prima facie obvious to one of ordinary skill in the art to include an at least partially X-ray amorphous active ingredient with a crystallinity less than 5%, within the teachings of De Miguel, because Higgins teaches the amorphous form of an active ingredient where the crystallinity is less than 5% [Abstract] can be given in dosage form [0015]. An ordinarily skilled artisan would be motivated to use the amorphous form of a substance because Higgins teaches the amorphous form shows a higher solubility and/or dissolution rate than crystalline forms of the same substance and results in better bioavailability as compared to an associated crystalline form [0004].
The claim requires a crystallinity of less than 50 wt.%. Higgins taught the X-ray amorphous active has a crystallinity of less than 5%, but does not explicitly disclose that it is a weight %. The ordinarily skilled artisan would have been motivated to have minimal crystallinity because Higgins teaches amorphous forms of a substance show a higher solubility and/or dissolution rate than crystalline forms of the same substance [0004]. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of converting an active pharmaceutical ingredient to a substantially amorphous form are known in the art, and as such, it would not have been inventive for the skilled artisan to have discovered the optimum wt.% via routine experimentation.
Further regarding claim 19, the limitation of “co-ground” and “rendered at least partially X-ray amorphous during co-grinding” is interpreted as a product-by-process limitation. Even though the 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, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the amorphous form of a pharmaceutically active substance of Higgins, reads on “an at least partially X-ray amorphous active”. As such, the patentability of the instant product does not depend on its method of production, and the Applicant' s limitation regarding the active being co-ground and rendered at least partially X-ray amorphous by co-grinding is not patentable, in view of De Miguel and Higgins.
Further regarding the claim 19 transitional phrase “consisting essentially of”, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" is construed as equivalent to "comprising”. See MPEP 2111.03.
Response to Arguments
Applicant's arguments filed 11/14/2025 with respect to claim 19 have been fully considered but they are not persuasive.
Applicant argues that neither Higgins nor De Miguel specifically discloses a crystallinity as a weight percentage, as required by the instant claim, and therefore, the cited references fail to teach each and every limitation.
The Examiner disagrees. The ordinarily skilled artisan would have been motivated to have minimal crystallinity because Higgins teaches amorphous forms of a substance show a higher solubility and/or dissolution rate than crystalline forms of the same substance [0004]. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of converting an active pharmaceutical ingredient to a substantially amorphous form are known in the art, and as such, it would not have been inventive for the skilled artisan to have discovered the optimum wt.% via routine experimentation.
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, 3-8 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,369,571 in view of Geyer et al. (US 5,466,865).
Claims 1, 3-8 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,400,050 in view of Geyer et al. (US 5,466,865).
Claims 1, 3-8 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,737,984 in view of Geyer et al. (US 5,466,865).
Claims 1, 3-8 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,115,258 in view of Geyer et al. (US 5,466,865).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims recite all of the features instantly recited for the composition except for the active ingredients being at least partially X-ray amorphous with a crystallinity of less than 40 wt.%.
Geyer discloses amorphous ibuprofen to be given in dosage form where least 95 wt.% is in the amorphous form based on the total amount of active (i.e., a crystallinity of at least less than 5 wt.%) (Col 5, lines 19-42; Col 2, lines 15-17; Col 8, lines 53-62). Geyer does not require the use of polymers to prepare amorphous form ibuprofen (full document). Geyer teaches that the drug in the amorphous form has less bitter taste, causes less burning sensation upon swallowing, and leads to better patient compliance (abstract; Col 8, lines 2-10, lines 53-62).
It would have been prima facie obvious to one of ordinary skill in the art to include at least partially X-ray amorphous active ingredients with a crystallinity of less than 40 wt.%., within the claims because Geyer teaches the amorphous form of ibuprofen where the crystallinity is less than at least 5 wt.% can be given in dosage form (Col 5, lines 19-42; Col 2, lines 15-17; Col 8, lines 53-62). An ordinarily skilled artisan would be motivated to use the amorphous form of the active ingredient, such as ibuprofen, because Geyer teaches that the drug in the amorphous form has less bitter taste, causes less burning sensation upon swallowing, and leads to better patient compliance (abstract; Col 8, lines 2-10, lines 53-62).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612