DETAILED ACTION
Examiner’s Note
All claims amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter). See MPEP 714. The applicant has failed to provide these markings, however, in the interest of compact prosecution, the Examiner has examined the claims without the markings. Any future claim amendments should include these markings as specified in MPEP 714.
The changes from the previous set of claims are as follows:
Claim 1 now includes the limitation “and wherein the surface-reacted calcium carbonate particles have a volume median particle diameter d50 (or d50 (vol)) of from 0.4 to 8 µm measured by using laser diffraction” and no longer includes the limitation, “wherein the one or more active(s) is/are rendered at least partially X-ray amorphous during co-grinding”.
Claim 19 now includes the limitation “and wherein the surface-reacted calcium carbonate particles have a volume median particle diameter d50 (or d50 (vol)) of from 0.4 to 8 µm measured by using laser diffraction” and the transitional phrase “consisting essentially of” has been changed to “consisting of”.
Previous Rejections
Applicants' arguments, filed 05/01/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Rejections - 35 USC § 103 (Maintained)
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, 3-7 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]. The surface reacted calcium carbonate particles have a volume medium grain diameter of from 1 to 50 µM measured by laser diffraction [0074] [0077]. 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 and the volume medium particle diameter of the surface-reacted calcium carbonate, 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” or “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.
Claim 19 recites the transition phrase “consisting of”. There is nothing in the disclosures of De Miguel or Geyer that is a required component that is not recited in claim 19.
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].
Response to Arguments
Applicant's arguments filed 05/01/2026 have been fully considered but they are not persuasive.
Applicant argues at pg. 7 that De Miguel is silent on a particle size reduction of the SRCC particles and that De Miguel does not disclose “a volume median particle diameter d50 of from 0.4 to 8 µM” recited in the instant claims because De Miguel discloses larger particles.
The Examiner disagrees. There is nothing in the instant claims that requires that the claimed volume medium particle diameter of the SRCC is from a size reduction and De Miguel discloses the surface reacted calcium carbonate particles have a volume medium diameter of from 1 to 50 µM [0074]. 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.
Applicant argues that a person of skill would not consider the SRCC of De Miguel to be a “carrier material” as recited in the current claims because the SRCC has a smaller size than the ibuprofen taught by Geyer.
The Examiner disagrees. The instant claim recites, “a carrier material being surface-reacted calcium carbonate particles”. Because De Miguel discloses the surface-reacted calcium carbonate particles, De Miguel reads on this limitation in the claim. Furthermore, De Miguel discloses the surface-reacted calcium carbonate is a suitable carrier material [0002] [0010].
Applicant argues that Geyer does not utilize or even mention SRCC, that Geyer requires melting and cooling the active without using solvents, and that De Miguel describes that the ibuprofen is first dissolved in a solvent, therefore, the skilled person would not have been motivated to utilize the product of Geyer when preparing the granules of De Miguel.
The Examiner disagrees. De Miguel discloses the SRCC and 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.%, as taught by Geyer, within the teachings of De Miguel. The recitation of a solvent in De Miguel would not dissuade or prohibit the ordinarily skilled artisan from using the X-ray amorphous active ingredient taught by Geyer and there is motivation to use the amorphous form of the active ingredient 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).
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, 3-7 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, 3-7 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, 3-7 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, 3-7 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.% (claim 1) or 50 wt.% (claim 19).
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 or 50 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).
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.
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
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