DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 02/04/2026, is acknowledged.
Applicant has previously elected without traverse the invention of Group I, claims 1-22, 51-52, drawn to a dosage form comprising a substrate with two opposing surfaces, wherein 1st surface comprises at least two cavities and the 2nd surface comprises an alignment feature(s).
Claims 1, 3-10, 13-14, 18, 23-50, 53 are pending in this action. Claims 16-17 have been cancelled. Claims 2, 11-12, 15, 19-22, 51-52 has been cancelled previously. Claims 1, 10, 13-14 have been amended. New claim 53 has been added. No new matter was added. Claims 23-50 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1, 3-10, 13-14, 18, 53 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application, filed May 18, 2021, claims benefit of provisional U.S. Application No. 63/031,133, filed May 28, 2020.
Claim Objections
Claim 10 is objected to because of the following informalities: Claim 10 comprises the typographic error “in the range from 1 to” that needs to be corrected to “in the range of from 1 to”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-10, 13-14, 18, 53 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Newly amended claim 1 recites the limitation “a deposited portion of a flowable material within each of the at least two cavities” that is not reasonably clear. First, it is noted that the term "flowable material” is not defined by the specification or claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Second, it is noted that the instant specification teaches that a flowable material can be a solution, emulsion, gel, suspension, etc. To this point, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Further, it is noted that that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). This limitation was interpreted as best understood as “wherein each of the at least two cavities comprise a deposited solidified portion comprising a 2nd active agent”. Clarification is required.
New claim 53 (dependent on claim 1) recites the limitation “diffusion of the deposited portion of the flowable material is less than 30 mm2 “, but it does so without including any materials that cause said result. To this point, it is noted that “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation.” Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Clarification is required.
Claims 3-10, 13-14, 18, are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1, 3-10, 13-14, 18, 53 are rejected under 35 U.S.C. 103 as being unpatentable over Hudson et al., US 2021/007981 (pub. date 10/17/2019 as WO 2019/199505A cited in IDS; hereinafter referred to as Hudson); and Sowden et al., WO 2018/017553 A2 (hereinafter referred to as Sowden); in view of Ting et al., EP 1416920B1 (hereinafter referred to as Ting see also US 6602521), Bunick et al., US 2007/0281022 (hereinafter referred to as Bunick), Ullman et al., US 4,258,027 (cited in IDS; hereinafter referred to as Ullman), and Hess et al., GB 2057878 (cited in IDS; hereinafter referred to as Hess).
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Hudson teaches solid pharmaceutical formulations prepared by additive manufacturing (Title; Abstract), wherein said formulations comprise (Fig. 2A shown in the right) a solid elongated substrate (element 11) comprising a surface with one or more depressions/cavities elongated along the same axis as the elongated substrate (elements 25) and comprising one or more active pharmaceutical ingredients deposited onto a surface of the substrate and/or within the depressions/cavities of the solid substrate, and one or more coatings applied over one or more surfaces of the solid substrate (Claims 1-7, 19; Fig. 2A; Para. 0004; 0025-0026, 0043, 0061-0066, 0077, 0094 as applied to claims 1, 3-5, 7-10, 13-14). Hudson provides examples of preparing dosage forms providing a fixed dose of aspirin of 50 mg (Para. 0103-0104).
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Sowden teaches a dosage form comprising (i) a tablet core having two opposite surfaces that can be in a variety of forms, e.g., elongated (Figs. 1-3) and/or can be coated; and (ii) one or more discontinuous coated regions (from 3 to 10) in various configurations on the surface of the substrate/tablet core that can be positioned longitudinally on the substrate/tablet core (Abstract; Figs. 18-19; Claims 1, 11, 13; Para. 0051-0054, 0084, 0102 as applied to claims 1, 7-8, 10). Sowden teaches that (i) the substrate/tablet core and the at least one discontinuous coated region each comprise an active agent, wherein the active agent in the substrate is different from the active agent in the at least one discontinuous coated region; and/or (ii) the substrate/tablet core releases active agent at a rate different from the release rate of active agent from the at least one discontinuous coated region; and/or (iii) the active agent in the substrate/tablet core can be chemically incompatible with the active agent in the at least one discontinuous coated region (Claims 12, 13, 26-29; Para. 0043, 0055 as applied to Claims 1, 6, 13). Sowden further teaches that the use of the discontinuous coated regions permits the ability to add different active agents (that can be incompatible), colors, flavors, sensates and textures; impart improved swallowability, perception of speed, taste masking, and visual recognition to aid in product selection (Claims 30, 31; Para. 0043, 00104 as applied to claim 18).
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Ting teaches elongated multiplex drug delivery systems, e.g., a coated tablet scored in the middle and containing (i) at least two distinct drug dosage compartments/cavities providing immediate drug release (shown in the right; top) that are (ii) enveloped by a scored extended-release compartment that allows the separation of said drug delivery system into individual drug dosage packages, each of which exhibit desired/controllable release profile (e.g., immediate and extended drug release) for the active agents as compared to one another and to that of the entire multiplex system (Fig.1; Para. 0001, 0009, 0026-0027; Examples). Ting provides examples of preparing dosage forms providing a dose of isosorbide-5-mononitrate (i.e., the active agent) of less than 25 mg (Para. 0042).
Bunick teaches dosage forms/tablets, methods and apparatus for their production, wherein said dosage forms comprise at least one active ingredient, a 1st surface comprising one or more cavities, and a 2nd exterior surface (Title; Abstract; Para. 0014, 0017, 0018). Bunick teaches that said tablets comprise a compressed core/substrate that may contain an active ingredient, wherein said core may include a sub-core/insert, which also may include one or more active ingredients, e.g., as a coating layer formed thereon (Para. 0140, 0182, 0184, 0186, 0188, 0211, 0233). Bunick further teaches that during the preparation of said tablets a proper alignment of the tablet with the molding cavities of the injection molding apparatus is required for providing desired structure of said tablets, e.g., having effective identification and/or distinguishing features (e.g., on the tablet surface) by using conventional manufacturing (Para. 0013, 0327-0328).
Ullman teaches dosage forms/tablets (e.g., elongated tablets) that have two opposing surfaces (here is as top and bottom surfaces), wherein the 1st surface comprises at least two sub-dosage units that do not overlap and can be equal in size, whereas the 2nd opposing surface comprises at least one alignment feature/groove (Figs. A-Y; Abstract; Col. 1, Lns. 10-19; Col. 6, Ln. 33). Ullman teaches that said tablets can be coated (Col. 6, Lns. 50-53); and may be composed of a variety of ingredients such as one or more active pharmaceutical ingredients, fillers, lubricants, carriers, flavoring ingredients, etc. (Col. 6, Lns. 41-45). Ullman further teaches that (i) said dosage forms may also have score markings positioned along both the top and bottom surfaces; and/or can be marked with corporate logo or colored to reflect particular dosage units being consumed (Abstract; Col. 6, Lns. 46-50); and (ii) arrangement of grooves/recesses (e.g., Fig. N) can be used during the manufacturing process for providing three equivalent multi-dosage portions (elements 324 and 326 on the top surface), or two equivalent multi-dosage portions (element 328 on the bottom surface).
Hess teaches elongated dosage forms/tablets that can be coated and provide controlled release of incorporated active substances (e.g., contained in two different layers), and wherein said tablets comprise notches on the top surface and/or on the bottom surface that can be used for dividing said tablets into partial doses proving controlled/desired drug release (Page 1, Ln. 9-Page 2, Ln. 6; Fig. 3; Page 4, Lns. 73-95).
Therefore, the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because every element of the invention has been collectively taught by the combined teachings of the references. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare solid pharmaceutical formulations in a form of tablets having different compartments for providing desired drugs release and comprising visual aids and/or alignment features on a surface of said tablets as taught by the cited prior art. Mere rearrangement of parts/elements, without any new or unexpected results, is within the ambit of a person of ordinary skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950). Further, it is noted that the change in form or shape, without any new or unexpected results, is an obvious engineering design. In re Dailey, 149 USPQ 47 (CCPA 1976), and the size of an article is not a matter of invention. In re Rose, 105 USPQ 237 (CCPA 1955). MPEP § 2144.04. With regard to the amounts as instantly claimed (claim 1), it is noted that differences in experimental parameters such as concentrations/amounts of compounds in a formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches dosage form structures comprising the same components. The determination of suitable or effective concentrations/amounts in formulations can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
CN 101102743 (cited in IDS; machine translation) - teaches drugs delivery vehicle/product comprising a plurality of components having active agents and providing selective control of the release rates of each of the active agents while still being delivered in a single product (Figs. 27, 32-41).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-10, 13-14, 18, 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-12 of copending Application No. 18/052,354.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: A dosage form comprising a coated substrate/tablet core with at least two cavities on an exterior surface of the coated substrate/tablet core, wherein the at least one cavity comprises simethicone/active agent and at least one material to immobilize the simethicone/active agent, wherein the diffusion of simethicone/active agent is less than 30 mm².”
In the present case, the instant claims are merely broader than copending application claims that include additional limitation (i.e., simethicone as the active agent in the cavity) and therefore are more specific. Regarding said specific active agent simethicone (as claimed in the copending application), it is noted that the instant application provides example of a dosage form comprising said active ingredient. Further, the copending application teaches that said dosage forms may include a deposition of additional active agent/loperamide or inactive ingredients in one or more cavities. Therefore, both applications are directed either to the same invention or to an obvious variation of the same invention. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant's arguments, filed 02/04/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner’s comments are set forth next.
In response to applicant’s argument that it is unclear how the claimed invention would have been prima facia obvious to one of ordinary skill in the art, as stated previously, the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). 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. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In the present case,
All cited references are reasonably drawn to the same field of endeavor that is solid pharmaceutical formulations/tablets/dosage forms comprising a core comprising an active agents and additional structural compartments/cavities/layers that also may include an active agent.
Cited prior art teaches that rearrangements/alignments of said compartments can be used for providing desired/controlled drugs release, and said tablets/dosage forms may include visual aids and/or can be in an elongated form.
Cited prior art teaches that the substrate/tablet core can release active agent at a rate different from the release rate of active agents located in different structural compartments.
Therefore, the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because every element of the invention has been collectively taught by the combined teachings of the references. Further, as stated previously, the mere rearrangement of parts, without any new or unexpected results, is within the ambit of a person of ordinary skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950). MPEP § 2144.04. Furthermore, the change in form or shape, without any new or unexpected results, is an obvious engineering design. In re Dailey, 149 USPQ 47 (CCPA 1976) (see MPEP § 2144.04). Applicant is advised to clarify the structure of the claimed dosage forms and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance. Further, to expedite the prosecution, it is noted that withdrawn claims need to be amended to include all limitations of the product claims to be rejoined.
Conclusion
No claim is allowed at this time.
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 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 OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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