Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 29 February 2024 and 8 March 2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicants’ election with traverse of Group I (claims 1-15 and 18) in the reply filed on 1 July 2026 is acknowledged. The traversal is on the ground(s) that the composition of claim 1 is a special technical feature that brings about unexpected results. This is not found persuasive because, as stated below in the 35 U.S.C. 103 Rejection, the prior art of Van Gessel and Kolter et al. make obvious the invention by showing the amounts of each ingredient are known to be combined in tableting compositions. Although the data in the specification does show dissolution times that vary, the statistical significance of the variations are unclear. Thus unexpected superiority cannot be determined and the technical feature does not make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application
3. The instant application is a national stage entry of PCT/EP2022/073172 filed 19 August 2022. Claims 1-18 are currently pending. Claims 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1 July 2026. Claims 1-15 and 18 are examined on the merits within.
Claim Objections
4. Claim 1 is objected to because of the following informalities: “0,5” should instead recite “0.5”. Appropriate correction is required.
5. Claim 18 is objected to because of the following informalities: Please insert “or” to show that the types of preparations are in the alternative, i.e., “A cosmetic or pharmaceutical preparation, a preparation of agrochemical actives, or a preparation in the sector of food, feed and food or feed supplementation.” Appropriate correction is required.
Claim Rejections – 35 U.S.C. 112(b)
6. 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.
7. Claims 6-8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
8. Claim 6 contains the trademark/trade name Kollidon CL-SF and Kollidon Cl-F. Claim 7 contains the trademark/trade name Kollidon CL-F. Claim 8 contains the trademark/trade name Kolliphor P 407 micro. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe polymers and, accordingly, the identification/description is indefinite.
Claim Rejections – 35 U.S.C. 103
9. 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.
10. Claim(s) 1-15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Gessel (U.S. Patent Application Publication No. 2013/0177649) in view of Kolter et al. (WO2012119997).
Regarding instant claims 1-3, Van Gessel teach a co-processed excipient composition suitable for tableting comprising at least one filler-binder, at least one disintegrant, and at least one lubricant, wherein said composition is coated with lactose. See abstract. Filler-binders hold the ingredient in the tablet together and are present in amounts of 78-98%. Filler-binders include lactose. See paragraph [0020]. Lubricants are present in amount of 0.2 to 2.2 %. See paragraph [0019]. Disintegrants are present in amounts of 21 to 10% including crosslinked polyvinyl pyrrolidone. See paragraph [0022]. The particle size of the granules is less than 0.5 mm. See claim 12.
Regarding instant claim 4, lactose is preferably in the monohydrate form. See paragraph [0021].
Regarding instant claim 5, lactose is preferably in crystalline form. See abstract. Since the preferred form is crystalline, it would have been obvious to minimize the amount of amorphous lactose.
Regarding instant claims 8-11, lubricants include sodium stearyl fumarate, magnesium stearate, and stearic acid. See paragraph [0019].
Van Gessel does not teach polyethylene glycol-polyvinyl alcohol graft copolymer.
Kolter et al. teach pharmaceutical formulations in the form of granules for the production of rapidly disintegrating tablets comprising non-film forming sugars, film forming sugars, crosslinked polyvinylpyrrolidone and water insoluble polymers. See paragraph [0002]. The composition comprises 60-96% non-film forming sugars, 1-10% film forming sugars, 3-25% disintegrant, 0-10% water insoluble polymer, and 0-15% excipients. See paragraphs [0012-0016]. Disintegrants including crosslinked polyvinylpyrrolidones. See paragraph [0023]. Water soluble polymers improve mouth feel by increasing softness and volume feel. Water soluble polymers include polyvinyl alcohol polyethylene glycol graft copolymers. See paragraph [0032]. Table 1 includes Kollidon CL-SF, Kollidon CL-F and 2% Kollicoat IR. The granules have a mean particle size of 100 to 600 microns. See paragraph [0053].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add 2% Kollicoat IR (polyethylene glycol-polyvinyl alcohol graft copolymer) to the formulation of Van Gessel because Kolter et al teach that water soluble polymers improve mouth feel by increasing softness and volume feel. One would have a reasonable expectation of success because both references are directed to similar combination of ingredients in similar amounts. It would have been well within the purview of the skilled artisan to modify the Hausner Ratio, packing fraction, and angle of repose to optimize the formulation to achieve the desired physical properties of the granules.
Double Patenting
11. 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.
12. Claims 1-15 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 16 of copending Application No. 18/714342 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 18/714342 are directed to tableting compositions comprising lactose, water soluble polyethylene glycol-polyvinyl alcohol graft copolymer, crosslinked insoluble polyvinylpyrrolidone, and lubricant with a particle size between 50 and 500 micron. The claims are also directed to the same amounts of each of these ingredients. The only difference lies in the fact that Application No. 18/714342 also includes a colorant and is thus more specific. The invention of Application No. 18/714342 is in effect a "species of the "generic" invention of the instant application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus the two are not patentably distinct. The dependent claims are included in this rejection for further narrowing the particle size, types of polymers, lubricants, and properties of the invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
13. No claims are allowed at this time.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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