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
Election/Restriction
Applicant's election with traverse of claims 1, 3-12, and 16 in the reply filed on 06/18/2026 is acknowledged. The traversal is on the grounds that the claims are linked by a special technical feature sufficient to bring about unity of invention. This is not found persuasive because the search system and the focus of the invention are completely different, requiring an undue burden on the patent examiner. While searches may seem to be overlapping, however extensive since the patent examiner searches the databases mostly literally. Rarely do applicants present claims to an inventions where the distinctness of the invention are readily clear such as a chemical compound and a gene sequence. It is the responsibility of the examiner to enforce 35 USC 101, which allows the applicant to obtain a patent for a single invention. In the opinion of the examiner the applicants present four distinct inventions.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10/21/2024 and 09/22/2025 have been considered here.
Status of Claims
Claims 1-16 are now pending. Claims 2 and 13-15 are withdrawn.
Claims 1, 3-12, and 16 will be examined on the merits herein.
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.
Claims 1, 3-4, 6, 9-12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012119997 (Kolter, 2012; as submitted on IDS of 10/21/2024; machine translation provided by PE2E via FIT) in view of WO 2013017234 (Schwier, 2013).
In regards to claims 1, 3-4, and 6, Kolter teaches a directed tableting auxiliary composition (see Kolter, page 7, paragraph 3). Kolter teaches composition G comprising mannitol in an amount of 85% by weight, crosslinked insoluble polyvinylpyrrolidone (Kollidon CL) in an amount of 10% by weight, and PEG-PVA graft copolymer in an amount of 2% by weight (Kollicoat IR) (see Kolter, Table 1). The particle size of the composition is taught to be 301 µm (see Kolter, Table 2). Further it is taught that the granules have an average particle size of 100-600µm, more preferably 140-400µm (see Kolter, page 6, final paragraph). The composition is taught to comprise a pigment, such as titanium dioxide, but no amount is taught (see Kolter, claim 7; page 4, final paragraph).
In regards to claim 16, the composition of Kolter is taught as a pharmaceutical formulation (see Kolter, abstract).
Kolter is silent on the use of lactose, an amount for the colorant, and a lubricant.
In regards to claim 1, Schwier teaches a composition for direct tableting (see Schwier, page 64, paragraph 8) comprising a sugar such as lactose or mannitol (see Schwier, page 15, paragraph 4) in an amount of 75% by weight (see Schwier, page 15, final paragraph), a coating such as titanium dioxide (i.e., a colorant) (see Schwier, page 8, paragraphs 2-5) in an amount of at most 5% by weight (see Schwier, page 28, paragraph 3), and a lubricant in an amount of at most 10% by weight (see Schwier, page 17, second paragraph).
In regards to claims 9-10, the lubricant is taught to be magnesium stearate (see Schwier, page 17, second paragraph).
In regards to claim 11, as the lubricant is taught to be part of the matrix material of the composition, it is understood as being located on a surface of the granules. Using the broadest reasonable expectation, one with ordinary skill in the art would understand that the surface doesn’t necessarily mean the outer surface of the granule. However even using this understanding of the surface being an external or outer surface, Schwier teaches that the lubricant is added to the dry granules as an external excipient (see Schwier, page 78, example 4-3).
In regards to claims 1, 3-4, 6, 9-11, and 16, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Kolter and Schwier to formulate the instant composition as both references are drawn to a particulate composition for direct tableting using similar materials. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, Schwier teaches that mannitol and lactose are both known fillers that can be used in compositions for direct tableting (see Schwier, page 15, paragraph 4). It would be obvious to one with ordinary skill in the art to combine the teachings of Kolter and Schwier according to known methods (see Kolter, page 7, paragraph 3) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
In regards to claim 12, as the combination of teachings of Kolter and Schwier would yield an identical composition as instantly claimed, the properties, such as the angle of repose, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Claims 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012119997 (Kolter, 2012; as submitted on IDS of 10/21/2024; machine translation provided by PE2E via FIT) in view of WO 2013017234 (Schwier, 2013) as applied to claims 1, 3-4, 6, 9-12, and 16 above, and further in view of US PGPUB 20210236430 A1 (Waldman, 2021).
The teachings of Kolter and Schwier have been described supra.
The teachings of Kolter and Schwier are silent on the use of lactose monohydrate and the colorant being an organic dye or a lake thereof.
In regards to claim 5, Waldman teaches a tablet made from direct compression of powdered actives/excipients (see Waldman, paragraphs 0152-0154) comprising lubricants, such as magnesium stearate or stearic acid (see Waldman, paragraph 0131), and fillers such as lactose (see Waldman, paragraph 0126) and more specifically lactose monohydrate (see Waldman, paragraphs 0040-0043).
In regards to claims 7-8, the composition is taught to comprise a coloring agent, such as titanium dioxide or D&C red 33 or FD&C red 3, among others (see Waldman, paragraph 0133).
In regards to claims 5 and 7-8, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Kolter and Schwier with Waldman to formulate the instant composition as all of the references are drawn to a particulate composition for direct tableting using similar materials. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would be obvious to one with ordinary skill in the art to combine the teachings of Kolter and Schwier with the teachings of Waldman according to known methods of direct tableting (see Kolter, page 7, paragraph 3) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Further in regards to coloring agent, one with ordinary skill in the art would be motivated to simply substitute the titanium dioxide of Kolter and Schwier with the D&C or FD&C dyes listed in Waldman as all of these are listed as equivalents that are known to be used in tablets to obtain predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to simply substitute one known element for another to obtain predictable results.
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.
Claim 1, 3-12, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-10, 12, 15, and 18 of copending Application No. 18684728 (the reference application) in view of US PGPUB 20210236430 A1 (Waldman, 2021).
The reference application teaches a composition comprising almost identical compounds in identical amounts (see claims 1, 4, 6-10) as the instant claims. Further, the particle size of the granules (see claims 2-3) are the same as instantly claimed. The placement of the lubricant, angle of repose, and use of the composition in a specific type of preparation is also taught to be the same (see claims 12, 15, and 18).
The reference application is silent on the use of a colorant in the composition.
The teachings of Waldman have been described supra.
In regards to claims 1, 3-12, and 16, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of the reference with Waldman to formulate the instant composition as both references are drawn to a particulate composition for direct tableting using similar materials. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would be obvious to one with ordinary skill in the art to combine the teachings of the reference application with the teachings of Waldman according to known methods of direct tableting (see Waldman, paragraphs 0152-0154) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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