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
A second 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 10, 2025 has been entered.
Claims 1, 11-15, 17, 18 and 20 are pending.
Claims 2-10 are cancelled.
Claims 1, 17, 18 and 20 are currently amended.
Claims 11-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1, 17, 18 and 20 as filed on November 10, 2025 are under consideration.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim objections are withdrawn, all previous claim rejections under 35 USC 112(b) are withdrawn, all previous claim rejections under 35 USC 112(d) are withdrawn, all previous claim rejections under 35 USC 103 over Yu are withdrawn, and all previous claim rejections under 35 USC 103 over O’Sullivan are withdrawn.
Applicant’s arguments 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 17 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 as previously amended recites the mannitol/fatty acid ratio is 1 to 7. Applicant’s Remarks of April 30 2025 cite to paragraph [0056] of a published application in support of the amendment. The instant specification as filed discloses:
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There is no disclosure of a ratio of 1 to 7. Rather, the bounded ranges disclosed range from 4 to 7. Claim 1 introduces new matter. Claim 1 may also introduce new matter in view of Applicant’s statements at page 6 of the Remarks citing to the 132 Declaration that “the instantly claimed ratio of mannitol/fatty acids of 1 to 7 is critical for achieving the best stability to humidity” because a ratio of 1 to 7 is not disclosed and because Applicant’s Remarks suggest a ratio of 1 to 7 is a different invention than originally disclosed. Claims 17 and 20 are included in this rejection because they depend from claim 1 and thus they also recite new matter. Claim 18 is not included in this rejection because the range of 4 to 7 is disclosed.
Response to Arguments: Claim Rejections - 35 USC § 112(a)
Applicant’s citation to case law at pages 4-5 of the Remarks for the proposition that Applicant need not disclose that which is claimed is acknowledged but not found persuasive for the reasons already set forth in the rejection. Therefore, the rejection is properly maintained and made again.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 17, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (US 2004/0068000, published April 8, 2004) in view of Satomi et al. (US 2011/0135927, published June 9, 2011).
Guo teaches compression coated tablets (title; abstract; claims; paragraph [0025]).
The coating comprises a filler inclusive of mannitol in an amount of about 25 to 100 wt% (claims 2, 3; paragraphs [0016], [0017]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05.
The coating may optionally comprise lubricant and/or disintegrant; lubricants include stearic acid (C18 fatty acid) and may be present in an amount of about 0 to 25 wt% (claim 4; paragraphs [0016], [0018]-[0020], [0022]; Examples), as required by instant claims 17, 20. Regarding the weight ratio mannitol/fatty acids of 1 to 7, of 4 to 7 as required by instant claims 1, 18, Guo renders obvious ratios of 25 / 25 to 100 / 0. Regarding the desired property of stability with respect to humidity as required by instant claim 20, because Guo renders obvious coatings comprising the fatty acids as instantly claimed, it is presumed that the tablets of Guo are also characterized by stability with respect to humidity.
The coating comprises 20 to 95 wt% of the solid dosage form (claim 5; paragraph [0021]).
The coating does not require film-forming polymers of synthetic origin or binders (whole document).
Guo does not specifically teach crystallized mannitol as required by claim 1.
This deficiency is made up for in the teachings of Satomi.
Satomi teaches an excipient for compressed tablets comprising novel spherical particles of crystalline mannitol; the excipient avoids conventional compressing troubles about mannitol like capping, sticking, etc., assuring a high tablet hardness (title; abstract; claims; paragraph [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mannitol of the compression coating of Guo to comprise the crystalline mannitol of Satomi in order to avoid conventional compressing troubles with mannitol.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant's arguments have been considered but are substantially moot in light of the new grounds of rejection necessitated by Applicant’s amendments.
Applicant’s allegations of superior results at pages 7-8 of the Remarks is acknowledged but not found persuasive for reasons of record. Regarding inherency, Applicant’s statements are incorrect. See MPEP 2112 V.
Many of the difficulties encountered in the prosecution of patent applications may be alleviated if each applicant includes, at the time of filing or no later than the first reply, claims varying from the broadest to which they believe they are entitled to the most detailed that they are willing to accept.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Unknown (JP 5000509 B2, as evidenced by the Google translation) is the closest prior art as identified by USPTO artificial intelligence and teaches sugar coatings comprising sugar, binder, cellulose and water-soluble polymer (title; abstract; claims).
Frorer (US 2,305,960) teaches edible products comprising substantially non-hygroscopic pulverulent mannitol crystals on its exterior surface (title; claims).
Baker (US 3,185,626) teaches a process for sugar coating core tablets comprising aqueous syrups comprising a sugar inclusive of mannitol (title; claims; column 1, lines 8-11; column 2, lines 9-14; Examples).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/Examiner, Art Unit 1619
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600