DETAILED ACTION
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 .
Election/Restrictions
Applicants’ election of Group I (claims 1-4 and 12-13) drawn to a composition comprising at least 1.5-30% by weight of potassium sodium tartrate tetrahydrate, is acknowledged. The election was made without traverse.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 5-11 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction/election requirement in the reply filed 6/18/26.
Accordingly, claims 1-4 and 12-13 are under current examination.
Status of Claims
No new claim set was filed in response to the Restriction/Election requirement.
Amended claims
Newly canceled claims
Newly added claims
Previously canceled claims
Instantly withdrawn claims
5-11
Claims under instant examination
1-4 and 12-13
Claim Objections
Claims 1-4 are objected to because of the following informalities:
Claim 1 recites multiple lists without adding a comma after each species in the list (e.g., after component d, e and f).
Claim 1 recites “…disintegrant e. 0-98.5% by weight of at least one active ingredient a total of constituents a. to e being 100% by weight. or a powder mixture…”. The Examiner suggests amending to “…disintegrant, and e. 0-98,5% by weight of at least one active ingredient, wherein a total of constituents a[[.]] to e being 100% by weight[[.]] or a powder mixture…” in order to separate phrase and remove periods that are not at the end of the sentence. A similar amendment is suggested for the last two lines of claim 1 and claims 2-3.
Appropriate correction is required.
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 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 1-4 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ji (CN 104739802; published: 7/1/15).
The English language machine translation of Ji is attached herein. The passages cited below which indicate the teachings of the ‘802 publication are based on its English translation.
Ji is directed to a preparation method of pharmaceutical composition for treating digestive system disease [Title].
With regards to instant claims 1-3 and 12-13, Ji teach a enteric tablet wherein the parts by weight of each pharmaceutical ingredient are: 14-17 parts by weight of lansoprazole (active ingredient), 52-56 parts by weight of lactose (filler), 17-22 parts by weight of microcrystalline cellulose (filler), and 9.8-11.4 parts by weight of tartaric acid potassium sodium, 7.5-10 parts by weight of an internally added disintegrant crospovidone, 3.3-3.9 parts by weight of an additional disintegrant crospovidone, 1.5-2.2 parts by weight of povidone K30 (i.e., polyvinylpyrrolidone; binder), 22-25 Parts by weight of binder solvent 95% ethanol, 0.7-1.0 parts by weight of polysorbate 80, 1.2-1.8 parts by weight of micronized silica gel, 6.4-8.6 parts by weight of hypromellose phthalate, 0.6 - 1.0 part by weight of n-butyl stearate, 2.0 - 2.8 parts by weight of talc, and 145-152 parts by weight of a coating liquid solvent of 95% ethanol. The Examiner notes that although the claims do not require any particular fillers, binders, disintegrants or active ingredients, the underlined ingredients above are described in the instant specification. When adding all of the ingredients above that read on components a-e of the instant claims, the total comes to 127.1-147.5 parts by weight (i.e., 100% of components a-e equals 127.1-147.5 parts). Based on “a total of constituents a to e being 100% by weight), the composition of Ji comprises:
9-13 wt.% active ingredient (sample math: Ji teaches 14-17 parts by weight; 14/127.1 x 100 = 11%; 17/127.1 x 100 = 13%; 14/147.5 x 100 = 9%; 17/147.5 x 100 = 12%; low to high range = 9-13%)
47-61 wt.% filler;
7-9 wt.% PST;
7-11 wt.% disintegrant; and
16-21 wt.% binder (the active ingredient, filler and PST ranges are within the claimed ranges recited in instant claims 1-3 and the disintegrant and binder ranges are merely close and/or overlapping). As indicated in MPEP §2144.05(I): “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” As indicated in MPEP §2144.05(I): a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
With regards to instant claim 4, Ji teaches that the powder particle diameter is 80 mesh orders (i.e., 177 micrometers which is less than 300 micrometers) [see claim 4].
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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