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
Claims 24-53 are pending.
Election/Restrictions
Applicant's election with traverse of the invention of Group I, claims 24-37, drawn to a tablet, and the species of (a) nicardipine as the insoluble drug and (b) citric acid as the penetration enhancer or carrier material, in the reply filed on 6/9/26 is acknowledged.
The traversal of the groups of inventions is on the ground(s) that all claims share a single general inventive concept, all claims belong to the identical technical field, and examination of all claims will not impose any serious examination burden on the Office. This is not found persuasive because even though the inventions of these groups require the technical feature of a solid dispersion of an insoluble drug, comprising an insoluble drug and a carrier material; wherein the insoluble drug is selected from the group consisting of nicardipine, nifedipine, felodipine, or pharmaceutically acceptable salts thereof, and the carrier material is selected from the group consisting of organic acids, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Yoshida et al. (US 20110020455). Burden on the examiner is not a criterion under PCT Rule 13.1.
Applicant further argues that Yoshida et al. do not exemplify the elected species of nicardipine and citric acid. This is not found persuasive. Yoshida et al. teach a solid dispersion of an insoluble drug, comprising an insoluble drug and a carrier material (e.g. abstract); wherein the insoluble drug is selected from the group consisting of nifedipine, and nicardipine (e.g. paragraph 0062) and the carrier material is selected from the group consisting of organic acids (e.g. paragraph 0209). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
The requirement is still deemed proper and is therefore made FINAL.
Claims 38-53 are withdrawn as being drawn to a nonelected invention.
Claims 32 are withdrawn as not being directed to the elected species.
Claims 24-31 and 33-37 are under consideration to the extent that the composition comprises the elected species.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 2/7/24 and 6/9/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Drawings
The drawings are objected to because Figures 3-5 contain text which is illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 24-30 and 33-37 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 100393302; cited in IDS and full translation provided herein).
Liu et al. teach a tablet comprising an osmotic pump controlled release preparation (e.g. abstract). Liu et al. teach the composition comprises a tablet core, a semi-permeable membrane coating, and a drug-release hole (e.g. abstract), the tablet core comprises a solid dispersion of the insoluble drug and an organic acid (i.e. penetration enhancer and/or carrier) (e.g. abstract and page 4, paragraph 2), where the insoluble drug is nicardipine and the carrier is citric acid (e.g. page 3). Liu et al. teach that the drug, organic acid, and other excipients are directly compressed into tablets or granulated and then compressed into tablets (i.e. a solid dispersion), and then coated with a semi-permeable membrane and laser perforated to obtain an insoluble drug combination with a constant drug release rate and complete drug release (e.g. page 2-3). The organic acids in the composition form a saturated solution when it meets water, resulting in a higher osmotic pressure, which provides the drug release power of the osmotic pump tablet. At the same time, the organic acids have a significant solubilization effect on insoluble drugs. By increasing the solubility of the drug, it improves drug release rate and degree of insoluble drug osmotic pump tablet (e.g. page 3, paragraph 1).
Regarding Claims 24-30, while there is not a single example comprising both of the claimed components (nicardipine and citric acid), the ingredients are included among a short list of preferred ingredients. The table on page 7 exemplifies a composition comprising nicardipine hydrochloride and citric acid. It would have been obvious to have selected either nicardipine hydrochloride or nicardipine. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Regarding Claims 33-35, Liu et al. teach that the weight ratio of the insoluble drug in the tablet core to the organic acid is 1:0.5 to 1:50, or more preferably 1:0.5 to 1:20 (e.g. page 3), which overlaps the claimed range. 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) (MPEP 2144.05.I).
Regarding Claims 36 and 37, Liu et al. exemplify citric acid as being about 69 wt% of the tablet core (e.g. as calculated from the table on page 7), which is within the range of claim 36 and slightly above the range of claim 37. However, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. In the instant case, 69% citric acid and 60% citric acid are expected to have similar solubilizing qualities. In addition, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the citric acid concentration through routine experimentation to arrive at the concentration of 20-60% in order to optimize the resulting product. As Liu et al. do not generally teach a concentration for the citric acid it would have been obvious to vary the concentration through routine experimentation.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 100393302; cited in IDS and full translation provided herein), as applied to claims 24-30 and 33-37, and further in view of Teraoka et al. (International Journal of Pharmaceutics, 2004).
Regarding Claims 24-30 and 33-37 the teachings of Liu et al. are described supra. They are silent as to the crystallinity of the nicardipine. This is made up for by the teachings of Teraoka et al.
Teraoka et al. teach photostability and physicochemical properties of nicardipine polymorphs (α- and β-form) (e.g. abstract). Teraoka et al. teach that the apparent photodegradation rate constant of β-form was greater than that of α-form (e.g. abstract and “Conclusion”).
Regarding Claim 31, it would have been obvious to one of ordinary skill in the art at the time of filing to select the α-form of nicardipine. One of ordinary skill in the art would have been motivated to seek out additional guidance, as Liu et al. are silent as to the crystallinity, and further would have been motivated to select α-form as Teraoka et al. teach it to have less photodegradation.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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