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 .
Status of claims
Claims 1-11 are cancelled by applicant. Claims 12-27 are new claims. Claims 12-27 are pending and under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IN202121006827, filed on February 18, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Rejections and Objections Withdrawn
All objections, 35 USC § 112 rejections, and 35 USC § 103 over claim 1-11 imposed in the previous correspondence are withdrawn due to applicant’s cancellation of all original claims (1-11).
Claim Objection
New claim 14 is objected to for reciting “the group consisting of… peanut oil… arachis oil”. However, arachis oil is peanut oil. Thus, the claim appears to list the same oil twice as separate members of a closed Markush group. Applicant may delete the repetitive term and leave one. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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.
Claims 14 and 18 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.
New claim 14 recites that “the vehicle is selected from the group consisting of: a) a non-aqueous solvent selected from the group consisting of… b) a lipophilic solvent selected from the group consisting of…”. However, it is unclear whether components a) and b) are mutually exclusive (i.e., “or”), conjunctional (i.e., “and”), or may be used both alone and in mixtures (i.e., “and/or”). Additionally, this makes it unclear if a) and b) are the options of the Markush group or in one reading it might just read through option a) if “or” is intended.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, new claim 18 recites the broad recitation “glyceryl esters” and the claim also recites “like glyceryl monooleate, glyceryl monostearate…”, which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
Rejections Modified in view of cancelling the previously presented claims (1-11) and significantly altering the scope of the new claims (i.e., limiting the release retardant to only hydrogenated soya phosphatidyl choline (HSPC) per present claims 12 and 27; altering the claim language in present claim 15 from “comprising” to “consisting of”; asserting that the drug, the vehicle, the HSPC, and the stabilizer make up 100% w/w of the composition per present claim 27, which leaves no room for other components)–– Prior art references modified.
Claims 12-27 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO2019144079A1) in view of Zhang et al. (US20130156853A1).
Li et al. teaches an injectable, low-viscosity liquid buprenorphine composition that forms a stable, in-situ depot for sustained drug delivery lasting from one week to three months, enhancing both stability and bioavailability (abstract). Li et al. teaches that this composition contains buprenorphine at concentrations ranging from 1% to 40% w/w (page 14, paragraph 50). Li et al. teaches that the composition may contain solvents/vehicles from the following group (alone or in combination): benzyl alcohol (which is also a stabilizer), benzyl benzoate, propylene glycol, and polyethylene glycol, at concentrations ranging from 5% to 90% w/w (page 7, paragraphs 15 & 16). Li et al. teaches that inherent release retardants including stearic acid and palmitic acid may be included in the composition at concentrations ranging from 0.1% to 40% w/w (page 15, paragraph 58). Li et al. teaches that additional antioxidants/stabilizers such as butylated hydroxyanisole and butylated hydroxytoluene can be incorporated into the composition (page 23, paragraph 80). Li et al. teaches that this composition can be delivered via intramuscular or subcutaneous administration, with the duration of sustained release able to be achieve 1-3 months or longer (page 25, paragraph 86). Li et al. teaches that this composition can be administered with a syringe that has a fill volume of 1 mL (page 18, paragraph 70), and further states that it may be may be pre-filled into one syringe for use (page 10, paragraph 34). Li et al. teaches that this composition can be used to treat and pain opioid addiction (page 6 & 7, paragraph 0013).
Zhang et al. discloses a liquid composition of an insoluble medicament and a preparation method thereof [¶abstract]. Zhang et al. teaches that “insoluble medicament” includes those that are “slightly soluble”, “very slightly soluble” or “practically undissolved or undissolved” (which would encompass buprenorphine) [¶27]. Zhang et al. teaches that the composition can be injectable [¶40]. Zhang et al. teaches that by weight, the composition may include the insoluble medicament at 0.01-10%, oil for injection at 0%-20%, phospholipid at 10-80%, and solvent at 20-89%. Zhang et al. teaches that hydrogenated soybean phosphatidylcholine (HSPC), distearyl phosphatidylcholine (DSPC), dipalmitoyl phosphatidylcholine (DPPC), and dimyristoyl phosphatidylcholine (DMPC) can be used as a stabilizing phospholipid [¶30, 42, and example 15 that uses HSPC to provide uniform transparent and clear liquid]. Zhang et al. teaches that the oil for injection can include soybean oil, sesame oil, peanut oil, cottonseed oil, castor oil, peanut oil, and a mixture thereof [¶31]. D1 further teaches that stabilizing agents such as cholesterol can also be added to the composition as an additive [¶34]. Zhang teaches “moreover the phospholipid possesses certain viscosity and stabilization by super-saturation, and could maintain the medicaments in oil phase, oil-water interface or form complicated phospholipid complex when emulsified with water.” (paragraph 42).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Li et al.’s injectable sustained release buprenorphine depot composition to include Zhang et al.’s hydrogenated soybean phosphatidylcholine as the claimed release-retarding phospholipid, because Li et al. teaches sustained-release injectable buprenorphine compositions using selectable vehicles, solvents, stabilizers, oils, and release-modifying excipients to control depot formation, stability, and release duration, while Zhang et al. teaches injectable liquid compositions for insoluble medicaments using HSPC/phospholipid (stabilizing phospholipid in Zhang), injectable oils, solvents, and cholesterol as formulation components/additives. A person of ordinary skill in the art would have been motivated to use Zhang et al.’s stabilizing HSPC, injectable oils, and cholesterol in Li et al.’s buprenorphine depot composition to predictably modulate drug dispersion, depot structure, stability, and sustained release behavior, with a reasonable expectation of success because both references are directed to liquid formulations for poorly soluble/insoluble drugs using injectable excipients within overlapping concentration ranges. The “consisting of” limitation per claim 15 is satisfied because neither Li et al. nor Zhang et al. require any excluded component; rather, the references teach selectable components, such that the composition could be formulated to consist of buprenorphine, a vehicle/stabilizer such as benzyl alcohol, HSPC as the release-retarding agent, and where claimed, oils or cholesterol, with the recited compositions making up 100% w/w of the composition. In preparing a composition by teachings of Li and Zhang, the composition will acquire the stabilizing effect of Zhang’s HSPC.
Response to Arguments
Applicant’s arguments with respect to claims 1-11 have been considered but are moot because of applicant’s cancellation of these claims.
Regarding applicant’s arguments for the new claims (12-27), these arguments are not persuasive because the present rejection relies on a different combination of prior art references responsive to the significantly altered claim scopes. Thus, applicant’s arguments against the former prior art rejections do not overcome the rejection presently maintained.
Conclusions
No claim is found allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 9:00AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613
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