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/Restriction
Inventor’s election, without traverse, of the claims of Group I, is acknowledged. However, given inventor’s subsequent amendments to the claims, the election/restriction requirement is withdrawn. All claimed subject matter will be examined.
Claim Rejections - 35 USC § 112
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.
Claim 16 is 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.
In step (a) of the process, the limitation “…both [emphasis added] tenofovir alafenamide and/or [emphasis added] bictegravir…” is unclear because it does not make logical or grammatical sense.
The examiner respectfully suggests that the term both should be deleted.
Claims 30 and 56-58 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.
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). Claim 30, for instance, recites the broad recitation in part (ii) “..a temperature from 60 to 160°C…”, and the claim also recites “…preferably [emphasis added] from 80 to 140°C…” which is the narrower statement of the range/limitation. The claim(s) are 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.
Analysis of other instances in claim 30, and in claims 56-58, with respect to “preferably”, “more preferably” and “most preferably” limitations is similar.
Claim 40 is 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.
The dependency of the claim is unclear because it depends from a canceled claim.
Furthermore, in parts (ii) and (iv), the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 47 is 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.
In part (iii), the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 55 is 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.
The dependency of the claim is unclear because it depends (alternatively) from canceled claims 35 and 44.
Allowable Subject Matter
Claims 1, 3, 7, 9, 14, 19, 22, 25-27, 29, 36, 39 and 45 are allowed. The following is a statement of reasons for the indication of allowable subject matter:
Antimicrobial Agents and Chemotherapy (posted online 01 February 2021), 65(4), e02320-20 (12 pages) appears to be the closest prior art. The reference is drawn to a concept evaluation study of a combination of bictegravir (BIC) and tenofovir alafenamide (TAF) nanoformulations (abstract). The BIC + TAF-loaded nanoformulations are produced utilizing an oil-in-water emulsion method by combining polyvinyl alcohol (a hydrophilic polymer) with dichloromethane containing PLGA (poly lactic-co-glycolic acid), Pluronic F127 (aka poloxamer 407, a synthetic, amphiphilic, non-ionic, triblock copolymer surfactant), BIC and TAF (page 7, MATERIALS AND METHODS). Significantly, the reference does not teach the utilization of the different and distinct surfactants (i.e. structurally and chemically non-equivalent surfactants) of the instant invention (vitamin-E-polyethylene glycol-succinate, sodium deoxycholate, polysorbates 20 and 80, dioctyl sulfosuccinate, polyethylene glycol (15)-hydroxystearate, polyoxyethylene (20) cetyl ether, polyvinyl alcohol, and their combinations). Nor would one of ordinary skill have found it obvious to substitute the instant surfactants for the Pluronic F127 of the cited art. There is no motivation to do so.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Antiviral Research (2019), 167, pp. 83-88 is cited to show a bictegravir loaded nano-drug delivery system (formed from an organic phase containing poly lactic-co-glycolic acid and bictegravir, and an aqueous phase containing polyvinyl alcohol) (abstract; page 84, column 1, 2.4. BIC NP formulation and characterization).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 7/14/2026
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