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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-2, 5-8, 11-13, and 15-16 are pending.
Election/Restriction
Applicant’s election with traverse of Group I (claims 1-2, 5-8, 11-13, and 15-16) in the reply filed 8/11/2026 is acknowledged. Applicant’s species election with traverse of i) Formula (I) poly(ω-pentadecalactone-co-o-dioxanone) (specific polymer) ii) polyesters (particulate polymer) iii) EFdA/Compound I (anti-viral agent) iv) rod (implant form) in the reply filed 8/11/2026 is acknowledged.
The traversal is on the grounds that the claimed inventions share a special technical feature that makes a contribution over the prior art. Applicant argues that the inventive concept of “a biodegradable polyester matrix delivering antiviral agent(s) in an amount effective to inhibit viral proliferation over an extended multi-month period” is novel in view of the prior art.
This is not found persuasive because Applicant has not shown that the claimed special technical feature makes a contribution over the prior art. This claimed technical feature is a biodegradable implant polymeric composition interspersed with a therapeutic agent. Eaton (WO2004082525A2, published 4/13/2006, cited in IDS filed 11/4/2024) teaches a biodegradable implant comprising a sustained release therapeutic agent dispersed within a biodegradable matrix (claim 1). Eaton teaches that this polymer may comprise polyesters (par. [0032]). Eaton teaches that this therapeutic agent may be an antiviral agent (par. [0024]). Finally, Eaton teaches that the therapeutic agent may be released from the implant over a prolonged period of time, up to and including “at least about three months” (par. [0042]). In all, Eaton teaches a biodegradable polyester matrix that may further comprise an antiviral, wherein the antiviral is released over a prolonged period of time. This reads on the inventive concept as claimed by Applicant. Therefore, the instant invention does not make a contribution over the prior art, and unity of invention is lacking.
Further, the instant invention does not make a contribution over the prior art as evidenced by alternative references Saltzman and Li applied herein. Specifically, see below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-4, 17-21 and 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1-2, 5-8, 11-13, and 15-16 are under consideration to the extent of the elected species, e.g. the polymer is poly(ω-pentadecalactone-co-o-dioxanone) (i.e. Formula I), the particulate polymer is polyester, the antiviral agent is EFdA (i.e. Compound I), and the implant form is rod.
Specification
The use of the term Tween™, which is a trade name or a mark used in commerce, has been noted in this application (pg. 22 line 18). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
The use of the term Pluronic™, which is a trade name or a mark used in commerce, has been noted in this application (pg. 22 line 18). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicants cooperation is requested in reviewing the entire disclosure to ensure proper use of all Trademarks.
At page 19, line 4 of the specification, Application No. 16344633 is disclosed, which has not been patented and should be updated with the corresponding US patent number, which is US Patent No. 11,766,400. Applicants’ cooperation is requested in reviewing the entire disclosure for additional non-provisional Application nos. whose status has changed and may require correction.
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 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 1-2, 5-8, 11-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Saltzman et al. (US20200054553A1, published 2/20/2020) in view of Li et al. (Long-acting biodegradable implant for sustained delivery of antiretrovirals (ARVs) and hormones, Journal of Controlled Release, Vol. 340, pp. 188-199, published 12/10/2021).
Saltzman teaches a biodegradable contraceptive implant (abstract). Saltzman teaches that this implant is a non-injectable biodegradable contraceptive implant comprising a biocompatible polyester copolymer and an effective amount of therapeutic agent to be released over a period of one to twenty-four months (claim 1). Regarding the polymer, Saltzman teaches that the implant is comprised of poly(ω-pentadecalactone-co-p-dioxanone) (i.e. PDL-co-DO) having the following general formula:
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Saltzman continues to teach that m and n are independently integer values of less than or equal to about 1500 (par. [0050]-[0052]; claim 2) (cf. claim 1(A)). Further, the polymer has a dioxanone (DO) mol % content in the range of about 20 to about 60% (claim 3) (cf. claim 2). Saltzman continues to teach that the implant is suitable for subcutaneous implantation (par. [0122]; claim 7), and that it degrades over a period of up to about 24 months (claim 8) (cf. claim 8). The implant may be in the shape of a rod, which is suitable for implantation (par. [0078]) (cf. claim 11). The overall amount of drug loading is from about 1% to about 80% (par. [0064]) (cf. claim 12). The implant may further comprise a coating or a core, wherein the coating and core can be drug-free (par. [0100]) (cf. claims 15-16). This coating is comprised of PDL-co-DO, which is a polyester copolymer (par. [0103]) (cf. claim 13). The implant may also comprise additional therapeutic, prophylactic, or diagnostic agents (claim 11) (cf. claim 13). Further, Saltzman teaches that other therapeutics may be delivered using the claimed technology, and names antivirals as one such therapeutic (par. [0069]).
However, Saltzman does not teach the inclusion of EFdA, which is an antiviral agent, specifically anti-HIV, in an effective amount to achieve a desired pharmaceutical dosage over a period of one to 24 months.
This deficiency is made up for by Li.
Li teaches a subcutaneous biodegradable implant for sustained delivery of therapeutic agents such as antiretrovirals including 4’-ethynyl-2-fluoro-2’-deoxyadenosine (EFdA) (abstract). Li uses a biodegradable polymer of poly(ε-caprolactone) as the main component of the implant (intro). EFdA is a known compound that is anti-HIV, acting as a nucleoside reverse transcriptase inhibitor (cf. claims 5-7). Li teaches that EFdA can successfully be incorporated into a polymer matrix designed for subcutaneous implantation and sustained drug release (conclusion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Li to the teachings of Saltzman (i.e. incorporating EFdA as taught by Li into the implant as taught by Saltzman). The resulting invention would be an implant designed for subcutaneous implantation, wherein the implant comprises of a polymer matrix of PDL-co-DO, wherein the polymer is loaded with about 1% to about 80% EFdA for release into a subject, wherein this amount is sufficient to achieve a desired dosage over a period of one to 24 months, wherein the drug is released for an extended period of time, specifically about one to 24 months, wherein the polymer matrix degrades over a period of up to about 24 months, wherein the implant may comprise an additional agent or a coating, wherein the coating is drug-free, as is the core, wherein the implant is rod-shaped (cf. claim 1). One of ordinary skill in the art would be motivated to combine these teachings as inclusion of an antiviral into the polymer matrix of Saltzman is already suggested in place of a contraceptive, and EFdA is an antiretroviral known to be successfully applied to a sustained release implant comprising a polymer as taught by Li. One of ordinary skill in the art would have a reasonable expectation of success in swapping the contraceptive drug of Saltzman with the antiretroviral EFdA of Li as Saltzman already suggests using an antiviral therapeutic, such as EFdA, in a polymer implant for sustained release, as has been done by Li. Further, Saltzman suggests other drugs aside from contraceptives that can be used with the invention, and names antivirals as one such class of drug that would be compatible with the polymer matrix. One of ordinary skill in the art would select EFdA as the antiviral used as its use in other sustained release polymer formulations has been demonstrated in the art.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW RYAN BURKE whose telephone number is (571)272-8949. The examiner can normally be reached Mon-Fri. 8am-5pm.
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/MATTHEW RYAN BURKE/Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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