DETAILED ACTION
Claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, 34, and 42 are pending. Of these, claim 42 is withdrawn as directed to a nonelected invention. Therefore, claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, and 34 are under consideration on the merits.
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 the Rejections
The 112(b) rejection is withdrawn in view of the amendment.
The 103 rejection over Swarner is withdrawn with respect to claims 4 and 23 and revised for the remaining claims in view of the amendment, and a new rejection is applied to claims 4 and 23 incorporating the teachings of a new secondary reference and was necessitated by the amendment.
The 103 rejection over Johnson is withdrawn in view of Applicant’s invocation of 102(b)(2)(C).
The provisional double patenting rejection is withdrawn and replaced with a nonprovisional rejection in light of the issuance of the copending application.
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 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34 are rejected under 35 U.S.C. 103 as unpatentable over Swarner et al. (US Pat. Pub. 2018/0235900; of record in IDS).
As to claims 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34, Swarner discloses a reservoir device comprising an active agent disposed within a reservoir defined by a porous polymer membrane to allow diffusion of the active when the device is positioned subcutaneously in the body of a subject (paragraphs 4 and 11). The device may comprise an active agent such as a therapeutic, a preventative, or a contraceptive, and more than one active agent may be used in combination (claims 1 and 13), and the active may be a small molecule (the elected species of active agent of claims 1, 11, 22, and 24)(paragraph 44), such as tenofovir Alafenamide Fumarate of claims 4 and 23 (paragraph 44), and the use of tenofovir Alafenamide Fumarate in combination with a contraceptive meets the requirement of claims 1 and 22 that the first active is for treatment or prevention of HIV and the second active is for preventative indications and/or therapeutic needs other than HIV. The polymer membrane may comprise polycaprolactone (the elected species of polymer of claims 1, 15, 22, and 29 which is biodegradable and which is a homopolymer of claims 17 and 27), and may have a molecular weight of 15,000-80,000 Da, which is within the range of claims 16 and 30 (paragraphs 42 and 45). The device allows for zero order release kinetics for the active agents and releases the actives for 60 days as recited by claim 22 (paragraph 42).
Regarding claims 3, 12, and 25, the reservoir may comprise an excipient along with the active agents (paragraph 43) and which may be castor oil, which is the elected species of excipient (claim 12).
Regarding claims 2 and 31, the thickness of the polymer membrane may be 1-30 microns, which is below the recited range (paragraph 57).
As to claims 21 and 32, the device may be in the shape of a cylinder with a length of 40 mm, which is within the recited range (paragraphs 43 and 53).
Regarding claim 34, the device may fragment at month 3, which is one month after the 60 days to depletion of the active, which reads on the 1-6 month range recited by the claim (Table 1 on page 6).
As to claims 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34, Swarner does not further expressly disclose a specific embodiment wherein the active agent is a small molecule, the polymer is polycaprolactone, and the excipient is castor oil as was elected by Applicant. Additionally, the thickness of the polymer membrane that is expressly disclosed by Swarner is below the range recited by claims 2 and 31 as discussed above.
As to claims 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Swarner by selecting polycaprolactone as the polymer membrane, castor oil as the excipient, and a small molecule as the active agent, because Swarner expressly teaches that the foregoing ingredients are suitable for use as the polymer membrane, excipient, and small molecule respectively. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301). MPEP § 2144.07.
Regarding claims 2 and 31, it further would have been prima facie obvious to vary the thickness of the membrane to arrive at an amount within the recited range, because the skilled artisan would have recognized that the thickness of the polymer membrane is a result effective variable that will affect the ease with which it fragments, and thus the time to fragmentation upon implantation subcutaneously into the body of a subject. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Applicant’s Arguments
Applicant argues that Swarner does not teach or suggest a device comprising a first active for the treatment or prevention of HIV and a second active for preventative and/or therapeutic needs other than HIV.
In response, this argument is not persuasive because Swarner expressly teaches that the active may be an HIV therapeutic or a contraceptive (which is a preventative for needs other than HIV), and also expressly teaches that more than one of the active may be used in combination, as discussed in the revised rejection, supra.
New Rejection
Claims 4 and 23 are rejected under 35 U.S.C. 103 as unpatentable over Swarner et al. (US Pat. Pub. 2018/0235900; of record in IDS) as applied to claims 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34, and further in view of Sidman (US Pat. No. 4,450,150; of record in IDS).
The teachings of Swarner are relied upon as discussed above, but Swarner does not further expressly disclose that the contraception agent serving as the second active agent is levonorgestrel as recited by claims 4 and 23.
Sidman teachings implantable drug delivery depots comprising fertility control agents for delivery such as the contraceptive levonorgestrel (Abstract and column 9, 5th full paragraph).
As to claims 4 and 23, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Swarner implantable reservoir device by selecting levonorgestrel as the type of contraceptive, because Swarner teaching selecting a contraceptive as an active and places no limitations on the identity of the contraceptive, and Sidman teaches that levonorgestrel is a suitable contraceptive for release from an implantable reservoir device, such that the skilled artisan reasonably would have expected that it could be used as the contraceptive in the Swarner implantable reservoir device. Such a modification is merely the combining of known prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, and 34 are rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-9 of US Pat. No. 12,515,027 and in view of Swarner et al. (US Pat. Pub. 2018/0235900 where indicated below.
The teachings of Swarner are relied upon as discussed above.
Although the reference claims are not identical to the present claims, they are not patentably distinct because they recite a reservoir device defined by a biodegradable permeable polymer membrane having a thickness of 100-300 microns comprising polycaprolactone homopolymer having a molecular weight of 15,000-140,000 Da, the membrane further comprising an active agent formulation comprising an excipient that is castor oil, wherein the active agent formulation comprising a small molecule such as tenofovir alafenamide fumarate or levonorgestrel and wherein more than one active may be used in combination, wherein a second active agent also may be present, wherein the device has a cylindrical shape with a length of between 10 mm and 50 mm, the device allowing for diffusion of the active through the polymer membrane with zero order release kinetics for a time period of at least 100 days when positioned subcutaneously in the body of a subject.
Although the reference claims do not specify that the polymer membrane is configured to undergo fragmentation at about 1-6 months after depletion of the active from the device, the reference device will be capable of undergoing fragmentation within said time period because it comprises the same ingredients and structural configuration that are recited by the claims. Additionally, the skilled artisan would have been motivated to select a fragmentation within the claimed range in light of Swarner’s teaching that a reservoir device comprising a polycaprolactone membrane for subcutaneous release of an active suitably can possess a fragmentation period within the presently recited time range.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Response to Applicant’s Arguments
Applicant argues that the claims as amended are patentably distinct from the reference claims, but did not provide any argument in support of this conclusory statement.
In response, the amended claims are not viewed as patentably distinct for the reasons discussed in the rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600