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 .
Status of Application
Claims 1-20 are pending in this application.
No claim amendments have been submitted
All claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on January 2, 2024 is acknowledged. A signed copy is attached to this office action.
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.
Claims 7-12 and 17-21 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.
The claims recite “cycle 1”; “cycle 2”; “cycle 3”; and “first cycle”; “second cycle”; and “third cycle”, respectively, however, there is no recitation in claim 1 of cycles. After a review of the specification, it is unclear if the cycles are referring to treatment cycles or menstrual cycles. The specification discloses treatment cycles can vary including a 28, 26, 24, or 21 day insertion period (paragraph 0075), whereas the menstrual cycle is disclosed to be 28 days (paragraph 0076). Clarification and amendment is requested.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kiser et al. (US 2014/0209100).
Kiser discloses an intravaginal drug delivery device, such as a ring (abstract). The device comprises a drug containing core with a hydrophilic elastomer surrounding, at least in part the core (paragraph 0020).
Contraceptive agents, hormones, and estrogen receptor modulators may be delivered with the device (paragraph 0032).
Ethyl estradiol and etonogestrel are disclosed (paragraph 0034; claim 29; Example 4).
The devices are adapted to delivery pharmaceutically effective amounts of each drug (paragraph 0035).
The device capable of providing sustained delivery of one or more vaginally administrable drugs in a substantially zero order release profile. The devices exhibit a substantially zero order release profile of the drug over at least one day or the devices exhibit a substantially zero order release profile of the drug over at least several days (e.g., over at least 2, 3, 4, 5, or 6 days), over at least a week, over at least one month, or over more than a month (e.g., over at least 45, 60, or 90 days) (paragraph 0036).
The device comprises a rate controlling membrane over the drug containing core (paragraph 0061).
The devices exhibit release rates of about 5 mg, about 10 mg, about 25 mg, about 50 mg, about 75 mg, about 100 mg, about 150 mg, about 200 mg, about 500 mg, about 750 mg, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg of drug per day and ranges between and including any two such values (paragraph 0036).
Regarding claims 2-4, as noted above, the device exhibits release rates of including about 5 mg and about 10 mg, which is less than an average of 0.120 mg and 0.010 mg, as recited in the instant claims.
Regarding claims 5-20, the claims recite the functional properties of the device recited in claim 1. Since the prior art of Kiser discloses a core comprising ethyl estradiol and etonogestrel which exhibits release rates including about 5 mg and about 10 mg, it would therefore have the same functional properties as those recited in the instant claims. Applicant’s attention is directed to MPEP 2112.01 which discloses "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Kiser does not exemplify a device having ethinyl estradiol and etonogestrel, however, both active agents are disclosed as acceptable agents to be included in a contraceptive device. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have incorporated two known and disclosed agents into the device disclosed by Kiser in order to achieve the benefits of each agent individually.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/240284. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and copending claims recite a drug delivery device comprising a core of ethinyl estradiol and etonogestrel with a membrane covering said core. Both devices are additionally disclosed to deliver 0.013 mg per day of ethinyl estradiol over a period of time ranging from 21 days to 3 months. The release profile of etonogestrel is disclosed in dependent claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Holmberg et al. (US 2018/0104181) which discloses a method for altering the release characteristics of a long acting drug delivery device containing at least two drugs in different segments, wherein the segments are arranged to a specific sequence. Additionally disclosed is a drug delivery device with reduced initial burst containing two different drugs in different segments. The invention further relates to a delivery device manufactured according to the a.m. method and its use in contraception and gynecological therapies (abstract).
The matrix/core material thermoplastic polymer can be ethylene-vinyl acetate (EVA) (paragraph 0066).
The membrane material can be the same as the core segment material (paragraph 0065).
Devices include intravaginal rings (paragraph 0019).
Particularly preferred drugs include ethinyl estradiol (paragraph 0052) and etonogestrel (paragraph 0051).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
Prosecution Insights