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/Restrictions
Applicant’s election without traverse of Group I, claims 1 (in part), 2 (in part), 3-5, and 11-13 in the reply filed on 08/07/2026 is acknowledged.
Claims 6-10 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2026.
Claims 1(in part), 2 (in part), 3-5, and 11-13 are under current examination.
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 1-5 and 11-13 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 term “long-acting” in each of claims 1-5 and 11-13 is a relative term which renders the claim indefinite. The term “long-acting” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The requisite duration of action of the composition is unclear.
The term “high polymer” in claims 1 and 2 is a relative term which renders the claim indefinite. The term “high polymer” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the limitation(s) this language imposes on the polymer is unclear.
Regarding each of claims 1-5 and 11-13, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
There is no conjunction (e.g. “and” or “or”) between the ultimate and penultimate phrases in claim 1, line 10 therefore it is unclear whether all limitations of each phrase in the claim are required or whether compositions meeting the requirements of any of the limitations fall within the scope of the claims.
Each of claims 2-5 and 11-13 recite a tilde “~” punctuation mark between the values in the ranges of molecular weights, parts, and ratio of LA:GA. This renders the claim indefinite because the tilde typically indicates an approximate value; however, the claims do not make it clear whether the approximate value is intended.
Claims 3-5 and 11-15 place a limitation on the parts of pramipexole and parts of polymer that are present without indicating whether this is in terms of weight, or mole, or volume. Thus the actual proportion of these ingredients required by the claims is unclear.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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 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 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over University of Jinan (CN111728956; publication date: 10/02/2020; cited in the IDS filed 09/16/2024).
With regard to claim 1, Jinan discloses a sustained release (i.e. long-acting) formulation comprising microspheres (title) containing 5-40% wt pramipexole pamoate, and 60-95% wt polylactic-co-glycolic acid (PLGA; abstract, claim 1).
With regard to claim 2, the PLGA has a molecular weight of from 5000-50000 daltons (claim 2), and a LA:GA ratio of 75:25 – 50:50. The foregoing ranges overlap with the ranges recited in the instant claims (see MPEP 2144.05).
Claims 3-5 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over University of Jinan (CN111728956; publication date: 10/02/2020; cited in the IDS filed 09/16/2024) as applied to claims 1, 2, 4, 5, 12, and 13 above, and further in view of Wu et al. (US 20140377189; publication date: 12/25/2014).
With regard to claims 3-5 and 11-13, the salt is taught by Jinan is a pamoate salt therefore, Jinan does not teach the claimed counterions required by the instant claims.
Wu, in the analogous art of dopamine agonists (rotigotine; abstract), teaches that palmitate and stearate were recognized as counterions for this class of drug (0009). It would have been prima facie obvious to use stearate or palmitate as the counterion in a pharmaceutically acceptable salt of pramipexole because one having ordinary skill would have recognized these substances as suitable (see MPEP 2144.07).
With regard to the ratio of LA to GA required by instant claims 3-5 and 11-13, and the parts of pramipexole and PLGA, as noted above, the prior art teaches overlapping ranges for these parameters. With regard to the theoretical drug loading, the examiner considers it a matter of routine for one of ordinary skill to determine the optimal amount of drug that can be loaded into the formulation. Moreover, “theoretical loading” is a fraction of the initial amount of drug used to compound a formulation that remains contained in the formulation after manufacture is complete. This places no limitation on the actual amount of drug in the claimed final product.
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 1-3, 5 11, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18847512 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia the claims of the copending application embrace a long acting sustained release formulation of pramipexole comprising pramipexole pamoate or palmitate and PLGA having LA:GA ratios, percentages of polymer and pramipexole salt, and PLGA molecular weight overlapping with the claimed ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18847512 (reference application) as applied to claims 1-3 and 11 above, and further in view of Wu et al. (US 20140377189; publication date: 12/25/2014).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
The relevant limitations of the copending application are set forth above. The application is silent with respect to the specific pramipexole salts required by claims 4, 5, 12, and 13.
Wu, in the analogous art of dopamine agonists (rotigotine; abstract), teaches that in addition to palmitate, stearate and pamoate were recognized as counterions for this class of drug (0009). It would have been prima facie obvious to use stearate as the counterion in a pharmaceutically acceptable salt of pramipexole because one having ordinary skill would have recognized these substances as suitable (see MPEP 2144.07).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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, Ali Soroush can be reached at (571)272-9925. 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.
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
