DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 07/10/2026, is acknowledged. Applicant’s statement regarding the foreign references recited in the instant specification (Pages 16, 41, 44) is acknowledged. Amendments to the specification have been withdrawn.
Claims 19-32 are pending in this application. Claims 1-18 have been cancelled. New claims 19-32 have been added. No new matter was added. Claims 19-32 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation of U.S. Patent Application No. 16/755,371, filed April 10, 2020, 2008 and now issued as U.S. Patent No. 12,053,464, which is a 371 of PCT/US2018/56724, filed October 19, 2018, which claims benefit of provisional U.S. Application No. 62/574,978, filed October 20, 2017.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 comprises the typographic error “wherein the weight ratio of the first matrix formulation” that needs to be corrected to “wherein a weight ratio of the first matrix formulation”.
Claim 19 comprises the typographic error “is 1:50 to 50:1” that needs to be corrected to “is from 1:50 to 50:1”.
Claim 19 comprises the typographic error “900 ml simulated gastric fluid” that needs to be corrected to “900 ml of simulated gastric fluid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 19-32 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 pre-AIA the applicant regards as the invention.
New claim 19 discloses a method of treating or preventing pain comprising administering to a patient a composition but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process the applicant is intending to encompass. A claim is indefinite where it merely recites a use/administering without any active, positive steps delimiting how this use/administering is actually practiced. Clarification is required.
Claim 19 recites the limitation “the active agent (B) comprises buprenorphine or a pharmaceutically acceptable salt thereof” that is not reasonably clear. Does this limitation disclose the active agent (B) as a mixture that may include other compounds even in large amounts (i.e., comprising)? Similar is applied to the limitations “at least one active agent comprising the active agent (A)”, “at least one active agent comprising the active agent (B). Clarification is required.
Claim 19 recites the term "about” that is a relative term, which renders the claim indefinite. This term 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. Similar is applied to claims 22, 23, 25, 27, 28. Clarification is required.
Claim 29 (dependent on claim 19) recites the limitation “the dosage form comprises a plurality of particles, each particle comprising said core-shell structure”. To this point, it is noted that independent claim 19 discloses “dosage form comprising a core-shell structure”. Therefore, it is unclear what part of the claimed product (to be used in the claimed method) must have a core-shell structure – a dosage form (claim 19), or particles included into the dosage form (claim 29). Clarification is required.
Claims 20-21, 24, 26, 30-32 are rejected as being dependent on rejected independent claim 19 and failing to cure the defect
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1, 95 of U.S. Patent No. 8,808,740; (2) claims 1, 13 of U.S. Patent No. 12,053,464.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because prior patents also claim: A method of treating or preventing pain by administering to a patient in need thereof a solid controlled release dosage form comprising: a core comprising a 1st drug dispersed in a 1st controlled release matrix material; and a shell/layer encasing the core and comprising a 2nd drug dispersed in a 2nd controlled release matrix material, e.g., opioid analgesic. The prior patents also teach that (i) the matrix material may include/comprise PEO having an average molecular weight of 100,000-10,000,000 Da; (ii) one can use buprenorphine/opioid analgesic in combination with other active agents, e.g., hydrocodone, oxycodone; and (iii) the weight ratio of the core to the shell as a result-effective variable. Further, it is noted that claims of prior patent US 8,808,740 are merely broader than the instant claims prior that include additional limitations and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patents.
Response to Arguments
Applicant's arguments, filed 07/10/2026, have been fully considered, but they are moot in view of amendments to the claims. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Applicant is advised to clarify the claim language, the claimed method as well as the product/dosage form to be used in the claimed method and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art, to place the application in condition for allowance
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach a method for treating or preventing pain in a patient in need thereof by administering to the patient solid oral extended-release dosage forms comprising core-shell structure as instantly claimed, wherein said core-shell structure (i) comprises buprenorphine (i.e., a strong opioid medicine mainly used to treat moderate to severe pain, e.g., during or after an operation or a serious injury, or pain from cancer) in combination with other opioid analgetic/agonist such as hydrocodone and/or oxycodone (ii) does not include an opioid antagonist, and (iii) provides buprenorphine release as instantly claimed (i.e. 20-75 wt% at 1 hr) and an extended release of additional opioid analgetic/agonist included in said dosage form.
Conclusion
Claims 19-32 are rejected but would be allowable if rewritten or amended to overcome the objections and rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action as well as double patenting rejection of record.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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