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 1-10 in the reply filed on 1/26/2026 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: line 10 recites “the first biocompatible” which is interpreted as “the first biocompatible polymer” as recited in line 6. Appropriate correction is required.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,684,763. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all the elements of claim 1 are to be found in claim 1 of the patent. The difference between claim 1 of the application and claim 1 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claim 1 of the patent is in effect a “species” of the “generic” invention of claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan (US 2013/0038632).
As to claim 1, Kaplan discloses a dissolvable microneedle array (200) for transdermal insertion into a patient comprising: a base portion (214); and a plurality of microneedles (210) extending from the base portion, the plurality of microneedles including a first controlled release component, the first controlled release component comprising a first bioactive component and a first biocompatible polymer that interacts with the first bioactive component to provide a first controlled release profile of the first bioactive component [0011; 0110], wherein the first bioactive component is complexed with, integrated to, or otherwise encapsulated by the first biocompatible to form the first controlled release component [0110], and wherein the first controlled release profile of the first bioactive component is triggered by a temperature sensitive phase transition [0235].
As to claim 2, Kaplan discloses the microneedle array of claim 1, further comprising a second bioactive component that is different from the first bioactive component [0011; 0110].
As to claim 3, Kaplan discloses the microneedle array of claim 2, wherein the second bioactive component is complexed with, integrated to, or otherwise encapsulated by a second biocompatible polymer to form a second controlled release component [0110].
As to claim 4, Kaplan discloses the microneedle array of claim 3, wherein the first and second biocompatible polymers are different, and the first controlled release profile is different from a second controlled release profile of the second controlled release component [0110].
As to claim 5, Kaplan discloses the microneedle array of claim 3, wherein the first and second biocompatible polymers are the same [0110].
As to claim 6, Kaplan discloses the microneedle array of claim 1, wherein the first biocompatible polymer is selected from the group consisting of PLGA, P(L)LA, P(D,L)LA, PCL, PLCL [0086; 0110].
As to claim 7, Kaplan discloses the microneedle array of claim 3, wherein the second biocompatible polymer is selected from the group consisting of PLGA, P(L)LA, P(D,L)LA, PCL, PLCL [0086; 0110].
As to claim 8, Kaplan discloses the microneedle array of claim 1, further comprising a second bioactive component and, in use, the second bioactive component is configured to be released from the microneedle array with an initial burst release kinetic activity and the first bioactive component is configured to have a delayed release relative to the second bioactive component [0097].
Allowable Subject Matter
Claims 9 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art, US 2013/0038632 to Kaplan and US 2002/0082543 to Park, fails to suggest or disclose the microneedle array of claim 1, wherein the first controlled release profile of the first bioactive component is also triggered by a second trigger signal, the second trigger signal being selected from the group consisting of trigger signals based on electric-field triggers, light triggers, and ultrasound triggers; and the microneedle array of claim 4, wherein the second controlled release profile of the second bioactive component is triggered by a second trigger signal, the second trigger signal being selected from the group consisting of trigger signals based on electric-field triggers, light triggers, and ultrasound triggers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IMANI N HAYMAN whose telephone number is (571)270-5528. The examiner can normally be reached 5:30 AM - 3:30 PM.
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/IMANI N HAYMAN/Supervisory Patent Examiner, Art Unit 2841