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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/31/2026 is being considered by the examiner. The non-patent document labeled “Sodiuin Inetabisulfite” in the IDS does not have a copy in the application folder, therefore the document is not considered.
Claim Status
Applicants’ amendments and arguments filed 09/29/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 2-4 and 6-16 are canceled.
Claims 1 and 5 are amended.
Claim 1 remains withdrawn.
Claim 5 is examined on the merits.
Maintained Rejections Updated to Account for Claim Amendments
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.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. US12233156B2 in view of Hori et al. (US20190350840A1, published 11/21/2019, hereafter Hori). Although the claims at issue are not identical, they are not patentably distinct from each other.
US12233156B2 claims a microneedle device comprising a substate and a coating (claim 1; according to the claim limitations of the instant claim 5). US12233156B2 further claims the coating to comprise sulfated polysaccharide, specifically chondroitin sulfate, and an active substance, specifically dexmedetomidine or a pharmaceutically active salt thereof (claim 1; according to the claim limitations of the instant claim 5). Claim 2 of US12233156B2 claims the concentration of the sulfated polysaccharide to be 0.5 parts by mass or more with respect to 100 parts by mass of the coating (according to the claim limitations of the instant claim 5). Claim 3 of US12233156B2 claims the mass ratio of the sulfated polysaccharide to the biologically active substance is 0.089 to 0.222 (according to the claim limitations of the instant claim 5).
US12233156B2 fails to claim the addition of isoproterenol or a pharmaceutically acceptable salt thereof and ethylenediaminetetraacetic acid or a pharmaceutically acceptable salt thereof as in instant claim 5. Further, US12233156B2 fails to claim the concentration ranges of ethylenediaminetetraacetic acid or a pharmaceutically acceptable salt thereof, dexmedetomidine or a pharmaceutically acceptable salt thereof, or isoproterenol or a pharmaceutically acceptable salt thereof as in instant claim 5.
Hori claims a microneedle device comprising: a substrate; microneedles disposed on the substrate; and a coating formed of the microneedles (claim 1; according to the claim limitations of the instant claim 5). Claim 1 of Hori further claims the coating comprises dexmedetomidine or a pharmaceutically acceptable salt thereof and isoproterenol or a pharmaceutically acceptable salt thereof (according to the claim limitations of the instant claim 5). Hori teaches a microneedle coating composition comprising dexmedetomidine or a pharmaceutically acceptable salt thereof and isoproterenol or a pharmaceutically acceptable salt thereof (claim 6; according to the claim limitations of the instant claim 5). Hori further teaches dexmedetomidine hydrochloride alone has a slow increase of dexmedetomidine concentration in plasma making it difficult to obtain an expected therapeutic effect at an expected time ([0005]; according to the claim limitations of the instant claim 5). Hori solves this problem by blending isoproterenol with dexmedetomidine hydrochloride improves the increase rate of dexmedetomidine concentration in the plasma ([0006]; according to the claim limitations of the instant claim 5). Claim 3 of Hori claims the coating further comprising a stabilizer (according to the claim limitations of the instant claim 5). Hori teaches that the addition of a stabilizer in the coating resulted in improvement in the stability of dexmedetomidine hydrochloride and isoproterenol hydrochloride ([0065]; according to the claim limitations of the instant claim 5). Hori teaches the concentration of the dexmedetomidine or pharmaceutically acceptable salt thereof is 10 to 90%, preferably 40 to 85%, and more preferably 60 to 80% of the coating ([0023]; according to the claim limitations of the instant claim 5). Hori teaches the total amount isoproterenol and a pharmaceutically acceptable salt thereof is from 0.3 parts or more based on 100 parts by mass of a total amount of dexmedetomidine and a pharmaceutically acceptable salt thereof in the coating ([0008]; according to the claim limitations of the instant claim 5). Further, Hori teaches the total amount of isoproterenol and a pharmaceutically acceptable salt thereof in the coating may be 0.3 parts by mass or more and examples include 0.2% or more, 0.8% or more, 2.4% or more, and 4.8% or more ([0024]; according to the claim limitations of the instant claim 5). Hori further teaches the stabilizer to be ethylenediaminetetraacetic acid (EDTA) and Hori teaches a sample composition with a concentration of stabilizer of 1.2 parts by mass ([0027] and [0067]; according to the claim limitations of the instant claim 5). Table 6, Example 6, of Hori provides an example composition with a concentration of isoproterenol hydrochloride of 4.4 parts by mass and a concentration of stabilizer of 1.2 parts by mass which calculates to a mass ratio of isoproterenol hydrochloride to stabilizer that is 0.27 ([0067]; according to the claim limitations of the instant claim 5). The same example as above, example 6, teaches the concentration of the base to be 14.7 parts by mass ([0064] – Table 6; according to the claim limitations of the instant claim 5). Furthermore, Hori teaches the addition of a base is to perform the function of retaining a drug to the microneedles, and also increase the viscosity of a coating composition ([0026]; according to the claim limitations of the instant claim 5). Hori further teaches the base to be a water-soluble polymer such as polysaccharides ([0026]; according to the claim limitations of the instant claim 5).
Furthermore, Hori teaches that the addition of a stabilizer in the coating resulted in improvement in the stability of dexmedetomidine hydrochloride and isoproterenol hydrochloride ([0065]; according to the claim limitations of the instant claim 5). Hori further teaches the stabilizer to be ethylenediaminetetraacetic acid (EDTA) and Hori teaches a sample composition with a concentration of stabilizer of 1.2 parts by mass ([0027] and [0067]; according to the claim limitations of the instant claim 5).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to modify the microneedle device coating composition comprising chondroitin sulfate, and dexmedetomidine or a pharmaceutically active salt thereof as outlined by US12233156B2 by addition of isoproterenol or a pharmaceutically acceptable salt thereof and ethylenediaminetetraacetic acid at a concentration of 1.2 parts by mass as outlined by Hori under TSM, see MPEP 2143(G). As outlined by Hori, adding isoproterenol or a pharmaceutically acceptable salt thereof improves the increase rate of dexmedetomidine concentration in the plasma and ethylenediaminetetraacetic acid increases the stability of the composition which would motivate someone skilled in the art to advantageously combine both isoproterenol or pharmaceutically acceptable salt thereof and ethylenediaminetetraacetic acid at a known concentration of 1.2 parts by mass with the microneedle device of US12233156B2 as it would have a reasonable expectation of success. Further, it would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim the microneedle device coating composition comprising chondroitin sulfate, dexmedetomidine or a pharmaceutically active salt thereof, isoproterenol or pharmaceutically acceptable salt thereof, and ethylenediaminetetraacetic acid as outlined by US12233156B2 in view of Hori with the ready for improvement with the known technique of adjusting the concentrations of the dexmedetomidine or a pharmaceutically active salt thereof, isoproterenol or pharmaceutically acceptable salt thereof, and ethylenediaminetetraacetic acid as outlined by Hori. Adjusting the forementioned components of the microneedle device coating composition as claimed by instant claim 5 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Response to Applicant’s Arguments
Applicant’s arguments filed on 03/26/2026 have been considered.
In regards to the 35 USC § 103 rejections, Applicant’s amendments have necessitated new grounds of rejection and the previous rejections of record have been withdrawn.
In regards to Applicant’s request to rejoin claim 1, Applicant requests that that upon allowance of claim 5, that claim 1 should be rejoined. In response, it is noted that claim 5 has not been deemed allowable. Therefore, the restriction requirement is maintained and claim 1 is not rejoined.
In regards to the non-statutory double patenting rejection, Applicant states a Terminal Disclaimer is filed within. However, a Terminal disclaimer is not found within the Application folder. Therefore, the double patenting rejection of record is maintained and updated for amendments. It is noted that there is no power of attorney of record as is shown on the filing receipt. If this is incorrect then please file a request for a corrected filing receipt.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611