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
This application has PRO 63/797,544 (04/30/2025)
and PRO 63/698,171 (09/24/2024).
Drawings / Figures
The drawings are objected to because Figs. 1-3 all have illegible text. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant did not respond to this objection. Failure to properly respond will be treated as non-responsive and result in abandonment – MPEP 714.03.
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.
Claims 1, 82-115 are rejected under 35 U.S.C. 103 as being unpatentable over Yocca et al. (US20220202373) in view of Pongpeerapat et al. (US10772871, published 2020-09-15).
Yocca teaches treating agitation by administration of dexmedetomidine ([0151] “Any anti-agitation agent that can reduce sympathetic nervous system activity may be used as part of the system herein to prevent the emergence of agitation. One particular group of suitable agents are alpha-2-adrenergic receptor agonists.”; [0155]: “In a preferred embodiment, the alpha-2 adrenergic receptor agonist is dexmedetomidine”; [0209]: “Anti-agitation agents, including alpha-2 adrenergic receptor agonists such as dexmedetomidine … in the form of pharmaceutical compositions suitable for … transdermal … administration”) in Alzheimer’s patients ([0174]: “in patients suffering from neurodegenerative disease, such as Alzheimer's disease”) using a diagnostic process including ABS ([0174]: “measuring agitation in dementia patients include Cohen-Mansfield Agitation Inventory (CMAI), Agitated behavior scale (ABS), battery of scales for dementia (e.g.; BAS, ABID, MPI) could be used as a baseline for validation of the new digital measure such as Middelheim Frontality Score (MFS), Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD), Cornell Scale for Depression in Dementia (CSDD).”). Yocca teaches monitoring patient agitation indicators / scores across multiple days including determining a baseline ([0384]-[0388]; [0511]; [0615]-[0641]).
Yocca teaches the pharmaceutical composition administered as a transdermal patch ([0211]; [0216]), but does not teach the particular transdermal patch configuration as in the claims.
Yocca teaches monitoring signs of emergence of agitation in patients with ABS ([0174]: “signs of emergence of agitation are monitored in patients”, “measuring agitation in dementia patients include … Agitated behavior scale (ABS)”), but does not teach a particular score or assessment schedule.
Pongpeerapat teaches dexmedetomidine transdermal delivery patches (Abstract, Example 1, claim 1) comprising 1 mg of dexmedetomidine (col. 26, line 22), a pressure sensitive adhesive comprising a hydroxyl functionalized acrylate polymer and lauryl lactate (claim 1: “An extended release transdermal delivery device” … “lauryl lactate in an amount of from 1 % w/w to 5 % w/w and an acrylate pressure sensitive adhesive with pendant hydroxyl functional groups”) and a backing layer comprising polyethylene and polyethylene terephthalate (claim 1; col 10, line 47, to col 11, line 5), and have a delivery area of 20 cm2 (col 10, lines 30-40). Pongpeerapat teaches the transdermal patches are useful for treating Alzheimer’s disease patients (col 15, line 50) and those experiencing agitation (col 18, line 25) and evaluating the efficacy at multiple timepoints (col 18).
One of ordinary skill in the art following the teaching of Yocca would have considered using Pongpeerapat’s transdermal patch because they are in the same field of endeavor, both teach transdermal delivery, use the same therapeutic, and treat the same Alzheimer’s patients. One of ordinary skill in the art would have also considered utilizing well-known diagnostic techniques, including ABS as taught by Yocca, and evaluated patients score to determine the need and effectiveness of the therapy and using scoring above 22 as being in need and compare to baseline over time to determine whether continued therapy was appropriate as is routine in the art. Thus, one of ordinary skill in the art had a reasonable expectation of success in the combination and arriving at the invention of claim 1.
Regarding claims 82 and 83, both Yocca and Pongpeerapat teach treating Alzheimer’s disease patients.
Regarding claim 84, Yocca teaches assessing patients using MMSE ([0618], [0666]-[0667]) which one of ordinary skill in the art would have also considered using in the same manner to assess patient need for therapy over time.
Regarding claim 85, Yocca teaches using ABS to assess patient need for therapy and one of ordinary skill in the art would consider adjusting treatment according to patient response over time as is routine in the art.
Regarding claims 87and 88, Yocca teaches assessing patient progress using diagnostics for agitation and neuropsychiatric disease ([0174]) and would be reflected in other known diagnostics and inherently improve with therapy which one of ordinary skill in the art would have also considered using in the same manner to assess patient need for therapy over time.
Regarding claim 89-90, Yocca teaches assessing patients using CGI for agitation and neuropsychiatric disease ([0390]) which one of ordinary skill in the art would have also considered using in the same manner to assess patient need for therapy over time.
Regarding claims 91-96 specifying various mg dosages of dexmedetomidine, Yocca and Pongpeerapat both teach using a therapeutically effective amount of dexmedetomidine and Pongpeerapat specifically teaches ranges including 0.1 mg to 10 mg (col 6, line 9) which is a well-known results-effective variable routinely optimized in the art such that one of ordinary skill in the art would arrive at the claimed effective doses of 1.46 mg and 2.92 mg within the prior art range with a reasonable expectation of success.
Regarding claim 97-100 specifying the surface area Pongpeerapat teaches adjusting the surface area to optimize the therapeutic delivery including a range of 10 cm2 to 100 cm2 (col 10) which one of ordinary skill in the art would know is a well-known results effective variable for optimization and arrive at the claimed 12 cm2 with a reasonable expectation of success.
Regarding claim 101, Pongpeerapat teaches a release liner configuration in the same manner as claimed (col 41, Example 14).
Regarding claims 102-103 specifying the flux, Pongpeerapat teaches the same flux as shown in Figures 1-21.
Regarding claim 104-106, both Yocca and Pongpeerapat teach treating Alzheimer’s disease patients, Yocca and Pongpeerapat both teach using a therapeutically effective amount of dexmedetomidine and Pongpeerapat specifically teaches ranges including 0.1 mg to 10 mg (col 6, line 9) which is a well-known results-effective variable routinely optimized in the art such that one of ordinary skill in the art would arrive at the claimed effective doses of 1.46 mg within the prior art range, and Pongpeerapat teaches adjusting the surface area to optimize the therapeutic delivery including a range of 5 cm2 to 1000 cm2 which one of ordinary skill in the art would know is a well-known results effective variable for optimization and arrive at the claimed 6 cm2 all with a reasonable expectation of success.
Regarding claim 107-109, both Yocca and Pongpeerapat teach treating Alzheimer’s disease patients, Yocca and Pongpeerapat both teach using a therapeutically effective amount of dexmedetomidine and Pongpeerapat specifically teaches ranges including 0.1 mg to 10 mg (col 6, line 9) which is a well-known results-effective variable routinely optimized in the art such that one of ordinary skill in the art would arrive at the claimed effective doses of 2.92 mg within the prior art range, and Pongpeerapat teaches adjusting the surface area to optimize the therapeutic delivery including a range of 10 cm2 to 100 cm2 (col 10) which one of ordinary skill in the art would know is a well-known results effective variable for optimization and arrive at the claimed 12 cm2 all with a reasonable expectation of success.
Regarding claim 110, as with claim 1, the method of treating agitation comprising applying transdermal patches comprising dexmedetomidine is obvious over Yocca in view of Pongpeerapat teaching treating Alzheimer’s disease patients, Yocca and Pongpeerapat both teach using a therapeutically effective amount of dexmedetomidine and Pongpeerapat specifically teaches ranges including 0.1 mg to 10 mg (col 6, line 9) which is a well-known results-effective variable routinely optimized in the art such that one of ordinary skill in the art would arrive at the claimed effective doses of 1.46 mg within the prior art range, and Pongpeerapat teaches adjusting the surface area to optimize the therapeutic delivery including a range of 10 cm2 to 100 cm2 (col 10) which one of ordinary skill in the art would know is a well-known results effective variable for optimization and arrive at the claimed 12 cm2, and further Pongpeerapat teaches a backing layer comprising polyethylene and polyethylene terephthalate (claim 1; col 10, line 47, to col 11, line 5), and have a delivery area of 20 cm2 (col 10, lines 30-40). Pongpeerapat teaches the transdermal patches are useful for treating Alzheimer’s disease patients (col 15, line 50) and those experiencing agitation (col 18, line 25) and evaluating the efficacy at multiple timepoints (col 18) and Yocca teaches using ABS to assess patient need for therapy and one of ordinary skill in the art would consider adjusting treatment according to patient response over time as is routine in the art.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Regarding new claims 111-112 specifying episodic and chronic agitation, Yocca teaches a method of preventing an episode of agitation (claim 33) and one of ordinary skill in the art would have considered applying the same prevention technique to chronic episodes of agitation.
Regarding claim 113 specifying a number of prior episodes of agitation prior to applying the transdermal patch, one of ordinary skill in the art would have considered varying how and when the patch was applied to optimize prevention of agitation through routine experimentation and arrive at the claimed invention with a reasonable expectation of success.
Regarding claims 114 and 115 further specifying maintaining the patch on skin for four days, Pongpeerapat teaches this limitation (col 14; col 19: “In some embodiments, applying and maintaining a transdermal delivery device containing a single layer dexmedetomidine composition in contact with a subject includes delivery of a target amount of dexmedetomidine, such as for example an average cumulative amount of dexmedetomidine delivered over the course of a dosage interval (e.g., 7 days or longer)”). One of ordinary skill in the art following the teaching of Yocca would have considered varying how long and when the patch was applied to optimize prevention of agitation through routine experimentation and arrive at the claimed invention with a reasonable expectation of success.
Response to Remarks - 35 USC § 103
Applicant agues that neither Yocca nor Pongpeerapat teach administration to a subject who is not agitated.
This argument is not persuasive because Yocca teaches monitoring for signs of emergence of agitation and preventing agitation (Yocca claim 33: “A method of preventing the emergence of agitation in a subject”). One of ordinary skill in the art following the teaching of Yocca would have considered monitoring for emergence and “prevention” as reasonably suggesting application to a subject who is not yet agitated and arrive at the claimed invention.
Applicant argues that the cited art does not teaches the claimed transdermal patch.
This argument is not persuasive because Yocca teaches administering anti-agitation agents including specifically dexmedetomidine in a transdermal form (Yocca [0208]-[0209]: “Anti-agitation agents, including alpha-2 adrenergic receptor agonists such as dexmedetomidine … may be used in the present disclosure to prevent agitation in the form of pharmaceutical compositions suitable for … transdermal … administration.”; [0216]: “Transdermal patches”). Yocca also teaches dosing as a variable which achieves a recognized result of preventing emergence of agitation including the same amounts as in the instant claims ([0225]-[0231]). Pongpeerapat teaches dexmedetomidine transdermal delivery patches (Abstract, Example 1, claim 1) comprising 1 mg of dexmedetomidine (col. 26, line 22), a pressure sensitive adhesive comprising a hydroxyl functionalized acrylate polymer and lauryl lactate (claim 1: “An extended release transdermal delivery device” … “lauryl lactate in an amount of from 1 % w/w to 5 % w/w and an acrylate pressure sensitive adhesive with pendant hydroxyl functional groups”) and a backing layer comprising polyethylene and polyethylene terephthalate (claim 1; col 10, line 47, to col 11, line 5), and have a delivery area of 20 cm2 (col 10, lines 30-40). Pongpeerapat teaches the transdermal patches are useful for treating Alzheimer’s disease patients (col 15, line 50) and those experiencing agitation (col 18, line 25) and evaluating the efficacy at multiple timepoints (col 18). One of ordinary skill in the art following the teaching of Yocca regarding administration via transdermal patches would have considered Pongpeerapat’s teaching and arrive at the claimed invention with a reasonable expectation of success.
Applicant argues that there was no motivation to combine the teachings of the prior art.
This argument is not persuasive because both references describe therapeutic transdermal delivery of dexmedetomine to a subject and thus are in the same field of endeavor and would be within what one of ordinary skill in the art would consider in following the teaching of Yocca regarding transdermal delivery of dexmedetomine.
Applicant argues that the person of ordinary skill would not have had a reasonable expectation of success in modifying the Yocca treatment method with the patch of Pongpeerapat.
This argument is not persuasive because Yocca teaches administering anti-agitation agents including specifically dexmedetomidine in a transdermal form (Yocca [0208]-[0209]: “Anti-agitation agents, including alpha-2 adrenergic receptor agonists such as dexmedetomidine … may be used in the present disclosure to prevent agitation in the form of pharmaceutical compositions suitable for … transdermal … administration.”; [0216]: “Transdermal patches”). Yocca also teaches dosing as a variable which achieves a recognized result of preventing emergence of agitation including the same amounts as in the instant claims ([0225]-[0231]). Pongpeerapat teaches dexmedetomidine transdermal delivery patches (Abstract, Example 1, claim 1) comprising 1 mg of dexmedetomidine (col. 26, line 22), a pressure sensitive adhesive comprising a hydroxyl functionalized acrylate polymer and lauryl lactate (claim 1: “An extended release transdermal delivery device” … “lauryl lactate in an amount of from 1 % w/w to 5 % w/w and an acrylate pressure sensitive adhesive with pendant hydroxyl functional groups”) and a backing layer comprising polyethylene and polyethylene terephthalate (claim 1; col 10, line 47, to col 11, line 5), and have a delivery area of 20 cm2 (col 10, lines 30-40). Pongpeerapat teaches the transdermal patches are useful for treating those experiencing agitation (col 18, line 25) and evaluating the efficacy at multiple timepoints (col 18). One of ordinary skill in the art following the teaching of Yocca regarding administration via transdermal patches would have considered Pongpeerapat’s teaching and arrive at the claimed invention with a reasonable expectation of success.
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, 82-115 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10772871 in view of Yocca et al. (US20220202373). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims the transdermal delivery device and method of use as detailed in the 35 USC 103 rejection supra and renders the claims obvious for the same reasons.
Claims 1, 82-115 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10987342 in view of Yocca et al. (US20220202373) and Pongpeerapat et al. (US10772871). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims the transdermal delivery device and method of use as detailed in the 35 USC 103 rejection supra and renders the claims obvious for the same reasons.
Response to Remarks - Double Patenting
Applicant argues by referencing the arguments in the 35 USC 103 rejections.
The arguments are not persuasive for the same reasons provided above.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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