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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/4/26 (3/12/26 RCE) has been entered.
Acknowledgments
This office action is in response to the reply filed on 3/4/26 (3/12/26 RCE). In the reply, the applicant amended claims 1,14,37,231,238; canceled claims 38,254,258,393; added new claims 394-397. Claims 1-2,5-10,14-15,24-26,37,39,45-47,185,231-232,235-236,238-242,255-257,261-263,295,327,359-360,390-391,394-397 are pending.
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.
Claims 1-2,5-10,14-15,24-26,37,39,45-47,185,231-232,235-236,238-242,255-257,261-263,295,327,359-360,390-391,394-397 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2017/0080196) (“Lee”) in view of Chen et al. (US 10,869,832) (“Chen”).
(claims 1, 231, 239) Lee discloses a periodontal drug delivery system (see abstract) comprising a microneedle patch, the microneedle patch comprising: a support layer 30 comprising a surface capable of a sealable application (Figs. 14a,b) to a diseased periodontal tissue of a subject in need thereof; and a plurality of transdermal microneedles 10 having bases disposed on the surface of the detachable support layer and projecting perpendicularly therefrom, wherein the transdermal microneedles comprise nano/microparticles loaded/coated with a drug 20, and the transdermal microneedles are formulated for sustained release of the drug ([0025,0076], viscous material affects the sustained release).
Lee does not directly disclose the support layer or the microneedles being detachable and wherein the detachable support layer comprises a first drug, the detachable support layer is formulated for immediate release of the first drug, and wherein the microneedles are loaded with a second drug. Chen, in the analogous art, teaches these features. The support layer 12 of Chen is formulated for immediate release of a first drug as it detaches from the substrate 11 and the microneedles 13 are loaded with a second drug and these microneedles detach from the supporting structure 12, C6L8-22, C3L42-50, C16L17-39. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the support layer and microneedles of Lee with the detachable support layer and microneedles as taught by Chen for less discomfort for a user (Chen C3L63-65, C4L38-60, C16L17-39, Figs. 3, 4, 5, 6a,b)
The first drug comprising an antibiotic or antibacterial agent and the second drug comprising an immunomodulatory cytokine or a growth factor are design considerations. Chen and Lee both disclose devices for use in an oral cavity (Chen C6L26-32-oral cavity) (Lee [0003] Figs.14a,b, delivery to gums G).
Further, substances delivered depends on the use of the substance delivery device (Chen C6L22) (Chen C8L3-11-substances delivered by the device are not limited) A person of ordinary skill in the art has good reason to pursue the known options of agents to apply to the system of Lee/Chen to cure a periodontal disease within his or her technical grasp.
This first drug is formulated for immediate release and can be an antibiotic or antibacterial selected from tetracycline, doxycycline, chlorhexidine and or minocycline, as above with design choice.
(claims 2, 232, 360) the detachable support layer, the transdermal microneedles, or both, independently comprise a biodegradable polymer. (Chen, C11L59-61,C16L12-16)
(claims 5, 6, 235, 236) the detachable support layer 12 is non-membranous and non-adhesive (Chen, the support layer is dissolvable, porous).
(claim 7) the first drug S1 is an antibiotic (Chen, C8L54-59, C8L3-11, {chitosan is a natural bioactive polymer with functional properties such as antibacterial, anti-infective activity}).
(claims 8, 238) the first drug is present within the detachable support layer, the first drug is coated on the detachable support layer, or a combination thereof. (Chen, C3L42-50, C16L8-16) The antibiotic or antibacterial is selected from tetracycline, doxycycline, chlorhexidine and or minocycline, as above with design choice.
(claims 9, 10) the first drug and second drug are dispersed within a biodegradable polymer (Chen, C3L42-50, C16L8-16).
(claim 14) the immunomodulatory cytokine, growth factor or combination thereof is encapsulated in the nano/microparticles, wherein the encapsulated nano/microparticles are dispersed within a biopolymer (Chen, C3L42-50, C16L8-16, C8L3-11).
(claim 15) the biopolymer comprises alginate and calcium chloride (Lee [0024]).
(claims 24, 240) the drug-loaded transdermal microneedles have a height ranging from about 300 microns to about 1200 microns (Chen, C7L43-60)
(claims 25, 241) the drug-loaded transdermal microneedles comprises a base diameter of from about 100 microns to about 400 microns. (Chen, C7L43-60)
(claims 26, 242) the drug-loaded transdermal microneedles have an aspect ratio of height to diameter of about 5 or more. (Chen, C7L43-60)
(claim 37) the second drug loaded in the transdermal microneedles comprises microparticles comprising an immunomodulatory cytokine, a growth factor, or combination thereof, and the detachable support layer comprises an antibiotic. (Chen, C8L54-59, C8L3-11, C3L42-50 {chitosan is a natural bioactive polymer with functional properties such as antibacterial, anti-infective activity}).
(claim 255) the drug loaded transdermal microneedles comprises an immunomodulatory cytokine, and the detachable support comprises an antibiotic or antibacterial agent. Chen, C8L54-59, C8L3-11, C3L42-50
(claim 39) the second drug loaded in the transdermal microneedles comprise an immunomodulatory cytokine, and the detachable support comprises an antibiotic. (Chen, C8L54-59, C8L3-11, C3L42-50)
(claims 45, 261) the diseased periodontal tissue comprises periodontal ligament, cementum, gingiva, and/or alveolar bone. (Lee [0084,0137,0148,0003)
(claims 46, 262) the subject has periodontitis and/or gingivitis. (treatment to gums Lee [0084,0137,0148,0003])
(claims 47, 185, 263, 295, 327, 359, 390, 391) A method for regenerating periodontal tissue in a subject in need thereof, the method comprising sealably applying to the periodontal tissue the periodontal delivery system of claim 1—see rejection above with respect to claims 1, 45, 46
(claims 256, 257) the antibiotic or antibacterial agent is tetracycline, doxycycline, chlorhexidine and/or minocycline;
an amount of from about 50 ng up to about 1,500 ng of the antibacterial agent per transdermal microneedle patch. (Chen C8L3-11, the inventions of Chen and Lee are not limited by the substances and amounts to be delivered—this is an obvious design choice)
(claims 394-397) the immunomodulatory cytokine is IL-4 or IL-10 or the combination thereof and the growth factor being TGF-β is, as above, design considerations. Chen and Lee both disclose devices for use in an oral cavity (Chen C6L26-32-oral cavity) (Lee [0003] Figs.14a,b, delivery to gums G).
Further, substances delivered depends on the use of the substance delivery device (Chen C6L22) (Chen C8L3-11-substances delivered by the device are not limited) A person of ordinary skill in the art has good reason to pursue the known options of agents to apply to the system of Lee/Chen to cure a periodontal disease within his or her technical grasp, KSR.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that neither Chen nor Lee disclose antibiotics or antibacterial agents in the support layer, nor an immunomodulatory cytokine and/or growth factor in nano/microparticles in the microneedles.
Chen and Lee both disclose devices for use in an oral cavity (Chen C6L26-32-oral cavity) (Lee [0003] Figs.14a,b, delivery to gums G). Further, substances delivered depends on the use of the substance delivery device (Chen C6L22) (Chen C8L3-11-substances delivered by the device are not limited) A person of ordinary skill in the art has good reason to pursue the known options of agents to apply to the system of Lee/Chen to cure a periodontal disease within his or her technical grasp KSR. Further, one of ordinary skill in the art would have been able to carry out a simple substitution of one agent for another to obtain predictable results when used in the same area of treatment (oral cavity, gums [Chen and Lee]), KSR.
The claimed subject matter is known. Both the use of Lee (and Chen) to address periodontal diseases in its application of its device to the gums and the substances delivered depends on the use of the substance delivery device (Chen C6L22) (Chen C8L3-11-substances delivered by the device are not limited). Therefore, a person of ordinary skill in the art has good reason to pursue the known options of agents to apply to the system of Lee/Chen to cure a periodontal disease within his or her technical grasp.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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, Kevin Sirmons can be reached at 571-272-4965. 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.
/DEANNA K HALL/Primary Examiner, Art Unit 3783
Prosecution Insights