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 .
Acknowledgments
This office action is in response to the reply filed on 8/3/26. In the reply, the applicant amended claims 1,3-8,17-18, 20; canceled claims 9-10,14-16; added new claims 23-27. Claims 1-8, 11-13, 17-20, 23-27 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 1-5, 11-13, 18-20, 23-25, 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chattaraj et al. (US 2015/0112302) (“Chattaraj”) in view of Joseph et al. (US 2018/0207356) (“Joseph”). Chattaraj discloses: (reference sections provided below are examples and non-limiting)
(Claims 1, 18), Chattaraj discloses a drug delivery device (the invention is for use with an infusion pump for delivery of fluid medication; paragraph [0041]) comprising: a reservoir configured to receive a fluid (the infusion pump includes a self-contained reservoir for storing medication; paragraph [0044]); a cannula (penetrating body per claim 18) in fluid communication with the reservoir (a pump for drawing the fluid medication from the reservoir and advancing it by way of an infusion cannula to the tissue of the patient to be treated; paragraph [0044]), the cannula configured to be inserted into subcutaneous tissue or muscle tissue of a patient (the distal end of the cannula is inserted into the patient subcutaneously; paragraph [0044]); and a pump configured to deliver a fluid from the reservoir to the cannula (a pump for drawing the fluid medication from the reservoir and advancing it by way of an infusion cannula to the tissue of the patient to be treated; paragraph [0044]), wherein the cannula comprises a bioactive agent configured to cause a tissue response to decrease a pressure required to deliver fluid from the reservoir (the cannula is provided with a coating 27 of a response-inhibiting agent (bioactive agent) the response-inhibiting agent-coated cannula provides a direct supply of a response-inhibiting agent is directly delivered into a patient's internal tissues environment to achieve an anti-coagulation effect and/or prevent encapsulation of a subcutaneously inserted cannula (decrease pressure required); paragraph [0074]).
Chattaraj discloses the invention as substantially claimed, including the cannula or penetrating body including a response-inhibiting agent [0010]. Chattaraj discloses some typical examples of response-inhibiting agents that can be used but is not exhaustive [0090-0098] [0141]. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute any of the bioactive agents as specified in claims 4-8, 15, 17, 20 for the response-inhibiting agent as taught by Chattaraj as a simple substitution of one known element for another to obtain predictable results (KSR).
Arguendo, Joseph, in the analogous art, teaches a cannula coated with one or more compounds [0112]. The coating is non-limiting to include a agent configured to cause a tissue response to decrease a pressure required to deliver fluid from the reservoir such as at least one of a vasodilator or a nitrovasodilator ([0112] e.g., hydralazine). 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 coat the cannula of Chattaraj with a vasodilator or nitrovasodilator as taught by Joseph as a simple substitution within a device claim.
Claims 2,19: the cannula (penetrating body) comprises at least one of a catheter and a needle (the infusion set includes an insertion needle, which is assembled with the soft cannula; paragraph [0044]).
Claim 3: In the combination, the tissue response from Joseph, above, comprises vasodilation [0112].
Claims 4,20: Again from Joseph, the bioactive agent further comprises an enzyme, a histamine, and a chemical irritant [0112]
Claim 5: the bioactive agent comprising the nitrovasodilator comprises at least one of nitrate, niacinamide, and nitroprusside. Joseph [0112]
Claim 11: the bioactive agent comprises a material forming the cannula or a secondary metabolite arising from the degradation of a material forming the cannula [0078]
Claim 12: the bioactive agent is embedded within the cannula, the bioactive agent configured to be released at a controlled rate upon insertion of the cannula into subcutaneous tissue or muscle tissue of a patient [0012] [0081]
Claim 13: the cannula comprises a coating, the bioactive agent carried in the coating [0012] [0060] [0069]
Claim 14: the coating comprises a frangible coating (is released) [0081]
Claim 16: the bioactive agent is configured to prevent encapsulation of the cannula and prevent bioformed tissue encapsulation [0047] [0050]
Claims 23,24: the tissue response caused by the bioactive agent comprises inducing vasodilation of lymph capillaries or blood capillaries. Joseph [0112]
Claim 25: the bioactive agent of Chattaraj/Joseph is capable of selectively inducing vasodilation of only blood capillaries or only lymphatic capillaries (this is a design consideration, functional language)
Claim 27: The claim recites functional language which Joseph is capable of performing and measuring based on design considerations with the same bioactive agent, a vasodilator that decreases a pressure required to deliver fluid from the reservoir.
Claims 6-8, 17,26 are rejected under 35 U.S.C. 103 as being unpatentable over Chattaraj.
Chattaraj/Joseph discloses the invention as substantially claimed, including the cannula or penetrating body including a response-inhibiting agent [0010]. Chattaraj discloses some typical examples of response-inhibiting agents that can be used but is not exhaustive [0090-0098] [0141]. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute any of the bioactive agents as specified in claims 6-8 for the response-inhibiting agent as taught by Chattaraj as a simple substitution of one known element for another to obtain predictable results (KSR) in a device claim.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record.
Conclusion
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 DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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