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 with traverse of claims 1-4, 6-15 and 17-18 in the reply filed on 9/18/2025 is acknowledged. The traversal is on the ground(s) that there is no burden in searching both sets of claims. This is not found persuasive because the inventions are classified in different international search areas making the overall search area overly large and burdensome.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 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) 1-4, 9-13, 15 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (USPGPub 2005/0149157).
Regarding claims 1-4, 9-13, 15 and 17 Hunter teaches providing a medical implant such as a sensor [0890] or an infusion set (devices for continuous subarachnoid infusions being reasonably implicit of an “infusion set” or at least part thereof) with a coating thereon that may comprise an elastase inhibitor [0291-0292], an antimicrobial agent [0436] or an anti-inflammatory agent [0436]wherein the provided drugs may be provided with a carrier [0131] that may be a synthetic matrix [0168] wherein the medical device may be sterilized and packaged [1034].
Regarding claim 18, Hunter further teaches the use of pacemakers and ICD systems that have sensors thereon [0145][0152] which may be coated by the same drugs listed above in the rejection of claim 1. Additionally it noted that the sensors of Hunter read upon analyte sensors wherein the sensors would reasonably be able of detecting analytes that are detectable based upon electrical charge variations. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (USPGPub 2005/0149157) as applied to claims 1-4, 9-13, 15 and 17-18 above.
Regarding claims 6-7, the teachings of Hunter are as shown above. Hunter is silent as to whether the elastase inhibitors are intracellular or extracellular in nature. However, reasonably this covers all possibilities given that all elastase inhibitors fall into one of these two categories. Therefore, given a limited number of defined possibilities, it would have been considered “obvious to try” for one of ordinary skill in the art before the effective filing date of the claimed invention to attempt to use intracellular or extracellular elastase inhibitors wherein either option would provide predictable results that would be expected to function in the invention of Hunter.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (USPGPub 2005/0149157) as applied to claims 1-4, 9-13, 15 and 17-18 above and further in view of Masters (USPGPub 2003/0007991).
Regarding claim 8, the teachings of Hunter are as shown above. Hunter fails to teach wherein the medical device comprises a therapeutic nucleic acid as an active agent in the medical coating. However, Masters teaches that it is known to incorporate DNAs and RNAs as active agents in coated medical devices [0146] such as pacemakers (abstract) wherein the benefit provided is relative to the specific nucleic acid chosen as described. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the DNA or RNA derivatives and variations of Masters in the invention of Hunter in order to gain the specific drug/therapeutic benefit provided dependent upon the specific DNA or RNA derivative or variation chosen.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (USPGPub 2005/0149157) as applied to claims 1-4, 9-13, 15 and 17-18 above and further in view of Mirov (USPGPub 2018/0165422).
Regarding claim 14, the teachings of Hunter are as shown above. Hunter fails to teach wherein the medical device to be coated is a drug-injecting pen. However, Mirov teaches that it is known to provided the same sensors to medical devices such as drug dispensing pens that are provided to implantable medical devices [0071]. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drug-injecting pen of Mirov for the implantable medical device of Hunter as a simple substitution of one medical device for another wherein the substitution would be predictable based upon the teachings of Mirov.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717