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 .
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.
Claims 51-52 recites the limitations "the agent" in the claims. There is insufficient antecedent basis for this limitation in the claim. For the purposes of the current examination the examiner will assume that the applicant intended for the claims to have similar meaning as
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.
Claims 1-2, 4, 6-7, 10-13 and 55-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lazarov et al. (USPGPub2003/0044596).
Regarding claim 1, Lazarov teaches that it is known to provide and implantable device [0017] with a coating comprising lactoferrin [0024].
Regarding claim 2, Lazarov further teaches wherein the coating may comprise heparin.
Regarding claim 4, heparin is a known ROS.
Regarding claims 6-7, lactoferrin is both and intracellular inhibitor and an extracellular inhibitor.
Regarding claim 10 and 55, Lazarov teaches a wherein the preferred embodiment provides heparin in conjunction with albumin and fibrinogen [0024], wherein reasonably the albumin and fibrinogen can be considered as “carriers” for the heparin.
Regarding claims 11 and 56, fibrinogen and albumin as a carrier material would be considered to be a biological matrix.
Regarding claim 12, Lazarov teaches wherein the medical device may be a sensor [0017].
Regarding claim 13, heparin is further considered to be an anti-inflammatory agent.
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lazarov et al. (USPGPub2003/0044596) as applied to claims 1-2, 4, 6-7, 10-13 and 55-56 above and further in view of Behfar (USPGPub 2019/0275071).
Regarding claim 8, the teachings of Lazarov are as shown above. Lazarov fails to teach wherein the implant further includes modified messenger RNA. However, Behfar teaches that it is known to incorporate modified messenger RNA [0082] into coating for medical implants [0096] for the purpose of providing gene therapy specific to the RNA provided. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the modified messenger RNA of Behfar in the therapeutic coating of Lazarov in order to provide the additional benefit of the specific gene therapy provided by the modified messenger RNA of Behfar.
Claims 9, 15-18, 51-52 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Lazarov et al. (USPGPub2003/0044596) as applied to claims 1-2, 4, 6-7, 10-13 and 55-56 above and further in view of Hunter et al. (USPGPub 2005/0149157).
Regarding claim 9, the teachings of Lazarov are as shown above. Lazarov fails to teach the use of an antimicrobial agent in combination with his active agents. However, Hunter teaches that it is known to incorporate antimicrobial agents [0436] into coatings for medical devices likely for the purpose of reducing infection. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the antimicrobial agents of Hunter in the therapeutic coating of Lazarov in order to provide antimicrobial activity in the invention of Lazarov as was done in Hunter.
Regarding claim 15, the teachings of Lazarov are as shown above. Lazarov fails to teach wherein the medical device to be coated is part of an infusion set. However, Hunter teaches that itis known to provide active agent coating to devices for infusion sets such as continuous subarachnoid infusion devices [0079] as well as sensors. 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 subarachnoid infusion device of Hunter into the device coating method of Lazarov as a simple substitution of one drug delivery implantable device for another wherein the results of the substitution would be predictable there would be a reasonable expectation of success based upon the teachings of Hunter that both types of devices are suited for his active agent delivery coating system.
Regarding claim 17, the teachings of Lazarov are as shown above. Lazarov fails to teach wherein the medical device is enclosed in sterile packaging. However, Hunter teaches that it is known to package medical devices in sterile medical packaging [1034] likely for the purpose of preventing contamination before use. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to package the medical device of Lazarov as guided by Hunter in order to provide said contamination prevention in the devices of Lazarov prior to implantation.
Regarding claim 18, Lazarov teaches that it is known to provide and implantable device [0017] with a coating comprising lactoferrin [0024]. Lazarov fails to teach wherein the medical device is an analyte sensor although as cited above Lazarov does teach coating sensors in general. However, Hunter teaches that it is known to pacemakers and ICD systems that have sensors thereon [0145][0152]. 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). 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 medical devices of Lazarov comprising sensors for those of Hunter comprising sensors as a simple substitution of one known medical sensor coated with active agents for another wherein the results of the substitution would have been predictable and the there would have been a reasonable expectation of success based upon the teachings of Hunter disclosing the ability to coat medical sensors with active agent coatings.
Regarding claims 51-52, lactoferrin is both and intracellular inhibitor and an extracellular inhibitor.
Regarding claim 54, the teachings of Lazarov are as shown above. Lazarov fails to teach the use of an antimicrobial agent in combination with his active agents. However, Hunter teaches that it is known to incorporate antimicrobial agents [0436] into coatings for medical devices likely for the purpose of reducing infection. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the antimicrobial agents of Hunter in the therapeutic coating of Lazarov in order to provide antimicrobial activity in the invention of Lazarov as was done in Hunter.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lazarov et al. (USPGPub2003/0044596) as applied to claims 1-2, 4, 6-7, 10-13 and 55-56 above and further in view of Mirov (USPGPub 2018/0165422).
Regarding claim 14, the teachings of Lazarov 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 provide the 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 Lazarov as a simple substitution of one medical device for another wherein the substitution would be predictable based upon the teachings of Mirov.
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lazarov et al. (USPGPub2003/0044596) in view of Hunter et al. (USPGPub 2005/0149157) as applied to claims 9, 15-18, 51-52 and 54 above and further in view of Behfar (USPGPub 2019/0275071).
Regarding claim 53, the teachings of Behfar are applicable to the teachings of Lazarov in view of Hunter in the same manner that they are applicable to the teachings of Lazarov alone in the rejection of claim 8 above.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot in view of new grounds of rejection entirely dependent on newly provided art provided based upon the currently amended claims.
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 ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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, Dah-Wei Yuan can be reached at 571-272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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