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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group III, claims 20, amended claims 33-44 and newly added claims 45-52 in the reply filed on 06/01/2026 is acknowledged. Thus, claims 20, 33-52 are presently pending in this application.
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Redler (7641912) in view of Rodriguez (2015/0282929) further in view of Dillon et al. (4431449) “Dillon”.
Redler discloses a method of inhibiting microbial growth on a medical device and/or maintaining sterilizing said medical device (abstracta and col. 1, lin. 27-31 disclose medical devices) comprising: providing a medical device (col. 1, lin. 27-31); said medical device is configured to be implanted into a patient (surgical implants; col. 1, lin. 27-31); applying a coating on at least a portion of said medical device prior to said medical device being implanted in the patient (col. 3, lin. 5-10; the coating is obviously applied prior to implantation since it’s sprayed on the surface); said coating includes a) zirconium salt, b) zirconia, and/or c) Zr(IV) complexes (claim 1); said coating has a thickness of 0.01-500 um (col. 5, lin. 66-67). Redler is silent regarding said medical device is a prosthetic heart valve; said prosthetic heart valve includes an expandable frame and one or more a leaflet and a skirt; said coating is coated on at least a portion of an outer surface of said leaflet and/or said skirt to inhibit or prevent microbial growth on said outer surface of said leaflet and/or skirt that includes said coating; and at least partially removing said coating from said medical device prior to inserting said medical device into a patient.
However, Rodriguez teaches a similar method comprising: a. providing a medical device 20 (Fig. 2); said medical device is configured to be implanted into a patient (abstract and par. 0056); said medical device is a prosthetic heart valve (par. 0056); said prosthetic heart valve includes an expandable frame 26 and one or more a) a leaflet 28 and b) a skirt 30; b. applying a coating on at least a portion of said medical device prior to said medical device being implanted in the patient (par. 0031) ; said coating includes a) zirconium salt, b) zirconia, and/or c) Zr(IV) complexes (par. 0031 discloses zirconium coating); said coating is coated on at least a portion of an outer surface of said leaflet and/or said skirt to inhibit or prevent microbial growth on said outer surface of said leaflet and/or skirt that includes said coating (the combination of the antimicrobial coating of Redler and the leaflets/skirt of Rodriguez would arrive at the leaflets and skirt being coated). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in Redler to include medical device is a prosthetic heart valve; said prosthetic heart valve includes an expandable frame and one or more a leaflet and a skirt; said coating is coated on at least a portion of an outer surface of said leaflet and/or said skirt to inhibit or prevent microbial growth on said outer surface of said leaflet and/or skirt that includes said coating, as taught and suggested by Rodriguez, for increasing longevity of heart valves (par. 0002).
Furthermore, Dillon teaches a similar method of coating medical devices (col. 1, lin. 15-17) comprising at least partially removing said coating from said medical device prior to inserting said medical device into a patient (col. 9, lin. 58-59). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in Redler in view of Rodriguez to include at least partially removing said coating from said medical device prior to inserting said medical device into a patient, as taught and suggested by Dillon, for providing a finished implant with excess coating removed from its surface.
Allowable Subject Matter
Claims 33-52 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “said one or more leaflets and/or said one or more skirts are at least partially formed of a low heat material that cannot be sterilized at temperatures above 150°C without at least partially damaging said one or more leaflets and/or said one or more skirts; applying a removable coating on at least a portion of said low heat material” and “said removable coating is formulated to be removable from said medical device by use of a) water, b a saline solution, or c) an acid solution; said removable coating is removable from said medical device without damaging said medical device; said removable coating has a lower volatility than glutaraldehyde” as set forth in claims 33 and 45. The closest prior art of Redler (7641912) in view of Rodriguez (2015/0282929) further in view of Dillon et al. (4431449) “Dillon” fail to disclose these limitations, therefore, the claims have not been found anticipated by or obvious over any prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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