DETAILED ACTION
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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
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 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.
Status of the Claims
Claim(s) 1-10 and 12-18 is/are pending. Claim(s) 9 and 13-16 is/are withdrawn. Claim(s) 11 is/are canceled.
Response to Arguments
Applicant’s arguments with respect to claims 1-8, 10, 12, and 17-18 have been considered but are moot in view of the new grounds of rejection.
Applicant argues that the prior art to Hill and Mullick does not teach amended claim 10, now requiring compound 11 or compound 39. No additional arguments regarding cited features of the prior art are provided.
The Examiner notes that Mullick’s Figure 1k is re-used herein, as the compounds for the current Application’s compound 39 and compound 22 appear to be identical (see Applicant’s Figures 16 and 29). The Examiner does note in some instances “NH” is typed as “HN” and “OC” is typed as “CO”. However, due to the number of available bonds, “NH” and “HN” would both have the “N” in the backbone, with the H attached to the N. Likewise, the “C” would be in the backbone, with the “O” attached to the “C” in the “CO”. Applicant’s Specification (PG Publication US 202/0188096 A1) describes in detail how compound 39 is made (e.g. [0292]-[0294], but does not describe in the same detail how compound 22 is made (e.g. [0249], [0254]-[0256]). Thus, provided with this disclosure, the only evidence before the Examiner indicates compounds 22 and 39 are identical in structure.
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 2, 4, and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “one or more leaflets”. It is unclear if this feature is the same or different that the “at least one leaflet” introduced in claim 1. For purposes of examination the Examiner considers this language to be “the at least one leaflet’.
Claim 8 recites “a polyurethane’. It is unclear if this is the same or different than the polyurethane introduced in claim 7.
Claim(s) 4 is/are rejected as dependent from a rejected claim.
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.
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) 1-4, 6-8, 10, 12, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Hill, et al (Hill) (US 2006/0190074 A1) as discussed supra, and further in view of Mullick, et al (Mullick) (US 2011/0207893).
Regarding Claims 1 and 10, Hill teaches a prosthetic valve (e.g. abstract) that can take a first form wherein the valve is open and a second form wherein the valve is closed (e.g. [0018]),
the valve comprising a leaflet assembly (e.g. Figure 1B, below (as shown) ring #140) having at least one leaflet attached to a supporting element (portion #102 of leaflet assembly),
the leaflet having a free margin (e.g. [0018], leaflet edge at #120) that can move between a first position wherein the valve takes the first form and a second position wherein the valve takes the second form (e.g. [0018]),
wherein the prosthetic valve, or a portion thereof, has a surface (the valve inherently has a surface) comprising a base polymer (e.g. [0027], polycarbonate urethane); and
wherein the prosthetic valve exhibits reduced thrombogenecity (e.g. [0077]).
Hill discloses the invention substantially as claimed but fails to teach an oligofluorinated additive.
Mullick teaches claimed compound 39 (e.g. Figure 1k) used for heart valves (e.g. [0079]) of polycarbonate urethane (e.g. [0016]).
Hill is concerned with the same field of endeavor as the claimed invention, namely heart valves.
Mullick is reasonably pertinent to the Applicant’s invention. The claimed invention is directed to the problem of reducing thrombogenicity of the prosthetic valve, that is, to reduce the formation of blood clots on the prosthetic valve (e.g. Applicant’s Specification, page 6, line 25-26, “The invention features implantable prosthetic valves having a surface modified to reduce the risk of forming thrombi post implantation.”).
Mullick at [0076] discloses that “[t]he surface modifiers and admixtures of the invention can also be used in implantable medical devices (e.g central venous catheters to impart reduced occlusion properties, and increased blood compatibility).” Mullick at [0079] discloses that prostheses, such as artificial heart valves, may be formed from its admixtures. Mullick’s disclosure at [0076] that the surface modifiers and admixtures can “impart reduced occlusion properties” and “increased blood compatibility” is sufficient evidence that Mullick is reasonably pertinent to the same problem with which the claimed invention is involved.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hill such that the leaflets of polycarbonate urethane have the specific composition of polycarbonate urethane and additive of claimed compound claim 39 as taught by Mullick to “impart reduced occlusion properties” and/or “increased blood compatibility” to the prosthetic heart valve (e.g. Mullick, [0076]).
Regarding Claim 2, the prosthetic valve comprises the leaflet assembly comprising one or more leaflets attached to a stent (e.g. Hill, Figure 1B, two leaflets are shown).
Regarding Claim 3, each of the one or more leaflets have the surface comprising the base polymer and the oligofluorinated additive (e.g. Hill, [0027], matrix #122 is made of the base polymer and the oligofluorinated additive of claim 1 and [0022], #122 form the leaflets).
Regarding Claim 4, the valve is a bileaflet (e.g. Hill, Figure 1D).
Regarding Claim 6, the surface concentration of the oligofluorinated additive is 0.05% to 15% (w/w) (e.g. Mullick, [0072]).
Regarding Claim 7-8, the base polymer comprises a polyurethane or a polyolefin (e.g. Hill, [0027], polycarbonate ureathane).
Regarding Claim 12, the device is a valve within an expandable stent (e.g. Figures 1A-D).
Regarding Claim 17, the combination of Hill and Mullick teaches a prosthetic valve (e.g. Hill, abstract) that can take a first form wherein the valve is open and a second form wherein the valve is closed (e.g. Hill, [0018]),
the valve comprising a leaflet assembly (e.g. Hill, Figure 1B, below (as shown) ring #140) having at least one leaflet attached to a supporting element (Hill, portion #102 of leaflet assembly),
the leaflet having a free margin (e.g. Hill, [0018], leaflet edge at #120) that can move between a first position wherein the valve takes the first form and a second position wherein the valve takes the second form (e.g. Hill, [0018]),
wherein the prosthetic valve, or a portion thereof, has a surface (the valve inherently has a surface) comprising a base polymer (e.g. Hill, [0027], polycarbonate urethane) and an oligofluorinated additive (e.g. Mullick, Figure 1k, [0079], [0016]); wherein the prosthetic valve exhibits reduced thrombogenicity (e.g. Hill, [0077]); and
wherein the surface comprises from 0.05% (w/w) to 15% (w/w) of the oligofluorinated additive (e.g. Mullick, [0072]).
Regarding Claim 18, the combination of Hill and Mullick teaches a prosthetic valve (e.g. Hill, abstract) that can take a first form wherein the valve is open and a second form wherein the valve is closed (e.g. Hill, [0018]),
the valve comprising a leaflet assembly (e.g. Hill, Figure 1B, below (as shown) ring #140) having at least one leaflet attached to a supporting element (Hill, portion #102 of leaflet assembly),
the leaflet having a free margin (e.g. Hill, [0018], leaflet edge at #120) that can move between a first position wherein the valve takes the first form and a second position wherein the valve takes the second form (e.g. Hill, [0018]),
wherein the prosthetic valve, or a portion thereof, has a surface (the valve inherently has a surface) comprising a base polymer (e.g. Hill, [0027], polycarbonate urethane) and an oligofluorinated additive (e.g. Mullick, Figure 1k, [0079], [0016]);
wherein the prosthetic valve exhibits reduced thrombogenicity (e.g. Hill, [0077]); and
wherein the base polymer comprises a polyurethane or a polyolefin (e.g. Hill, [0027], polycarbonate ureathane).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Hill, et al (Hill) (US 2006/0190074 A1) as discussed supra, and further in view of Mullick, et al (Mullick) (US 2011/0207893) as discussed supra and further in view of Kobrin, et al (Kobrin) (US 2006/0251795 A1).
Regarding Claim 5, the combination of Hill and Mullick discloses the invention substantially as claimed but fails to teach the surface thickness is 1-100 microns.
Kobrin teaches a medical device surface of 1 micron thickness (e.g. [0109]) to form a layer usable as a mechanically structural or bonding layer (e.g. [0109]).
Hill are concerned with the same field of endeavor as the claimed invention as discussed supra for claim 1 and Mullick is reasonably pertinent to Applicant’s invention as discussed supra for claim 1.
Kobrin is concerned with the same field of endeavor as the claimed invention, namely surfaces for medical implants (e.g. heart valves) (e.g. Kobrin, [0068]).
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 combination of Hill and Mullick such that the surface thickness in 1 micron as taught by Kobrin in order to provide a surface that is usable as a mechanically structural or bonding layer (e.g. Kobrin, [0109]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on (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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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 8/9/2025