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 .
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive.
Claim Interpretation
Applicant argues the interpretation of “consisting essentially of” as “comprising” in the previous rejection. Applicant explains that Example 1 in the specification supports the use of the transitional phrase “consisting essentially of” because a medical device was coated using a 0.7% solution of poly(vinylidene fluoride-co-hexafluoropropylene) in 90/10 acetone which resulted in a lower clot weight over time than uncoated devices and that this demonstrates the basic and novel characteristics of the claimed invention. Applicant further explains that in a case where reasonably small amounts of solvents and/or other materials present while coating may still be present after the coating process, such material would not materially affect the basic and novel characteristics of the claimed invention like in example 3.
The examiner respectfully disagrees. Examples 1 and 2 discuss the use of a coating formed by a 0.7% solution of poly(vinylidene fluoride-co-hexafluoropropylene) in 90/10 acetone resulting which resulted in a lower clot weight over time. However, applicant does not include a discussion of what would materially alter the basic and novel properties of the poly(vinylidene fluoride-co-hexafluoropropylene) material (see MPEP 2111.03 example - Applicant’s statement in the specification that "silicon contents in the coating metal should not exceed about 0.5% by weight" along with a discussion of the deleterious effects of silicon provided basis to conclude that silicon in excess of 0.5% by weight would materially alter the basic and novel properties of the invention. Thus, "consisting essentially of" as recited in the preamble was interpreted to permit no more than 0.5% by weight of silicon in the aluminum coating.); In re Janakirama-Rao, 317 F.2d 951, 954, 137 USPQ 893, 895-96 (CCPA 1963)). Example 3 discusses the use of either a coating formed from a 0.7% solution of poly(vinylidene fluoride-co-hexafluoropropylene) or a 1% poly[bis (trifluoroethoxy)phosphazene] solution which was dried without the use of acetone and also resulted in the lower clot weights over time for coated meshes when compared with uncoated control meshes (para. 0073). In light of the examples, the interpretation of “comprising” is appropriate because the specification does not clearly discuss what would materially alter the basic and novel properties of the poly(vinylidene fluoride-co-hexafluoropropylene) material i.e., what constitutes as reasonably small amounts other materials still present in the coating.
Even if "consisting essentially of” was interpreted as limiting the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention”, the teaching reference of record (Gale) would still read on the limitation. Gale teaches an anti-thrombogenic coating consisting essentially of poly(vinylidene fluoride- co-hexafluoropropylene) and a drug (para. 0012, 0016, 0020, 0026). MPEP 2111.03 states “Prior art hydraulic fluid required a dispersant which appellants argued was excluded from claims limited to a functional fluid "consisting essentially of" certain components. In finding the claims did not exclude the prior art dispersant, the court noted that appellants’ specification indicated the claimed composition can contain any well-known additive such as a dispersant, and there was no evidence that the presence of a dispersant would materially affect the basic and novel characteristic of the claimed invention. The prior art composition had the same basic and novel characteristic (increased oxidation resistance) as well as additional enhanced detergent and dispersant characteristics. In light of this interpretation, the drug used in Gale does not materially affect the basic and novel characteristics of the poly(vinylidene fluoride-co-hexafluoropropylene) coating and the rejection would still be maintained.
103 Rejection
Applicant’s argues that none of the cited art references appear to teach or suggest the anti-thrombogenic coating as claimed.
The examiner respectfully disagrees. Gale teaches an anti-thrombogenic coating consisting essentially of poly(vinylidene fluoride- co-hexafluoropropylene) (para. 0012, 0016, 0020, 0026) as stated in the response above. Therefore, the 103 rejections of claims 1, 14, and 20 are maintained.
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.
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) 1-5, 8, 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al. (US 20180310925) [hereinafter Inouye] in view of Phan et al. (US 5192286) [hereinafter Phan], Turkington et al. (US 20170027552) [hereinafter Turkington] and Gale (US 20070299511).
Regarding claim 1, Inouye discloses an occlusive medical device 100 (Fig. 3, para. 0074), comprising:
an expandable frame 110 configured to shift between a first configuration (Fig. 1) and an expanded configuration (Fig. 2, para. 0051); and
an occlusive fabric 120 disposed along at least a portion of the expandable frame 110 (Fig. 3, para. 0051, 0053).
Inouye further discloses wherein the occlusive fabric 120 may be mesh or filter-like material that is permeable to blood and other fluids (para. 0062).
However, Inouye fails to disclose that the occlusive fabric includes a plurality of filaments.
Phan teaches a permeable occlusive fabric 26 of mesh or filter-like material (Fig. 1, col. 4 lines 14-18), wherein the fabric includes a plurality of filaments (col. 4 lines 14-18 and lines 31-33 discloses that “individual fibers or bundles of fibers (yarns) may be woven into the fabric by conventional techniques, such as weaving, braiding, knitting, and the like”).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Phan to the occlusive fabric of Inouye would have yielded predicable results, namely, fabric comprising a plurality of filaments woven together to form a filter-like material that would allow fluid to pass therethrough (col. 4 lines 14-18 and lines 31-33 of Phan). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
Inouye further discloses that the fabric may include anti-thrombogenic agents (para. 0078 of Inouye). However, Inouye in view of Phan fails to disclose an anti-thrombogenic coating incorporated within the fabric.
Turkington in the same field of endeavor teaches a left atrial appendage implant comprising an occlusive fabric (interpreted as polymeric membrane of cup-shaped occluder 210) and an anti-thrombogenic coating incorporated within the fabric (Fig. 8, para. 0073 teaches that the anti-thrombogenic coating may be disposed thereon and embedded therein).
The substitution of one known coating configuration (anti-thrombogenic coating disposed on and embedded within the occlusive fabric, as taught in Turkington) for another (anti-thrombogenic coating included in the occlusive fabric of Modified Inouye) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution for the coating configuration of Turkington would have yielded predictable results, namely, an alternative way of providing the medical device with anti-thrombogenic characteristics (para. 0073 of Turkington). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
However, modified Inouye fails to disclose wherein the anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene).
Gale in the same field of endeavor of occlusive devices 10 (Fig. 1, para. 0010) teaches that it is known in the art to coat devises with anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene) (para. 0012, 0016, 0020, 0026).
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 anti-thrombogenic coating in modified Inouye to include the anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene) of Gale since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07)
Regarding claim 14, Inouye discloses a left atrial appendage device 100 (Fig. 3, para. 0052, 0074), comprising:
an expandable frame 110 configured to shift between a first configuration (Fig. 1) and an expanded configuration (Fig. 2, para. 0051); and
an occlusive fabric 120 disposed along at least a portion of the expandable frame 110 (Fig. 3, para. 0051, 0053).
Inouye further discloses wherein the occlusive fabric 120 may be mesh or filter-like material that is permeable to blood and other fluids (para. 0062).
However, Inouye fails to discloses that the occlusive fabric includes a fiber bundle.
Phan teaches a permeable fabric 26 of mesh or filter-like material (Fig. 1, col. 4 lines 14-18), wherein the fabric includes a fiber bundle (col. 4 lines 14-18 and lines 31-33 discloses that “individual fibers or bundles of fibers (yarns) may be woven into the fabric by conventional techniques, such as weaving, braiding, knitting, and the like”).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Phan to the occlusive fabric of Inouye would have yielded predicable results, namely, fabric comprising fiber bundles woven together to form a filter-like material that would allow fluid to pass therethrough (col. 4 lines 14-18 and lines 31-33 of Phan). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
Inouye further discloses that the occlusive fabric may include anti-thrombogenic agents (para. 0078 of Inouye). However, Inouye in view of Phan fails to disclose an anti-thrombogenic coating incorporated within the fiber bundle.
Turkington in the same field of endeavor teaches a left atrial appendage implant comprising an occlusive fabric (interpreted as polymeric membrane of cup-shaped occluder 210) and an anti-thrombogenic coating incorporated within the fabric (Fig. 8, para. 0073 teaches that the anti-thrombogenic coating may be disposed thereon and embedded therein).
The substitution of one known coating configuration (anti-thrombogenic coating disposed on and embedded within the fiber bundle, as taught in Turkington) for another (anti-thrombogenic coating included in the occlusive fabric of Modified Inouye) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution for the coating configuration of Turkington would have yielded predictable results, namely, an alternative way of providing the medical device with anti-thrombogenic characteristics (para. 0073 of Turkington). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
However, modified Inouye fails to disclose wherein the anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene).
Gale in the same field of endeavor of occlusive devices 10 (Fig. 1, para. 0010) teaches that it is known in the art to coat devises with anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene) (para. 0012, 0016, 0020, 0026).
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 anti-thrombogenic coating in modified Inouye to include the anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene) of Gale since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07)
Regarding claim 2, Modified Inouye discloses wherein the plurality of filaments are arranged into a fiber bundle (col. 4 lines 14-18 and lines 31-33 of Phan).
Regarding claims 3 and 15, Modified Inouye disclose wherein the anti-thrombogenic coating is disposed along an interior region of the fiber bundle (para. 0073 of Turkington discloses that the anti-thrombogenic coating is embedded into the fabric and thereby disposed along an interior region of the fiber bundle which forms the fabric).
Regarding claims 4 and 16, Modified Inouye discloses wherein the plurality of filaments include polyethylene terephthalate (para. 0076 of Inouye).
Regarding claim 5, Modified Inouye discloses wherein the plurality of filaments include polyester (para. 0076 of Inouye).
Regarding claim 8, Modified Inouye discloses wherein the plurality of filaments are arranged in a non-woven configuration (col. 4 lines 19-20 of Phan discloses that the permeable fabric 26 of mesh or filter-like material may be formed of a non-woven fabric).
Claim(s) 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al. (US 20180310925) [hereinafter Inouye] in view of Phan et al. (US 5192286) [hereinafter Phan], Turkington et al. (US 20170027552) [hereinafter Turkington], and Gale (US 20070299511) as applied to claim 1 above, and further in view of Nielsen (US 20160256168).
Regarding claims 6 and 7, Modified Inouye discloses all of the limitations set forth above in claim 1. However, Modified Inouye fails to disclose wherein the anti-thrombogenic coating encapsulates at least some of the plurality of filaments/individually coats each of the plurality of filaments.
Nielsen in the same field of endeavor teaches a medical implant 1 (Fig. 1, para. 0060), comprising a plurality of filaments (interpreted as strands 1000; Figs. 1-2a, para. 0060) and a coating 1004 (Fig. 2b, para. 0060), wherein the coating 1004 individually coats, and thereby encapsulates, each of the plurality of filaments 1000 (see Figs. 2b, 3b-3c which illustrates the strands 100 being individually coated with and thereby individually encapsulated by coating 1004, para. 0060, 0068).
The substitution of one known coating configuration (individually coating/encapsulating the plurality of filaments with anti-thrombogenic coating, as taught in Nielsen) for another (anti-thrombogenic coating disposed on the plurality of filaments of Modified Inouye) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution for the coating configuration of Nielsen would have yielded predictable results, namely, an alternative way of coating the plurality of filaments such that the coating individually surrounds the plurality of filaments instead of being disposed on a surface of the plurality of filaments (para. 0060, 0068 of Nielsen). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
Claim(s) 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al. (US 20180310925) [hereinafter Inouye] in view of Phan et al. (US 5192286) [hereinafter Phan], Nielsen (US 20160256168), and Gale (US 20070299511).
Regarding claim 19, Inouye discloses a left atrial appendage device 100 (Fig. 3, para. 0052, 0074), comprising:
an expandable frame 110 configured to shift between a first configuration (Fig. 1) and an expanded configuration (Fig. 2, para. 0051); and
an occlusive member 120 disposed along at least a portion of the expandable frame 110 (Fig. 3, para. 0051, 0053).
Inouye further discloses wherein the occlusive member 120 may be mesh or filter-like material that is permeable to blood and other fluids (para. 0062).
However, Inouye fails to discloses that the occlusive member includes a fiber bundle that includes one or more filaments.
Phan teaches a permeable occlusive member 26 of mesh or filter-like material (Fig. 1, col. 4 lines 14-18), wherein the occlusive member includes a fiber bundle that includes one or more filaments (col. 4 lines 14-18 and lines 31-33 discloses that “individual fibers or bundles of fibers (yarns) may be woven into the fabric by conventional techniques, such as weaving, braiding, knitting, and the like”).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Phan to the occlusive member of Inouye would have yielded predicable results, namely, an occlusive member comprising fiber bundles including one or more filaments woven together to form a filter-like material that would allow fluid to pass therethrough (col. 4 lines 14-18 and lines 31-33). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007))
Inouye further discloses that the occlusive member may include anti-thrombogenic agents (para. 0078). However, Inouye in view of Phan fails to disclose an anti-thrombogenic coating disposed on the occlusive member and encapsulating at least some of the one or more filaments.
Nielsen in the same field of endeavor teaches a medical implant 1 (Fig. 1, para. 0060), comprising a plurality of filaments (interpreted as strands 1000; Figs. 1-2a, para. 0060) and a coating 1004 (Fig. 2b, para. 0060), wherein the coating 1004 encapsulates each of the plurality of filaments 1000 (see Figs. 2b, 3b-3c which illustrates the strands 100 being individually coated with and thereby individually encapsulated by coating 1004, para. 0060, 0068).
The substitution of one known coating configuration (encapsulate the one or more filaments with anti-thrombogenic coating, as taught in Nielsen) for another (anti-thrombogenic coating disposed on the one or more filaments of Modified Inouye) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution for the coating configuration of Nielsen would have yielded predictable results, namely, an alternative way of coating the plurality of filaments such that the coating individually surrounds the plurality of filaments instead of being disposed on a surface of the plurality of filaments (para. 0060, 0068 of Nielsen). (KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
However, modified Inouye fails to disclose wherein the anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene).
Gale in the same field of endeavor of occlusive devices 10 (Fig. 1, para. 0010) teaches that it is known in the art to coat devises with anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene) (para. 0012, 0016, 0020, 0026).
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 anti-thrombogenic coating in modified Inouye to include the anti-thrombogenic coating consists essentially of poly(vinylidene fluoride- co-hexafluoropropylene) of Gale since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07)
Regarding claim 20, Modified Inouye discloses wherein the anti-thrombogenic coating encapsulates all of the one or more filaments (para. 0060, 0068 of Nielsen).
Conclusion
THIS ACTION IS MADE FINAL. 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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771