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 .
Information Disclosure Statement
The information disclosure statement filed 08/26/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Foreign Document No. 1 (EP 2379322B1) has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the plurality of openings, of composite material, being formed sporadically throughout the metal substrate (claim 9), the leaflet(s), of the prosthetic heart valve, having a greater number of openings formed in areas of the metal substrate in which greater flexibility is desired (claim 11), and the leaflet(s), of the prosthetic heart valve, having a lesser number of openings formed in areas of the metal substrate in which greater strength and less flexibility is desired (claim 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 9 is 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 9 recites the term “sporadically”, on line 2; this term is a relative term which renders the claim indefinite. The term “sporadically” is not defined in the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102
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 1-10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sogard et al. (US PG Pub. 2009/0117334), hereinafter Sogard.
Regarding claims 1 and 2, Sogard discloses a prosthetic heart valve (1076) comprising a support structure (1078); and a valve assembly, including a plurality of leaflets (1060), disposed within the support structure (1078), illustrated in Figure 10 ([0097], Lines 1-3 & [0100]), wherein each leaflet (1060) is formed from a composite material (1000/100), the composite material (100) including a metal substrate (102) in the form of a perforated sheet having a plurality of openings (114), and a polymer (104) coated on the metal substrate, illustrated in Figure 1, wherein the perforated sheet includes perforations/openings (114) formed by laser cutting and/or etching ([0003]; [0019]; [0035], Lines 1-6; [0037] & [0101], Lines 5-6).
Regarding claim 3, Sogard discloses the prosthetic heart valve according to claim 1, wherein the perforated sheet (made up of members 106), of the metal substrate (102), has a thickness of between about 50 µm and about 500 µm ([0049], Lines 1-6 – to clarify, the arcuate members 106 make up the perforated sheet/metal substrate 102, and therefore, the thickness of the arcuate members 106 would be the thickness of the perforated sheet).
Regarding claim 4, Sogard discloses the prosthetic heart valve according to claim 1, wherein the perforated sheet (made up of members 106), of the metal substrate (102), is a foil having a thickness of about 25 µm ([0049], Lines 8-10 – to clarify, though it is not specifically disclosed the perforated sheet is a foil, it is stated that the perforated sheet can have a thickness of 25 µm or less, which would put it in the category of foil; as disclosed in paragraph [0044] of the originally filed specification of the current application at hand, which states “A metal foil is thinner than a metal sheet” and that a “foil may have a thickness of about 25 µm”).
Regarding claim 5, Sogard discloses the prosthetic heart valve according to claim 1, wherein the perforated sheet (102) comprises nitinol ([0052]).
Regarding claim 6, Sogard discloses the prosthetic heart valve according to claim 1, wherein the perforated sheet (102) includes multiple perforated sheets layered on one another ([0027], Lines 1-5).
Regarding claims 7 and 15, Sogard discloses the prosthetic heart valve according to claim 1, wherein the polymer (104) is selected from the group consisting of polytetrafluoroethylene, polyurethane, polyester, polyimides or combinations thereof ([0060], Lines 1-2 & [0061]).
Regarding claim 8, Sogard discloses the prosthetic heart valve according to claim 1, wherein the polymer (104) is coated on the metal substrate (102) in a plurality of layers ([0057]; [0064] & [0151]).
Regarding claim 9, Sogard discloses the prosthetic heart valve according to claim 1, wherein the plurality of openings (114) are formed sporadically throughout the metal substrate, illustrated in Figure 1.
Regarding claim 10, Sogard discloses the prosthetic heart valve according to claim 1, wherein the plurality of openings (114) are formed in a predetermined pattern (116) in the metal substrate (102), illustrated in Figures 1-8 ([0028]; [0037] & [0038]).
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.
Claims 11-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sogard.
Regarding claims 11 and 12, Sogard discloses the prosthetic heart valve according to claim 1, wherein different parameters of the perforated sheet/metal substrate (102) can be modified to adjust its characteristics, i.e. compliance, stiffness, flexibility, including having different fenestration patterns at different regions of the perforated sheet in order to provide a different characteristic at each region ([0047] & [0094]). Thus, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to adjust the fenestration pattern, of the metal substrate, by increasing and/or decreasing the number of openings/apertures at desired areas of the metal substrate, in order to adjust the compliance/stiffness/flexibility at said desired area.
Regarding claims 13 and 14, Sogard discloses the prosthetic heart valve according to claim 1, and though it is not specifically disclosed the composite material has a thickness of between about 30 µm and about 800 µm, more specifically between about 50 µm and about 600 µm, these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate thickness for the composite material, including between about 50 µm and about 600 µm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). Furthermore, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the thickness of the composite material being between about 30 µm and about 800 µm, more specifically between about 50 µm and about 600 µm, as opposed to being any other value/range.
Regarding claim 16, Sogard discloses the prosthetic heart valve according to claim 1, wherein the polymer (104) is coated in multiple layers on the metal substrate (102) ([0057]; [0064] & [0151]); and though it is not specifically disclosed that each layer comprises a different polymer, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate material(s) for the layers of the composite material, including having each layer of polymer coating comprise a different polymer, in order to tailor the characteristics/behaviors of the composite material, as taught by Sogard ([0054], Lines 1-2); and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of each of the multiple layers of polymer being different polymer, as opposed to the same.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7, 8, 15 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 8 of U.S. Patent No. 11,883,280. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a prosthetic heart valve comprising a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets, wherein each leaflet is formed from a composite material, the composite material including a metal substrate in the form of a perforated sheet having a plurality of openings, and a polymer coated on the metal substrate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 10/14/2026
