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 .
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 2-8 and 17 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.
Regarding claim 2, the claim recites “wherein said valve is comprises of a composite of a first material and a second material” (emphasis added by Examiner). Claim 1, from which claim 2 depends, previously recites “a first material”. It is unclear whether the “first material” of claim 2 refers to the same material previously introduced in claim 1 or to a different and separate material, therefore rendering the claim indefinite. For examination purposes, it will presume to refer to the same material. Claims 3-8 are indefinite by virtue of their dependency on indefinite base claim 2.
Regarding claim 17, the claim recites “comprises Neodymium coated with a biocompatible polymer, silicon nitride, silicon carbide, titanium nitride, or pyrolytic carbon”. It is unclear whether the claim intends to recite a) that a first alternative in the list of alternatives of the magnets can comprise Neodymium coated with a biocompatible polymer (and the second alternative is silicon nitride, etc.), or b) that the claim requires Neodymium to be coated with a list of materials, the list starting with a biocompatible polymer and then the next alternative is silicon nitride, etc. For examination purposes, it will presume to be the first option.
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.
Claim(s) 1, 9-10, 12, 14, 16, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,108,425 to Hwang (hereinafter “Hwang”) (cited in an IDS dated 01/22/2024).
Regarding claim 1, Hwang discloses (see abstract; Figs. 1-14; and Col. 3, line 64 - Col. 8, line 16) a valve device (10, Fig. 1) comprising: two or more leaflets (14) each comprising: at least a first material which reduces electrostatic forces between blood and device components, reduces adhesion between blood and device components or a combination thereof (see Col. 10, lines 9-14); and a valve constraining ring (12), comprising: at least a first material which reduces electrostatic forces between blood and device components, reduces adhesion between blood and device components or a combination thereof (see Col. 10, lines 9-14); and internally located attachment regions (24) for said two or more leaflets (see Figs. 1-3 and Col. 3, lines 15-51); and one or more extending projections (80), which reduce turbulent flow through the device (see Col. 7, lines 23-58) which are located on the leaflets of the valve device (see Figs. 5 & 8-10).
Hwang further discloses (claim 9) wherein said two or more leaflets, said valve constraining ring, or a combination thereof is comprised of an at least semi-flexible material (see Col. 8, lines 44-50); (claim 10) wherein said two or more leaflets, said valve constraining ring, or a combination thereof is comprised of at least a first region that is flexible and a second region that is more rigid than said first region (see Col. 8, lines 44-55); (claim 12) wherein said two or more leaflets, said valve constraining ring, or a combination thereof is comprised of a metal, a polymeric material, or a combination or composite thereof (see Col. 10, lines 9-11); (claim 14) wherein said two or more leaflets, said valve constraining ring, or a combination thereof is comprised of pyrolytic carbon (PyC) (see Col. 10, lines 9-11); (claim 16) wherein said two or more leaflets, said valve constraining ring, or a combination thereof further comprises a coating (see Col. 10, line 9-10); (claim 22) a method of performing cardiac valve repair or replacement surgery on a patient comprising the steps of applying the valve device of claim 1 to replace a defective or malfunctioning valve in a subject (see Col. 2, line 64 - Col. 3, line 14).
Claim(s) 1 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6,638,303 to Campbell (hereinafter “Campbell”) (cited in an IDS dated 01/22/2024).
Regarding claim 1, Campbell discloses (see abstract; Figs. 1-22; Col. 3, lines 26-35; and Col. 7, line 49 - Col. 13, line 40) a valve device (10), comprising: two or more leaflets (14/16) each comprising: at least a first material (pyrocarbon) which reduces electrostatic forces between blood and device components, reduces adhesion between blood and device components or a combination thereof (see Col. 7, lines 53-54 and Col. 3, lines 36-49); and optionally at least a first magnet (11a) incorporated within at least one of said leaflets (see Col. 8, lines 37-60 and Figs. 2-3); and a valve constraining ring (20), comprising: at least a first material ("ceramic") which reduces electrostatic forces between blood and device components, reduces adhesion between blood and device components or a combination thereof (see Col. 12, lines 21-24); and internally located attachment regions (26) for said two or more leaflets (see Col. 9, lines 3-17 and Figs. 1-3); and optionally at least a second magnet (11b) (see Col. 8, lines 46-53 and Figs. 4-6) of matched polarity to said first magnet, incorporated within the valve constraining ring at regions proximal to said first magnet within said leaflet such that repulsive forces are present when said first magnet and said second magnet are brought into proximity with each other in the absence of flow (see Col. 9, line 19 - Col. 10, line 42); and one or more extending projections (ear 28, see Col. 9, lines 4-6 and Figs. 1/3, the ears define the pivots), which reduce turbulent flow through the device (see Col. 3, lines 26-35), or proximally thereto, which are located on the leaflets of the valve device (see Figs. 1/3).
Campbell further discloses (claim 17) wherein said first magnet, said second magnet or a combination thereof comprises pyrolytic carbon (PyC) (see Col. 13, lines 33-39); (claim 18) further comprising at least a third magnet incorporated within said leaflet structure, which third magnet is weaker in terms of its strength and opposite in terms of its polarity as compared to said first magnet (see Figs. 10-11 and Col. 10, lines 21-42); (claim 19) wherein said third magnet is incorporated within the same leaflet as said first magnet (see Figs. 10-11 and Col. 10, lines 21-42); and (claim 20) wherein said third magnet is incorporated within a different leaflet as said first magnet (see Fig. 2)
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.
Claim(s) 2-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of US 5,477,864 to Davidson (hereinafter “Davidson”).
Regarding claims 2-8, Hwang does not specifically disclose wherein said valve is comprised of a composite of a first material and a second material; wherein said first material and said second material are located on the same surface exposed regions of said two or more leaflets, said valve constraining ring, or a combination thereof, whereby said first material is a more apically located layer and said second material is a more basally located layer; wherein said first material and said second material are located on the same surface exposed regions of said two or more leaflets, said valve constraining ring, or a combination thereof, whereby said first material is a more basally located layer and said second material is a more apically located layer; wherein said first material and said second material are located on different surface exposed regions of said two or more leaflets, said valve constraining ring, or a combination thereof; wherein said two or more leaflets comprise said first material on a first surface of the leaflet and said second material on an opposing surface of the leaflet; wherein said two or more leaflets comprise said first material on a first surface of said leaflet and a second of said two or more leaflets comprise said second material on a first surface of said leaflet and wherein a first of said two or more leaflets comprise said second material on a second surface of said leaflet and a second of said two or more leaflets comprise said first material on a second surface of said leaflet. Essentially, claims 2-8 have to do with the composition, orientation, and arrangement of the first material versus the second material on the valve device.
Davidson discloses (see abstract; Fig. 4; and Col. 5, line 57 - Col. 8, line 37), in the same field of endeavor, a heart valve comprising a first material (base material of valve) and a second material (zirconia coating, see Col. 6, lines 34-50), wherein the coating is applied to certain surfaces of the heart valve such as areas subjected to conditions of wear (for example, mating parts) for the purpose of providing a low-thrombus, blood-compatible surface favorable in reducing the incidence of blood clots (see Col. 4, lines 34-37). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hwang with the coating taught by Davidson applied at various parts of the valve subject to conditions for wear for the purpose of providing a low-thrombus, blood-compatible surface favorable in reducing the incidence of blood clots. In making the proposed combination, it would have further been obvious to one having ordinary skill, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398,82 USPQ2d 1385,1395- 97(2007)), to obtain the predictable result of a heart valve having the appropriate locations treated with the coating as necessary (the locations as specified in claims 3-8) to arrive at the optimal coating application to the various portions of the heart valve which should be coated to achieve the benefits discussed above.
Claim(s) 11, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang.
Regarding claims 11, 13, and 15, Hwang discloses the claimed invention but fails to specifically disclose wherein the first material is ceramic or comprises a ceramic layer, wherein the leaflets and/or ring comprise nitinol, stainless steel, PTFE, polyester, silicon or a combination or composite thereof, or Zirconia toughened alumina (ZTA), boron carbide, nanocrystalline zirconium oxide or combinations thereof. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the valve components out of the listed materials, since 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 as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Further, these materials are known in the art of mechanical heart valves as being suitable for use (ceramic: US 2003/0083741 A1 to Woo at [0013]/[0019]; nitinol: Woo at [0045]; boron carbide: US 2003/0114925 to Molina at [0026]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of US 2012/0323317 A1 to Karapetian et al. (hereinafter “Karapetian”).
Hwang discloses the invention substantially as claimed as discussed above, however, with respect to claim 21, Hwang fails to specifically disclose at least one externally located ratcheting locking mechanism is constructed such that advancement of a suture-like structure therethrough is uni-directional and regulated. Karapetian discloses (see abstract; Figs. 23-26; and [0096]-[0102]), in the same field of endeavor, a prosthetic heart valve (82) comprising at least one externally located ratcheting locking mechanism (at 88, see Fig. 23 and [0097]) is constructed such that advancement of a suture-like structure (90) therethrough is uni-directional and regulated (see Figs. 23-26 and [0097]/[0101]) for the purpose of providing a lower ring to clamp a heart valve annulus between the valve and the lower ring to secure the device in place while resisting separation of the devices (see [0097]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hwang's device with the ratcheting mechanism taught by Karapetian in order to provide a lower ring to clamp a heart valve annulus between the valve and the lower ring to secure the device in place while resisting separation of the devices.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892 notice of references cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771