CTNF 18/140,998 CTNF 94617 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions and Status of Claims 08-25-01 AIA Applicant’s election without traverse of invention I, claims 1-12 and to species A corresponding to instant claim 7 in the reply filed on 5/1/26 is acknowledged. 08-06 AIA Claim s 8 and 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/1/26 . As such, claims 1-7 and 9-12 are examined in this office action as claim 8 is withdrawn and claims 13-19 are canceled in the reply dated 5/1/26 . Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-7 and 9-12 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 1 recites the limitation “manipulating the SMA to (i) promote R-phase formation following implantation in a subject, or (ii) cause the R-phase and austenite phase to converge” in the last two lines of the claim. It is not clear what is meant by the term “manipulating”. It is not clear if this encompasses merely physical manipulation of the SMA, whether “manipulating” encompasses any sort of treatment of the SMA, or some other meaning. It is not clear what step must be taken such that R-phase formation is promoted following implantation in a subject, or causing the R-phase and austenite phase to converge. Claims 2 and 9-12 are also rejected as they depend from claim 1 and do not solve the above issue. Claim 1 recites the limitation “cause the R-phase and austenite phase to converge” in the last line of the claim. It is not clear what is meant by causing the two phases to “converge”. It not clear if this means that the phases are physically moving closer to one another, whether R-phase is transitioning into austenite phase, whether this refers to the endotherm peaks via differential scanning calorimetry, whether this refers to the convergence of other properties of these phases, or some other meaning. Claims 2-7 and 9-12 are also rejected as they depend from claim 1 and do not solve the above issue. Claim 2 recites the limitation “decrease in modulus” in the last line of the claim. It is not clear what is meant by “modulus”. It is not clear if this is a requirement to measure something and if so it is not clear what it is a measurement of. It is not clear if this intends to refer to bulk modulus, elastic modulus, shear modulus, Young’s modulus, or some other meaning. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-7 and 10-11 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by “The Effects of Applied Strain and Heat Treatment on the Properties of NiTi Wire During Shape Setting” (as cited on IDS dated 4/28/23) of Zapoticla . As to claims 1, 3-7 and 10-11 , it is not clear what is meant by “manipulating” nor by R-phase and austenite phase converging, see 112(b) rejection above. For the purposes of applying prior art, these will be interpreted as requiring a heat treatment as this is disclosed in the dependent claims that causes the endotherm peaks via differential scanning calorimetry of the R-phase and austenite phase to approach an overlapping state. Zapoticla discloses heat treating a Ti-50.8 at.% Ni wire with a diameter of 0.02 inches (0.495 mm) (Zapoticla, pg. 26, section 4.1), meeting the limitation of an element comprising a shape memory alloy as equiatomic Ti-Ni alloy Nitinol is a shape memory alloy and as this is a wire, it can be a structural element of an implantable medical device under displacement-controlled fatigue conditions, meeting the claim limitations. This also meets the claim 10 limitations where the SMA comprises Ni and Ti as well as the claim 11 limitation where these are substantially equiatomic as 50.8 at% Ni means the Ti is 49.2 at% and these values are substantially equal. Zapoticla discloses where heat treatment was performed at 450 and 550°C with 0% applied strain for 2, 5, 10, and 30 minutes (Zapoticla, pg. 32, Table II), meeting the claim 1 limitation of “manipulating” the SMA, the claim 3 limitation of heat treating the SMA, the claims 4-6 limitations of heating the SMA at 450°C or greater, 500°C or greater, and in a range from 450°C to 550°C, and the claim 7 limitation of heat treating without stress/strain turning of the SMA. However, Zapoticla does not explicitly disclose (i) promote R-phase formation following implantation in a subject, or (ii) cause the R-phase and austenite phase to converge. Nevertheless, Zapoticla discloses the same starting material of a Ti-50.8 at.% Ni wire and applies an identical method of at 450 and 550°C with 0% applied strain for 2, 5, and 10 minutes, the same method applied to the same materials would produce the same properties of R-phase formation following implantation in a subject, and (ii) cause the R-phase and austenite phase to converge. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes , a prima facie case of either anticipation or obviousness has been established.” In re Best , 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (emphasis added), see MPEP § 2112.01(I) . As to claim 2 , it is not clear what is meant by “modulus”, see 112(b) rejection of claim 2 above. For the purposes of applying prior art, this will be interpreted as elastic modulus as this is recited as being a manipulated modulus in paragraph [0014] of the specification. Zapoticla discloses where heat treatment at 450, 500, and 550°C for 5 and 10 minutes decreases the elastic modulus of the Ti-Ni wire (Zapoticla, pg. 78, Figure 63) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over “The Effects of Applied Strain and Heat Treatment on the Properties of NiTi Wire During Shape Setting” (as cited on IDS dated 4/28/23) of Zapoticla . As to claim 9 , Zapoticla discloses a Ti-50.8 at.% Ni wire with a diameter of 0.02 inches (0.495 mm) (Zapoticla, pg. 26, section 4.1). However, Zapoticla does not explicitly disclose where the structural element is formed to have a length-to-depth ratio of 8:1 or less. However, this is nothing more than a difference in the size of the structural element and it is obvious to form structural elements in different shapes in sizes as appropriate for the medical device. Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to selected a length-to-depth ratio of 8:1 or less to thereby create an appropriate medical device. The MPEP notes that in Gardner v. TEC Syst., Inc. , 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (emphasis added), see MPEP § 2144.04(IV)) . 07-21-aia AIA Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0217385 A1 of Thompson in view of “The Effects of Applied Strain and Heat Treatment on the Properties of NiTi Wire During Shape Setting” (as cited on IDS dated 4/28/23) of Zapoticla As to claim 12 , Thompson discloses artificial valves for use as a venous valve or a heart valve (Thompson, abstract), meeting the limitation of a heart valve and its associated frame. Thompson discloses a one-way valve with a frame made of a shape memory material such as Nitinol wire (Thompson, paragraph [0041]-[0042] and Fig. 7). However, Thompson does not disclose a shape memory alloy of claim 1. Zapoticla teaches heat treating a Ti-50.8 at.% Ni wire with a diameter of 0.02 inches (0.495 mm) (Zapoticla, pg. 26, section 4.1) and heat treating at 450 and 550°C with 0% applied strain for 2, 5, 10, and 30 minutes (Zapoticla, pg. 32, Table II). Thus, as noted in claim 1 rejection above, Zapoticla discloses where R-phase formation following implantation in a subject, and (ii) cause the R-phase and austenite phase to converge. Zapoticla teaches that heat treatment with no applied strain results in higher ultimate tensile strength (Zapoticla, pg. 70, Fig. 54). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the heat treated Ti-50.8 at.% Ni wire taught by Zapoticla into the one way valve disclosed by Thompson, thereby increasing the ultimate tensile strength of the frame of the valve frame (Zapoticla, pg. 70, Fig. 54). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joshua S Carpenter whose telephone number is (571)272-2724. The examiner can normally be reached Monday - Friday 8:00 am - 5:30 pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Hendricks can be reached at (571) 272-1401. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOSHUA S CARPENTER/Examiner, Art Unit 1733 /JOPHY S. KOSHY/Primary Examiner, Art Unit 1733 Application/Control Number: 18/140,998 Page 2 Art Unit: 1733 Application/Control Number: 18/140,998 Page 3 Art Unit: 1733 Application/Control Number: 18/140,998 Page 4 Art Unit: 1733 Application/Control Number: 18/140,998 Page 5 Art Unit: 1733 Application/Control Number: 18/140,998 Page 6 Art Unit: 1733 Application/Control Number: 18/140,998 Page 7 Art Unit: 1733 Application/Control Number: 18/140,998 Page 8 Art Unit: 1733 Application/Control Number: 18/140,998 Page 9 Art Unit: 1733
Prosecution Insights