CTNF 18/505,714 CTNF 88684 DETAILED ACTION 12-151 AIA 26-51 12-51 Status of Claims Claims 1-20 are pending. 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. 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 Claim 17 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. 07-34-10 Regarding claim 17, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). 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 (s) 1-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webler et al. (US 2014/0277392) in view of Andreacchi (US 7,357,854) . Regarding claim 1, Webler discloses a process for electropolishing alloys of a metallic stent including cobalt, chromium, tungsten and platinum (title, abstract, [0006], [0051]) comprising (= a process for electrochemical mass removal and/or electropolishing a metallic body formed from a cobalt-chromium-tungsten-platinum alloy), the process comprising: Positioning the metallic body in an electropolishing electrolyte solution [0009] (= positioning the metallic body in an electrolyte solution in an electropolishing cell), Wherein the electrolyte solution comprises sulfuric acid, hydrochloric acid and phosphoric acid [0009] (= wherein the electrolyte solution includes each of H 2 SO 4 , HCl, and H 3 PO 4 ) including 3-10 parts sulfuric acid, 3-10 hydrochloric acid, 5-15 phosphoric acid [0068]; and Wherein the electrolyte further comprises ethylene glycol [0010] (= wherein the electropolishing electrolyte further comprises ethylene glycol); Electrochemically removing mass and/or electropolishing the metallic stent in the electrolyte solution with an alternating current having a ratio of about 1:1 to about 3:1 [0093] which overlaps the claimed range therefore a prima facie case of obviousness exists (= electrochemically removing mass and/or electropolishing the metallic body in the electrolyte solution in the electropolishing cell, wherein the electrochemical mass removal and/or electropolishing includes an alternating current with a forward:reverse current ratio of at least 3:1). Regarding the claimed volumetric ratio of the sulfuric acid, hydrochloric acid and phosphoric acid, Webler discloses 3-10 parts sulfuric acid, 3-10 hydrochloric acid, 5-15 phosphoric acid [0068]. Webler further discloses a range of compounds (in that order) of 3:3:5 to about 2:2:3 which does not overlap the claimed range. To further address the claimed ratio of sulfuric acid to hydrochloric acid or phosphoric acid, the teachings of Andreacchi are herein cited for disclosing an electropolishing process for treating a cobalt-chromium based stent with an electrolyte comprising 6 parts sulfuric acid, 1 part hydrochloric acid and 1 part phosphoric acid to produce an exceptional ultrasmooth, bright and shiny surface (abstract; 6:1:1 solution, Col. 4 lines 11-41, 55-62). Andreacchi discloses another electrolyte comprising 6 parts by volume total of 5 parts by volume sulfuric acid and 1 part by volume hydrochloric acid or phosphoric acid. Andreacchi discloses that the concentration of acids may vary according to a particular smoothness requirement (Col. 5 lines 7-8). Andreacchi further discloses that the 6:1:1 solution is able to withstand a greater water concentration and metal ion concentration before becoming ineffective to further polish the stents (Col. 5 lines 30-32). Andreacchi discloses the stent comprising cobalt, chromium, tungsten and platinum (Co;. 1 lines 63-64, Col. 6 lines 20-25). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to produce a method comprising in a volumetric ratio where at least 5 times more sulfuric acid is provided relative to hydrochloric acid or phosphoric acid because in a similar method as Webler, Andreacchi teaches the use of a 6:1:1 (sulfuric acid, hydrochloric acid, phosphoric acid) solution that provides an ultrasmooth, bright and shiny surface that is also able to withstand a greater water concentration and metal ion concentration before becoming ineffective to further polish the stents. Regarding claim 2, Webler discloses the electrolyte comprising 2-20 parts by volume ethylene glycol (Table 1). Andreacchi discloses the claimed acid ratio above. Regarding claim 3, Webler discloses pulses having a duration in the range of 0.003 to about 0.010 seconds [0009]. Regarding claim 4, Webler discloses the body comprising a stent [0022]. Regarding claim 5, Webler discloses 20-65 weight % platinum [0008]. Regarding claim 6, Webler discloses cobalt, chromium, platinum [0007], tungsten [0051] and nickel [0055]. Regarding claim 7, Webler discloses 18-39 weight % cobalt [0008]. Regarding claim 8, Webler discloses 10-25 weight % chromium [0008]. Regarding claim 9, Webler discloses nickel in an amount of 1-25 weight percent along with manganese [0055]. Regarding claim 10, Webler discloses the alloy is substantially free of molybdenum [0008]. Regarding claim 11, Webler appears to not include carbon (entire document). Regarding claim 12, Webler does not appear to include silicon, phosphorous or sulfur (entire document). Regarding claim 13, Webler discloses manganese in an amount of 1 – 25 weight percent [0054]. Regarding claims 14-15, Webler discloses iron in an amount of 5-12 wt % [0047]. Webler discloses manganese in an amount of 1 – 25 weight percent [0054]-[0056]. Regarding claim 16, Webler discloses 20 – 65 % platinum [0008]. Webler discloses 18-39 weight % cobalt [0008]. Regarding claim 18, Webler discloses 20 – 65 % platinum [0008]. Webler discloses 18-39 weight % cobalt [0008]. Webler discloses 10 – 25 weight % chromium [0008]. Webler discloses nickel in an amount of 1 – 25 weight percent along with manganese [0055]. Webler discloses manganese in an amount of 1 – 25 weight percent [0054]. Webler and Andreacchi do not explicitly disclose the amount of tungsten present, however, given the overlapping amounts of the other metals within the alloy, one of ordinary skill in the art would necessarily arrive at the claimed range. Regarding claim 19, Webler does not disclose the inclusion of silicon or phosphorus therefore reads on the claimed 0 value. Webler discloses that iron is optional and therefore reads on the claimed 0 value. Andreacchi discloses the inclusion of carbon (Col. 6 lines 20-32). Anreacchi does not explicitly disclose the amount of carbon, however, Andreacchi discloses the main components as cobalt and chromium, therefore one of ordinary skill in the art would necessarily expect a small amount of carbon to be present. Regarding claim 20, Webler in view of Andreacchi discloses the claimed method described above. Webler discloses other elements (e.g. iron, manganese) as optional and therefore not present. Webler discloses a voltage in the range of 5 to about 25 volts [0011] . 07-21-aia AIA Claim (s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webler et al. (US 2014/0277392), in view of Andreacchi (US 7,357,854) and in further view of Simpson (US 2020/0038207) . Regarding claim 17, Webler in view of Andreacchi fail to disclose the precipitate inclusions comprising tungsten. In the same or similar field of metal alloys for stents, Simpson discloses the presence of fine precipitates including tungsten that strengthen the alloy [0043]. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to produce a method comprising precipitate inclusions including tungsten because Simpson discloses that an alloy can be strengthened with the presence of precipitates . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2022/0145474 – pulsing with stent, cobalt, chromium Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFANIE S WITTENBERG whose telephone number is (571)270-7594. The examiner can normally be reached Monday - Friday, 7:00 am -4:00 pm EST. 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, Luan Van can be reached at (571) 272-8521. 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. /Stefanie S Wittenberg/Primary Examiner, Art Unit 1795 Application/Control Number: 18/505,714 Page 2 Art Unit: 1795 Application/Control Number: 18/505,714 Page 3 Art Unit: 1795 Application/Control Number: 18/505,714 Page 4 Art Unit: 1795 Application/Control Number: 18/505,714 Page 5 Art Unit: 1795 Application/Control Number: 18/505,714 Page 6 Art Unit: 1795 Application/Control Number: 18/505,714 Page 7 Art Unit: 1795 Application/Control Number: 18/505,714 Page 8 Art Unit: 1795 Application/Control Number: 18/505,714 Page 9 Art Unit: 1795
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