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 .
Status of Claims
Claims 5-6, 9, and 11 are examined in this office action of as claims 1-2, 4, and 7 are withdrawn as directed to a nonelected invention, claims 3, 8, 10, and 12 are canceled and claims 5, 9, and 11 were amended in the reply dated 12/8/25.
Claim Objections
Claim 5 is objected to because of the following informalities: the clarity of the claim would be improved by explicitly reciting what is obtained by performing heat treatment, namely line 2 should recite “cobalt-chromium alloy member, wherein the cobalt-chromium alloy member is obtained by…”. Appropriate correction is required.
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.
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.
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.
Claims 5-6, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0363115 A1 of Richter in view of US 2012/0067464 A1 of Chiba.
As to claims 5-6 and 9, Richter discloses a Co-Ni based alloy with the composition as shown in Table A below.
Table A
Element
Claims 5 and 9 limitations (mass %)
Richter claim 1 (wt%)
Ni
23 to 32%
25 to 29% (claim 9)
About 20 to about 50%
Co
37 to 48%
About 10 to about 50%
Mo
8 to 12%
9 to 11% (claim 9)
About 2 to about 20%
Cr
Remainder and unavoidable impurities
About 10 to about 30%
Cr + Mo
20 to 40%
23 to 38% (claim 9)
About 12 to about 50%
Thus, the composition in Richter overlaps the claimed amounts for Ni, Co, Mo, and Cr as well as the amount of Cr + Mo. As the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness is established as it 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 to select the claimed composition over the prior art disclosure since the prior art teaches improved resistance to physical fatigue, a high corrosion resistance and the ability to be drawn into a thin wire (Richter, paragraph [0038]) throughout the disclosed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) . See MPEP § 2144.05 I. Richter discloses where this is a medical device comprising a wire according to the composition of the embodiment (Richter, paragraph [0114]), meeting the limitation where this is a medical device and where the cobalt-chromium alloy member has a wire shape and the claim 6 limitation of a medical device including a wire.
Further, Richter discloses where the alloy is prepared by vacuum induction or arc melting, electro-slag melting, homogenization, cogging, finish rolling, and a straightening step (Richter, paragraphs [0122]-[0131]). Richter discloses where the straightening step is a cold straightening step carried out from about 10 to about 100°C (Richter, paragraph [0140]), meeting the limitations where the cobalt-chromium alloy as processed material being obtained by causing the cobalt-chromium alloy material to be subjected to cold plastic working into a predetermined shape. However, Richter does not disclose performing heat treatment on a cobalt-chromium alloy as-processed material for 1 minute or more and 60 minutes or less at a temperature exceeding a recrystallization temperature of a cobalt-chromium alloy material and not more than 1100°C.
Chiba relates to the same field of endeavor of Co-Ni based alloys (Chiba, paragraph [0013]). Chiba discloses where the member is formed using cold rolling at a reduction ratio of 15% or more and 90% or less, followed by heat treatment at 350°C or more (Chiba, paragraphs [0082] and [0083]). Chiba discloses where the ultimate tensile strength varies from 1,030 to 2,600 MPa and breaking elongation varies from 0.40 to 61.80% (Chiba, Tables 3 and 4) and Chiba also specifically discloses sample 14 which is cold rolled with a reduction ratio of 90% -- reading upon cold plastic working into a predetermined shape – and then performs a heat treatment at 1050°C for 1 hour to produce a finished member – reading upon a heat treatment between recrystallization temperature and 1100°C as well as the claim 9 limitation of between 900 and 1100°C (Chiba, Table 3 and paragraph [0133]). Chiba teaches that this produces a Co—Ni-based alloy excellent in mechanical characteristics such as hardness and tensile strength (Chiba, paragraph [0027]).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a heat treatment at 1050°C for 1 hour as taught by Chiba into the method disclosed by Richter, thereby producing a Co—Ni-based alloy excellent in mechanical characteristics such as hardness and tensile strength (Chiba, paragraph [0027]).
Thus, as Richter discloses a patentably indistinct composition and the combination of Richter and Chiba applies a substantially identical method thereto, it would be expected by a person of ordinary skill in the art that the same method applied to the same starting materials would produce the same properties of tensile strength of 800 to 1200 MPa, a uniform elongation of 25 to 60%, and a breaking elongation of 30 to 80% as well as the claim 9 properties of a tensile strength of 850 to 1200 MPa, a uniform elongation of 50 to 60%, and a breaking elongation of 60 to 80%. “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 11, Richter is silent concerning the cobalt-chromium alloy member having a crystal structure consisting of a face-centered cubic lattice (fcc) or a crystal structure consisting of a face-centered cubic lattice (fcc) and a hexagonal lattice (hcp), an average crystal grain size of 5 to 30 μm, and a deformation band metallographic structure.
However, as noted in the rejection of claim 5 above, Richter discloses a patentably indistinct composition and Richter in combination with Chiba applies a substantially identical method thereto, it would be expected by a person of ordinary skill in the art that the same method applied to the same starting materials would produce the same properties of a crystal structure consisting of a face-centered cubic lattice (fcc) or a crystal structure consisting of a face-centered cubic lattice (fcc) and a hexagonal lattice (hcp), the average crystal grain size is 5 to 30 µm and where there is a deformation band metallographic structure. “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).
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 5-6, 9 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-21 of copending Application No. 18/686624 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘624 application discloses a cobalt-chromium alloy member, which has a composition of, in terms of mass%, 23 to 32% of Ni, 37 to 48% of Co, and 8 to 12% of Mo, a remainder thereof containing Cr and an unavoidable impurity, the composition satisfying a relationship of 20 <[Cr%] + [Mo%] <40 exhibiting a tensile strength of 800 to 1200 MPa and a breaking elongation of 30 to 80% in claim 1 and where it is a medical device is a wire as in claim 8. While ‘624 application does not disclose a uniform elongation, as it discloses the same composition and same method of making the member, it would exhibit the same properties. Further, the instant dependent claims are substantially identical to the claims in the ‘634 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
With respect to the abstract, applicant’s amendments cure the previous issues, therefore the specification objection is withdrawn.
With respect to the 112(b) rejection concerning “uses” in claim 5, applicant’s amendment to recite that the device “includes” a cobalt-chromium alloy member cures the indefiniteness issue and finds support in paragraph [0010] of the specification as filed as it discloses where the member is used in a medical device and where the member is a wire which is attached to a medical stint, indicating that applicant has support for where the device includes materials other than the cobalt-chromium alloy member.
With respect to the 112(b) rejection concerning the “heat treatment” in lines 2-6 of claim 5, applicant’s amendments cure the previous issue but see new objection above.
With respect to the 112(b) rejection concerning “a band-like deformation zone”, applicant’s amendment to recite a “deformation band metallographic structure” cures the previous indefiniteness issue. Further, this amendment, while not literally recited in the specification, has support as paragraph [0027] recites twin-deformation occurs between the fee to hcp and Fig. 6 shows the deformation bands in the metallographic structure.
With respect to the 103 rejection over Chiba in view of Sugai, it is agreed that applicant’s amendment to close the composition to exclude other elements overcomes the rejection as Chiba requires the inclusion of titanium and iron (Chiba, paragraph [0013]) which instant claim 5 now excludes (Applicant’s remarks, pg. 8, 2nd paragraph). However, see new rejection over Richter in view of Chiba above.
With respect to the double patenting rejection over application 18/686624, applicant argues that since this is a provisional rejection, a response is not required and that the amendments cure the double patenting issue (Applicant’s remarks, pg. 8, last paragraph – pg. 9, 1st paragraph).
However, the provisional nature of the instant double patenting rejection refers only to the fact that neither application involved is an issued US patent. All rejections must be addressed and applicant’s amendments do not address the issues for the reasons stated in the Double Patenting rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Joshua S Carpenter whose telephone number is (571)272-2724. The examiner can normally be reached Monday - Friday 8:00 am - 5:30 pm.
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/JOSHUA S CARPENTER/Examiner, Art Unit 1733
/JOPHY S. KOSHY/Primary Examiner, Art Unit 1733