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 Objections
Claim 35 is objected to because of the following informalities: the limitation recites “inserter tool of claim 1” in line 4 which is believed should recite “inserter tool of claim 29”. Appropriate correction is required.
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 29-37 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 29 is rejected as indefinite for the recitation of “impeding axial movement of the plate retainer assembly relative to the body” in line 7-8. Looking to the specification as originally filed in the abstract and Para. [0003], [0049], [0055], and [0063]-[0066] the applicant only describes wherein the lock impedes movement of the sled relative to the body portion when in the lock position. Therefore, it is unclear how the lock is meant to impede the retainer assembly. In the interest in compact prosecution the limitation will be reviewed as if the limitation recited the sled.
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) 29-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lintula et al (US Patent Pub. 20180242987A1).
Lintula discloses an inserter tool that could be used as a calcaneal plate inserter tool. Specifically in regards to claim 29, Lintula recites a body portion (212/202); a plate retainer assembly (290) coupled to the body portion (212/202); a sled (240) coupled to the body portion (212/202) and movable relative to the body portion (212/202), the sled (240) including a guide portion (244/242); a lock (232) coupled to the body portion (212/202) and operable between a lock position (Fig. 12) and an unlocked position (Fig. 19), the lock (232), when in the lock position (Fig. 12), impeding movement of the plate retainer assembly (290) relative to the body portion (212) (Fig. 11-22; and Para. [0063]-[0069],[0071]).
In regards to claim 30, Lintula recites wherein the plate retainer assembly (290) extends through an aperture (aperture through 212 for 290 in Fig. 12) in the body portion (212) (Fig. 11-12; ad Para. [0068],[0071]).
In regards to claim 31, Lintula recites wherein the lock (232) comprises: a slider (234) passing through an opening (opening for 234, see Fig. 20) in the body portion (212) and engaging the sled (240) when the lock (232) is in the locked position (Fig. 12); a button (button portion of 232) coupled to the slider (234); and a biasing element biasing the lock (232) into the lock position (Fig. 12) and cooperating with the button to disengage the lock from the lock position upon depression of the button (Fig. 12, 19-20; and Para. [0065]-[0067]).
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.
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niver et al (US Patent Pub. 20230060073A1) in view of Castaneda (US Patent Pub. 20050085824A1).
Niver discloses an inserter tool that could be used as a calcaneal plate inserter tool. Specifically in regards to claim 29-30, Niver recites a body portion (12/14); a sled (20/22) coupled to the body portion (12/14) and movable relative to the body portion (12/14), the sled (20/22) including a guide portion (16); a lock (45 on 22/45 on 20) coupled to the body portion (12/14) and operable between a lock position and an unlocked position, the lock (45 on 22/20), when in the lock position, impeding movement of the sled (20/22) relative to the body portion (12/14) (Fig. 1-8; and Para. [0030]-[0032],[0036]-[0037],[0039]). However, the reference is silent as to a plate retainer assembly.
Castaneda discloses an inserter tool that could be used as a calcaneal plate inserter tool. Specifically, in regards to claim 29, Castaneda recites a tool (100) having a body portion (106) and a guide portion (104), and a plate retainer assembly (150) coupled to the body portion (106) (Fig. 1-4; and Para. [0043],[0046]). In regards to claim 30, Castaneda recites wherein the plate retainer assembly (150) extends through an aperture (116) in the body portion (106) (Fig. 1). It would have been obvious to one having ordinary skill in the art at the time the invention was filed by modifying the body portion (12/14) of Niver to have a plate retainer assembly as taught in Castaneda in order to have a way to lock the plate in place and drill a hole for a fastener at the same time.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lintula.
Lintula discloses an inserter tool comprising a body, a sled having a guide portions, a lock, and a plate retainer assembly. In regards to claim 33, Lintula discloses wherein the slider (234) includes a first element (opening in 234) configured to engage a second element (252) formed in the sled (240) when the lock is in the locked position to thereby provide an index position of the sled (240) relative to the bod portion (212) (Fig. 19-22; and Para. [0067]). However, the reference is silent as to multiple second elements. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the sled (240) of Lintula to have multiple recessed regions on the arms since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niver in view of Castaneda as applied to claim 29 above, and father in view of Laird (US Patent Pub. 20110106086A1).
Niver in view of Castaneda discloses an inserter tool comprising a body, a sled having a guide portions, a lock, and a plate retainer assembly. However, the references are silent as to the plate retainer assembly being composed of a sleeve and drill guide.
Laird discloses an inserter tool that could be used as a calcaneal plate inserter tool. Specifically, in regards to claim 34, Laird recites a tool (150) having a plate retainer assembly (134/190), and wherein the plate retainer assembly comprises: a sleeve (190) coupled to the body portion (body of 150); and a removable coupling drill guide (134) having a threaded distal end, the coupling drill guide (134) passing through the sleeve (190) (Fig. 14; and Para. [0082]-[0083]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the plate assembly (290) of Castaneda to have a composition of a sleeve and drill guide fitted therein as taught in Laird since an assembly with an extra guiding sleeve is particularly useful in situations where it is highly desirable to minimize the possibility of the fixing element cross-threading in the drilled hole, for example, where the fixing elements are relatively long (Para. [0083]).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Treace et al (US Patent Pub. 20160235454A1) in view of Lintula.
Treace discloses a method. Specifically, in regards to claim 35, Treace recites selecting a calcaneal plate (40) from among plural calcaneal plates of different sizes (See Fig. 1, Para. [0033]), attaching the selected calcaneal plate (40) to the plate inserter tool (80), and using the inserter tool to install the calcaneal plate (40) (Fig. 1; and Para. [0002], [0004], [0033] and claims 1 and 29). However, the reference is silent as to the inserter being the inserter of claim 1.
Lintula discloses a method. Specifically, in regards to claim 35, Lintula recites attaching an implant to the inserter tool of claim 1, and using the inserter tool to install the implant (Fig. 11-22; and Para. [0063]-[0069],[0071],[0082]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the inserter of Treace to include a retainer assembly, sled, guide portion, and lock as taught in Lintula in order to have an inserter that allows for the implant to be inserted while imaging allows to check correct alignment (Para. [0063]).
Claim(s) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Treace in view of Lintula as applied to claim 35, in further view of Turbett (US Patent Pub. 20190021806A1).
Treace in view of Lintula disclose a method for selecting a calcaneal plate from plural plates of different sizes, attaching the plate to an inserter tool of claim 29; and using the inserter to insert the plate. However, the combination is silent as to how the tool is sterilized.
Turbett in regards to claims 36-37, recites sterilizing the plate inserter tool for subsequent use, and wherein the plate inserter tool is wrapped with a cellulose sterilization wrap (Para. [0006],[0054]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the method of Treace to include sterilization as taught in Turbett in order to maintain sterility after removal from the sterilizer, the trays are wrapped in a material that allows the sterilizing agent to pass through, but protecting the inner tray from microorganisms until use (Para. [0006]).
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 29-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 13, 15, and 23-24 of U.S. Patent No. 12484916B2, referred herein as Pat. ‘916. Although the claims at issue are not identical, they are not patentably distinct from each other because
Claims 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 23 of Pat. ‘916. Pat. ‘916 recites a calcaneal plate inserter tool [claim 1 col. 9 lines 49, claim 23 col. 11 lines 27] comprising: a body portion [claim 1 col. 9 lines 50, claim 23 col. 9 lines 28]; a plate retainer assembly coupled to the body portion [claim 1 col. 9 lines 51, claim 23 col. 11 lines 29]; a sled coupled to the body portion and movable relative to the body portion, the sled including a guide portion [claim 1 col. 9 lines 52-54, 59; claim 23 col. 11 lines 29-30, 36]; a lock coupled to the body portion and operable between a lock position and an unlocked position, the lock, when in the lock position, impeding axial movement of the a plate retainer assembly relative to the body [claim 1 col. 9 lines 55-58; claim 23 col. 11 lines 32-35, col. 11 line 38 to col. 12 line10].
Claims 30-34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5 and 24 of Pat. ‘916 for reciting substantially similar limitations.
Claim 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 15 of Pat. ‘916. Pat. ‘916 recites a method comprising performing the following steps in any order appropriate [claim 13 col. 10 lines 36-38]: selecting a calcaneal plate from among plural calcaneal plates of different sizes [claim 13 col. 10 lines 39-40]; attaching the selected calcaneal plate to the calcaneal plate inserter tool of claim 1 [claim 13 col. 10 lines 41-42]; and using said calcaneal plate inserter tool to install the calcaneal plate [claim 15].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
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