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 .
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 19-22, 24-26, and 38 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5-9, 13, 15, 19 of U.S. Patent No. 11045262.
Claims 19-22 of the current application map to claims 1, 3, 11, 13, ,14, 15, 19 of the patent and claim 38 of the current application maps to claims 1, 3, 11, 14 and 19 of the patent. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Regarding claims 24-26, such elements are disclosed by claims 4, 6-9. Although dependency mapping is not identical, the two sets of claims taken as a whole with the above mapped claims would result in the claims of the Application being an obvious “generic” device of the patent “species”
Claims 19-22, 24-27,30-35, 38 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 13-20 of U.S. Patent No. 12053246.
Claims 19-22 and 27 of the current application map to claims 1, 7, 8, 10, 11, 14, of the patent. Claims 30-35 of the current application map to claims 13-20 of the Patent. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Regarding claims 24-26, 29, such elements are disclosed by claims 2, 5, 6, 9. Although dependency mapping is not identical, the two sets of claims taken as a whole with the above mapped claims would result in the claims of the Application being an obvious “generic” device of the patent “species”
It is noted that the amendment does not overcome the Double Patenting rejection. The amendment only adds functional limitations which do not distinguish the claim structurally from the Patents listed above.
Claim Rejections - 35 USC § 102
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) 19, 23-27, 29, 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Couture et al. (U.S. Publication No. 2004/0039396).
Couture et al. discloses a system (10) for mounting a cut guide on a patient during a surgical procedure, the system comprising: a position tracker (44) comprising a mounting feature (46)(Figure 6) and configured to be affixed against a bone of the patient, wherein a longitudinal axis of the position tracker is substantially parallel to an anatomical axis of the bone (In figure 10A, the block is shown attached to a tibia which would result in the longitudinal axis element 44 substantially parallel to the longitudinal axis of the tibia); and a cut guide (paragraph 36, “The guide body 12 comprises cutting guide surfaces, such as the two drill guide holes 36, which extend through the guide body 12. The guide body 12 also includes means for engagement to a cutting guide, comprising, for example, a pair of mounting points 38 having peg holes 40 are disposed on the top of the guide body, permitting engagement with another drill/cutting guide block for example.”) comprising: a receptacle (49) configured to selectively receive the mounting feature (Figure 5, 6, paragraph 38), a locking mechanism (48) configured to selectively lock the mounting feature in the receptacle, and a plurality of pin receptacles (see below),
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each of the plurality of pin receptacles configured to receive a bone pin therethrough to affix the cut guide to a bone of the patient (the holes are considered capable of), wherein at least one of the position tracker and the cut guide comprises a stopping feature configured to limit a depth of insertion of the mounting feature into the receptacle (as seen in Figure 5b and 6, the portion that enters the receptacle 49 is narrower than the rest of the position tracker, therefore, ledge formed therebetween is a stopping feature), wherein the mounting feature is configured to be inserted into the receptacle in a single orientation (paragraph 38, “An alignment pin 46 located on the calibration instrument fits into a corresponding notch 49 in the guide body, to ensure that the calibration instrument 44 is correctly oriented relative to the positioning guide block”).
Regarding claim 23, the stopping feature physically blocks insertion of the mounting feature in the receptable (Figure 5B and 6 as per claim 19 above)
Regarding claim 24, it can be construed from Figure 6, and the description of Figure 5b that the posts of 44 are analogous to posts 15 and the posts 15 are for markers 17. Thus, the position tracker comprises a plurality of position markers.
Regarding claim 25, the position tracker comprises a frame, and wherein the plurality of position markers are mounted on the frame, and wherein the plurality of position markers are mounted in a known pattern for tracking by a surgical navigation system. As stated for claim 24, such can be construed from Figure 6 and the description of Figure 5B.
Regarding claim 26, the cut guide comprises a tibia cut guide (52, Figure 5a) comrpsing a guide slot (Figure 5a, left side of the block 52) configured to guide a cutting tool to resect the bone, and wherein the bone is a tibia. This claim is considered functional, as such the disclosure of a guide block capable of guiding a saw will satisfy the function, thus, element 52 satisfies the claim.
Regarding claim 29, the cut guide is configured to adjust one or more of a resection depth , a varus angle, a valgus angle , and a slope of the bone (paragraph 47).
Regarding claim 27, the locking mechanism comprises a locking screw (48) configured to extend into the receptacle to selectively lock the mounting feature in the receptacle (paragraph 38).
Regarding claim 38, Couture et al. discloses a system (10) for mounting a cut guide on a patient during a surgical procedure, the system comprising: a position tracker (44) comprising a mounting feature (46)(Figure 6) and configured to be affixed against a bone of the patient, wherein a longitudinal axis of the position tracker is substantially parallel to an anatomical axis of the bone (In figure 10A, the block is shown attached to a tibia which would result in the longitudinal axis element 44 substantially parallel to the longitudinal axis of the tibia); and a cut guide (paragraph 36, “The guide body 12 comprises cutting guide surfaces, such as the two drill guide holes 36, which extend through the guide body 12. The guide body 12 also includes means for engagement to a cutting guide, comprising, for example, a pair of mounting points 38 having peg holes 40 are disposed on the top of the guide body, permitting engagement with another drill/cutting guide block for example.”) comprising: a receptacle (49) configured to selectively receive the mounting feature (Figure 5, 6, paragraph 38), a plurality of pin receptacles (see below),
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each of the plurality of pin receptacles configured to receive a bone pin therethrough to affix the cut guide to a bone of the patient (the holes are considered capable of), wherein at least one of the position tracker and the cut guide comprises a stopping feature configured to limit a depth of insertion of the mounting feature into the receptacle (as seen in Figure 5b and 6, the portion that enters the receptacle 49 is narrower than the rest of the position tracker, therefore, ledge formed therebetween is a stopping feature), wherein the mounting feature is configured to be inserted into the receptacle in a single orientation (paragraph 38, “An alignment pin 46 located on the calibration instrument fits into a corresponding notch 49 in the guide body, to ensure that the calibration instrument 44 is correctly oriented relative to the positioning guide block”).
Response to Arguments
In response to Applicant’s argument that the device of Couture fails to disclose the position tracker configured to be affixed against a bone of the patient, wherein a longitudinal axis of the position tracker is substantially parallel to an anatomical axis of the bone, the Examiner respectfully disagrees. Couture discloses in figure 10A that the block is attached to a tibia which would result in the longitudinal axis element 44 substantially parallel to the longitudinal axis of the tibia.
Allowable Subject Matter
Claims 36, 37, 39 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The method claims contain the allowable subject matter from previously filed Application 17328027. The only rejection for those claims is a Double Patenting Rejection. As such the claims would be in condition for allowance following the proper filing of a Terminal Disclaimer or incorporating the objected to claims which are not subject to the Double Patenting Rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW YANG/Primary Examiner, Art Unit 3775
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