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.
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Claims 21-40 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,602,400 in view of Sayler et al. (US 2008/0306375).
Regarding the application claims 21-23, claim 1 of the patent recites the all of the limitations as claimed accept it fails to recite that the operating members are each configured to rotate about the respective adjustment axis or an axis parallel to the respective adjustment axis associated with the operating member (application claim 21, lines 7-9).
Regarding the application claims 30 and 40, the patent claims 9 and 8 recite all the limitations as claimed, respectively, accept they fail to recite that the operating members are each configured to rotate about the respective adjustment axis or an axis parallel to the respective adjustment axis associated with the operating member (application claim 30, lines 7-9; application claim 40, lines 9-10).
However, Sayler et al. disclose the surgical arm as described below including operating members which are each configured to rotate about their respective adjustment axis or an axis parallel to a respective adjustment axis associated with the operating members using hand rotation (¶[0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Sayler et al. to have configured the operating members of the patent claims 1, 30 or 40 to be rotatable about their respective adjustment axis as claimed in order to allow a user to adjust a position of the surgical arm using hand rotation.
Regarding the application claims 24-29 and 31-39, the patent claims 2-7 and 10-18 recite all of the limitations as claimed, respectively.
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.
Claims 21 and 25-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sayler et al. (US 2008/0306375).
Regarding claim 21, Sayler et al. disclose a surgical arm comprising: a first interface (204 or 130) configured to receive a device (200) for performing or assisting a surgical procedure (¶[0131]); multiple adjustment members (140a-d) configured to adjust the surgical arm relative to a respective adjustment axis; and at least two operating members (802a-d) configured to operate different ones of the adjustment members, wherein the operating members are marked with different visual codings (¶[0124]), and wherein the operating members are each configured to rotate about the respective adjustment axis or an axis parallel to the respective adjustment axis associated with the operating member (¶[0127]).
Regarding claim 25, the operating members are configured rotatably (¶[0113]).
Regarding claim 26, at least a first one of the adjustment members is configured to adjust the surgical arm along a translational adjustment axis and at least a second one of the adjustment members is configured to adjust the surgical arm around a rotational adjustment axis (¶[0100]).
Regarding claim 27, the surgical arm comprises at least one of a tracking device (“fiducial markers” - 117; Abstract) configured to be tracked by a surgical navigation system and a second interface (110; Figure 3A) for receiving the tracking device.
Regarding claim 28, the different visual codings are different colors (¶[0124]).
Regarding claim 29, a guidance device (204; 130 being the interface) is coupled to the first interface (Figure 3A), wherein the guidance device defines an operative axis and is configured to guide a surgical tool along the operative axis (¶[0131]).
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.
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 non-obviousness.
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Sayler et al. (US 2008/0306375).
Regarding claim 22, Sayler et al. disclose at least two locking members (404a and 404b) that are associated with different ones of a different embodiment of the operating members (402a-d; Figure 10A), wherein each of the locking members is configured to lock the surgical arm in position with respect to a specific movement relative to the respective adjustment axis of the associated operating member (¶[0115]).
Sayler et al. fail to disclose that in this embodiment, the operating members are marked with coding as claimed.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have marked or color-coded this embodiment of the operating members as claimed in order to provide the same advantage as the color-coded embodiment; namely to allow quick identification of which operating member corresponds to which adjustment member to effect a desired movement (¶[0015]).
Regarding claim 24, Sayler et al. fail to disclose that the locking members are configured rotatably. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the locking members as rotatable dials, wheels or knobs since the examiner takes Official notice of the equivalence of dials, levers, wheels, knobs, buttons, etc. for their use in providing a simple on/off switch (which is essentially the function of the Sayler et al. locking members) and the selection of any of these known equivalents to provide an on/off switch for the locking members would be within the level of ordinary skill in the art. Furthermore, since Applicant’s publication in paragraph [0013] discloses that the locking members can be rotatable knobs or pivoting levers, thus absent a teaching as to criticality of the claimed rotatability, the rotatable knob is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to this particular feature. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA
1975).
Claims 30-40 are rejected under 35 U.S.C. 103 as being unpatentable over Sayler et al. (US 2008/0306375) in view of Jenkins et al. (US 2009/0171184).
Regarding claims 30 and 40, Sayler et al. disclose the surgical arm as described above, including the limitations already addressed above. Sayler et al. further disclose a method comprising the steps of: determining at least one of a current position and a current orientation of the first interface or a device received by the first interface; determining, based on the pre-determined surgical approach, at least one of a target position and a target orientation of the interface or the device; based on a difference between at least one of the current and target positions and the current and target orientations, determining that an adjustment of the surgical arm is required relative to at least one adjustment axis (¶[0029], [0088], [0097]).
Sayler et al. disclose triggering a display of which adjustment axis should be adjusted (¶[0097]) but fail to disclose triggering a display of the coding of the operating members during this display.
Jenkins et al. disclose a very similar surgical arm as Sayler et al. (Figures 6D and 7) and further disclose triggering a display of a visual coding associated with at least one operating member associated with at least one adjustment axis so as to provide a visual guidance to a user as to which operating member to adjust in order to correct the trajectory of a device (Table 2J; Table 2M).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Jenkins et al. to have configured the display of Sayler et al. to display the visual coding of the operating members so that a user can more easily and rapidly determine which operating member to adjust to correct the trajectory of the device.
Regarding claim 31, the visual guidance comprises a display of the visual coding in combination with an indication of a direction in which the associated operating member is to be operated (Tables 2J and 2M of Jenkins et al.).
Regarding claim 32, the visual guidance comprises a display of the visual coding in combination with an indication of an amount by which the associated operating member is to be operated (Table 2J and 2M of Jenkins et al.).
Regarding claim 33, the indication of an amount by which the associated operating member is to be operated is in the form of at least one of a first number of geometric elements and a first geometric form in association with the visual coding of the operating member (Tables 2J and 2M of Jenkins et al.).
Regarding claim 34, at least one of a second number of geometric elements and a second geometric form in association with a visual coding different than the visual coding of the first number of geometric elements and the first geometric form, respectively, the second number of geometric elements or the second geometric form being indicative of an amount by which the associated operating member has been operated (Tables 2J and 2M of Jenkins et al.).
Regarding claim 35, the method further comprises determining a specific adjustment axis relative to which the surgical arm deviates the most among all adjustment axes from the pre-determined surgical approach; and prioritizing the provision of visual guidance for said specific adjustment axis over any other adjustment axis (Tables 2J and 2M of Jenkins et al.).
Regarding claim 36, the method further comprises triggering a display of a numerical value indicative of an amount by which a specific adjustment axis deviates from the pre-determined surgical approach (Tables 2J and 2M of Jenkins et al.).
Regarding claim 37, the method further comprises triggering a display of a superposition of at least one of the current position and the current orientation of the first interface or a device received in the first interface relative to the pre-determined surgical approach (Tables 2J and 2M of Jenkins et al.).
Regarding claim 38, the at least one of a current position and a current orientation of the first interface or the device received by the first interface is determined by tracking, using a surgical navigation system, a tracking device that is in a fixed spatial relationship with at least one of the first interface and the device received by the first interface (¶[0099]; [0106] of Sayler et al.).
Regarding claim 39, Sayler et al. disclose a computer program product, comprising computer program instructions to perform the method steps of claim 10 when executed by a processor (¶[0056]-[0059]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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