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 .
Election/Restrictions
Applicant’s election without traverse of Species C (triangulation guide 2800 shown in Fig. 28-31) in the reply filed on 11/04/2025 is acknowledged. Claims 4, 11, 12, and 23, drawn to non-elected species, have been withdrawn from consideration by applicant.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/504248, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63/504248 does not disclose:
the limitation of claim 2: wherein the guide body includes a pair of cantilevered arms defining a gap therebetween for receiving the first instrument;
the limitation of claim 19: allow movement of the first cannula along an arcuate path.
Accordingly, the effective filing date of claims 2-3, 5, 19-20 is 12/19/2023 while the effective filing date of claims 1, 6-10, 13-18, 21-22, 24-25 is 5/25/2023.
Claim Objections
Claim 9 is objected to because of the following informalities: Claim 9, line 2, “defines” should be “defining”. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ray (US Patent No. 3457922).
Regarding Claim 1, Ray discloses a triangulation guide (Fig. 1) for multi-portal procedures, the triangulation guide comprising:
a guide body (16) configured to hold a first instrument (tripod assembly shown below); and
a first instrument clamp (slit holding ball 18 shown below) coupled to the guide body and configured to hold a second instrument (drill shown in Fig. 10) (see figure below); wherein the first and second instruments are movable relative to one another while held by the guide body and the first instrument clamp, respectively, (nut 15 can be loosened to move tripod assembly and screw 19 can be loosened to move drill in first clamp) and wherein the guide body and the first instrument clamp are configured to maintain triangulation of the first and second instruments (when all fasteners are tightened).
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Regarding Claim 2, Ray discloses the guide body (16) includes a pair of cantilevered arms (16, 16’, Fig. 1) defining a gap (see figure below) therebetween for receiving the first instrument (Fig 1, col. 3; ln. 16-20).
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Regarding Claim 5, the first instrument clamp comprises a jaw (shown above) and an actuation element (19) including a threaded body configured to threadably engage the jaw to adjust a width of the gab (see figure above and col. 3; ln. 15-20).
Claim(s) 1, 6-10, 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jordan (US Patent No. 8986316 B1).
Regarding Claim 1, Jordan discloses a triangulation guide (10, Fig. 1) for multi-portal procedures, the triangulation guide comprising:
a guide body (20+30) configured to hold a first instrument (100, see figure below); and
a first instrument clamp (60) coupled to the guide body and configured to hold a second instrument (100) (see figure below); wherein the first and second instruments (100, 100) are movable relative to one another while held by the guide body and the first instrument clamp, respectively, (col. 3; ln. 20-27) and wherein the guide body and the first instrument clamp are configured to maintain triangulation of the first and second instruments (col.2; ln 21-38).
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Regarding Claim 6, further comprising a second instrument clamp (60, see below) coupled to the guide body and configured to hold the first instrument.
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Regarding Claim 7, the second instrument clamp (60) is slidable along a slot (25) of the guide body (col. 3; ln. 20-36) and detachable from the guide body (can be deconstructed as shown in Fig. 6).
Regarding Claim 8, the second instrument clamp (60) is fixedly coupled to the guide body (when locked by anchor locking means 70 as described in col. 3; ln. 24-27).
Regarding Claim 9, the guide body (20+30) includes a slot (25, 35) [defining] a travel path for moving at least one of the first or second instrument relative to the other of the first or second instruments (col. 3; ln. 29-36).
Regarding Claim 10, wherein the triangulation of the first and second instruments includes keeping the first and second instruments positioned along an imaginary plane, and wherein one of the first or second instruments is slidable relative to the guide body to adjust an angular orientation of the first instrument relative to the second instrument between 10-30 degrees. This intended use limitation is fully capable by the device of Jordan wherein the tools are in the plane shown below and can be moved 10-30 degrees relative to each other (an angle within the capability of the angular range disclosed in col. 3; ln. 34).
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Regarding Claim 13, at least one of the first or second instrument (100, 100) is a cannula (tube described in col. 4; ln. 15-26).
Regarding Claim 14, further comprising a locking mechanism (70) configured to lock the triangulation guide to hold the first and second instruments at fixed angular positions relative to one another (col. 3; ln. 61-63).
Regarding Claim 15, the first instrument clamp (60) has a locked configuration to grip the second instrument (100) and unlocked configuration to release the second instrument (the tightening or loosening of lock screw 98 as described in col. 4; ln. 4-14).
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) 16-22, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US Patent No. 8986316 B1) in view of Gitis et al. (US Publication No. 2003/0208206 A1).
Regarding Claim 16, Jordan discloses a method for using the drill guide in joint repair surgeries (col. 4; ln. 58-col. 5; ln. 40),the method comprising:
inserting a first cannula (100) into a first entrance formed in a subject (shown in Fig. 4, there must be an ‘entrance’ through the skin for the drill guide to contact the bone);
inserting a second cannula (100) into a second entrance formed in the subject, wherein the second entrance is spaced apart from the first entrance (Fig. 4); and
positioning a multi-portal holder (10) to hold the first and second cannulas at a fixed relative position while instruments (drills) are delivered through the first and second cannulas (Fig. 4, col. 4; ln. 58-col. 5; ln. 25).
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Although Jordan describes the guide as useful in “other joint” repair surgeries (col. 5; ln. 24-25), Jordan is silent to using the guide to specifically treat a subject’s spine.
Gitis teaches using a multiport curvilinear adjustable access guide (Fig. 5) in the same field of endeavor in a spinal surgery [0075]. It would have been obvious to one having ordinary skill in the art before the effective filing date to use the guide of Jordan during a spinal surgery as taught by Gitis in order to align two drills or other tools for treating the patient.
Regarding Claim 17, Jordan discloses setting a distance between the first and second cannulas (100, 100); setting an angular orientation between the first and second cannulas; and locking the multi-portal holder to hold the first and second cannulas at the distance and the angular orientation (col. 4; ln. 65-col. 5; ln. 25).
Regarding Claim 18, Jordan discloses the guide may be repositioned for a second drilling location (col. 5; ln. 22-23). It would have been obvious when repositioning the guide to unlock it’s position and adjust at least one of the distance or angle and then relock it to assume a second drilling location as a predictable way to adjust the drilling location.
Regarding Claim 19, Jordan discloses the multi-portal holder (10) includes a triangulation guide (20+30+60) configured to hold the first and second cannulas (100, 100) and allow movement of the first cannula along an arcuate path (path of slots 25, 35) (fig. 1).
Regarding claim 20, Jordan discloses the triangulation guide has elongated slot (25, 32, Fig. 1) and an instrument clamp (60) configured to hold the first cannula, wherein the instrument clamp slides along the slot while the first cannula and the second cannula are positioned generally along an imaginary plane, see below. (col. 3; ln. 29-36, Jordan)
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Regarding Claim 21, Jordan discloses the triangulation guide comprises one or more instrument holders (60, 60) each configured to hold one of the first and second cannulas or a working instrument (fig. 1).
Regarding Claim 22, the triangulation guide comprises an articulating guide joint (60) configured to allow articulation of the first and second cannulas while keeping the first and second cannulas positioned generally along an imaginary plane (cannulas 100 can rotate about their longitudinal axes or articulate within length of slot 25/35 due to joints 60) (col. 3; ln. 55-col. 4; ln. 14, Jordan).
Regarding Claim 24, the multi-portal holder is configured to allow rotation of the first cannula relative to the second cannula (when screw 98 is loosened, the cannula 100 can rotate individually about its axis, also, cannulas can rotate relative to each other due to pivot 40, Fig. 4-5, Jordan)).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US Patent No. 8986316 B1) in view of Gitis et al. (US Publication No. 2003/0208206 A1) in further view of Gleason et al. (US Publication No. 2021/0085341 A1).
Regarding Claim 25, Jordan in view of Gitis discloses the method of claim 16 above but are silent to coupling an instrument holder to a surgical bed; reconfiguring an arm of the instrument holder; and positioning an instrument in a jaw of the instrument holder, wherein the jaw is coupled to the arm and configured to grip the instrument when the arm is at a fixed configuration for holding the instrument in the subject supported by the surgical bed.
Gleason discloses an access device in the analogous art of spinal surgical portals which uses a bed-attached instrument holder (100) with a jaw (Fig. 13) to grip and position an instrument relative to the patient during surgery to assist with the procedure (Fig. 8) [0052-0060]. Gleason disclose the arm of the holder 100 is adjustable to provide desired positioning of the instrument [0054].
It would have been obvious to one having ordinary skill in the art before the effective filing date to use a bed-attached adjustable instrument holder with a jaw as taught by Gleason to grip and position an instrument relative to the patient during surgery to assist with the procedure. It would have been obvious to couple the instrument and positing the instrument in the jaw and adjust (reconfigure) the arm to the desired position so that the instrument is located in the proper position for the surgical need.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan (US Patent No. 8986316 B1) in view of Wakayama et al. (US Publication No. 2015/0157468 A1).
Regarding Claim 2, Jordan discloses the triangulation guide of claim 1 as described in the rejection above. Jordan discloses a gap or slot (25/35) in the guide body which receives the first instrument (via clamp 60). However, Jordan is silent to a pair of cantilevered arms defining this gap.
Wakayama discloses a multi-portal triangulation guide in the analogous art of which forms the slot or gap to accommodate the instrument by a pair of cantilever arms (13, 13, Fig. 1, [0040]) .
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the formation of the close-ended arcuate gap (25/35) of Jordan with an open-ended gap arcuate formed by cantilever arms as taught by Wakayama in order to use an equivalent gap construction known in the art which would predictably allow the sliding of the instrument and clamp therein.
Regarding Claim 3, each of the cantilevered arms is arcuate (Jordan teaches this in Fig. 1), and wherein the first instrument is movable along a curvature of the pair of cantilevered arms (described by Jordan as moving along slot 25/35 in col. 3; ln. 20-27).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773