DETAILED ACTION
This office action is in response to the application and amendments filed on 10/22/24 and 1/14/25. Claims 21-40 are pending. Claims 21-40 are rejected.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit https://www.uspto.gov/patents/apply/forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,160,709, in view of US Patent Application 2008/0177391 to Mitchell et al.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,138,203, in view of US Patent Application 2008/0177391 to Mitchell et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application recite structures that are recited in each of the patented inventions in the same or nearly the same terminology, including, inter alia, “a base,” “a head end support,” “a foot end support,” “a patient support,” “pelvic pads,” and “chest pad”. Regarding the method steps of “rolling the patient into a lateral decubitus position,” it would have been obvious to use the claimed structures for the claimed method of performing spinal surgery, at least because Mitchell teaches the use of the lateral decubitus position for spinal surgery, in at least paragraph [0068]. The claimed structures of the instant application, as well as the prior patented apparatus, can inherently be used to perform spinal surgery while positioning a user in the claimed manner.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,339,430.
Patent No. 9,339,430 discloses each of the recited structures of the claimed invention in similar, though not identical language. Regarding method steps directed toward positioning a patient for surgery, Patent No. 9,339,430 does not claim these steps, however the claimed structures are inherently capable of performing the claimed positioning steps. The patent further discloses positioning the apparatus is the claimed lateral decubitus position in Fig. 149, and column 19, lines 5-10, and discloses “insertion of spinal implants” in column 1, lines 57-58.
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the recited claims can be found entirely within the subject matter of the claims of the patented claims. The claims of the instant Application are therefore fully encompassed by (and anticipated or made obvious by) the claims of the patent regardless of the differing scope of the claims. Furthermore, to the degree to which the claims are different from the patented claims, the changes would have been obvious to one of ordinary skill in the art at the time the invention was made.
Examiner notes that during the prosecution of the grand-parent application (now patent 11,160,709), a restriction requirement was required. While MPEP §804.1 in general prohibits a double patenting rejection in a child application that resulted from a restriction requirement, this prohibition does not apply in this circumstance because there were no withdrawn claims in the parent application that became claims in the instant application. Moreover, the claims in both the patented case as well as in the instant application are substantially different than the original set of claims that was subject to a restriction requirement.
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 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; or
(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.
Claims 21-32, and 35-40 are rejected under 35 U.S.C. 102(a)( ) as being anticipated by US Patent Application Publication 2014/0109316 to Jackson et al. (“Jackson”).
Claim 21. Jackson discloses:
“providing a surgical table comprising: a base comprising a head end support, a foot end support and a rail connecting the head and foot end supports, a patient support coupled to the head end support, a chest pad coupled to the patient support, and a lower body support connected to the foot end support, the lower body support comprising first and second pelvic pads.” See at least Abstract and Fig. 1, pelvic pads are seen at #286.
Regarding method steps:
“positioning a patient in a prone position on the patient support; supporting a first side of the patient's pelvis on the first pelvic pad and supporting a second side of the patient's pelvis on the second pelvic pad; and rolling the patient into a lateral decubitus position such that the pelvic pads are vertically aligned,” Jackson discloses use of the lateral decubitus position in column 19, lines 5-10, and this position can be seen in Fig. 149 and 220-225.
Claim 22. The method of performing spinal surgery recited in claim 21, wherein the first pelvic pad is oriented above the second pelvic pad when the pelvic pads are vertically aligned (the apparatus of Jackson is capable of lateral rotation, see Figs. 220-239 which disclose a lateral rotation axis).
Claim 23. The method of performing spinal surgery recited in claim 21, further comprising moving the first pelvic pad away from the first side of the patient's pelvis (Jackson paragraph [0502] and Figs. 66-80 disclose structures that allow pelvic pads to be moved; specifically paragraph [0513]-[0515] and Fig. 80) and delivering an implant into the patient's spine with the patient in the lateral decubitus position (Jackson anticipates the placement of spinal implants in paragraph [0006] and the use of the lateral decubitus position in paragraph [0324]).
Claim 24. The method of performing spinal surgery recited in claim 21, wherein the first pelvic pad is oriented upwardly over the second pelvic pad when the pelvic pads are vertically aligned, the method further comprising moving the first pelvic pad away from the patient's pelvis (the apparatus of Jackson is capable of rotation as described in at least the Abstract, which causes pelvic pads #286 to be vertically aligned).
Claim 25. The method of performing spinal surgery recited in claim 21, further comprising inserting an implant into the patient's spine (Jackson anticipates the placement of spinal implants in paragraph [0006] and the use of the lateral decubitus position in paragraph [0324]) and moving the first pelvic pad toward the patient's pelvis such that the pelvic pads are vertically aligned (Jackson paragraph [0502] and Figs. 66-80 disclose structures that allow pelvic pads to be moved; specifically paragraph [0513]-[0515] and Fig. 80; additionally pelvic pads are seen to be vertically aligned by lateral rotation of the patient support in Figs. 166-167).
Claim 26. The method of performing spinal surgery recited in claim 21, further comprising retracting the rail (rail is seen at #25 in Jackson, Fig. 2) to move the head end support and the foot end support closer to each other (Jackson paragraph [0407] discloses “It is foreseen that the cross-bar 25 may be telescoping”).
Claim 27. The method of performing spinal surgery recited in claim 26, further comprising coupling outer frame members to the surgical table after retracting the rail (Jackson Fig. 3, #306 and 308; also see paragraph [0492]; alternatively, see paragraph [0550] which discloses a removable patient support #15’ which reads on Applicant’s outer frame members).
Claim 28. The method of performing spinal surgery recited in claim 27, further comprising removing one of the outer frame members from the surgical table after rolling the patient into the lateral decubitus position (see Jackson paragraph [0550] which discloses a removable patient support #15’ which reads on Applicant’s removable outer frame members).
Claim 29. The method of performing spinal surgery recited in claim 21, further comprising elevating the head end support to a first height and elevating the foot end support to a second height that is different than the first height (see at least Jackson Fig. 24).
Claim 30. The method of performing spinal surgery recited in claim 29, wherein the patient support comprises an upper body support structure (Jackson discloses numerous embodiments and configurations, however an upper body support structure is disclosed at least at #362 in Fig. 3, and discussed in paragraph [0526]), the upper body support structure having left and right upper body support members (Jackson Fig. 3), the patient support comprising a central support structure that is positioned underneath the left and right upper body support members after the head end support and foot end support are elevated (as best understood from Applicant’s paragraph [0143] and Fig. 33, a central support structure is beam #160 which extends from one column and helps to support the patient; Jackson discloses numerous structures that could be a beam that provides this support functionality, for example, in paragraph [0550] which discloses a removable patient support #15’ which reads on Applicant’s central support structure; alternatively, chest pad #368 is seen to be removable in Fig. 163).
Claim 31. The method of performing spinal surgery recited in claim 21, further comprising securing the patient to the patient support via straps that are fitted around the patient (Jackson paragraph [0527] discloses “The patient's arms are positioned and removably attached or strapped onto adjustable arm boards 372”; alternatively, thigh support sling #354, discussed in paragraph [0522] and seen in Fig. 1).
Claim 32. The method of performing spinal surgery recited in claim 31, wherein the lower body support includes first and second thigh support members (Jackson paragraph [0522] discloses “The upper leg support portion 346 includes a pair of spaced opposed rails 352” which read on Applicant’s first and second thigh support members), the straps being positioned around a knee region of the patient and around the thigh support members (Jackson discloses thigh support sling #354, discussed in paragraph [0522] and seen in Fig. 1, which reads on Applicant’s straps positioned around a knee region).
Claim 35. The method of performing spinal surgery recited in claim 21, further comprising: pivoting the patient support from a neutral position to a non-neutral position; and rotating the patient support from the non-neutral position to the neutral position (Applicant’s “neutral position” is seen to be a prone position as in Applicant’s Fig. 26, and a non-neutral position is interpreted as a position that is not a prone position; the apparatus of Jackson is capable of providing both a prone position, as seen in numerous figures, but at least in Fig. 1, and a non-prone position, also seen in numerous figures, but at least in Fig. 166).
Claim 36. The method of performing spinal surgery recited in claim 35, wherein the lower body support includes left and right pelvic support members, the method further comprising pivoting the left pelvic support member out of the way of a surgical site (Jackson paragraph [0502] and Figs. 66-80 disclose structures that allow pelvic pads to be moved; specifically paragraph [0513]-[0515] and Fig. 80).
Claim 37. The method of performing spinal surgery recited in claim 21, further comprising moving the head end support relative to the foot end support to move the patient into an extended position (the apparatus of Jackson is capable of various positions including a flexed or an extended position as seen in Figs. 235-236; compare to Applicant’s Figs. 37-38).
Claim 38. The method of performing spinal surgery recited in claim 21, further comprising telescoping the rail to move the head end support relative to the foot end support (Jackson paragraph [0407] discloses “It is foreseen that the cross-bar 25 may be telescoping”).
Claim 39. Jackson discloses:
“providing a surgical table comprising: a base comprising a head end support, a foot end support and a rail connecting the head and foot end supports, a patient support coupled to the head end support, a chest pad coupled to the patient support, and a lower body support connected to the foot end support, the lower body support comprising first and second pelvic pads.” See at least Abstract and Fig. 1, pelvic pads are seen at #286.
Regarding method steps:
“positioning a patient in a prone position on the patient support; supporting a first side of the patient's pelvis on the first pelvic pad and supporting a second side of the patient's pelvis on the second pelvic pad; and rolling the patient into a lateral decubitus position such that the pelvic pads are vertically aligned,” Jackson discloses use of the lateral decubitus position in column 19, lines 5-10, and this position can be seen in Fig. 149 and 220-225.
Regarding: “and inserting an implant into the patient's spine and moving the first pelvic pad toward the patient's pelvis such that the pelvic pads are vertically aligned, wherein the first pelvic pad is oriented above the second pelvic pad when the pelvic pads are vertically aligned”; Jackson anticipates the placement of spinal implants in paragraph [0006] and the use of the lateral decubitus position in paragraph [0324]. Regarding the pads being vertically aligned, Jackson paragraph [0502] and Figs. 66-80 disclose structures that allow pelvic pads to be moved; specifically paragraph [0513]-[0515] and Fig. 80. Additionally the pelvic pads of Jackson are seen to be vertically aligned by lateral rotation of the patient support in Figs. 166-167.
Claim 40. This claim recites many of the same limitations as claims 1 and 39, and is rejected in the same manner; see above. Regarding, “the method further comprising moving the first pelvic pad away from the patient's pelvis,” Jackson paragraph [0502] and Figs. 66-80 disclose structures that allow pelvic pads to be moved; specifically paragraph [0513]-[0515] and Fig. 80.
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 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 of this title, 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.
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2014/0109316 to Jackson et al. (“Jackson”) in view of US Patent Application 2012/0144589 to Skripps et al. (“Skripps”).
Claim 33. The method of performing spinal surgery recited in claim 32, further comprising positioning straps around a torso region of the patient and the patient support (Jackson discloses arm straps and thigh straps, but does not disclose torso straps; Skripps teaches a similar apparatus and teaches the use of torso straps #140 in Fig. 12; it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the apparatus of Jackson with torso straps as taught by Skripps to more securely hold a patient during rotation of the apparatus and also since doing so would have simply been combining prior art elements according to known methods to yield predictable and obvious results..
Claim 34. The method of performing spinal surgery recited in claim 21, wherein the patient support comprises an upper body support structure, the upper body support structure having left and right upper body support members, the method further comprising coupling a lateral support board to one of the upper body support members and tilting the patient support about 90 degrees such that the lateral support board is at a lowest point of the patient support and the patient is in the decubitus position (Jackson does not disclose lateral support boards; Skripps teaches a similar apparatus and teaches the use of lateral support boards #136 in Figs. 1 and 12; it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the apparatus of Jackson with lateral support boards as taught by Skripps to more securely hold a patient during rotation of the apparatus and also since doing so would have simply been combining prior art elements according to known methods to yield predictable and obvious results).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYLES A THROOP whose telephone number is (571)270-5006. The examiner can normally be reached 8:00 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Troutman can be reached at 571-270-3654. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MYLES A THROOP/ Primary Examiner, Art Unit 3679