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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
The information disclosure statement filed 10/24/2025 (Foreign Patent Cite #18) fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Applicant is advised that should claims 38-45 be found allowable, claim 49-56 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 41 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5 of prior U.S. Patent No. 12,350,173 (hereinafter ‘173). This is a statutory double patenting rejection. ‘173 discloses all the limitation of Claim 41, which includes parent claims 36-40 (see claims 1-5 in ‘173).
Claim 52 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5 of prior U.S. Patent No. 12,350,173 (hereinafter ‘173). This is a statutory double patenting rejection. ‘173 discloses all the limitation of Claim 52, which includes parent claims 49-51(see claims 1-5 in ‘173).
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 36-40, 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 12 of U.S. Patent No. 12,350,173 (‘173). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘173 discloses all the limitations of Claim 36 (see claim 1) with the exception that ‘173 further discloses an insertion instrument (see last clause of claim 1).
‘173 also discloses the limitations Claims 37-40 (see claims 2-5, respectively), and Claim 48 (see claim 12).
Claims 49-51, 59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,350,173 (‘173). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘173 discloses all the limitations of Claim 49 (see claim 1-3) with the exception that ‘173 further discloses an insertion instrument (see last clause of claim 1).
‘173 also discloses the limitations Claims 50-51 (see claims 4-5, respectively), and Claim 59 (see claim 12).
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 nonobviousness.
Claims 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over McLuen US 2013/0211525 in view of Stone US 6,387,130, Crook US 2009/0234364, Buttler US 2014/0371754 and Yeung US 2011/0098628.
Regarding Claim 36, McLuen discloses a bone fusion surgical system (Figs 1-5) for manipulating a bone fusion device in a desired location, the system comprising:
a bone fusion device (Figs 1-5) having a body (#114) with one or more device channels (one of the channels #122 and/or #120), a positioning element (#108) having a positioning aperture (#134) and one or more extendable tabs (#130), wherein manipulation of the positioning element enables the tabs to be extended away from the body (paragraph 43).
McLuen does not disclose a rescue hook rod to remove and reposition the bone fusion device having an elongated arm with a base handle at a first end, a hook with a dull tip at a second end opposite the first end, and a straight portion that extends between the base handle and the hook, wherein the base handle includes a top surface that is flat, the top surface of the base handle includes a first visual indicator that indicates an orientation of the hook with respect to the base handle, and the hook follows a curved path such that the dull tip of the hook points in a direction substantially/generally parallel to an axis of the straight portion of the elongated arm.
Stone disclose a spinal implant (#20a-20c) and a rescue hook rod (Fig 9) having an elongated arm (see Fig below) with a base handle at a first end (opposite the hook and outside the body, not shown, there would be a handle that used to handle and manipulate the rescue hook rod), a hook (#66) with a tip at a second end opposite the first end (Fig 9), and a straight portion that extends between the base handle and the hook (see Fig below), the hook allows one to manually adjust the position of the spinal implant (bottom of Col 4 to Col 5 line 10).
PNG
media_image1.png
549
822
media_image1.png
Greyscale
Crook discloses a hook rod (Fig 1-2), having an elongated arm (see Fig below) with a base handle at a first end (see Fig below) and a hook (#28) with a dull tip at a second end opposite the first end (see Fig below), the hook follows a curved path within a plane (fig 2, plane containing the page) such that the dull tip of the hook points in a direction substantially/generally parallel to an axis of the elongated arm (see Fig below, Fig 1 where due to the u/c-shaped hook with the dull tip, the hook is pointing towards the base handle in a direction generally parallel to the axis, see also Response to Arguments above) are within the plane between the handle and the hook (see Fig below, Fig 2, where the arm is between the hook and handle and also located in the plane), where the u/c-shaped hook with the dull tip provides a known shape to engage a spinal implant (#12, paragraph 17).
PNG
media_image2.png
505
939
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify McLuen to include the rescue hook rod with a hook in view of Stone above because the hook allows one to manually adjust the position of the spinal implant. It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the shape of the hook of McLuen as modified by Stone to be u/c-shaped and have a dull tip in view of Crook because this provides a known alternative shape of a hook to engage a spinal implant. The examiner notes that with the modification, the rescue hook (Fig 9 of Stone) would have the u-shaped hook of Cook (Fig 2) and would have a dull tip pointing in a direction substantially/generally parallel to the axis of the straight portion and would be sized according to engage the fusion device. Examiner notes that the modification in view of Cook is a change of shape where applicant has not disclosed that such a U-shape solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing hook to reposition an spinal device. See MPEP 2144.04 (IV)(B).
Buttler discloses an instrument (Fig 7a-7b) with an elongated rod (#3d) wherein the base handle includes a top surface (as seen in Fig 7b) and a bottom surface (opposite the top surface, Fig 7b) that are flat (“flattened sides” paragraph 49, as seen in Figs 7a-7b where the top and bottom surfaces are the flattened sides) and parallel (Fig 7a-7b) a plane (plane of the page as seen in Fig 7b, see also Fig 7b where the plane extends normal to the page) bisecting the elongated arm, where the handle provides a known shape for a surgeon to grip the instrument (abstract, paragraph 8, 38).
It would have been obvious to have ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the rescue rod of McLuen as modified to include a base handle with flat top and bottom surfaces that are parallel in view of Buttler above because this provides a known shape for a surgeon to grip the instrument.
Yeung, pertinent to the problem of indicating the orientation of a distal/working end of a spinal tool, discloses an instrument (Fig 10-13) with an elongated arm (#101) with a base handle (#130) at a first end (Fig 13) and a working tip (#310) at a second end opposite the first end (Fig 13), wherein a surface of the base handle includes a first visual indicator (#153a) that indicates an orientation of the working tip with respect to the base handle (paragraph 201).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the rescue hook rod of McLuen as modified by Stone, to include a base handle with a surface of the base handle that includes a first visual indicator in view of Yeung because the visual indicator an orientation of the tip (hook) with respect to the base handle.
Regarding Claim 37, McLuen as modified discloses at least one of the device channels (#120 as seen in Fig 3 in McLuen, see fig below) has a channel height (dotted line see fig below) and is positioned along a side of the bone fusion device (side as seen in Fig 3 in McLuen, see also Fig below) such that a perimeter of the one of the device channels is defined by a side wall of the body (Fig 3 in McLuen, see also Fig below), wherein the side wall has a side wall width (thickness of the sidewall as best seen in Fig 2 in McLuen shown below).
PNG
media_image3.png
438
589
media_image3.png
Greyscale
Regarding Claim 48, McLuen as modified discloses the claimed invention as discussed above but does not disclose an additional rescue hook rod that matches the rescue hook rod.
However, it would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system of McLuen as modified to include an additional rescue hook rod that matches the rescue hook rod in order to have a spare in case the rescue hook rod is not be able to be used, such as being damaged, not sterilized, misplaced, etc.
Claims 38-39, 49-50, 59 are rejected under 35 U.S.C. 103 as being unpatentable over McLuen US 2013/0211525, Stone US 6,387,130, Crook US 2009/0234364, Buttler US 2014/0371754 and Yeung US 2011/0098628, as applied to claim 36 above, and further in view of Palmatier US 2011/0301712.
Regarding Claim 38-39, McLuen as modified discloses wherein the hook forms a U-shape (as modified by Crook, see annotated figure 2 above) and that the width of the sidewall is relatively thin (as seen in Fig 2 in McLuen), wherein a first portion (portion of the hook that is directly coupled to the straight portion, see Fig 9 of Stone) of the U-shape formed by the hook parallel to the axis of the straight portion plane (with the modification, the rescue hook, Fig 9 of Stone, has a first portion coupled to the straight portion and thus extends parallel to the axis) but does not explicitly disclose the width of the U-shape is slightly greater than the side wall width such that the side wall is able to slide into the hook within the U-shape, the hook has a hook width that is less than the channel height such that the hook is able to slide into the channel.
Palmatier discloses a system (Fig 24e) comprising a bone fusion device (#400) having a device channel (slot #42, paragraph 80, see also Fig 2) with a channel height (height of #42, Fig 2) and is positioned along a side of the bone fusion device (Fig 24e, 2) such that a perimeter of the one of the device channels is defined by a side wall of the body (Fig 2, 24e), wherein the side wall has a side wall width (depth of the slot #42, Fig 2, 24e), a hook (#474) the hook forms a U-shape (Fig 24e) and the width of the U-shape is slightly greater than the side wall width such that the side wall is able to slide into the hook within the U-shape (as seen in Fig 24i where the width is slightly greater than the sidewall width as the hook is engaged with the channel #42), wherein the U-shape formed by the hook parallel to a plane (plane of the page as seen in Fig 24e), and perpendicular to the plane (Fig 24e-24i, perpendicular to the plane defines a width of the hook), the hook has a hook width that is less than the channel height such that the hook is able to slide into the channel (as seen in Fig 24e-24i, paragraph 80), where this allows the hook to engage the channel to move the bone fusion device (paragraph 80).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify McLuen as modified by Stone/Cook to have the width of the U-shape is slightly greater than the side wall width such that the side wall is able to slide into the hook within the U-shape, the hook has a hook width that is less than the channel height such that the hook is able to slide into the channel in view of Palmaetier above because this allows the hook to engage the channel to move the bone fusion device, where a device channel is a known feature for a hook to hook onto to move the bone fusion device. It is noted that with the modification, the hook of Stone would engage the channel from the exterior of the sidewall. The examiner notes that a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). See MPEP 2144.04 (IV)(A).
McLuen as modified also discloses the limitations of Claim 49 (see claim objection above and see rejections for Claims 36-38 above), Claims 50 (see rejection for claim 39 above).
Regarding Claim 59, McLuen as modified discloses the claimed invention as discussed above but does not disclose an additional rescue hook rod that matches the rescue hook rod.
However, it would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system of McLuen as modified to include an additional rescue hook rod that matches the rescue hook rod in order to have a spare in case the rescue hook rod is not be able to be used, such as being damaged, not sterilized, misplaced, etc.
Claims 40, 51 are rejected under 35 U.S.C. 103 as being unpatentable over McLuen US 2013/0211525, Stone US 6,387,130, Crook US 2009/0234364, Buttler US 2014/0371754 and Yeung US 2011/0098628, as applied to claim 4 above, and in further view of Levy US 20170000627.
Regarding Claim 40, 51, McLuen as modified discloses the first visual indicator is positioned on a first side of the base handle (as seen in Fig 13 in Yeung) where the handle discloses a second side (proximal most side of the handle, Fig 13 in Yeung) but does not disclose a second visual indicator is positioned on the second side of the base handle, wherein the second visual indicator indicates the orientation of the hook with respect to the base handle.
Levy discloses an instrument (Fig 6b) with a handle (#49) and a working end (#47) and one or more visual indicators (#51) on the handle (paragraph 54) to indicate the position of the handle and thus the working end (paragraph 54), the visual indicator (#51) positioned on the second side of the base handle (proximal most surface of the handle, Fig 6b) so that the user can see the visual indicator when looking straight down to the handle (ie when the longitudinal axis of the instrument is aligned and parallel with the line of sight of the user) .
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify McLuen as modified to have the second side of the base handle (proximal most end) include a second visual indicator in view of Levy above so that one can visualize the position of the handle and thus the hook when looking straight down onto the handle. The examiner notes that with the modification, the first visual indicator is a line on the first side and the second visual indicator can also be a line aligned with the first visual indicator and thus allows one to see the indicators when the line of sight of the user is transverse to the longitudinal axis of the rescue hook rod or when aligned and parallel to the longitudinal axis of the rescue hook rod.
Claims 48 are rejected under 35 U.S.C. 103 as being unpatentable over McLuen US 2013/0211525, Stone US 6,387,130, Crook US 2009/0234364, Buttler US 2014/0371754 and Yeung US 2011/0098628, as applied to claim 36 above, and further in view of Tomko US 2008/0269756.
McLuen as modified discloses the claimed invention as discussed above but does not disclose an additional rescue hook rod that matches the rescue hook rod.
Furthermore, Tomko discloses a system in the form of a kit (Fig 3) where the kit includes implants and tools including first and second tools (#60a and #60b or #70a and #70b) match each other but are of different sizes (having the same configuration, paragraph 23) where one can use the appropriate sized tool and implant (paragraph 93).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system of McLuen to be in a kit and offering fusion devices and rescue hook rods, where there would be an additional rescue hook that matches the rescue hook rod, in view of Tomko so that one can use the appropriate sized tool and implant. It is noted that the additional rescue hook and the rescue hook rod would match each other (having the same configuration) but just different sizes.
Claims 59 are rejected under 35 U.S.C. 103 as being unpatentable over McLuen US 2013/0211525, Stone US 6,387,130, Crook US 2009/0234364, Buttler US 2014/0371754, Yeung US 2011/0098628 and Palmatier US 2011/0301712, as applied to claim 49 above, and further in view of Tomko US 2008/0269756.
McLuen as modified discloses the claimed invention as discussed above but does not disclose an additional rescue hook rod that matches the rescue hook rod.
Furthermore, Tomko discloses a system in the form of a kit (Fig 3) where the kit includes implants and tools including first and second tools (#60a and #60b or #70a and #70b) match each other but are of different sizes (having the same configuration, paragraph 23) where one can use the appropriate sized tool and implant (paragraph 93).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the system of McLuen to be in a kit and offering fusion devices and rescue hook rods, where there would be an additional rescue hook that matches the rescue hook rod, in view of Tomko so that one can use the appropriate sized tool and implant. It is noted that the additional rescue hook and the rescue hook rod would match each other (having the same configuration) but just different sizes.
Allowable Subject Matter
Claims 42-47, 53-58 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 an examiner’s statement of reasons for allowance:
The claims are similar to that of parent application 17/228,417 and Claims 42-47, 53-58 are indicated allowable of the same reasons as discussed on page 6 of the Notice of Allowance mailed 3/14/2026.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
See PTO-892 for art of cited interest which shows an instrument with a handle having a visual indicator (#176).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773
Prosecution Insights