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Patent Application 17748301 - SYSTEMS AND METHODS FOR JOINT FUSION - Rejection

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Patent Application 17748301 - SYSTEMS AND METHODS FOR JOINT FUSION

Title: SYSTEMS AND METHODS FOR JOINT FUSION

Application Information

  • Invention Title: SYSTEMS AND METHODS FOR JOINT FUSION
  • Application Number: 17748301
  • Submission Date: 2025-04-07T00:00:00.000Z
  • Effective Filing Date: 2022-05-19T00:00:00.000Z
  • Filing Date: 2022-05-19T00:00:00.000Z
  • National Class: 623
  • National Sub-Class: 021190
  • Examiner Employee Number: 83337
  • Art Unit: 3775
  • Tech Center: 3700

Rejection Summary

  • 102 Rejections: 2
  • 103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

Office Action Text


    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 .

Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.


The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.


Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.
In claim 20, “the staple” lacks a proper antecedent. It appears that claim 20 should depend from claim 17 and will be considered as such for the purposes of examination. 

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) 1-6, 12, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dacosta et al. (U.S. Publication No. 2019/0336140).
	Dacosta et al. discloses a method of fusing a joint (abstract), the method comprising: inserting a first temporary bone fixation member (614) into a first bone (602) at a first distance from a joint between the first bone and a second bone (604) (Figure 63); excising the joint to create a resected joint, the excising step comprising: cutting a base of the first bone adjacent the joint; and cutting a base of a second bone adjacent the joint (Paragraph 185, “after the bones 602, 604 have been cut…”); inserting a second first temporary bone fixation member (616) into the second bone at a second distance relative to the resected joint (Figure 63); compressing the joint using a compressor block (550) such that a resected face of the first bone is moved towards a resected face of the second bone (it can be construed from paragraph 185 and figures 63, 64 that the joint is compressed); and after the compressing step, permanently fixing the first bone to the second bone across the resected joint (paragraph 185).
Regarding claim 2, the first bone is a metatarsal, the second bone is a cuneiform or cuboid bone, and the joint is a tarsometatarsal joint (paragraph 180).
Regarding claim 3, the method further comprising placing a reversible cut guide (100, it is noted that “reversible does not bear any inherent structure and the guide of Dacosta is reversible if one so desires) across a joint in a first orientation (Figure 54), the reversible cut guide comprising: a body having a first portion (140) and an opposed second portion (130); a primary temporary bone fixation hole (142) that extends through the first portion of the body; a second temporary bone fixation hole that extends through the second portion of the body (132) parallel to the first temporary bone fixation hole (Figure 1, 58); and a cutting slot (116) that extends through the body between the first and second temporary bone fixation holes (Figure 1).
Regarding claim 4, the method further comprising inserting an auxiliary bone fixation member (610) into the first bone through an auxiliary bone fixation hole (144) that extends through the first portion (140) of the reversible cut guide (Figure 58).
Regarding claim 5, in the first orientation the cutting slot is aligned with the base of the first bone, and the excising step further comprises cutting the base of the first bone through the slot (Figure 62, paragraph 184).
Regarding claim 6, the reversible cut guide further includes a paddle (128) that extends from the body between the first and second portions of the cut guide; and the method further comprises inserting the paddle into the joint (Figure 54).
Regarding claim 12, the method further comprising prior to compressing the joint, inserting a spacer (128) into the resected joint between the first bone and the second bone. Since element 128 is in the joint during resection, it is considered still inserted in the resected joint. Furthermore, since the guide is removed and then the joint compressed, the “spacer” is inserted in the resected joint prior to compressing. 
Regarding claim 13, the compressor block (550) comprises: a block body having a bone-facing surface (556) and an opposed outer surface (554); a proximal temporary bone fixation hole (570) that extends through the body from the outer surface to the bone-facing surface at a first angle of less than 90 degrees relative to the top surface and the bottom surface (Figure 65, the trajectory of hole 572 is less than 90 degrees to the top and bottom surfaces of the compressor block at a point away from hole 570); and a distal temporary bone fixation hole (572) extending through the body from the outer surface to the bone-facing surface at the first angle (the two holes as seen in figure 65 have mirroring angles) relative to the outer surface and the bone-facing surface, wherein the proximal and distal bone fixation holes converge as they extend from the outer surface to the bone-facing surface (Figure 65).
Claim(s) 1, 17, 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hollis et al. (U.S. Publication No. 2021/0022879).
Hollis et al. discloses a method of fusing a joint (paragraph 5), the method comprising: inserting a first temporary bone fixation member (310) into a first bone (104) at a first distance from a joint between the first bone and a second bone (108) (Figure 12B); excising the joint to create a resected joint, the excising step comprising: cutting a base of the first bone adjacent the joint; and cutting a base of a second bone adjacent the joint (Paragraph 122); inserting a second first temporary bone fixation member (316) into the second bone at a second distance relative to the resected joint (Figure 13); compressing the joint using a compressor block (500) such that a resected face of the first bone is moved towards a resected face of the second bone (paragraph 136, “the resected face 104a…can be abutted against resected face 108a…”); and after the compressing step, permanently fixing the first bone to the second bone across the resected joint (Figure 22).
Regarding claim 17, the step of permanently fixing the first bone to the second bone comprises placing a staple (726) over the joint such that a first leg of the staple is inserted into the first bone and a second leg of the staple is inserted into the second bone (Figure 18, 22).
Regarding claim 21, the joint is fixed using a bone plate (710) and a plurality of bone screws (730), and wherein at least one of the plurality of bone screws is a cross screw extending at an angle of less than 90 degrees relative to the bone plate (as seen in Figures 19 and 20, aperture 717 would direct a screw with an angle of less than 90 degrees relative to the rest of the bone plate).

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) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hollis et al. (U.S. Publication No. 2021/0022879) in view of Gaston et al. (U.S. Publication No. 2020/0000464).
Hollis et al. discloses the claimed invention except for placing the staple includes: positioning a guide leg of a drill guide over the first bone; pre-drilling a first pilot hole in the first bone through the first guide leg; positioning a second guide leg of the drill guide over the second bone; pre-drilling a second pilot hole in the second bone through the second guide leg; and inserting the first leg of the staple in the first pilot hole and the second leg of the staple in the second pilot hole.
Gaston teaches a method of inserting a staple to fuse a joint (120) by positioning a guide leg (41) of a drill guide (27) over the first bone (115); pre-drilling a first pilot hole in the first bone through the first guide leg (Figure 18); positioning a second guide leg (43) of the drill guide (27) over the second bone (110); pre-drilling a second pilot hole in the second bone through the second guide leg (Figure 17); and inserting the first leg of the staple in the first pilot hole and the second leg of the staple in the second pilot hole (Figure 20, 21). This allows for a precise desired orientation of the bones (Paragraph 5). 
It would have been obvious to one skilled in the art at to modify the method of inserting the staple of Hollis et al. with the method as taught by Gaston, as such would provide for a precise orientation of the bones. 
Regarding claim 20, it is noted that Gaston teaches that the first and second pilot holes are drilled over guide wires 30 with a cannulated reamer (31). Furthermore, Hollis discloses that the staple is inserted where the temporary fixation members were (Figures 16-18). Thus, it would have been obvious with a high likely hood of success to drill pilot holes with a cannulated reamer over the temporary bone fixation members with the combination of Hollis and Gaston to provide the benefits of a precise desired orientation of the bones. 

Allowable Subject Matter
Claims 7-11, 14-16, 19, 22-24 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 prior art alone or in combination fails to disclose a method of fusing a joint removing the reversible cut guide from the first orientation and placing it across the joint in a second orientation opposite the first.
The prior art alone or in combination fails to disclose the use of the compressor block where proximal and distal temporary fixation members are inserted into respective proximal and distal temporary bone fixation holes of the compressor block. 
The prior art alone or in combination fails to disclose removing the temporary bone fixation members and pre-drilling pilot holes during the staple insertion process. 
The prior art alone or in combination fails to disclose that a bone plate is used to secure the joint such that it is slid over the first and second pins prior to compressing the joint and inserting a first screw through a first aperture of the bone plate. 

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.
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, Kevin Truong can be reached on 571-272-4705. 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.





/ANDREW YANG/Primary Examiner, Art Unit 3775                                                                                                                                                                                                        


    
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
    


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