DETAILED ACTION
Election/Restrictions
Applicants’ election with traverse of Group 1, claims 1-12 in the reply filed on 8/14/2026 is acknowledged. The traversal is on the ground(s) that there is no necessary burden to sustain the requirement for election of all claims. This is not found persuasive because the examination of invention 2 would require a complete search of the CPC group 2 A61B17/0401 (48,709 hits), wherein the elected group 1, the CPC of group 1 A61B2017/0409 (29,985 hits) would not. The CPC of group 1 contains over 29,985 patent documents that are not classified in any of the search area for nonelected invention 2. This would place a serious search burden if a restriction were not required.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/14/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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) 1-4, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Housman et al U.S 2021/0290218.
Claim 1: Housman et al disclose an insertion tool for inserting a suture anchor into bone as best seen in figures 4a-b, comprising: a handle 407; an intermediate shaft 405/505 extending along a longitudinal axis between a proximal end and a distal end, the proximal end of the intermediate shaft being rotatably coupled to the handle (see paragraph 41) and the distal end of the intermediate shaft being configured to couple to an anchor body 400 of a suture anchor 401, the intermediate shaft 405/505 being rotatable relative to the handle 407 so as to rotate the anchor body relative to the handle; an inner shaft 403 concentrically disposed within the intermediate shaft (see figure, 4a), the inner shaft having a distal end configured to couple to an eyelet (see claim 12) positionable distally of and separate from the anchor body; and an outer shaft 417 concentrically disposed about the intermediate shaft and configured to translate distally relative to the handle so as to advance the anchor body distally towards the eyelet (see paragraphs 12,38).
Claims 2-3: Housman et al disclose wherein the inner shaft 403 is rotationally
fixed relative to the handle 407; wherein the distal end of the intermediate shaft 405/505 has a keyed outer profile complementary to an inner profile of a passage within the anchor body 400, see paragraph 10.
Claim 4: Housman et al disclose wherein rotation of the intermediate shaft 405/505 relative to the handle 407 and distal translation of the outer shaft relative to the handle are both driven by a rotatable knob coupled to the handle (see paragraph 11).
Claim 9: Housman et al disclose a system for inserting a suture anchor 401 into bone, comprising: the insertion too (see fig. 4a, paragraph 37) of claim 1; the anchor body 400; and the eyelet (see claim 12).
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palese WO 2019/014557.
Claim 1: Palese disclose an insertion tool 22 for inserting a suture anchor into bone as best seen in figures 1a-b, comprising: a handle 28/32; an intermediate shaft 6 extending along a longitudinal axis between a proximal end and a distal end, the proximal end of the intermediate shaft 6 being rotatably coupled to the handle (see paragraph 67) and the distal end of the intermediate shaft being configured to couple to an anchor body 12 of a suture anchor 10, the intermediate shaft 6 being rotatable relative to the handle 28/32 so as to rotate the anchor body relative to the handle (see figures 5,6, paragraph 71); an inner shaft 26 concentrically disposed within the intermediate shaft (see figure, 5), the inner shaft having a distal end configured to couple to an eyelet (16) positionable distally of and separate from the anchor body 12; and an outer shaft 24 concentrically disposed about the intermediate shaft (see fig. 6) and configured to translate distally relative to the handle so as to advance the anchor body distally towards the eyelet (see paragraph 65).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Housman et al in view of Baird AU 2012319123.
Claim 8: Housman et al disclose the invention substantially as claimed, but is silent regarding wherein the handle includes at least one cleat along an outer surface of the handle, the cleat being configured to secure a free end of a repair suture extending proximally from the eyelet. However, Baird teaches the handle 40 includes at least one cleat 34 along an outer surface of the handle, the cleat being configured to secure a free end of a repair suture extending proximally from the eyelet 28 (it is noted that the anchoring system further comprises an insertion member which is engageable with the anchor body to deploy the anchor in bone. The insertion member comprises a proximal handle portion and an insertion tube connected to a distal end of the handle portion. A suture pulley rod is extendable from and 15 retractable into a distal end of the insertion tube. A pair of cleat retainers are provided on a distal end of the pulley rod, wherein a gap is disposed between the pair of cleat retainers. A rotatable knob is disposed on the handle portion for retracting and extending the pulley rod relative to the insertion tube. A knob release slide disposed on the handle. 20 In another aspect of the invention, there is disclosed a method for securing soft tissue to bone, which comprises steps of driving an implantable anchor having a body distally into a desired bone site, using an insertion device, to a predetermined initial deployment depth, and applying pressure to suture or tissue disposed between the anchor body and adjacent bone, using a recess disposed on an 25 outer surface of the body and a pinch ramp also disposed on the outer surface of the body, proximal to the suture recess. Additional steps include tensioning free ends of the suture or tissue disposed between the anchor body and adjacent bone to a 4 A-2562PCT desired level, withdrawing a pulley rod proximally into an insertion tube comprising a portion of the insertion device, and driving the implantable anchor a further distance distally into the bone site to finally deploy the anchor. The suture or tissue is pinched between barbs on an outer surface of the implant body and 5 adjacent bone and also between cleats on both sides of the anchor body to lock the suture or tissue in place. Further inventive method steps include withdrawing the pulley rod from the anchor body and releasing the insertion device therefrom; and trimming the free suture ends to complete the procedure. In still another aspect of the invention, there is provided an anchoring 10 system for securing tissue to bone, which comprises an insertion member which is engageable with an anchor body to deploy the anchor body in bone. The insertion member comprises a proximal handle portion, an insertion tube connected to a distal end of the handle portion, and a suture pulley rod extendable from and retractable into a distal end of the insertion tube. A pair of cleat retainers are 15 disposed on a distal end of the pulley rod, wherein a gap is disposed between the pair of cleat retainers. A rotatable knob is provided on the handle portion for retracting and extending the pulley rod relative to the insertion tube, and a knob release slide is disposed on the handle. The invention, together with additional features and advantages thereof, 20 may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawing. Brief Description of the Drawings 25 Figs. 1-4 are isometric views of an implantable anchor constructed in accordance with the principles of the present invention, illustrating the anchor from four different perspectives). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Housman et al with the handle includes at least one cleat along an outer surface of the handle, the cleat being configured to secure a free end of a repair suture extending proximally from the eyelet as taught by Baird in order to pinch the suture to increase the pullout strength of the suture construct.
Allowable Subject Matter
Claims 5-7,10-12 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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, Darwin Erezo can be reached at 571-272-4695. 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.
/VI X NGUYEN/Primary Examiner, Art Unit 3771
Prosecution Insights