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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/5/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 and 5-7 have been considered, but are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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.
Claims 1, 7, and their dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Amended claim 1 states that the at least one loop is separate from the soft anchor member. New claim 7 states that each of the loops are configured to slide independently of the soft anchor member. The disclosure does not appear to have adequate support for these limitations. While the Applicant has cited paragraph 0014 from the present specification for support for these amendments, paragraph 0014 only describes the loops being separate and independent from each other. It does not describe the soft anchor member also being separate and independent. Appropriate correction and/or clarification is required.
Claim 3 and its dependent claims are 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. Amended claim 3 states “the anchor comprises two loops passing through the series of slots in the anchor member.” It is unclear if the two loops of claim 3 are intended to be part of the same element as the “at least one loop” recited in claim 1. Claim 3 also states “wherein loop further comprises a fixed end attached to the other loop and a free end.” It is unclear if this recitation is intending to refer to one of the two loops or to each of the two loops. It is further unclear if the free end recited in claim 3 encompasses the same element as the free end recited in claim 1. Appropriate correction and/or clarification is required.
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) 1-3 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone et al. (Pub. No. US 2007/0185532 A1; hereinafter “Stone”) in view of Jaervinen (WO 01/95835 A1).
Stone teaches the following regarding claim 1: a method of attaching soft tissue to bone (para. 0042), comprising the steps of: providing a soft anchor member (e.g., 100) (Figs. 5-7I) having a series of slots (openings at ends and on the body of elements 100) formed therein (Figs. 5-7I); providing at least one loop (e.g., 104 and/or 106) separate from the soft anchor member (Figs. 5-7I) and having a predetermined diameter that is woven through the series of slots in the anchor member (e.g., Figs. 5-7I) and terminates in a free end (e.g., 106a, 106b) that, when pulled, will cause the loop to slide relative to the anchor member (paras. 0044-0047, 0050-0051); driving the anchor member into a bone so that the loop remains on the outside of the bone (e.g., Figs. 6, 19; paras. 0042); passing a soft tissue through the loop (paras. 0042, 0046-0051); pulling the free end of the loop to reduce the diameter of the loop until the soft tissue is securely trapped within the loop (paras. 0046-0051).
Stone teaches the limitations of the claimed invention, as described above. However, it does not specify that the soft tissue being secured to the bone is a tendon. Jaervinen teaches that it is well known in the art that a fixation anchor is utilized for attaching ligaments or tendons to the bone (abstract; pgs. 16-17), as would be needed to properly address the injury or damaged tissue for a particular patient. It would have been obvious to one having ordinary skill in the art to apply the invention of Stone to a soft tissue tendon and bone, as taught by Jaervinen, in order to properly address the injury or damaged tissue for a particular patient. Such a modification would be made with a reasonable expectation of success.
Stone teaches the following regarding claim 2: the method of claim 1, wherein the anchor member transitions from a first configuration (pre-anchored configuration) that was able to pass through the hole in a bone (Figs. 5, 10; paras. 0044-0051) into a second configuration (fully anchored configuration) that cannot pass through the hole in the bone in response to sliding of the loop relative to the anchor member as the free end of the loop is pulled (e.g., Figs. 6, 7B; paras. 0044-0051).
As best interpreted, Stone teaches the following regarding claim 3: the method of claim 2, wherein the anchor comprises two loops (e.g., 104, 106) passing through the series of slots in the anchor member (Figs. 5-7I), wherein loop further comprises a fixed end (enclosed ends of 104, 106) attached to the other loop (Figs. 5-7I) and a free end (106a, 106b) configured to slide relative to the other loop (paras. 0044-0057, 0050-0051) and wherein the fixed ends are configured to form a tube through which the free end of the other loop can freely pass (Fig. 5).
Stone teaches the following regarding claim 7: the method of claim 3, wherein each of the loops are configured to slide through the plurality of slots independently of each other and of the soft anchor member (paras. 0044-0051).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone in view of Jaervinen, further in view of Hu et al. (CN 104814786 A; hereinafter “Hu”).
Stone, as modified by Jaervinen, teaches the limitations of the claimed invention, as described above. Stone further recites an inserter (130) extending along a longitudinal axis (Fig. 10). However, they do not recite using the inserter having a first end configured as a fork having a pair of spaced apart tines, which are configured to form a hole in a bone when driven therein. Hu teaches that it is well known in the art that an orthopedic procedure comprises using an inserter instrument (30), having a first end configured as a fork having a pair of spaced apart tines (Fig. 8), which are inserted into a patient and configured to form a hole in a bone when driven therein (pg. 7 of the provided English translation), for the purpose of allowing the user to more easily form a hole in the patient’s bone at the desired size and location. It would have been obvious to one having ordinary skill in the art to modify the invention of Stone and Jaervinen to utilize an inserter instrument, as taught by Hu, in order to allow the user to more easily form a hole in the patient’s bone at the desired size and location. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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