DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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
This Office action is in response to the applicant’s communication filed on 1/5/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see pages 7-10, with respect to the deficiencies of McDevitt in view of the amended subject matter of claim 62 have been fully considered and are persuasive. Therefore, the previous prior art rejections have been withdrawn. However, upon further consideration, new ground(s) of rejection are made under McDevitt in view of Heaven et al. (US 2010/0198258), as set forth below.
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 (i.e., changing from AIA to pre-AIA ) 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 62-64 and 66-72 are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt et al. (US 5,935,129) in view of Heaven et al. (US 2010/0198258).
McDevitt discloses (see Figs. 1(a)-3(c)) an apparatus (5) and method for anchoring objects to bone (21) and method comprising the following claim limitations:
(claim 62) A method for securing a first object to a second object (i.e., attaching soft tissue to bone, see Abstract; col. 1, lines 6-29), the method comprising providing an apparatus (5, Fig. 1(a)) comprising an elongated body (4, Fig. 1(a)) having a distal end (23, Fig. 2), a proximal end (22, Fig. 2), and a lumen (i.e., shown generally at inner diameter 8 in Fig. 1(a)) extending within the elongated body (4) (as shown in Figs. 1(a)-3(c)), wherein the lumen (8) comprises a first section (13, Fig. 1(a)) at a distal end of the lumen (8) having a first diameter (i.e., widened lumen diameter in camming surface section 13) and a second section (i.e., proximal cylindrical lumen section having inner diameter 8) proximal to the first section (13) having a second diameter (at 8, Fig. 1(a)) that is smaller than the first diameter (as expressly shown in annotated Fig. 1(a) in the Response to Arguments section above); at least one slit (28, Fig. 2) extending through a side wall of the elongated body (4) and communicating with the lumen (as shown in Figs. 1(a)-3(c)), wherein the at least one slit (28) has a distal end (at 28a in Fig. 2) and a proximal end (at 28b in Fig. 2), with the distal end (28a) of the at least one slit (28) being spaced from the distal end (23) of the elongated body (4) (as shown in Fig. 2) and with the proximal end (28b) of the at least one slit (28) being spaced from the proximal end (22) of the elongated body (4) (as shown in Fig. 2); and an expander (2/7, Figs. 1(a)-3(c)) extending through the lumen of the elongated body (4) (as shown in Figs. 1(a)-3(c)), the expander comprising an elongated element (2, Fig. 1(a)) and an expanding portion (7, Fig. 1(a)) located at a distal end of the expander (as expressly shown in (Fig. 1(a)); inserting the elongated body (4) into the second object (21, Fig. 3(a) (as expressly shown in Fig. 3(a)); applying tension to the elongated element (2) to move the expander proximally within the lumen of the elongated body (4) so as to position at least a portion of the expanding portion (7) within the second section of the lumen and adjacent to the at least one slit (28) (as expressly shown in Figs. 3(a)-3(c); col. 4, lines 1-5), wherein positioning the at least a portion of the expanding portion (7) within the second section of the lumen and adjacent to the at least one slit (28) causes the at least one slit (28) to widen (as shown in Figs. 3(b)-3(c)), causing the elongated body (4) to radially expand in the vicinity of the at least one slit (28) (as expressly shown in Figs. 3(a)-3(c); col. 2, lines 5-29 and 41-49);
(claim 63) wherein the at least one slit (28) comprises two longitudinal edges (as shown at each longitudinal edge of slot 28 in Fig. 2), and further wherein when the elongated body (4) is expanded, the two longitudinal edges of the slit (28) expand (as expressly shown in Figs. 3(a)-3(c); col. 2, lines 5-29 and 41-49);
(claim 64) wherein the expanding portion (7) is larger than the lumen in the vicinity of the at least one slit (28) (as shown in Figs. 1(a)-3(c));
(claim 67) wherein the first object comprises tissue and the second object comprises bone (21) (see Abstract; col. 1, lines 6-29 and 56-59; col. 2, lines 5-7; col. 7, lines 57-65; attaching soft tissue via a suture to bone via a bone hole anchor is expressly disclosed);
(claim 68) wherein there are two longitudinally-extending slits (28), and further wherein the two longitudinally-extending slits (28) are diametrically opposed to one another (i.e. an embodiment comprising an even number of slots would provide diametrically opposed slots) (col. 6, lines 53-57; col. 8, lines 38-48; one or more slots and more specifically 2 to 10 slots (with 3-4 slots being the preferred configurations) are expressly disclosed, with exemplary Fig. 7 depicting 3 evenly-spaced slots); and
(claim 69) further comprising an inserter (64, Figs. 3(a)-3(c)) for manipulating the elongated body (4), wherein the expander (2/7) extends through a portion of the inserter (64) (as expressly shown in Figs. 3(a)-3(c); col. 7, lines 9-22).
McDevitt fails to expressly disclose the expander comprising an elongated element in the form of a suture and the expanding portion comprising a suture knot and an enlarged article, wherein the suture passes through soft tissue to secure tissue to bone.
However, Heaven teaches (see Figs. 1A-1E) a similar method for attaching soft tissue to bone comprising an elongated element in the form of a suture (550) and the expanding portion comprising a suture knot (350) and an enlarged article (300), wherein the suture (550) passes through soft tissue to secure tissue to bone (see Abstract and claims 29-30; [0003]; [0008]; [0010]; [0014]; [0058]; [0110]). Accordingly, Heaven teaches that it is known that a suture attached to an expanding portion comprising a suture knot and an enlarged article for securing soft tissue to bone and an elongated element attached to an expanding portion (i.e., disclosed in McDevitt) are elements that are functional equivalents for providing a proximal tensioning element to cause expansion of a bone anchor for attaching soft tissue to bone. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the suture, knot and enlarged article taught by Heaven for the stem and larger diametered portion of McDevitt because both elements were known equivalents for providing a proximal tensioning element to cause expansion of a bone anchor for attaching soft tissue to bone within the suture anchoring art. The substitution would have resulted in the predictable results of providing a proximal tensioning element to cause expansion of a bone anchor for attaching soft tissue to bone to the device of McDevitt.
Allowable Subject Matter
Claims 50-61 are allowed.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious a method for securing a first object to a second object as claimed that includes, in combination with the claim(s) as a whole, regarding claim 50, a first suture loop having an enlargement wherein the first loop and elongated body defining an eyelet proximal to the elongated body and a second suture extending through the eyelet.
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, each teaching an expander comprising a suture and an expanding portion for expanding an anchor when the expander is proximally pulled or tensioned:
Lee et al. (US 5,354,298);
Le et al. (US 5,486,197);
Larsen et al. (US 5,948,000); and
Thelen et al. (US 2006/0052788).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771