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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-16) in the reply filed on 10/17/25 is acknowledged.
Applicant’s election of Group A Species vi (Fig. 14-19) and Group B Species vii (Fig. 14-17) in the reply filed on 10/17/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/17/25.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a tensioning mechanism” in claims 1 and 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 10-16 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.
Claim 10 recites “a tensioning mechanism”, it is unclear to the examiner if this is the same or different than the “tensioning mechanism” introduced in claim 1. It appears to the examiner that it is the same and it should be –the tensioning mechanism--.
Claim Rejections - 35 USC § 102
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 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 and 9-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lantz et al. (2020/0022693).
Lantz discloses the following claimed limitations:
Claim 1: A system (5) ([0092]) for repairing or reconstructing soft tissue, the system comprising: an instrument (20) (Fig. 61 and [0092]) having a handle (300) (Fig. 61 and [0134]) an extension (110) (Fig. 61), the extension opposite the handle (Fig. 61); an implant (10) (Fig. 21 and [0134]), releasably engaged with the instrument (Fig. 19); and a suture (105) threaded through at least a portion of the implant (Fig. 24), wherein the suture is engaged with a tensioning mechanism (wishbone mechanism seen in Fig. 61 and [0134-146] where it is all the parts that go inside housing 305) of the instrument (Fig. 61) .
Claim 2: wherein the implant comprises: a top portion (see figure below); a bottom portion (see figure below); and a body portion (see figure below) disposed between the top portion and the bottom portion (see figure below), wherein the top portion, the bottom portion, and the body portion are arranged about a common longitudinal axis (see figure below) and is monolithic (see figure below).
Claim 3: wherein the implant is cannulated (50) (Fig. 23 and [0093]) through the top portion and at least a portion of at least one of the body portion and the bottom portion (Fig. 23 and [0093]).
Claim 4: wherein the implant further comprises: at least one vent (85) disposed along an outer surface of at least one of the top portion and the body portion (see figure below), wherein the at least one vent establishes fluid communication between the outer surface and an inner surface the implant (see figure below)
PNG
media_image1.png
408
783
media_image1.png
Greyscale
Claim 9: wherein the implant is releasably couplable with a tip (tip seen in Fig. 33 and 34) of the extension of the implant instrument (Fig. 33-34).
Claim 10: wherein the instrument comprises a tensioning mechanism (wishbone mechanism seen in Fig. 61 and [0134-146] where it is all the parts that go inside housing 305) disposed within a housing (305) of the instrument (Fig. 61 and [0134-146]).
Claim 11: wherein the tensioning mechanism comprises: a first arm (see figure below); a second arm (see figure below); and a resilient member (see figure below).
Claim 12: wherein the second arm is pivotably coupled with the first arm (see figure below).
Claim 13: wherein the instrument further comprises: a track (path where suture passes as seen in Fig. 72) disposed on at least a portion of an outer surface of the handle (Fig. 72), wherein the track is configured to receive at least a portion of the suture at least partially therein (Fig. 72)
Claim 14: wherein the second arm comprises an engagement portion (see figure above) configured to engage with at least a portion of the suture (see figure below), wherein the engagement portion is arranged adjacent to at least a portion of the track (Fig. 68-72)
Claim 15: wherein the resilient member is a spring (340) (Fig. 61 and [0134-146]).
Claim 16: wherein actuation of at least one of the first arm and the second arm compresses the spring ([0144]).
PNG
media_image2.png
810
818
media_image2.png
Greyscale
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 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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barbieri et al. (2006/0276841) in view of Martinek et al. (2005/0240199).
Barbieri discloses the following claimed limitations:
Claims 1 and 10:
Barbieri discloses a system for repairing or reconstructing soft tissue, the system comprising: an instrument (12) (Fig. 1 and [0089]) having a handle (14) (Fig. 1 and [0089]) an extension (16) (Fig. 1 and [0089]), the extension opposite the handle (Fig. 1); an implant (28, 112) (Fig. 1 and 29), releasably engaged with the instrument (Fig. 17-18); and a suture (22) threaded through at least a portion of the implant (Fig. 1, 12, 13, and 35).
Barbieri discloses all the claimed limitations above including a delivery instrument (Fig. 1), however Barbieri does not specify the details of the delivery instrument specifically a tensioning mechanism.
Martinek discloses the same delivery instrument as Barbieri however Martinek discloses the details of the instrument including a tenisoning mechanism (116) disposed within a housing (102) of the instrument (Fig. 1-4 and [0051]).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Barbieri with the tensioning mechanism in view of the teachings of Martinek, in order to maintain the suture tension during the procedure ([0051]).
Barbieri further discloses:
Claim 2: wherein the implant comprises: a top portion (see figure below); a bottom portion (see figure below); and a body portion (see figure below) disposed between the top portion and the bottom portion (see figure below), wherein the top portion, the bottom portion, and the body portion are arranged about a common longitudinal axis (33) and is monolithic (see figure below).
Claim 3: wherein the implant is cannulated (120) (Fig. 28, 29, 32, and 33 and [0114]) through the top portion and at least a portion of at least one of the body portion and the bottom portion (see figure below and Fig. 28, 29, 32, and 33 and [0114]).
Claim 4: wherein the implant further comprises: at least one vent (118) disposed along an outer surface of at least one of the top portion and the body portion (see figure below), wherein the at least one vent establishes fluid communication between the outer surface and an inner surface the implant (Fig. 28, 29, 32, and 33)
Claim 5: wherein the implant further comprises: a threading (116, see figure below) disposed along at least a portion of the outer surface of the top portion and the body portion (see figure below), wherein the threading comprises a plurality of threads equidistantly spaced from one another (Fig. 28, 29, 32, and 33 and [0114]).
Claim 6: wherein the threading is configured to span at least a portion of the at least one vent (see figure below).
Claim 7: wherein the implant further comprises: at least one tap (see figure below) arranged on an outer surface of the bottom portion of the implant (see figure below).
Claim 8: wherein the at least one tap comprises a plurality of taps (see figure below) arranged about the outer surface of the bottom portion of the implant (see figure below), wherein the plurality of taps protrude from the outer surface and are equidistantly spaced from one another (see figure below).
PNG
media_image3.png
701
834
media_image3.png
Greyscale
Claim 9: wherein the implant is releasably couplable with a tip (18) of the extension of the implant instrument (Fig. 1 and [0089]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art appears to teach the claimed limitations when considered alone or in combination.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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, Elizabeth Houston can be reached at (571) 272-7134. 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.
/DIANNE DORNBUSCH/ Primary Examiner, Art Unit 3771