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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 03/19/2026. Claim 1 is amended. Claims 6-10 are cancelled. Claims 23-27 are new. Claims 1-5 and 11-27 are currently pending, with claims 5 and 11-22 withdrawn from consideration.
The objection of claim 1 has been withdrawn due to applicant’s amendment.
The rejection of claims 1-4 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment; however, see new rejection of claim 1 under 35 U.S.C. 112(b) below.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/19/2026, with respect to the rejection(s) of claim(s) 1-2 and 4 under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden; and claim 3 under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden and White, have been fully considered but are not persuasive.
Applicant argues Stone and Spedden do not teach the newly recited limitations, because Stone and Spedden are directed towards a single, individual anchor (Remarks, pg. 7).
In response to applicant’s argument, it is respectfully submitted the arguments are narrower than the claim limitations. As previously discussed, the term ‘separate’ does not preclude separate structures of a single device meeting the claimed limitation. Further, the claim language recites multiple structures defining a single tether, as well as several ‘portions’ of an anchor, such that multiple portions of a single device is considered to meet the claim limitation. Accordingly, the rejection is maintained.
Applicant’s arguments with respect to claims 23-27 have been fully considered, and new claims 23-27 are rejected as discussed below.
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, line 16, the phrase “configured to coupled the second ends” should read “configured to couple the second ends”. Appropriate correction is required.
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: “interlock mechanism…configured to couple” in claim 1.
Para. [0080] of the published application describes the mechanism configured to couple as clamps, clips, locks, etc. or any suitable mechanism to secure the two tether portions together. “Mechanism configured to couple” uses the generic placeholder “mechanism” coupled with the term “configured to couple”, and the term “mechanism” is not preceded by a structural modifier since the term “configured to couple” does not imply any structure.
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.
Claims 1-4 and 23-27 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.
Regarding claim 1, the claim recites “when the first and second anchors are fully dep[;ed” in line 17. It is unclear what term is being referred to, as there appears to be a typo. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to recite when the first and second anchors are fully deployed, which appears consistent with the instant specification.
Regarding claim 23, the claim recites “the interlocking mechanism”. There is insufficient antecedent basis for this limitation in the claim, since an interlocking mechanism has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the interlock mechanism previously introduced.
Regarding claim 24, the claim recites “the interlocking mechanism”. There is insufficient antecedent basis for this limitation in the claim, since an interlocking mechanism has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the interlock mechanism previously introduced.
Regarding claim 25, the claim recites “the interlocking mechanism”. There is insufficient antecedent basis for this limitation in the claim, since an interlocking mechanism has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the interlock mechanism previously introduced.
Regarding claim 26, the claim recites “the interlocking mechanism”. There is insufficient antecedent basis for this limitation in the claim, since an interlocking mechanism has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the interlock mechanism previously introduced.
Regarding claim 27, the claim recites “the tightening mechanism”. There is insufficient antecedent basis for this limitation in the claim, since a tightening mechanism has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the tightening capability previously introduced.
Further, the claim recites “the interlocking mechanism”. There is insufficient antecedent basis for this limitation in the claim, since an interlocking mechanism has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the interlock mechanism previously introduced.
Claims 2-4 are indefinite due to their dependencies on indefinite base claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 1-2, 4, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 2011/0208239 A1) (previously of record) in view of Spedden (US 2009/0318962 A1) (previously of record).
Regarding claim 1, Stone discloses (see abstract; paras. [0038]-[0073]; figs. 2-14b) a tethered anchor (10D, figs. 5-5a) comprising:
a first anchor (includes 46 and second portion 30, fig. 5) including a first anchor portion (46, para. [0039]) and a first tether portion (second portion 30, paras. [0039] and [0052]; figs. 2 and 5), the first tether portion being elongate (fig. 5) and extending between a first end and a second end (annotated fig. 5a), the first tether portion being formed of a flat construct (formed of flat construct 74, para. [0050]; fig. 5), the first anchor portion defining a width that is greater than a width of the first tether portion (see width of loop 46 being greater than width of second portion 30, figs. 5-5a), the first anchor portion being integrally formed with the first tether portion (single or unitary structure 14, para. [0038]; fig. 5) and configured to anchor to tissue at a first position (depicted in fig. 5b anchored to soft tissue 75, para. [0051]) and extending from the first end of the first tether portion (depicted in figs. 5-5a);
a second anchor (includes 47 and second end 26) separate from the first anchor (considered to be separate from the structures forming the first anchor, since the instant spec. does not provide a special definition for the term “separate”, and the Merriam-Webster dictionary definition defines the term as “to make a distinction between” or “individual”, such that loops 46 and 47 and their respective tether portions are considered to be distinct/individual and therefore separate, fig. 5a) and including a second anchor portion (47, para. [0050]) and a second tether portion (second end 26), the second tether portion being elongate (fig. 5) and extending between a first end and a second end (annotated fig. 5a), the second anchor portion being integrally formed with the second tether portion (fig. 5) and configured to anchor to tissue at a second position (para. [0045]; fig. 5b) extending from the first end of the second tether portion, the second position being spaced from the first position (fig. 5b); and
an interlock mechanism (34, considered to correspond to the structure disclosed for the mechanism interpreted under 112(f), since 34 provides self-locking capability of the loops, paras. [0039] and [0044]) separate from the first and second anchors (considered to be distinct from 46 and 47, fig. 5a), the interlock mechanism configured to coupled the second ends of the first and second tether portions together (via locking, para. [0043]) when the first and second anchors are fully deployed so as to define a single tether (single tether depicted in figs. 5-5b), the interlock mechanism having a tightening capability (via tension and self-locking, paras. [0042]-[0044]) configured to adjust a length of the single tether (considered to be capable of adjusting the length of the tether when tension is applied causing suture 14 to constrict and reduce in diameter, as this limitation is functional, and the first and second tether portions are considered to be capable of adjusting in length when pulled, or when additional tension by the accordion configuration 34 is applied after the size of the loop is set, paras. [0042]-[0044]).
However, Stone fails to disclose the flat construct specifically being formed of film.
Spedden teaches (paras. [0013]-[0016], [0179] and claim 8; figs. 1 and 6), in the same field of endeavor, a tethered anchor (paras. [0054] and [0168]) comprising a tether portion (suture construct, paras. [0013]-[0016] and [0179]), the tether portion formed of a film construct (formed of film layers, para. [0179]), for the purpose of integrating and incorporating bioactive materials into the suture construct for long-term delivery, enabling medical personnel to utilize and reintroduce bioactive materials extracted from a patient to a wound or target surgical site for therapeutic purposes (abstract, paras. [0011]-[0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the tethered anchor of Stone to comprise a plurality of film layers, in order to provide the capability of integrating and incorporating bioactive materials into the anchor for long-term delivery, enabling medical personnel to utilize and reintroduce bioactive materials extracted from a patient to a wound or target surgical site for therapeutic purposes when desired, based on the suggestions and teachings of Spedden (abstract, paras. [0011]-[0016]).
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Annotated Figure 5A of Stone
Regarding claim 2, Stone (as modified) teaches the anchor of claim 1. Stone (as modified) further teaches wherein the flat film construct comprises a plurality of layers of film material (para. [0179] of Spedden).
Regarding claim 4, Stone (as modified) teaches the anchor of claim 1. Stone further discloses wherein the first tether portion and the first anchor portion have substantially the same thickness (formed of single or unitary structure 14, considered to have the same thickness, figs. 2 and 5) where the first tether portion extends from the first anchor portion (figs. 2 and 5-5a).
Regarding claim 23, Stone (as modified) teaches the tethered anchor of claim 1. Stone further discloses wherein the interlocking mechanism is a clamp (considered to be a clamp, as the instant spec. does not provide a specific definition of the term ‘clamp’, therefore, under broadest reasonable interpretation, a clamping structure binds or constricts pressing two or more parts together to hold them firmly, and 34 is considered to press the first and second tether portions together to hold them firmly, figs. 5-5a).
Regarding claim 25, Stone (as modified) teaches the tethered anchor of claim 1. Stone further discloses wherein the interlocking mechanism is a lock (considered to be a lock due to self-locking capability, paras. [0043]-[0044]).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden as applied to claim 2 above, and further in view of White (US 2010/0168864 A1) (previously of record).
Regarding claim 3, Stone (as modified) teaches the anchor of claim 2.
However, Stone (as modified) fails to teach further comprising at least one radiopaque marker inserted between the plurality of layers of film material.
White teaches (para. [0164]), in the same field of endeavor, a tethered anchor (abstract) comprising a plurality of layers (articular layer 105 formed by one or more layers of material, para. [0055]), and further comprising at least one radiopaque marker (para. [0164]) inserted between the plurality of layers (embedded in layer 105, considered to encompass being inserted between layers, para. [0164]), for the purpose of augmenting the visibility of the device when implanted as viewed by X-ray and/or fluoroscopic equipment (para. [0164]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of layers of film material of Stone (as modified) to include a radiopaque marker inserted between the plurality of layers, in order to augment the visibility of the device when implanted as viewed by X-ray and/or fluoroscopic equipment when desired, based on the suggestions and teachings of White (para. [0164]).
Claim(s) 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden as applied to claim 1 above, and further in view of Overes (US 2011/0270278 A1).
Regarding claim 24, Stone (as modified) teaches the tethered anchor of claim 1.
However, Stone (as modified) fails to teach wherein the interlocking mechanism is a clip.
Overes teaches (para. [0280]; figs. 22a-c), in the same field of endeavor, a tethered anchor (figs. 22a-c), wherein an interlocking mechanism is a clip (154), in place of alternative interlocking mechanisms (see at least twist tie 132, para. [0265]; fig. 19c).
The substitution of one known element (the interlocking mechanism as a clip) for another (the interlocking mechanism as strands wrapped or twisted around each other, para. [0265] of Overes, fig. 5a of Stone) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the clip as taught by Overes, would have yielded predictable results, specifically, securing strands and preventing the strands from moving relative to each other when desired.
Regarding claim 26, Stone (as modified) teaches the tethered anchor of claim 1.
However, Stone (as modified) fails to teach wherein the interlocking mechanism is a latch.
Overes teaches (paras. [0291]-[0292]; figs. 25a-b), in the same field of endeavor, a tethered anchor (figs. 25a-b), wherein an interlocking mechanism is a latch (ratchet teeth of collar and strands considered to constitute a latch), in place of alternative interlocking mechanisms (see at least twist tie 132, para. [0265]; fig. 19c).
The substitution of one known element (the interlocking mechanism as a latch) for another (the interlocking mechanism as strands wrapped or twisted around each other, para. [0265] of Overes, fig. 5a of Stone) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the latch as taught by Overes, would have yielded predictable results, specifically, securing strands and preventing the strands from moving in a specific direction relative to each other when desired.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Stone in view of Spedden as applied to claim 1 above, and further in view of Martin (US 2015/0066081 A1).
Regarding claim 27, Stone (as modified) teaches the tethered anchor of claim 1.
However, Stone (as modified) fails to teach wherein the tightening mechanism includes a screw or knob on the interlocking mechanism which, when activated, is configured to bring the first anchor portion and the second anchor portion closer together.
Martin teaches (para. [0172]; figs. 20a-21), in the same field of endeavor, a tethered anchor (4001) comprising a tightening mechanism (4000) including a screw (4076), in place of alternative locking mechanisms (para. [0145]).
The substitution of one known element (the interlocking mechanism including a screw) for another (alternative locking mechanisms, para. [0145] of Martin, fig. 5a of Stone) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the interlocking mechanism including a screw as taught by Martin, would have yielded predictable results, specifically, enhancing the friction effect and increasing the holding force of the tether when desired.
Stone (as modified) further teaches wherein the tightening mechanism includes a screw on the interlocking mechanism which, when activated, is configured to bring the first anchor portion and the second anchor portion closer together (combination considered to further teach the interlocking mechanism including a screw, which upon tightening would reduce the length of the first and second tether portions relative to each other, such that the screw is considered to be capable of bringing the first and second anchor portions of Stone closer together).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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