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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/09/2025 has been entered.
Response to Amendment
The amendment filed 12/09/2025 has been entered. Claims 1-4 and 6-21 remain pending in the application, claim 5 is cancelled, and claims 17-20 are withdrawn. Applicant’s amendments to the claims have overcome the 112(b) rejections and the interpretation of the prior art rejection previously set forth in the Final Office Action mailed 09/09/2025, however a new rejection of Hiorth in view of Haasl (figure 4 embodiment) is applied as outlined below.
As discussed in the Applicant-initiated interview of 12/03/2025, the amendments overcame the rejection of Haasl with respect to the figure 6 embodiment. However after further consideration of Haasl, the embodiment of figure 4 reads on the claim language and the shape of the hooks/tips of figure 4 are similar to that of Applicant’s hooks/tips of figure 49B and 50B.
Response to Arguments
Applicant’s amendments filed 12/09/2025 overcome the previous rejections. However, in light of the claim amendments, a new rejection of Hiorth in view of Haasl is applied as outlined below. All arguments directed to the claims as amended are addressed in the body of the rejection below. Arguments applicable to the current interpretation of the prior art will be addressed. The Office is not interpreting end region 38 to be the most distal curve section of the hook, as the curve section 36 in figures 2 and 4-5 is now interpreted as the most distal curve section of the hook.
Applicant argues on page 10 that Diduch does not disclose/teach the tip 8 with a widest part and rather, the eyelet 6 is the widest part of the puncturing component section 36 and the eyelet 6 is hollow to enable a suture line to pass through. The Office respectfully disagrees. The interpretation of the tip is the part of element 36 which includes the eyelet 6 and the sharpened tip 8. Using this interpretation, “the tips are shaped such that a widest part 6 of each tip 36 is wider than a preceding portion of its respective hook.”
Applicant also argues on page 10 that additionally, the widest part of Diduch, the eyelet 6, is open and not smooth. However, as shown in annotated figure 16d below, the top portion of the widest part of the eyelet 6 is smooth.
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Applicant argues on page 11 that the tips 8 of the puncturing component sections 36 do not have an ovate shape and rather, the shape of the tip 8 is triangular and the shape of the eyelet 6 is a taurus (i.e. donut), with an oval shaped hollow or aperture to enable a suture line to pass through. The Office respectfully disagrees. The definition of ovate according to Merriam-Webster is “shaped like an egg” and the oval shaped eyelet 6 is shaped like an egg, or ovate. Additionally, as explained and shown in annotated figure 16d above, the top surface of the eyelet 6 is smooth. Therefore, the rejection is maintained.
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: “locking mechanism” in claim 16.
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, 6-16, and 21 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 1 recites in line 11 “a curvature of the tip” and in line 15 recites “the curvature of the tip is a most distal curve section of the hook.” It is unclear as to which one or if all of the tips of the number of hooks is/are being claimed. For the purposes of examination, the Office will interpret the claim to mean just one tip. Claims 2-4, 6-16, and 21 are rejected due to their dependency on claim 1.
Claim 10 recites in lines 1-2 “a curvature of the tips”. It is unclear if this is the same curvature of claim 1 or in addition thereto. For the purposes of examination, the Office will interpret the claim to mean the same curvature as recited in claim 1.
Claim 12 recites in lines 1-2 “wherein the tip is a pointed tip.” It is unclear which one or if all of the tips/pointed tip(s) of the number of hooks is/are being claimed. For the purposes of examination, the Office will interpret the claim to mean “wherein the tips are pointed tips.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 10 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 10 recites “the springback force pulling the anchor through the body tissue” in lines 2-3 which is positively claiming “the body tissue.” For the purposes of examination, the Office will interpret the claim to mean “the springback force is configured to pull the anchor through the body tissue.”
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.
Claims 1-4, 6-10, 15-16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hiorth et al. (US PGPub 2017/0252032) in view of Haasl et al. (US PGPub 2015/0051616), hereinafter known as “Hiorth” and “Haasl,” respectively.
With regards to claim 1, Hiorth discloses (Figures 1-36) an anchor system for implantation in body tissue to hold a line 14 (Abstract; paragraphs 32-35), the anchor system comprising:
an anchor 9 comprising a number of hooks 42 for engagement with the body tissue (figures 30-32; paragraphs 101-102) and having a folded configuration (figure 30) and an unfolded configuration (figures 32-32), wherein the anchor 9 is made of an elastic material (paragraph 19) such that it can be elastically deformed into the folded configuration (figure 30) by application of a constraining force (paragraphs 19, 23, and 32), and will return to the unfolded configuration (figures 31-32) when no constraining force is applied (paragraphs 23 and 32), and wherein an end of each of the hooks 42 comprises a tip.
Hiorth is silent wherein the tips are formed to curve towards a central axis of the anchor when the anchor is in the folded configuration; wherein a curvature of the tip is formed such that a contact point between the anchor and a container device used to constrain the anchor in the folded configuration is a tangential contact between the container device and a smooth surface of the tips; and wherein the curvature of the tip is a most distal curve section of the hook.
However, in a similar field of endeavor of anchors, Haasl teaches (Figures 2 and 4-5) wherein the tips are formed to curve towards a central axis of the anchor 18 when the anchor 18 is in the folded configuration (figure 4);
wherein a curvature of the tip is formed such that a contact point between the anchor 18 and a container device 146 used to constrain the anchor 18 in the folded configuration (figure 4) is a tangential contact between the container device 146 and a smooth surface of the tips 18 (figure 4; paragraph 43); and
wherein the curvature of the tip is a most distal curve section of the hook (figure 4 – curve section 36 is a most distal curve section of the hook that is in tangential contact with the container device 146; end region 38 is straight as disclosed in paragraph 36).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor of Hiorth to include wherein the tips are formed to curve towards a central axis of the anchor when the anchor is in the folded configuration; wherein a curvature of the tip is formed such that a contact point between the anchor and a container device used to constrain the anchor in the folded configuration is a tangential contact between the container device and a smooth surface of the tips; and wherein the curvature of the tip is a most distal curve section of the hook as taught by Haasl for the purpose of helping to guide anchoring members away laterally away from the tissue entry point and then back out of the tissue at a location that is laterally spaced from the entry point (paragraph 41 of Haasl).
With regards to claim 2, as rejected above, it would be obvious to modify the anchor system of Hiorth to include the curvature of the tips as taught by Haasl. Haasl further discloses wherein each hook 18 has at least one point of inflection 34 in its curvature (figure 2). Thus, when incorporating the curvature of the tips as taught by Haasl, the claimed limitation is considered obvious.
With regards to claim 3, as rejected above, it would be obvious to modify the anchor system of Hiorth to include the curvature of the tips as taught by Haasl. Haasl further discloses wherein a curvature of each tip is such that in the folded configuration (figure 4) each tip is configured to be 0 to 30 degrees to the normal of a surface of body tissue the anchor 18 is to be implanted in (functional limitation – paragraphs 45-46 – anchor is formed from shape memory material such as Nitinol and therefore can exhibit the qualities of being at an angle between 0 and 30 degrees to the normal of a surface of body tissue). Thus, when incorporating the curvature of the tips as taught by Haasl, the claimed limitation is considered obvious.
With regards to claim 4, the combination of Hiorth/Haasl disclose further comprising a container device (Hiorth - paragraph 19 – “papillary anchor housing”) for applying the constraining force, the container device housing the anchor in its folded configuration (Haasl – see figure 4 for how the container device 146 houses the anchor 18 in the folded configuration, applying the curvature of the anchor of Haasl to the anchor of Hiorth would result in the papillary anchor housing of Hiorth to apply the constraining force to house the anchor in the folded configuration shown in figure 30).
With regards to claim 6, Hiorth/Haasl discloses the anchor system as claimed in claim 4. Hiorth further discloses wherein the anchor 9 comprises an elastic metal (paragraph 19). The combination is silent wherein the container device comprises a composite material.
However, in a similar field of endeavor of anchors, Haasl teaches wherein the container device 146 comprises a composite material (paragraph 45 – PEEK).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the container device of Hiorth to comprise a composite material as taught by Haasl for the purpose of achieving a desired direction due to the material characteristics of PEEK.
With regards to claim 7, as rejected above, it would be obvious to modify the anchor system of Hiorth to include the curvature of the tips as taught by Haasl. Haasl further discloses wherein in the folded configuration (figure 4), outermost portions of the anchor 18 are portions of the hooks spaced apart from the ends of the tips of the hooks (figure 4 – curved region 36 is spaced from the end of the hooks and extends outermost relative to the end of the hook as it is in contact with 146). Thus, when incorporating the curvature of the tips as taught by Haasl, the claimed limitation is considered obvious.
With regards to claim 8, as rejected above, it would be obvious to modify the anchor system of Hiorth to include the curvature of the tips as taught by Haasl. Haasl further discloses wherein when the anchor 18 is in the folded configuration (figure 4), the hooks include a first curve portion extending towards the central axis of the anchor 18, a second curve portion extending away from the central axis of the anchor 18, and a third curve portion where the tips curve back towards the central axis of the anchor 18 (see annotated figure 4 below – the first curve portion (proximal region) curves toward the central axis, the second curve portion (proximal half of 36) curves away from the central axis of the anchor 18, and the third curve portion (distal half of 36) curves back towards the central axis of the anchor 18). Thus, when incorporating the curvature of the tips as taught by Haasl, the claimed limitation is considered obvious.
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With regards to claim 9, as rejected above, it would be obvious to modify the anchor system of Hiorth to include the curvature of the tips as taught by Haasl. Haasl further discloses wherein the unfolded configuration (figures 2 and 5) of the hooks 18 includes a first curved portion 32 with a first direction of curvature extending along a majority of a length of a particular hook the hooks 18, followed by a second curved portion 36 with an opposite direction of curvature at the tip of the particular hook 18 (paragraphs 32-35; figure 2). Thus, when incorporating the curvature of the tips as taught by Haasl, the claimed limitation is considered obvious.
With regards to claim 10, as rejected above, it would be obvious to modify the anchor system of Hiorth to include the curvature of the tips as taught by Haasl. Haasl further discloses wherein a curvature of the tips provides a springback force, the springback force pulling the anchor 18 through the body tissue when the anchor 18 unfolds from the folded configuration (figure 4) to the unfolded configuration (figure 5) during implantation (paragraphs 40-41 – “ push member 142 may be distally advanced to push device 10 distally so that anchoring members 18 engage target region 148. In doing so, anchoring members may shift to the second configuration as shown in FIG. 5. When in the second configuration, anchoring members 18 may have the compound curved configuration”). Thus, when incorporating the curvature of the tips as taught by Haasl, the claimed limitation is considered obvious.
With regards to claim 15, Hiorth further discloses wherein the anchor 9 is formed from a tube that has been cut to provide tines 42 extending from one end of the tube, with these tines 42 then having been curved and heat set to form the unfolded configuration of the hooks and tips (paragraphs 21, 25, and 102).
With regards to claim 16, Hiorth further discloses wherein the anchor 9 includes a locking mechanism 28 (see Note below) arranged to clamp the line 14 when no force is applied to the locking mechanism 28 (paragraphs 22-24 and 101-103).
Note – 112(f) interpretation – Applicant’s locking mechanism is a resiliently deformable locking segment that may be formed in a wall of the anchor and divided from the wall by one or more slits and clamps the chord when no force is applied (page 33 lines 15-19); Hiorth’s locking mechanism is a locking segment that clamps the chord when no force is applied (paragraphs 22-24, 87, 101-103; figures 15-18); therefore both locking mechanism are equivalent in clamping the chord when no force is applied to the locking mechanism).
With regards to claim 21, Hiorth further discloses wherein the locking mechanism 28 comprises a locking ring 28 that is able to be elastically deformed to release the line 14 from the locking mechanism 28 for adjustment of a length of the line 14 (paragraphs 22-23 and 87; figures 15-18).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hiorth in view of Haasl, and further in view of Diduch et al. (US PGPub 2017/0007233), hereinafter known as “Diduch.”
With regards to claims 11-12, Hiorth/Haasl disclose the anchor system as claimed in claim 1. Hiorth further discloses wherein the anchor 9 comprises a pointed tip at the end of each hook (see pointed tip of anchor 9 in figures 30-32). The combination is silent wherein the tips are shaped such that a widest part of each tip is wider than a preceding portion of its respective hook, and wherein the widest part of each tip defines the smooth surface (claim 11); and wherein the tip is a pointed tip, wherein a shape of the tips comprises an ovate body, wherein the ovate body comprises the pointed tip at the end of each hook, wherein the ovate body defines the smooth surface, and wherein the smooth surface is located behind the pointed tip (claim 12).
However, in a similar field of endeavor of anchors (paragraph 34), Diduch teaches (Figures 16d and 16h) wherein the tips 36 are shaped such that a widest part 6 of each tip 36 is wider than a preceding portion of its respective hook, and wherein the widest part of each tip defines the smooth surface (figures 16d and 16h; see annotated figure 16d below); and wherein the tip 36 is a pointed tip (see distal end of tip 36), wherein a shape of the tips 36 comprises an ovate body, wherein the ovate body comprises the pointed tip 8 at the end of each hook, wherein the ovate body defines the smooth surface, and wherein the smooth surface is behind the pointed tip anchor (figures 16d and 16h; paragraph 66; see annotated figure 16d below).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor tips of Hiorth/Haasl to have an ovate body as taught by Diduch for the purpose of decreasing the stresses exerted on the anchor (paragraph 50 of Diduch) as the anchor punctures the tissue.
Claims 13-14 is rejected under 35 U.S.C. 103 as being unpatentable over Hiorth in view of Haasl, and further in view of Ewers et al. (US PGPub 2008/0009888), hereinafter known as “Ewers.”
With regards to claims 13-14, Hiorth/Haasl disclose the anchor system as claimed in claim 1. The combination is silent wherein the hooks are formed with openings along their length (claim 13); and wherein the openings in the hooks comprise slits extending along some or all of the length of the hooks (claim 14).
However, in a similar field of endeavor of anchors, Ewers teaches (Figures 6A-6C) wherein the hooks 90 are formed with openings 97 along their length (paragraph 59); and
wherein the openings 97 in the hooks 90 comprise slits 97 extending along some of the length of the hooks 90 (paragraph 59).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hooks of Hiorth/Haasl to include opening/slits extending along some of the lengths of the hooks as taught by Ewers for the purpose of creating a relatively larger engagement surface or "footprint" for each of the struts to contact the surface of the tissue (paragraph 59 of Ewers).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 12/29/2025
/SARAH A LONG/Primary Examiner, Art Unit 3771