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
The amendment filed 06/11/2025 has been entered. Claims 1, 4-12, 14, 18-19, and 21-25 remain pending in the application, claims 2-3, 13, 15-17, and 20 are cancelled, claims 8-12, 14, 18-19, and 21-25 are withdrawn, and claims 26-27 have been added. Applicant’s amendments to the claims have overcome each claim objection, however has not overcome the prior art rejection previously set forth in the Non-Final Office Action mailed 02/11/2025.
Response to Arguments
Applicant's arguments filed 06/11/2025 have been fully considered but they are not persuasive.
With regards to Applicant’s remarks on pages 7-9 in that Hayhurst fails to disclose “wherein the anchor comprises a tubular body with a weakened section at the centre of its length to allow for elastic bending of the tubular body,” the Office respectfully disagrees. The Office is not relying on inherency in making the rejection that Hayhurst discloses the weakened section. The Applicant has not specified what the section is weakened relative to. Therefore, the entirety of the anchor is interpreted to having repeated weakened sections including that of the centre of the anchor. The language “weakened section” is broad enough that because the anchor can be moldable and bent into a U-shape, the section of where the anchor bends is interpreted as the weakened section. The material of the anchor makes the anchor weak, and a section of the anchor that bends reads on the claimed language of “a weakened section.” The definition of weakened is “to make weak, lessen the strength of” according to Merriam-Webster and thus the anchor, made of an elastic material, is considered to be weakened as compared to another material (such as stainless steel) because the claims have not identified what the section is weakened relative to. New claims 26-27 now impart structure to the weakened section that would require further search since Hayhurst does not disclose the openings that cut into the tubular body. However, these features are taught by Yellin as applied in the rejection below, and thus claims 26-27 are not novel and would not further advance prosecution. Therefore, the rejection is maintained.
With regards to Applicant’s remarks on pages 10-12 in that Wahr fails to disclose “wherein the anchor comprises a tubular body with a weakened section at the centre of its length to allow for elastic bending of the tubular body,” the Office respectfully disagrees. The Applicant has not specified what the section is weakened relative to. Therefore, the entirety of the anchor is interpreted to having repeated weakened sections including that of the centre of the anchor. The anchor 40 of Wahr is a flexible, cylindrical arm made from a metallic wire as Applicant states on page 11. Paragraphs 65 and 68 of Wahr disclose that arms 40 have super-elastic properties. Thus, reading on the claim language of being a tubular body that bends elastically. Furthermore, the language “weakened section” is broad enough that because the anchor can be moldable and bent into a U-shape (as seen in figure 17), the section of where the anchor bends is interpreted as the weakened section. The material of the anchor makes the anchor weak, and a section of the anchor that bends reads on the claimed language of “a weakened section.” The definition of weakened is “to make weak, lessen the strength of” according to Merriam-Webster and thus the anchor, made of an elastic material, is considered to be weakened as compared to another material (such as stainless steel) because the claims have not identified what the section is weakened relative to. New claims 26-27 now impart structure to the weakened section that would require further search since Wahr does not disclose the openings that cut into the tubular body. However, these features are taught by Yellin as applied in the rejection below, and thus claims 26-27 are not novel and would not further advance prosecution. Therefore, the rejection is maintained.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayhurst (US Patent 4,741,330).
With regards to claim 1, Hayhurst discloses (Figures 1-6) an anchor 10 for implantation in body tissue 18 to hold a line 12, the anchor 10 comprising:
an elastic material (Col 5 lines 4-21) formed to have an unfolded configuration (figures 1, 4 and the solid lines in figure 6) for placement within the body tissue 18, and a folded configuration (figures 3 and the dotted lines in figure 6) for use prior to deployment of the anchor 10 and arranged to permit placement of the anchor 10 into an anchor tube 14 prior to deployment (Col 4 lines 44-59; Col 5 lines 4-26);
wherein the anchor 10 is arranged to be elastically deformed into the folded configuration (figure 3) by application of a constraining force (force of the tube 14), and will return to the unfolded configuration (figure 1) when no constraining force is applied (Col 5 lines 4-10);
wherein when the anchor 10 is in the unfolded configuration (figure 1) the anchor has an elongate configuration comprising two anchor pins 20/22 extending in opposite directions with one either side of a centre of the anchor 10, whilst when the anchor 10 is in the folded configuration (figure 3) the two anchor pins 20/22 both extend in the same direction;
wherein ends of the anchor pins 20/22 are arranged to pierce the body tissue 18 (Col 4 line 60 – Col 5 line 10); and
wherein the anchor 10 comprises a tubular body 10 with a weakened section at the centre of its length to allow for elastic bending of the tubular body (Col 5 lines 4-21 – dotted lines of figure 6 show the U-shaped anchor with a bend at the middle when conformed to the tube 14, solid lines show the elongate shape when not constricted by the tube 14, therefore the bend indicates the weakened section as the bend is how the anchor conforms to both shapes).
Claims 1 and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wahr et al. (US PGPub 2002/0183787), hereinafter known as “Wahr.”
With regards to claim 1, Wahr discloses (Figures 1-11C and 14-20) an anchor 14 for implantation in body tissue (SS) to hold a line 16 (paragraph 53), the anchor 14 comprising:
an elastic material (paragraphs 65 and 68 – arms 50 of are made from the preferred materials of the arms 40) formed to have an unfolded configuration (figures 11B-11C and 18-19) for placement within the body tissue SS, and a folded configuration (figure 17) for use prior to deployment of the anchor 14 and arranged to permit placement of the anchor 14 into an anchor tube 20 prior to deployment (paragraphs 76 and 90);
wherein the anchor 14 is arranged to be elastically deformed into the folded configuration (figure 17) by application of a constraining force (force of the tube 20), and will return to the unfolded configuration (figures 18-19) when no constraining force is applied (paragraphs 76-77);
wherein when the anchor 14 is in the unfolded configuration (figures 18-19) the anchor 14 has an elongate configuration comprising two anchor pins 50 extending in opposite directions with one either side of a centre of the anchor 14 (figure 11B-11C - see any two of the arms 50 extending in opposite directions), whilst when the anchor 14 is in the folded configuration (figure 17) the two anchor pins 50 both extend in the same direction;
wherein ends of the anchor pins 50 are arranged to pierce the body tissue SS (functional limitation – paragraph 64 – “any structure of sufficient size and shape to hold the septum primum (SP) in contact with the septum secondum (SS) to close the PFO may be used”); and
wherein the anchor 14 comprises a tubular body 14 with a weakened section at the centre of its length to allow for elastic bending of the tubular body (paragraphs 76-77 – figure 17 show the U-shaped anchor with a bend at the middle when conformed to the tube 20, figures 18-19 lines show the elongate shape when not constricted by the tube 20, therefore the bend indicates the weakened section as the bend is how the anchor conforms to both shapes).
With regards to claim 4, Wahr discloses a coating or covering 52 for promoting growth in the body tissue (paragraph 69), wherein the coating or covering 52 covers a main part of the anchor 14 but leaves the ends of the anchor pins 50 exposed (figure 11C; paragraphs 68-69 – covering 52 has a hole for surrounding anchor attachment hub 36 that allows the ends of the arms 50 to be placed through its radially oriented passages 51, therefore these ends of the arms 50 are exposed to the covering 52).
With regards to claim 5, Wahr discloses wherein the coating or covering 52 is provided by a sheath of biocompatible material (paragraph 69 – “ePTFE”).
With regards to claim 6, Wahr discloses wherein the sheath 52 is sutured to the anchor 50 (figure 11C; paragraph 69).
With regards to claim 7, Wahr discloses openings through a material of the anchor pins 50 (paragraph 69 – “arm 50 may have a loop 54 formed at each of its ends, creating eyelets for a suture 56 to connect arm 50 to covering 52”).
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 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wahr in view of Yellin et al. (US PGPub 2013/0226290), hereinafter known as “Yellin.”
With regards to claims 26-27, Wahr discloses the anchor as claimed in claim 1. Wahr is silent wherein the weakened section comprises an opening cut into the tubular body (claim 26); and wherein the weakened section comprises two or more openings cut into the tubular body (claim 27).
However, in a similar field of endeavor of anchors, Yellin teaches (Figure 14) wherein the weakened section comprises an opening cut into the tubular body (figure 14; paragraph 137); and wherein the weakened section comprises two or more openings cut into the tubular body (figure 14; paragraph 137).
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 Wahr to include wherein the weakened section comprises two or more openings cut into the tubular body as taught by Yellin for the purpose of giving the anchor greater flexibility or strength, and to enhance anchoring within the heart tissue (paragraph 137 of Yellin).
Conclusion
THIS ACTION IS MADE FINAL. 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 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 09/10/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771