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 Arguments
In response to applicant's argument that the references fail to show the amended features of claim 1, it is noted that the features upon which applicant relies was taught in the non-final rejection mailed on 09/15/2025, see claim 2. Additionally, see new claim 1 rejection below. The applicant provides no argument to as why this feature was not taught by the prior art in response to the non-final office action.
Information Disclosure Statement
The information disclosure statement filed 07/24/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a translated copy of “A Pharmaceutical agent for the heart and drugs” has not been provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Claim 1 has phrasing that repeats claim language leaving the language incomplete “wherein the first frame component and the second frame component, and at least one of the first frame component and the second frame component includes”
Claim 3 recites “the eyelets” and “the one or more eyelets” inconsistently.
Appropriate correction is required.
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 1-10 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 and 6 recites wherein the “eyelets or arranged on either side” and then proceeds to recite the eyelets arranged on a specific side, the language is contradictory and unclear.
Dependent claims are likewise rejected
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2, which depends from claim 1, repeats the same limitation as in claim 1, therefore a further limitation of the subject matter is not provided.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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) 1-2, 4, 7, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McNamara (US 20120265296 A1).
Regarding claim 1, McNamara teaches an implantable medical device (see annotated fig 2), comprising a first frame component configured to conform to an anatomy of a patient (see annotated fig 2);
a second frame component configured to conform to an anatomy of a patient (see annotated fig 2) wherein the first frame component and the second frame component, and at least one of the first frame component and the second frame component includes inner apices and outer apices (see annotated fig 2);
and wherein at least one of the first frame component and the second frame component includes a star shape having the inner apices and the outer apices (see annotated fig 2) and the at least one of the first frame component and the second frame component includes an exterior side and an interior side (see annotated fig 2), and one or more eyelets are arranged on either side of at least one of the inner apices and the outer apices (see annotated fig 2), wherein each of the inner apices (see annotated fig 2, the inner most point, circled) includes one of the eyelets arranged on the exterior side of the at least one of the first frame component and the second frame component (see annotated fig 2, eyelet is on exterior side compared to inner most point) and each of the outer apices includes one of the eyelets arranged on the interior side of the at least one of the first frame component and the second frame component (see annotated fig 2, eyelet is on interior side compared to outermost point).
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Annotated figure 2
Regarding claim 2, McNamara teaches wherein each of the inner apices (see annotated fig 2, the inner most point, circled) includes one of the eyelets arranged on the exterior side of the at least one of the first frame component and the second frame component (see annotated fig 2, eyelet is on exterior side compared to inner most point) and each of the outer apices includes one of the eyelets arranged on the interior side of the at least one of the first frame component and the second frame component (see annotated fig 2, eyelet is on interior side compared to outermost point).
Regarding claim 4, McNamara teaches wherein the star shape is a curved star shape (see annotated fig 2, see ends are curved not pointed).
Regarding claim 7, McNamara teaches wherein the eyelets are oval shaped ([0136], eyelets can be different shapes).
Regarding claim 9, McNamara teaches wherein at least one of the first frame component and the second frame component includes the star shape having elongate elements (see annotated fig 2), with variable widths or one or more curvatures between the outer apices and the inner apices (there is at least one curvature in the elongate element, see annotated fig 2).
Regarding claim 10, McNamara teaches wherein at least one of the first frame component and the second frame component includes the star shape having elongate elements with elongate elements connected by interconnecting struts near the inner apices (see fig 4).
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.
Claim(s) 3, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over McNamara (US 20120265296 A1) in view of Carley (9554786).
Regarding claim 3, McNamara teaches wherein at least one of the first frame component and the second frame component includes an exterior side and an interior side (see annotated fig 2), and one or more eyelets are arranged with the inner apices (see annotated fig 2) are on the exterior side of the at least one of the first frame component and the second frame component (see annotated figure 2) and the eyelets arranged with the outer apices (see annotated fig 2) are on the interior side of the at least one of the first frame component and the second frame component (see annotated fig 2).
McNamara fails to teach wherein the eyelets are open, Carley teaches a closure device (abstract) wherein the eyelet opens in a direction facing away from the apices (see annotated figure 12). 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 inner and outer apices of the device taught by McNamara by including the eyelet openings facing away from the apices, as taught by Carley, in order to incorporate a known design of an apices that would have predictable results of engaging tissue (MPEP 2143).
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Annotated figure 12
Regarding claim 5, McNamara teaches a device with outer apices eyelets (see annotated figure 2) but fails to teach wherein the eyelets are open, Carley teaches a closure device (abstract) wherein the eyelet opens in a direction facing away from the apices (see annotated figure 12). 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 outer apices of the device taught by McNamara by including the eyelet openings facing away from the apices, as taught by Carley, in order to incorporate a known design of an apices that would have predictable results of engaging tissue (MPEP 2143).
Regarding claim 8, McNamara teaches wherein at least one of the first frame component and the second frame component includes an exterior side and an interior side (see annotated fig 2), and the eyelets arranged with the outer apices (see annotated fig 2) are on the interior side of the at least one of the first frame component and the second frame component (see annotated fig 2).
McNamara fails to teach wherein the eyelets are open, Carley teaches a closure device (abstract) wherein the eyelet opens in a direction facing away from the apices (see annotated figure 12). 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 outer apices of the device taught by McNamara by including the eyelet openings facing away from the apices, as taught by Carley, in order to incorporate a known design of an apices that would have predictable results of engaging tissue (MPEP 2143).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over McNamara (US 20120265296 A1) in view of Schwartz (US 20200085600 A1).
Regarding claim 6, McNamara teaches wherein the one or more eyelets are arranged on either side of at least one of the inner apices (see annotated fig 2), but fails to teach linear apices sections. Schwartz teaches a connection stent (abstract) wherein the outer apices and at least one of the first frame component and the second frame component includes linear portions arranged between the eyelets and the outer apices (see annotated figure 90). 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 outer apices of the device taught by McNamara by including the linear portions, as taught by Schwartz, in order to incorporate a known design of an apices that would have predictable results of engaging tissue (MPEP 2143).
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Annotated figure 90
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 HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.L.P./Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774