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 .
This action is in response to the amendment filed on 05/27/2026. Claims 1-3, 5-8, 10, and 21-32 are pending. Claims 1 and 26 are independent. Claims 4, 9, and 11-20 are canceled. Claims 21-32 are newly added. Claims 26-32 are withdrawn by the examiner for the reason(s) below.
Election/Restrictions
Newly submitted claims 26-32 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: invention I (claims 1-3, 5-8, 10, and 21-25) are directed to locking ferrule whereas invention II (claims 26-32) are directed to a system. Inventions II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because each of the plurality of the locking barbs is away from the slanted distal end. The subcombination has separate utility such as it prevents suture from moving away from the slanted end direction.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 26-32 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 25 recites the limitation “a slanted edge of the slanted distal end is a planar surface oriented at a transverse angle relative to the longitudinal centerline axis” which does not have sufficient support in the original disclosure and is considered as new matter. First, the specification is completely silent on that. Secondly, none of the drawings show that the slanted edge of the slanted distal end is a planar surface (or flat) oriented at a transverse angle relative to the longitudinal centerline axis. Figures 1, 3, and 4 are the side view and cross-section of side views of the invention. They are not sufficient to support that the slanted edge of the slanted distal end is a planar surface oriented at a transverse angle relative to the longitudinal centerline axis. Instead, the specification discloses that slanted edge of the slanted distal end includes a curved lip which is also recited in claim 10.
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) 1-3, 5-8, 10, and 21-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ward et al. (US Pat. No.: 8,784,439).
Regarding claims 1-3, 5-8, 10, and 21-25, Ward discloses [claim 1] a locking ferrule (95, Figs. 58 and 59 and Col. 11, lines 3-30. The T-bar anchor mechanism 95 is fully capable to be used for performing a cardiac valve procedure) fully capable for performing a cardiac valve procedure, comprising: a body (body of 95, Figs. 58 and 59) extending along a longitudinal centerline axis between a proximal end (round end, see Figure below) and a slanted distal end (slanted end, see Figure below); the body including an outer diameter wall (outer diameter wall of 95, Figs. 58 and 59), an inner diameter wall (inner diameter wall of 95, Figs. 58 and 59), and a cannulation (central lumen of 95, Figs. 58 and 59) that is circumscribed by the inner diameter wall; and a plurality of locking barbs (99, Fig. 59) extending into the cannulation and configured to establish a one-way locking mechanism for locking a suture relative to the body (Col. 11, lines 12-14; also see Col 10, lines 51-59); wherein each of the plurality of locking barbs is angled in a direction toward the proximal end and away from the slanted distal end (Fig. 59, starting from the free end of the barbs to the attached end of the barbs, each of the plurality of locking barbs is angled in a direction toward the proximal end and away from the slanted distal end)
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[claim 2] wherein the plurality of locking barbs are integral features of the body (Fig. 59);
[claim 3] wherein each of the plurality of locking barbs includes a pointed tip (Fig. 59);
[claim 5] wherein the plurality of locking barbs each protrude inwardly from the inner diameter wall (Fig. 59);
[claim 6] wherein the plurality of locking barbs are arranged in at least a first row and a second row (Fig. 59, the plurality of locking barbs are arranged in at least a first row and a second row with each row comprising a top and bottom barbs shown in Fig. 59);
[claim 7] wherein a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row (Fig. 59, a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row along the longitudinal direction because the plurality of locking barbs of the first row are staggered relative to the plurality of locking barbs of the second row along the longitudinal direction);
[claim 8] wherein the slanted distal end extends along an axis that is transverse to the longitudinal centerline axis (Figs. 58 and 59);
[claim 10] wherein a slanted edge of the slanted distal end includes a curved lip (the end curved portion/lip around 97f of the slanted edge, Fig. 58);
[claim 21] wherein the plurality of locking barbs are configured such that a pointed tip of each of the plurality of locking barbs is fully capable to interdigitate with a thickened section of the suture received within the cannulation to lock the suture against movement in one direction (the plurality of locking barbs are configured such that a pointed tip of each of the plurality of locking barbs is fully capable to interdigitate with a thickened section of the suture received within the cannulation to lock the suture against movement in one direction because the pointed tip of each of the plurality of locking barbs is configured to lock a suture against movement in one direction);
[claim 22] wherein the cannulation tapers in a direction toward the slanted distal end such that the cannulation is narrower within the slanted distal end than within the proximal end (Fig. 58 or 59);
[claim 23] wherein the cannulation extends across an entire length of the body from the proximal end to the slanted distal end (Fig. 59);
[claim 24] wherein the slanted distal end includes a slanted edge fully capable for directionally leaning the body away from a structure associated with a heart valve being repaired during the cardiac valve procedure (Figs. 58 and 59, a slanted edge at the slanted distal end is fully capable for directionally leaning the body away from a structure associated with a heart valve being repaired during the cardiac valve procedure depending on the method used, such as by engaging the tissue against the cut-away section of the distal end);
[claim 25] wherein a slanted edge of the slanted distal end is a planar surface (planar surface at the end surface of the distal end as shown in Fig. 59) oriented at a transverse angle relative to the longitudinal centerline axis.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-8, 10, and 21-25 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument(s) on pages 6-8 of the remarks, Ward discloses a locking ferrule (95, Figs. 58 and 59 and Col. 11, lines 3-30. The T-bar anchor mechanism 95 is fully capable to be used for performing a cardiac valve procedure) fully capable for performing a cardiac valve procedure, comprising: a body (body of 95, Figs. 58 and 59) extending along a longitudinal centerline axis between a proximal end (round end, see Figure below) and a slanted distal end (slanted end, see Figure below); the body including an outer diameter wall (outer diameter wall of 95, Figs. 58 and 59), an inner diameter wall (inner diameter wall of 95, Figs. 58 and 59), and a cannulation (central lumen of 95, Figs. 58 and 59) that is circumscribed by the inner diameter wall; and a plurality of locking barbs (99, Fig. 59) extending into the cannulation and configured to establish a one-way locking mechanism for locking a suture relative to the body (Col. 11, lines 12-14; also see Col 10, lines 51-59); wherein each of the plurality of locking barbs is angled in a direction toward the proximal end and away from the slanted distal end (Fig. 59, starting from the free end of the barbs to the attached end of the barbs, each of the plurality of locking barbs is angled in a direction toward the proximal end and away from the slanted distal end)
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Furthermore, regarding claim 7, Ward discloses that wherein a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row (Fig. 59, a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row along the longitudinal direction because the plurality of locking barbs of the first row are staggered relative to the plurality of locking barbs of the second row along the longitudinal direction).
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In response to the argument(s) on page 8 of the remarks, claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 25 recites the limitation “a slanted edge of the slanted distal end is a planar surface oriented at a transverse angle relative to the longitudinal centerline axis” which does not have sufficient support in the original disclosure and is considered as new matter. First, the specification is completely silent on that. Secondly, none of the drawings show that the slanted edge of the slanted distal end is a planar surface (or flat) oriented at a transverse angle relative to the longitudinal centerline axis. Figures 1, 3, and 4 are the side view and cross-section of side views of the invention. They are not sufficient to support that the slanted edge of the slanted distal end is a planar surface oriented at a transverse angle relative to the longitudinal centerline axis. Instead, the specification discloses that slanted edge of the slanted distal end includes a curved lip which is also recited in claim 10.
Regarding claim 24, the slanted distal end of Ward’s locking ferrule includes a slanted edge fully capable for directionally leaning the body away from a structure associated with a heart valve being repaired during the cardiac valve procedure (Figs. 58 and 59, a slanted edge at the slanted distal end is fully capable for directionally leaning the body away from a structure associated with a heart valve being repaired during the cardiac valve procedure, such as by engaging the tissue against the cut-away section of the distal end).
Claims 26-32 are withdrawn for the reason(s) stated above.
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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, 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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/JING RUI OU/Primary Examiner, Art Unit 3771
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