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 .
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 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.
Response to Amendment
The Response filed June 3, 2026 has been entered. Claims 16-30 are pending in the application.
Election/Restriction
Applicant’s election of Invention I in the reply filed on June 3, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 28, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation - 35 USC § 112
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 limitations 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 limitations are:
locking feature (of the first core member) as recited in line 4 of claim 17;
locking feature (of the second core member) as recited in line 10 of claim 17.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite 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 § 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.
Claims 16-17, 23-24, and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shibata et al. (U.S. Patent Application Publication No. 20080312665; hereinafter “Shibata”).
Regarding claim 16, Shibata discloses a clipping system for treating tissue (Figs. 1-2), comprising:
a first clip (10; Fig. 4) including a first capsule (combination of tail portion (15) and fastening ring (18); Fig. 3) extending longitudinally from a proximal end to a distal end and including a first channel (inner passage of ring (18); Fig. 4) extending therethrough, and a first pair of clip arms (11), proximal ends of which are slidably received within the first channel to move the first clip arms between an open configuration (Fig. 3), in which distal ends of the first clip arms are separated from one another to receive a tissue therebetween, and a closed configuration (Fig. 2), in which the distal ends of the first clip arms are drawn toward one another to grip a tissue therebetween, the proximal end of the first capsule including a pivot feature (15a) extending across the first channel thereof (Figs. 3-4); and
a second clip (10; Fig. 1; para.[0034]) including a second capsule (combination of tail portion (15) and fastening ring (18); Fig. 3) extending longitudinally from a proximal end to a distal end and including a second channel (inner passage of ring (18); Fig. 4) extending therethrough, and a second pair of clip arms (11), proximal ends of which are slidably received within the second channel to move the second clip arms between an open configuration (Fig. 3), in which distal ends of the second clip arms are separated from one another to receive the tissue therebetween, and a closed configuration (Fig. 2), in which the distal ends of the second clip arms are drawn toward one another to grip the tissue therebetween, the distal ends of the second clip arms configured to engage the pivot feature of the first clip so that the first and second clips are releasably and pivotally connected to one another in an insertion configuration (e.g., clip arms (11) are configured to releasably connected with tail portion (15; para. [0034]) and at least capable of allowing pivotal movement between clips (10) when inserted into a patient).
Regarding claim 17, Shibata discloses the system further comprising:
a first core member (14) received between and connected to the proximal ends of the first pair of clip arms to couple the proximal ends of the first pair of clip arms to one another (Figs. 3-4; para. [0027]), the first core member including a locking feature (reduced diameter ends of shaft (14; Fig. 4) meet or are an equivalent to the corresponding structure described in the specification as performing the claimed function (e.g., wings; Spec. para. [0065])) movable between an unlocked configuration, in which the first core member is slidable within the first channel (e.g., prior to and/or while shaft (14) is being assembled into the clip), and a locked configuration, in which the locking feature of the first core member engages a corresponding portion of the first capsule to lock the first pair of clip arms in the closed configuration (e.g., while the shaft (14) is assembled into the clip; Fig. 2); and
a second core member (14) received between and connected to the proximal ends of the second pair of clip arms to couple the proximal ends of the second pair of clip arms to one another (Figs. 3-4; para. [0027]), the second core member including a locking feature (reduced diameter ends of shaft (14; Fig. 4) meet or are an equivalent to the corresponding structure described in the specification as performing the claimed function (e.g., wings; Spec. para. [0065])) movable between an unlocked configuration, in which the second core member is slidable within the second channel (e.g., prior to and/or while shaft (14) is being assembled into the clip), and a locked configuration, in which the locking feature of the second core member engages a corresponding portion of the second capsule to lock the second pair of clip arms in the closed configuration (e.g., while the shaft (14) is assembled into the clip; Fig. 2).
Regarding claim 23, Shibata discloses wherein the pivot feature includes a curved distal surface (annotated Fig. 4 below) configured to pivotally engage a correspondingly curved portion of the distal ends of the second pair of clip arms (Fig. 1).
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Regarding claim 24, Shibata disclose wherein the pivot feature may be one of machined into a material of the first capsule, stamped from a portion of a wall of the first capsule, and formed of a separate element connected to the proximal end of the first capsule (e.g., the structure of tail portion (15; para. [0028]) is capable of being one of machined, stamped, and formed as claimed).
Regarding claim 27, Shibata discloses wherein the first capsule includes a stop (annotated Fig. 4 below) positioned distally of the pivot feature, the stop configured to prevent a proximal movement of the second pair of clip arms relative thereto when the distal ends of the second pair of clip arms is engaged with the pivot feature of the first clip, in the insertion configuration (e.g., the stop is capable of preventing proximal movement of the second pair of clip arms when gripped by the clip arms).
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Regarding claim 28, Shibata discloses wherein the stop is stamped from a material of the wall of the first capsule and bent radially inwards (annotated Fig. 4 above).
Allowable Subject Matter
Claims 18-22, 25-26, and 29-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 18, the prior art does not show by itself or in combination, the limitation “the enlarged distal end [ of the control member] is releasably received within a proximal portion of the first core member so that the remaining length passes through an opening extending through the pivot feature of the first clip, between the second clip arms and through the second core member to a proximal end that is configured to be accessible a user,” as read with all the limitations of the claim.
Claims 19, 22, 25-26, and 29-30 are objected to as being dependent upon allowable claim 18.
Regarding claim 20, the prior art does not show by itself or in combination, the limitation “a connector received within holes extending through each of the proximal ends of the first and second clip arms and through an elongated opening extending through each of the first and second core members,” as read with all the limitations of the claim.
Claim 21 is objected to as being dependent upon allowable claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Griego (U.S. Patent No. 9763669) disclosing a multiple clip assembly having clips releasably connected to one another (Figs. 30-48);
Boulnois et al. (U.S. Patent Application Publication No. 20100191257) disclosing a multiple clip assembly having a rails extending through clips and connected by joints (Figs. 5A-7E);
Ortiz Garcia et al. (U.S. Patent Application Publication No. 20230248370) disclosing a clip assembly having a core member (Figs. 4-11);
Yamada (WO 2019131713) disclosing a clip connection that is freely rotatable (Figs. 6-11).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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