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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 3, 2025 and July 7, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 3-8 are objected to because of the following informalities:
In claim 3, the phrase “defined annually” (line 4) should read - - defined annularly - -.
Claims 4-8 each recite the limitation “as claimed claim” in the preamble that should read - - as claimed in claim - -.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “rear end of the shaft . . abuts with an end surface of the stopping section” (claim 4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Examiner notes that Fig. 7a of the Drawings appears to illustrate a front end of the shaft abutting the stopping section.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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:
operating member in claim 1.
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 9, 10, and 12 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 9 recites the limitation “the two connecting ribs” in lines 2-3. There is insufficient antecedent basis for this limitation in the claims because this is the first reference to a connecting rib in the claim.
Claim 10 recites the limitation “the two connecting ribs” in lines 1-2. There is insufficient antecedent basis for this limitation in the claims because this is the first reference to a connecting rib in the claim.
Claim 12 recites the limitation “the two connecting ribs” in lines 1-2. There is insufficient antecedent basis for this limitation in the claims because this is the first reference to a connecting rib in the claim.
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 1-2, 4-6, 8-10, 12-16, 18-20, 22-24, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tu et al. (U.S. Patent No. 9826974; hereinafter “Tu”).
Regarding claim 1, Tu discloses a capsule knotting module, characterized in that the capsule knotting module comprises:
an operating member (30; drive member (30) meets or is an equivalent to the corresponding structure described in the specification as performing the claimed function) arranged at a rear end of the capsule knotting module (Fig. 2);
a knotting member (20) arranged at a front end of the capsule knotting module and having a through hole (21) formed through the knotting member (Fig. 2; col. 3, ll. 61-63), and a shaft (25) extending through the through hole and protruding from the front end of the capsule knotting module (col. 3, ll. 63-67); and
a suture (40) having two ends, one of the two ends of the suture connected to a part of the operating member (Fig. 5; col. 4, ll. 14-16), and the other end of the suture extending through the through hole and the shaft and extending toward and exposed from the front end of the capsule knotting module (Fig. 3; col. 4, ll. 12-14), wherein
at least a part of a knotting end of the suture is wrapped around an outer circumference of the shaft and forms a pre-knot (41), and a sliding loop (42) is formed between the shaft and the pre-knot (Fig. 6; col. 4, ll. 25-27); and
a size of the sliding loop is varied according to a distance between the operating member and the knotting member (Figs. 12A-12F; col. 7, ln. 40 – col. 8, ln. 8).
Regarding claim 2, Tu discloses wherein the knotting member (20) comprises a connecting portion (27) detachably connected with the operating member (large diameter section (27) is connected with drive member (30) and is capable of detachment, such as by removing the drive member from within the large-diameter section).
Regarding claim 4, Tu discloses wherein the knotting member comprises a stop portion (64) formed on the knotting member (Figs. 2 and 8), and the stop portion comprises an extension section formed on a surface of the knotting member (as sleeve (60) has a connection on the surface of body (20) via latch section (65); Fig. 8) and extending toward the front end of the capsule knotting module and a stopping section (64) protruding in a diametrical direction of the through hole from a front end of the extension section (Fig. 8), wherein a rear end of the shaft (25) protruding out from the through hole (21) abuts with an end surface of the stopping section (i.e., the portion of fitting section (28) distal to stopper plate (64) constitutes a rear end of body (25) and abuts an end surface of the stopper plate (Fig. 8; col. 5, ll. 41-44).
Regarding claims 5, 6 and 8, Tu discloses wherein the operating member (30) comprises a pull rod (30) formed diametrically on the operating member (the rod has a diametrical dimension), one of the ends of the suture (A) is bound on the pull rod (at loop section (321); Fig. 5; col. 4, ll. 14-16)).
Regarding claim 9, 10 and 12, Tu discloses wherein two connecting ribs (bends forming loop (321) and loop (322); Fig. 5) protrude respectively from two ends of the pull rod (12) and extend toward the front end of the capsule knotting module (e.g., loops (321, 322) extend from the proximal end of drive member (30) toward the distal end thereof; Fig. 5), the suture (40) extends through the through hole (21), a cavity (26), and a space between the two connecting ribs (space between loops (321, 322); Fig. 5) and is bound on the pull rod (col. 4, ll. 14-16).
Regarding claims 13 and 14, Tu discloses the module further comprising a housing (62) covering at least a part of a front end of the operating member and at least a part of a rear end of the knotting member (Fig. 7), wherein
a pull rod (30) is formed on the front end of the operating member, one of the ends of the suture is bound on the pull rod (via loop (321); Fig. 5), an operating portion (70) is formed on a rear end of the operating member (Figs. 12A-12B) and protrudes out of the housing, and the operating portion is connected with the pull rod by an extending arm (72; Fig. 12B); and
the connecting portion (27) is formed on the rear end of the knotting member at a position adjacent to the operating portion (Fig. 2), at least a part of the connecting portion is overlapped with at least a part of the front end of the operating member in the housing (Fig. 12B), a front end of the operating portion is slidable relative to the connecting portion in the housing (Figs. 12C-12D), and a notch (forming the lumen of body (27)) is defined in a surface of the connecting portion corresponding to the operating member (Fig. 5), wherein
the operating member comprises a connecting rib (32) protruding from the operating portion (Fig. 5), the extending arm and the connecting rib (321) are spaced from each other, and a raised part (322; Fig. 5) protrudes from the connecting rib on a front end extending into the housing and facing the groove (Fig. 5).
Regarding claim 15, 16, and 18, Tu discloses wherein a tying portion (28) is defined on at least a part of the shaft protruding from the through hole (Fig. 8; col. 4, ll. 19-25), and a length of the tying portion is varied according to a relative position of the shaft and the through hole (Figs. 12D-12E; col. 8, ll. 26-28), wherein:
during an operation, at least a part of the suture (40) extends through the sliding loop (Fig. 12D), and the sliding loop (42) is pulled to be shrunk and abuts with the outer circumference of the shaft (25; col. 7, ln. 66 – col. 8, ln. 2);
the sliding loop continues to be shrunk and pushes the shaft to move into the through hole to decrease the length of the tying portion (e.g., as suture (40) is moved proximally, the sliding loop is shrunk and tubular body (25) moves proximally; col. 8, ll. 22-28); and
when the shaft is completely moved inside the through hole (Figs. 12E), and the pre-knot (41) is detached from the shaft and is tied with the sliding loop (42) and at least a part of the suture (40) to form a secure knot (44; col. 8, ll. 29-32).
Regarding claim 19, 20, and 22, Tu discloses wherein at least a part of the shaft (22) is securely held in the through hole (Fig. 3; col. 3, ln. 60 – col. 4, ln. 4), wherein
during an operation, at least a part of the suture (40) extends through the sliding loop (Fig. 12D), and the sliding loop (42) is pulled to be shrunk and abuts with the outer circumference of the shaft (25; col. 7, ln. 66 – col. 8, ln. 2);
the operating member (10) is continuously pulled to make the pre-knot (Al) to move toward the front end of the capsule knotting module (col. 8, ll. 20-22) until the pre-knot is detached from the shaft (col. 8, ll. 26-28); and
the pre-knot (41) is detached from the shaft and is tied with the sliding loop and at least a part of the suture, and a secure knot (44) is formed (col. 8, ll. 29-32).
Regarding claim 23, 24, and 26, Tu discloses wherein the knotting end of the suture (40) is connected with a surgical needle (45; Fig. 2; col. 4, ll. 11-12).
Allowable Subject Matter
Claim 3 would be allowable if rewritten to overcome the objections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 7, 11, 17, 21, and 25 would be allowable as being dependent upon claim 3.
The following is a statement of reasons for the indication of allowable subject matter:
Kaji (U.S. Patent No. 5702407) is considered the most pertinent art to claim 3. Kaji, a reference in the suturing device field of endeavor, teaches providing a connecting portion (8) with a cavity (95) defined in a rear end of a knotting member (90), wherein a groove (96) is defined annularly in an inner wall of the cavity (Fig. 24A), and an operating member (4) comprises two connecting ribs (92) extending toward the cavity and spaced from each other, each connecting rib having a raised part (94) diametrically protruding from a front end of the connecting rib at a position corresponding to the groove and engaged with the groove. Kaji further discloses that the raised part (94) and the groove (96) are engaged via stepped portions (col. 14, ll. 10-17).
Thus, Kaji does not disclose the raised part “engaged with the groove [] in a concave-convex manner,” as recited in claim 3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kammerer et al. (U.S. Patent No. 5769862) disclosing a knot applicator with a tube (20) configured to allow a user to pull a knot off of the tube (Figs. 12-13);
Kawaura et al. (U.S. Patent No. 8241323) disclosing a tissue closing device with a suture anchored to a rib (155; Figs. 7(a)-7(b)).
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
