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 .
Election/Restrictions
Claims 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/2/2026.
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.
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 is:
Claim 10, line 2: “a locking mechanism”
this limitation is being interpreted to cover the corresponding structures as recited by the specification, and equivalents thereof: “a ratchet mechanism” (PP [0032]) or “a trigger in the form of a lever” (PP [0037])
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.
Claim 3 is 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 3 recites the limitation "the first flexible strand and the second flexible strand" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim, since the flexible strands were introduced in claim 2 and claim 3 depends directly from claim 1. This renders the claim indefinite as it is unclear what the intended dependency is. It is recommended that claim 3 be amended to depend from claim 2. Examination will continue under the assumption that claim 3 depends from claim 2 instead.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-7, 9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Racenet et al. (US PGPub 2019/0133571 A1).
With respect to claim 1, Racenet et al. discloses a surgical instrument (10 in Fig. 1) comprising:
a shaft (30) having a longitudinal axis (X), a distal end (left end), and a proximal end (right end);
a jaw assembly (40, see also Fig. 5) located at the distal end (40 is on the left end of 30) and comprising:
a stationary jaw (44 in Fig. 5, PP [0031]: “a stationary jaw member 44”) fixedly mounted to the distal end of the shaft (left end of 30 in Fig. 1), the stationary jaw (44 in Fig. 5) having two separate contacting sites located on a surface of the stationary jaw (44g and 44f); and
a first movable jaw and a second movable jaw (42 and 46, PP [0031]: “Suturing jaw member 42 and grasping jaw member 46 of end effector 40 are pivotably coupled to stationary jaw member 44 of end effector 40”), wherein the first movable jaw and the second movable jaw (42 and 46) are mounted to the distal end of the shaft (see Figs. 1 and 8A-B, PP [0031]: “end effector 40 of suturing and grasping device 10 is supported on shaft assembly 30 (FIG. 1) of suturing and grasping device 10 and includes a suturing jaw member 42, a stationary jaw member 44, and a grasping jaw member 46”); and
a handle assembly (20 in Fig. 1) configured to move the first movable jaw (42) from a first position to a second position with respect to the stationary jaw (44, see Figs. 8A-B, PP [0040]: “movable handle 22 of handle assembly 20 of suturing and grasping device 10 is pivotable relative to stationary handle 24 of handle assembly 20 to axially translate drive shaft 34 of drive assembly 32 of suturing and grasping device 10”, PP [0041]: “as drive shaft 34 of drive assembly 32 translates from the neutral position (see FIGS. 1 and 7A) toward a distal direction, as indicated by arrow “X2” (see FIGS. 3, 7B, 7C, 8B), suturing jaw member 42 pivots from a closed or approximated position (FIG. 7A) relative to stationary jaw member 44 toward an open or unapproximated position (FIG. 7C) relative to stationary jaw member 44”) and to form a first opening (see opening between 44 and 42 in Fig. 8B), and to move the second movable jaw (46) from a first position to a second position with respect to the stationary jaw (44, see Figs. 8A-B, PP [0040]: “movable handle 22 of handle assembly 20 of suturing and grasping device 10 is pivotable relative to stationary handle 24 of handle assembly 20 to axially translate drive shaft 34 of drive assembly 32 of suturing and grasping device 10… As drive shaft 34 of drive assembly 32 translates from a neutral position (e.g., with pins 36a, 36b of drive shaft 34 centrally disposed along elongated channels 44e of stationary jaw member 44, see FIGS. 1 and 6A) toward a proximal direction, as indicated by arrow “X1” illustrated in FIGS. 2, 6B, and 6C, for example, grasping jaw member 46 pivots from a closed or approximated position (FIG. 6A) relative to stationary jaw member 44 toward an open or unapproximated position (FIG. 6C) relative to stationary jaw member 44”) and to form a second opening (see opening between 44 and 46 in Fig. 8A).
Regarding claim 2, Racenet et al. further discloses wherein the first opening (see opening between 44 and 42 in Fig. 8B) retains and secures a first flexible strand (the opening between 44 and 42 is configured to retain a first flexible strand upon closure of the first movable jaw 42, see Figs. 8A-B) and wherein the second opening (see opening between 44 and 46 in Fig. 8A) retains and secures a second flexible strand, since the opening (the opening between 44 and 46 is configured to retain a second flexible strand upon closure of the second movable jaw 46, see Figs. 8A-B).
Regarding claim 3, Racenet et al. further discloses wherein at least one of the first flexible strand and the second flexible strand is a suture, suture tape, elastic material, suture tube, or suture sheath (see suture “S” in Fig. 1, the jaws 42 and 46 are configured to retain).
Regarding claim 6, Racenet et al. further discloses wherein one of the two contacting sites (44g and 44f in Fig. 5) is a most distal end of the stationary jaw (44, see Figs. 8A-B, the jaws 42 and 46 contact the distal-most surface of 44 when the jaws are closed).
Regarding claim 7, Racenet et al. further discloses wherein the first movable jaw (42 in Fig. 5) has a first length, and the second movable jaw (46) has a second length (see lengths of 42 and 46 in the profile views of Figs. 8A-B).
Regarding claim 9, Racenet et al. further discloses wherein the first length is about equal to the second length (see Figs. 8A-B, 42 and 46 are about the same length).
Regarding claim 12, Racenet et al. further discloses wherein the instrument (10 in Fig. 1) is a suture grasper, suture receiver, or suture passer (PP [0017]: “a suturing and grasping device, and a needle and suture used therewith”, see Fig. 1 with suture “S”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Racenet et al. (US PGPub 2019/0133571 A1), as applied to claim 1 above, and further in view of McGregor (US Patent No. 7,727,256 B2).
Regarding claim 4, Racenet et al. fails to disclose wherein, when in the second position, a most distal tip of the first movable jaw engages one of the two separate contacting surfaces of the stationary jaw and forms the first opening, since the first opening of Racenet et al. is formed when the first movable jaw is open.
In the same field of graspers for manipulating sutures (abstract), McGregor teaches a device (10 in Fig. 2) comprising a handle (14), an elongate shaft (32), and a movable jaw portion (22) wherein the movable jaws (112 and 116) engage a respective contacting surface (100 and 104) in the closed position to form an opening (108).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Racenet et al. device according to the teachings of McGregor and include the jaw structure as taught, where the movable jaws include a wider diameter distal end and a narrower diameter proximal region for defining an opening when closed. One of ordinary skill in the art would have been motivated to perform this modification since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art (see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966), see MPEP 2144.04). The modification as proposed would not alter the main operating principle of the Racenet et al. device, since the McGregor jaws are also configured for manipulating sutures (col. 1, lines 33-34: “the jaws of the instrument may have teeth to grasp tissue or a suture”), but would instead simply and predictably allow the Racenet et al. device “to pull on a suture without holding the suture in place” (col. 1, lines 35-36 of McGregor).
Regarding claim 5, Racenet et al. fails to disclose wherein, when in the second position, a most distal tip of the second movable jaw engages another of the two separate contacting sites of the stationary jaw and forms the second opening, since the second opening of Racenet et al. is formed when the second movable jaw is open.
In the same field of graspers for manipulating sutures (abstract), McGregor teaches a device (10 in Fig. 2) comprising a handle (14), an elongate shaft (32), and a movable jaw portion (22) wherein the movable jaws (112 and 116) engage a respective contacting surface (100 and 104) in the closed position to form an opening (108).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Racenet et al. device according to the teachings of McGregor and include the jaw structure as taught, where the movable jaws include a wider diameter distal end and a narrower diameter proximal region for defining an opening when closed. One of ordinary skill in the art would have been motivated to perform this modification since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art (see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966), see MPEP 2144.04). The modification as proposed would not alter the main operating principle of the Racenet et al. device, since the McGregor jaws are also configured for manipulating sutures (col. 1, lines 33-34: “the jaws of the instrument may have teeth to grasp tissue or a suture”), but would instead simply and predictably allow the Racenet et al. device “to pull on a suture without holding the suture in place” (col. 1, lines 35-36 of McGregor).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Racenet et al. (US PGPub 2019/0133571 A1), as applied to claim 1 above.
With respect to claim 6, Racenet et al. fails to disclose wherein the first length is different from the second length.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Racenet et al. device such that the first length is different from the second length. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have been obvious to try. With respect to determining movable jaw lengths in a pair of forceps comprising two movable jaws and a stationary jaw, there are a finite number of identified and predictable solutions (each movable jaw is the same length, or they are different lengths) that one of ordinary skill in the art could have pursued with a reasonable expectation of success, as a pair of forceps would still be operational with different jaw lengths as claimed. Furthermore, doing so would have been obvious since it has been held that a change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2144.04).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Racenet et al. (US PGPub 2019/0133571 A1), as applied to claim 1 above, and further in view of Schmieding et al. (US PGPub 2003/0220659 A1).
Regarding claim 10, Racenet et al. discloses wherein the handle assembly (20 in Fig. 1) includes a pair of handles (22 and 24), but fails to disclose wherein the handle assembly includes a locking mechanism.
In the same field of suture passers (abstract), Schmieding et al. discloses an instrument (100 in Fig. 1) comprising a handle assembly (20) which includes a pair of handles (21 and 23) and a locking mechanism (26 and 28 in Fig. 2).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Racenet et al. device according to the teachings of Schmieding et al. to include a locking mechanism. One of ordinary skill in the art would have been motivated to perform this modification in order to provide a way for the Racenet et al. device to be locked in a closed position, such as “during the advancement of the instrument… [when] it is not necessary for the surgeon to maintain hand position at the finger loops of the instrument” (PP [0026] of Schmieding et al.). Such a modification would not alter the main operating principle of the Racenet et al. device, but would simply and predictably provide a mechanism for controlling the configuration of the jaw assembly.
Regarding claim 11, Racenet et al. as modified by Schmieding et al. further discloses wherein the locking mechanism (26 and 28 in Fig. 2 of Schmieding et al.) includes a ratchet mechanism (PP [0026]: “grasper ratchet 26”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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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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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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