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 Election/Restriction response filed on 02/06/2026. Claims 1-20 are pending. Claims 1, 13, and 20 are independent. Claims 6, 11, 15, and 20 are withdrawn by applicant. Claim 17 is withdrawn by the examiner for the reason(s) below.
Election/Restrictions
Applicant’s election without traverse of Species A (Figures 3-4C) in the reply filed on 02/06/2026 is acknowledged.
Applicant indicates that claims 1-5, 7-10, 12-14, and 16-19 are readable on the elected species and claims 6, 11, 15, 17, and 20 are withdrawn. However, claim 17 is depending on the withdrawn claim 15 and is therefore withdrawn. Claims 6, 11, 15, 17, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/06/2026.
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(s) is/are: “an actuation mechanism structured to allow articulation of the first and second effector elements” in claim 3, “closure element…configured to urge the end effector towards the second configuration” in claim 9, “alignment features configured to align the first and the second end effector elements as the end effector moves into the second configuration to facilitate alignment of the first coupler element with the second coupler element” in claim 12, “a securement mechanism…configured to secure at least one of the first coupler element or the second coupler element in a first configuration of the end effector” in claim 13. Based on the specification [Para. [0044]), the actuation element is/are rods, gears, rack and pinions, pistons, levers, bands, threads, ropes, pulleys, etc. Based on the specification [Para. [0057]), the closure element is mechanical linkages, rope wires, threads, sutures, filaments, extrusions, springs, rubber bands, bungee cords, any other suitable closure element, or any combination thereof. Based on the specification [Para. [0059]), the alignment feature is one or more notches, lips, grooves, indents, detents, protrusion, or other mating features. Based on the specification (Paras. [0065] and [0066], the securement mechanism is a string, a twine, a rope, a thread, a band, a chain, a rod, etc.
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 1-5, 7-10, 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 1 recites the limitation "the coupler first portion" in line 6 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the coupler second portion" in line 9 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-5, 7-10, and 12 are rejected because they depend on claim 1.
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112(b) issue(s) state above.
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, 7, 8, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vargas (US Pub. No.: 2005/0251179).
Regarding claim 1, Vargas discloses an apparatus (anastomosis tool 30, Fig. 17), comprising: an interface (handle 250, Fig. 17); an elongate body coupled to the interface and extending longitudinally therefrom (members 280 and 282, Fig. 17); and an end effector coupled to a distal end the elongate body (cartridges 252 comprising proximal component 254 coupled to a distal end of members 280 and 282, Fig. 17; cartridges 252 are detachably connected to the handle 250 ... Each cartridge 252 includes at least one finger 324 corresponding to an aperture 322 in the corresponding member 280, 282. Each finger 324 is connected to the proximal component 254 of the cartridge 252, para. [0090]), the end effector including: a first end effector element (top cartridge 252 coupled to member 282 via finger 324 having tooth 326 for attaching to corresponding aperture 322 in member 282, Fig. 17) defining a first receptacle structured to hold a first coupler element of a coupler (first coupler element shown as top clamp 20 comprising a lower extended portion configured to be received within a first receptacle of top cartridge 252 as shown in Fig. 17; Each cartridge 252 may include a proximal component 254 to which the clamp 20 is connected, para. [0089]), a coupler first portion configured to receive an axial end of a first vessel (each clamp 20 comprises a first arm 22 and a second arm 24 as shown in Fig. 9 configured to receive an axial end of a tissue structure 2, such as a blood vessel as shown in Fig. 1; tissue structures 2, 4 may be blood vessels ... microvascular anastomosis may be used to connect tissue structures 2, 4, para. (0041]; When in the open position, the clamp 20 is capable of receiving a tissue structure 2, 4 between the first arm 22 and the second arm 24 ... clamp 20 can be closed, trapping and firmly holding the tissue structure 2, 4 between the first arm 22 and the second arm 24, para. [0047]), and a second end effector element (bottom cartridge 252 coupled to member 280 via finger 324 having tooth 326 for attaching to corresponding aperture 322 in member 280, Fig. 17) defining a second receptacle structured to hold a second coupler element of the coupler (second coupler element shown as bottom clamp 20 comprising a lower extended portion configured to be received within a second receptacle of bottom cartridge 252 as shown in Fig. 17; Each cartridge 252 may include a proximal component 254 to which the clamp 20 is connected, para. [0089]), a coupler second portion configured to receive an axial end of a second vessel (each clamp 20 comprises a first arm 22 and a second arm 24 as shown in Fig. 9 configured to receive an axial end of a tissue structure 4, such as a blood vessel as shown in Fig. 1; tissue structures 2, 4 may be blood vessels ... microvascular anastomosis may be used to connect tissue structures 2, 4, para. [0041]; When in the open position, the clamp 20 is capable of receiving a tissue structure 2, 4 between the first arm 22 and the second arm 24 ... clamp 20 can be closed, trapping and firmly holding the tissue structure 2, 4 between the first arm 22 and the second arm 24, para. [0047]), wherein the end effector is configured to move between a first configuration in which at least a portion of the first end effector element is separate from a corresponding portion of the second end effector element such that the first coupler element is separate from the second coupler element (see Fig. 11 showing end effector clamps 20 in a first configuration in which the first clamp 20 is separate from the second clamp 20), and a second configuration in which at least the portion of first end effector element is proximate to the corresponding portion of the second end effector element (see Fig. 11A showing end effector clamps 20 proximate each other; handle 250 includes a first member 280 and a second member 282 that are movable relative to one another. The handle 250 may include a pin 284 that may be fixed to one of the members 280, 282, where the members 280, 282 are rotatable about the pin 284, para. (0089]) such that the first coupler element is coupled to the second coupler element so as to couple the first vessel to the second vessel (After the first member 280 and second member 282 have been moved to the second position, the first member 280 and second member 282 may be locked or otherwise restrained relative to one another. Any suitable mechanism or structure may be used to lock the members 280, 282 together. For example, a catch and aperture (not shown) may be used to hold the members 280, 282 together, where the catch and aperture are analogous to the catch 262 and aperture 264 used to hold the arms 22, 24 of each clamp 20 together, para. (0072]; an anastomosis tool is used to connect two tissue structures end-to-end, para. [0005]).
Regarding claim 2, Vargas discloses the apparatus of claim 1, and further discloses wherein: proximate ends of the first end effector element and the second end effector element are coupled to a distal end of the elongate body (bottom and top cartridges 252 coupled to members 280 and 282 via proximal end fingers 324 having teeth 326 for attaching to corresponding apertures 322 in member 280 and 282, Fig. 17), the first coupler element and the second coupler element are configured to be removably coupled to corresponding distal ends of the first end effector element and the second effector element, respectively (top and bottom clamps 20 comprising a lower extended portion configured to be received within first and second receptacles of top and bottom cartridges 252 as shown in Fig. 17; Each cartridge 252 may include a proximal component 254 to which the clamp 20 is connected, para. (0089]), and the first and the second end effector elements configured to articulate about the distal end of the elongate body in a first direction to move the end effector between the first and the second configurations (see Fig. 11 showing trigger 290 affixed to member 282 and 280 at pivot 288 such that clamps 20 are configured to articulate about the upper end of members 280 and 282 to move between the first open position and second closed position).
Regarding claim 3, Vargas discloses the apparatus of claim 2, and further discloses wherein the proximate ends of the first and the second end effector elements are coupled to the distal end of the elongate body via an actuation mechanism structured to allow articulation of the first and second effector elements (see Fig. 11 showing trigger 286 affixed to member 282 and 280 at pivot 288 such that clamps 20 are configured to articulate about the upper end of members 280 and 282 to move between the first open position and second closed position).
Regarding claim 7, Vargas discloses the apparatus of claim 3, and further discloses wherein the actuation mechanism includes: at least one rod coupled to a corresponding one of the first end effector element or the second end effector element (see Figs. 12 and 17 showing a trigger 286 comprising crossbar 292 coupled to the first cartridge 252 via first clamp 20; trigger 286 includes a crossbar 292. The crossbar 292 extends across the open volume within the trigger 286, and may be positioned near the distal end of the trigger 286. The crossbar 292 is substantially cylindrical in shape, para. [0069]) and configured to rotate to cause the end effector to move between the first and second configurations (trigger 286 begins to rotate about the pin 288, causing the crossbar 292 to rotate about the pin 288 as well, para. [0073]; each clamp 20 is closed onto a tissue structure 2, 4 when the anastomosis tool 30 is in the first position, in which the clamps 20 are spaced apart from one another. To actuate the anastomosis tool 30, the user squeezes the trigger 286 and the first member 280 toward one another. The biasing member 320 resists this compressive force, causing the first member 280 and the second member 282 to move closer to one another, while the trigger 286 does not move substantially relative to the second member 282, para. [0086)).
Regarding claim 8, Vargas discloses the apparatus of claim 7, and further discloses wherein the at least one rod is coupled to the corresponding one of the first end effector element or the second end effector element proximate to a radially outer edge of the corresponding one of the first end effector element or the second end effector element (see Fig. 12 showing crossbar 292 coupled to a lower end of a first clamp 20 and Fig. 17 in which the lower end of a first clamp 20 is proximate to a radially outer edge of a corresponding cartridge 252 to which first clamp 20 is coupled to).
Regarding claim 13, Vargas discloses an apparatus (anastomosis tool 30, Fig. 17), comprising: an elongate body (members 280 and 282, Fig. 17); an end effector coupled to a distal end the elongate body (cartridges 252 comprising proximal component 254 coupled to a distal end of members 280 and 282, Fig. 17; cartridges 252 are detachably connected to the handle 250 ... Each cartridge 252 includes at least one finger 324 corresponding to an aperture 322 in the corresponding member 280, 282. Each finger 324 is connected to the proximal component 254 of the cartridge 252, para. [0090]), the end effector including: a first end effector element (top cartridge 252 coupled to member 282 via finger 324 having tooth 326 for attaching to corresponding aperture 322 in member 282, Fig. 17) defining a first receptacle structured to hold a first coupler element of a coupler (first coupler element shown as top clamp 20 comprising a lower extended portion configured to be received within a first receptacle of top cartridge 252 as shown in Fig. 17; Each cartridge 252 may include a proximal component 254 to which the clamp 20 is connected, para. [0089]), the first coupler element configured to receive an axial end of a first vessel (each clamp 20 comprises a first arm 22 and a second arm 24 as shown in Fig. 9 configured to receive an axial end of a tissue structure 2, such as a blood vessel as shown in Fig. 1; tissue structures 2, 4 may be blood vessels ... microvascular anastomosis may be used to connect tissue structures 2, 4, para. [0041]; When in the open position, the clamp 20 is capable of receiving a tissue structure 2, 4 between the first arm 22 and the second arm 24 ... clamp 20 can be closed, trapping and firmly holding the tissue structure 2, 4 between the first arm 22 and the second arm 24, para. [0047]), and a second end effector element (bottom cartridge 252 coupled to member 280 via finger 324 having tooth 326 for attaching to corresponding aperture 322 in member 280, Fig. 17) defining a second receptacle structured to hold a second coupler element of the coupler (second coupler element shown as bottom clamp 20 comprising a lower extended portion configured to be received within a second receptacle of bottom cartridge 252 as shown in Fig. 17; Each cartridge 252 may include a proximal component 254 to which the clamp 20 is connected, para. [0089]), the second coupler element configured to receive an axial end of a second vessel (each clamp 20 comprises a first arm 22 and a second arm 24 as shown in Fig. 9 configured to receive an axial end of a tissue structure 4, such as a blood vessel as shown in Fig. 1; tissue structures 2, 4 may be blood vessels ... microvascular anastomosis may be used to connect tissue structures 2, 4, para. [0041]; When in the open position, the clamp 20 is capable of receiving a tissue structure 2, 4 between the first arm 22 and the second arm 24 ... clamp 20 can be closed, trapping and firmly holding the tissue structure 2, 4 between the first arm 22 and the second arm 24, para. [0047]); and a securement mechanism operatively coupled to the end effector and configured to secure at least one of the first coupler element or the second coupler element in a first configuration of the end effector (top and bottom clamps 20 comprising a lower extended portion configured to be received within first and second receptacles of top and bottom cartridges 252 as shown in Fig. 17; Each cartridge 252 may include a proximal component 254 to which the clamp 20 is connected, para. [0089]), wherein the end effector is configured to move between the first configuration in which at least a portion of the first end effector element is separate from a corresponding portion of the second end effector element such that the first coupler element is separate from the second coupler element (see Fig. 11 showing end effector clamps 20 in a first configuration in which the first clamp 20 is separate from the second clamp 20), and a second configuration in which at least the portion of first end effector element is proximate to the corresponding portion of the second end effector element (see Fig. 11 A showing end effector clamps 20 proximate each other; handle 250 includes a first member 280 and a second member 282 that are movable relative to one another. The handle 250 may include a pin 284 that may be fixed to one of the members 280, 282, where the members 280, 282 are rotatable about the pin 284, para. [0089]) such that the first coupler element is coupled to the second coupler element so as to couple the first vessel to the second vessel (After the first member 280 and second member 282 have been moved to the second position, the first member 280 and second member 282 may be locked or otherwise restrained relative to one another. Any suitable mechanism or structure may be used to lock the members 280, 282 together. For example, a catch and aperture (not shown) may be used to hold the members 280, 282 together, where the catch and aperture are analogous to the catch 262 and aperture 264 used to hold the arms 22, 24 of each clamp 20 together, para. [0072]; An anastomosis tool is used to connect two tissue structures end-to-end, para. [0005]).
Allowable Subject Matter
Claims 4, 5, 9, 10, and 12 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and overcoming the 35 U.S.C. 112(b) rejections stated above.
Claims 14, 16, 18, and 19 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11751876 B2 Hayakawa; Thomas Edward Jo et al. discloses an anastomosis device for tubular vessel
US 20080082114 A1 McKenna; Robert H. et al. discloses a system for deploying a two-part anastomosis device.
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.
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/JING RUI OU/ Primary Examiner, Art Unit 3771
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