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
Applicant's election with traverse of claims 1-12 in the reply filed on 3/27/2026 is acknowledged. The traversal is on the ground(s) that there would be no serious burden by examining claims 13-19 in a single application. This is not found persuasive because the apparatus as claimed can be used in a materially different method, as it is not necessarily found in an area that would require ligation of a blood vessel. For example, the device as claimed can be used to clamp and cut cords or wires. Further, only one of the following reasons is required to be true:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Thus, the requirement is still deemed proper and is therefore made FINAL.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/27/2026.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites the limitation “the ligating clip” however claim 1 from which the claim depends recites “one or more ligating clips”. It is suggested to amend the language to recite “the one or more ligating clips” to maintain consistency with claim 1.
Appropriate correction is required.
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: “application device” and “cutting device“ in claim 1, “clip biasing system” in claim 6, and “biasing system” in claim 9.
Claim 1 recites the limitation of a “control system”. The term “system” is used as a substitute for “means” and is modified by functional language “control”. There is no corresponding structure in the claim, therefore invoking 112(f). Further, there is no corresponding structure in the specification, aside from labeling the control system as 120 or 120a (Paragraph 0039; 0041) therefore the scope of the limitation is indefinite.
Claim 1 recites the limitation of a “application device”. The term “device” is used as a substitute for “means” and is modified by functional language “to apply one or more ligating clips to the blood vessel to mechanically ligate the blood vessel”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “application device” is “a first compressive arm and a second compressive arm” (Paragraph 0012), “a housing including a compartment which is configured to hold a plurality of the ligating clips” (Paragraph 0013) or equivalents thereof.
Claim 1 recites the limitation of a “cutting device”. The term “device” is used as a substitute for “means” and is modified by functional language “configured to mechanically cut tissue including the blood vessel”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “cutting device” is “surgical scissors” (Paragraph 0027) or equivalents thereof.
Claim 6 recites the limitation of a “clip biasing system”. The term “system” is used as a substitute for “means” and is modified by functional language “to bias the plurality of ligating clip to move in a defined direction”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “clip biasing system” is “a spring, elastomeric element, or other resilient element 230” (Paragraph 0048) or equivalents thereof.
Claim 9 recites the limitation of a “biasing system”. The term “system” is used as a substitute for “means” and is modified by functional language “configured to bias at least one of the first blade and the second blade to an open state”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “biasing system” is “a spring or other resilient element” (Paragraph 0057) or equivalents thereof.
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 1-12 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 limitation “control system” in claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Claim 1 recites the limitation of a “control system”. The term “system” is used as a substitute for “means” and is modified by functional language “control”. There is no corresponding structure in the claim, therefore invoking 112(f). Further, there is no corresponding structure in the specification, aside from labeling the control system as 120 or 120a (Paragraph 0039; 0041) therefore the scope of the limitation is indefinite. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For examination purposes, the limitation will be seen as “an actuator” although the present specification distinguishes “an actuator” and “control system”.
Claims 2-12 are rejected due to their dependence on claim 1.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baxter et al. (US 20160081690 A1).
Regarding claim 1, Baxter discloses a system (10) for use in connection with a blood vessel, comprising:
a proximal section (proximal end of 30+20) comprising a control system (24, 26) (Figure 1; Paragraph 0039) (as noted above, “control system” invokes 112(f) and there is no corresponding structure in the present spec. For examination purposes, the limitation will be seen as any structure capable of controlling the device, thus the triggers of Baxter are seen as a control system.),
a distal section (30) (Figure 1; Paragraph 0037),
an application device (40) in connection with the distal section to apply one or more ligating clips (77) to the blood vessel to mechanically ligate the blood vessel (Figure 4-5; Paragraph 0047), the application system being in connection with the control system (Paragraph 0054) (As indicated above, the limitation “application device” invokes 112(f). The corresponding structure in Baxter is an end effector that includes first compressive arm (60) and a second compressive arm (50), which is equivalent to a first compressive arm and a second compressive arm, as disclosed in the present disclosure.), and
a cutting device (80+380) in operative connection with the distal section, the cutting device being configured to mechanically cut tissue including the blood vessel (Figure 6, 17; Paragraph 0050; 0080) (As indicated above, the limitation “cutting device” invokes 112(f). The corresponding structure in Baxter is surgical scissors comprising a first blade (380) which is pivotable relative to a second blade (80) (scissors comprise two blades and since blade 380 is pivotable to knife 80, the combination of the components are seen as scissors), which is equivalent to a surgical scissors, as disclosed in the present disclosure.).
Regarding claim 2, Baxter further discloses wherein the proximal section and the distal section are portions of an extending tube configured for use in endoscopic surgery (Figure 1; Paragraph 0001; 0037).
Regarding claim 3, Baxter further discloses wherein the cutting device comprises surgical scissors comprising a first blade (380) which is pivotable relative to a second blade (80) (scissors comprise two blades and since blade 380 is pivotable to knife 80, the combination of the components are seen as scissors) (Figure 16-17; Paragraph 0079; 0087).
Regarding claim 4, Baxter further discloses wherein the application device comprises a first compressive arm (60) and a second compressive arm (50) (Figure 1, 4; Paragraph 0045), wherein the ligating clip (one of 77) is positionable between the first compressive arm and the second compressive arm to compress the ligating clip to ligate the blood vessel (Figure 4; Paragraph 0049).
Regarding claim 5, Baxter further discloses wherein the application device comprises a housing (70) comprising a compartment (71) which is configured to hold a plurality of the ligating clips (Figure 5; Paragraph 0047), the application device being further configured to apply two or more of the plurality of ligating clips sequentially in time (Paragraph 0046; 0050-51).
Regarding claim 6, Baxter further discloses wherein the application device comprises a clip biasing system (78) to bias the plurality of ligating clip to move in a defined direction (Figure 4-5; Paragraph 0047) (As indicated above, the limitation “clip biasing system” invokes 112(f). The corresponding structure in Baxter is a wedge sled with cam surfaces, which is equivalent to a resilient structure, as disclosed in the present disclosure.) .
Regarding claim 7, Baxter further discloses wherein each of the plurality of ligating clips comprises a distal resilient section (legs of staple; labeled in Annotated Figure 5) and a proximal clamping section (labeled in Annotated Figure 5), the clamping section comprising a first tissue contacting member (inner surface of top of staple) and a second tissue contacting member (outer surface of top of staple) (Annotated Figure 5), the distal resilient section being attached to the proximal clamping section such that compression of the distal resilient section causes separation of the first tissue contacting member and the second tissue contacting member (Annotated Figure 5; Paragraph 0047).
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Regarding claim 8, Baxter further discloses wherein the compartment is in connection with a passage (72) through which one of the plurality of ligating clips may be forced, wherein forcing the one of the plurality of clips through the passage causes compression of the distal resilient section (Figure 4-5; Paragraph 0047).
Regarding claim 9, Baxter further discloses a biasing system (spring) in connection with the surgical scissors configured to bias at least one of the first blade and the second blade to an open state (Paragraph 0081) (As indicated above, the limitation “biasing system” invokes 112(f). The corresponding structure in Baxter is a spring, which is equivalent to a spring , as disclosed in the present disclosure.).
Regarding claim 10, Baxter further discloses wherein the cutting device further comprises a scissors compartment (384) into which and out of which at least a portion of the surgical scissors (380) may be moved, moving the at least a portion of the surgical scissors distally into the scissors compartment causing the first blade and the second blade to be forced toward a closed state via abutment of at least of the first blade and the second blade with the scissors compartment, and moving the surgical scissors proximally out of the compartment causing the surgical scissors to be forced toward the open state via the biasing system in connection with the surgical scissors (Figure 17; Paragraph 0079-80).
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.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baxter in view of Kostrzewski et al. (US 20130098966 A1).
Regarding claim 11, Baxter discloses the system of claim 1 but fails to exility disclose wherein the distal section of the system is movable relative to a proximal section to change the angle of the distal section relative to the proximal section.
However, Kostrzewski is directed to a surgical device (10) and teaches wherein the distal section of the system (400) is movable relative to a proximal section (210) to change the angle of the distal section relative to the proximal section (Figure 1; Paragraph 0117).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Baxter such that the distal section of the system is movable relative to a proximal section to change the angle of the distal section relative to the proximal section, as taught by Kostrzewski, as both references and the claimed invention are directed to surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baxter with the teachings of Kostrzewskiby incorporating wherein the distal section of the system is movable relative to a proximal section to change the angle of the distal section relative to the proximal section in order to increase flexibility and maneuverability of the end effector and allow for a greater range of motion.
Regarding claim 12, Baxter discloses the system of claim 2, but fails to explicitly disclose wherein the distal section of the system is movable relative to a proximal section to change the angle of the distal section relative to the proximal section.
However, Kostrzewski is directed to a surgical device (10) and teaches wherein the distal section of the system (400) is movable relative to a proximal section (210) to change the angle of the distal section relative to the proximal section (Figure 1; Paragraph 0117).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Baxter such that the distal section of the system is movable relative to a proximal section to change the angle of the distal section relative to the proximal section, as taught by Kostrzewski, as both references and the claimed invention are directed to surgical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Baxter with the teachings of Kostrzewskiby incorporating wherein the distal section of the system is movable relative to a proximal section to change the angle of the distal section relative to the proximal section in order to increase flexibility and maneuverability of the end effector and allow for a greater range of motion
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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