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 .
Response to Amendment
In light of Applicant’s amendment, claim(s) 1, 3-6 and 9-12 is/are amended. Claims 1-12 are now pending examination.
The interpretation(s) under 35 U.S.C. 112(f) of “application device”, “cutting device”, “control device” and “clip biasing system” is/are withdrawn in light of Applicant’s amendment.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 1 is/are withdrawn in light of Applicant’s amendment.
The objections to the claims are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 7/18/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the surgical stapler of Baxter does not constitute a system for use in connection with a blood vessel to harvest a section of the blood vessel, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Although the surgical stapler of Baxter does not explicitly harvest a blood vessel, it contains the same structures as the claimed invention thus is fully capable of being used for such a function. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Further, Baxter does disclose using the device across a blood vessel (Paragraph 0003; 0065).
Further, Applicant argues that the staples of Baxter are not equivalent to ligating clips. However, the claim provides no structure to the characteristics of the ligating clips (i.e., shape, materials, etc.). Ligating clips are designed to seal vessels, which can be done by a staple as well, as stated in Baxter “the vessels leading to an organ may be severed and closed by a stapler before removal of the organ”. The staples are similarly shaped to ligating clips thus are fully capable of performing the same function. The device of Baxter, including the staples, includes the claimed structures thus is fully capable of performing the intended use of the claimed invention.
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: “clip biasing system” in claim 6.
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.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The present disclosure fails to provide support for “a controller” and “the applicator being in connection with the controller via which the applicator is actuated to cause one of the one or more ligating clips to mechanically ligate the blood vessel” in claim 1. The present disclosure only mentions a “control system” but does not provide any potential structures that would constitute the 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) (previously of record).
Regarding claim 1, Baxter discloses a system (10) for use in connection with a blood vessel to harvest a section of the blood vessel (Paragraph 0003) ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.), comprising:
a proximal section (proximal end of 30+20) comprising a controller (100) (Figure 1; Paragraph 0039; 0056),
a distal section (30) (Figure 1; Paragraph 0037),
an applicator (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 applicator being in connection with the controller (abstract; Paragraph 0056; 0097), and
a cutter (80+380) in operative connection with the distal section, which is positioned adjacent to and spaced from the position of the applicator (Figure 5; Paragraph 0050), the cutter being in connection with the controller via which the cutter is actuated (Paragraph 0056; 0061) to mechanically cut tissue including the blood vessel (Figure 6, 17; Paragraph 0050; 0080) and is fully capable of doing such after the one of the one or more ligating clips mechanically ligates the blood vessel, thereby creating an open end of the section of the blood vessel (Paragraph 0003; 0058).
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 cutter 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 applicator comprises a first compressive arm (60) and a second compressive arm (50) (Figure 1, 4; Paragraph 0045), wherein the one of the one or more ligating clip (one of 77) is positionable between the first compressive arm and the second compressive arm to compress the one of the one or more ligating clip to ligate the blood vessel (Figure 4; Paragraph 0049).
Regarding claim 5, Baxter further discloses wherein the applicator comprises a housing (70) comprising a compartment (71) which is configured to hold a plurality of the ligating clips (Figure 5; Paragraph 0047), the applicator 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 applicator 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 wherein at least one of the first blade and the second blade of the surgical scissors is biased to an open state (Paragraph 0081).
Regarding claim 10, Baxter further discloses wherein the cutter 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) (previously of record).
Regarding claim 11, Baxter discloses the system of claim 1 but fails to explicitly disclose wherein the distal section of the system is movable relative to the 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 the 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 the 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 Kostrzewski by 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
