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 07/28/2026. Claims 1-20 are pending. Claims 1 and 17 are independent.
Election/Restrictions
Applicant’s election without traverse of Species E (Figures 7A-7H) for the Tissue Transection Device and Species Z (Figure 22) for the Introducer/Delivery Device in the reply filed on 07/28/2026 is acknowledged.
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.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
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.
Claim 1-20 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.
Claim 1 recites the limitation “wherein the at least one second cutting surface is located on a bottom edge of the second incision member” in lines 16-17 of the claim. The specification fails to describe that the at least one second cutting surface is located on a bottom edge of the second incision member. Instead, the specification describes that the first cutting surface and the second cutting surface provides a scissoring action (Paras. [0177] and [0178]). In the elected embodiment (Figs. 7A-7H), the first incision member 124 and the second incision member 126 forms a generally V-shape for providing a scissoring action to cut tissue between 124 and 126. Furthermore, it is unclear how scissoring action to cut tissue between 124 and 126 can be preformed when the at least one cutting surface is located on a bottom edge of the first incision member and the at least one second cutting surface is also located on a bottom edge of the second incision member. Claims 2-16 are rejected because they depend on claim 1.
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Claim 17 recites the limitation “wherein the second incision member comprises at least one second cutting surface located on a bottom edge of the second incision member” in lines 16-17 of the claim. The specification fails to describe that the at least one second cutting surface is located on a bottom edge of the second incision member. Instead, the specification describes that the first cutting surface and the second cutting surface provides a scissoring action (Paras. [0177] and [0178]). In the elected embodiment (Figs. 7A-7H), the first incision member 124 and the second incision member 126 forms a generally V-shape for providing a scissoring action to cut tissue between 124 and 126. Furthermore, it is unclear how scissoring action to cut tissue between 124 and 126 can be preformed when the at least one cutting surface is located on a bottom edge of the first incision member and the at least one second cutting surface is also located on a bottom edge of the second incision member. Claims 18-20 are rejected because they depend on claim 17.
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 1-20 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 “wherein the at least one cutting surface is located on a bottom edge of the first incision member” in lines 10-11 of the claim and “wherein the at least one second cutting surface is located on a bottom edge of the second incision member” in lines 16-17 of the claim. As explained above, the specification describes that the first cutting surface and the second cutting surface provides a scissoring action (Paras. [0177] and [0178]). In the elected embodiment (Figs. 7A-7H), the first incision member 124 and the second incision member 126 forms a generally V-shape for providing a scissoring action to cut tissue between 124 and 126. It is unclear how scissoring action to cut tissue between 124 and 126 can be preformed when the at least one cutting surface is located on a bottom edge of the first incision member and the at least one second cutting surface is also located on a bottom edge of the second incision member. Claims 2-16 are rejected because they depend on claim 1.
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Claim 17 recites “at least one cutting surface located on a bottom edge of the first incision member” in lines 10-11 of the claim and “wherein the at least one second cutting surface is located on a bottom edge of the second incision member” in lines 16-17 of the claim. As explained above, the specification describes that the first cutting surface and the second cutting surface provides a scissoring action (Paras. [0177] and [0178]). In the elected embodiment (Figs. 7A-7H), the first incision member 124 and the second incision member 126 forms a generally V-shape for providing a scissoring action to cut tissue between 124 and 126. Furthermore, it is unclear how scissoring action to cut tissue between 124 and 126 can be preformed when the at least one cutting surface is located on a bottom edge of the first incision member and the at least one second cutting surface is also located on a bottom edge of the second incision member. Claims 18-20 are rejected because they depend on claim 17.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20020115997 A1 Truckai, Csaba et al. discloses an electrosurgical system for cutting and sealing tissue.
US 20060264930 A1 Nishimura; Miyuki discloses a high frequency incision tool for endoscope.
US 20080312652 A1 Bell; Stephen G. et al. discloses a reverse sealing and dissection instrument.
US 20210137551 A1 Makower; Joshua et al. discloses a cutting instrument having incision members.
US 5649947 A Auerbach; Burt J. et al. discloses surgical instrument having a proximally extending cutting jaw.
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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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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/JING RUI OU/Primary Examiner, Art Unit 3771
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