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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/12/2024 was filed after the mailing date of the application on 03/12/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Claims 7-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/02/2026.
Claim Objections
Claims 1-7 are objected to.
Regarding claims 1-7, the claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
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 1-7 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.
Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim 1, the phrase "essentially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim 1, the phrase “mainly” renders the claim indefinite because it is unclear what the limitation does and does not entail. What does “a support that mainly extends along a longitudinal extension axis” mean? In other words, what would make the support “mainly” extend along a longitudinal extension axis, or what would disqualify the support from being extended along the longitudinal extension axis? Appropriate correction is required.
Further regarding claim 1, the Examiner cannot determine what is being claimed. Is the device the mechanical stand, the conductive needle, or the entire system? The Examiner is interpreting the device to be the entire system, however appropriate correction is required.
Regarding claims 2-7, claims 2-7 are rejected due to their dependency on 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.
Claims 2-3 are subjected to a 112f interpretation for the use of “means”. See the below three-prong analysis for each of the claims.
Regarding claim 2, the claim uses the phrase “rotation means configured to allow rotation of the support”, seen in p.[0121-0124] of the specification filed 03/12/2024. The Examiner is interpreting a rotation means as any structure that allows for the rotation of the device, such as a stepper electric motor, rotation shaft, or the like.
The claimed limitation uses the word “means”.
The term “rotation means” is modified by functional language “configured to allow rotation of the support”.
The term “rotation means” is not modified by sufficient structure, material, or acts to perform the recited function.
Regarding claim 3, the claim uses the phrase “the rotation means are configured to allow the rotation of the support” seen in p.[0121-0124] of the specification filed 03/12/2024. The Examiner is interpreting a rotation means as any structure that allows for the rotation of the device, such as a stepper electric motor, rotation shaft, or the like.
The claimed limitation uses the word “means”.
The term “rotation means” is modified by functional language “configured to allow rotation of the support”.
The term “rotation means” is not modified by sufficient structure, material, or acts to perform the recited function.
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma (US 2019/0090897), herein after “Ma”.
Regarding claim 1, Ma teaches “A device adapted to make one or more holes on a surface of a biocompatible tissue for revitalizing the tissue (abstract), comprising one or more conductive needles (313, p.[0044]) arranged on a mechanical stand (platform 312, Fig. 3A); the mechanical stand comprising a support that mainly extends along a longitudinal extension axis configured to be introduced into a cavity defined by an essentially tubular-shaped biocompatible tissue (Fig. 8A); the one or more conductive needles being directed towards an outer and/or inner surface of the support such as to make one or more holes spread out on at least one generatrixes of the tissue (Fig. 2C, Fig. 9B); the one or more holes being made with a depth which occupies at least a part of a thickness of the tissue (p.[0064]).”
Regarding claim 2, the limitations of claim 1 are taught as described above. Ma teaches “wherein the support is connected to rotation means configured to allow rotation of the support according to the longitudinal extension axis (p.[0086])”.
Regarding claim 3, the limitations of claim 2 are taught as described above. Ma teaches “wherein the rotation means are configured to allow the rotation of the support according to a discrete-type sequence of movements according to the longitudinal extension axis (p.[0086])”.
Regarding claim 4, the limitations of claim 1 are taught as described above. Ma teaches “wherein the mechanical stand is configured to be moved according to a revolution axis substantially corresponding to the longitudinal extension axis of the support (p.[0086])”.
Regarding claim 6, the limitations of claim 1 are taught as described above. Ma teaches “wherein a plurality of the conductive needles are orderly arranged on the mechanical stand to create at least an ordered row of the conductive needles, the ordered row being parallel to the longitudinal extension axis of the support (Fig. 3A)”.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Marzaro (US 2012/0269780), herein after “Marzaro”.
Regarding claim 5, the limitations of claim 1 are taught as described above. Ma does not teach "further comprising a power supply source connected to the one or more conductive needles adapted to provide to a tip of each needle a current whose intensity and whose waveshape are such to provide enough energy to cause opening of molecule bonds of the tissue which contact the tip of the needle", but Marzaro does in an analogous tissue resection device. Marzaro teaches ""further comprising a power supply source connected to the one or more conductive needles adapted to provide to a tip of each needle a current whose intensity and whose waveshape are such to provide enough energy to cause opening of molecule bonds of the tissue which contact the tip of the needle" in p.[0035]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Marzaro in Ma. As stated in Marzaro, "n order to efficiently avoid necrosis problems during the formation of the holes and/or reservoir cavities, said plurality of holes and/or reservoir cavities is preferably made by means of one or more metal needles connected to an electric power source, causing on the tip of each needle the passage of an electric current whose intensity and wave shape are such as to supply a quantity of energy sufficient to open the bonds that join the molecules of the organic tissue in proximity to the tip of said needle, each hole being such that the tip of said needle enters the space left free by the opening of said molecular bonds and makes said hole. It should be understood that the holes and/or the reservoir cavities can be made also in another manner, for example mechanically" and produces predictable results of electrifying the tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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