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 .
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 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, ll. 2-5 recites, “… a first component by which an opening in a second component of the instrument can be covered or closed…”. The use of the term “can be” renders the claim indefinite because it implies the limitations following are optional, i.e., the limitations “can be” present but does not necessarily have to be present. For examination purposes, this limitation has been interpreted as “… a first component by which an opening in a second component of the instrument is covered or closed…”.
As a result of dependence on claim 1, subsequent dependent claims 2-5 are also rejected as indefinite.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenbaum et al. (US 2018/0344427) (hereinafter Rosenbaum).
Regarding claim 1, Rosenbaum discloses a handheld surgical instrument (Abstract discloses trocar; Figs. 12-13 show trocar in different working positions) having a first component (scope 56) by which an opening in a second component (cannula 42 with opening 54) of the instrument is covered or closed (scope 56 covers opening 54 in Fig. 12), the first and second components being movable relative to each other (Figs. 12-13 show how scope 56 is movable relative to cannula 40), wherein a structural element made from a shape-memory material is arranged between these two components in order to produce a temperature-dependent relative arrangement of the two components (cleaning element 60; para. 59: “Cleaning element 60 may include a suitable biasing element, such as a spring or other device (e.g., a shape memory metal), to urge cleaning element 60 to return to the first position substantially covering second opening 54 when scope 56 is retracted proximally into access channel 50”).
Claims 6 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hegeman et al. (US 2007/0250113) (hereinafter Hegeman).
Regarding claim 6, Hegeman discloses a handheld surgical instrument (Abstract; Figs. 3-4) having a first component and a second component (individual jaws of end effector 102), the two components being movable relative to each other so that the instrument can be brought into different working positions (Figs. 3-4 depict how jaws are movable relative to each other to open and close), wherein the two components are mechanically coupled to each other by a structural element made from a shape- memory material (rod 125; para. 85: “In some embodiments, the movable tension bearing member or rod may comprise any flexible tension bearing material; in some embodiments Nitinol offers particular advantages as it is sufficiently flexible to accommodate articulation, and yet resilient enough to carry a compressive load that allows the rod to open an end effector, such as a set of jaws”).
Regarding claim 10, Hegeman discloses the shape-memory material is nitinol (para. 85).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenbaum in view of Houser et al. (US 2015/0351792) (hereinafter Houser).
Regarding claim 2, Rosenbaum does not disclose this structural element is a wave spring.
Houser, however, teaches a handheld surgical instrument (Fig. 1’) wherein a force limiting spring 155 is described in the art as a wave spring, due to the shape of the spring elements 159. It is advantageous to use a wave spring for force limiting spring 155 because it provides a high spring rate in a small physical size well suited to a surgical instrument (para. 51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Rosenbaum such that the structural element is a wave spring. Making this modification would be useful for providing a high spring rate in a small physical size well suited to a surgical instrument, as taught by Houser.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenbaum in view of Nitinol NPL (https://customwiretech.com/2021/07/the-nitinol-advantage/).
Regarding claim 5, Rosenbaum does not teach the shape-memory material is nitinol.
Nitinol NPL, however, teaches that nitinol is an especially valuable alloy because it is extremely elastic and can change shape depending on temperature. Nitinol NPL also teaches nitinol is an excellent material to use when creating components for minimally invasive medical devices (under “Nitinol’s Unique Properties”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Rosenbaum such that the shape-memory material is nitinol because it is extremely elastic, can change shape depending on temperature, and nitinol is an excellent material to use when creating components for minimally invasive medical devices, as taught by Nitinol NPL.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hegeman in view of Keating et al. (US 2013/0030462) (hereinafter Keating).
Regarding claim 7, Hegeman does not disclose this structural element is a spring.
Keating, however, teaches a laparoscopic surgical device comprising a pair of jaws (Abstract) wherein a shape memory spring material would be useful in embodiments which employ springs disposed between the jaws 115 and 116 to enable a larger opening without permanent deformation occurring. The spring component may also be placed in series (longitudinally) or in parallel (vertically) to achieve greater closure forces (para. 152).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Hegeman such that the structural element is a spring. Making this modification would be useful for enabling a larger opening without permanent deformation occurring and achieving greater closure forces, as taught by Keating.
Allowable Subject Matter
Claims 3-4 and 8-9 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.
Benecke (US 5665050) discloses a handheld surgical instrument comprising a superelastic-alloy force transmitting element (Abstract) such as nitinol (Col. 1, ll. 11-12).
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/A.A.G./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792