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 .
Preliminary Amendment
In light of Applicant’s amendment, claim(s) 18-51 is/are canceled. Claims 1-17 and 52-54 are now pending examination.
Claim Objections
Claims 1 and 52 are objected to because of the following informalities:
Claim 1 and 52 recite “at least one at least one elongate inner body made of superelastic material”, however it should recite “at least one elongate inner body made of superelastic material”.
Appropriate correction is required.
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 15-17 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.
The term “sufficient” in claim 15 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, it is indefinite as to what would comprise sufficient column strength in the claim “wherein the outer tubular body has sufficient column strength”. Claims 16-17 are rejected due to their dependence on claim 15.
Claim 17 recites the language “wherein the outer tubular body resists deformation when advanced through tissue in the second configuration during a suturing operation”, which is written as a method step, however the claim is an apparatus claim, rendering the scope of the claim indefinite.
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(s) 1-17 and 52-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lombardo (US 20190110788 A1) in view of Chanduszko et al. (US 20050101984 A1).
Regarding claim 1, Lombardo discloses a suturing needle comprising a needle body (10) having a leading end (14) and a trailing end (12) (Figure 1; Paragraph 0023), the needle body comprising an outer tubular body (28) having a proximal end (proximal end of 28) and a distal end (32) configured to pierce tissue (Figure 3-4; Paragraph 0003; 0025), and at least one elongate inner body (30) disposed within and operably coupled to the outer tubular body (Figure 5-7; Paragraph 0030), wherein the outer tubular body deforms from a first configuration (Figure 1) into a second configuration (Figure 6) in response to the application of force by the at least one elongate inner body on the outer tubular body (Figure 1, 6-7; Paragraph 0007; 0031).
Lombardo fails to explicitly disclose the at least one elongate inner body made of superelastic material.
However, Chanduszko is directed to a needle device and teaches an elongate inner body (14) made of nitinol (Paragraph 0047; 0050), which is a superelastic material according to the present disclosure.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lombardo such that the at least one elongate inner body made of superelastic material, as taught by Chanduszko, as both references and the claimed invention are directed to needles and Lombardo is silent to the material of the elongate inner body. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lombardo with the teachings of Chanduszko by incorporating the at least one elongate inner body made of superelastic material in order to be flexible and employ shape memory such that the shape can be returned to, substantially, the same shape the wire possessed prior to it being manipulated (Chanduszko Paragraph 0065).
Regarding claim 2, Lombardo further discloses wherein the outer tubular body defines at least one opening (40) therethrough when the outer tubular body is in the first configuration that decreases in spatial extent when the outer tubular body deforms from the first configuration into the second configuration (Figure 3-4, 6; Paragraph 0026).
Regarding claim 3, Lombardo further discloses wherein the at least one opening comprises a plurality of openings (40) defined along a length of the outer tubular body (Figure 3-4; Paragraph 0026).
Regarding claim 4, Lombardo further discloses wherein the first configuration is a generally linear configuration (Figure 1; Paragraph 0003).
Regarding claim 5, Lombardo further discloses wherein the second configuration is a curved configuration (Figure 6-7; Paragraph 0003).
Regarding claim 6, Lombardo further discloses wherein the second configuration is an arcuate configuration (Figure 6-7; Paragraph 0030).
Regarding claim 7, Lombardo further discloses wherein the second configuration defines a splined shape (Figure 6-7).
Regarding claim 8, Lombardo further discloses wherein the second configuration defines an out of plane shape (Figure 6-7).
Regarding claim 9, Lombardo further discloses wherein each opening in the plurality of openings is defined along a first lateral side (labeled in Annotated Figure 3) of the outer tubular body (Figure 3; Paragraph 0026).
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Regarding claim 10, Lombardo further discloses wherein no openings are defined along a second lateral side (labeled in Annotated Figure 3) of the outer tubular body opposite the first lateral side of the outer tubular body (Figure 3).
Regarding claim 11, Lombardo further discloses wherein a second lateral side (labeled in Annotated Figure 3) of the outer tubular body opposite the first lateral side of the outer tubular body is defined by a continuous surface free from openings (Annotated Figure 3).
Regarding claim 12, Lombardo further discloses wherein the outer tubular body is not diametrically expandable (Lombardo does not teach diametric expansion, thus the tubular body is not diametrically expandable).
Regarding claim 13, Lombardo further discloses wherein the outer tubular body is not diametrically contractable (Lombardo does not teach diametric contraction, thus the tubular body is not diametrically contractable).
Regarding claim 14, Lombardo further discloses wherein a cross-sectional height of the outer tubular body does not change when the outer tubular body deforms from the first configuration into the second configuration, as Lombardo does not teach any change in the cross-sectional height of the outer tubular body.
Regarding claim 15, as best understood in view of the 112(b) issues above, Lombardo further discloses wherein the outer tubular body has sufficient column strength when in the second configuration to be advanced through tissue to suture the tissue without deformation of the suturing needle (Lombardo does not teach deformation of the needle during insertion, thus the outer tubular body is seen to have sufficient column strength.).
Regarding claim 16, Lombardo further discloses wherein the outer tubular body is generally toroidally shaped when in the second configuration (Figure 6-7) (the outer tubular body is curved, which is seen as “generally toroidally shaped”.).
Regarding claim 17, as best understood in view of the 112(b) issues above, Lombardo further discloses wherein the outer tubular body resists deformation when advanced through tissue in the second configuration during a suturing operation (Lombardo does not teach deformation when the tubular body is advanced, thus Lombardo discloses wherein the outer tubular body resists deformation when advanced through tissue.).
Regarding claim 52, Lombardo discloses a suturing needle (10) comprising a needle body (10) having a leading end (14) and a trailing end (12) (Figure 1; Paragraph 0023), the needle body comprising a first body (28) having a proximal end (proximal end of 28) and a distal end (32) configured to pierce tissue (Figure 3-4; Paragraph 0003; 0025), and at least one elongate body (30) operably coupled to the first body (Figure 5-7; Paragraph 0030), wherein the first body deforms from a first configuration (Figure 1) into a second configuration (Figure 6) in response to the application of force by the at least one elongate body on the first body (Figure 1, 6-7; Paragraph 0007; 0031).
Lombardo fails to explicitly disclose the at least one elongate inner body made of superelastic material.
However, Chanduszko is directed to a needle device and teaches an elongate inner body (14) made of nitinol (Paragraph 0047; 0050), which is a superelastic material according to the present disclosure.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lombardo such that the at least one elongate inner body made of superelastic material, as taught by Chanduszko, as both references and the claimed invention are directed to needles and Lombardo is silent to the material of the elongate inner body. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lombardo with the teachings of Chanduszko by incorporating the at least one elongate inner body made of superelastic material in order to be flexible and employ shape memory such that the shape can be returned to, substantially, the same shape the wire possessed prior to it being manipulated (Chanduszko Paragraph 0065).
Regarding claim 53, Lombardo further discloses wherein the at least one elongate body is disposed parallel to the first body (Figure 2; Paragraph 0025) (Lombardo states “The inner tube 30 is positioned slidably within the outer tube 28”, thus the elongate body is parallel to the first body.).
Regarding claim 54, Lombardo further discloses wherein the least one elongate body is operably coupled to the first body at a plurality of locations along a length of the first body (the elongate body is welded to the first body at 32, as disclosed in Paragraph 0025, then is further coupled to the first body as both the inner tube 30 and outer tube 28 are bent, thus creating points of connection along the length of the first body.) (Figure 2, 6-7; Paragraph 0025).
Conclusion
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771