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 .
Election/Restrictions
Applicant’s election without traverse of Invention II in the reply filed on 2/24/2026 is acknowledged. Accordingly, Applicant canceled claims 1-17 and added claims 21-37. Claims 18-37 are pending examination.
Claim Objections
Claim 25 is objected to because of the following informalities:
Claim 25 contains the claimed range .005-.015”. In order to minimize the necessity in the future for converting dimensions given in the English system of measurements to the metric system of measurements when using printed patents as research and prior art search documents, all patent applicants should use the metric (S.I.) units followed by the equivalent English units when describing their inventions in the specifications of patent applications.
Appropriate correction is required.
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 33 is 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 disclosure fails to mention the limitation of claim 33, “wherein: a first portion of the smooth proximal beveled edge has the first angle relative to the axis of the hollow shaft; and a second portion of the smooth proximal beveled edge has the second angle relative to the axis of the hollow shaft”. Further, none of the drawings clearly depict such a configuration. Specifically, there seems to be no disclosure of the smooth proximal beveled edge being beveled at two angles.
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) 18, 20, 31-32, 34, and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng et al. (US 20110060349 A1).
Regarding claim 18, Cheng discloses a method of delivering a tissue anchor using a needle, the method comprising:
advancing a needle (230) to a target tissue (Paragraph 0095; 106), the needle including:
a hollow shaft (body of 230) (Figure 9-10; Paragraph 0100); and
a needle tip (240) including a sharp distal beveled edge (labeled in Annotated Figure 9) and a smooth proximal beveled edge (labeled in Annotated Figure 9) (Figure 9; Paragraph 0101);
puncturing the target tissue with the sharp distal beveled edge of the needle tip to form an opening in the target tissue (Paragraph 0097; 0106);
stretching the opening by advancing the smooth proximal beveled edge at least partially through the opening (according to the claim, advancing the smooth proximal beveled edge at least partially through the opening results in stretching the tissue, as the diameter of the opening would increase to allow the smooth proximal beveled edge through, as opposed to just the distalmost portion of the needle tip. As such, Cheng discloses stretching the tissue.) (Paragraph 0097; 0101); and
deploying a tissue anchor (352+350) distal of the opening from a lumen (lumen of 230) of the needle (Paragraph 0102; 0108).
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Regarding claim 20, Cheng further discloses wherein the smooth proximal beveled edge is radiused (The edge is curved, as shown in Figure 9) (Figure 9).
Regarding claim 31, Cheng discloses a method of delivering a tissue anchor using a needle, the method comprising:
advancing a needle (230) to a target tissue (Paragraph 0095; 106), the needle including:
a hollow shaft (body of 230) (Figure 9-10; Paragraph 0100); and
a needle tip (240) (Figure 9-10; Paragraph 0101) including:
a pointed tip (distal tip of 240) (Figure 9-10; Paragraph 0101);
a sharp distal beveled edge (labeled in Annotated Figure 9) (Figure 9; Paragraph 0101); and
a smooth proximal beveled edge (labeled in Annotated Figure 9) proximally adjacent the sharp distal beveled edge (Figure 9; Paragraph 0101), the sharp distal beveled edge being sharper than the smooth proximal beveled edge (the distalmost edge of the distal beveled edge pierces the tissue; therefore, the distal beveled edge is sharper than the proximal beveled edge) (Figure 9; Paragraph 0101);
puncturing the target tissue with the pointed tip and the sharp distal beveled edge to form an opening in the target tissue (Paragraph 0097; 0106);
stretching the opening by advancing the smooth proximal beveled edge at least partially through the opening (Paragraph 0097; 0101); and
deploying a tissue anchor (350+352) distal of the opening from a lumen (lumen of 230) of the needle (Paragraph 0102; 0108).
Regarding claim 32, Cheng further discloses wherein: the sharp distal beveled edge has a first angle relative to an axis of the hollow shaft (Figure 9; Paragraph 0101); and at least a portion of the smooth proximal beveled edge has a second angle relative to the axis of the hollow shaft that is less than the first angle (Figure 9; Paragraph 0101).
Regarding claim 34, Cheng further discloses wherein the smooth proximal beveled edge is radiused (The edge is curved, as shown in Figure 9) (Figure 9).
Regarding claim 36, Cheng further discloses wherein the hollow shaft includes a bend proximal of the needle tip that deflects the needle tip to align the pointed tip with an axis of the hollow shaft (Figure 6, 21; Paragraph 0106).
Claim(s) 31 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by an alternative interpretation of Cheng (US 20110060349 A1).
Regarding claim 31, Cheng discloses a method of delivering a tissue anchor using a needle, the method comprising:
advancing a needle (230) to a target tissue (Paragraph 0095; 106), the needle including:
a hollow shaft (body of 230) (Figure 9-10; Paragraph 0100); and
a needle tip (240) (Figure 9-10; Paragraph 0101) including:
a pointed tip (labeled in Annotated Figure 9(2)) (Figure 9-10; Paragraph 0101);
a sharp distal beveled edge (labeled in Annotated Figure 9(2)) (Figure 9; Paragraph 0101); and
a smooth proximal beveled edge (labeled in Annotated Figure 9(2)) proximally adjacent the sharp distal beveled edge (Figure 9; Paragraph 0101), the sharp distal beveled edge being sharper than the smooth proximal beveled edge (the distalmost edge of the distal beveled edge pierces the tissue; therefore, the distal beveled edge is sharper than the proximal beveled edge) (Figure 9; Paragraph 0101);
puncturing the target tissue with the pointed tip and the sharp distal beveled edge to form an opening in the target tissue (Paragraph 0097; 0106);
stretching the opening by advancing the smooth proximal beveled edge at least partially through the opening (according to the claim, advancing the smooth proximal beveled edge at least partially through the opening results in stretching the tissue, as the diameter of the opening would increase to allow the smooth proximal beveled edge through, as opposed to just the distalmost portion of the needle tip. As such, Cheng discloses stretching the tissue.) (Paragraph 0097; 0101); and
deploying a tissue anchor (350+352) distal of the opening from a lumen (lumen of 230) of the needle (Paragraph 0102; 0108).
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Regarding claim 33, Cheng further discloses wherein: a first portion (labeled in Annotated Figure 9(2)) of the smooth proximal beveled edge has the first angle relative to the axis of the hollow shaft; and a second portion (labeled in Annotated Figure 9(2)) of the smooth proximal beveled edge has the second angle relative to the axis of the hollow shaft (Annotated Figure 9(2)).
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) 19, 21-28, 30 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Higaki et al. (WO 2015105162 A1) (in text citations correspond with attached Espacenet translation).
Regarding claim 19, Cheng further discloses wherein: the sharp distal beveled edge has a first angle relative to an axis of the hollow shaft (Figure 9; Paragraph 0101); and at least a portion of the smooth proximal beveled edge has a second angle relative to the axis of the hollow shaft (Figure 9; Paragraph 0101), but fails to explicitly disclose the second angle is less than the first angle.
However, Higaki is directed to a needle device and teaches wherein: the sharp distal beveled edge (4+6) has a first angle (angle the distal edge of 6 at 90°) relative to an axis of the hollow shaft and at least a portion of the smooth proximal beveled edge (3) has a second angle (angle of 3) relative to the axis of the hollow shaft that is less than the first angle (angle of inclination towards the proximal end is less than 2°) (Figure 7; Page 14).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that the second angle is less than the first angle, as taught by Higaki, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Higaki by incorporating the second angle is less than the first angle in order to mitigate pain to the patient during insertion and reduce tissue damage (Higaki Page 14).
Regarding claim 21, Cheng discloses a method of delivering a tissue anchor using a needle, the method comprising:
advancing a needle (230) to a target tissue (Paragraph 0095; 106), the needle including:
a hollow shaft (body of 230) (Figure 9-10; Paragraph 0100); and
a needle tip (240) (Figure 9-10; Paragraph 0101) including:
a pointed tip (distal tip of 240) (Figure 9-10; Paragraph 0101);
a distal beveled edge (labeled in Annotated Figure 9) positioned adjacent the pointed tip, the distal beveled edge having a first angle relative to an axis of the hollow shaft (Figure 9; Paragraph 0101); and
a proximal beveled edge (labeled in Annotated Figure 9) positioned proximal of the distal beveled edge, the proximal beveled edge having a second angle relative to the axis of the hollow shaft that is less than the first angle (Figure 9; Paragraph 0101);
puncturing the target tissue with the pointed tip to form an opening in the target tissue (Paragraph 0097; 0106);
stretching the opening by advancing the proximal beveled edge at least partially through the opening (according to the claim, advancing the smooth proximal beveled edge at least partially through the opening results in stretching the tissue, as the diameter of the opening would increase to allow the smooth proximal beveled edge through, as opposed to just the distalmost portion of the needle tip. As such, Cheng discloses stretching the tissue.) (Paragraph 0097; 0101); and
deploying a tissue anchor (350+352) distal of the opening from a lumen (lumen of 230) of the needle (Paragraph 0102; 0108).
Cheng fails to explicitly disclose the second angle is less than the first angle.
However, Higaki is directed to a needle device and teaches wherein: the sharp distal beveled edge (4+6) has a first angle (angle the distal edge of 6 at 90°) relative to an axis of the hollow shaft and at least a portion of the smooth proximal beveled edge (3) has a second angle (angle of 3) relative to the axis of the hollow shaft that is less than the first angle (angle of inclination towards the proximal end is less than 2°) (Figure 7; Page 14).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that the second angle is less than the first angle, as taught by Higaki, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Higaki by incorporating the second angle is less than the first angle in order to mitigate pain to the patient during insertion and reduce tissue damage (Higaki Page 14).
Regarding claim 22, Cheng further discloses wherein the distal beveled edge includes: a sharp distal portion (portion of distal edge adjacent the pointed tip); and a smooth proximal portion (portion of distal edge adjacent proximal edge), wherein an edge of the smooth proximal portion is less sharp than an edge of the sharp distal portion (Figure 9-10).
Regarding claim 23, Cheng further discloses wherein the proximal beveled edge is smooth like the smooth proximal portion of the distal beveled edge (Figure 9-10).
Regarding claim 24, Cheng further discloses wherein the edge of the smooth proximal portion of the distal beveled edge is radiused (the edge is curved and formed on the cross-section of a tube 230, thus is radiused) (Figure 9-10).
Regarding claim 25, Cheng further discloses wherein the edge of the smooth proximal portion of the distal beveled edge has a radius of 0.015" (Paragraph 0101).
Regarding claim 26, Cheng discloses the method of claim 22, but fails to explicitly disclose wherein the smooth proximal portion of the distal beveled edge is electropolished.
However, Higaki is directed to a needle device and teaches electropolishing a beveled end (4) of a needle (T) (Page 10, end of 1st paragraph). As a result of modifying the edge of the needle, the smooth proximal portion of the distal beveled edge of Cheng would also be electropolished.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that the beveled edge is electropolished, as taught by Higaki, as both references and the claimed invention are directed to needle 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 Cheng with the teachings of Higaki by incorporating the beveled edge is electropolished in order to remove minute burrs and irregularities, creating a smooth finish (Higaki Page 10, end of 1st paragraph).
Regarding claim 27, Cheng further discloses wherein the pointed tip of the needle tip is coincident with an interior lumen wall of the needle tip (Figure 9-10).
Regarding claim 28, Cheng further discloses wherein the hollow shaft includes a bend proximal of the needle tip that deflects the needle tip to align the pointed tip with an axis of the hollow shaft proximal of the bend (Figure 6; 21; Paragraph 0106).
Regarding claim 30, Cheng further discloses wherein an inflection point (Labeled in Annotated Figure 9) separates the distal beveled edge from the proximal beveled edge (Annotated Figure 9).
Regarding claim 35, Cheng discloses the method of claim 31, but fails to explicitly disclose wherein the smooth proximal beveled edge is electropolished.
However, Higaki is directed to a needle device and teaches electropolishing a beveled end (4) of a needle (T) (Page 10, end of 1st paragraph). As a result of modifying the edge of the needle, the smooth proximal beveled edge of Cheng would also be electropolished.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that the beveled edge is electropolished, as taught by Higaki, as both references and the claimed invention are directed to needle 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 Cheng with the teachings of Higaki by incorporating the beveled edge is electropolished in order to remove minute burrs and irregularities, creating a smooth finish (Higaki Page 10, end of 1st paragraph).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Higaki as applied to claim 21 above and further in view of Utterberg (US 20040122380 A1)
Regarding claim 29, Cheng as modified by Higaki discloses the method of claim 21, but fails to explicitly disclose wherein a portion of the needle tip opposite the distal beveled edge is deflected to position the pointed tip towards an axis of the hollow shaft.
However, Utterberg is directed to a needle and teaches wherein a portion (41) of the needle tip (14) is deflected to position the pointed tip towards an axis of the hollow shaft (Figure 4; Paragraph 0029). As a result of the modification to Cheng, the portion of the needle tip would be opposite the distal beveled edge as it is located at the distalmost point of the needle tip.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng and Higaki such that a portion of the needle tip is deflected to position the pointed tip towards an axis of the hollow shaft, as taught by Utterberg, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng and Higaki with the teachings of Utterberg by incorporating a portion of the needle tip opposite the distal beveled edge is deflected to position the pointed tip towards an axis of the hollow shaft in order to reduce the forces acting upon the tissue during penetration to prevent excessive damage to the tissue (Utterberg Paragraph 0029).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng as applied to claim 31 above, in view of Utterberg (US 20040122380 A1).
Regarding claim 37, Cheng discloses the method of claim 31, but fails to explicitly disclose wherein a portion of the needle tip is deflected to position the pointed tip towards an axis of the hollow shaft.
However, Utterberg is directed to a needle and teaches wherein a portion (41) of the needle tip (14) is deflected to position the pointed tip towards an axis of the hollow shaft (Figure 4; Paragraph 0029).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cheng such that a portion of the needle tip is deflected to position the pointed tip towards an axis of the hollow shaft, as taught by Utterberg, as both references and the claimed invention are directed to needles. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng with the teachings of Utterberg by incorporating a portion of the needle tip is deflected to position the pointed tip towards an axis of the hollow shaft in order to reduce the forces acting upon the tissue during penetration to prevent excessive damage to the tissue (Utterberg Paragraph 0029).
Conclusion
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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/Z.J./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771