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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isaacson (US 2020/0324086) as evidenced by Munrow (US 2009/0131790).
Isaacson discloses the following limitations:
Claim 1. A puncture needle (10) (Figs. 1-6) comprising:
a main body (14) having a rod shape ([0052]);
a pyramidal portion (12) that has a pyramidal shape and is disposed at a distal end of the main body ([0053]); and
an ultrasound reflecting structure (66) three-dimensionally formed on a side portion of the pyramidal portion (Figs. 4A, 4B, 5; [0071], [0072]). Though Isaacson does not explicitly refer to hole 66 as “an ultrasound reflecting structure”, Applicant has disclosed “an ultrasound reflecting structure” as a structure that changes a direction and an intensity of reflection of emitted ultrasound ([0023]), such as a three-dimensional shape ([0028]-[0030]) formed into the surface of the side portion. Therefore, since the opening (66) of Isaacson is a three-dimensional shape formed into the side portion of the puncture needle, the opening would be capable of reflecting emitted ultrasound thereby encompassing the claimed language. Further, as evidenced by Munrow et al, an opening (305) formed on a side portion of a distal end of a puncture needle (217) is able to reflect ultrasound emitted and is therefore considered an ultrasound reflecting structure (Fig. 5E; [0057]).
Claim 2. The puncture needle according to claim 1, wherein the pyramidal portion has a polygonal pyramid shape having a plurality of flat portions (18, 20, 24) in the side surface ([0053], [0054]).
Claim 3. The puncture needle according to claim 2, wherein the ultrasound reflecting structure (66) is not located at an edge portion at which adjacent ones of the edge portions meet (Figs. 4A, 4B, 5; the hole 66 is centrally located between the edge portions).
Claim 4. The puncture needle according to claim 3, wherein:
a surface of the flat portion includes:
a blade region (24, 26, 28) in which the ultrasound reflecting structure is not formed, the blade region being disposed along the edge portion ([0054]), and
a reflection region (middle portion between the cutting edges) in which the ultrasound reflecting structure is formed, the reflection region being disposed inward of the blade region (Figs. 4A, 4B, 5; [0071]).
Claim 5. The puncture needle according to claim 2, wherein the ultrasound reflecting structure is located at a first (20) of the flat portions, and the ultrasound reflecting structure is not located at a second (18) of the flat portions (Figs. 4A, 4B; [0071]; i.e. one of the surfaces may include just one hole).
Claim 6. The puncture needle according to claim 3, wherein the ultrasound reflecting structure is located at a first (20) of the flat portions, and the ultrasound reflecting structure is not located at a second (18) of the flat portions (Figs. 4A, 4B; [0071]; i.e. one of the surfaces may include just one hole).
Claim 7. The puncture needle according to claim 4, wherein the ultrasound reflecting structure is located at a first (20) of the flat portions, and the ultrasound reflecting structure is not located at a second (18) of the flat portions (Figs. 4A, 4B; [0071]; i.e. just one of the surfaces may include just one hole).
Claim 8. The puncture needle according to claim 2, wherein the pyramidal portion has a triangular pyramid shape ([0053]; Fig. 1E, the three sides (18, 20, 22) meeting at the triangular tip (16)).
Claim 9. The puncture needle according to claim 3, wherein the pyramidal portion has a triangular pyramid shape ([0053]; Fig. 1E, the three sides (18, 20, 22) meeting at the triangular tip (16)).
Claim 10. The puncture needle according to claim 4, wherein the pyramidal portion has a triangular pyramid shape ([0053]; Fig. 1E, the three sides (18, 20, 22) meeting at the triangular tip (16)).
Claim 11. The puncture needle according to claim 5, wherein the pyramidal portion has a triangular pyramid shape ([0053]; Fig. 1E, the three sides (18, 20, 22) meeting at the triangular tip (16)).
Claim(s) 1, 2, 5, 12, 13, 16, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arts et al (US 2016/0206279).
Arts et al discloses the following limitations:
Claim 1. A puncture needle (Fig. 9) comprising:
a main body (213) having a rod shape ([0082]);
a pyramidal portion (238) that has a pyramidal shape and is disposed at a distal end of the main body (Fig. 9; [0143]); and
an ultrasound reflecting structure (242) three-dimensionally formed on a side portion of the pyramidal portion ([0143]).
Claim 2. The puncture needle according to claim 1, wherein the pyramidal portion has a polygonal pyramid shape having a plurality of flat portions in the side surface (Fig. 9; [0143])
Claim 5. The puncture needle according to claim 2, wherein the ultrasound reflecting structure is located at a first of the flat portions (top surface in Fig. 9), and the ultrasound reflecting structure is not located at a second of the flat portions (side surface in Fig. 9).
Claim 12. The puncture needle according to claim 1, wherein the ultrasound reflecting structure (242) is disposed at a distal side of the pyramidal portion (Fig. 9; [0143], i.e. the dimples are disposed across the entire flat surface, including the distal side).
Claim 13. The puncture needle according to claim 2, wherein the ultrasound reflecting structure is disposed at a distal side of the pyramidal portion (Fig. 9; [0143], i.e. the dimples are disposed across the entire flat surface, including the distal side).
Claim 16. A puncture needle (Fig. 9) comprising:
a main body (213) having a rod shape ([0082]);
a pyramidal portion (238) that has a pyramidal shape and is disposed at a distal end of the main body (Fig. 9; [0143]); and
an ultrasound reflecting structure (242) three-dimensionally formed on a side portion of the pyramidal portion, the ultrasound reflecting structure comprising a plurality of recesses (242) ([0143])
Claim 19. The puncture needle according to claim 16, wherein the plurality of recesses are a plurality of dimples (242) ([0143])
Claim 20. The puncture needle according to claim 16, wherein the ultrasound reflecting structure comprises a roughened surface comprising the plurality of recesses (242) ([0143], i.e. the plurality of dimples forms a textured surfaces due to the indentations of the dimples into the surface of the pyramidal portion and therefore forms a roughened surface (as opposed to a smooth surface with no dimples)).
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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munrow et al in view of Isaacson.
Claim 1. Munrow et al discloses a puncture needle (14) (Figs. 1-5) comprising:
a main body (48) having a rod shape ([0048]);
a tip (50) that has a shape and is disposed at a distal end of the main body ([0048]); and
an ultrasound reflecting structure (200, 303, 305, 308three-dimensionally formed on a side portion of the pyramidal portion (Figs. 5A, 5B, 5D-5F; [0055]-[0057]).
Munrow et al fails to disclose the tip (50) is a pyramidal portion having a pyramidal shape. Instead, Munrow et al discloses the tip has three flat surfaces (304) with three beveled edges (302) which meets at an apex, but also meets at other surfaces as well ([0056]; see side profile in Fig. 5B, where it is understood by one of ordinary skill in the art these merging surfaces form a shape not considered to be a pyramidal shape). Munrow et al further discloses it is advantageous for the center point of the tip to be offset from a centerline of the needle and that it is appreciated that the tip may comprise a variety of dimensions and shape and is not limited to what is shown in the figures ([0053]), indicating the shape of the tip is not critical as long as the tip is offset from the centerline.
However, in the same field of puncture needles, Isaacson teaches a needle with tip (12) having an offset apex (16) from the centerline (36) of the needle (10), wherein the tip (12) is a pyramidal portion having a pyramidal shape (having three flat sides 18, 20, 22; akin to the device of Munrow et al having three flat sides) disposed at a distal end of a main body (14) ([0075]; Fig. 6A). Therefore, since both Munrow et al and Isaacson are directed to offset tips of a needle for puncturing the body, and in light of Munrow’s disclosure of the shape of the tip may be other shapes, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify one shape of the tip (shape of Munrow et al) with another (pyramidal shape of Isaacson) to achieve the predictable result of providing a structure that will puncture tissue.
Claim 2. The combination discloses the invention substantially as claimed above, wherein Isaacson further discloses the pyramidal portion has a polygonal pyramid shape having a plurality of flat portions (18, 20, 24) in the side surface ([0053], [0054]).
Claim 3. The combination discloses the invention substantially as claimed above, wherein Munrow et al as modified further discloses the ultrasound reflecting structure (303, 305, 308) is not located at an edge portion at which adjacent ones of the edge portions meet (Figs. 5D-5F; [0056], [0057]).
Claim 4. The combination discloses the invention substantially as claimed above, wherein Isaacon further discloses, wherein:
a surface of the flat portion includes:
a blade region (24, 26, 28) in which the ultrasound reflecting structure is not formed, the blade region being disposed along the edge portion ([0054]), and
a reflection region (middle portion between the cutting edges) in which the ultrasound reflecting structure is formed, the reflection region being disposed inward of the blade region (Figs. 4A, 4B, 5; [0071]).
Claim 5. The combination discloses the invention substantially as claimed above, wherein Munrow et al as modified further discloses the ultrasound reflecting structure (305) is located at a first of the flat portions (top surface in Fig. 5E), and the ultrasound reflecting structure is not located at a second of the flat portions (side surface in Fig. 5E).
Claim 6. The combination discloses the invention substantially as claimed above, wherein Munrow et al as modified further discloses the ultrasound reflecting structure (305) is located at a first of the flat portions (top surface in Fig. 5E), and the ultrasound reflecting structure is not located at a second of the flat portions (side surface in Fig. 5E).
Claim 7. The combination discloses the invention substantially as claimed above, wherein Munrow et al as modified further discloses the ultrasound reflecting structure (305) is located at a first of the flat portions (top surface in Fig. 5E), and the ultrasound reflecting structure is not located at a second of the flat portions (side surface of Fig. 5E).
Claim 8. The combination discloses the invention substantially as claimed above, wherein Isaacon further discloses the pyramidal portion has a triangular pyramid shape ([0053]; Fig. 1E, the three sides (18, 20, 22) meeting at the triangular tip (16)).
Claim 9. The combination discloses the invention substantially as claimed above, wherein Isaacon further discloses the pyramidal portion has a triangular pyramid shape ([0053]; Fig. 1E, the three sides (18, 20, 22) meeting at the triangular tip (16)).
Claim 10. The combination discloses the invention substantially as claimed above, wherein Isaacon further discloses the pyramidal portion has a triangular pyramid shape ([0053]; Fig. 1E, the three sides (18, 20, 22) meeting at the triangular tip (16)).
Claim 11. The combination discloses the invention substantially as claimed above, wherein Isaacon further discloses the pyramidal portion has a triangular pyramid shape ([0053]; Fig. 1E, the three sides (18, 20, 22) meeting at the triangular tip (16)).
Claim 12. The combination discloses the invention substantially as claimed above, wherein Munrow et al as modified discloses the ultrasound reflecting structure (305) is disposed at a distal side of the pyramidal portion (Fig. 5E).
Claim 13. The combination discloses the invention substantially as claimed above, wherein Munrow et al as modified discloses the ultrasound reflecting structure (305) is disposed at a distal side of the pyramidal portion (Fig. 5E).
Claim 14. The combination discloses the invention substantially as claimed above, wherein Munrow et al as modified discloses the ultrasound reflecting structure (305) is disposed at a distal side of the pyramidal portion (Fig. 5E).
Claim 15. The combination discloses the invention substantially as claimed above, wherein Munrow et al as modified discloses the ultrasound reflecting structure (305) is disposed at a distal side of the pyramidal portion (Fig. 5E).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arts et al in view of Munrow et al.
Claims 17 and 18. Arts et al discloses the invention substantially as claimed above, but fails to disclose the plurality of recesses are a plurality of grooves, wherein the plurality of grooves are a plurality of transverse grooves extending in a direction orthogonal to a longitudinal axis of the main body.
However, in the same field of endeavor of puncture needles, Munrow et al teaches an echogenic puncture needle having a variety of ultrasound reflecting structures (Figs. 5A-5J), including a plurality of recesses that are in the form of a plurality of grooves (271) extending in a direction orthogonal to a longitudinal axis of the main body (Fig. 5I; [0059]). Therefore, since both Arts et al and Munrow et al are directed to needle visibility mechanisms via ultrasound, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify one ultrasound reflecting structure (dimples 242 of Arts et al) with another (transverse grooves 271 of Munrow et al) to achieve the predictable result of providing a structure that will reflect the emitted ultrasound in a manner that will allow for echo visibility.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE M SHI/Primary Examiner, Art Unit 3771