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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 8, 2023 and May 9, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 5 & 11 is/are objected to because of the following informalities:
In regards to claim 5, at line 2, the limitations “and some intersect none or said teeth” should apparently read -- and some intersect none [[or]] of said teeth--.
In regards to claim 11, at lines 1-2, the limitations “said though is flat” should apparently read -- said through is flat--.
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 12 & 13-20 is/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.
In regards to claim 12, at line 1, the limitations “said bearing” lack sufficient antecedent basis. Moreover, it is unclear Applicant’s reference to a “bearing” refers to an action (method step) or a physical element having a continuous cross-section.
In regards to claim 13, at line 4, the limitations “said core collector” lack sufficient antecedent basis. The Office has considered the claimed “core collector” to be the same as “the core” recited at line 2 of the claim.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al. (US 2017/0340352) (“Stone” hereinafter) in view of Jarial (US 2012/0022397).
In regards to claim 1, Stone discloses a biopsy needle set comprising:
an axially extending outer cannula 200 that has an inside wall and a central axis 226 (see at least figs. 6, 8-9 & 12-18 and par 0042);
an axially extending core collector 102 that slidingly fits inside the outer cannula 200 and has a sharp distal tip 124 and an axially extending cradle 126 proximal from the tip 124 (see at least figs. 1-5 & 12-18 and par 0036-0037);
PNG
media_image1.png
448
610
media_image1.png
Greyscale
wherein:
the cradle 126 comprises a trough formed between axially extending rows (152, 158, 164) of teeth 140 of an axially extending keel 132 (see at least figs. 12-14 and par 0039-0040);
the cradle 126 has an outer surface conforming to the cannula 200's inside wall (see at least figs. 5-6);
the keel 132 has a cross-section that decreases in thickness toward the lateral ends thereof (i.e., by virtue of having a semi-circular cross-section, see par 0039);
the teeth 140 of each row are axially spaced from each other (see at least fig. 3); and
the outer surface of the cradle 126 is sized to bear against the cannula 200's inside wall (see at least figs. 12-14) and
thereby resist bending of the cradle 126 due to forces acting on the tip 124 and cradle 126 while and when a portion of the cradle 126 is extending distally from the cannula 200 (see at least figs. 15-17).
Stone discloses a biopsy needle, as described above, that fails to explicitly teach a biopsy needle wherein the cradle comprises a trough formed between two axially extending rows of teeth rising from lateral ends.
However, Jarial teaches that it is known to provide a biopsy needle wherein the cradle (26, 28) comprises a trough formed between two axially extending rows of teeth 47 rising from lateral ends thereof (see at least fig. 11 and par 0033-0034).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Stone wherein the cradle comprises a trough formed between two axially extending rows of teeth rising from lateral ends as taught by Jarial since such a modification would amount to applying a known technique (i.e., as taught by Jarial) to a known device (i.e., as taught by Stone) ready for improvement to achieve a predictable result such as improving cutting performance and preventing severed tissue cores from being compacted when the cannula is retracted so the clinician can visibly observe the true length and physical quality of the cores upon retrieval (see at least par 0033 of Jarial)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 2, Stone discloses the biopsy needle set of claim 1, in which some cross-sections of the cradle 126 intersect only said keel 132 and are at axially spaced portions of the cradle 126 that lack said teeth 140 (see at least figs. 1-3 & 12-14).
In regards to claim 3, Stone discloses the biopsy needle set of claim 1, in which some cross-sections of the cradle 126 intersect only one of said teeth 140 (see at least figs. 1-3 & 12-14).
In regards to claim 4, Stone discloses the biopsy needle set of claim 1, that fails to explicitly teach a biopsy needle in which some cross-sections of the cradle intersect two of said teeth, one from each of said rows. However, Jarial teaches that it is known to provide a biopsy needle in which some cross-sections of the cradle (26, 28) intersect two of said teeth 47, one from each of said rows (see at least fig. 11 and par 0033-0034). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Stone in which some cross-sections of the cradle intersect two of said teeth, one from each of said rows as taught by Jarial since such a modification would amount to applying a known technique (i.e., as taught by Jarial) to a known device (i.e., as taught by Stone) ready for improvement to achieve a predictable result such as improving cutting performance and preventing severed tissue cores from being compacted when the cannula is retracted so the clinician can visibly observe the true length and physical quality of the cores upon retrieval (see at least par 0033 of Jarial)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 5, Stone discloses the biopsy needle set of claim 1, in which some cross-sections of the cradle 126 intersect at least one of said teeth 140 and some intersect none or said teeth 140 (see at least figs. 1-3 & 12-14).
In regards to claim 6, Stone discloses the biopsy needle set of claim 1, in which said keel 132 is sector-shaped in cross-section (i.e., by virtue of having a semi-circular cross-section, see par 0039).
In regards to claim 7, Stone discloses the biopsy needle set of claim 1, in which the outer surface of the cradle 126 extends over an arc of approximately half a circle (i.e., by virtue of having a semi-circular cross-section, see par 0039).
In regards to claim 8, Stone discloses the biopsy needle set of claim 1, in which the cannula 200 has a distal tip 216 beveled along a first angle and the tip 124 of the core collector 102 is beveled along a second angle opposite the first angle (see at least figs. 12-14).
In regards to claim 9, Stone discloses the biopsy needle set of claim 1, in which at least some of the teeth 140 have sharpened (i.e., pointed) tips 144 (see at least fig. 3 and par 0040).
In regards to claim 10, Stone discloses the biopsy needle set of claim 1, in which the surface of said keel 132 facing the cannula 200's inside wall is a continuous curve in cross-section (i.e., by virtue of having a semi-circular cross-section, see par 0039).
In regards to claim 11, Stone discloses the biopsy needle set of claim 1, in which the surface of said keel 132 facing said though is flat (see at least fig. 4 and par 0039).
In regards to claim 12, Stone discloses the biopsy needle set of claim 1, in which the surface of said bearing against the inside wall of the cannula 200 is continuous in cross-section (i.e., by virtue of having a semi-circular cross-section, see figs. 5-6 & 12-14 and par 0039).
In regards to claim 13, Stone discloses a method of extracting a tissue sample (244, 254) comprising:
providing a cannula 200 that has an inner wall and a core 102 that slidingly fits inside the cannula 200 (see at least figs. 12-14);
wherein said core collector 102 comprises a sharp distal tip 124 and a cradle 126 that is proximal from the tip 124 and comprises an axially extending keel 132 and rows (152, 158, 164) of teeth 140 rising from lateral ends of the keel 132 to thereby form a trough-shaped space between the teeth 140 (see at least figs. 1-5 & 12-18 and par 0036-0037 & 0040);
forcing the core collector 102 distally out of the cannula 200 and into tissue from an initial position in which the cradle 126 in inside the cannula 200 such that the outer surface of the cradle 126 bears against the cannula 200's inside wall as the cradle 126 is moving out of the cannula 200 and thereby resists bending of the cradle 126 portion that has exited the cannula 200 due to tissue exerting bending forces on the tip 124 and cradle 126 (see at least figs. 6, 8-9 & 12-18 and par 0042); and thereafter,
forcing the cannula 200 distally over the cradle 126 to sever a sample (244, 254) of tissue that is between said trough shaped space and the cannula 200's inside wall (see at least figs. 15-18).
Stone discloses a method, as described above, that fails to explicitly teach a method wherein said core collector comprises two rows of teeth rising from lateral ends of the keel to thereby form a trough- shaped space between the keel and the teeth.
However, Jarial teaches that it is known to provide a method wherein said core collector 20 comprises two rows of teeth 47 rising from lateral ends of the keel to thereby form a trough-shaped space between the keel and the teeth 47 (see at least fig. 11 and par 0033-0034).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Stone wherein said core collector thereof comprises two rows of teeth, as taught by Jarial, rising from lateral ends of the keel thereof to thereby form a trough-shaped space, as taught by Jarial, between the keel thereof and the teeth as taught by Jarial since such a modification would amount to applying a known technique (i.e., as taught by Jarial) to a known device (i.e., as taught by Stone) ready for improvement to achieve a predictable result such as improving cutting performance and preventing severed tissue cores from being compacted when the cannula is retracted so the clinician can visibly observe the true length and physical quality of the cores upon retrieval (see at least par 0033 of Jarial)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 14, Stone discloses the method of claim 13, in which the providing step comprises providing a core collector 102 with a cradle 126 some cross-sections of which intersect only said keel 132 and are at axially spaced portions of the cradle 126 that lack said teeth 140 (see at least figs. 1-3 & 12-18).
In regards to claim 15, Stone discloses the method of claim 13, in which the providing step comprises providing a core collector 102 with a cradle 126 some cross-sections of which intersect only one of said teeth 140 (see at least figs. 1-3 & 12-18).
In regards to claim 16, Stone discloses the method of claim 13, that to explicitly teach a method in which the providing step comprises providing a core collector with a cradle some cross-sections of which intersect two of said teeth, one from each of said rows. However, Jarial teaches that it is known to provide a method in which the providing step comprises providing a core collector 20 with a cradle (26, 28) some cross-sections of which intersect two of said teeth 47, one from each of said rows (see at least fig. 11 and par 0033-0034). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Stone in which the providing step comprises providing a core collector with a cradle some cross-sections of which intersect two of said teeth, one from each of said rows as taught by Jarial since such a modification would amount to applying a known technique (i.e., as taught by Jarial) to a known device (i.e., as taught by Stone) ready for improvement to achieve a predictable result such as improving cutting performance and preventing severed tissue cores from being compacted when the cannula is retracted so the clinician can visibly observe the true length and physical quality of the cores upon retrieval (see at least par 0033 of Jarial)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 17, Stone discloses the method of claim 13, in which the providing step comprises providing a core collector 102 with a cradle 126 some cross-sections of which intersect at least one of said teeth 140 and some intersect none or said teeth 140 (see at least figs. 1-3 & 12-18).
In regards to claim 18, Stone discloses the method of claim 13, in which the providing step comprises providing a core collector 102 in which said keel 132 is sector-shaped in cross-section (i.e., by virtue of having a semi-circular cross-section, see par 0039).
In regards to claim 19, Stone discloses the method of claim 13, in which the providing step comprises providing a core collector 102 with a cradle 126 the outer surface of which extends over an arc of approximately half a circle (i.e., by virtue of having a semi-circular cross-section, see at least fig. 4 and par 0039).
In regards to claim 20, Stone discloses the biopsy needle set of claim 13, in which the providing step comprises proving a core collector 102 in which at least some of said teeth 140 have sharpened (i.e., pointed) tips 144 (see at least fig. 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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, Jason M. Sims can be reached at 571-272-7540. 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.
/RENE T TOWA/ Primary Examiner, Art Unit 3791