DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Notice of Amendment
In response to the amendment(s) filed on 12/16/25, amended claim(s) 20 and 24, canceled claim(s) 28-29 and 31-34, and new claim(s) 37-39 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
Claim(s) 37 and 39 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.
For claim 37, the claim language “wherein the notch is substantially planar and oblique with respect to a longitudinal axis of the needle” is ambiguous. It is unclear how planar and oblique the notch needs to be to be considered “substantially” planar and oblique with respect to a longitudinal axis of the needle. The claim is examined as meaning “wherein the notch is planar and oblique with respect to a longitudinal axis of the needle.”
For claim 39, the claim language “wherein the notch has a width of about 0.5 mm to 1.5 mm” is ambiguous. It is unclear what the scope of “about” 0.5 mm to 1.5 mm is. Is 0.49 mm to 1.51 mm included? Is 0.45 mm to 1.55 mm included? Is 0.4 mm to 1.4 mm included? The claim is examined as meaning “wherein the notch has a width of 0.5 mm to 1.5 mm.”
For claim 39, the claim language “such that tissue is substantially prevented from entering the lumen through the notch during said advancing” is ambiguous. It is unclear how much preventing from the entering the lumen through the notch is considered to be “substantially” prevented. The claim is examined as meaning “such that tissue is prevented from entering the lumen through the notch during said advancing.”
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 20-21, 24-26, and 36-37 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. 2008/0045858 to Tessitore et al. (hereinafter “Tessitore”) in view of U.S. Patent No. 5,380,290 to Makower et al. (hereinafter “Makower”) and U.S. Patent Application Publication No. 2010/0298737 to Koehler.
For claim 20, Tessitore discloses a method of taking a tissue biopsy from a patient (Abstract), comprising:
advancing a needle (3) (Fig. 1) (para [0035]) into tissue of the patient (para [0036]), the needle comprising a needle lumen (10) (Fig. 3) (para [0035]) defined by a cannula wall (8) (Fig. 3) (para [0035]) extending to a distally-facing opening at a distal-most end of the needle (as can be seen in Fig. 3), the opening having a cross-sectional area equivalent to a cross-sectional area of the needle lumen (as can be seen in Fig. 3), wherein said advancing causes a core of tissue to be received through a distally-facing distal tip opening of the needle and axially into a lumen of the needle (as can be seen in Figs. 4-5), the core of tissue remaining connected to tissue distal of a distal tip of the needle (as can be seen in Fig. 5);
rotating the needle in the tissue of the patient (para [0038]);
during said rotating, pressing the core of tissue against an inner surface of the needle (see transition between Figs. 5-6, which pinches the tissue) with an edge defined by a notch (11) (Fig. 3) in the cannula wall of the needle (as can be seen in Fig. 3), wherein at least one edge of the notch is a cutting edge (23) (Fig. 3) (para [0038]) configured to (Examiner’s Note: functional language, i.e., capable of) cut tissue during said rotating (para [0038]), and wherein said rotating rotates the core of tissue and creates strain between the core of tissue and the tissue distal of the distal tip of the needle (para [0038]), said rotating shearing the core of tissue from the tissue distal of the distal tip of the needle (as can be seen in Fig. 6); and
withdrawing the needle from the tissue of the patient (para [0038]).
Tessitore appears does not expressly disclose wherein the notch extends from the distal tip opening such that an end surface of the needle defining the opening is discontinuous at the notch.
However, Makower teaches disclose wherein a notch (26) (Fig. 9) extends from a distal tip opening such that an end surface of the needle defining the opening is discontinuous at the notch (as can be seen in Fig. 9).
It would have been obvious to a skilled artisan to modify Tessitore wherein the notch extends from the distal tip opening such that an end surface of the needle defining the opening is discontinuous at the notch, in view of the teachings of Makower, for the obvious advantage of increasing the flexibility and/or bendability of Tessitore’s needle as it is entering tissue.
Tessitore and Makower do not expressly disclose wherein the notch defines less than 50% of a circumference of the needle lumen at the distal-most end of the needle.
However, Koehler teaches wherein a “notch … may be formed at any angle or depth to enable specimen notch 25 to hold a tissue specimen of adequate size for use in a conventional examination, such as a biopsy” (para [0026]) and that “it is preferred that the notch 25 has a depth to about one half the stylet diameter” (para [0027]) (emphasis added).
It would also have been obvious to a skilled artisan to optimize Tessitore wherein the notch defines less than 50% of a circumference of the needle lumen at the distal-most end of the needle given that Koehler recognizes that the depth of the notch is a result-effective variable that may be varied to achieve the result of holding a biopsy tissue specimen of adequate size (see para [0026] of Koehler). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Additionally, Koehler already recognizes that the depth may be “about” half, and “about” half would include percentages below 50% as well as above 50%. A skilled artisan would have combined the references as a simple substitution of one depth for another depth that would lead to the predictable result of holding a biopsy tissue sample of adequate size.
For claim 21, Tessitore further discloses wherein said rotating causes said portion of said notch to cut a profile through tissue within said lumen (para [0038]) (see transition from Fig. 5 to Fig. 6).
For claim 24, Tessitore further discloses wherein the notch comprising a cutting edge (23) extending into the lumen (as can be seen in Figs. 3 and 5-6).
For claim 25, Tessitore further discloses before said advancing: passing the needle through patient tissue with a mandrel (4) positioned within the needle lumen (as can be seen in Fig. 4), the mandrel blocking the distal tip opening of the needle so as to prevent coring of patient tissue (as can be seen in Fig. 4).
For claim 26, Tessitore further discloses withdrawing the mandrel through a proximal needle portion so that the distal tip opening of the needle is open (para [0036]).
For claim 36, Tessitore, as modified, further discloses wherein the notch has a width between a first side wall opposing a second side wall (as can be seen in Fig. 9 of Makower), and wherein the notch has a length extending from the opening to a proximal-most point of the notch (as can be seen in Fig. 9 of Makower), wherein the notch length is greater than the notch width (as can be seen in Fig. 9 of Makower).
For claim 37, Tessitore, as modified, further discloses wherein the notch is substantially planar and oblique with respect to a longitudinal axis of the needle (as can be seen in Fig. 3), such that the cutting edge is oriented to cut a profile through the core of tissue during said rotating (as can be seen in Fig. 3) (also see para [0038]).
Claim(s) 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tessitore in view of Makower and Koehler, and further in view of U.S. Patent Application Publication No. 2011/0224575 to Carrillo, Jr. et al. (hereinafter “Carrillo, Jr.”) (Examiner’s Note: the portions relied upon below of Carrillo, Jr. finding support in Fig. 2 and para [00013]-[00015] of U.S. Provisional Application No. 61/312,374).
For claim 27, Tessitore and Makower do not expressly disclose wherein said rotating includes rotation of the distal tip of the needle relative to a handle attached to the needle.
However, Carrillo Jr. teaches wherein said rotating includes rotation of the distal tip of the needle relative to a handle attached to the needle (as can be seen in Fig. 2) (para [0018]-[0019]).
It would have been obvious to a skilled artisan to modify Tessitore wherein said rotating includes rotation of the distal tip of the needle relative to a handle attached to the needle, in view of the teachings of Carrillo Jr., for the obvious advantage of being able to hold the device steady with the handle with the core of the tissue is occurring to get a stable sample.
Claim(s) 38 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tessitore in view of Makower and Koehler, and further in view of U.S. Patent Application Publication No. 2005/0015058 to Millerd.
For claim 38, Tessitore, Makower, and Koehler do not expressly disclose wherein the needle further comprises a longitudinal ridge fixed to an inner surface of the cannula wall within the lumen, the ridge being configured to engage the core of tissue to prevent rotation of the core of tissue relative to the needle during said rotating, thereby enhancing the strain created between the core of tissue and the tissue distal of the distal tip.
However, Millerd teaches a tubular element (12) that further comprises a longitudinal ridge (40) fixed to an inner surface of the tubular element wall within a lumen (para [0024]), the ridge being configured to (Examiner’s Note: functional language, i.e., capable of) engage the core of tissue to prevent rotation of the core of tissue relative to the needle during rotating (para [0024]), thereby enhancing the strain created between core of tissue and tissue distal of a distal tip (para [0024]).
It would have been obvious to a skilled artisan to modify Tessitore wherein the needle further comprises a longitudinal ridge fixed to an inner surface of the cannula wall within the lumen, the ridge being configured to engage the core of tissue to prevent rotation of the core of tissue relative to the needle during said rotating, thereby enhancing the strain created between the core of tissue and the tissue distal of the distal tip, in view of the teachings of Millerd, for the obvious advantage of preventing rotation inside of Tessitore’s tubular element so that the element collected inside of Tessitore’s tubular element is secure.
Claim(s) 39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tessitore in view of Makower and Koehler, and further in view of U.S. Patent Application Publication No. 2010/0137804 to Wiley.
For claim 39, Tessitore, Makower, and Koehler do not expressly disclose wherein the notch has a width of about 0.5 mm to 1.5 mm, such that tissue is substantially prevented from entering the lumen through the notch during said advancing.
However, Wiley teaches wherein a notch (840) has a width of about 0.5 mm to 1.5 mm (width is 20-100% of the length, para [0040], and length can be between 1-4 mm, para [0033]), such that tissue is substantially prevented (Examiner’s Note: functional language/intended use, i.e., capable of) from entering the lumen through the notch during said advancing (as can be seen in Fig. 8).
It would have been obvious to a skilled artisan to modify Tessitore wherein the notch has a width of about 0.5 mm to 1.5 mm, such that tissue is substantially prevented from entering the lumen through the notch during said advancing, in view of the teachings of Wiley, because such a width is a suitable width for Tessitore’s notch that does not comprise the structural strength/rigidity of Tessitore’s tubular element.
Response to Arguments
Applicant’s arguments filed 12/16/25 have been fully considered, but they are not persuasive.
In response, the newly claimed “at least one edge of the notch” that forms a “cutting edge” that is configured to “cut tissue” finds support in reference numerals “58” and “60.” For example, page 9, lines 19-20 of Applicant’s specification as originally filed states
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Additionally, page 13, lines 28-30 of Applicant’s specification as originally filed states
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So if the edge 58 and tooth 60 correspond to the claimed “cutting edge” of the “notch,” then a comparison can be made between Fig. 3 of Applicant’s specification and Fig. 3 of Tessitore
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As a result, the scope of the claim language, when viewed in light of Applicant’s specification, does not appear to be commensurate in scope with Applicant’s arguments. That is, Applicant appears to argue that 11 cannot be an edge of the notch 9 in Tessitore. But if that’s true, then 58/60 could not be an edge of the notch 50 in Applicant’s own specification. Since that interpretation contradicts Applicant’s specification, the examiner does not afford that scope to the claim language. Instead, a scope that is consistent with Applicant’s specification is afforded to the claim language.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791