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 .
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 2/6/26, amended claim(s) 14, 18, and 30-31, canceled claim(s) 15-17 and 19-21, and new claim(s) 34-36 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Election/Restrictions
Newly submitted claim(s) 36 is/are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of claims 14, 18, and 22-35 and the invention of claim 36 are directed to related apparatuses. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed can have a materially different design, mode of operation, function, or effect as evidenced by “wherein the needle sheath has a circular cross-section in a plane perpendicular to the extension direction X, the shaft portion of the needle has a first cross-sectional shape in a plane perpendicular to the extension direction X, and the intermediary has a second cross-sectional shape in the plane perpendicular to the extension direction X,” and “wherein the first cross-sectional shape is any of a circular segment and a circular sector, and the second cross-sectional shape is complementary to the first cross-sectional shape relative to the circular cross-section of the needle sheath, so as to define a cavity between the distal end of the shaft portion of the needle and the distal end of the intermediary, the cavity having a length in the extension direction X that is adjustable by movement of the intermediary relative to the needle in the extension direction X,” as recited in claim 14 and “wherein the needle sheath has a rectangular cross-sectional shape in a plane perpendicular to the extension direction X,” “wherein the shaft portion of the needle has a first cross-sectional shape in a plane perpendicular to the extension direction X, and the intermediary has a second cross-sectional shape in the plane perpendicular to the extension direction X,” and “wherein the first cross-sectional shape is a first rectangle and the second cross-sectional shape is a second rectangle complementary to the first rectangle relative to the rectangular cross-section of the needle sheath, so as to define a cavity between the distal end of the shaft portion of the needle and the distal end of the intermediary, the cavity having a length in the extension direction X that is adjustable by movement of the intermediary relative to the needle in the extension direction X,” as recited in claim 36. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 36 is/are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim(s) 14 is objected to because of the following informalities: “between proximal end” (line 2) appears that it should be “between a proximal end.”
Claim(s) 14 is objected to because of the following informalities: “having proximal end” (line 5) appears that it should be “having a proximal end.”
Claim(s) 14 is objected to because of the following informalities: “having proximal end” (line 10) appears that it should be “having a proximal end.”
Claim(s) 36 is objected to because of the following informalities: “between proximal end” (line 2) appears that it should be “between a proximal end.”
Claim(s) 36 is objected to because of the following informalities: “having proximal end” (line 5) appears that it should be “having a proximal end.”
Claim(s) 36 is objected to because of the following informalities: “having proximal end” (line 10) appears that it should be “having a proximal end.”
Appropriate correction is required.
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) 14, 18, 22-23, 25, and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2018/0333147 to Snow et al. (hereinafter “Snow”).
For claim 14, Snow discloses a biopsy needle arrangement (Abstract), comprising:
a needle sheath (120) (Fig. 1) (para [0032]) having a first length (length of 120) between a proximal end (123) (Fig. 3) (para [0033]) and a distal end (122) (Fig. 3) (para [0033]), the needle sheath comprising an elongated tube (“elongate tube,” para [0033])) having a sheath opening at the distal end of the needle sheath (as can be seen in Figs. 3 and 3A);
a needle (140) (Fig. 1) (para [0032]) having a proximal end (proximal end of 140) and a distal end (distal end of 140) and a second length (length of 140) that is greater than the first length of the needle sheath (see Figs. 2 and 9-9A), the needle comprising an elongated shaft portion with a distal end (unlabeled, but as can be seen in Figs. 1-2 and 9-9A) configured to fit inside (see Figs. 1-2 and 9-9A) and slide relative to the needle sheath along an extension direction X (unlabeled, but the axial direction of the biopsy needle arrangement, see Fig. 2) defined by the biopsy needle arrangement (para [0035] and [0039]), and a tip portion (156) (Fig. 9A) (para [0040]) at the distal end of the shaft portion of the needle (as can be seen in Fig. 9A); and
an intermediary (160) (Fig. 2) (para [0032]) having a proximal end (proximal end of 160) and a distal end (distal end of 160) and a third length (length of 160) that is greater than the first length of the needle sheath (see Figs. 2 and 9-9A), the intermediary comprising an elongated shaft portion parallel with the needle (see Figs. 2 and 9-9A) and configured to fit inside the needle sheath (see Figs. 2 and 9-9A) and further configured to slide relative to the needle sheath and to slide relative to the needle along the extension direction X (para [0039] and [0044]);
wherein the needle sheath has a circular cross-section in a plane perpendicular to the extension direction X (as can be seen in Fig. 3A), the shaft portion has a first cross-sectional shape in a plane perpendicular to the extension direction X (as can be seen in Fig. 4A), and the intermediary has a second cross-sectional shape in the plane perpendicular to the extension direction X (as can be seen in Fig. 5A); and
wherein the first cross-sectional shape is any of a circular segment and a circular sector (as can be seen in Fig. 4A), and the second cross-sectional shape is complementary to the first cross-sectional shape relative to the circular cross-section of the needle sheath (as can be seen in Fig. 5A), so as to define a cavity between the distal end of the shaft portion of the needle and the distal end of the intermediary (see Figs. 7A, 8A, and/or 9A), the cavity having length in the extension direction X that is adjustable by movement of the intermediary relative to the needle in the extension direction X (see Figs. 7A, 8A, 9A, and/or 11A).
For claim 18, Snow further discloses wherein the first cross-sectional shape and the second cross-sectional shape have a respective constant size and shape between the proximal ends and the distal ends of the needle and the intermediary, respectively (as can be seen in Figs. 2-5 and 7-11).
For claim 22, Snow further discloses wherein the distal end of the intermediary is configured with a surface in a plane that has a normal direction that is not parallel with the extension direction X of the biopsy needle arrangement (see 164 in Fig. 9A).
For claim 23, Snow further discloses wherein the tip portion has a first transverse width that is less than a second transverse width of the sheath opening (as can be seen in Figs. 1-2).
For claim 25, Snow discloses a needle connector (121) (Fig. 3) configured to attach the needle to an actuator device (108) (para [0038]); a sheath connector (141) (Fig. 4) configured to attach the needle sheath to the actuator device (para [0038]); and an intermediary connector (161) (Fig. 5) configured to attach the intermediary to the actuator device (para [0047]).
For claim 35, Snow further discloses wherein the first cross-sectional shape has a constant size between the proximal end of the shaft portion of the needle and the distal end of the shaft portion of the needle (as can be seen in Figs. 2-5 and 7-11), and the second cross-sectional shape has a constant size between the proximal end of the intermediary and the distal end of the intermediary (as can be seen in Figs. 2-5 and 7-11).
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.
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) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snow in view of U.S. Patent Application Publication No. 2009/0125039 to Mikkaichi et al. (hereinafter “Mikkaichi”).
For claim 24, Snow does not expressly disclose wherein the tip portion has a first transverse width that is greater than a second transverse width of the sheath opening.
However, Mikkaichi teaches wherein the tip portion has a first transverse width that is greater than a second transverse width of the sheath opening (para [0164]).
It would have been obvious to a skilled artisan to modify Snow wherein the tip portion has a first transverse width that is greater than a second transverse width of the sheath opening, in view of the teachings of Mikkaichi, for the obvious advantage of preventing the Snow’s needle from being too far withdrawn inside of its sheath.
Claim(s) 26, 28, 30, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snow in view of U.S. Patent Application Publication No. 2019/0365362 to Ralph.
For claim 26, Snow does not expressly disclose discloses wherein the needle connector is configured to disengage the needle from the actuator device when the needle is subjected to a force in a sliding direction that exceeds a threshold force.
However, Ralph teaches wherein the needle connector is configured to disengage the needle from the actuator device when the needle is subjected to a force in a sliding direction that exceeds a threshold force (para [0007]) (also see para [0002] and [0004]).
It would have been obvious to a skilled artisan to modify Snow wherein the needle connector is configured to disengage the needle from the actuator device when the needle is subjected to a force in a sliding direction that exceeds a threshold force, in view of the teachings of Ralph, for the obvious advantage of preventing the user from applying an over-excessive amount of force to the needle, which may harm the patient.
For claim 28, Snow, as modified, further discloses wherein the needle connector comprises a first needle connector part configured to be attached to the actuator device (“radially flexible feature,” para [0007] of Ralph), and a second needle connector part attached to the needle (“counterpart feature,” para [0007] of Ralph); and wherein, when the needle disengages from the actuator device, the first needle connector part disengages from the second needle connector part and the second needle connector part moves distally in the sliding direction relative to the first needle connector part (para [0007] of Ralph) (also see para [0002] and [0004] of Ralph).
For claim 30, Snow further discloses wherein: the sheath connector comprises a first sheath connector part configured to be attached to the actuator device (183) (Fig. 6), and a second sheath connector part attached to the needle sheath (130) (Fig. 3); and wherein, when the needle sheath disengages from the actuator device, the first sheath connector part disengages from the second sheath connector part (para [0038] and [0043]), and the first sheath connector part moves distally in the sliding direction relative to the second sheath connector part (para [0038] and [0043]).
For claim 32, Snow, as modified, further discloses wherein the first and second needle connector parts are arranged in a configuration selected from the group consisting of a click-fit configuration, a break-apart configuration, and a friction fit configuration (as can be seen in Fig. 5 of Ralph).
Claim(s) 27, 31, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snow in view of U.S. Patent Application Publication No. 2011/0237976 to Weitzel et al. (hereinafter “Weitzel”).
For claim 27, Snow does not expressly disclose wherein the sheath connector is configured to disengage the needle sheath from the actuator device when the needle sheath is subjected to a force in a direction opposite to a sliding direction that exceeds a threshold force.
However, Weitzel teaches wherein the sheath connector is configured to disengage the needle sheath from the actuator device when the needle sheath is subjected to a force in a direction opposite to a sliding direction that exceeds a threshold force (Fig. 6) (para [0035] and [0071]-[0074]).
It would have been obvious to a skilled artisan to modify Snow wherein the sheath connector is configured to disengage the needle sheath from the actuator device when the needle sheath is subjected to a force in a direction opposite to a sliding direction that exceeds a threshold force, in view of the teachings of Weitzel, because such a mechanism would be a suitable mechanism to achieve extending Snow’s needle into an extended position so that it may be ready to receive a sample and not be shielded by the needle sheath.
For claim 31, Snow further discloses wherein: the sheath connector comprises a first sheath connector part configured to be attached to the actuator device (183) (Fig. 6), and a second sheath connector part attached to the needle sheath (130) (Fig. 3); and wherein, when the needle sheath disengages from the actuator device, the first sheath connector part disengages from the second sheath connector part (para [0038] and [0043]), and the first sheath connector part moves distally in the sliding direction relative to the second sheath connector part (para [0038] and [0043]).
For claim 33, Snow further discloses wherein the first and second sheath connector parts are arranged in a configuration selected from the group consisting of a click-fit configuration, a break-apart configuration, and a friction fit configuration (para [0038] and [0043]).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snow in view of Weitzel, and further in view of Ralph.
For claim 29, Snow and Weitzel do not expressly disclose wherein the needle connector comprises a first needle connector part configured to be attached to the actuator device, and a second needle connector part attached to the needle; and wherein, when the needle disengages from the actuator device, the first needle connector part disengages from the second needle connector part and the second needle connector part moves distally in the sliding direction relative to the first needle connector part.
However, Ralph teaches wherein the needle connector comprises a first needle connector part configured to be attached to the actuator device (“radially flexible feature,” para [0007]), and a second needle connector part attached to the needle (“counterpart feature,” para [0007]); and wherein, when the needle disengages from the actuator device, the first needle connector part disengages from the second needle connector part and the second needle connector part moves distally in the sliding direction relative to the first needle connector part (para [0007]) (also see para [0002] and [0004]).
It would have been obvious to a skilled artisan to modify Snow wherein the needle connector comprises a first needle connector part configured to be attached to the actuator device, and a second needle connector part attached to the needle; and wherein, when the needle disengages from the actuator device, the first needle connector part disengages from the second needle connector part and the second needle connector part moves distally in the sliding direction relative to the first needle connector part, in view of the teachings of Ralph, for the obvious advantage of preventing the user from applying an over-excessive amount of force to the needle, which may harm the patient.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snow in view of U.S. Patent No. 5,649,547 to Ritchart et al. (hereinafter “Ritchart”).
For claim 34, Snow does not expressly disclose wherein the first cross-sectional shape has a first size, and the second cross-sectional shape has a second size, with a ratio of the first size to the second size of 0.25 to 2.
However, Ritchart teaches wherein the first cross-sectional shape has a first size, and the second cross-sectional shape has a second size, with a ratio of the first size to the second size of 0.25 to 2 (col. 3, lines 29-39).
It would have been obvious to a skilled artisan to modify Snow wherein the first cross-sectional shape has a first size, and the second cross-sectional shape has a second size, with a ratio of the first size to the second size of 0.25 to 2, in view of the teachings of Ritchart, because such a ratio is a suitable ratio for Snow’s tubular concentrically disposed tubular members to be able to slide past one another.
Response to Arguments
Applicant's arguments filed 2/6/26 have been fully considered.
With respect to the first argument, Snow also defines a cavity between the needle and intermediary. Figs. 7A, 8A, and/or 9A show the cavity between defined by these two structures (and to include the notch) and Fig. 11A shows where the cavity is thereby adjusted due to the translational movement of the intermediary relative to the needle. It is noted that a “cavity” is a negative space and therefore the claim language is claiming a negative space. Although the negative space is not labeled in Snow, the drawings show how the structures that anticipate the positively recited features of the claim are arranged such that the negative space is adjustable.
With respect to the second argument, Snow teaches that open channel 158 of the notch 157 may have a “semi-circular wall” (see para [0041]). And following Applicant’s logic that if “trocar 140 is an annulus, except at the notch 157, where the shape is a segment of an annulus” (see page 8 of the response) (Examiner’s Note: Snow never uses the term “annulus” in its disclosure), then trocar 140 must be have a circular wall, except at the notch 157, where the shape is a semi-circular wall.
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