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 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 7/31/25, amended claim(s) 1 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) 1, 3, 6-7, and 22-26 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 1, the claim language “the curved stylet causes the flexible needle to push off the ramp and increasingly diverge from the axis of the lumen at a second offset angle” is ambiguous. A single claim which claims both an apparatus and method steps is indefinite because the recited limitations is not directed to “a catheter assembly,” but instead to a method step. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). The claim is being examined as the curved stylet being configured to push the flexible needle off the ramp.
Dependent claim(s) 3, 6-7, and 22-26 fail to cure the ambiguity of independent claim 1, thus claim(s) 1, 3, 6-7, and 22-26 is/are rejected under 35 U.S.C. 112(b).
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) 1, 3, 6-7, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0079519 to Sung et al. (hereinafter “Sung”) in view of U.S. Patent Application Publication No. 2013/0225997 to Dillard et al. (hereinafter “Dillard”) and U.S. Patent Application Publication No. 2017/0049518 to Sinusas.
For claim 1, Sung discloses a catheter assembly (Abstract) comprising:
a catheter (210) (Fig. 4A) (para [0073]) defining a lumen therein (216b) (Fig. 4A) (para [0074]), the catheter including an opening (217b) (Fig. 4A) (para [0075]) formed in a sidewall at a distal end of lumen (as can be seen in Fig. 4A) (para [0075]);
a needle (220) (Fig. 4B) (para [0074]) disposable in the lumen (as can be seen in Fig. 4B) (para [0074]);
an offset mechanism (219b) (Fig. 4A) (para [0075]), wherein the offset mechanism comprises a ramp (as can be seen in Fig. 4A), the ramp having a sloped surface forming a distal end of the lumen adjacent the opening (as can be seen in Fig. 4A), the ramp configured to deflect the needle out of the lumen through the opening as the needle is advanced past the distal end of the catheter (as can be seen in Fig. 4A), wherein the ramp urges the flexible needle at a first offset angle from an axis of the lumen as it extends to the distal end of the catheter (as can be seen in Fig. 4A).
The needle in Sung appears to be flexible (see the lumen through which the needle is disposed, which is angled, thereby requiring the needle to be flexible to bend around those angles).
However, in the event that Sung’s needle is not flexible, Dillard teaches a flexible needle (Abstract).
It would have been obvious to a skilled artisan to modify Sung such that the needle is flexible, in view of the teachings of Dillard, for the obvious advantage of making it easy for Sung’s needle to navigate through Sung’s non-straight lumen.
Sung does not expressly disclose a curved stylet is coaxially disposable within the flexible needle such that the curved stylet can orient with the ramp, the curved stylet configured to cooperate to deflect the flexible needle out of the lumen through the opening, and the curved stylet causes the flexible needle to push off the ramp and increasingly diverge from the axis of the lumen at a second offset angle when it is extended past the distal end of the catheter for sampling of eccentric tissue regions, wherein the second offset angle is greater than the first offset angle.
However, Dillard teaches a curved stylet (1008) (Figs. 10 and/or 16C) (para [0115], “…1008, which, being curved…”) is coaxially disposable within a needle (1006, 1010) (para [0115], “the flexible needle 1006 is pushed over the guidewire 1008”) such that the curved stylet can orient with a ramp (unlabeled, but as can be seen in Figs. 11C and/or 16B), the curved stylet configured to (Examiner’s Note: functional language, i.e., capable of) cooperate, with a ramp (unlabeled, but as can be seen in Figs. 11C and/or 16B), to deflect the flexible needle out of a lumen through an opening (as can be seen in Fig. 16B), and the curved stylet causes the flexible needle to push off the ramp and increasingly diverge from the axis of the lumen at a second offset angle when it is extended past the distal end of the catheter for sampling (Examiner’s Note: functional language/intended use, i.e., capable of) of eccentric tissue regions (as can be seen in Fig. 16b), wherein the second offset angle is greater than the first offset angle (as can be seen in Fig. 16B, the first offset angle being the angle that element 1004 diverges (element 1004 being labeled in Fig. 16C, but not Fig. 16B) and the second offset angle being the angle that the rest of the needle, including elements 1008 and 1010 curve).
It would have been obvious to a skilled artisan to modify Sung to include a curved stylet is coaxially disposable within the flexible needle such that the curved stylet can orient with the ramp, the curved stylet configured to cooperate to deflect the flexible needle out of the lumen through the opening, and the curved stylet causes the flexible needle to push off the ramp and increasingly diverge from the axis of the lumen at a second offset angle when it is extended past the distal end of the catheter for sampling of eccentric tissue regions, wherein the second offset angle is greater than the first offset angle, in view of the teachings of Dillard, for the obvious advantage of providing an additional means by which to even more accurately guide/direct Sung’s needle to an area of interest for which the physician would like to take a biopsy.
Sung and Dillard do not expressly disclose that the ramp is located within the lumen.
However, Sinusas teaches a ramp located within a lumen (unlabeled, but as can be seen in Figs. 1A-2A).
It would have been obvious to a skilled artisan to modify Sun such that the ramp is located within the sampling lumen, in view of the teachings of Sinusas, because such a modification would be the simple substitution of the ramp being part of the wall of the lumen for the ramp being inside the lumen that would lead to the predictable result of deflecting the needle outwardly out the wall of the device.
For claim 3, Sung does not expressly disclose wherein the ramp defines an offset form the axis of the lumen in a range of 5 degrees to 25 degrees.
However, Sung does teach that the ramp defines an offset from the axis of the lumen at a “specific angle” (para [0075]), that the needle exits from the distal portion of the catheter at a “desired angle” (para [0015]), and that the angle may be modified (Figs. 18A and 18B) (para [0056]).
It would have been obvious to a skilled artisan to optimize Sung wherein the ramp defines an offset from the axis of the lumen in a range of around 5 degrees to around 25 degrees given that Sung recognizes that the angle of the ramp is a result-effective variable capable of being modified based upon a specific angle or desired angle. 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). A skilled artisan would have been motivated to make such a modification for the obvious advantage of getting a needle to exit at the right (or desired) location for which a physician wants to take a biopsy.
For claim 6, Sung does not expressly disclose wherein the curved stylet being configured to extend within the flexible needle from the opening at the distal end of the catheter at an angle that diverges from the axis of the lumen, the curved stylet further being configured to conform to a shape of the catheter while disposed within the lumen wherein an amount of curvature of the stylet is proportional to a length the stylet extends past the distal end of the catheter, wherein the stylet is further configured to be withdrawn from the lumen.
However, Dillard teaches the curved stylet being configured to extend within the needle from the opening (1002) (Fig. 10) (para [0115]) at the distal end of the catheter (1000) at an angle that diverges from the axis of the lumen (as can be seen in Figs. 13B, 14B, and 16B), the curved stylet further being configured to (Examiner’s Note: functional language, i.e., capable of) conform to a shape of the catheter while disposed within the lumen (see para [0216], which describes the guidewire as a “flexible section”) wherein an amount of curvature of the stylet is proportional to a length the stylet extends past the distal end of the catheter (Examiner’s Note: this limitation being construed in view of Figs. 3B and 3C of Applicant’s drawings) (see Figs. 2, 13B, and/or 16B of Dillard), wherein the stylet is further configured to (Examiner’s Note: functional language, i.e., capable of) be withdrawn from the lumen (para [0115]).
It would have been obvious to a skilled artisan to modify Sung wherein the curved stylet being configured to extend within the flexible needle from the opening at the distal end of the catheter at an angle that diverges from the axis of the lumen, the curved stylet further being configured to conform to a shape of the catheter while disposed within the lumen wherein an amount of curvature of the stylet is proportional to a length the stylet extends past the distal end of the catheter, wherein the stylet is further configured to be withdrawn from the lumen, in view of the teachings of Dillard, for the obvious advantage of providing an additional means by which to even more accurately guide/direct Sung’s needle to an area of interest for which the physician would like to take a biopsy.
For claim 7, Sung further discloses wherein the stylet is made from a shape memory alloy (see para [0111] of Dillard).
For claim 22, Sung, as modified, further discloses wherein the sloped surface of the ramp forms a triangular distal end of the sampling lumen when the sloped surface is viewed in cross-section (as can be seen in Figs. 1A-2A of Sinusas).
For claim 23, Sung further discloses wherein the sloped surface of the ramp, when viewed in cross-section, forms an angled surface relative to the axis of the sampling lumen (as can be seen in Fig. 4A).
For claim 24, Sung further discloses wherein a cross-section of the ramp includes an angled surface running from a proximal first point to a distal second point (as can be seen in Fig. 4A), wherein the proximal first point is on a sidewall of the sampling lumen and the distal second point forms a distal end of the opening (as can be seen in Fig. 4A).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung in view of Dillard and Sinusas, and further in view of U.S. Patent No. 6,371,968 to Kogasaka et al. (hereinafter “Kogasaka”).
For claim 25, Sung, Dillard, and Sinusas do not expressly disclose wherein the ramp comprises a hard plastic.
However, Kogasaka teaches where a sheath (1) is made of polycarbonate (col. 11, lines 56-58), and that the sheath includes a ramp (as can be seen in Fig. 2A).
Additionally, Sung teaches that its ramp is formed as part of a “sheath or catheter” (see para [0073]).
It would have been obvious to a skilled artisan to modify Sung wherein the ramp comprises a hard plastic, in view of the teachings of Kogasaka and Sung, because a hard plastic is a suitable material to make the ramp out of so that it can deflect the needle, which is what Sung wants its ramp to do.
For claim 26, Sung, Dillard, and Sinusas do not expressly disclose wherein the ramp comprises a polycarbonate.
However, Kogasaka teaches where a sheath (1) is made of polycarbonate (col. 11, lines 56-58), and that the sheath includes a ramp (as can be seen in Fig. 2A).
Additionally, Sung teaches that its ramp is formed as part of a “sheath or catheter” (see para [0073]).
It would have been obvious to a skilled artisan to modify Sung wherein the ramp comprises a polycarbonate, in view of the teachings of Kogasaka and Sung, because polycarbonate is a suitable material to make the ramp out of so that it can deflect the needle, which is what Sung wants its ramp to do.
Response to Arguments
Applicant’s arguments filed 7/31/25 have been fully considered.
With respect to the 112(a) rejection, Applicant’s amendments and arguments are persuasive and thus the rejection is withdrawn.
With respect to the 112(b) rejection, Applicant’s amendments and arguments are not persuasive. The examiner respectfully suggests amending the claim language to “the curved stylet is configured to cause the flexible needle” to overcome the rejection.
With respect to the 103 rejections, Applicant’s arguments will be treated in the order they were presented. In response to the first argument, Sung is not relied upon for this claim feature, Dillard is. With respect to the second argument, the ramp is unlabeled, but shown in Figs. 11C and/or 16B of Dillard. The ramp is the curved/inclined structure shown in either/both of those figures. With respect to the third argument, Dillard discloses a “flexible section 1008” of a “flexible needle 1002” (see para [0126]) and Figs. 11C and 16B show that element 1008 is configured to/capable of pushing the needle off of an unlabeled ramp and increasingly diverge from the axis of the lumen. That is, element 1008 is not exclusively limited to a guidewire. However, even in the embodiments that 1008 is a guidewire, a guidewire reads on a “stylet” as both are tubular structures that stiffen an overlaid structure (such as a catheter). With respect to third argument, Dillard discloses Figs. 11C and 16B show that element 1008 is configured to/capable of pushing the needle off of an unlabeled ramp and increasingly diverge from the axis of the lumen. With respect to the fourth argument, this claim language is subject to a 112(b) rejection and therefore the scope of the claim language is in question (since it is ambiguous). The examiner respectfully suggests clarifying the claim language in order to achieve more traction with their argument. With respect to the fifth argument, this argument is not commensurate in scope with the claim language. The claim is an apparatus-type claim and the claim language is functional claim language because it describes what the structure(s) do, not what the structure(s) are. A functional limitation is construed as having the full breath of its ordinary meaning such that if the prior art is capable of performing the function, then prior art reads on the functional limitation. Innova/Pure Water Inc. v. Safari Water Filtration Sys. Inc., 381 F.3d 1111, 1117-20, 72 USPQ2d 1001, 1020 (Fed. Cir. 2004). With respect to the sixth argument, this is a conclusory argument that fails to give any rational underpinning as to why the modification couldn’t “even more accurately guide/direct Sung’s needle to an area of interest for which the physician would like to take a biopsy.” With respect to the seventh argument, this argument relies on the premise that Dillard has no ramp, but the examiner maintains the position that Dillard has a ramp, as pointed out above. Both elements that can achieve the function of increasingly diverging the needle from the lumen axis are present in Dillard. Therefore, that functionality may then be modified into Sung to achieve the obvious result of “even more accurately guide/direct Sung’s needle to an area of interest for which the physician would like to take a biopsy.” With respect to the eighth argument, secondary considerations are secondary to the primary findings under KSR. The rationale is one of the established primary rationales of KSR and the secondary considerations do not overcome the primary findings. With respect to the ninth argument, the argument recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). However, the argument then proceeds to argue that neither of the references recognize the need or problem that is solved by the advantage listed in the rejection. As a result, the appears to contradict itself by recognizing that motivation doesn’t need to come from the references, but then argue that the motivation isn’t coming from the references.
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 on M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
