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 .
Response to Amendment
The examiner acknowledges the cancelations made to claims 1-7 and 15-24, with new claims 25-32 added to the claim set. Currently claims 8-14 and 25-32 are pending in the present application.
Claim Rejections - 35 USC § 103
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.
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) 8-11, 14, 27-29, 32 is/are rejected under 35 U.S.C. 103 as being anticipated by Chin (US Patent No 20070135681).
Regarding claim 8, Chin teaches a needle defining a lumen (needle 35 with bore 22, [0013]), the needle comprising: a proximal portion defining a first port of the lumen (see fig 1 in which the cutoff area of the needle 35 defines a proximal port); and a distal portion defining second port of the lumen (see distal tip 25 of fig 1 which defines a second port), wherein the lumen extends between and connects the first port and the second port (see fig 1 for the proximal port extending to the distal tip 25 defining the second port), and wherein the distal portion comprises: an open tip portion defining the second port (see distal tip 25 of fig 1 which defines a second port), wherein the open tip portion comprises at least one sharpened tip (distal tip 30, [0030]) configured to facilitate insertion of the distal portion into patient tissue (in which the distal tip facilitates penetration into the target tissue, [0030]); an opening connected with the lumen (see bore 22 in fig 1 which defines the opening into the lumen).
This particular needle 35 embodiment taught by Chin in figure 1 does not disclose a ramp at least partially obstructing the lumen and configured to urge patient tissue within the distal portion toward the opening during insertion of the distal portion into patient tissue.
However, further embodiments of the needle taught by Chin, for example needle 102 shown in the figure 4 does disclose a ramp at least partially obstructing the lumen and configured to urge patient tissue within the distal portion toward the opening during insertion of the distal portion into patient tissue (see edge 100 in fig 4A and 4B which is equivalent to the ramp and is used to help displace and guide the target tissue into the bore opening 110 during treatment, [0033]).
Therefore, it would have been obvious for one skilled in the art to incorporate the ramp edge 100 of the alternate needle embodiment of the Chin figure 4 with that of the main needle embodiment found in figure 1, as different needle shapes and edges would be used to allow for better cutting edges and smoother needle insertion for the desired application as taught by Chin, [0032] –[0033].
Regarding claim 9, Chin teaches the needle of claim 8, wherein the distal portion further comprises at least one additional port positioned proximally of the opening (see slits 20 which define a region equivalent to another port. Also found proximally to the bore opening 22, [0018]).
Regarding claim 10, Chin teaches the needle of claim 8, wherein the distal portion further comprises a plurality of slits positioned proximally of the opening (see slits 20 which define a region proximal to the bore opening 22, [0018]).
Regarding claim 11, Chin teaches the needle of claim 10, wherein the plurality of slits extend transverse to a longitudinal axis of the distal portion (wherein the slots 20 are positioned to be transversal or circumferentially found around the needle 35, [0025], see also fig 2 showing the slots 20 transversal to the longitudinal axis).
Regarding claim 14, Chin teaches the needle of any of claim 8, wherein the distal portion comprises a tab that is deformed inward to thereby define the ramp and the opening (see edge 100 in fig 4A and 4B which is equivalent to the ramp and is used to help displace and guide the target tissue into the bore opening 110 during treatment, [0033]).
Regarding claim 27, Chin teaches the needle of claim 8, wherein the open tip portion is positioned distal to the opening (see from figure 1 in which the distal tip portion 30 is found distal to the opening defined by the bore 22).
Regarding claim 28, Chin teaches the needle of claim 8, wherein the lumen extends distally beyond the ramp (see from the figure 4a and 4b in which the distal point 105 which still defines the lumen extends beyond the ramp edge 100).
Regarding claim 29, Chin teaches the needle of claim 8, wherein the ramp projects into the lumen (see from the figure 4b in which the cutting-edge projects into the lumen, see also [0033] in which it describes how the cutting edge 100 or the ramp has a gradually increasing diameter and due to the angle of the edge does project into the lumen).
Regarding claim 32, Chin teaches the needle of claim 8, wherein the opening has a closed periphery (see from Chin figure 1 in which the opening defined by the bore hole 22 has a closed periphery via needle 35).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin (US Patent No 20070135681) in view of Malek (US Patent No 20200406018).
Regarding claim 12, Chin teaches the needle of claim 8 wherein the needle comprises an outer surface (outer sheath 10, [0014]) and an inner surface (inner sheath 15, [0014]).
Chin does not teach wherein the outer surface is more hydrophilic than the inner surface.
However, the analogous drug delivery catheter system of Malek does teach a needle wherein the outer surface is more hydrophilic than the inner surface (wherein the second lumen 3305 which is the outer surface of the needle element 3350 can include or be coated with a hydrophilic agent for treatment, [0117]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the flexible needle system taught by Chin to have the hydrophilic needle outer surface taught by Malek in order to increase the lubricity of the lumen with respect to the treatment site as disclosed by Malek, [0117].
Regarding claim 13, Malek teaches the needle of claim 12, wherein at least one of the outer surface or the inner surface comprises a surface treatment that alters a hydrophilicity of the at least one of the outer surface or the inner surface (wherein the second lumen 3305 which is the outer surface of the needle element 3350 can include or be coated with a hydrophilic agent for treatment, [0117], by definition altering the hydrophilicity).
Claim(s) 25-26, 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin (US Patent No 20070135681) in view of Boubes (US Patent No 20200268981).
Regarding claim 25, Chin teaches the needle of claim 8.
Chin does not explicitly disclose wherein the opening is positioned proximal to the second port.
However, the analogous needle tip assembly as taught by Boubes does disclose an opening is positioned proximal to the second port (see the opening or outlet 245 which is found on the interior or bottom side from the needle aperture 240 which is seen as the second port, [0061], see also fig 25).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the flexible needle configuration with the needle tip assembly taught by Boubes as they are analogous needle devices and the needle tip assembly allows for better fluid irrigation and needle insertion during treatment as taught by Boubes, [0061].
Regarding claim 26, the combination teaches the needle of claim 8, wherein the distal portion further comprises a slot formed opposite the opening (from Boubes, wherein the outlet 245 is found opposite of the opening 240 of the needle assembly, fig 25); and wherein a distal tip of the ramp is received in the slot (from Boubes, see in which the interior needle tip cover 150 which is seen as the equivalent ramp is found in alignment with the outlet 245, fig 25).
Regarding claim 30, the combination teaches the needle of claim 8, wherein the ramp is defined by a tab that is bent into the lumen (from Boubes, see in which the needle tip protector 100 which defines the ramp end 150 is partially defined in the needle lumen and is bent to define a ramp component, fig 25, see also [0070]).
Regarding claim 31, the combination teaches the needle of claim 8, wherein the opening is formed in a sidewall of the needle (from Boubes, wherein the opening 245 is found on the outer needle assembly 250, [0061]), and wherein the ramp projects from the sidewall across a longitudinal axis of the distal portion (from Boubes, see in which the needle tip protector 100 which defines the ramp end 150 is partially defined in the needle lumen and is bent across the longitudinal axis to define a ramp component, fig 25, see also [0070]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/22/2025, with respect to the rejection(s) of claim(s) 8 and all dependent claims under the 102 rejection of the prior art of record Chin have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of different embodiments of the prior art of record Chin.
The argument made that the previous 102 rejection of claim 8 relies on two separate embodiments disclosed in the Chin reference, has been considered and found persuasive. Therefore, the examiner has removed the previous 102 rejection. However, after further consideration the present rejection still maintains the prior art of record of Chin as a newly stated 103 rejection which relies on multiple obvious embodiment combinations which are taught within the Chin reference. Therefore, claim 8 and all remaining dependent claims remain rejected under the new prior art of record rejection set forth in the present office action.
With regards to the new claims 25-32, as they presented new claim limitations in the claim set, further search and consideration was applied in which the new prior art of record Boubes was found to reasonably teach and disclose all of the new claim limitations as found in the preset office action. Regarding new claims 25-32 they remain rejected under the new prior art of record rejection of Chin in view of Boubes set forth in the present office action.
All other dependent claims remain rejected due to their dependency on the rejected claim 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794