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 statements (IDS) submitted on 02/05/2022 and 09/30/2025 were filed before the current action on the merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
The Response to Election / Restriction filed 06/04/2025 has been entered. Applicant’s election without traverse of Group I, Species A, thus claims 1 and 3-13 is acknowledged. Accordingly claims 2 and 14-20 have been withdrawn. Claims 1 and 3-13 are pending on the application.
Claim Objections
Claims 7 and 12 objected to because of the following informalities:
Regarding claim 7, the claim recites the limitation “the inlet/outlet port of the connector” in line 2 of the claim. However, only an outlet port has antecedent basis. It is recommended that applicant change this to “outlet port” to avoid confusion.
Regarding claim 12, the claim recites the limitation “the inlet/outlet port” in line 1 of the claim. However, only an outlet port has antecedent basis. It is recommended that applicant change this to “outlet port” to avoid confusion.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3 and 10-11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Levin (US 20120089136 A1).
Regarding claim 1, Levin discloses
An assemblable cryoneedle (Levin Fig 1a par [0057]) comprising:
an outer elongated needle, configured to be inserted into a treatment area of a subject, the outer elongated needle comprising a sealed distal portion and a proximal portion comprising an opening (Levin Fig 1a (101) par [0058]);
an inner elongated needle, configured to be inserted into the outer elongated needle (Levin Fig 1a (103) par [0059]),
the inner elongated needle comprising:
a proximal portion, having a proximal opening and configured to be connected to a cryogen source (Levin Fig 1a (113) par [0061]), and
a distal portion, having a distal opening, wherein the proximal and distal openings of the inner elongated needle define a lumen there between (Levin Fig 1a (103) lumen clearly visible between proximal and distal openings); and
a connector (Levin Fig 1a (125) par [0065]) comprising:
a distal portion having a distal opening (Levin Fig 1a distal opening near element (120));
a proximal portion having a proximal opening, wherein the connector's proximal and distal openings define a lumen there between (Levin Fig 1a proximal opening (124)); and
an outlet port fluidly connected to the lumen (Levin Fig1a (126) par [0065]),
the connector is configured to detachably couple the outer elongated needle with the inner elongated needle (Levin par [0066]),
wherein the connector is configured to facilitate flow of a cryogen from the proximal portion to the distal portion of the inner elongated needle, back from the sealed distal portion of the outer elongated needle, and out through the outlet port of the connector (Levin Fig1a, par [0065]).
Regarding claim 3, Levin discloses the cryoneedle of claim 1. Levin further discloses wherein the proximal portion of the outer elongated needle is connectable to the distal portion of the connector, and the proximal portion of the inner elongated needle is connectable to the proximal portion of the connector (Levin Fig 1a par [0064]).
Regarding claim 10, Levin discloses the cryoneedle of claim 1. Levin further discloses wherein at least a portion of the proximal portion of the outer elongated needle is circumferentially expanded to facilitate coupling and retaining the proximal portion of the outer elongated needle to the connector (Levin Fig 1a flanging (112) par [0058]).
Regarding claim 11, Levin discloses the cryoneedle of claim 1. Levin further discloses wherein the proximal portion of the inner elongated needle further comprising one or more circumferentially expanded cone-shaped collars, to facilitate direct or indirect connection and sealing of the inner elongated needle to the cryogen source (Levin Fig 1a (117) par [0062]).
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.
Claims 4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Levin (US 20120089136 A1) in view of Dewaele (US 20110004157 A1).
Regarding claim 4, Levin discloses the cryoneedle of claim 1. Levin fails to explicitly disclose wherein the outer elongated needle, the inner elongated needle and/or the connector are manufactured by CNC machining.
However, Dewaele discloses a tubular medical instrument (Dewaele Fig 3A (1) par [0149]) where the tubular structure is manufactured by CNC machining (Dewaele par [0158]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used CNC machining to manufacture at least part of the invention of Levin, as CNC manufacture is known in the art as a standard technique for tubular members (Dewaele par [0158]).
Regarding claim 8, Levin discloses the cryoneedle of claim 1. Levin further discloses wherein the proximal portion of the outer elongated needle is detachably connectable to the distal portion of the connector (Levin Fig1a (110,120) par [0058]).
Levin fails to explicitly disclose coupling via screwing.
However, Dewaele discloses a tubular medical instrument (Dewaele Fig 19) where a tubular member is connected to a connector via screwing (Dewaele Fig 19 tubular member (162) connector (166) par [0197]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Levin to include parts which couple via screwing, as such a fitting is a secure connection for fluid lines (Dewaele par [0197]).
Regarding claim 9, Levin discloses the cryoneedle of claim 1. Levin further discloses wherein the proximal portion of the inner elongated needle is detachably connectable to the proximal portion of the connector (Levin Fig1a (116,124) par [0066]).
Levin fails to explicitly disclose coupling via screwing.
However, Dewaele discloses a tubular medical instrument (Dewaele Fig 19) where a tubular member is connected to a connector via screwing (Dewaele Fig 19 tubular member (162) connector (166) par [0197]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Levin to include parts which couple via screwing, as such a fitting is a secure connection for fluid lines (Dewaele par [0197]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Levin (US 20120089136 A1) in view of Bliweis (US 20090292279 A1).
Regarding claim 5, Levin discloses the cryoneedle of claim 1. Levin fails to explicitly disclose wherein the sealed distal portion of the outer elongated needle further comprising a sharp tip configured to penetrate the treatment area.
However, Bliweis discloses a similar cryoprobe medical instrument (Bliweis Fig 2a (1310) par [0116]) comprising a sharp tip configured to penetrate the treatment area (Bliweis Fig 2a (1314) par [0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Levin with a sharp tip for penetrating tissue, as this facilitates insertion of the device (Bliweis par [0117]).
Regarding claim 6, Levin discloses the cryoneedle of claim 1. Levin further discloses wherein a fluid flow circulation capacity is maintained between an outer surface of the inner elongated needle and an inner surface of the outer elongated needle and inside the inner elongated needle (Levin Fig 1a, par [0065]).
Levin fails to explicitly disclose wherein at least a portion of the outer elongated needle and the inner elongated needle are bent.
However, Bliweis discloses a similar cryoprobe medical instrument (Bliweis Fig 2a (1310) par [0116]) wherein at least a portion of the needle is bent (Bliweis Fig 2a (1316) par [0118]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Levin to include a bent section such as disclosed by Bliweis, as such a bent section allows for direction of the probe towards a desired direction upon insertion (Bliweis par [0118]).
Regarding claim 7, Levin discloses the cryoneedle of claim 1. Levin further discloses wherein the proximal portion of the inner elongated needle and/or the outlet port of the connector is configured to be connected directly or indirectly to a cryogen source (Levin Fig 1a par [0065]).
Levin fails to explicitly disclose a splitter which facilitates concomitantly connecting a plurality of cryoneedles to a single cryogen source.
However, Bliweis discloses a similar cryoprobe medical instrument (Bliweis Fig 6b (601) par [0166]) comprising a splitter which facilitates concomitantly connecting a plurality of cryoneedles to a single cryogen source (Bliweis Fig 6b (615) par [0167]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Levin to use a splitter, as this allows for multiple probes to be used or controlled concomitantly (Bliweis par [0167]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Levin (US 20120089136 A1) in view of Burger (US 20120265186 A1).
Regarding claim 12, Levin discloses the cryoneedle of claim 1. Levin does not explicitly disclose wherein the outlet port is couplable to the connector by mechanical pressure, adjusted by tolerance values there between.
However, Burger discloses a similar fluid-based invasive medical device (Burger Fig 13 par [0063]) wherein a port is couplable by mechanical pressure (Burger Fig 13 (704) par [0101]; by broadest reasonable interpretation any adjustment must done by tolerance values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Levin to use mechanical pressure as a method of connection for a fluid port, as such a connection is known in the art to be releasable (Burger par [0101]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Levin (US 20120089136 A1) in view of Baust (US 5916212 A).
Regarding claim 13, Levin discloses the cryoneedle of claim 1. Levin fails to explicitly disclose the connector further comprising one or more thermally insulating gripping elements configured to facilitate gripping of the cryoneedle by a user.
However, Baust discloses a cryoneedle with connector and handle (Baust Fig 6 cryoneedle (29) handle (2) col 5 line 21-25) comprising one or more thermally insulating gripping elements configured to facilitate gripping of the cryoneedle by a user (Baust Fig 6 (4) col 5 line 66 – col 6 line 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Levin to have thermally insulating gripping elements, as this allows for ease of holding the invention (Baust col 5 line 66 – col 6 line 5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Becton whose telephone number is (571)272-9570. The examiner can normally be reached Monday-Friday 9am-5pm ET.
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/MATTHEW DAVID BECTON/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794