DETAILED ACTION
Applicant’s response, filed May 20, 2026 is fully acknowledged by the Examiner. Currently, claims 1-24 are pending. The following is a complete response to the May 20, 2026 communication.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-12 in the reply filed on May 20, 2026 is acknowledged. The traversal is on the ground(s) that “no undue burden on the Examiner to consider all claims in the single application”. This is not found persuasive because the Examiner maintains that the inventions set forth in Group I and II fail to have unity of invention as outlined in the April 15, 2026 Restriction requirement. The Examiner does not find that Applicant’s allegation with respect to the lack of burden by the Examiner effectively traverses that the Examiner’s position that the groups fail to have unity of invention as discussed in 37 CFR 1.475 and MPEP § 1893.03(d).
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 20, 2026.
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 .
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.
Claims 5-12 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.
Regarding claim 5, the claim recites the limitation of “the control module obtains all data … obtains all temperatures … controls switching … locks a gas interface … and identifies the ablation needle …” therein. The Examiner is of the position that such recites method-like language in an apparatus claim. This renders the scope of the claim as indefinite because it is unclear if infringement of the claim would occur when a system including the claimed control module is simply provide and capable of performing the above-listed steps/functions, or if infringement would only occur when the control module is actively performing each of the claimed steps. The Examiner respectfully suggests Applicant utilize language such as “configured to obtain”, “configured to control”, “configured to lock”, and “configured to identify” to address the issue. Appropriate correction is required.
Regarding claim 6, the claim recites the limitation of “the control module” therein. There is insufficient antecedent basis for this limitation in the claim. In particular, claim 6 recites dependency from claim 1, and neither of claims 1 nor 6 provide a proper basis for the term of “the control module”. The Examiner respectfully notes that dependent claim 5 recites a control module but dependency on this claim was removed in the May 26, 2023 preliminary amendment. Claims 7-12 are rejected due to their dependency on claim 6. Appropriate correction is required.
Regarding claim 6, the claim recites the limitation in line 4 of “preparation of the ablation needle”, the limitation in lines 10-11 of “selection of the refrigeration high-pressure pipeline and the refrigeration low-pressure pipeline”, and the limitation in line 16 of “use of the ablation needle” therein. It is the Examiner’s position that the inclusion of these limitations and their manner of recitation within the remaining body of the claim renders the scope of the claim as indefinite because it is unclear if each recitation is intended as an introductory statement defining the effect that the subsequent steps are intended to achieve or, alternatively, if such are steps in and of themselves that need to be performed. This manner of claim drafting appears to be generally narrative in format and the Examiner respectfully requests that the language of the claim be amended to clearly define the steps to be performed by the control method. Claims 7-12 are rejected due to their dependency on claim 6. Appropriate correction is required.
Regarding claim 6, the claim recites “the ablation needle” in line 4 of the claim. This limitation renders the scope of the claim as indefinite given that parent claim 1 requires at least two (2) ablation needles. Accordingly, the recitation of “the ablation needle” in line 4 renders the scope of the claim as indefinite because it is unclear if such is only referring to a single ablation needle of the at least two ablation needles in claim 1, or if such preparation is intended for each ablation needle of the at least two ablation needles. This is further exacerbated by the subsequent limitation in line 4 of claim 6 of “marking each of the ablation needles”. In general, the Examiner respectfully requests that line 4 (and the balance of the claim) be amended to clearly recite the number of ablation needles required for the preparation step as well as the subsequent manner in which each of the ablation needles is treated in the preparation step. Claims 7-12 are rejected due to their dependency on claim 6. Appropriate correction is required.
Regarding claim 6, the claim recites in lines 6-7 of the claim the limitation of “the temperature of the ablation needle may be collected” therein. The Examiner is of the position that this recitation renders the scope of the claim as indefinite because it is unclear if such a recitation is referring to conditional status of the system of claim 1 or, alternatively, is referring to an optional, active step of the method that may or may not be performed during the “preparation” step of the method in claim 6. Thus, the Examiner finds the scope of the claim as indefinite because it is unclear if this at-issue limitation is a required step of the claimed method, is optionally required and/or is only directed towards some manner of functional capability of the system for performing the method. Claims 7-12 are rejected due to their dependency on claim 6. Appropriate correction is required.
Regarding claim 6, the claim recites the limitation of “the rewarming power supply” and “the ablation needle identification interface in lines 7-8 of the claims. Each limitation fails to have proper antecedent basis in the claims. In particular, claim 6 recites dependency from claim 1, and neither of claims 1 nor 6 provide a proper basis for each of the above-noted claim terms. Claims 7-12 are rejected due to their dependency on claim 6. Appropriate correction is required.
Regarding claim 6, the claim recites “the on/off of the gas path” in line 17 of the claim. The Examiner is of the position that such a limitation fails to have proper antecedent basis in the claims as neither claim 1 or 6 provide for the gas path having an on/off condition but, rather, claim 1 provides for an on/off of the gas circuit. Claims 7-12 are rejected due to their dependency on claim 6. Appropriate correction is required.
Regarding claim 6, the claim recites “the opening and the closing is required to be performed for the main gas pipeline …or the refrigeration low-pressure pipeline main valve” in lines 18-20 of the claim. The Examiner is of the position that this recitation renders the scope of the claim as indefinite because parent claim 1 only provides for each of the recited valves to have on/off states, and claim 1 only sets forth opening and closing with respect to the pipe exhaust hole. Claims 7-12 are rejected due to their dependency on claim 6. Appropriate correction is required.
Regarding claim 6, the claim recites the limitation of “the shared pipeline” in the last two lines of the claim. The Examiner is of the position that such a limitation fails to have proper antecedent basis in the claims as neither claim 1 or 6 provides a proper basis for “a shared pipeline”. Claims 7-12 are rejected due to their dependency on claim 6. Appropriate correction is required.
Regarding claim 8, the claim recites “performing one of the exhausting operations” therein. The Examiner is of the position that such a limitation fails to have proper antecedent basis in the claims as neither of parent claims 1 or 6 provide a proper basis for an exhausting operation. Appropriate correction is required.
Regarding claim 10, the claim utilizes the recitation of “first/second/third/ therein. The Examiner is of the position that this manner of claim drafting renders the scope of the claim as indefinite because it is unclear if the claim requires each of the first gas output pressure regulating device, the second gas output pressure regulating device and the third gas output pressure regulating device, if each gas pressure output regulating device is only required in the alternative, and if the functionality and methodology prescribed within the claim is are prescribed individually to each of the first, second and third gas output pressure regulating device, or if the functionality and methodology can be mixed between respective ones of the first, second and third gas output pressure regulating devices. Appropriate correction is required.
Regarding claim 11, the claim recites the limitation of “the gas reaches the place, by the control module” therein. Each of “the gas”, “the place” and “the control module” fail to have proper antecedent basis in the claims given that none of parent claims 1 and 6 provide a proper basis for each limitation. Appropriate correction is required.
Regarding claim 12, the claim recites the limitation of “the pressure value … is close to 0”. The term “close” in the claim is a relative term which renders the claim indefinite. The term “close” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the instant case, the Examiner is not aware of a set standard for the term of “close” to determine how near and/or far from a pressure value of 0 the measurement would necessarily need to be in order to qualify as “close to 0” as claimed. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Longsworth (US Pat. No. 5,452,582), and further in view of Yang et al. (CN 107951558 A1). **The Examiner notes that the reference to Yang below are made with respect to the attached machine translation of the ‘558 document**
Regarding claim 1, Longsworth provides for a multichannel cryo ablation system (see figure 6), employing a high-pressure gas source, the multichannel cryoablation system comprising:
a main gas pipeline provided with a gas source input port (gas pipeline between 42 and the connection point at the dashed rectangular box as in figure 6), wherein the gas source input port is used to be connected with a high- pressure nitrogen source (via the connection to the source at 42),
a rewarming pipeline communicated with the main gas pipeline (pipeline branching downward with in the dashed box in figure 6 with the regulator at 50), the rewarming pipeline being provided with a first gas output pressure regulating device (50), wherein the first gas output pressure regulating device may regulate a gas output pressure of the rewarming pipeline (see col. 4; 66 – col. 5; 17 discussing the function of 50), the rewarming pipeline is divided into N rewarming branch channels following the rewarming pipeline main valve, and each of the rewarming branch channels is provided with a branch channel valve to realize the on/off of a gas circuit (see each of the branches off the rewarming pipeline for connection to the valves 52),
a refrigeration supply pipeline (pipeline extending straight within the dashed box in figure 6 with the regulator at 44) communicated with the main gas pipeline and configured to provide for a high pressure and a low pressure (see col. 4; 56-65), wherein the refrigeration high-pressure pipeline is provided with a second gas output pressure regulating device (44), the second gas output pressure regulating device may regulate a gas output pressure of the refrigeration high-pressure pipeline (as in col. 4; 56-65), the refrigeration supply pipeline including a gas path that is communicated with the N refrigeration branch channels, each of the refrigeration branch channels being provided with a branch channel valve to realize the on/off of the gas circuit (see each of the branches off the supply pipeline for connection to the valves 48),
N channel pipelines, each of the channel pipelines having one end used to be connected with an ablation needle, and the other end used to be connected with one of the refrigeration branch channels and/or one of the rewarming branch channels (each of the individual tubes 18), a pipe exhaust hole (78), each of the ablation needles is connected with an air outlet or is provided with the air outlet (return path of each needle),
wherein N is a positive integer greater than or equal to 2 (see figure 6 with at least two channel pipelines).
While Longsworth provides for a plurality of the features as set forth above, Longsworth fails to provide for that the gas source is a high-pressure nitrogen gas source and further fails to provide that the main gas pipeline includes a first pressure measuring device and a main gas valve, wherein the first pressure measuring device is used to obtain a gas pressure of the high-pressure nitrogen cylinder, and the main gas valve may realize the on/off of the high-pressure nitrogen in the main gas pipeline;
Yang discloses a similar device as that of Longsworth wherein a cooling gas source is a high-pressure gas source in form of nitrogen (as claimed) or argon (as disclosed in Longsworth). Yang further provides for a main gas pipeline (see figure 1 with the pipeline between 1 and the branch point) that includes a first pressure measuring device (25) and a main gas valve (2), wherein the first pressure measuring device is used to obtain a gas pressure of the high-pressure nitrogen cylinder (25 is a pressure gauge), and the main gas valve may realize the on/off of the high-pressure nitrogen in the main gas pipeline (2) is an electromagnetic valve).
Longsworth further fails to provide that the rewarming pipeline includes a second pressure measuring device and a rewarming pipeline main valve, wherein the second pressure measuring device is used to obtain an output pressure of the first gas output pressure regulating device, and the rewarming pipeline main valve may realize the on/off of the high-pressure nitrogen in the rewarming pipeline;
Yang further discloses a second pressure measuring device and a rewarming pipeline main valve (see figure 1 with the measuring device at 30 and the valve at 6) wherein the second pressure measuring device is used to obtain an output pressure of the first gas output pressure regulating device (with 30 at the output of 6), and the rewarming pipeline main valve may realize the on/off of the high-pressure nitrogen in the rewarming pipeline (via 6 being an electromagnetic valve).
While Longsworth provides for the pressure pipeline as disclosed above, and further contemplates for varying pressures to be provided, and for various sources of high-pressure gas to be utilized for different functions, Longsworth fails to provide for a both a high pressure refrigeration supply pipeline and a refrigeration low-pressure pipeline, each pipeline communicated with the main gas pipeline respectively.
With respect to the high-pressure pipeline, Longsworth fails to provide for the claimed third pressure measuring device and a refrigeration high-pressure pipeline main valve, wherein the third pressure measuring device is used to obtain an output pressure of the second gas output pressure regulating device, and the refrigeration high-pressure pipeline main valve may realize the on/off the high-pressure nitrogen in the refrigeration high-pressure pipeline. With respect to the refrigeration low-pressure pipeline, Longsworth fails to provide for each of the claimed features of this pipeline.
Yang, however, provides for a plurality of refrigeration pipelines that are respectively connected to the main gas pipeline (see figure with the pipelines extending from the split after element 9 and with one passing through 10 and the other passing through 11) wherein the various pathways are described throughout as providing different temperatures at different pressures; see the description in Examples 1 and 2). Yang further provides for the each of the refrigeration pressure pipelines to include a respective pressure measuring device and a refrigeration main valve (see respective ones of 26/27 and 10/11), wherein each pressure measuring device is used to obtain an output pressure of its respective pressure regulating device (via each of 26/27 providing for a pressure output at the valve), and each refrigeration main valve may realize the on/off the high-pressure nitrogen in the refrigeration high-pressure pipeline (via each valve 10/11 functioning to turn on/off). Yang also displays that a part of the refrigeration low-pressure pipeline following the its main valve shares a section of gas path with a part of the refrigeration high-pressure pipeline following the its main valve, wherein the gas path is communicated with the a refrigeration output for supplying refrigeration to a surgical device (via 21). Last, Yang provides for the pipeline with its medical device to include a fifth pressure measuring device (29) and a valve for controlling the opening and closing of a pipe exhaust hole (third valve 4).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have first utilized both a high-pressure and a low-pressure refrigeration pipeline in place of the single adjustable pressure refrigeration pipeline as in Longsworth to provide for an alternative manner of providing different pressure levels of the nitrogen gas to be supplied to the remainder of the system. Yang readily provides that such achieves differing levels of cooling at distal end of a suitable cryoprobe thereby providing the ability to readily control the speed of tissue freezing during treatment.
The Examiner further finds that the addition of the various valve and pressure measuring devices would have been further obvious to one of ordinary skill in the art in light of the teaching of Yang. Such provides for redundant levels of flow control and pressure monitoring in the multiplexed system of Longsworth such that abnormal pressure conditions can be readily addressed and isolated via the valving an each location within the system.
Regarding claim 2 Longsworth provides that N is a positive integer greater than or equal to 3 (see figure 6 with at least three channel pipelines).
Regarding claim 3, in view of the combination of Longsworth and Yang in claim 1 above, each of the main gas valve, the rewarming pipeline main valve, the refrigeration high-pressure pipeline main valve, the refrigeration low-pressure pipeline main valve, the branch channel valve, and the valve for controlling the opening and closing of the pipe exhaust hole are each electromagnetic valves. In particular, Longsworth contemplates solenoid valves as in col. 4; 56-65) and Yang provides for electromagnetic valves for the various valves disclosed throughout.
Regarding claim 4, in view of the combination of Longsworth and Yan in the rejection of claim 1 above, each of the first/second/third gas output pressure regulating device is a pressure reducing valve (via the respective disclosures of each regulating device functioning to reduce pressure).
Allowable Subject Matter
Claims 5-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mitchiner (US Pat. No. 4,275,734) provides for a cryosurgical system where the high-pressure gas is supplied at two different pressure (see figure 2 and the pipelines through 44 and 42).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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