DETAILED ACTION
Applicant’s preliminary amendment, filed January 16, 2025, is fully acknowledged by the Examiner. Currently, claims 21-40 are pending and newly added, with claims 1-20 cancelled. The following is a complete response to the January 16, 2025 communication.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the requirement in each of claims 30 and 39 of the distal-most end of the inflow tube insert to be “in fluid communication with the fluid outflow chamber” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30 and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 30 and 39, each claim requires therein that a distal-most end of the inflow tube insert is in fluid communication with the fluid outflow chamber. The Examiner has reviewed the instant disclosure but has failed to find any mention of the inflow tube insert being in fluid communication with the fluid outflow chamber. While the Examiner understands that the insert is provided in figure 2 at reference numeral 52 and for its distal end to be located within a portion of the outflow chamber at 38, there is nothing in the disclosure that reasonably suggests that the insert 52 is in fluid communication with the chamber 38. Paragraph [0008] suggests that the tube insert is “adhered to the inflow tube member and interacting with the hub divider to form a seal prohibiting fluid flow between the inflow chamber and outflow chamber except via the spacing between the coaxial cable and the first tubular member and between the first tubular member and the second tubular member.” The Examiner is of the position that this disclosure in [0008] reasonably suggests the opposite of the claimed arrangement; namely that there is no fluid communication between the tube insert and the outflow chamber so as to ensure the sealing between the two chambers and the specific fluid flow paths.
Paragraph [0022] provides further disclosure with respect to the inflow tube insert 52 and, much like the disclosure in [0008], sets forth that the insert 52 is bonded/adhered to the first tubular member 18 and that the insert seals the inflow/outflow chambers from one another through the interaction with the hub divider. The Examiner is of the position that this additional disclosure in [0022], again, reasonably suggests the opposite of the claimed arrangement; namely that there is no fluid communication between the tube insert and the outflow chamber so as to ensure the sealing between the two chambers and the specific fluid flow paths. The Examiner further finds that figure 2 also fails to reasonably suggest for the claimed fluid communication between the insert and the outflow chamber as set forth in each of claism 30 and 39.
Thus, it is for at least the reasoning set forth above that the Examiner finds that each of claims 30 and 39 contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Appropriate correction is required.
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 23 and 36 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 claims 23 and 36, the claim presently recites that limitation of “the fluid within the fluid inflow chamber causes the flange to compress the hub divider and form a fluid seal between the flange and the hub divider to force fluid within the fluid inflow chamber into the fluid channel defined by the tubular member.” The Examiner is of the position that the highlighted language above is method-like language in an apparatus claim that renders the scope of the claim as indefinite. In particular, the Examiner is of the position that the scope of the claim is indefinite because it is unclear if infringement of the claim would occur when the flange of the antenna assembly is actively compressing the hub divider and forming the fluid seal as claimed, or when a microwave assembly with a flange functionally capable of compressing and forming the fluid seal is provided. The Examiner respectfully suggests that functional claim terms such as “wherein the flange is configured to compress the hub divider and form a fluid seal between the flange and the hub divider in response to fluid within the fluid inflow chamber so as to force the the fluid within the fluid inflow chamber into the fluid channel defined by the tubular member” would appear sufficient to define over the present issue. 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 21, 22, 24-28, 31-35, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan et al. (US Pat. Pub. 2014/0276739 A1) further in view of Odaka et al. (US Pat. No. 6,175,580 A1).
Regarding claim 21, Brannan discloses a microwave ablation antenna assembly, comprising a handle assembly (handle at 23), a coaxial cable extending through the handle assembly (feedline 14), a hub disposed within the handle assembly and configured to receive the coaxial cable (40), the hub including a fluid inflow chamber (first chamber 147) and a fluid outflow chamber (second chamber 143), a hub divider coupled to the hub and separating the fluid inflow chamber from the fluid outflow chamber (160, see figure 3A), a tubular member coaxially surrounding the coaxial cable and defining a fluid channel between the tubular member and the coaxial cable, wherein the tubular member is received through an opening extending through the hub divider and the fluid channel is in fluid communication with the fluid inflow chamber (224 with the fluid channel at 37).
While Brannan provides for the tubular member to be sealed at the location that it passes through the hub divider, Brannan fails to specifically provide for an inflow tube insert disposed within the opening extending through the hub divider, wherein the inflow tube insert coaxially surrounds the tubular member to fluidly seal the fluid inflow chamber from the fluid outflow chamber. Odaka provides for an alternative manner of providing a seal between a tubular passage and a shaft/tubular member (see figure 2B). In particular, Odaka provides for a tube insert (82) disposed within an opening extending through a structure (within the tubular passageway within 78), wherein the tube insert coaxially surrounds a tubular member (see figure 2B with 82 surrounding 80) to fluidly seal the fluid inflow chamber from the fluid outflow chamber (see col. 4; 46-56 providing for the seal via the tube arrangement at 82).
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 utilized the alternative sealing arrangement in Odaka of a tube insert in place of the elastomeric interference fit in Brannan to provide for a known manner of sealing a tubular member within a tubular passageway within a surgical device. The Examiner is further of the position that either arrangement would function equally as well as one another and with a reasonable expectation of success to provide for the requisite fluid sealing between the inflow and outflow chambers of Brannan.
Regarding claim 22, in view of the combination with Odaka to utilize the inflow tube insert as shown in figure 2B above, the Examiner is further of the position that the inflow tube insert forms a flange (see figure 2B with the flange portion at the area indicated by the lead line attached to 82). The Examiner is further of the position that the placement of the insert into the hub divider from the proximal end would then result in the flange being placed within the fluid inflow chamber.
Regarding claim 24, in view of the combination of Brannan and Odaka above, wherein the flange of the insert per the combination would be out of physical contact with the hub (via the flange extending only along the hub divider and put of contact with the hub itself).
Regarding claim 25, in view of the combination of Brannan and Odaka above, the inflow tube insert would be bonded to an outer surface of the tubular member (via, in the assembled stated, the insert being held together with the tubular member at 224).
Regarding claim 26, in view of the combination of Brannan and Odaka in the rejection of claim 21 above, the proximal-most end of the tubular member (proximal-most end of 224 in Odaka) is disposed proximal to a distal-most end of the inflow tube insert (via 224 extending proximal to the surface of the divider 160 where the distal-most end of the insert per Odaka would extend within).
Regarding claim 27, in view of the combination of Brannan and Odaka in the rejection of claim 21 above, the combination provides that at least a portion of the inflow tube insert is in direct contact with the hub (as shown in figure 2B of Odaka where the insert 82 is in contact with the structure surrounding the insert; such would then provide for the insert 82 to be in contact with the hub 160 of Brannan).
Regarding claim 28, the combination in the rejection of claim 21 above provides for the inset to have an outer diameter, and for the opening in the hub divider to have an inner diameter. While the combination does not explicitly set forth that an outer diameter of the inflow tube insert is greater than a diameter of the opening extending through the hub divider, the Examiner is of the position use of an interference fit between the hub divider and the inflow tube insert such that the outer diameter of the insert would be some degree larger than the inner diameter of the hub opening would have been an obvious, if not inherent, feature to achieve the sealing fit as shown in figure 2B of Odaka.
Regarding claim 31, Brannan discloses a microwave ablation antenna assembly comprising a handle assembly (handle at 23), a coaxial cable extending through the handle assembly (feedline 14), a hub disposed within the handle assembly and configured to receive the coaxial cable (40), the hub including a fluid inflow chamber (first chamber 147) and a fluid outflow chamber (second chamber 143), a hub divider coupled to the hub and separating the fluid inflow chamber from the fluid outflow chamber (hub divider 160, see figure 3A).
While Brannan provides for the inflow chamber to be sealed from the outflow chamber at the location that it passes through the hub divider, Brannan fails to specifically provide for an inflow tube insert disposed within the opening extending through the hub divider, wherein the inflow tube insert coaxially surrounds the coaxial cable to fluidly seal the fluid inflow chamber from the fluid outflow chamber. Odaka provides for an alternative manner of providing a seal between a tubular passage and an inner member (see figure 2B). In particular, Odaka provides for a tube insert (82) disposed within an opening extending through a structure (within the tubular passageway within 78), wherein the tube insert coaxially surrounds the inner member (see figure 2B with 82 surrounding 80) to fluidly seal the fluid inflow chamber from the fluid outflow chamber (see col. 4; 46-56 providing for the seal via the tube arrangement at 82).
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 utilized the alternative sealing arrangement in Odaka of an inner member in place of the elastomeric interference fit in Brannan to provide for a known manner of sealing a tubular member within a tubular passageway within a surgical device. The Examiner is further of the position that either arrangement would function equally as well as one another and with a reasonable expectation of success to provide for the requisite fluid sealing between the inflow and outflow chambers of Brannan.
Regarding claim 32, Brannan further provides for a tubular member coaxially surrounding the coaxial cable and defining a fluid channel between the tubular member and the coaxial cable (224 with the fluid channel at 37). The Examiner then notes that combination with Odaka in the rejection of claim 31 above would provide that the inflow tube insert coaxially surrounds the tubular member and the fluid channel is in fluid communication with the fluid inflow chamber.
Regarding claim 33, in view of the combination of Brannan and Odaka above, the inflow tube insert would be bonded to an outer surface of the tubular member (via, in the assembled stated, the insert being held together with the tubular member at 224).
Regarding claim 34, in view of the combination of Brannan and Odaka in the rejection of claim 21 above, the proximal-most end of the tubular member (proximal-most end of 224 in Odaka) is disposed proximal to a distal-most end of the inflow tube insert (via 224 extending proximal to the surface of the divider 160 where the distal-most end of the insert per Odaka would extend within).
Regarding claim 35, in view of the combination with Odaka to utilize the inflow tube insert as shown in figure 2B above, the Examiner is further of the position that the inflow tube insert forms a flange (see figure 2B with the flange portion at the area indicated by the lead line attached to 82). The Examiner is further of the position that the placement of the insert into the hub divider from the proximal end would then result in the flange being placed within the fluid inflow chamber.
Regarding claim 37, in view of the combination of Brannan and Odaka above, wherein the flange of the insert per the combination would be out of physical contact with the hub (via the flange extending only along the hub divider and put of contact with the hub itself).
Regarding claim 40, Brannan provides for a microwave ablation antenna assembly comprising a handle assembly configured to receive a coaxial cable (handle at 23), the handle assembly housing a fluid inflow chamber and a fluid outflow chamber; a hub divider disposed within the handle assembly and separating the fluid inflow chamber from the fluid outflow chamber; and an inflow tube insert disposed within an opening extending through the hub divider, the inflow tube insert having a proximal end portion in fluid communication with the fluid inflow chamber and a distal end portion in fluid communication with the fluid outflow chamber, wherein the inflow tube insert fluidly seals the fluid inflow chamber from the fluid outflow chamber.
Allowable Subject Matter
Claims 23 and 36 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.
Claims 29 and 38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Durign the search of the prior art, the above cited Brannan and Odaka references were identified by the Examienr as the closest prior art to the instant claims.
With respect to the subject matter in each of claims 23 and 36, while the Odaka reference provides for an exemplary insert structure, the sealing arrangement set forth therein (see figure 2B) fails to be disclosed as functioning in conjunction with fluid pressure within an inflow chamber so as cause its flange to compress the hub divider (per the combination with Brannan) so as to form the claimed fluid seal. With respect to the subject matter in each of claims 29 and 38, the combination of Brannan and Odaka fails to reasonably suggest for the distal end of the insert to be adhered to the wall of the hub as claimed. Nothing in Odaka suggests the use of adhesive in combination with the claimed insert, let alone for the combination of Brannan and Odaka to specifically utilize adhesive between the distal end fo the insert and the wall of the hub as claimed. The Examiner has failed to find any other reference or combination of reference that would disclose, fairly suggest, or otherwise render obvious each of the features set forth in any of claims 23, 29, 36 and 38.
Conclusion
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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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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