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 (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.
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 17 is 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.
Claim 17 recites the limitation "the antennae" in line 3. There is insufficient antecedent basis for this limitation in the claim since a plural amount of antenna has not been previously set forth.
Claim Rejections - 35 USC § 102
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 1-2, 7, 9-12, 15-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2022/0361947).
Regarding claim 1, Wang discloses a microwave ablation probe tip (see Fig. 2) comprising: a post portion configured to be received in an ablation probe needle (see portion of first branch tube at groove 2211, Fig. 2), the post portion comprising one or more annular grooves (see annular groove 2211, Fig. 2); and an insertion portion (see 221, Fig. 2) comprising a shoulder at which the insertion portion is connected to the post portion (as indicated in annotated Figure 2 below, [0072]), wherein the insertion portion tapers in a direction away from the shoulder (see tapered portion at the distal end of the tip, Fig. 2).
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Annotated Figure 2 of Wang
Regarding claim 2, Wang further discloses wherein each of the one or more annular grooves extends circumferentially around an outer surface of the post portion (the groove is disclosed as annular in [0071], therefore the groove extends fully around the outer surface of the post portion, Fig. 2).
Regarding claim 7, Wang further discloses wherein the insertion portion terminates at a point (as shown in Fig. 2).
Regarding claim 9, Wang further discloses wherein the post portion includes a center bore (see interior lumen of the post portion, Fig. 2).
Regarding claim 10, Wang further discloses a tube positioned in the center bore and extending out of the center bore in a direction away from the insertion portion (see cooling tube 240 extending in the bore and in a direction away from the distal tip, Fig. 2).
Regarding claim 11, Wang further discloses wherein the tube is configured to receive a microwave antenna therein (see internal lumen of 240 configured to receive segment 232 of the coaxial cable, Fig. 2).
Regarding claim 12, Wang discloses a microwave ablation probe (see Fig. 2-3) comprising: a shell defining an axially extending inner cavity (see tube 222 defining an axially extending lumen within, Fig. 2); a cable positioned in the inner cavity and comprising a microwave antenna (see coaxial cable 230 positioned within the lumen and comprising a microwave antenna, Fig. 2); and a tip connected at a distal end of the shell (see 210, Fig. 2), the tip comprising a post portion received inside the distal end of the shell (see portion of first branch tube at groove 2211 received inside the distal end of 222, Fig. 2) and an insertion portion connected to the post portion and extending away from the distal end of the shell (as indicated in annotated Figure 2 above, [0072]), the post portion comprising one or more annular grooves (see annular groove 2211, Fig. 2).
Regarding claims 15 and 16, Wang further discloses the limitations of these claims under the same citations and rationale as that already set forth in the rejection of claims 7 and 9 above.
Regarding claim 18, Wang discloses this claim under the same citations and rationale as that applied to claim 12 above. Wang further discloses an ablation console comprising a microwave generator (see [0080]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Blumenkranz et al. (US 2020/0138514).
Regarding claim 3, Wang discloses the limitations of claim 1, however fails to further disclose wherein the one or more annular grooves comprises a first groove, a second groove, and a third groove axially spaced apart from each other.
Blumenkranz teaches a microwave device tip (see Fig. 25) comprising multiple grooves on post portion of the distal tip axially spaced apart from each other (see grooves 335; [0098]-[0099], Fig. 25). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the groove in post portion disclosed by Wang to comprise a first groove, a second groove, and a third groove axially spaced apart from each other in light of Blumenkranz, the motivation being to provide a fluid seal at the distal end of the device (see Blumenkranz [0099]) and further since it has been held that mere duplication of the parts of a device has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (MPEP 2144.04 (VI)(B)). In the instant case, providing three grooves would produce the expected result of further ensuring a fluid tight seal for the distal end of the device.
Claims 4-6, 8, 13-14 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Eaton-Evans et al. (US 2022/0160426).
Regarding claim 4, Wang discloses the limitations of claim 1 and further teaches wherein the insertion portion comprises a seating surface configured to contact and end surface of the ablation probe needle (see surface at the interface between 221 and 222, Fig. 2), however Wang fails to further disclose wherein the seating surface is angled relative to the end surface of the ablation probe needle.
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Annotated Figure 6 of Eaton-Evans
Eaton-Evans teaches a microwave ablation needle tip (see Fig. 6) wherein the seating surface of the insertion portion is angled relative to the ablation probe needle (see angled seated surface relative to 112 as indicated in the annotated Figure 6 of Eaton-Evans above). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the seating surface as disclosed by Wang into an angled seating surface relative to the ablation needle probe in light of Eaton-Evans in order to have a suitable shape adapted for piercing tissue (see Eaton-Evans [0142]). Additionally, a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. See MPEP 2144(IV)(B). In the instant case, there is no evidence of record that indicates that this feature shows unexpected results over the existing prior art structure would produce.
Regarding claims 5 and 6, Eaton-Evans further teaches wherein the seating surface is angled in a direction away from the post portion and wherein the seating surface is positioned radially outward of an outer surface of the post portion (as shown in Fig. 6 of Eaton-Evans).
Regarding claim 8, Wang discloses the limitations of claim 1, however fails to specifically disclose wherein the insertion portion comprises a conical shape.
Eaton-Evans teaches a microwave ablation needle tip (see Fig. 6) wherein the insertion portion comprises a conical shape (see [0142]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the insertion portion as disclosed by Wang into conical shape in light of Eaton-Evans in order to have a suitable shape adapted for piercing tissue (see Eaton-Evans [0142]).
Regarding claims 13 and 14, Wang in view of Eaton-Evans further teaches the limitations of these claims under the same citations and rationale as that applied in the rejection of claims 4-6 above.
Regarding claims 19 and 20, Wang discloses the limitations of claims 1 and 12, however fails to further disclose wherein the post portion and the insertion portion are integrally formed from a ceramic material using an injection molding process.
Eaton-Evans teaches a microwave ablation needle tip (see Fig. 6) wherein the post portion and the insertion portion are integrally formed from a ceramic material (see [0143] and Fig. 6). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to made the insertion portion and post portion as disclosed by Wang such they were integrally formed from a ceramic material in light of Eaton-Evans in order to provide sufficient strength to pierce tissue (see Eaton-Evans [0142]-[0143]), and further since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Wang in view of Eaton-Evans fails to specifically teach an injection molding process is used to integrally form the post portion and insertion portions, however even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985). In the instant case, the prior art product is materially the same as the claimed structure as defined above and therefore is not patentable in light of the prior art even though Eaton-Evans only teaches a general “moulding” process for the product (see Eaton-Evans [0142]).
Allowable Subject Matter
Claim 17 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Wang et al. (US 2022/0361947), Eaton-Evans et al. (US 2022/0160426), Cronin et al. (US 2016/0262832), and Cronin et al. (US 2008/0275436), fails to reasonably teach or suggest a ferrule positioned over the antenna, the ferrule extending in an axial direction from the antennae and at least a portion of the ferrule received inside the center bore of the post portion when considered in combination with the additional requirements of the claim. The closest prior art teaches coverings/ferrules for the antennas located in the distal tips; however, the closest prior art discloses the coverings/ferrules outside of the bore formed by the post portion as defined by the claims and fails to provide any reasonable suggestion or motivation for moving the covering/ferrule into this specific location.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794