DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 10/21/2025.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Specification
The amendment filed 11/13/202 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the “disclosure of the priority applications are hereby incorporated in their entirety by reference” is regarded as new matter. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. See MPEP 608.01(p) I B & 1893.03(b):
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: indent the elements that comprise “the radiating tip portion” in ll. 6 & 11. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “the proximal portion” to -the proximal portion of the distal dielectric sleeve- in ll. 21. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “to the proximal dielectric sleeve” to -than the proximal dielectric sleeve- in ll. 2. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “(PEEK), glass-filled” to –(PEEK), or glass-filled- in ll. 2. Appropriate correction is required.
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 6 & 11 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.
Claim 6 recites the limitation “wherein the radiating tip portion is secured to the flexible coaxial cable by a collar mounted over a junction therebetween, and wherein the collar is conductive and electrically connects the outer conductor with an outer conductor of the flexible coaxial cable”; however, claim 1, upon which claim 6 depends, recites: “a collar, the radiating tip portion being secured to the distal end of the flexible coaxial cable by the collar, and the collar being also arranged to electrically connect an outer conductor of the flexible coaxial cable to the outer conductor of the proximal coaxial transmission line” First, it is unclear if Applicant is attempting to claim two “collars”. Second, if only one “collar” is claimed, it is unclear how claim 6 further limits claim 1 from which it depends since claim 6 recites the same limitations as claim 1. For purposes of examination, the “collar” in claim 6 will be interpreted as being the same “collar” in claim 1.
Claim 11 recites the limitation “a length equal to or greater than 40 mm” which is an unbounded range and therefor indefinite.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6-10 & 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al. (2016/0135887) in view of Moorman et al. (2002/0058932).
Concerning claims 1 & 6¸ as illustrated in at least Figs. 1 & 6, Prakash et al. disclose an electrosurgical instrument (microwave antenna assembly 10; [0052]) comprising:
a flexible coaxial cable configured to convey microwave energy (cable 15 connects to microwave power source 28; [0052]);
a radiating tip portion mounted on a distal end of the flexible coaxial cable and configured to receive the microwave energy, wherein the radiating tip portion is substantially rigid to permit insertion into biological tissue (radiating portion 12 has a tapered end 24 which terminates at a tip 26 to allow for insertion into tissue; [0052]), and wherein the radiating tip portion comprises:
a proximal coaxial transmission line for conveying the microwave energy, wherein the proximal coaxial transmission line comprises an inner conductor that extends from a distal end of the flexible coaxial cable, the inner conductor being electrically connected to a center conductor of the flexible coaxial cable, a proximal dielectric sleeve mounted around the inner conductor, and an outer conductor mounted around the proximal dielectric sleeve (coaxial line left of junction member 102 comprises inner conductor 112 connected to center conductor of feedline 14 and cable 15, dielectric material 114 and outer conductor 110; [0063]); and
a distal needle tip mounted at a distal end of the proximal coaxial transmission line, wherein the distal needle tip comprises a distal dielectric sleeve mounted around a distal portion of the inner conductor (dielectric junction member 102 is a dielectric sleeve that mounts around a distal portion of inner conductor 112 and forms a distal needle tip in conjunction with distal tip 124; [0056], [0063-0064]), wherein the distal needle tip is configured as an open-ended monopole antenna to operate as a half wavelength transformer to deliver the microwave energy from the distal needle tip (assembly 10 can be a monopole antenna; [0052], [0066]), and
wherein a distal portion of the outer conductor overlays a proximal portion of the distal dielectric sleeve to form, with a portion of the inner conductor, an intermediate coaxial transmission line between the proximal coaxial transmission line and the distal needle tip (outer conductor 110 overlays proximal portion of dielectric junction member 102 to form, with the inner conductor 112, an intermediate coaxial transmission line between the proximal coaxial transmission line and the distal needle tip; [0063-0064]), wherein the outer conductor ends at the proximal portion of the distal dielectric sleeve such that a distal portion of the of the distal dielectric sleeve is free of the outer conductor and is continuous with the proximal portion (outer conductor 110 ends at stepped portion 104 of dielectric junction member 102 such that distal portion of dielectric junction member 102 is free of outer conductor 110 and continuous with the proximal portion; [0063]), wherein the inner conductor extends through the proximal portion and the distal portion of the distal dielectric sleeve (inner conductor 112 extends through dielectric junction member 102 and into distal tip 120; [0063-0064]), wherein the outer conductor is a conductive tube, configured to exhibit longitudinal rigidity sufficient to transmit a force to penetrate a duodenum wall (outer conductor 110 is a conductive tube and exhibits longitudinal rigidity sufficient to transmit force into tissue; [0016], [0053-0054]), and
wherein the electrosurgical instrument further includes a collar, the radiating tip portion being secured to the distal end of the flexible coaxial cable by the collar, and the collar being also arranged to electrically connect an outer conductor of the flexible coaxial cable to the outer conductor of the proximal coaxial transmission line (feedline 14 connects radiating portion 12 to cable 15 and thus connects outer conductors together; [0052], [0055]).
Prakash et al. fail to disclose the diameter of the flexible coaxial cable is greater than a diameter of the proximal coaxial transmission line. However, Moorman et al. disclose a larger diameter coaxial cable is less lossy. Thus, it would have been obvious to one of ordinary skill in the art to modify the invention of Moorman et al. such that the diameter of the flexible coaxial cable is greater than a diameter of the proximal coaxial transmission line in order to provide the benefit of a coaxial cable that is less lossy as taught by Moorman et al. ([0054])
Concerning claim 7, Prakash et al. disclose the distal dielectric sleeve (102) has a bore (108) formed therethrough for receiving the inner conductor (110), and wherein the distal needle tip further comprises a tip element (120) mounted at a distal end of the distal dielectric sleeve (102) to close the bore (108) ([0057]; Fig. 5-6).
Concerning claim 8, Prakash et al. disclose a distal end (124) of the distal dielectric sleeve (102) is sharpened ([0065]; Fig. 6).
Concerning claim 9, Prakash et al. disclose the distal dielectric sleeve (102) made from a different material (hard ceramic) than the proximal dielectric sleeve (114) (air) ([0056], [0060]).
Concerning claim 10, Prakash et al. disclose the distal dielectric sleeve (102) is any of a ceramic, polyether ether ketone (PEEK), or glass-filled PEEK ([0060]).
Concerning claim 12, Prakash et al. disclose the radiating tip portion (120) has a maximum outer diameter equal to or less than 1.2 mm since the tip tapers to a point ([0065]; Fig. 6).
Concerning claim 13, Prakash et al. disclose a microwave choke (170) or balun fabricated on an outer surface of the proximal coaxial transmission line (left side of junction member 102) ([0017], [0068]; Fig. 9A-B).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al. (2016/0135887), as applied to claim 1, in further view of Turovskiy et al. (2005/0149010).
Concerning claim 4, Prakash et al. fail to disclose the inner conductor has a diameter that is less than the diameter of the center conductor of the flexible coaxial cable. However, Turovskiy et al. teaches an inner conductor (696) that has a diameter that is less than a diameter of a center conductor (694) of a flexible coaxial cable (690). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Prakash et al. such that the inner conductor has a diameter that is less than the diameter of the center conductor of the flexible coaxial cable in order to provide the benefit of the center conductor of the flexible coaxial cable functioning as a heat sink to facilitate conductive cooling of the microwave antenna as taught by Turovskiy et al. ([0104]; Fig. 26A-C).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al. (2016/0135887), as applied to claim 1, in further view of Hancock et al. (2010/0145328).
Concerning claim 11, Prakash et al. disclose the radiating tip portion (12) to have a length of about 1.42 inches (36 mm) and thus fail to disclose the radiating tip portion has a length equal to or greater than 40 mm. However, Hancock et al. disclose an electrosurgical instrument comprising a radiating tip portion having a length in the longitudinal direction equal to or greater than 40 mm and a radiating tip portion having a maximum outer diameter equal to or less than 1.2 mm ([0034], [0012], [0114]. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Prakash et al. such that the radiating tip portion has a length in the longitudinal direction equal to or greater than 40 mm in order to provide the benefit of delivering microwave radiation in a uniform matter to an appropriate tissue target as taught by Hancock et al. ([0034], [0112], [0114]) and since it has been held that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists". In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Moorman et al. (2002/0058932) teach an electrosurgical instrument comprising a coaxial cable (100), a radiating tip (40) comprising a proximal coaxial transmission line (80), a distal tip (35, 10) mounted at a distal end of the proximal coaxial transmission line (80), the distal tip (35, 10) comprising a distal dielectric sleeve (60) mounted around a distal portion of an inner conductor (81, 55).
Cronin et al. (2007/0191825) teach an electrosurgical instrument comprising a coaxial cable (12), a radiating tip (1) comprising a proximal coaxial transmission line (204), a distal tip (215, 216) mounted at a distal end of the proximal coaxial transmission line (204), the distal tip (215, 216) comprising a distal dielectric sleeve (204) mounted around a distal portion of an inner conductor (210), but fails to disclose “a distal portion of the outer conductor [of the proximal coaxial transmission line” overlays a proximal portion of the distal dielectric sleeve to form, with a portion of the inner conductor, an intermediate coaxial transmission line between the proximal coaxial transmission line and the distal needle tip”.
Bra et al. (2014/0052125) teaches a microwave choke (1408) or balun fabricated on an outer surface of a proximal end of coaxial transmission line (32) for optimizing control, focus, and/or direct the general radiating pattern of the radiating portion and to improve impedance matching, reduce reflections and/or standing waves and improve efficiency as taught by Bra et al. ([0200]; Fig. 14A-F)
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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