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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Cronin (US 2007/0043346), Prakash (US 2009/0198227), Sliwa (US 2010/0228162) and Silverstein (US 4,582,067).
Regarding claims 1-5, Cronin discloses what can be considered a generic electromagnetic (EM) ablation device which includes an instrument shaft for conveying EM energy (1) and a distal end assembly to receive EM energy from the shaft and delivery EM energy for tissue treatment (2). The shaft further comprises a standard coaxial cable (1). The end assembly includes a radiating tip portion including a dielectric tip (5), a distal portion of the inner conductor extending into the tip (distal end of 8) and an intermediate dielectric element around the distal portion (3 or 4). Cronin does not disclose the assembly includes a magnetostrictive ultrasound transducer connected to the inner and outer conductors of the coaxial cable within/on the intermediate dielectric element. However, using multiple ablation elements is common in the art and connecting such elements in a functional manner, and where such function elements are located, is well within the level of ordinary skill. The fact that Applicant has recited mutually exclusive species of this embodiment (“on or in,” claims 4 and 5), some of which are not shown, further supports the position that Applicant is relying on the same level of ordinary skill in the art to both enable the invention and to show possession of the claimed invention at the time the application was filed that is relied upon for rejection. Prakash discloses microwave probe and teaches that the probe can also be modified to deliver other types of energy including radiofrequency, laser, ultrasound and cryotherapy ([0034]). The fact that Prakash does not disclose any details of how the potential combination of five different ablation modalities would work is yet more evidence that these modifications are well within the level of ordinary skill in the art. Prakash does not disclose what kind of ultrasound transducer is used, presumably because it makes no meaningful difference. Agreeing with that assessment is Sliwa which discloses an ablation device and teaches that the ultrasonic transducer can be any number of types including magnetostrictive ([0030]), where the transducer is specifically located on the distal end assembly (fig. 1). Thus Prakash and Sliwa teach the functional equivalence of ablation energy types and transducer types, respectively (MPEP 2144.06). As for the manner in which the transducer is rendered functional by connecting it to an energy source, Silverstein teaches that that a transducer can be connected by conductors to a source of energy by using the inner and outer conductors of a coaxial cable (see discussion associated with the coaxial cable 124 and the transducer 114 in figure 7C). As for the location of the of the transducer, since “on or in” covers all possibilities for radial positioning there only remains longitudinal positioning where with respect to the dielectric portions that form the distal end assembly of the device (i.e. where the treatment elements would be located) there are a finite number of possibilities. For example, both Sliwa (fig. 1) and Silverstein (fig. 7C) discloses that the transducer is located immediately proximal to the distal end of the assembly. It has been held that choosing between a finite number of identified, predictable solutions with a reasonable expectation of success is an obvious modification (MPEP 2141(III)). Further, there is no evidence that putting the transducer at a specific location along the assembly produces an unexpected result (within the meaning of MPEP 716.02(a)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Cronin to include any number of commonly known ablation elements in addition to the microwave antenna such as ultrasound transducers such as taught by Prakash, including any commonly known type of ultrasound transducer such as magnetostrictive as taught by Sliwa, including connecting the transducer in any manner commonly known to be functional such as by connecting connection points on the transducer to the inner and outer conductor of a coaxial cable such as taught by Silverstein, including locating the transducer anywhere on or in the distal end assembly such as on or in any of the three dielectric elements that comprise the distal end assembly, that would produce the predictable result of allowing a user to treat tissue at that location along the assembly using ultrasonic energy. Regarding the claim language “cutting,” this is a functional limitation. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, ultrasonic energy from the device of Cronin as modified can be used to cut tissue not least because whether tissue is cut depends on the type of tissue, the thickness of tissue, the electrical parameters at which the transducer is operated at, the duration of the treatment, and how much force is applied to tissue during the operation.
Claims 1-4, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hancock (US 2018/0280084), Sliwa and Silverstein.
Regarding claims 1-4, 6 and 7, Hancock, as the sole inventor of the invention recited in the pending claims, has clearly previously disclosed all the elements related to a forceps (fig. 1) with a microstrip antenna (fig. 6) powered by a coaxial cable ([0094]). Compare, for example, figures 2-6B of Hancock with figures 9-12 of the pending application which are essentially identical. Hancock does not disclose any of the details regarding a magnetostrictive transducer, including how the transducer is powered. However, Hancock does contemplate using ultrasonic energy for a cutting element which passes between the jaws ([0028]). The fact that Hancock does not show or describe any details of this embodiment in the prior art suggests that a person of ordinary skill in the art would know how to implement an ultrasonic cutting blade in a forceps device. Further, that the pending application does not show this embodiment at all suggests that Applicant is relying on the same level of ordinary skill in the art to both enable the invention, and to show possession of the claimed invention at the time the application was filed, as is applied to the prior art in these rejections. Sliwa discloses an ablation device and teaches that the ultrasonic transducer can be any number of types including magnetostrictive ([0030]), which is a teaching of functional equivalence (MPEP 2144.06). As for the manner in which the transducer is rendered functional by connecting it to an energy source, Silverstein teaches that that a transducer can be connected to a source of energy by using the inner and outer conductors of a coaxial cable (see discussion associated with the coaxial cable 124 and the transducer 114 in figure 7C). Therefore, before the application was filed, it would have been obvious to modify the device of Hancock to use apply any commonly known cutting energy to the blade including ultrasonic energy from a transducer as taught by Hancock, including using any commonly known type of transducer including magnetostrictive as taught by Sliwa, including connecting the transducer in any manner commonly known to be functional such as by connecting connection points on the transducer to the inner and outer conductor of a coaxial cable such as taught by Silverstein, that would produce the predictable result of allowing the device of Hancock to cut tissue using ultrasonic energy. Regarding the claim language “cutting,” this is a functional limitation. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, ultrasonic energy from the device of Hancock as modified can be used to cut tissue not least because whether tissue is cut depends on the type of tissue, the thickness of tissue, the electrical parameters at which the transducer is operated at, the duration of the treatment, and how much force is applied to tissue during the operation.
Claims 1-4, 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hancock in view of Waaler (US 2013/0289561), Sliwa and Silverstein.
Regarding claims 1-4, 6, 8-10, Hancock, as the sole inventor of the invention recited in the pending claims, has clearly previously disclosed all the elements related to a forceps (fig. 1) with a microstrip antenna (fig. 6) powered by a coaxial cable ([0094]), including using similar terminology for the various strips/layers (as discussed with respect to figures 6-8, e.g. using “underside” instead of the claimed “under surface”). Compare, for example, figures 2-6B of Hancock with figures 9-12 of the pending application. Note in particular that only one jaw is supplied with EM energy (e.g. the bottom jaw in fig. 2 of Hancock). Hancock does not disclose a specific type of transducer on the jaw between the strips (or on the other jaw from the strips), or the details such as what kind of transducer is used or how the transducer is made functional. However, the prior art recognizes that many types and combinations of ablation elements can be located the surface of jaws, including antennas and ultrasonic transducers, such as taught by Waaler ([0008]). Once again, the fact that Waaler does not disclose any details about these various combinations suggests that this type of modification is well within the level of ordinary skill in the art. Waaler does not disclose the type of transducer or where the transducer is located with respect to the strips. Sliwa discloses an ablation device and teaches that the ultrasonic transducer can be any number of types including magnetostrictive ([0030]). Thus Waaler and Sliwa teach the functional equivalence of ablation energy types on jaws and transducer types, respectively (MPEP 2144.06). As for the manner in which the transducer is rendered functional by connecting it to an energy source, Silverstein teaches that that a transducer can be connected by conductors to a source of energy by using the inner and outer conductors of a coaxial cable (see discussion associated with the coaxial cable 124 and the transducer 114 in figure 7C). As for where the transducers are located on the surface jaws, there are a limited number of options with respect to the strips: on the active strip, between the active strip and the ground strip, on the ground strip, and outside the ground strip if the transducer is located on the jaw with the antenna, on the other jaw, or some combination thereof. It has been held that choosing between a finite number of identified, predictable solutions with a reasonable expectation of success is an obvious modification (MPEP 2141(III)). Further, the fact that Applicant has again claimed mutually exclusive species of this feature is more evidence that putting the transducer in any of these locations on the surface of the jaws does not produce an unexpected result (within the meaning of MPEP 716.02(a)). Therefore, before the application was filed, it would have been obvious to modify the instrument of Hancock to include any commonly known ablation element including ultrasound transducers on the jaws for treating tissue, such as taught by Waller, including any commonly known type of transducer such as a magnetostrictive transducer as taught by Sliwa, including connecting the transducer in any manner commonly known to be functional such as by connecting connection points on the transducer to the inner and outer conductor of a coaxial cable such as taught by Silverstein, and including locating the transducers anywhere they would be able to treat tissue including any combination of locations with respect to the other elements of the jaw, including both at least between the ground strip and the conductive strip and only on the jaw that does not have the microstrip antenna, that would produce the predictable result of allowing a user to treat tissue grasped by the jaws with ultrasonic energy. Regarding the claim language “cutting,” this is a functional limitation. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, ultrasonic energy from the device of Hancock as modified can be used to cut tissue not least because whether tissue is cut depends on the type of tissue, the thickness of tissue, the electrical parameters at which the transducer is operated at, the duration of the treatment, and how much force is applied to tissue during the operation.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Cronin, Prakash, Sliwa and Choi (US 2008/0027423).
Regarding claim 11, Cronin discloses what can be considered a generic electromagnetic (EM) ablation device which includes an instrument shaft for conveying EM energy (1) and a distal end assembly to receive EM energy from the shaft and delivery EM energy for tissue treatment (2). The shaft further comprises a standard coaxial cable (1). The end assembly includes a radiating tip portion including a dielectric tip (5), a distal portion of the inner conductor extending into the tip (distal end of 8) and an intermediate dielectric element around the distal portion (3 or 4). Cronin does not disclose the instrument includes a magnetostrictive ultrasound transducer mounted on the shaft. However, using multiple ablation elements is common in the art and there are countless arrangements of these elements disclosed in the prior art. Prakash discloses microwave probe and teaches that the probe can also be modified to deliver other types of energy including radiofrequency, laser, ultrasound and cryotherapy ([0034]). The fact that Prakash does not disclose any details of how the potential combination of five different ablation modalities would work is yet more evidence that these modifications are well within the level of ordinary skill in the art. Prakash does not disclose what kind of ultrasound transducer is used, presumably because it makes no meaningful difference. Agreeing with that assessment is Sliwa which discloses an ablation device and teaches that the ultrasonic transducer can be any number of types including magnetostrictive ([0030]), where the transducer is specifically located on the distal end assembly (fig. 1). Thus Prakash and Sliwa teach the functional equivalence of ablation energy types and transducer types, respectively (MPEP 2144.06). As for where the location of the transducer, Choi discloses an ablation instrument and teaches that transducers can be located both a distal end assembly (43, fig. 3E) but also more proximally along the shaft (41). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Cronin to include any number of commonly known ablation elements in addition to the microwave antenna such as ultrasound transducers such as taught by Prakash, including any commonly known type of ultrasound transducer such as magnetostrictive as taught by Sliwa, including locating the transducer(s) anywhere they would function such as along the shaft as taught by Choi, that would produce the predictable result of allowing a user to treat tissue at that location along the instrument using ultrasonic energy.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cronin, Prakash, Sliwa and Hancock (US 2008/0234574), hereinafter Hancock2.
Regarding claim 12, Cronin discloses what can be considered a generic electromagnetic (EM) ablation device which includes an instrument shaft for conveying EM energy (1) and a distal end assembly to receive EM energy from the shaft and delivery EM energy for tissue treatment (2). The shaft further comprises a standard coaxial cable (1). The end assembly includes a radiating tip portion including a dielectric tip (5), a distal portion of the inner conductor extending into the tip (distal end of 8) and an intermediate dielectric element around the distal portion (3 or 4). Cronin does not disclose the instrument includes a magnetostrictive ultrasound transducer mounted on the shaft. However, using multiple ablation elements is common in the art and there are countless arrangements of these elements disclosed in the prior art. Prakash discloses microwave probe and teaches that the probe can also be modified to deliver other types of energy including radiofrequency, laser, ultrasound and cryotherapy ([0034]). The fact that Prakash does not disclose any details of how the potential combination of five different ablation modalities would work is yet more evidence that these modifications are well within the level of ordinary skill in the art. Prakash does not disclose what kind of ultrasound transducer is used, presumably because it makes no meaningful difference. Agreeing with that assessment is Sliwa which discloses an ablation device and teaches that the ultrasonic transducer can be any number of types including magnetostrictive ([0030]), where the transducer is specifically located on the distal end assembly (fig. 1). Thus Prakash and Sliwa teach the functional equivalence of ablation energy types and transducer types, respectively (MPEP 2144.06). As for what material used to make the transducer, Hancock2 teaches that Terfenol-D is preferable for that purpose ([0058]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Cronin to include any number of commonly known ablation elements in addition to the microwave antenna such as ultrasound transducers such as taught by Prakash, including any commonly known type of ultrasound transducer such as magnetostrictive as taught by Sliwa, including using any commonly known magnetostrictive material including Terfenol-D as taught by Hancock2, that would produce the predictable result of allowing a user to treat tissue at that location along the instrument using ultrasonic energy.
Response to Arguments
Applicant's arguments filed 19 September 2025 have been fully considered but they are not persuasive. As noted in the rejections, changing the claim word “treatment” to “cutting” only limits the prior art to be capable of cutting rather than the more generic treatment. Aside from the parameters relevant to cutting listed in the rejections, it is noted the claims do not recite a degree of cutting or a location of cutting relative to any part of the system. Thus, even if the device “ablates” tissue during normal use, it is conceivable that such tissue destruction would qualify as a “cut.” As noted by Applicant in the remarks, Sliwa does specifically use the word “incise” to describe the ablation, mimicking the use of a mechanical cutting element in a MAZE procedure. However, in the interest of compact prosecution, it is noted that the prior art is familiar with using magnetostrictive transducers for cutting. Sinelnikov (US 2013/0060140), for example, teaches that ultrasound generated by either piezoelectric or magnetostrictive transducers is useful for cutting, ablating and coagulating tissue ([0006]). Cuny (US 2004/0193198) also includes a similar teaching ([0047]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794