DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s Amendment filed February 3, 2026 (hereinafter “02/03/26 Amendment") has been entered, and fully considered. In the 02/03/26 Amendment, the Specification was amended to address various grammatical issues. Further, all of previously pending claims 30-58 were cancelled (claims 1-29 were previously cancelled), and claims 59-86 were newly added. Therefore, claims 59-86 are now pending in the application.
3. The cancellation of claims 30-58 has rendered moot the claim objections and the rejections under §§ 112(b), 102 & 103 previously set forth in the Non-Final Office Action mailed 08/05/25 (“08/05/25 Action”).
4. New claim objections, and new rejections under §§ 112(a), 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Objections
5. Claims 59-61, 63, 64, 68, 72, 74, 76-78, & 80-83 are objected to because of the following informalities:
a. Independent claim 59 recites “at least one electrode body” in lines 2-3, line 5, & line 11, “electrode” in line 7, and “electrode body” in line 13, and line 14. Dependent claims 60 & 62 each recite “at least one electrode body” while dependent claims 63, 64, 68, 70, 72-74, & 77-81 recite “electrode body.” Applicant should select and utilize consistent terminology to refer to the electrode body in independent claim 59, as well as in the claims that depend therefrom.
b. In claim 59, lines 5-7, the recitation of “the at least one electrode body comprises an electrode surface including cross-sectional surfaces orientated orthogonally to a longitudinal extension of the probe, surface areas of the electrode disposed along a first axial portion of the longitudinal extension” should instead recite --the at least one electrode body comprises a longitudinal extension of the probe, and has an electrode surface including cross-sectional surfaces orientated orthogonally to the longitudinal extension, surface areas of the electrode disposed along a first axial portion of the longitudinal extension-- to more fully clarify that the electrode body is the longitudinal extension of the probe.
c. In claim 59, line 8, the recitation of “inceasing” should recite --increasing-- to correct the grammatical error.
d. In claim 59, lines 9-10, the recitation of “and the surface areas include a peripheral edge” should instead recite --and the cross-sectional surfaces include a peripheral edge-- since it is the cross-sectional surfaces that comprise the electrode surface (as previously recited in lines 5-6 of the claim). This change also harmonizes the claim language with that of, e.g., dependent claims 60 and 62, each of which recites “the peripheral edge of the cross-sectional surfaces”.
e. In claim 59, lines 11-12, the recitation of “the probe has a bending stiffness that does not change shape under an effect of an applied bending moment” should instead recite --the probe has a bending stiffness such that it does not change shape under an effect of an applied bending moment--.
f. In claim 59, line 13, the recitation of “applied traversely” should instead recite --applied transversely-- to correct the grammatical error.
g. In claim 60, lines 1-2, the recitation of “are continually curved” should instead recite --is continually curved--.
h. In claim 61, line 2, the recitation of “along a first axial portion” should instead recite --along the first axial portion--.
i. In claim 63, line 1, the recitation of “comprising” should instead recite --further comprising--.
j. In claim 63, line 4, the recitation of “oriented orthogonally to the longitudinal extension of the electrode body” should instead recite --oriented orthogonally to the longitudinal extension--.
k. In claim 63, line 5, the recitation of “as distance from the distal dome end increases” should instead recite --as the distance from the distal dome end increases--.
l. In claim 64, line 2, the recitation of “the first axial portion the electrode body” should instead recite --the first axial portion of the electrode body-- to correct the grammatical error.
m. In claim 64, lines 2-3, the recitation of “longitudinal sections orientated orthogonally to a cross-sectional surface” should instead recite --longitudinal sections orientated orthogonally to the cross-sectional surfaces--.
n. In claim 68, lines 3-4, the recitation of “when the probe has a bending moment applied of at least 0.3 Nm acting on the electrode body” should instead recite --under an effect of an applied bending moment of at least 0.3 Nm acting on the electrode body--.
o. In claim 72, line 1, the recitation of “comprising” should recite --wherein--.
p. In claim 72, line 2, the recitation of “an electrode surface of the electrode body” should recite --the electrode surface of the electrode body--.
q. In claim 74, lines 2-3, the recitation of “at least one of an electrode surface of the electrode body, a joint on the probe and the probe is coated with a friction reducing coating” should instead recite --wherein at least one of the electrode surface of the electrode body, the joint on the probe, and the probe is coated with a friction reducing coating--.
r. Claim 76 recites the limitations “wherein the two flattened surfaces include one of: both opposed flattened electrode surfaces have at least one level surface area; the opposed flattened electrode surface having at least one convexly curved surface area and includes at least one convexly curved surface area and another of the flattened electrode body surfaces includes at least one concavely curved surface area; and one of two opposed electrode surfaces includes at least one curved surface area and another of the electrode surfaces including at least one concave surface area.”
Claim 76 should be rewritten as follows to ensure consistent usage of the “two opposed flattened body surfaces” previously recited in claim 59 (from which claim 76 depends):
wherein the two opposed flattened body surfaces are arranged according to one of the following:
each of the two opposed flattened body surfaces has at least one level surface area;
a first of the two opposed flattened body surfaces has at least one convexly curved surface area, and a second of the two opposed flattened body surfaces has at least one concavely curved surface area; or
a first of the two opposed flattened body surfaces has at least one curved surface area, and a second of the two opposed flattened body surfaces has at least one concave surface area.
s. In claim 77, line 3, the recitation of “the oval cross-section” should instead recite --the oval-shaped cross-section-- to be consistent with the prior recitation in the claim.
t. In claim 78, line 3, the recitation of “a longitudinal axis” should instead recite --the longitudinal axis-- since antecedent basis for the longitudinal axis was previously provided in claim 77 (from which claim 78 depends).
u. In claim 80, lines 2-3, the recitation of “the electrode body does not radially protrude in an axial projection beyond the rigid hollow cannula” should instead recite --a radial extent of the electrode body does not project beyond a radial dimension of the rigid hollow cannula-- to be consistent with the language in the Specification.
v. In claim 81, line 2, the recitation of “the electrode body has outer surfaces shaped in a figure eight” should instead recite --the electrode body has outer surfaces matching an outer contour of a figure eight--.
w. Independent claim 82 recites “at least one freely accessible electrode body” in lines 1-2, “at least one accessible electrode body” in lines 5, “at least one electrode body” in line 7, “accessible electrode body” in line 11, “electrode body” in lines 13 & 14, the “body” in line 16, and “freely accessible electrode body” in line 19. Applicant should select and utilize consistent terminology to refer to the electrode body in independent claim 82. Note also the rejection under § 112(b) (below) concerning the recitations of “accessible” and “freely accessible.”
x. In claim 82, lines 6-8, the recitation of “wherein surface areas along a first axial portion contain a distal dome end of the at least one electrode body continuously increase in cross-section” should instead recite --wherein surface areas along a first axial portion contain a distal dome end of the at least one electrode body and continuously increase in cross-section--.
y. In claim 82, lines 11-12, the recitation of “the probe body” should instead recite --the probe-- to be consistent with the prior recitation in line 2 of the claim (and because antecedent basis has not been provided for “the probe body”).
z. In claim 82, line 13, the recitation of “a longitudinal extension of the probe” should instead recite --the longitudinal dimension of the probe-- to be consistent with the prior recitation in line 6 of the claim.
aa. In claim 82, lines 11-13, the recitation of “the probe body has a bending stiffness, which under an effect of a bending moment of at least 0.1 Nm acting on the electrode body transversely to a longitudinal extension of the probe, does not change shape” should instead recite --the probe has a bending stiffness, such that under an effect of a bending moment of at least 0.1 Nm acting on the electrode body transversely to the longitudinal dimension of the probe, the probe does not change shape--.
ab. In claim 82, line 17, the recitation of “distally surface section” should instead recite --distal surface section--.
ac. In claim 82, line 20, the recitation of “the distance” should instead recite --a distance--.
ad. Independent claim 83 recites “at least one accessible electrode body” in lines 2-3, & “accessible electrode body” in lines 11, 17, & 19-20. Applicant should select and utilize consistent terminology to refer to the electrode body in independent claim 83. Note also the rejection under § 112(b) (below) concerning the recitation of “accessible.”
ae. In claim 83, line 6, the recitation of “a longitudinal extension of the probe” should instead recite --a longitudinal dimension of the probe--.
af. In claim 83, line 8, the recitation of “incease” should recite --increase-- to correct the grammatical error.
ag. In claim 83, lines 11-12, the recitation of “the probe body” should instead recite --the probe-- to be consistent with the prior recitation in line 2 of the claim (and because antecedent basis has not been provided for “the probe body”).
ah. In claim 83, line 13, the recitation of “a longitudinal extension of the probe” should instead recite --the longitudinal dimension of the probe-- for consistency.
ai. In claim 83, lines 11-13, the recitation of “the probe body has a bending stiffness, which under an effect of a bending moment of at least 0.1 Nm acting on the electrode body transversely to a longitudinal extension of the probe, does not change shape” should instead recite --the probe has a bending stiffness, such that under an effect of a bending moment of at least 0.1 Nm acting on the electrode body transversely to the longitudinal dimension of the probe, the probe does not change shape--.
aj. In claim 83, line 16, the recitation of “the body” should instead recite --the molded body--.
ak. In claim 83, line 19, the recitation of “the body” should instead recite --the molded body--.
Appropriate correction is required.
Claim Interpretation
6. 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.
7. Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
8. Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
9. 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.
10. 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.
11. CLAIMS 84-86
12. Newly added dependent claims 84-86 each include the limitation:
“wherein the distal dome comprises means for undoing or separating tissue layers to be treated without lesion formation.”
13. The claim limitation in claims 84-86 of “means for undoing or separating tissue layers to be treated without lesion formation” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses the recitation “means” coupled with functional language “for undoing or separating tissue layers to be treated without lesion formation” without reciting sufficient structure to achieve the function.
14. Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 84-86 have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
15. In addition to the passages cited by Applicant in the Remarks [see 02/03/26 Amendment, pg. 10], a review of the specification shows that the following appears to be corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
The mamilla-like, smooth, and dome-shaped projection [see published Specification (U.S. 2023/0022232) at, e.g., ¶[0022] (“in the area of its distal end, the dome-shaped electrode body has a mamilla-like, also smooth and dome-shaped projection through which the mechanical separation process is sparingly supported when distally advancing the probe designed in accordance with the invention”); see also ¶[0054]; FIGS. 3a, b]; and
Surface finish/coating to increase sliding ability [see published Specification (U.S. 2023/0022232) at, e.g., ¶’s [0028], [0071]].
16. If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
17. If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
18. For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 112(a)
19. 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.
20. Claim 70 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
21. New dependent claim 70 recites the limitation:
70. The device according to claim 59, wherein:
the electrode body comprises a metal or a metal alloy formed as a monopolar electrode which is electrically connected to the at least one electrical line extending along the probe and comprises a bipolar electrode including two electrical lines extending along the probe.
Emphasis added.
As recited, the claim requires that the electrode body be formed as both a monopolar electrode which is electrically connected to the at least one electrical line, and a bipolar electrode including two electrical lines extending along the probe.
However, neither the as-filed Specification nor the priority applications describe the electrode body as comprising both a monopolar and a bipolar electrode. By contrast, the Specification describes the monopolar and bipolar electrode configurations as separate, alternative embodiments. For example, and with reference (citations) to the published application [U.S. 2023/0022232], the Specification recites:
[0019] The electrode body, which is preferably made of a metal or metal alloy, is either a monopolar electrode connected with one electrical line running along the probe, or a bipolar electrode connected with two electrical lines running along the probe.
¶[0019] of the published Specification, emphasis added.
Similarly, ¶[0050], in referencing FIGS. 2a & 2b, describes the embodiments as being separate, with the bipolar embodiment further requiring an electrically insulating intermediate layer (13) disposed between the two electrode body halves:
[0050] In FIG. 2a, a longitudinal section through a bipolar electrode body 2 is shown, which for the purpose of electrical contacting envisages two electrical contact sleeves 8 into which the ends of the electrical lines 3 enter and are firmly connected to the electrode body 2. Additionally, the electrode body 2 is separated by an electrically insulating intermediate layer 13 into two electrode body halves 2′, 2″ that are electrically insulated from each other. In contrast, FIG. 2b shows a monopolar electrode body 2 with just one electrical contact sleeve.
¶[0050] of the published Specification, emphasis added.
PNG
media_image1.png
224
414
media_image1.png
Greyscale
While it is appreciated that a word-for-word recitation of a claim limitation in the specification is not required to comply with the written description requirement [see, e.g., Ex parte Sorenson, 3 U.S.P.Q.2d 1462, 1463 (Bd. Pat. App. & Int’f 1987) (“[A]ppellant’s specification need not describe the claimed invention in ipsis verbis to comply with the written description requirement...”)], Examiner can find no language or description to support this limitation or, at the very least, to reasonably convey to one of ordinary skill in the art that the electrode body comprises a metal or a metal alloy formed as a monopolar electrode which is electrically connected to the at least one electrical line extending along the probe and comprises a bipolar electrode including two electrical lines extending along the probe. Moreover, the drawing figures also fail to convey support for this newly added limitation.
Accordingly, for the foregoing reasons, the as-filed Specification does not convey with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed in dependent claim 70.
Claim Rejections - 35 USC § 112(b)
22. 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.
23. Claims 69-71, 79, 80, 82, 83, 85, & 86 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
24. Claim 69 recites the limitation “the accessible electrode body” in line 2. There is insufficient antecedent basis for this recitation in the claim.
25. Claim 70 recites the limitation “the electrode body comprises a metal or a metal alloy formed as a monopolar electrode which is electrically connected to the at least one electrical line extending along the probe and comprises a bipolar electrode including two electrical lines extending along the probe” in lines 2-4. This recitation renders the claim indefinite, as it is not clear whether the recited “two electrical lines” are provided in addition to the “at least one electrical line,” or whether the “at least one electrical line” is intended to comprise one of the two electrical lines. As such, it is not clear how many electrical lines are required. For this reason, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
26. Claim 71 recites the limitation “a guide sleeve extending along the probe which is connected to a medical instrument in at least one of is parallel to the probe or is centered and slides within and along a working channel of a resectoscope” in lines 2-4. This claim is indefinite, at least in that it is grammatically unclear, creating ambiguity. For example, it is not clear whether the guide sleeve or the probe is connected to the medical instrument, whether the guide sleeve or the medical instrument is parallel to the probe, and whether the recited “medical instrument” is intended to comprise the “resectoscope,” or whether the “medical instrument” and “resectoscope” are intended to be alternative devices with which the probe may be used. For this reason, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
27. Claim 79 recites the limitation “the electrode body includes a shovel shape having a flattened electrode body surface.” This recitation renders the claim indefinite, as it is not clear whether the recited “flattened electrode body surface” is intended to be one of the “two opposed flattened body surfaces” previously recited in independent claim 59 (from which claim 79 depends), or a separate/additional flattened body surface. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
28. Claim 80 is rejected as ultimately depending from a claim (claim 79) rejected under 35 U.S.C. 112(b).
29. Claim 82 recites the limitation “at least one freely accessible electrode body” in lines 2-3, and “accessible electrode body” in line 5. These recitations render the claim indefinite, as it is not clear what is meant, or what structure is required, by the recitations of “freely accessible” and “accessible.” The terms “freely accessible” and “accessible” are not art-recognized terms, they are not defined by the claim, and the specification does not provide an explanation or guidance as to the metes and bounds of “freely accessible” and “accessible.” As such, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required. For purposes of examination, the terms “freely accessible” and “accessible” are being interpreted as “exposed.”
30. Claim 82 recites the limitations “the body is a shovel shape with a flattened electrode body surface, has a straight section on a proximal side, is convexly curved with an adjoining distally surface section” in lines 16 & 17. This recitation renders the claim indefinite, as it is not clear whether the recited “a flattened electrode body surface” is intended to comprise one of the “two flattened electrode body surfaces” previously recited in lines 14-15 of the claim, or whether the “a flattened electrode body surface” is provided in addition to the “two flattened electrode body surfaces.” As such, it is not clear how many electrode body surfaces are required. As such, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
31. Claim 82 further recites the limitation “an other flattened electrode body surface is convexly curved.” This recitation likewise renders the claim indefinite as it is not clear whether the recited “an other flattened electrode body surface” is intended to be one of the “two flattened electrode body surfaces” previously recited in lines 14-15 of the claim, or whether the “an other flattened electrode body surface” is provided in addition to the “two flattened electrode body surfaces” and/or the “a flattened electrode body surface” separately recited in line 16. Still further, it is not clear whether the recited “an other flattened electrode body surface,” which is “convexly curved,” is intended to be the “convexly curved” portion of the shovel shape previously recited in lines 16-17 of the claim. For each of the foregoing reasons, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
32. Claim 85 is rejected as ultimately depending from a claim (claim 82) rejected under 35 U.S.C. 112(b).
33. Claim 83 recites the limitation “at least one accessible electrode body” in lines 2-3. This recitation renders the claim indefinite, as it is not clear what is meant, or what structure is required, by the recitation of “accessible.” The term “accessible” is not an art-recognized term, it is not defined by the claim, and the specification does not provide an explanation or guidance as to the metes and bounds of “freely accessible.” As such, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required. For purposes of examination, the term “accessible” is being interpreted as “exposed.”
34. Claim 86 is rejected as ultimately depending from a claim (claim 83) rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
35. 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.
36. Claims 59-69, 71, 76, & 83 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 6,855,145 to Ciarrocca (“Ciarrocca”).
37. Regarding claim 59, Ciarrocca discloses a device for the enucleation of intracorporeal prostate tissue regions comprising:
a probe [probe (10) - col. 3, ll. 44-48] including a rigid hollow cannula [elongate shaft (18) - col. 3, ll. 44-48; col. 4, ll. 15-20] and a distal end including at least one electrode body [distal end (100) includes an active and return electrode portion (e.g., FIG. 4d) and is therefore considered an electrode body - col. 4, ll. 53-56; FIGS. 4a, 4b, 4d] to which electrical energy is applied by at least one electrical line which runs longitudinally along the probe [e.g., col. 2, ll. 54-57; col. 3, line 44 - col. 4, line 7; col. 5, ll. 55-63];
the at least one electrode body [(100)] comprises an electrode surface [inner concave face - col. 5, ll. 55-63; FIG. 4d] including cross-sectional surfaces orientated orthogonally to a longitudinal extension of the probe [cross-sectional surfaces of distal end (100) (which includes inner concave face) extend orthogonally to a longitudinal axis of the probe - FIGS. 4a, 4b, 4d], surface areas of the electrode [(100)] disposed along a first axial portion of the longitudinal extension containing a distal dome [first side portion (130) and second side portion (132) (FIG. 4d) extend along a first axial portion of distal end (100), which is dome-shaped - see FIG. 4d)] including surface areas of the distal dome continuously inceasing [increasing] in cross-sectional area as a distance from an end of the distal dome increases [see FIG. 4d where the cross-sectional area continually increases in the proximal direction; Ciarrocca describes this from the opposite perspective - see col. 5, ll. 2-4 (“the width decreases in the distal direction (tapers) so that the distal end has an overall substantially U-shaped configuration”)] and the surface areas include a peripheral edge which is smooth and has no edges or corners [see, e.g., col. 4, ll. 53-56 & ll. 65-67];
the at least one electrode body [(100)] is distally connected to the probe [col. 4, ll. 53-56; FIGS. 4a, 4b, 4d], the probe has a bending stiffness that does not change shape under an effect of an applied bending moment of at least 0.1 Nm applied traversely along a cross-sectional axis of a cross section of the electrode body [NOTE: Applicant’s Specification describes the dimensional stability of the probe for applied bending moments under 0.1 Nm (see Applicant’s published Specification (U.S. 2023/0022232, published Jan. 26, 2023) at ¶[0026]), and also describes that “dimensional stability” is ensured by the hollow cannula being made of a metallic material - see Applicant’s published Specification (U.S. 2023/0022232) at ¶[0025] (“In order to ensure dimensional stability, it is evident to produce the probe, in the form of a hollow cannula, of a metallic material, for example instrument steel, or a robust, rigid, preferably fiber-reinforced plastic with a suitably thickly selected hollow cannula wall thickness”); Ciarrocca, in a similar fashion, discloses that shaft (18) may be rigid, and formed of a metal such as, e.g., stainless steel alloys (col. 4, ll. 8-10); as such, it is the Examiner’s position that Ciarrocca satisfies this claim limitation because it discloses use of the same material and comprises the same structure as the claimed device, and would therefore be expected to perform in the same manner as the claimed device when a bending moment (under 0.1 Nm) is applied transversely along a cross-sectional axis of a cross section of the electrode body. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. MPEP § 2112.01]; and
the electrode body [(100)] comprises two opposed flattened body surfaces [the first side portion (130) and second side portion (132) are opposed from one another on the inner concave face - see col. 5, ll. 55-63 (“the inner concave face of the distal end of the probe includes a first side portion 130, a second side portion 132, and a middle portion 134 adjacent to the first and second side portions and separating them from one another. In this embodiment, the first side portion is the active electrode, the second side portion is the return electrode, and the middle portion electrically insulates the active and return electrodes from one another”); FIG. 4d] and has a spatula shape [Examiner considers Ciarrocca as disclosing a spatula shape given its resemblance to Applicant’s spatula shape; compare Applicant’s spatula shape shown in FIG. 8a with Ciarrocca’s shape in FIG. 4a].
38. Regarding claim 60, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein the peripheral edge of the cross-sectional surfaces of the at least one electrode body [(100)] are continually curved [col. 4, ll. 53-67].
39. Regarding claim 61, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein the distal dome along a first axial portion has a spatial shape corresponding to a spatial radiation intensity distribution of a laser beam with a Gaussian intensity distribution, a paraboloid or ellipsoid [broadly, the spatial shape of the distal dome corresponds (similar in form) to an ellipsoid - see FIGS. 4b, FIG. 4d].
40. Regarding claim 62, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein the peripheral edge of the cross-sectional surfaces of the at least one electrode body has only curved and straight peripheral edge sections [col. 4, ll. 61-67; FIGS. 4a, 4b, 4d].
41. Regarding claim 63, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses: a second axial portion of the electrode body [(100)] adjoins the first axial portion of the electrode body [with reference to FIG. 4a, the second axial portion of electrode body (100) comprises the portion of electrode body (100) that extends in the proximal direction from surface (104a) of the inner concave surface, and has a uniform diameter] and has cross-sectional surfaces along the second axial portion of the electrode body which are orientated orthogonally to the longitudinal extension of the electrode body [cross-sectional surfaces of the second axial portion are oriented (extend) orthogonally to the longitudinal axis of the electrode body (100)] and do not change as distance from the distal dome end increases [as noted above, the second axial portion is the portion of electrode body (100) that extends in the proximal direction from surface (104a) of the inner concave surface, and has a uniform diameter (FIG. 4a)].
42. Regarding claim 64, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein the first axial portion [of] the electrode body has longitudinal sections [e.g., first side portion (130), second side portion (132), and middle portion (134) are all longitudinally-arranged (see FIG. 4d) and therefore comprise “longitudinal sections”] orientated orthogonally to a cross-sectional surface including a continuous peripheral edge [the sections are orientated orthogonally to a cross-sectional surface of surface (104b) (see FIG. 4a) which include a continuous peripheral edge, i.e., the peripheral edge of surface (104b) (see FIGS. 4a, 4d)].
43. Regarding claim 65, Ciarrocca discloses all of the limitations of claim 64 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein the continuous peripheral edge is shaped as a circle, a parabola, a partial ellipse or a partial oval [as best seen in FIG. 4d, the continuous peripheral edge of surface (104d), which includes portions (130, 132, 134) is shaped as a partial ellipse].
44. Regarding claim 66, Ciarrocca discloses all of the limitations of claim 65 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein the probe transmits at least one of thrust and pressure forces along the longitudinal extension of the probe [similar to claim 59 above, it is the Examiner’s position that Ciarrocca satisfies this claim limitation because it comprises the same structure as the claimed device (i.e., Ciarrocca discloses all of the structural limitations of the claimed device for the reasons set forth above), and would therefore be expected to perform in the same manner as the claimed device, including transmitting at least one of thrust and pressure forces along the longitudinal extension of the probe].
45. Regarding claim 67, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein the rigid hollow cannula [(18)] comprises a metallic material [col. 4, ll. 15-20].
46. Regarding claim 68, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein dimensions of the probe do not change in an area of the electrode body distally connected to the probe when the probe has a bending moment applied of at least 0.3 Nm acting on the electrode body transversely to the longitudinal extension of the probe [NOTE: similar to claim 59 above, it is the Examiner’s position that the device of Ciarrocca satisfies this claim limitation because it comprises the same structure as the claimed device (i.e., Ciarrocca discloses all of the structural limitations of the claimed device for the reasons set forth above), and would therefore be expected to perform in the same manner as the claimed device including when a bending moment of 0.3 Nm is applied acting on the electrode body transversely to the longitudinal extension of the probe].
47. Regarding claim 69, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein an area of the accessible electrode body distally connected to the probe extends from an electrode tip of the distal dome of the probe a maximum of 30 mm [an area of electrode body (100) comprising outer convex face (102) and inner concave face (104) extends from the tip of the distal dome over a length (“l”) (shown in FIG. 4a) of 1-3 cm (10-30 mm) [see col. 5, ll. 1-9].
48. Regarding claim 71, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
As best understood [see rejection under § 112(b) above], Ciarrocca further discloses a guide sleeve extending along the probe which is connected to a medical instrument in at least one of is parallel to the probe [e.g., col. 3, ll. 37-43 - used with an endoscope] or is centered and slides within and along a working channel of a resectoscope.
49. Regarding claim 76, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further discloses wherein the two flattened surfaces include one of:
both opposed flattened electrode surfaces have at least one level surface area [Ciarrocca discloses that the two opposed flattened electrode body surfaces (the first side portion (130) and second side portion (132) in FIG. 4d) each have at least one level (flat) surface area - col. 4, ll. 53-67; FIGS. 4a, 4d];
the opposed flattened electrode surface having at least one convexly curved surface area and includes at least one convexly curved surface area and another of the flattened electrode body surfaces includes at least one concavely curved surface area; and
one of two opposed electrode surfaces includes at least one curved surface area and another of the electrode surfaces including at least one concave surface area.
50. Regarding claim 83, and as best understood [see rejection under § 112(b) above], Ciarrocca discloses a device for the enucleation of intracorporeal prostate tissue regions comprising:
a probe [probe (10) - col. 3, ll. 44-48] including a rigid hollow cannula [elongate shaft (18) - col. 3, ll. 44-48; col. 4, ll. 15-20] and a distal end with at least one accessible electrode body [the electrode body comprises first side portion (130) (the active electrode), second side portion (132) (the return electrode), and middle portion (134) positioned therebetween - col. 5, ll. 55-63; FIG. 4d] to which electrical energy is applied via at least one electrical line running longitudinally along the probe [e.g., col. 2, ll. 54-57; col. 3, line 44 - col. 4, line 7; col. 5, ll. 55-63];
the at least one accessible electrode body [(130), (132), (134)] comprises a dome-shaped electrode surface [portions (130, 132, 134) collectively define a dome-shaped surface - col. 5, ll. 55-63; FIG. 4d] with cross-sectional surfaces orientated orthogonally to a longitudinal extension of the probe [cross-sectional surfaces of portions (130, 132, 134) extend orthogonally to a longitudinal axis of the probe - FIGS. 4a, 4b, 4d] with surface areas along a first axial portion containing a distal dome end of the at least one accessible electrode body [portions (130, 132, 134) define a distal dome end - see FIG. 4d)] which continuously incease [increase] in cross-section as a distance from the distal dome end increases [see FIG. 4d where the cross-sectional area continually increases in the proximal direction; Ciarrocca describes this from the opposite perspective - see col. 5, ll. 2-4 (“the width decreases in the distal direction (tapers) so that the distal end has an overall substantially U-shaped configuration”)] and cross-sectional surfaces including a peripheral edge which is smooth and contains no edges or corners [see, e.g., col. 4, ll. 53-56 & ll. 65-67]; and
at least in an area of the accessible electrode body distally connected to the probe [col. 4, ll. 53-56; FIGS. 4a, 4b, 4d], the probe body has a bending stiffness, which under an effect of a bending moment of at least 0.1 Nm acting on the electrode body transversely to a longitudinal extension of the probe, does not change shape [NOTE: Applicant’s Specification describes the dimensional stability of the probe for applied bending moments under 0.1 Nm (see Applicant’s published Specification (U.S. 2023/0022232, published Jan. 26, 2023) at ¶[0026]), and also describes that “dimensional stability” is ensured by the hollow cannula being made of a metallic material - see Applicant’s published Specification (U.S. 2023/0022232) at ¶[0025] (“In order to ensure dimensional stability, it is evident to produce the probe, in the form of a hollow cannula, of a metallic material, for example instrument steel, or a robust, rigid, preferably fiber-reinforced plastic with a suitably thickly selected hollow cannula wall thickness”); Ciarrocca, in a similar fashion, discloses that shaft (18) may be rigid, and formed of a metal such as, e.g., stainless steel alloys (col. 4, ll. 8-10); as such, it is the Examiner’s position that Ciarrocca satisfies this claim limitation because it discloses use of the same material and comprises the same structure as the claimed device, and would therefore be expected to perform in the same manner as the claimed device when a bending moment (under 0.1 Nm) is applied transversely along a cross-sectional axis of a cross section of the electrode body. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. MPEP § 2112.01],
wherein distally from the rigid hollow cannula [shaft (18)], a spatula or shovel-shaped molded body is applied [distal end (100) - col. 4, ll. 53-56] on which distally the electrode body is mounted [first side portion (130) (the active electrode), second side portion (132) (the return electrode), and middle portion (134) are mounted on distal end (100) - see col. 5, ll. 10-13; col. 5, ll. 55-63; FIG. 4d; NOTE: Examiner considers distal end (100) of Ciarrocca as disclosing a spatula shape given its resemblance to Applicant’s spatula shape; compare Applicant’s spatula shape shown in FIG. 8a with Ciarrocca’s shape in FIG. 4a];
the molded body [(100)] comprises two parallel flattened body surfaces [the surfaces on which first side portion (130) and second side portion (132) are respectively mounted - col. 5, ll. 10-13; col. 5, ll. 55-63; FIG. 4d], and either the body [(100)] comprises an electrically insulating material [plastic] on which distally the accessible electrode body is mounted [col. 5, ll.10-28], or the body is made of an electrically conductive material on which distally the accessible electrode body is mounted by an electrical insulator.
Claim Rejections - 35 USC § 103
51. 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.
52. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
53. Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Ciarrocca.
54. Regarding claim 81, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca explicitly contemplates variability in the geometric configuration of the electrode tip (100) [see col. 4, ll. 56-67 (“Although the inner and outer faces are described as convex and concave, it is to be understood that these terms are meant to describe the overall configuration of the faces and are not to be limited to any particular geometric configuration. For example, in the illustrated embodiment, the outer convex face is defined by a substantially continuous curved surface, whereas the inner concave surface is defined by two substantially flat surfaces 104a, 104b that intersect to form the concave surface. Multiple intersecting curved and/or flat surfaces may be used to define the overall concave and convex faces described herein”)].
Ciarrocca does not, however, disclose:
wherein the electrode body has outer surfaces shaped in a figure eight.
However, given Ciarrocca’s express teaching (noted above) that multiple intersecting curved and/or flat surfaces may be used to define the overall concave and convex faces, it is the Examiner’s position that it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the claimed invention, to contour the outer surfaces of the electrode body in any number of ways, including, e.g., wherein one or more surfaces resemble an outer contour of a figure eight, since such a modification amounts merely to a change in shape, which has long been held to be an example of a common practice that normally requires only ordinary skill in the art, and is hence considered a routine expedient. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
55. Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Ciarrocca in view of U.S. Patent No. 6,494,881 to Bales et al. ("Bales").
56. Regarding claim 72, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca does not, however, disclose:
an electrode surface of the electrode body is polished or honed.
Bales, in a similar field of endeavor, teaches that it was known to polish an electrode surface to prevent debris from sticking thereto [see col. 10, ll. 26-28].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ciarrocca such that an electrode surface of the electrode body is polished, since such a modification would provide the benefit/advantage of preventing debris from sticking to the electrode during a procedure, as explicitly taught by Bales.
57. Claims 73-75 are rejected under 35 U.S.C. 103 as being unpatentable over Ciarrocca in view of GB 2308979A to Goble et al. (“Goble”).
58. Regarding claim 73, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca does not, however, disclose:
wherein the electrode body [(100)] is connected to the probe by a biocompatible, electrically insulating joint.
Goble, in a similar field of endeavor, teaches an electrosurgical instrument for treating tissue with RF energy [Abstract]. More particularly, Goble teaches a probe [electrode unit (E1) - pg. 9, ll. 25-26; FIG. 1] including a rigid hollow cannula [shaft (10) - pg. 9, ll. 28-31; FIG. 1] and a distal end with an electrode body [active electrode (14)] to which electrical energy is applied via at least one electrical line [(14b, 14c) - pg. 10, ll. 10-16; FIG. 1] running longitudinally along the probe [FIG. 1]. Goble teaches that the electrode body [(14)] comprises a dome-shaped active tip (14a) [pg. 6, ll. 13-14, 25-26; FIG. 1] with cross-sectional surfaces orientated orthogonally to a longitudinal axis of the probe [(E1)], with surface areas which continuously increase in cross-section as a distance from the distal dome end increases [FIG. 1].
Goble further teaches that the electrode body [(14)] is connected to the probe by a biocompatible, electrically insulating joint [insulation sleeve (16) - pg. 10, ll. 16-22; pg. 22, ll. 24-31; FIG. 1].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ciarrocca such that the electrode body [(100)] is connected to the probe by a biocompatible, electrically insulating joint, as taught by Goble, since such a modification would provide the benefit/advantage of helping to prevent unintended electrical shorts that may arise given the proximity of the electrode surfaces (130, 132) in Ciarroca to the elongate metal shaft (18) to which the electrode body is connected. Still further, such a particular, known technique for connecting an electrode body to a distal end of a probe shaft was clearly recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Goble), and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Ciarrocca, and the results (connecting an electrode body to the distal end of a probe shaft) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
59. Regarding claim 74, the combination of Ciarrocca and Goble teaches all of the limitations of claim 73 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further teaches wherein at least one of an electrode surface of the electrode body, a joint on the probe and the probe is coated with a friction reducing coating [Ciarrocca further teaches that the probe is coated with a friction reducing coating - e.g., polytetrafluoroethylene (PTFE) - col. 4, ll. 20-29].
60. Regarding claim 75, the combination of Ciarrocca and Goble teaches all of the limitations of claim 74 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca further teaches wherein the coating comprises one of PTFE, TPU, polysiloxane or hydrogel [Ciarrocca further teaches that the coating is polytetrafluoroethylene (PTFE) - col. 4, ll. 20-29].
61. Claims 77 & 78 are rejected under 35 U.S.C. 103 as being unpatentable over Ciarrocca in view of U.S. Patent Application Publication No. 2009/0254078 to Just et al. ("Just").
62. Regarding claim 77, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
While Ciarrocca teaches some variability in the geometric configuration of the electrode tip (100) [see col. 4, ll. 53-67], Ciarrocca does not disclose:
wherein the electrode body includes an oval-shaped cross-section which is symmetrical to a longitudinal axis of the oval cross-section.
Just, in a similar field of endeavor, teaches various embodiments of electrodes and/or electrode tips [Abstract]. Just further teaches that it was known to provide an electrode tip having a non-circular cross-section, such as an oval cross-section [see ¶[0079]; FIGS. 4-6]. Just teaches that a benefit of such a geometry is that it can help a user orient the electrode tip relative to a target tissue since such a geometry is more stable and resistant to a "rolling" movement - which can help provide some mechanical or physical feedback (e.g., resistance to twisting or rotation) to the user with respect to the positioning of the operative portion of the electrode tip relative to a surface [¶[0079]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ciarrocca such that the electrode body includes an oval-shaped cross-section which is symmetrical to a longitudinal axis of the oval cross-section (i.e., centered along a longitudinal axis of the oval cross-section), since such a modification would provide the benefit/advantage of assisting a user in positioning the tip of the electrode body in a desired position (relative to a target tissue surface) via mechanical or physical feedback in the form of a resistance to twisting or rotation that is afforded by the oval-shaped geometry, as explicitly taught by Just.
63. Regarding claim 78, the combination of Ciarrocca and Just teaches all of the limitations of claim 77 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca was modified above (in the rejection of claim 77) such that the electrode body includes an oval-shaped cross-section. As modified, Ciarrocca further teaches that the oval-shaped cross-section of the electrode body is not symmetrical relative to an axis orthogonal to a longitudinal axis of the oval-shaped cross-section [this limitation is satisfied because the electrode (body) still maintains its curved configuration (shown in FIG. 4a), despite the cross section being “stretched” (or extended) into an oval-shaped cross-section].
64. Claims 84 & 86 are rejected under 35 U.S.C. 103 as being unpatentable over Ciarrocca in view of U.S. Patent Application Publication No. 2003/0097130 to Muller et al. ("Muller").
65. Regarding claim 84, Ciarrocca discloses all of the limitations of claim 59 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca does not explicitly teach:
wherein the distal dome comprises means for undoing or separating tissue layers to be treated without lesion formation.
Muller, in a similar field of endeavor, relates to an electrode arrangement for electrothermal treatment of the human or animal body, and in particular to electrocoagulation [¶[0002]]. Muller teaches that it was known in the art to coat electrodes with biocompatible materials that are easily slidable into body tissue [e.g., ¶’s [0050]-[0051] (slip or anti-friction coating)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ciarrocca such that the distal dome include a slip or anti-friction coating, as taught by Muller, since such a modification would provide the benefit/advantage of facilitating insertion of the probe into tissue before energy is applied (i.e., without lesion formation).
66. Regarding claim 86, Ciarrocca discloses all of the limitations of claim 83 for the reasons set forth in detail (above) in the Office Action.
Ciarrocca does not explicitly teach:
wherein the distal dome comprises means for undoing or separating tissue layers to be treated without lesion formation.
Muller, in a similar field of endeavor, relates to an electrode arrangement for electrothermal treatment of the human or animal body, and in particular to electrocoagulation [¶[0002]]. Muller teaches that it was known in the art to coat electrodes with biocompatible materials that are easily slidable into body tissue [e.g., ¶’s [0050]-[0051] (slip or anti-friction coating)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ciarrocca such that the distal dome include a slip or anti-friction coating, as taught by Muller, since such a modification would provide the benefit/advantage of facilitating insertion of the probe into tissue before energy is applied (i.e., without lesion formation).
Allowable Subject Matter
67. Dependent Claims 79 & 80
68. Dependent claim 79 would be allowable if rewritten to overcome the claim objection(s) and the rejection(s) under 35 U.S.C. § 112(b), set forth in detail above, and to include all of the limitations of the base claim and any intervening claims.
In addition to the limitations of independent claim 59, dependent claim 79 further requires the limitations of “the electrode body includes a shovel shape having a flattened electrode body surface, which on a proximal side of the shovel shape includes a straight surface section which is joined distally to a convexly curved surface section; and the flattened electrode body surface is convexly curved and distally has a bulbous and rounded thickening.”
Neither Ciarrocca (the closest prior art of record), nor the other references of record, either alone or in combination, fairly teach or suggest the claimed configuration, particularly the electrode body surface requiring the distal bulbous and rounded thickening. For this reason, claim 79 would be allowable over the references of record.
69. Dependent claim 80 depends from dependent claim 79, and would therefore be allowable by virtue of its dependence from claim 79.
70. Independent Claim 82 (& Dependent Claim 85)
71 Independent claim 82 would be allowable if rewritten or amended to overcome the claim objection(s) and the rejection(s) under 35 U.S.C. § 112(b) set forth in this Office action.
Independent claim 82 is directed to a device for the enucleation of intracorporeal prostate tissue regions, and requires, inter alia, a probe including a rigid hollow cannula and a distal end with an electrode body to which electrical energy is applied.
In addition to the limitations concerning the cross-sectional surfaces of the dome-shaped electrode surface (not reproduced here), claim 82 additionally requires that the electrode body comprise two flattened electrode body surfaces and have an adjoining bulbous or rounded thickening having a diameter which is larger than the distance between the two flattened electrode body surfaces. Neither Ciarrocca (the closest prior art of record), nor the other references of record, either alone or in combination, fairly teach or suggest this limitation. For this reason, claim 82 would be allowable over the references of record.
72. Dependent claim 85 depends from independent claim 82, and would therefore be allowable by virtue of its dependence from claim 82.
Response to Arguments
73. As noted above, the cancellation of claims 30-58 has rendered moot the claim objections and the rejections under §§ 112(b), 102 & 103 previously set forth in the 08/05/25 Action.
74. New claim objections, and new rejections under §§ 112(a), 112(b) & 103 are set forth herein addressing newly added claims 59-86, necessitated by Applicant’s Amendment.
Conclusion
75. 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 extension fee 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 date of this final action.
76. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bradford C. Blaise/Examiner, Art Unit 3794