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 .
Election/Restrictions
Applicant's election with traverse of Group II, Species 1.I and 2.C, claims 27-33, in the reply filed on 4/24/26 is acknowledged. The traversal is on the ground(s) that “As both the method and the device are able to produce an emission cone having an optical radiation that is maximal on an outer volume and optical radiation that is minimal in an inner volume, it is believed that the device as claimed is not used to practice another and materially different method”. This is not found persuasive because the device does not require that it is used in a method to thermo-ablate a cancerous lesion in a tissue of a patient, and having an intended result of generating a laser thermal ablation lesion of the tissue having a sphericity ratio higher than 0.7. As noted in the restriction requirement, “the product can be used for entirely diagnostic purposes (e.g. spectrometry, OCT etc.), or medical procedures that do not involve thermo-ablation of a cancerous lesion (e.g. coagulation of a wound, lithotripsy, Low Level Light Therapy etc.). In addition, the product could be used in non-medical processes, such as curing adhesives, welding, etching, or cutting, in manufacturing processes.” Just because a cone of light is produced in both with some common characteristics, it does not limit the product to require use of the product in the method of Claim 27, and it does not preclude the product from use in a myriad other methods.
Claims 1-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected product, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/24/26.
Applicant did not traverse the species requirement with any argument. Because applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In addition, the elected species of Fig. 31-33 are drawn to combining an axicon with a single-core fiber, in contrast to the embodiments of Fig. 29 and 30 (see ¶¶ 122, 126). Thus, Claim 31 is drawn to a non-elected species. Claims 2 (tapered end), 9 (as admitted by Applicant in their reply), 11-14 (multiple sources), 15 (as admitted by Applicant in their reply), 16 (lateral diffusion), 17-20 (as admitted by Applicant), 24-26 (multicore fiber).
Thus, Claims 2, 9, 11-15, 17-20, and 24-26, 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse on the basis of species election, in the reply filed on 4/24/26.
Elected claims 27-30, and 32-33 are examined below.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The abstract of the disclosure is objected to because: the numerals and parentheses should be omitted. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Priority
The instant application is a Continuation-In-Part (CIP) of prior Application No. 15/734833. ¶¶ 100-126, and Fig. 29-33 are part of the added subject matter, that is not disclosed in the parent cases. Claims 32-33 are drawn to this new subject matter, and do not find support in the parent cases. Neither the single core fiber nor the axicon are supported in the parent case. Thus Claims 32-33 have a different effective filling date (7/31/24) from claims 27-31, which are supported in the parent case.
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 27-30, and 32-33 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.
1) Regarding Claim 27, it is unclear what “higher than greater than 0.7” is meant to convey. The terms appear to be incomplete, as another part of the range appears to be missing. Greater than 0.7 and higher than what? Or does that mean much higher than anything greater than 0.7, and how much?
2) Regarding Claim 27, it is not clear whether the “a laser thermal ablation lesion of the tissue” in the last step, is related to the “laser thermo-ablation” of the preamble, the “a cancerous lesion” of the preamble”, the “at least one laser source” of line 3, the emitted “optical beam” from the output end of lines 5-6. Is the laser ablation lesion generated by the laser source and optical beam claimed or is this a separate treatment? Is the optical beam claimed applied to tissue? Is the ablation lesion of the tissue related to the treatment of the cancerous lesion or is it a separate treatment?
In addition, while the last limitation of “generating a laser thermal ablation lesion of the tissue having a sphericity ratio higher than greater than 0.7” is an intended result of some step or steps, it is not clear which step or steps results in said intended result. There is no clear link between the last clause and any of the claimed steps. Applicant is reminded that method steps require positively recited actions taken by the inventive entity, and any intended results (e.g. effects of the steps on tissue) must flow from and be linked to the positively recited steps of the claim, else the claims are incomplete for failing to recite essential aspects of the invention. Which steps cause the generation of the effect of the lesion as claimed?
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 27-30 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 93/14430 by Saadatmanesh.
According to MPEP 2112.02, a prior art device anticipates a claimed process if the device carries out the process during normal operation. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). Furthermore, where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). So long as the positively recited active steps of the method are met, then any intended results must also be met, else the claims are incomplete for failing to recite essential aspects of the claimed invention.
Regarding Claim 27, Saadatmanesh teaches a method for treating by laser thermo-ablation a cancerous lesion in a tissue of a patient (e.g. abstract, 6:6-8; 12:11-19: laser ablation of cancerous tissue), the method comprising the following steps:
generating an optical beam with a laser source (e.g. 1:6-14, 12:28—13:12: laser sources);
injecting the optical beam into an entrance end of an optical fiber (e.g. abstract, 1:6-14, Fig. 1, Fig. 5: the beam in injected into fiber 20/200);
propagating the optical beam along the optical fiber and emitting the optical beam from an output end of the optical fiber according to an emission cone, wherein an intensity of exiting optical radiation is maximal on an outer volume of the emission cone and is minimal in an inner volume of the emission cone (e.g. abstract, Fig. 1, Fig. 3-5: the beam is emitted in a hollow cone pattern, wherein the inner portion of the cone has the minimum intensity and the outer volume has the maximum intensity); and
thus, the intended result of generating a laser thermal ablation lesion of the tissue having a sphericity ratio higher than greater than 0.7 must naturally flow from the aforementioned steps, else the claims are incomplete for failing to recite the steps essential to produce the claimed intended result (also note, that Saadatmanesh explicitly discloses circular patterns, see Fig. 3-4, whose sphericity as measured on the plane of incidence, which is not precluded by the claim, would be 1, and certainly above 0.7 or 0.8 or 0.85, as well as combinations of the axial movement Fig. 3 and the angular movements of Fig. 4 to produce spherical volumes with a sphericity of 1). Also see, e.g. 3:4-27,4:9-28,6:1-21,8:10—9:25,10:31-35,17:10-34,19:14-22,20:11—21:2,22:3-23, 26:30-31,29:1-21.
Regarding Claim 28, Saadatmanesh teaches the method of Claim 27, wherein the laser thermal ablation lesion has a sphericity ratio equal to or greater than 0.8 (also note, that Saadatmanesh explicitly discloses circular patterns, see Fig. 3-4, whose sphericity as measured on the plane of incidence would be 1, and certainly above 0.7 or 0.8 or 0.85).
Regarding Claim 29, Saadatmanesh teaches the method of Claim 27, wherein the laser thermal ablation lesion has a sphericity ratio equal to or greater than 0.85 (also note, that Saadatmanesh explicitly discloses circular patterns, see Fig. 3-4, whose sphericity as measured on the plane of incidence would be 1, and certainly above 0.7 or 0.8 or 0.85).
Regarding Claim 30, Saadatmanesh teaches the method of Claim 27, further comprising the following steps: injecting the optical beam into the optical fiber with such an inclination as to reduce the fundamental transmission mode along the optical fiber, and to promote the transmission according to at least one higher-order transmission mode, so that the optical radiation at the output end of the optical fiber has a cone-shaped distribution wherein the intensity is maximal in the peripheral volume of an emission cone and is minimal inside the emission cone (Noting that “such an inclination” includes zero inclination, both the embodiment of Fig. 1, with the inclined injection, and the embodiment of Fig. 5, with zero inclination, meet the claimed limitations, both resulting in the hollow cone emission).
Regarding Claim 32, Saadatmanesh teaches the method of claim 27, wherein the optical fiber is a single-core optical fiber (9:15-16, 13:23-29, Fig. 2: single core fiber).
Allowable Subject Matter
Claim 33 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Saadatmanesh does not teach Claim 33, as a whole.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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