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 without traverse of Group II, Claims 12-20, in the reply filed on 11/17/2025 is acknowledged.
Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/25.
Drawings
The drawings are objected to because: in Fig. 1, “thru air” should be corrected to “through air”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 12-20 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) In Claim 12, the combination of the passive “to be emitted from a fiber optic cable in a liquid environment” and “to cause a gaseous pathway” makes it unclear as to whether the claim requires actually causing the pathway in a liquid environment or not. The scope of the claim is unclear as to whether it requires any emission of the laser energy, let alone emission in the liquid environment. This further makes the passive “form vapor bubbles” and “is formed” of Claim 13 unclear. If the scope of claim 12 does not require the actual emission of laser, then what does “form vapor bubbles” refer to? Thus, the scope of Claims 12 and 13 are unclear as the passive claiming of “to be emitted”, “to cause a gaseous pathway”, “pulses form”, “pathway is formed” are unclear as to whether they refer to steps, intended results, intended uses, intended fields of use, or otherwise optional limitations. A person having ordinary skill in the art would have to make speculative assumptions concerning the metes and bounds of the claim, and the delineation between active steps required by the method and intended results thereof. An undisputable method claim has clauses that are designated by a present participle and separated with a comma (or a semicolon that includes a comma). See Credle v. Bond, 25 F.3d 1566, 1572 (Fed. Cir. 1994). Also see Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986), requiring active positive steps for a method to be definite.
The claims are interpreted under the broadest reasonable interpretation, wherein the foregoing passive limitations are drawn to intended fields of use or results.
2) In Claim 12, “within a threshold of a specified distance” is incomplete and indefinite, because a distance requires a frame of reference in order to be complete. The claims do not require any point of reference to define the distance. Thus, any type of threshold of a distance without a frame of reference, makes the metes and bounds of the claims unclear and is indefinite. Note that this rejection does not carry over and apply to Claim 16, as the dependent claim requires “receiving an indication of a distance between an end of the fiber optic cable and a target, wherein the distance is the specified distance”, thus providing a frame of reference for the distance and the step by which it is specified.
3) Regarding Claim 15, the terms “lower level” are relative and subjective. Lower compared to what?
4) Claim 20 is a method claim that depends on product Claim 4, and does so referencing “The method of claim 4”. There is no method in Claim 4, thus this reference lacks clear antecedence, and it is also unclear as to which method claim, Claim 20 depends on. For examination purposes, it is taken to depend on Claim 12, under the broadest reasonable interpretation.
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 12-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0298449 by Khachaturov, and incorporated therein US 2019/0183573 by Waisman (parent of and incorporated by reference in ¶¶ 1,8,10,15,16 of Kachaturov).
Regarding Claim 12, Khachaturov teaches a method (¶3), comprising:
generating, at a laser source, a plurality of pulses of laser energy (e.g. abstract, ¶¶ 17, 40-45: laser pulses), the plurality of pulses of laser energy to be emitted from a fiber optic cable disposed in a liquid environment (e.g. abstract, ¶¶ 2-3, 36-37: optical fiber with fiber tip 204 is within a liquid medium within a body lumen; Furthermore, even though Kachaturov explicitly teaches the claimed step, as shown above, this limitation is taken as an intended field of use that does not clearly require the fiber optic cable or it being in a liquid environment, and Kachaturov’s teachings are clearly applicable in a field of use of fiber optic cable in a liquid environment); and
modulating the instantaneous power of the plurality of pulses of laser energy (e.g. ¶¶ 19-20, 22, 24, 26, 35-45: modulating laser parameters, including energy and pulse width, thus modulating instantaneous power, ie. power at some point in time of any or any combination of the pulses or sub-pulses; Note that the timing of the laser pulses and the number of pulses also meets modulating instantaneous pulse power, see e.g. ¶¶ 15, 39-40, 46; More details on the modulation of power are offered in Waisman, e.g. ¶¶ 38-39, 66-74, Fig. 5-7: power control of bubble formation; It should also be noted here that the step of power modulation would include the modulation of power as the pulses of laser energy travel through the liquid medium, where they are absorbed, thereby changing their power, see e.g. Waisman ¶47 and Fig. 1C) to cause a gaseous pathway in the liquid environment to collapse within a threshold of a specified distance [e.g. ¶¶ 21, 34-46 and Fig. 2: the bubbles are shifted forward at a distance away from the fiber tip, in order to collapse away from the tip and prevent backburn, and also before the target in order to treat the target with a shockwave from the cavitation. Regardless of where the bubble collapses in that space, it will be within a hypothetical threshold, which includes a zero threshold, a threshold greater than zero (see Claim 20) and any other threshold under the broadest reasonable interpretation (need not be a ratio of the distance or smaller than the distance), of a distance from any hypothetical point of reference, including points in the bubble, the threshold being capable of being specified. One example would be the distance being definable from the center of the bubble, and as Kachaturov notes in ¶ 37, the bubble collapses towards its center (and away from the tip) and thus within a threshold of a distance from the center of the bubble, that distance being zero within a margin of error thershold. In the same example, the distance is also definable with respect to the tip of the fiber and/or the target, and thereafter specified based on observation of the bubble collapsing away from the tip (¶ 37) or capable of being specified at any time based on bubble dynamics (¶39). More generally, shifting the bubble away from the tip to “a distance in front of the fiber” (¶35) so that it does not collapse on the tip and does not cause burnback of the tip nor degradation due to shockwaves caused by cavitation (e.g. ¶37-38) and so that the position of the bubble is “distanced from the …fiber tip …and closer to the target tissue” (¶ 36) is sufficient to meet “within a threshold of a specified distance” as claimed. The claim does not require, inter alia: a) the frame of reference of the distance, b) limits to the threshold, c) any type of laser setting to specify the distance, and d) the timing and manner of the distance being specified; Furthermore, even though Kachaturov explicitly teaches these limitations under the broadest reasonable interpretation, as shown above, this limitation is taken as an intended result of the step of modulating. The fiber is not clearly required by the claim. The fiber is not clearly required to be in a liquid environment by the claim. The claim does not even clearly require emitting the laser anywhere. 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)].
Regarding Claim 13, Kachaturov teaches the method of claim 12, wherein the plurality of laser pulses form vapor bubbles in the liquid medium and wherein the gaseous pathway is formed by the vapor bubbles (e.g. ¶10, 57: bubbles form a pathway).
Regarding Claim 14, Kachaturov teaches the method of claim 13, wherein the instantaneous power is modulated with an opposite phase to the growth of the vapor bubbles (e.g. Waisman, ¶¶ 47-51, Fig. 1C: pulse power is reduced as the bubble grows).
Regarding Claim 15, Kachaturov teaches the method of claim 14, wherein the instantaneous power is modulated to a lower level at a time estimated for the vapor bubble to reach a maximal size (e.g. Waisman, ¶¶ 47-51, Fig. 1C: pulse power is reduced as the bubble grows, being the lowest as the bubble is at a maximal size).
Regarding Claim 16, Kachaturov teaches the method of claim 12, comprising: receiving an indication of a distance between an end of the fiber optic cable and a target, wherein the distance is the specified distance (¶20-21, 40: the distance is measured); and modulating the instantaneous power of the plurality of pulses of laser energy based on the distance, the initial power of the plurality of pulses of laser energy, and an absorption coefficient of the liquid at a wavelength of the laser source (Kachaturov ¶20-21, 40; Waisman ¶ 44-47,53-54, Fig. 1C: distance of fiber tip to target, initial pulse energy, repetition rate, and the absorption in the liquid medium are the basis of power modulation).
Regarding Claim 17, Kachaturov teaches the method of claim 12, comprising: receiving an indication of an updated distance between the end of the fiber optic cable and the target; and modulating the instantaneous power of the plurality of pulses of laser energy to cause the gaseous pathway in the liquid environment to collapse within the threshold of the updated distance (Kachaturov ¶ 21-22, 40: closed loop; Waisman, ¶¶58: the distance between the tip and the target is used in the closed feedback loop to control the power of the pulses).
Regarding Claim 20, Kachaturov teaches the method of claim 12, wherein the threshold is greater than or equal to 0 (as discussed in Claim 12, the threshold can be zero or greater than zero).
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kachaturov and incorporated therein Waisman, as applied to Claim 12.
Regarding Claim 19, Kachaturov teaches the method of claim 12, yet it does not explicitly disclose wherein the threshold is less than or equal to the specified distance times 0.3.
However, Kachaturov teaches that the bubble collapses closer to the target than the fiber tip (¶36), thus teaching a working range of less than or equal to 0.5 of the distance between the fiber tip and the target, which is measured (¶21,40). Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to perform a method according to the teachings of Kachaturov so that a bubble collapses within the working range of less than or equal to 0.3 of the distance between the tip and the target and closer to the target, as: a) according to MPEP 2144.05, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) and a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties (MPEP 2144.05). Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985), and b) this would only amount to a matter of routine optimization within the working ranges to predictably treat the target tissue and protect the fiber with the cavitation shockwave closer to the target than the fiber.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 17/535,182 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 6 of the copending application anticipates Claim 12:
Regarding Claim 12, Claim 6 of the copending application teaches a method (MPEP 2112.02: product anticipate methods if the device carries out the process during normal operation), comprising:
generating, at a laser source (Claim 1: fiber laser), a plurality of pulses of laser energy, the plurality of pulses of laser energy to be emitted from a fiber optic cable disposed in a liquid environment (Claim 1: controller initiates a pulse energy for the fiber laser); and
modulating the instantaneous power of the plurality of pulses of laser energy to cause a gaseous pathway in the liquid environment to collapse within a threshold of a specified distance (Claim 1: distance between tip and target is used to control pulse power; Claim 6: time of bubble collapse controls pulse frequency, and thus power).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Kachaturov and incorporated by reference therein Waisman fail to teach determining whether an absolute difference between the distance and the updated distance is greater than or equal to a second threshold; and terminating generation of the plurality of pulses of laser energy based on a determination that the absolute difference is greater than or equal to the second threshold, in addition to the limitations of Claim 12 and intervening Claim 17, and provided all other issues are resolved.
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