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 .
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 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 21 of U.S. Patent No. 11,648,057. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 9; 18/133457
Claim 1 & 21; 11,648057
A catheter system…comprising:
A catheter system…comprising:
a light source…a balloon…the balloon interior receiving a balloon fluid;
a light source…a balloon…the balloon interior receiving a balloon fluid;
a light guide that is configured to receive the first light energy…the first light energy inducing generation of a plasma within the balloon interior;
a light guide that is configured to receive the first light energy…the first light energy inducing generation of a plasma within the balloon interior;
an optical analyzer assembly that is configured to optically analyze a second light energy…including a safety shutdown system that is selectively activated.
an optical analyzer assembly that is configured to optically analyze a second light energy…including a safety shutdown system that is selectively activated.
…wherein a pulse of the first light energy being directed through the light guide…produces a plasma flash captured by the optical analyzer assembly via the second light energy…that indicates an operational condition of the catheter system…
(claim 21)…the optical analyzer being configured to optically analyze the second light energy to detect at least two of (i)-(vi).
Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 9 of the present invention does not define a structurally different catheter system. It merely recites the intended operation and capabilities of the same system already claimed by U.S. Pat. 11,648,057. It would have been obvious to one of ordinary skill in the art to utilize the analyzer of U.S. Pat 11,648,057 to detect operational conditions, as this is the fundamental purpose of such a component. Therefore, the claimed system is not patentably distinct.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-12, 14-18 & 20-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultheis (US 2021/0128241) in view of Melsky et al. (US 2011/0082452) and Umstadter (US 2006/0293644).
Schultheis discloses;
A method for treating a treatment site within or adjacent to a vessel wall or a heart valve with a catheter system (Abstract; Fig. 1)
generating first light energy with a light source (104) (e.g., laser/light source generating light energy delivered to a catheter system, [0036]);
positioning a balloon…the balloon having a balloon wall…receiving a balloon fluid (e.g., via the disclosed balloon catheter positioned at a treatment site, including a balloon defining an interior configured to receive fluid-see balloon structures and fluid-filled balloon description.
receiving the first light energy at a guide proximal end of a light guide (e.g., delivery of light energy from the source into a light guide/fiber entering the catheter assembly [0036]).
guiding the first light energy…toward a distal end…positioned within the balloon interior (e.g., discloses guiding light through optical fibers to a distal region within the catheter/balloon structure [0036]-[0040]; Fig 1).
Schultheis further discloses delivery of high-intensity laser energy capable of producing ionizing radiation at a target region [0037]. However, Schultheis does not explicitly disclose that the first light energy induces plasma within the balloon interior or that a second light energy generated using the first light energy is optically analyzed.
Umstadter teaches that when high-intensity laser light interacts with matter, the interaction produces plasma and associated electromagnetic radiation. In particular, such laser-plasma interactions inherently generate electromagnetic emissions resulting from the incident laser energy ([0043], [0058]) . Accordingly, Umstadter teaches that radiation (including optical radiation) is generated using the incident laser energy, thereby corresponding to the claimed ‘second light energy…generated using the first light energy.’
It would have been obvious to one of ordinary skill in the art to recognize that the high-intensity laser energy delivered by the catheter system of Schultheis would induce plasma at the treatment site, as taught by Umstadter, and that such plasma would emit radiation generated from the first light energy.
Melsky teaches an optical analysis system configured to detect and analyze optical signals transmitted through an optical path, including signals returning from a distal region of a device and to control system operation based on the detected signals. Thus, Melsky teaches:
optically analyzing a second light energy, and
using such analysis for system monitoring and control, including feedback mechanisms.
Further, optical systems inherently allow propagation of light in both forward and reverse directions within a light guide, thereby corresponding to the claimed feature of the second light energy moving in a direction opposite the first direction. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the catheter system of Schultheis to include optical analysis of radiation generated during laser treatment, as taught by Melsky, and to recognize that such radiation is generated as a result of laser-induced plasma interactions, as taught by Umstadter.
The motivation for such combination is to provide real-time monitoring of treatment conditions and improved operational safety, since analysis of emitted radiation from laser-material interactions provides information regarding the state of the treatment site. The combination represents the predictable use of known elements according to their established functions. Melsky further teaches controlling system operation based on detected optical signals. It would have been obvious to incorporate a safety shutdown system that inhibits delivery of light energy in response to detected conditions, as this is a known and predictable safety feature in optical systems.
Claim Objections
Claims 13 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provides a reason(s) as to why the argument are not persuasive:
In respect to the double patenting rejection, the applicant request reconsideration in view of the amendment of claim 9.
Applicant requests reconsideration of the nonstatutory double patenting rejection. This request is not persuasive.
The amendment of claim 9 recites, in part:
“a second light energy…generated using the first light energy…”
However, this limitation does not render claim 9 patentably distinct from the claims of the reference patent.
Claim 1 and 21 of U.S. Patent No 11,648,057 disclose a catheter system including:
a light source,
a light guide configured to deliver light energy,
generation of plasma at treatment site, and
an optical analyzer configured to analyze light signals and control system operation.
The claimed “second light energy…generated using the first light energy” merely describes the inherent or intended operation of the system when high-energy light interacts with matter to produce plasma and associated emissions.
Such functionality does not impart a structural distinction over the catheter system recited in the reference patent, but instead reflects the expected result of operating the system as disclosed.
Accordingly, the claimed subject matter represents an obvious variation of the invention claimed in U.S. Patent No. 11,648,057 and is not patentably distinct thereform.
The applicant submits that claims 1, 9 and 15 are patentable over the combination of Schultheis, Melsky, Bacher.
The applicant’s arguments are not persuasive.
First, the examiner acknowledges that Bacher discloses optical signals associated with separate sources. However, the rejection does not rely on Bacher to teach the generation of second light energy from the first light energy.
Rather, as set forth in the present rejection, the limitation directed to:
“a second light energy…generated using the first light energy.”
is taught or suggested by the combination of Schultheis in view of Umstadter, not Bacher.
In addition, Schultheis teaches delivering high-intensity laser energy via a catheter system to a treatment site (e.g., [0036]-[0037]).
Umstadter further teaches that when such laser energy interacts with a target material or tissue, the interaction creates a plasma that radiates ionizing radiation (e.g., [0043]).
Thus, Umstadter explicitly teaches that radiation is generated as a direct result of the incident laser energy, i.e. the first light energy. Accordingly, the radiation emitted from the plasma corresponds to the claimed:
“second light energy…generated using the first light energy.”
Additionally, Umstadter teaches that the emitted radiation may be detected using a detector to generate information about the treatment site [e.g., 0058].
Melsky teaches optical systems configured to detect and analyze optical signals and to control systems operation based on such detected signals.
It would have obvious to one having ordinary skill in the art to utilize the optical analysis system of Melsky to analyze the radiation emitted from the plasma generated by the laser energy in Schultheis, as modified by Umstadter, in order to monitor treatment conditions and improve system safety.
In conclusion, the applicant’s argument is directed to teachings of Bacher and the alleged use of separate optical sources. However, the argument does not address the teachings of Umstadter, which explicitly disclose the radiation is generated from laser-induced plasma and therefore is generated using the first light energy. Accordingly, when the teaching of Schultheis, Melsky and Umstadter are properly considered, the combination teaches or renders obvious disputed limitation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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