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 .
Status of Claims
Claims 1-3, 5-7, 10-13, 15-19, and 22-24 are rejected. Claims 4, 8-9, 14, and 20-21 are canceled.
Response to Arguments
Provisional Rejection for Nonstatutory Double Patenting
The nonstatutory double patenting rejection will be maintained until a Terminal Disclaimer is filed. MPEP 804 states:
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see Remarks, filed 6/9/26, with respect to claims 1-3, 5-7, 10-13, 15-19, and 22-24 have been fully considered and are persuasive. The 112(a) and 112(b) rejections of claims 1-3, 5-7, 10-13, 15-19, and 22-24 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see Remarks, filed 6/9/26, with respect to claims 1-3, 5-7, 10-13, 15-19, and 22 have been fully considered and are persuasive. The 103 rejection of claims 1-3, 5-7, 10-13, 15-19, and 22 has been withdrawn. Specifically, that Segalescu fails to disclose the claimed configuration and positioning of the tapered portion outside of and proximal of the balloon.
Regarding claims 23-24, Applicant's arguments filed 6/9/25 have been fully considered but they are not persuasive. Applicant asserts that claim 23 has been amended similarly to claim 1. However, the Examiner disagrees. Claim 23 was not amended to recite “wherein the first fiber member distal region is outside of an inflatable balloon” as amended in claim 1.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/12/26 and 6/24/26 are being considered by the examiner.
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.
The factual inquiries 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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Massimini (US 20200406010 filed on 6/17/20 as cited in the IDS) in view of Segalescu (US 20070282301 filed on 2/27/05).
Regarding claim 23, Massimini teaches a method for treating a treatment site within or adjacent to a vessel wall or a heart valve, the method comprising steps of: fusing a distal region of a first fiber member of an optical fiber to a proximal region of a second fiber member of the optical fiber to define a fused region of the optical fiber such that the second fiber member extends distally from the first fiber member (¶103-the longitudinal protection structure 1810 can be a first component fused between the distal tip 1814 of the proximal portion 1804 of the first light guide 1802 and the proximal tip 1816 of the continuation of the first light guide 1808; Fig. 18) and the first fiber member extends proximally from the second fiber member (¶53-proximal portion 104 of light guide 110 in Fig. 1), the optical fiber having an optical fiber proximal end (¶53-proximal portion 104 of light guide 110 in Fig. 1) and an optical fiber distal end (¶57-a balloon fluid 124 within balloon 122 at the distal portion 106; Fig. 1); that is spaced apart from the optical fiber proximal end and from the optical fiber distal end (Figs. 6-7-a plurality of light diffusers spaced apart/along the length of the fiber (602, 604 and 606/702 or 704)), wherein the optical fiber includes a first portion positioned proximal to a portion (Figs. 6-7-see the left side of the light guide before the plurality of fiber diffusers) and a second portion positioned distal to the portion (Figs. 6-7-see the right side of the light guide after the plurality of fiber diffusers), wherein the first portion includes a first constant diameter (Fig. 6-sections adjacent to the diffusers 602/604/606 (where light travels/remains within the fiber, shown by arrows) are of a constant diameter) and wherein the second portion includes a second constant diameter (Fig. 6-sections adjacent to the diffusers 602/604/606 (where light travels/remains within the fiber, shown by arrows) are of a constant diameter); positioning the optical fiber such that the optical fiber distal end is positioned within an inflatable balloon (¶57-a balloon fluid 124 within balloon 122 at the distal portion 106; Fig. 1); coupling an energy source in optical communication with the fiber proximal end of the optical fiber (¶54-the light source 116 can be in optical communication with the first light guide 110; ¶55; Fig. 1); and receiving an energy pulse from the energy source into the fiber proximal end of the optical fiber to generate a plasma pulse within the inflatable balloon (¶55-the light source 116 of catheter system 100 can be configured to provide sub-millisecond pulses of light from the light source through the at least first light window and second light window, thereby inducing plasma formation in a balloon fluid, causing rapid bubble formation, and imparting pressure waves upon the treatment site).
However, Massimini is silent to tapering a portion of the optical fiber between the optical fiber proximal end and the optical fiber distal end to provide a tapered portion of the optical fiber that is tapered in a direction toward the optical fiber distal end, wherein the tapered portion is located in the first fiber member, and the second constant diameter being smaller than the first constant diameter.
Segalescu relates to devices and methods that facilitate percutaneous endoluminal therapy of blood vessels or other anatomical structures. More particularly, the present invention relates to devices that are capable of dilating a stenotic vessel while reducing the risk of restenosis after the procedure (¶1). Segalescu further teaches the invention using the following steps:
tapering a portion of the optical fiber between the fiber proximal end and the fiber distal end to provide a tapered portion of the optical fiber that is tapered in a direction toward the fiber distal end (¶93-still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section), wherein the tapered portion is located in the first fiber member (Fig. 10a-section 31 is in the first fiber member; ¶65), and the second constant diameter being smaller than the first constant diameter (the second diameter would have to be smaller, as the diffuser would be a tapered/thinner leading to a smaller diameter for the next non-emitting section; ¶93).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include tapering a portion of the optical fiber between the optical fiber proximal end and the optical fiber distal end to provide a tapered portion of the optical fiber that is tapered in a direction toward the optical fiber distal end, wherein the tapered portion is located in the first fiber member, and the second constant diameter being smaller than the first constant diameter of Segalescu as a simple substitution of one known configuration of an optical fiber for another known configuration that provides the same function.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Massimini in view of Segalescu as applied to claims 6 and 23 above, and further in view of Yu (US 20180042677 filed on 8/11/17).
Regarding claim 24, the combination of Massimini and Segalescu teaches the method of claim 23. However, the combination of Massimini and Segalescu does not teach a step of encircling at least the fused region of the optical fiber with a ferrule.
Yu teaches a step of encircling at least the fused region of the optical fiber with a ferrule (¶51-the portion of optical fiber 612 with diffused cladding 617 may be inserted into passage 650 of ferrule 644, and may be fused with ferrule 644).
Yu relates generally to treating subjects using lasers. More specifically, the present disclosure relates to systems, devices, and related methods for laser lithotripsy (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Massimini to include a step of encircling at least the fused region of the optical fiber with a ferrule of Yu in order for the concentration of laser energy 306 increasing the overall energy delivered to targeted material 333, thereby speeding up treatment times, allowing harder materials to be broken down, and/or giving the user precise control over aiming of laser energy 306 (Yu, ¶37).
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.
Claims 1, 5-7, 10-13, 15-19, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 10-19, 23, 25-28 of copending Application No. 17/666172 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. See the table below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented and claims of the copending Application anticipates the claims of the instant application according to the mapping provided in the table below.
Claims of the Instant Application (17/673221)
Claims of Copending Application (17/666172)
1
1
5
5
6
4, 6
7
7
10
10
11
11
12
12
13
4, 13
15
15
16
4, 16
17
17
18
18
19
1, 19
22
23, 24
23
25
24
7, 27
Claims 2-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 10-19, 23, 25-28 of copending Application No. 17/666172 in view of US 20200129195.
This is a provisional nonstatutory double patenting rejection.
Claims of the Instant Application (17/673221)
Claims of Copending Application (17/666172)
Secondary Reference (US 20200129195)
2
McGowan teaches wherein the step of tapering includes tapering the optical fiber using a fusion splicer (¶100-a fused splicing, a fused splicing forming at least one internal mirror, and a splicing of two or more diffuse regions; ¶12). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include wherein the step of tapering includes tapering the optical fiber using a fusion splicer of McGowan in order for treating a calcified lesion within or adjacent to the vessel wall (McGowan, ¶3).
3
McGowan teaches the step of splicing the optical fiber using a core matched fiber (¶100-a splicing of two or more diffuse regions, suitable materials for a fiber diffuser can include, but not be limited to, the materials of the core or cladding).Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the copending application to include the step of splicing the optical fiber using a core matched fiber of McGowan in order for treating a calcified lesion within or adjacent to the vessel wall (McGowan, ¶3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10782477: which relates generally to medical devices, and in particular, to a surgical optical fiber and process of making the same (col. 1 and lines 13-15); Fig. 5.
THIS ACTION IS MADE FINAL. 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 LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
Prosecution Insights