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 .
Response to Amendment
Claim Amendments filed 28 April 2026 are acknowledged. Claims 1-28 and 30-33 are pending with claim 29 being cancelled.
Response to Arguments
Applicant’s arguments, see pages 7-9 of the applicant’s response, filed 28 April 2026, with respect to claims 1-18 have been fully considered and are persuasive. The 35 U.S.C. 103 rejections of claims 1-18 has been withdrawn.
Applicant’s arguments, see pages 9-11 of the applicant’s response, filed 28 April 2026, with respect to the rejection of claim 19 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of 35 U.S.C. 103 with respect to Sinofsky in view of Lin.
The amendments to claim 19 is sufficient to overcome the previously presented 35 U.S.C. 102 rejection, but Lin teaches each a plug direct attached to the instrument core at the distal end of the instrument core (Figures 4G-4I light scattering tip “31” attached directly to the end of the fiber core “14”) and the plug defining a conical surface (Figure 4H light scattering tip “31” in a conical shape). Sinofsky teaches a reflective end cap (abstract) and Lin teaches where the end tip is configured to scatter light radially (paragraph [0044]). Therefore, a combination of Sinofsky and Lin would render the current invention obvious.
Following the above logic, the 35 U.S.C. 102(a)(1) rejections of claims 20-28 are withdrawn. However, upon further consideration, a new ground of rejection is made in view of 35 U.S.C. 103 with respect to Sinofsky in view of Lin.
The 35 U.S.C. 103 rejections of claims 32-33 with respect to Sinofsky in view of Lin are maintained. Similarly, the 35 U.S.C. 103 rejections of claims 30-31 with respect to Sinofsky and Lin in view of Matsui are maintained.
The rejection of claim 29 are withdrawn due to the claim being cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 19-28 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Sinofsky (WO 9607451 A2) in view of Lin (US 20150231287 A1).
Regarding claim 19, Sinofsky teaches an elongate instrument for disinfecting a medical device (abstract), comprising: an instrument core extending along a length of an instrument from a proximal end to a distal end (Figure 1 scattering core “22”); and a plurality of optical fibers disposed within the instrument core and extending along the length of the instrument from the proximal end to a disinfection zone located at the distal end (Figure 3 fiber optics “12a”, “12b”, 12c”, “12d” and “12e” extend along the length of instrument “40a”), wherein the plurality of optical fibers terminate at the distal end of the instrument core ( Figure 2 plurality of fibers “12A”-“12C” terminate in distal end of housing “20”); one or more reflective surfaces disposed on the conical surface (Figure 20 conical end cap “226” fitted with a reflective mirror “240”) within the disinfection zone, the reflective surfaces configured to direct light radially outward from the instrument wherein each of the one or more reflective surfaces is defined by the conical surface having a reflective material disposed thereon (radiation is reflected at tip to encounter scatters which provide further radial diffusion, page 3 lines 34-37); and a connector at the proximal end configured to couple with a light source (diffuser apparatus is coupled to a source of phototherapeutic radiation, page 16 lines 25-26), but does not teach a plug directly attached to the instrument core at the distal end of the instrument core, the plug defining a conical surface. However, Lin teaches a plug direct attached to the instrument core at the distal end of the instrument core Figures 4G-4I light scattering tip “31” attached directly to end of fiber core “14”), the plug defining a conical surface (Figure 4H light scattering tip “31” in a conical shape).
Sinofsky and Lin are considered analogous to the current invention because all are in the field of fiber optic disinfection devices. Therefore, it would have been obvious to one of ordinary skill in the art to combine the medical device sterilizing device taught by Sinofsky with the placement of the tip against the fiber core as taught by Lin because Lin teaches such a tip will allow the UV light to be scattered in both the radial and forward directions (paragraph [0110]).
Regarding claim 20, the combination of Sinofsky and Lin teaches wherein the instrument is configured for insertion into a medical device (inserted into the lumen requiring sterilization, page 20 line 5).
Regarding claim 21, the combination of Sinofsky and Lin teaches wherein the medical device is a tubular medical device (lumen can be endoscope lumen, page 20 line 9, Sinofsky).
Regarding claim 22, the combination of Sinofsky and Lin teaches wherein the medical device is a catheter (incorporated into a catheter, page 5 line 28, Sinofsky).
Regarding claim 23, the combination of Sinofsky and Lin teaches wherein the medical device is a vascular catheter (catheter having fiber optic fed via a major artery, page 2 lines 19-20, Sinofsky).
Regarding claim 24, the combination of Sinofsky and Lin teaches wherein the instrument is configured to insertion into the medical device while the medical device is inserted within a patient body (incorporated into catheter instruments that are introduced into the patient’s body, page 16 lines 30-31, Sinofsky).
Regarding claim 25, the combination of Sinofsky and Lin teaches wherein the instrument defines a circular cross-section (Figure 2A shows a circular cross section of the instrument, Sinofsky).
Regarding claim 26, the combination of Sinofsky and Lin teaches a sheath extending between the proximal end and the disinfection zone, the sheath disposed over the instrument core so as to cover the core (outer sheath surrounds the entire optical transmission apparatus, page 8 lines 2-3, Sinofsky).
Regarding claim 27, the combination of Sinofsky and Lin teaches wherein the sheath comprises a material transparent to ultraviolet light (sheath is formed from Teflon or other fluorocarbon polymers, page 19 lines 30-31, Sinofsky).
Regarding claim 28, the combination of Sinofsky and Lin teaches wherein the optical fibers are disposed adjacent a circumferential surface of the instrument core (Figure 2A optic fibers “12a”, “12b”, “12c”, and “12e” disposed around the circumference of the core, Sinofsky).
Regarding claim 32, the combination of Sinofsky and Lin teaches all aspects of the current invention as described above except wherein graduation marks disposed on the instrument along at least a portion of the length. However, Lin further teaches graduation marks disposed on the instrument along at least a portion of the length (plurality of stopper markings corresponds to a different potential length of the first lumen, paragraph [0046]).
Sinofsky and Lin are considered analogous to the current invention as described above. Therefore, it would have been obvious to one of ordinary skill in the art to further modify the medical device sterilizing device taught by Sinofsky and Lin with the indicia taught by Lin because Lin teaches the markers may be used as a guide for appropriate fiber optic positioning in the lumen (paragraph [0095]).
Regarding claim 33, the combination of Sinofsky and Lin teaches all aspects of the current invention as discussed above except wherein the instrument comprises a handle disposed at the proximal end, the handle configured for manipulation of the instrument by a clinician. However, Lin further teaches wherein the instrument comprises a handle disposed at the proximal end, the handle configured for manipulation of the instrument by a clinician (operator may manipulate adapter by holding adapter handle, paragraph [0294]).
Sinofsky and Lin are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to one of ordinary skill in the art to further modify the medical device sterilizing device taught by Sinofsky with the handle taught by Lin because Lin teaches a handle allows the operator to properly install the cable in place (paragraphs [0295]-[0296]).
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sinofsky and Lin in view of Matsui (US 20230293741 A1).
Regarding claim 30, the combination of Sinofsky and Lin teaches all aspects of the current invention as discussed above except each optical fiber comprises a cavity formed in a cladding of the optical fiber and extending laterally across an optical core of the optical fiber, the optical core configured to propagate the light along the optical fiber, and the inside wall of the instrument is defined by an angled wall of the cavity. However, Lin further teaches each optical fiber comprises a cavity formed in a cladding of the optical fiber and extending laterally across an optical core of the optical fiber, the optical core configured to propagate the light along the optical fiber, a wall of the cavity is a reflective surface configured to direct light from the optical core radially outward from the instrument (air bubbles may be included into the core and allow the light to exceed the angle of total internal reflection and reflect UV toward the walls of the catheter, paragraph [0189], and discrete discontinuities such as cuts or scoring in the cladding and core of the fiber optic cable, paragraph [0181]), but does not teach wherein the cavity has an angled wall. However, Matsui teaches wherein the cavity has an angled wall (Figure 10 grating “38” angled along fiber “15”).
Sinofsky, Lin, and Matsui are considered analogous to the current invention because all are in the field of fiber optic disinfection devices. Therefore, it would have been obvious to one of ordinary skill in the art to further modify the medical device sterilizing device taught by Sinofsky and Lin with the cavities taught by Lin because Lin teaches the air bubbles will act as a scattering center that allow light to escape from the core interface (paragraph [0189]). Furthermore, it would have been obvious to one of ordinary skill in the art to combine the sterilizing fiber optic device taught by Sinofsky and Lin with the angled shape of the cavities taught by Matsui because such shaping helps further realize lateral radiation (paragraph [0084]) and improve decontamination at the intended surface (paragraph [0086]).
Regarding claim 31, the combination of Sinofsky, Lin, and Matsui teaches all aspects of the current invention including wherein the core comprises one or more notches disposed on the circumferential surface along the disinfection zone, the notches extend inward to the optical fibers, and the notches are configured to passage of light therethrough (fiber optic cable may contain discontinuities such as cuts or scoring to scatter UV radiation radially towards the walls of the catheter, paragraph [0181], Lin).
Allowable Subject Matter
Claims 1-18 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the closest prior art is Sinofsky in view of Lin and Matsui as previously identified in the Non-Final Office action mailed 28 January 2026. However, the applicant’s amendments filed 28 April 2026 overcomes the previously presented 35 U.S.C. 103 rejections. A combination of Sinofsky, Lin, and Matsui fails to teach an instrument core comprising a notch extending radially inward to each optical fiber and the notch is aligned with the cavity of reach optical fiber to provide an aperture for the light reflected by the reflective surface.
Claims 2-18 are allowable due to their dependence on claim 1.
The prior art as a whole does not teach the claimed invention of claims 1-18 within the claim environment.
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.
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799
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