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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04 November 2025 has been entered.
Response to Amendment
Claim amendments filed 04 November 2025 are acknowledged. Claims 1-33 are pending.
Response to Arguments
Applicant’s arguments, see pages 8-9 of the applicant’s response, filed 04 November 2025, with respect to the rejections of claims 1 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 Therefore, the rejection has been withdrawn.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 and Matsui (US 20230293741 A1).
The amendments to claim 1 is sufficient to overcome the previously presented 102 rejections, but Lin teaches each optical fiber includes a cavity formed in a cladding of the optical fiber and extending across an optical core of the optical fiber (discrete discontinuities such as cuts or scoring in the cladding and core of the fiber optic cable, paragraph [0181]) and Matsui teaches wherein such a discontinuity has an angled shape (Figure 10 grating “38” angled along fiber “15”). Additionally, Sinofsky teaches a reflective surface along the axial direction of the instrument that would direct the light radial outward (longitudinal reflector strip creates an azimuthal exposure pattern, page 11 lines 30-32) and Lin describes surfaces within the fiber optic cable that reflect the UV radiation outward an allow the light to exceed the angle of total internal reflection to escape the core-cladding interface (paragraph [0189]). Therefore, a combination of Sinofsky, Lin and Matsui would render the current invention obvious.
Following the above logic, the rejections of claims 2-18 have been also been withdrawn and new grounds of rejections are made in view of 35 U.S.C. 103 with respect to Sinofsky in view of Lin and Matsui.
Applicant's arguments filed 04 November 2025, with respect to the rejection of claim 19 under 35 U.S.C. 102(a)(1) have been fully considered but they are not persuasive. Sinofsky explicitly teaches reflecting light radially outward using a reflective surface on the inside wall of the instrument (longitudinal reflector strip creates an azimuthal exposure pattern, page 11 lines 30-32). Therefore, the 35 U.S.C. 102(a)(1) rejection of claim 19 is maintained
Applicant’s arguments, see page 10 of the applicant’s response, filed 04 November 2025, with respect to the rejection of claim 29 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, new grounds of rejections are made in view of 35 U.S.C. 103 with respect to Sinofsky in view of Lin.
The additional structural limitation requiring the plug to be directly attached to the distal end of the instrument core is sufficient to overcome the previously presented 102 rejection, Lin teaches a light scattering tip directly attached to the end of the fiber optic cable (Figure 4G tip “31” attached to cable “30” where core “14” terminates). Therefore, a combination of Sinofsky and Lin would render the current invention obvious.
Applicant's arguments, see page 10, filed 04 November 2025, with respect to the rejection of claim 30 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Lin explicitly teaches that the discontinuities formed either discretely or indiscreetly maybe formed in both the cladding and the core of the optical fiber (discrete discontinuities such as cuts or scoring in the cladding and core of the fiber optic cable, paragraph [0181]).
Applicant’s arguments, see page 10, filed 04 November, with respect to the rejection of claim 30 under 35 U.S.C. 103 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 and Matsui.
While Lin explicitly teaches that the discontinuities formed either discretely or indiscreetly maybe formed in both the cladding and the core of the optical fiber (discrete discontinuities such as cuts or scoring in the cladding and core of the fiber optic cable, paragraph [0181]), the additional limitation requiring an angled cavity wall is sufficient to overcome the previously presented rejection. However, Matsui teaches wherein such a discontinuity has an angled shape (Figure 10 grating “38” angled along fiber “15”). Therefore, a combination of Sinofsky, Lin, and Matsui would render the current invention obvious.
Following the above logic, the rejections of claims 20-28 and 32-33 have been maintained. Additionally, the rejection of claim 31 has been withdrawn and a new ground of rejection is made in view of 35 U.S.C. 103 with respect to Sinofsky in view of Lin and Matsui.
Information Disclosure Statement
The information disclosure statement filed 06 December 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
No copy of non-patent literature document three has been provided.
Claim Rejections - 35 USC § 102
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 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 19-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinofsky (WO 9607451 A2).
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 at the distal end (Figure 3 fiber optics “12a”, “12b”, 12c”, “12d” and “12e” extend along the length of instrument “40a”); one or more reflective surfaces within the disinfection zone, the reflective surfaces configured to direct the light radially outward from the instrument wherein each of the one or more reflective surfaces is defined by an inside wall of the instrument having a reflective material disposed thereon (longitudinal reflector strip creates an azimuthal exposure pattern, page 11 line 30-32, and Figure 5 reflector strip “62”); 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).
Regarding claim 20, Sinofsky 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, Sinofsky teaches wherein the medical device is a tubular medical device (lumen can be endoscope lumen, page 20 line 9).
Regarding claim 22, Sinofsky teaches wherein the medical device is a catheter (incorporated into a catheter, page 5 line 28).
Regarding claim 23, Sinofsky teaches wherein the medical device is a vascular catheter (catheter having fiber optic fed via a major artery, page 2 lines 19-20).
Regarding claim 24, Sinofsky 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).
Regarding claim 25, Sinofsky teaches wherein the instrument defines a circular cross-section (Figure 2A shows a circular cross section of the instrument).
Regarding claim 26, Sinofsky 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).
Regarding claim 27, Sinofsky 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).
Regarding claim 28, Sinofsky 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).
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 29 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Sinofsky in view of Lin (US 20150231287 A1).
Regarding claim 29, Sinofsky teaches a plug coupled to the instrument core at a distal end of the instrument core (distal end with an end plug, page 10 line 35), wherein: the plug includes a conical surface (Figure 6B reflective surface formed in a concave shape “28b” in end plug “26”), but does not teach the plug is directly attached to the instrument core wherein the plurality of optical fibers terminate at the distal end of the instrument core. However, Lin teaches the plug is directly attached to the instrument core wherein the plurality of optical fibers terminate at the distal end of the instrument core (Figures 4G-4I light scattering tip “31” attached directly to end of fiber core “14”).
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 32, Sinofsky 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 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 combine the medical device sterilizing device taught by Sinofsky 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, Sinofsky 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 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]).
Claims 1-18 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sinofsky in view of Lin and Matsui (US 20230293741 A1).
Regarding claim 1, Sinofsky teaches a system for disinfecting a medical device (abstract), comprising an elongate instrument (Figure 1 elongate instrument “10”) 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 at the distal end (Figure 3 fiber optics “12a”, “12b”, 12c”, “12d” and “12e” extend along the length of instrument “40a”); and light source operatively coupled with the instrument at the proximal end (ultraviolet flash lamp employed as light source and coupled to the optical fiber, page 7 lines 20-21, and light source “136” attached to proximal end of instrument “100”), such that light from the light source propagates distally along the optical fibers (serve as a waveguide for light propagating through the fiber, page 4 lines 1-2), wherein the elongate instrument is configured to redirect the light propagating along the optical fibers, radially outward from the instrument (portion of light escapes outward through the housing, page 4 line 3), and a reflective surface extending across the cladding, and in the cladding reflects the light propagating along the optical fiber in the radially outward direction (longitudinal reflector strip creates an azimuthal exposure pattern, page 11 lines 30-32), but does not teach each optical fiber includes a cavity formed in a cladding of the optical fiber and extending across an optical core of the optical fiber, or an angled wall of the cavity. However, Lin teaches each optical fiber includes a cavity formed in a cladding of the optical fiber and extending across an optical core of the optical fiber (discrete discontinuities such as cuts or scoring in the cladding and core of the fiber optic cable, paragraph [0181]),and the cavities having a reflective surface that reflects the light propagating along the optical fiber in the radially outward direction (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]), 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 combine the medical device sterilizing device taught by Sinofsky with the cavities taught by Lin because Lin teaches such discontinuities allows the UV radiation to scatter toward the luminal walls of a catheter (paragraph [0181]). 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 2, the combination of Sinofsky, Lin, and Matsui teaches wherein the instrument is configured for insertion into a medical device (inserted into the lumen requiring sterilization, page 20 line 5, Sinofsky).
Regarding claim 3, the combination of Sinofsky, Lin, and Matsui teaches wherein the medical device is an elongate tubular medical device (lumen can be endoscope lumen, page 20 line 9, Sinofsky).
Regarding claim 4, the combination of Sinofsky, Lin, and Matsui teaches wherein the medical device is a catheter (incorporated into a catheter, page 5 line 28, Sinofsky).
Regarding claim 5, the combination of Sinofsky, Lin, and Matsui 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 6, the combination of Sinofsky, Lin, and Matsui 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 7, the combination of Sinofsky, Lin, and Matsui teach wherein the instrument defines a circular cross-section (Figure 2A shows a circular cross section of the instrument, Sinofsky).
Regarding claim 8, the combination of Sinofsky, Lin, and Matsui teaches wherein the instrument comprises a conical reflective surface within the disinfection zone (Figure 6B reflective surface formed in a concave shape “28b”, Sinofsky).
Regarding claim 9, the combination of Sinofsky, Lin, and Matsui teaches wherein each optical fiber comprises the reflective surface within the disinfection zone (optical transmissive fiber tip having a reflective end, page 3 lines 30-31, Sinofsky).
Regarding claim 10, the combination of Sinofsky, Lin, and Matsui teaches wherein the reflective surface is configured to direct fiber optic light radially outward from the instrument (longitudinal reflector strip creates an azimuthal exposure pattern, page 11 line 30-32, Sinofsky).
Regarding claim 11, the combination of Sinofsky, Lin, and Matsui teaches wherein a wavelength range of the light extends only between 100 nm and 400 nm (sterilizing ultraviolet radiation ranges from 400 to 200 nanometers, page 7 lines 13-14, Sinofsky).
Regarding claim 12, the combination of Sinofsky, Lin, and Matsui teaches wherein the instrument comprises a sheath extending along the length (outer sheath surrounds the entire optical transmission apparatus, page 8 lines 2-3, Sinofsky).
Regarding claim 13, the combination of Sinofsky, Lin, and Matsui 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 14, the combination of Sinofsky, Lin, and Matsui teaches all aspects of the current invention as discussed above except wherein the instrument comprises indicia disposed on the instrument along at least a portion of the length. However, Lin further teaches wherein the instrument comprises indicia disposed on the instrument along at least a portion of the length (plurality of stopper markings that correspond to the length of the lumen, paragraph [0016]).
Sinofsky, Lin, and Matsui 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 the medical device sterilizing device taught by Sinofsky, Lin and Matsui 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 15, the combination of Sinofsky, Lin, and Matsui teaches wherein the indicia comprise graduation marks (plurality of stopper markings corresponds to a different potential length of the first lumen, paragraph [0046], Lin).
Regarding claim 16, the combination of Sinofsky, Lin, and Matsui teaches all aspects of the current invention as discussed above except a timer configured to provide an alert at the conclusion of a defined time. However, Lin further teaches a timer configured to provide an alert at the conclusion of a defined time (UV light source may contain timer, paragraph [0104], and controller may inform operator of the status, paragraph [0124]).
Sinofsky, Lin, and Matsui 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, Lin, and Matsui with the timed alarm taught by Lin because Lin teaches the timer allows for the desired UV dose to be delivered to the medical device (paragraph [0138]).
Regarding claim 17, the combination of Sinofsky, Lin, and Matsui 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, Lin, and Matsui 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, Lin, and Matsui with the handle taught by Lin because Lin teaches a handle allows the operator to properly install the cable in place (paragraphs [0295]-[0296]).
Regarding claim 18, the combination of Sinofsky, Lin, and Matsui teaches an interconnect extending between the instrument and light source, the interconnecting optical fibers to facilitate propagation of the light between the light source and the instrument (ultraviolet radiation delivered via one or more optical fibers having a light-diffusing assembly coupled thereto, page 7 lines 3-4, and diffuser apparatus is coupled to a source of phototherapeutic radiation, page 16 lines 25-26, Sinofsky).
Regarding claim 30, Sinofsky 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 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 as described above. 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 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).
Conclusion
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799