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 .
Claims 1, 3, 8, 9, 11, 12, 13, 14, 15, and 16 are examined in this office action.
Claims 1, 8, 9, 11, 15, and 16 are amended.
Claims 2, 4, 5, 6, and 7 are withdrawn.
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.
Claim(s) 1, 3, 8-9, 11-12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ball et al. (US Pub No. 2018/0369560 A1).
Regarding claim 1, Ball discloses an adapter (optical plug 300, Fig. 3A) for connecting a connector (male luer fitting 220 and female luer fitting 210, Fig. 2) provided at a proximal end (See annotated Fig. 7) of a flexible hollow light-guiding tube (catheter 722, Fig. 7) to a light source device (UV light unit 702, Fig. 7),
the connector (male luer fitting 220 and female luer fitting 210, Fig. 2) including at one end a connector portion having a hollow cylindrical tubular member (male luer fitting 220, Fig. 2) and at the other end a hollow cylindrical base tube (female luer fitting 210, Fig. 2) that is disposed coaxially with the tubular member ("Male luer fitting 220 has an insertion end 222 adapted for insertion into an internal cavity 212 of the female luer fitting 210." - Para [0060]), with the light-guiding tube drawn out from the base tube toward a side opposite to the tubular member (Figs. 2 and 7),
wherein the adapter (optical plug 300, Fig. 3A) comprises:
a first connecting portion (base end 320, Fig. 3A) adapted to be connected to and disconnected from the light source device ("The sterilizer body 810 can have a UV light unit 702 …" - Para [0090]); ("The sterilizer body 810 can have an optical plug region 814 that optionally can be in contact with the optical plug 830 …" - Para [0089]);
a second connecting portion (insertion end 310, Fig. 3A) adapted to be connected to and disconnected from the connecting portion (female luer fitting 210, Fig. 2) of the connector ("The insertion end 310 is designed to be inserted into the internal cavity 212 …" - Para [0061], Fig. 7); and
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a light-guiding member (optical plug 1210, Fig. 120) adapted to guide light emitted from the light source device to a proximal end surface (inner surface 1314, Fig. 13B) of the light-guiding tube ("The light 1324 exiting from the front window of the optical plug has been reflected internally and redirected, and illuminates … the inner surface 1314 of the attached catheter." - Para [0098], Fig. 13B).
Ball discloses the claimed invention except for “the entire connector including the connector portion and the base tube being integrally formed as a single component”. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ball include “the entire connector including the connector portion and the base tube being integrally formed as single component”, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See MPEP 2144.04.
Regarding claim 3, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, wherein
the light-guiding member (optical plug 1210, Fig. 120) includes an annular light exit end surface (front window 312, Fig. 3A) from which light is emitted ("… light 1324 exiting from the front window of the optical plug …" - Para [0098], Fig. 13B) toward the proximal end surface of the light-guiding tube ("The light 1324 exiting from the front window of the optical plug has been reflected internally and redirected, and illuminates … the inner surface 1314 of the attached catheter." - Para [0098], Fig. 13B).
Regarding claim 8, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, wherein
when the second connecting portion (insertion end 310, Fig. 3A) is connected to the connector portion (female luer fitting 210, Fig. 2) of the connector ("The insertion end 310 is designed to be inserted into the internal cavity 212 …" - Para [0061], Fig. 7), the light- guiding member (optical plug 730, Fig. 7) is inserted into the tubular member (female luer fitting 210, Fig. 7) ("A user can insert the insertion end of an optical plug 730 into a female luer fitting 210 …" - Para [0086], Fig. 7).
Regarding claim 9, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, further comprising
a lens (base window 732, Fig. 7) adapted to focus light emitted from the light source device (UV light unit 702, Fig. 7) toward a light entrance end surface (base sidewall 322, Fig. 3A) of the light-guiding member (optical plug 300, Fig. 3A) ("… light rays entering the plug through the base window are transmitted through the plug to the insertion end 310 via multiple internal reflections off of the base sidewall 322." - Para [0061]).
Regarding claim 11, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, further comprising
an engagement structure (sterilizer body 810, Fig. 8) adapted to engage with the light source device (UV light unit 702, Fig. 7) ("The sterilizer body 810 can have a UV light unit 702 …" - Para [0090]) when the first connecting portion (base end 820, Fig. 8) is connected to the light source device ("The sterilizer body 810 can have an optical plug region 814 that optionally can be in contact with the optical plug 830 …" - Para [0089], Fig. 8).
Regarding claim 12, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, further comprising
an intermediate portion (intermediate bevel 302, Fig. 3A) between the first connecting portion (base end 320, Fig. 3A) and the second connecting portion (insertion end 310, Fig. 3A) ("Optical plug 300 can have an intermediate bevel 302 between the insertion end 310 and the base end 320." - Para [0061]).
Regarding claim 15, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, wherein
the second connecting portion (insertion end 310, Fig. 3A) includes a fitting structure (sidewall 734, Fig. 7) adapted to be fitted to the connector portion (female luer fitting 210, Fig. 2) of the connector (luer system 200, Fig. 2) (See annotated Fig. 7).
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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.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ball et al. (US Pub No. 2018/0369560 A1) in view of Bencke et al. (US Patent No. 10,850,059 B2).
Regarding claim 13, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, wherein
Ball does not expressly disclose that the intermediate portion is provided with a holding surface.
Bencke teaches that the intermediate portion (second end 9004, Fig. 7B) is provided with a holding surface (flats 9046, Fig. 7B) (“… flats 9046 are included on opposed sides where a user would naturally grip.” – Para [106]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the adapter of Ball to include that the intermediate portion is provided with a holding surface as taught by Bencke to provide grip for actuation (Bencke, Para [96]).
Regarding claim 14, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, wherein
Ball does not expressly disclose that the intermediate portion is provided with a rising surface that protrudes outward in a radial direction.
Bencke teaches that the intermediate portion is provided with a rising surface that protrudes outward in a radial direction (See annotated Fig. 6A).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the adapter of Ball to include that the intermediate portion is provided with a holding surface as taught by Bencke to provide grip for actuation (Bencke, Para [96]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ball et al. (US Pub No. 2018/0369560 A1) in view of Koken et al. (JP 2015119387 A).
Regarding claim 16, Ball discloses the adapter (optical plug 300, Fig. 3A) as recited above, wherein
the connector portion (female luer fitting 210, Fig. 2) of the connector (luer system 200, Fig. 2) further includes an outer cylinder (female luer fitting harness 712, Fig. 7) surrounding the tubular member (female luer fitting 210, Fig. 2) Ball does not expressly disclose a female thread provided on an inner circumferential surface of the outer cylinder that opposes the tubular member.
Koken teaches a female thread (female screw 916, Fig. 4B) provided on an inner circumferential surface of the outer cylinder (inner surface of outer cylinder 915, Fig. 4B) that opposes the tubular member (male luer 911, Fig. 4B) ("A female screw 916 is formed on the inner surface of the outer cylinder 915 facing the male luer 911." - Para [3],Fig. 4B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the adapter of Ball to include a female thread provided on an inner circumferential surface of the outer cylinder that opposes the tubular member as taught by Koken for a liquid substance to be administered to the patient (Koken, Para [1]).
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 6/22/2026, with respect to the rejection(s) of claim(s) 1, 3, 8, 9, 11, 12, 13, 14, 15, and 16 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ball.
102
Applicant argues on page 7 that the connector portion having the alleged hollow cylindrical tubular member (the male luer fitting 220 having the male insertion end 222) is separate from the alleged base tube (the female luer fitting 210). Therefore, Ball is not concerned with an adapter for a structure in which the entire connector including the connector portion and the base tube is integrally formed as a single component, as required by claim 1.
Examiner interprets that it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ball to include "the entire connector including the connector portion and the base tube being integrally formed a single component", since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See MPEP 2144.04
Applicant argues on page 7 that the alleged second connecting portion (the insertion end 310) of the alleged adapter (the optical plug 300) can be connected to and disconnected from the alleged base tube (the female luer fitting 210) instead of to/from the connector portion (having the alleged tubular member (the male luer fitting 200)).
Examiner interprets that Ball teaches the claimed limitation "a second connecting portion adapted to be connected to and disconnected from the connector portion of the connector" of claim 1 because the female luer fitting 210 is interpreted to be the connector portion of the connector 200.
Applicant argues on pages 7 and 8 that when the alleged adapter (the optical plug 730) guides light from the alleged light source device (the UV light unit 702) to the alleged light-guiding tube (the catheter 722), the connector portion having the alleged hollow cylindrical tubular member (the male luer fitting 220 having the male insertion end 222) is not used or presented. Therefore, Ball does not disclose or teach a light-guiding member that guides light emitted from the light source device to a proximal end surface of the light-guiding tube (that is drawn out toward the side opposite to the tubular member (of the connector portion)), as required by claim 1.
Examiner interprets that Ball teaches the claimed limitation "the light-guiding tube drawn out from the base tube toward a side opposite to the tubular member" by combining the male luer 220 from Fig. 2 with the Figures 7, 8, 12, and 13 that depict the light guiding tube. The male luer fitting is mated to the proximal end of the female luer fitting which would be the side opposite of the light-guiding tube as shown in Figs. 7, 8, 12, and 13.
103
Applicant argues on pages 8 and 9 that claims 13, 14, and 16 do not remedy the deficiencies of Ball noted above relative to claim 1.
Examiner interprets the above rejection and response teach claim 1.
With respect to applicant's arguments the rejection above teaches the claimed limitations and the rejection above is maintained.
Conclusion
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 ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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