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 .
DETAILED ACTION
Response to Amendment
The amendment filed on 3/12/2026 has been received and claims 1-12, 14-16, 18-20 and 22-23 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/12/2026 has been entered.
Election/Restrictions
Claims 15-16, 18-20, and 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/06/2024.
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(s) 1-5, 8-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bak (20120321509) in view of Eckhardt (20030017073).
As to Claim 1, Bak (‘509) discloses a sterilization device (see Figures 1A-9) comprising:
a body (1) comprising at least one indicator light (see entire document, particularly p. 3 [0051], p. 13 – Claim 6), a battery (see entire document, particularly p. 3 [0056], p. 7 – [0125], p. 12 – [0182] , p. 13 – Claim 13), and a light source (100, 11); and
an adapter cap (8) comprising at least one lens (4) and a substrate (i.e. body of 8); wherein the adapter cap (8) is configured to sterilize a medical and/or non-medical device capable of being a vial (see entire document, particularly Abstract, p. 2 [0027], p. 3 [0029]-[0030]).
The limitation that “the adapter cap is inserted onto a vial” is not given patentable weight as it is directed to a manner of operating the claimed device/an intended use of the claimed device. (see MPEP §2114(II) and §2115).
Bak (‘509) does not appear to specifically teach that the substrate is configured to provide a color change.
It was known in the art before the effective filing date of the claimed invention to provide a substrate configured to provide a color change. Eckhardt (‘073) discloses a sterilization device comprised of an adapter cap (59) (see Figures 13A-13C) and/or housing (57) (see Figures 12A-12B) comprising a substrate (i.e. body of the cap/housing) configured to provide a color change (see entire document, particularly p. 9 [0099] – lines 4-8 and 15-17) in order to visually show an exposure to UV light so as to indicate a disinfection/sterilization operation has successfully occurred and/or that an object to be treated or the cap/housing was properly positioned (see entire document, particularly p. 9 [0099] – lines 7-8, 11-15 and 17-21). It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a substrate/body/material that provide a color change in the sterilization device of Bak as a known configuration to the adapter cap in order to as shown by Eckhardt.
As to Claim 2, Bak (‘509) discloses that the battery is at least 6 V (see entire document, particularly p. 7 – [0125], p. 10 [0160] – line 5).
As to Claim 3, the at least one indicator light (see entire document, particularly p. 3 [0051], p. 13 – Claim 6) of Bak (‘509) is capable of turning green and after the vial is sterilized.
As to Claim 4, Bak (‘509) discloses that the light source (100) is a light emitting diode (11) (see entire document, particularly p. 3 [0052] – lines 4-5, p. 5 [0088] – line 7, p. 6 [0118] – line 6).
As to Claim 5, Bak (‘509) discloses that the light source (100) emits ultraviolet C light (see entire document, particularly p. 3 [0052], p. 5 [0088], p. 6 [0118], p. 7 [0120], p. 9 [0145]).
As to Claim 8, the adapter cap (8) of Bak (‘509) is capable of being sterile.
As to Claim 9, the adapter cap (8) of Bak (‘509) is capable of being disposable.
As to Claim 10, Bak (‘509) does not appear to specifically teach that the adapter cap is a vial cap. However, as Bak (‘509) discloses that the adapter cap/sterilization device is easy to adapt by changing the thread/coupling part so as enable use with any medical or non-medical devices with a lumen (see entire document, particularly p. 3 [0029]-[0030] – last 5 lines), it would have been well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide/size an adapter cap in any desired size/form such as that of a vial cap in the sterilization device of Bak in order to allow connection/mating with various other objects such as a vial so as to prevent or remove germs therein (see entire document, particularly p. 3 [0029] – last 3 lines). Only the expected results would be attained.
As to Claim 11, Bak (‘509) discloses that the sterilization device further includes a switch (6).
As to Claim 12, the sterilization performed by the sterilization device of Bak (‘509) is capable of occurring in less than about 10 sec.
As to Claim 14, microbial reduction by the sterilization device of Bak (‘509) is capable of being a 7-log microbial reduction (see entire document, particularly p. 4 [0069]).
Thus, Claims 1-5, 8-12 and 14 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Bak (‘509) and Eckhardt (‘073).
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Bak (20120321509) in view of Eckhardt (20030017073) as applied to claim 1 above, and further in view of Gertner (20080208297).
Bak (‘509) and Eckhardt (‘073) are relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 103.
Neither Bak (‘509) nor Eckhardt (‘073) appears to specifically teach that the light source has a wavelength of about 275 nm or a power of about 30 mW.
It was known in the art before the effective filing date of the claimed invention to provide a light source having a wavelength of about 275 nm and a power of about 30 mW in a sterilization device. Gertner (‘297) discloses a sterilization device (100) (see Figures 1A-9C) comprising a body (104) comprising a battery (110) and a light source (126, 128, 130), and an adapter (106) capable of being inserted onto an object capable of being a vial and configured to sterilize the object/vial, wherein the light source (126) a wavelength of about 275 nm (see entire document, particularly p. 8 [0095] – lines 5-6) and a power of about 30 mW (see entire document, particularly p. 1 [0009], pp. 9-10 [0108]), in order to provide appropriate light treatment to a surface (see entire document, particularly Abstract).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a wavelength of about 275 nm and a power of about 30 mW for the light source of the sterilization device of Bak as modified by Eckhardt as known configurations of the light source in order to provide appropriate wavelength and power so as to ensure full and successful treatment of the surface as shown by Gertner.
Thus, Claims 6-7 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Bak (‘509), Eckhardt (‘073), and Gertner (‘297).
In the event that the claim limitation is amended to recite a separate and distinct substrate is provided with the adapter cap, the following rejection will apply.
Claim(s) 1-5, 8-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bak (20120321509) in view of Eckhardt (20030017073) and Sharavara (20140038305).
As to Claim 1, Bak (‘509) discloses a sterilization device (see Figures 1A-9) comprising:
a body (1) comprising at least one indicator light (see entire document, particularly p. 3 [0051], p. 13 – Claim 6), a battery (see entire document, particularly p. 3 [0056], p. 7 – [0125], p. 12 – [0182] , p. 13 – Claim 13), and a light source (100, 11); and
an adapter cap (8) comprising at least one lens (4) and a substrate (i.e. body of 8); wherein the adapter cap (8) is configured to sterilize a medical and/or non-medical device capable of being a vial (see entire document, particularly Abstract, p. 2 [0027], p. 3 [0029]-[0030]).
The limitation that “the adapter cap is inserted onto a vial” is not given patentable weight as it is directed to a manner of operating the claimed device/an intended use of the claimed device. (see MPEP §2114(II) and §2115).
Bak (‘509) does not appear to specifically teach that the adapter cap comprises a separable/separate substrate configured to provide a color change.
It was known in the art before the effective filing date of the claimed invention to provide a substrate configured to provide a color change. Eckhardt (‘073) discloses a sterilization device comprised of an adapter cap (59) (see Figures 13A-13C) and/or housing (57) (see Figures 12A-12B) comprising a substrate (i.e. body of the cap/housing) configured to provide a color change (see entire document, particularly p. 9 [0099] – lines 4-8 and 15-17) in order to visually show an exposure to UV light so as to indicate a disinfection/sterilization operation has successfully occurred and/or that an object to be treated or the cap/housing was properly positioned (see entire document, particularly p. 9 [0099] – lines 7-8, 11-15 and 17-21). It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a substrate/body/material that provide a color change in the sterilization device of Bak as a known configuration to the adapter cap in order to as shown by Eckhardt.
While Eckhardt (‘073) does not appear to specifically teach that the adapter cap/housing includes a separate substrate that is configured to provide a color change, it would have been well within the purview of one of ordinary skill in the art to provide only a separate component/portion of the adapter cap/housing in the form of a separable/separate substrate which provides the color change in the sterilization device of Bak as modified by Eckhardt as a matter of engineering choice (see MPEP 2144 (V)(C)). In particular, Sharavara (‘305) exemplifies that a color changing agent can be placed on a variety of substrates in order to allow evaluation using human eye instead of requiring a machine to detect an exposure to UV light (see entire document, particularly pp. 3-4 [0020] and p. 4 [0024]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a separable/separate substrate in the adapter cap of Bak as modified by Eckhardt as a known alternate configuration in order to allow visualization of the color change from UV exposure with only eyes of the user in the adapter cap as exemplified by Sharavara.
As to Claim 2, Bak (‘509) discloses that the battery is at least 6 V (see entire document, particularly p. 7 – [0125], p. 10 [0160] – line 5).
As to Claim 3, the at least one indicator light (see entire document, particularly p. 3 [0051], p. 13 – Claim 6) of Bak (‘509) is capable of turning green and after the vial is sterilized.
As to Claim 4, Bak (‘509) discloses that the light source (100) is a light emitting diode (11) (see entire document, particularly p. 3 [0052] – lines 4-5, p. 5 [0088] – line 7, p. 6 [0118] – line 6).
As to Claim 5, Bak (‘509) discloses that the light source (100) emits ultraviolet C light (see entire document, particularly p. 3 [0052], p. 5 [0088], p. 6 [0118], p. 7 [0120], p. 9 [0145]).
As to Claim 8, the adapter cap (8) of Bak (‘509) is capable of being sterile.
As to Claim 9, the adapter cap (8) of Bak (‘509) is capable of being disposable.
As to Claim 10, Bak (‘509) does not appear to specifically teach that the adapter cap is a vial cap. However, as Bak (‘509) discloses that the adapter cap/sterilization device is easy to adapt by changing the thread/coupling part so as enable use with any medical or non-medical devices with a lumen (see entire document, particularly p. 3 [0029]-[0030] – last 5 lines), it would have been well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide/size an adapter cap in any desired size/form such as that of a vial cap in the sterilization device of Bak in order to allow connection/mating with various other objects such as a vial so as to prevent or remove germs therein (see entire document, particularly p. 3 [0029] – last 3 lines). Only the expected results would be attained.
As to Claim 11, Bak (‘509) discloses that the sterilization device further includes a switch (6).
As to Claim 12, the sterilization performed by the sterilization device of Bak (‘509) is capable of occurring in less than about 10 sec.
As to Claim 14, microbial reduction by the sterilization device of Bak (‘509) is capable of being a 7-log microbial reduction (see entire document, particularly p. 4 [0069]).
Thus, Claims 1-5, 8-12 and 14 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Bak (‘509), Eckhardt (‘073), and Sharavara (‘305).
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Bak (20120321509) in view of Eckhardt (20030017073) and Sharavara (20140038305) as applied to claim 1 above, and further in view of Gertner (20080208297).
Bak (‘509), Eckhardt (‘073), and Sharavara (‘305) are relied upon for disclosure described in the rejection of claim 1 under 35 U.S.C. 103.
None of Bak (‘509) or Eckhardt (‘073) nor Sharavara (‘305) appears to specifically teach that the light source has a wavelength of about 275 nm or a power of about 30 mW.
It was known in the art before the effective filing date of the claimed invention to provide a light source having a wavelength of about 275 nm and a power of about 30 mW in a sterilization device. Gertner (‘297) discloses a sterilization device (100) (see Figures 1A-9C) comprising a body (104) comprising a battery (110) and a light source (126, 128, 130), and an adapter (106) capable of being inserted onto an object capable of being a vial and configured to sterilize the object/vial, wherein the light source (126) a wavelength of about 275 nm (see entire document, particularly p. 8 [0095] – lines 5-6) and a power of about 30 mW (see entire document, particularly p. 1 [0009], pp. 9-10 [0108]), in order to provide appropriate light treatment to a surface (see entire document, particularly Abstract).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide a wavelength of about 275 nm and a power of about 30 mW for the light source of the sterilization device of Bak as modified by Eckhardt and Sharavara as known configurations of the light source in order to provide appropriate wavelength and power so as to ensure full and successful treatment of the surface as shown by Gertner.
Thus, Claims 6-7 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Bak (‘509), Eckhardt (‘073), and Sharavara (‘305), and Gertner (‘297).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 and 14 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: CN201727766/WO2011146505 (a sterilization container/device comprised of a cap which includes a chamber with a liquid configured to provide a color change), WO2016044821 (a sterilization device comprised of an adapter cap formed of a material which provides a color change).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758