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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/15/2026 has been entered.
Response to Amendment
This is an office action in response to Applicant's arguments and remarks filed on 4/15/2026. Claims 8-9, 11, 14, 22, 25-28 are pending in the application and are being examined herein.
Status of Objections and Rejections
The objection to the claims has been withdrawn in view of Applicant's amendment.
The objection to claim 29 has been obviated by Applicant's cancellation.
The rejections of claims 23-24 and 29 are obviated by Applicant's cancellation.
The rejections of claims 8 and 22 under 35 USC 112 are withdrawn in view of Applicant's amendment.
All rejections under 35 U.S.C. 102 and 35 U.S.C. 103 withdrawn in view of Applicant's amendment.
New grounds of objection are necessitated by the amendments.
New grounds of rejection under 35 U.S.C. 112 are necessitated by the amendments.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Claim Objections
Claims 9, 22, and 28 are objected to because of the following informalities:
Claim 9, please change “at least one second light sources” to “at least one second light source” in line 1.
Claim 22, please change “wherein the inactivated viral particles comprises a vaccine” to “wherein the inactivated viral particles comprise a vaccine” in lines 12-13.
Claim 28, please change “wherein the inactivated viral particles comprises a vaccine” to “wherein the inactivated viral particles comprise a vaccine” in lines 1-2.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 28 recites “wherein the inactivated viral particles comprises a vaccine.” Claim 22, from which claim 28 depends, recites the same limitation in lines 12-13.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8-9, 11, 14, 22, and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Dodd et al. (US 20170021042 A1) in view of Church et al. (US 20200397931 A1) (eligible as prior art under 35 U.S.C. 102(a)(2) with an effective filing date of 6/22/2019).
Regarding claim 8, Dodd teaches a device (system 100) for reducing pathogens within biological fluids ([0036]) by emitting photons into a fluid (illumination system 132 includes light sources 186 and 190 for emitting photons into a fluid flowing through a flow cell 170, [0040]), the device comprising:
a fluid channel (Fig. 1B, flow cell 170) configured to transfer the fluid containing a photosensitizer ([0049) from an inlet (Fig. 1B, biological fluid flows from bag 162 into flow cell 170 via an inlet, [0041-0042]) to an outlet thereof (Fig. 1B, biological fluid flows from flow cell 170 to bag 178 via an outlet, [0041-0042]); and
at least one first fluorescent light source (one of the light sources 186 and 190 may be a fluorescent bulb, [0082]) emitting ultraviolet light and at least one second light source adjacent the fluid channel (Fig. 1B, light sources 186 and 190 positioned adjacent to flow cell 170 and are configured to emit UV light)
the at least one first light source having a different peak wavelength than the at least one second light source (light sources 186 and 190 may emit at a combination of different light ranges, which is understood that the two light sources may emit at different peak wavelengths [0048]), and
wherein the at least one first fluorescent light source configured to have a narrowband wavelength output of between 310 to 320 nm (one of the light sources 186 or 190 may emit within a UVB wavelength including 315 nm [0048]),
wherein the photosensitizer comprises riboflavin and UV light irradiated by the first light source activates the riboflavin (photosensitizer comprises riboflavin, [0049]).
However, while Dodd contemplates the inactivation of pathogens within a plurality of biological fluids [0036] utilizing a photosensitizer contained therein [0049], Dodd does not teach wherein the device is capable for producing inactivated viral particles and wherein the ultraviolet light activates the photosensitizer comprising riboflavin and selectively inactivates the viral particles within the biological fluid. One having ordinary skill in the art would be concerned with the selective deactivation of specific pathogens within a biological fluid, motivating one to turn towards Church.
Church teaches the treatment of a biological fluid wherein the biological fluid may comprise a vaccine [0044] and the means for treatment comprise an array of light sources [0008]. Church teaches the biological fluid to comprise a pathogen inactivation compound, such as a photosensitizer including riboflavin [00112], wherein the inactivation compound is photoactivated by light and used to control the inactivation of pathogens within the biological fluid [0112] such that a target concentration of viral particles is inactivated [0118].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system as taught by Dodd with the array of light sources and photosensitizer as taught by Church because Church teaches the elements to work in tandem to inactivate a target number of viral particles within a vaccine ([0044, [0112], [0118]) and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A) and 2143(I)(G).
Regarding claim 9, Modified Dodd teaches the device of claim 8, wherein at least one second light sources is an LED light source (Dodd, one of the light sources 186 and 190 may be an LED, [0082]).
Regarding claim 11, Modified Dodd teaches the device of claim 8, wherein the first fluorescent light source has a peak wavelength selected from: a peak UV-B wavelength, a peak UV-C wavelength, and a peak UV-A wavelength (Dodd, light sources 186 and 190 may emit a light with a peak within the UV-A, UV-B, and UV-C wavelengths, [0048]).
Regarding claim 14, Modified Dodd teaches the device of claim 8, wherein at least one of the first and second light sources has a peak wavelength outside of UV-B, UV-C, or UV-A (Dodd, light sources 186 and 190 may emit visible light which is outside the UV spectrum, [0048]).
Regarding claim 22, Dodd teaches a device (system 100) for reducing pathogens within biological fluids ([0036]) by emitting photons into a fluid (illumination system 132 includes light sources 186 and 190 for emitting photons into a fluid flowing through a flow cell 170, [0040]), the device comprising:
a fluid channel (Fig. 1B, flow cell 170) configured to transfer the fluid containing a photosensitizer ([0049) from an inlet (Fig. 1B, biological fluid flows from bag 162 into flow cell 170 via an inlet, [0041-0042]) to an outlet thereof (Fig. 1B, biological fluid flows from flow cell 170 to bag 178 via an outlet, [0041-0042]); and
at least one first fluorescent light source (one of the light sources 186 and 190 may be a fluorescent bulb, [0082]) emitting ultraviolet light and at least one second light source adjacent the fluid channel (Fig. 1B, light sources 186 and 190 positioned adjacent to flow cell 170 and are configured to emit UV light),
the at least one first light source having a different peak wavelength than the at least one second light source (light sources 186 and 190 may emit at a combination of different light ranges, which is understood that the two light sources may emit at different peak wavelengths [0048]), and
wherein the at least one first fluorescent light source configured to have a narrowband wavelength output of between 310 to 320 nm (one of the light sources 186 or 190 may emit within a UVB wavelength including 315 nm [0048]),
wherein the photosensitizer comprises riboflavin and UV light irradiated by the first light source activates the riboflavin (photosensitizer comprises riboflavin, [0049]).
However, while Dodd contemplates the inactivation of pathogens within a plurality of biological fluids [0036] utilizing a photosensitizer contained therein [0049], Dodd does not teach wherein the device is capable for producing inactivated viral particles and wherein the ultraviolet light activates the photosensitizer comprising riboflavin and selectively inactivates the viral particles within the biological fluid. One having ordinary skill in the art would be concerned with the selective deactivation of specific pathogens within a biological fluid, motivating one to turn towards Church.
Church teaches the treatment of a biological fluid wherein the biological fluid may comprise a vaccine [0044] and the means for treatment comprise an array of light sources [0008]. Church teaches the biological fluid to comprise a pathogen inactivation compound, such as a photosensitizer including riboflavin [00112], wherein the inactivation compound is photoactivated by light and used to control the inactivation of pathogens within the biological fluid [0112] such that a target concentration of viral particles is inactivated [0118].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system as taught by Dodd with the array of light sources and photosensitizer as taught by Church because Church teaches the elements to work in tandem to inactivate a target number of viral particles within a vaccine ([0044, [0112], [0118]) and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A) and 2143(I)(G).
Regarding claim 25, Modified Dodd teaches the device of claim 22, wherein at least one second light source is an LED light source (Dodd, one of the light sources 186 and 190 may be an LED, [0082]).
Regarding claim 26, Modified Dodd teaches the device of claim 22, wherein the first fluorescent light source has a peak wavelength selected from: a peak UV-B wavelength, a peak UV-C wavelength, and a peak UV-A wavelength (Dodd, light sources 186 and 190 may emit a light with a peak within the UV-A, UV-B, and UV-C wavelengths, [0048]).
Regarding claim 27, Modified Dodd teaches the device of claim 22, wherein at least one of the first and second light sources has a peak wavelength outside of UV-B, UV-C, or UV-A (Dodd, light sources 186 and 190 may emit visible light which is outside the UV spectrum, [0048]).
Regarding claim 28, Modified Dodd teaches the device of claim 22, wherein the inactivated viral particles comprises a vaccine (Church, [0044], [0112], [0118]).
Response to Arguments
In the arguments presented on pages 4-6 of the amendment, filed 4/15/2026, the Applicant argues that the riboflavin recited in the claims is not an incidental material being acted upon by a generic structure and instead is in a cooperative relationship with the ultraviolet light emitted by the first light source, rendering the limitation as eligible for patentable weight with respect to the rejection(s) of claim(s) 22-26, 25, and 27-28 under 35 U.S.C. 102.
This argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the prior art Dodd and Church. See rejection above.
In the arguments presented on page 6-7 of the amendment, filed 4/15/2026, the Applicant argues that Tiren in view of Mochizuki and Shturm do not teach a photochemical system designed to activate a photosensitizer and selectively inactivate viral particles in a fluid with respect to the rejection(s) of claim(s) 8-9, 11, 14, and 24 under 35 U.S.C. 103.
This argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the prior art Dodd and Church. See rejection above.
Conclusion
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/N.S.S./Examiner, Art Unit 1758
/SEAN E CONLEY/Primary Examiner, Art Unit 1799
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