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 Arguments
Applicant’s amendments and arguments, filed 4 April 2025, with respect to the rejections of the pending claims over Goodrich have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Hirsch, as presented below.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2021/203015 to Hirsch.
In the specification and figures, Hirsch discloses the method as claimed by Applicant. With regard to claims 1 and 4, Hirsch discloses injecting treated blood into a patient, wherein the blood has been treated with a catalyst (riboflavin), and the blood has been exposed to UV radiation (see pages 6, 25, Table 4, claim 45).
With regard to claims 2 and 5, Hirsch discloses that the types of radiation may comprise UVA, UVB, and UVC light (see Table 2).
With regard to claim 17, Applicant is not setting forth a step of a method, but is reciting a property of the blood used in the method. Hirsch teaches that the patient whose blood is being treated may have an infection (see p25, claim 1).
With regard to claims 18-19, Hirsch discloses that the patient may have a pathogen, including SARS-CoV-2, and the pathogen is inactivated, improving patient outcome (see p 26, claim 11).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over by WO 2021/203015 to Hirsch.
With regard to claim 3, Hirsch does not disclose that the blood is outside the patient for a predetermined amount of time. However, the amount of time the blood is outside the patient depends on at least treatment volume and flow rate. Hirsch discloses that the treatment volume is variable, which necessarily affects the length of time blood is outside the patient. (see p15 line 31 to p16 line 3). One having ordinary skill in the art at the time of filing would have been capable of modifying a treatment volume in order to optimize treatment outcomes, including the amount of time blood was outside a patient’s body.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over by WO 2021/203015 to Hirsch in view of WO 2017/205590 to Sowemimo-Coker et al.
In the specification and figures, Hirsch discloses the method substantially as claimed by Applicant. With regard to claims 6-8, Hirsch discloses the steps claimed by Applicant, but not the claimed concentration of riboflavin. Sowemimo-Coker discloses a method of inactivating blood pathogens comprising the steps of adding riboflavin to a blood product in the concentration/ratio of 40-60µM (establishing a ratio of blood product to riboflavin) and irradiating the combined product with UV light between 265-400nm, demonstrating that the reference is relevant to Applicant’s invention as well as the Hirsch reference (see Sowemimo-Coker ¶0077). The concentration (molarity) of riboflavin in the patient as disclosed by Sowemimo-Coker is a dosage. The amount of riboflavin and the resulting ratio of bodily fluid to riboflavin claimed by Applicant is also a dosage. Sowemimo-Coker discloses that the dosage of riboflavin is variable to achieve a desired patient result (i.e., reduction in hemolysis, see ¶0015). It has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A). In the instant case, attaining the concentration claimed by Applicant is within the skill of a worker in the art to alter the concentration or ratio of riboflavin combined with patient blood to achieve maximum pathogen activation with minimum hemolysis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WO 2014/028688 Erickson
Autologous blood transfusion using UV and riboflavin
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 14 April 2025