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 .
Claim Objections
Claims 8-13 and 16-56 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 8-13 and 16-56 not been further treated on the merits.
Claim Interpretation
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are: “the step of removing” in claim 12.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
The term “the step of removing ” recited in claim 12 will be interpreted as “the step of removing a portion of blood from a patient”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-13, 27, 30, and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “between about” and “at least about” in claims 12-13, 30, and 32 are relative terms which renders the claim indefinite. The term “between about” and “at least about is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is uncertain if between about 20% is exactly 20% or can be 19.5% or 19.9%, etc.
The term “a dosage sufficient” in claim 27 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear what sufficient dosage would be to improve a treatment outcome.
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyde et al. (US 20120109039 A1), hereinafter referred to as “Hyde”.
Regarding Claim 1, Hyde teaches a method of treating a patient having or being at risk of cytokine storm syndrome (devices 300 are disclosed herein for controlling or modulating an inflammatory response in a subject, see Paragraph [0005], Figures 3A-B; i.e. treating cytokine storm syndrome, see Paragraph [0035]-[0039]) comprising:
a. removing a portion of blood from the patient (extracorporeal device configured to receive peripheral blood through a flow route, see Paragraph [0030]-[0031]; [0050]-[0052]; Figures 3A-B);
b. exposing the portion of blood to ultraviolet radiation (a treatment chamber 320 configured to receive peripheral blood of a subject through a flow route, the treatment chamber including one or more reactive biological or chemical compounds that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The one or more reactive components can include, but are not limited to an energy source, see Paragraph [0028]; the energy source being ultraviolet radiation, see Paragraph [0122]);
c. placing the exposed portion of blood into the patient (returning the processed blood back to the subject, see Paragraph [0050]-[0052], Figure 3A); wherein the method improves a treatment outcome of the cytokine storm syndrome (proper modulation/control prevents and treats cytokine storm syndrome, see Paragraph [0035]-[0037]).
Regarding Claim 2, Hyde teaches a method of treating a patient having or being at risk of cytokine storm syndrome (devices 300 are disclosed herein for controlling or modulating an inflammatory response in a subject, see Paragraph [0005], Figures 3A-B; i.e. treating cytokine storm syndrome, see Paragraph [0035]-[0039]) comprising:
a. removing a portion of blood from a donor (extracorporeal device configured to receive peripheral blood through a flow route, see Paragraph [0030]-[0031]; [0050]-[0052]; Figures 3A-B);
b. exposing the portion of blood to radiation (a treatment chamber 320 configured to receive peripheral blood of a subject through a flow route, the treatment chamber including one or more reactive biological or chemical compounds that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The one or more reactive components can include, but are not limited to an energy source, see Paragraph [0028]; the energy source being ultraviolet radiation, see Paragraph [0122]);
c. placing the exposed portion of blood into the patient (returning the processed blood back to the subject, see Paragraph [0050]-[0052], Figure 3A); wherein the method improves a treatment outcome of the cytokine storm syndrome (proper modulation/control prevents and treats cytokine storm syndrome, see Paragraph [0035]-[0037]).
Regarding Claim 3, Hyde teaches a method of treating a patient having or being at risk of autoimmune disease (devices 300 are disclosed herein for controlling or modulating an inflammatory response in a subject such as autoimmune disease, see Paragraph [0005], Figures 3A-B) comprising:
a. removing a portion of blood from a donor (extracorporeal device configured to receive peripheral blood through a flow route, see Paragraph [0030]-[0031]; [0050]-[0052]; Figures 3A-B);
b. exposing the portion of blood to radiation (a treatment chamber 320 configured to receive peripheral blood of a subject through a flow route, the treatment chamber including one or more reactive biological or chemical compounds that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The one or more reactive components can include, but are not limited to an energy source, see Paragraph [0028]; the energy source being ultraviolet radiation, see Paragraph [0122]);
c. placing the exposed portion of blood into the patient (returning the processed blood back to the subject, see Paragraph [0050]-[0052], Figure 3A); wherein the method improves a treatment outcome of autoimmune disease (treating the autoimmune disease, see Paragraph [0005]).
Regarding Claim 4, Hyde teaches a method of treating a patient having or being at risk of an infectious disease (devices 300 are disclosed herein for controlling or modulating an inflammatory response in a subject such as an infectious disease, see Paragraph [0005], Figures 3A-B) comprising:
a. removing a portion of blood from a donor (extracorporeal device configured to receive peripheral blood through a flow route, see Paragraph [0030]-[0031]; [0050]-[0052]; Figures 3A-B);
b. exposing the portion of blood to radiation (a treatment chamber 320 configured to receive peripheral blood of a subject through a flow route, the treatment chamber including one or more reactive biological or chemical compounds that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The one or more reactive components can include, but are not limited to an energy source, see Paragraph [0028]; the energy source being ultraviolet radiation, see Paragraph [0122]);
c. placing the exposed portion of blood into the patient (returning the processed blood back to the subject, see Paragraph [0050]-[0052], Figure 3A); wherein the patient develops an immune response against the infectious disease (treating the infectious disease, see Paragraph [0005]).
Regarding Claim 5, Hyde teaches a method of modulating leukocytes in a patient (devices 300 are disclosed herein for controlling or modulating an inflammatory response in a subject, see Paragraph [0005], Figures 3A-B; the one or more reactive components can be configured to modulate an activity of one or more leukocytes, see Paragraph [0034]-[0037]):
a. removing a portion of blood from a donor (extracorporeal device configured to receive peripheral blood through a flow route, see Paragraph [0030]-[0031]; [0050]-[0052]; Figures 3A-B);
b. exposing the portion of blood to radiation (a treatment chamber 320 configured to receive peripheral blood of a subject through a flow route, the treatment chamber including one or more reactive biological or chemical compounds that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The one or more reactive components can include, but are not limited to an energy source, see Paragraph [0028]; the energy source being ultraviolet radiation, see Paragraph [0122]);
c. placing the exposed portion of blood into the patient (returning the processed blood back to the subject, see Paragraph [0050]-[0052], Figure 3A); wherein the method improves a treatment outcome of a disease (treating the inflammatory disease, see Paragraph [0005]).
Regarding Claim 6, Hyde teaches a method of treating a patient having or being at risk of COVID-19 (devices 300 are disclosed herein for controlling or modulating an inflammatory response in a subject such as an infectious disease, see Paragraph [0005], Figures 3A-B; it is understood that COVID-19 is an infectious disease) comprising:
a. removing a portion of blood from a donor (extracorporeal device configured to receive peripheral blood through a flow route, see Paragraph [0030]-[0031]; [0050]-[0052]; Figures 3A-B);
b. exposing the portion of blood to ultraviolet radiation a treatment chamber 320 configured to receive peripheral blood of a subject through a flow route, the treatment chamber including one or more reactive biological or chemical compounds that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The one or more reactive components can include, but are not limited to an energy source, see Paragraph [0028]; the energy source being ultraviolet radiation, see Paragraph [0122]);
c. placing the exposed portion of blood into the patient (returning the processed blood back to the subject, see Paragraph [0050]-[0052], Figure 3A); wherein the method improves a treatment outcome of the COVID-19 (treating the infectious disease, see Paragraph [0005]).
Regarding Claim 7, Hyde further teaches wherein the patient has, had, or is at risk of cytokine storm syndrome (treating cytokine storm syndrome, see Paragraph [0035]-[0039]).
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.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde (US 20120109039 A1) in view of Edelson (US 4321919 A).
Regarding Claim 14, Hyde teaches all of the limitations of claim 1. However, Hyde does not explicitly disclose wherein the type of ultraviolet radiation is selected from the group consisting of UVA, UVB, UVC, near ultraviolet, middle ultraviolet, far ultraviolet, hydrogen Lyman-alpha, vacuum ultraviolet, extreme ultraviolet, and combinations thereof.
Edelson teaches a method and system are disclosed for externally treating human blood, with the objective of reducing the functioning lymphocyte population in the blood system of a human subject (see Abstract; Figure 1) comprising blood withdrawal from a human subject (12) into an extracorporeal blood flow stream (18) passing to irradiation chamber (28) to be treated with radiation source (30); wherein the type of ultraviolet radiation is selected from the group consisting of UVA, UVB, UVC, near ultraviolet, middle ultraviolet, far ultraviolet, hydrogen Lyman-alpha, vacuum ultraviolet, extreme ultraviolet, and combinations thereof (the radiation source is UVA radiation, see Col. 6 ln 24).
Hyde and Edelson are analogous art because both teach externally treating human blood with radiation.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the ultraviolet energy source of Hyde and replace it with using UVA radiation, as taught by Edelson. Edelson teaches using UVA radiation allows for the chamber (or at least wall 34) can therefore typically be comprised of various substantially UVA-transparent plastics, as are commonly used in tubing constructed for administration of standard intravenous solutions, such as polyvinyl chloride and the like (see Col. 6 ln 28-33).
Regarding Claim 15, Hyde and Edelson teach all of the limitations of claim 14 and Edelson further teaches wherein the type of ultraviolet radiation is selected from the group consisting of UVA, UVB, UVC, and combinations thereof (UVA radiation, see Col. 6 ln 24).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Prior art like Edelson (US 4613322 A) teaches a method of treating a patient having or being at risk of an infectious disease (a method has been found which enables safe and effective reduction of the functioning population of certain blood constituents. More particularly, the method of the present invention enables the reduction of the functioning population of certain nucleated cells and undesirable antigenic chemical substances, such as undesirable auto-reactive antibodies, in the blood supply of a human subject, see Col. 3 ln 61-68; Col. 4 ln 1-2) comprising: a. removing a portion of blood from a donor (blood requiring such treatment is withdrawn from the subject, se Col. 4 ln 3-4); b. exposing the portion of blood to radiation (irradiated with UV radiation, see Col. 4 ln 5); c. placing the exposed portion of blood into the patient (he irradiated blood is then returned to the subject, see Col. 4 ln 36); wherein the patient develops an immune response against the infectious disease (the return of the correctly-functioning members of the treated cell population induces a species of feedback inhibition to the pathological state sought to be counteracted, see Col. 4 ln 43-46).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas J. Weiss can be reached at (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.R./ (9/15/2025)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781