DETAILED ACTION
Status of the Claims
1. Claims 1-13 are pending.
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 1-3 is 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.
Claim 1 recites the limitation "the subject" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph for being dependent on claim 1.
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.
Claim(s) 1-4, 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bar-Or et al. (US 2017/0059549).
Claim 1. Bar-Or et al. teach a method of diagnosing and treating acute circulatory failure in a patient in need thereof (method of diagnosing and treating septic shock (type of acute circulatory failure) in a subject; [0081]) comprising:
measuring a level of redox potential in a sample obtained from said patient (measuring oxidation reduction potential of sample from subject; [0081]),
determining that the redox potential is downregulated compared to a reference value (determining if ORP is decreased compared to prior ORP; [0081]), and
treating the subject determined to have a downregulated redox potential for acute circulatory failure (treating the subject based on the sepsis status; [0081]).
Claim 2. Bar-Or et al. teach the sample is a whole blood sample [0044].
Claim 3. Bar-Or et al. teach a downregulation of said redox potential as compared to a predetermined reference value indicates that the patient suffers from acute circulatory failure (decreased ORP is compared to prior ORP value indicates subject suffers from sepsis; [0081]).
Claim 4. Bar-Or et al. teach a method of predicting the outcome of a patient after an acute circulatory failure and treating the patient (measuring ORP to determine subject after sepsis and treating the subject; [0081][0082]) comprising:
determining the measuring a level of redox potential in a sample obtained from said patient (measuring ORP in a sample obtained from subject; [0081]),
determining that the level of the redox potential is upregulated compared to a predetermined reference value (increase in ORP compared to reference ORP; [0081][0082]), and
treating the patient identified as having an upregulated redox potential value with a treatment suitable for a patient with a poor outcome (treating subject having greater ORP with antibiotics;[0083]).
Claim 6. Bar-Or et al. teach the sample is a whole blood sample [0084].
Claim 7. Bar-Or et al. teach an upregulation of said redox potential as compared to a predetermined reference value indicates that the patient has a poor outcome (increase in ORP is indicative of progressive development or worsening of severe infection; [0083]).
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) 5-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Claim 5. Bar-Or et al. teach the acute circulatory failure is induced by cardiopulmonary by-pass surgery (ORP is measured to detect cardiovascular disease such as myocardial hypertrophy or myocardial infarction [0095][0069] or during extracorporeal circulation [0190] which is core component of cardiopulmonary bypass, thus it is obvious if not apparent myocardial infarction i.e. acute circulatory failure is induced by cardiopulmonary bypass surgery.
Claim 8. Bar-Or et al. do not teach said redox potential is measured at least 10 minutes after the initiation of cardiopulmonary by-pass (CPB). However, Bar-Or et al. teach measurement of ORP of a biological sample can be done at multiple time points such [0066], thus one of ordinary skill in the art before the effective filing date of the invention could easily setup the device to measure ORP at least 10 minutes after initiation of CPB.
Claim 9. Bar-Or et al. do not teach the level of redox potential is at least 20% higher than said predetermined reference value. However, Bar-Or et al. teach higher ORP value is indication of lesser capacity to withstand oxidative stress and lower ORP value indicates greater capacity to withstand oxidative stress [0063], thus discovering optimum ORP value being 20% higher than predetermined reference value without producing any new or unexpected results is within the ambit of a person of ordinary skill in the art.
Claim 10. Bar-Or et al. teach the predetermined reference value is a redox potential value obtained from a sample from said patient (reference value could be ORP value of subject did not have the condition; [0064]). Bar-Or et al. do not teach reference value is redox potential obtained before a surgery. However, one of ordinary skill in the art could easily take ORP value before surgery to monitor oxidative stress of subject during and after surgery.
Claim 11. Bar-Or et al. teach ORP values are measured in mV (see Fig 6) but do not teach a level of redox potential comprised between 138,1 and 149,5 mV indicates that said patient has a poor postoperative outcome. However, discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art.
Claim 12. Bar-Or et al. teach determining the level of redox potential in a whole blood sample obtained from said patient [0084]. Bar-Or et al. do not teach said redox potential is measured at least 10 minutes after the initiation of cardiopulmonary by-pass (CPB). However, Bar-Or et al. teach measurement of ORP of a biological sample can be done at multiple time points such [0066], thus one of ordinary skill in the art before the effective filing date of the invention could easily setup the device to measure ORP at least 10 minutes after initiation of CPB. Bar-Or et al. do not teach the level of redox potential of at least 20% as compared to a redox potential value obtained from a sample of said patient before said cardiopulmonary by-pass indicates that the patient has a poor postoperative outcome. However, Bar-Or et al. teach higher ORP value is indication of lesser capacity to withstand oxidative stress and lower ORP value indicates greater capacity to withstand oxidative stress [0063], thus discovering optimum ORP value being 20% as compared to a redox potential value obtained from a sample of said patient before said cardiopulmonary by-pass indicates that the patient has a poor postoperative outcome without producing any new or unexpected results is within the ambit of a person of ordinary skill in the art.
Claim 13. Bar-Or et al. teach determining the level of redox potential in a whole blood sample obtained from said patient [0084]. Bar-Or et al. do not teach said redox potential is measured at least 10 minutes after the initiation of cardiopulmonary by-pass (CPB). However, Bar-Or et al. teach measurement of ORP of a biological sample can be done at multiple time points such [0066], thus one of ordinary skill in the art before the effective filing date of the invention could easily setup the device to measure ORP at least 10 minutes after initiation of CPB. Bar-Or et al. teach ORP values are measured in mV (see Fig 6) but do not teach a level of redox potential comprised between 138,1 and 149,5 mV indicates that said patient has a poor postoperative outcome. However, discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art.
Conclusion
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
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