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 .
Election/Restrictions
Claims 14-21, 26, 27, 46-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected set of method claims, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/27/2026.
Applicant's election with traverse of claims 22-25 and 28-31 in the reply filed on 04/27/2026 is acknowledged. The traversal is on the ground(s) that the present record does not support the conclusion that the three claim groups are independent of distinct, nor that examination together would impose the serious search or examination burden. This is not found persuasive because the groupings are distinct inventions/embodiments with distinct limitations and classifications. The groupings of patently distinct inventions/embodiments require multiple class/subclass searches as well as keyword searches resulting in a burdensome search.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 22, 25, and 28-31 are rejected under 35 U.S.C. 103 as being obvious by Cezar et al. (US 20080187952 A1) (hereon referred as Cezar) in view of Chapman (WO 2013033609 A2).
Regarding claim 22, Cezar teaches a method for treating a mammal having cancer (“methods for determining tumor response to IR treatment…to assess patient response to cancer treatment”, paragraph [0020]) wherein said method comprises:
Detecting a presence of an altered level of at least five metabolites in a sample from said mammal (“methods using metabolomics for detecting and assessing the presence of small molecules in irradiated cell populations”, paragraph [0002], “alterations in small molecules such as sugars, organic acids, amino acids, fatty acids, and low molecular weight compounds are measured and used to assess the effects of ionizing radiation on biochemical pathways”, paragraph [0042]); and
Administering a cancer treatment to said mammal (“small molecules altered in response to IR…radiotherapy remains the primary treatment”, paragraph [0073])
Cezar does not teach administering a cancer treatment to said mammal wherein the cancer treatment is not a radiation therapy.
However, Chapman teaches a method for treating a mammal having cancer and administering cancer treatment that is not a radiation therapy to said mammal (“implementation of an immunotherapy strategy for treating, reducing the symptoms of, or preventing cancer”, paragraph [00235])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Cezar with Chapman and provide the mammal having cancer a cancer treatment that is not radiation therapy, in order to reduce radiation exposure when detecting the altered levels of the metabolites in a sample from said mammal.
Regarding claim 25, Cezar in view of Chapman teaches said detecting comprises LC-MS (“the chromatograms were inspected after each LC-MS run”, paragraph [0068]).
Regarding claim 28, Cezar in view of Chapman teaches said mammal being a human (“a “patient” may be a human”, paragraph [0051]).
Regarding claim 29, Cezar in view of Chapman teaches said sample being selected from the group consisting of whole blood, serum, plasma, urine…jejunum tissue, lung tissue, heart tissue, kidney tissue, skin tissue, gastrointestinal tract tissue, cardiovascular system tissue, CNS tissue, hematopoietic cells, and a fecal sample (“biomarkers in patient biofluids…blood and fluid components thereof such as plasma and serum urine…saliva”, paragraph [0013], “metabolites present in chemically complex samples such as biofluids, tissues, and media from cancer cell cultures”, paragraph [0008]).
Regarding claim 30, Cezar in view of Chapman teaches all the limitations of claim 22.
Furthermore, Chapman teaches a method of detecting and treating cancer in a patient (“methods of detecting cancer in a sample obtained from subject…as well as therapeutics and methods of treating cancer”, abstract), the cancer treatment comprising administering an anti-cancer agent selected from the group consisting of a chemotherapeutic agent, a targeted cancer drug (“evaluating the effect of a candidate cancer drug...administering the drug to a patient”, paragraph [00168]), an immunotherapy drug (“immunotherapy…for treating, reducing the symptoms of, or preventing cancer”, paragraph [00235]), and a hormone therapy drug (“detecting cancer…chosen from homo sapiens…homo sapiens anti-Mullerian hormone (AMH)”, paragraph [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Cezar with Chapman and provide more cancer treatments in addition to surgery and other therapies (“immunotherapy involves the use of monoclonal antibodies in cancer treatments…these agents may be administered alone or in conjunction with radiation or chemotherapeutic agents”, paragraph [0036]) for the patient.
Regarding claim 31, Cezar in view of Chapman teaches the cancer treatment comprising surgery (“radiation therapy may be used alone or in combination with other cancer treatments, such as chemotherapy or surgery”, paragraph [0003]).
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being obvious over Cezar in view of Chapman and further in view of Kurland (Integrative Metabolic Signatures for Hepatic Radiation Injury).
Regarding claim 23, Cezar in view of Chapman teaches all the limitations of claim 22, but does not teach the altered level of said at least five metabolites being in an increased level from a select group.
However, Kurland teaches the altered level of the at least five metabolites being in an increased level from a group of D-glucose (“glucose metabolites…were elevated 3 to 9 fold”, lines 2-4, page 15), uridine, valine, L-isoleucine, and L-phenylalanine (“liver biomarkers…predominant among them were amino acids…and DNA damage markers (uridine)”, lines 8-10, page 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Cezar in view of Chapman with Kurland and select those specific metabolites with an increased level as biomarkers in order to help determine whether a mammal has been exposed to radiation and determine whether or not that mammal is likely to develop one or more injuries from radiation exposure (“metabolite as a biomarker for radiation injury detection”, lines 7-8, page 7).
Regarding claim 24, Cezar in view of Chapman teaches all the limitations of claim 22, but does not teach the altered level of said at least five metabolites being in a decreased level from a select group of hippuric acid, phenol sulfate (“several metabolites that changed…hippuric acid and phenol sulfate…decreased for WBI (whole body irradiation)”, lines 39-42, page 8), hypoxanthine (“hypoxanthine branch were altered…hypoxanthine and xanthine levels were decreased”, lines 3-5, page 16), riboflavin (“riboflavin…decreased for WBI”, lines 5-6, page 23), and proline betaine (“a number of amino acids were significantly reduced in mouse liver at 24 hours after WLI (whole liver irradiation) including…proline”, lines 8-9 page 16 and line 1 page 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Cezar in view of Chapman with Kurland and select those specific metabolites with a decreased level as biomarkers in order to help determine whether a mammal has been exposed to radiation and determine whether or not that mammal is likely to develop one or more injuries from radiation exposure (“metabolite as a biomarker for radiation injury detection”, lines 7-8, page 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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