DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-15 are pending.
Claims 1-14 have been amended.
Claims 1-15 are examined on the merits.
Claim Rejections - 35 USC § 103
3. 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.
4. Claim(s) 1-8 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel et al., US 2017/0189445 A1 (published July 6, 2017/ IDS reference #2 submitted January 10, 2024), and further in view of Trikha et al., WO 2017/210463 A1 (published 07 December 2017). Michel teaches treating tumor proliferation of glial cells with xenon gas as an inhalable drug in combination with an N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, in particular, memantine or nitromemantine, see page 1, sections 0002, 0009, 0018-0020, 0022, 0023, 0025, and 0029. Chemotherapy was not administered to the patient, see entire document.
The xenon is in a gas mixture with nitrogen and oxygen, see page 1, sections 0026-0028. “The gas containing xenon is administered to the patient by inhalation”, see page 2, sections 0041 and 0048. “[T]he xenon gas is administered to the patient for an inhalation time of a few minutes to a few hours, typically between 15 minutes and 6 hours, preferentially less than 4 hours”, see page 2, section 0075.
Michel does not teach the patient’s glioma cells (cancerous glial cells) were initially treated with radiation therapy (RT) and the xenon gas is administered:
-after RT at the latest 360 minutes (6 hours) after the completion of the RT (claim 3);
-immediately after completion of the RT (claim 4); and/ or
-continues for at least 30 minutes or for about 360 (6 hours) minutes (claims 5 and 6).
However, Michel does teach spans of time xenon gas is inhaled that overlaps with the time points set forth in claims 3-6, see page 2, section 0075.
Furthermore, Trikha teaches treating malignant glioma with a combination of therapeutic agents including radiotherapy, see abstract; page 1, section 0004; and page 3, section 0012. In some embodiments, the glioma has a “…promoter of the subject's gene encoding O6-methylguanine- DNA methyltransferase is unmethylated.”, see page 2, section 0010; and section 00220 bridging pages 29 and 30.
Chemotherapy was not administered to the patient at the same as RT, nor inhalation of xenon gas, see entire document.
Trikha teaches concomitant treatment including focal radiotherapy (RT), see section 00282 bridging pages 46 and 47. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the focal RT prior the xenon gas treatment because both documents teach combinatorial therapy, as well as “it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art…Furthermore, if there is language referring to order, such as first and second, it should be understood in an exemplary sense and not in a limiting sense.”, see Michel, page 6, section 0141; and Trikha, page 196, section 00778.
One of ordinary skill in the art would have been motivated to administer the therapeutic agents in the manner set forth to arrive at a successful and effective treatment for the purpose of achieving the desired treatment outcome. Further, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings well known in the art, the manner at which any pharmaceutical composition is administered may be adjusted and optimized.
"[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
5. Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel et al., US 2017/0189445 A1 (published July 6, 2017/ IDS reference #2 submitted January 10, 2024), and further in view of Trikha et al., WO 2017/210463 A1 (published 07 December 2017). Michel teaches treating tumor proliferation of glial cells with xenon gas as an inhalable drug in combination with another anti-cancer therapeutic agent, see page 1, sections 0002, 0009, 0018-0020, 0022, 0023, 0025, and 0029. “[T]he xenon gas is administered to the patient for an inhalation time of a few minutes to a few hours, typically between 15 minutes and 6 hours, preferentially less than 4 hours”, see page 2, section 0075.
Michel does not teach the in vitro study of sensitizing glioma cells for radiation in vitro, wherein glioma cells were initially treated with radiation therapy (RT), and the xenon gas is administered thereafter.
However, Trikha teaches treating malignant glioma with a combination of therapeutic agents including radiotherapy, see abstract; page 1, section 0004; page 3, section 0012. In some embodiments, the glioma has a “…promoter of the subject's gene encoding O6-methylguanine- DNA methyltransferase is unmethylated.”, see page 2, section 0010; and section 00220 bridging pages 29 and 30.
Trikha teaches concomitant treatment including focal radiotherapy (RT), see section 00282 bridging pages 46 and 47. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the RT prior the xenon gas treatment because both documents teach combinatorial therapy, as well as “it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art…Furthermore, if there is language referring to order, such as first and second, it should be understood in an exemplary sense and not in a limiting sense.”, see Michel, page 6, section 0141; and Trikha, page 196, section 00778.
Trikha also teaching in vitro studies utilizing multiple glioma cell, see page 108, section 00391
One of ordinary skill in the art would have been motivated to adapt the in vivo assays, to in vitro assays, wherein the therapeutic agents would be administered in the manner set forth to arrive at a successful and effective treatment for the purpose of validating the desired treatment outcome. Further, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings presented in Trikha and also it is well known in the art, the manner at which any pharmaceutical composition is administered may be adjusted and optimized.
"[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
6. Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel et al., US 2017/0189445 A1 (published July 6, 2017/ IDS reference #2 submitted January 10, 2024), and further in view of Trikha et al., WO 2017/210463 A1 (published 07 December 2017) and Schulz-Ertner et al. (J. Clin. Oncol. 25(8): 953-964, March 10, 2007). Michel teaches treating tumor proliferation of glial cells with xenon gas as an inhalable drug in combination with an N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, in particular, memantine or nitromemantine, see page 1, sections 0002, 0009, 0018-0020, 0022, 0023, 0025, and 0029. Chemotherapy was not administered to the patient, see entire document.
The xenon is in a gas mixture with nitrogen and oxygen, see page 1, sections 0026-0028. “The gas containing xenon is administered to the patient by inhalation”, see page 2, sections 0041 and 0048. “[T]he xenon gas is administered to the patient for an inhalation time of a few minutes to a few hours, typically between 15 minutes and 6 hours, preferentially less than 4 hours”, see page 2, section 0075.
Michel does not teach the patient’s glioma cells (cancerous glial cells) were initially treated with radiation therapy (RT) and the xenon gas is administered:
-after RT at the latest 360 minutes (6 hours) after the completion of the RT (claim 3);
-immediately after completion of the RT (claim 4); and/ or
-continues for at least 30 minutes or for about 360 (6 hours) minutes (claims 5 and 6).
Michel does not teach explicitly teach the focal RT is ionizing radiation including photon beam radiation, proton beam radiation and heavy ion beam radiation.
However, Michel does teach spans of time xenon gas is inhaled that overlaps with the time points set forth in claims 3-6, see page 2, section 0075.
Furthermore, Trikha teaches treating malignant glioma with a combination of therapeutic agents including radiotherapy, see abstract; page 1, section 0004; and page 3, section 0012. In some embodiments, the glioma has a “…promoter of the subject's gene encoding O6-methylguanine- DNA methyltransferase is unmethylated.”, see page 2, section 0010; and section 00220 bridging pages 29 and 30.
Chemotherapy was not administered to the patient at the same as RT, nor inhalation of xenon gas, see entire document.
Trikha teaches concomitant treatment including focal RT, see section 00282 bridging pages 46 and 47. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the RT prior the xenon gas treatment because both documents teach combinatorial therapy, as well as “it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art…Furthermore, if there is language referring to order, such as first and second, it should be understood in an exemplary sense and not in a limiting sense.”, see Michel, page 6, section 0141; and Trikha, page 196, section 00778.
Schulz-Ertner teaches particle RT using particle beams, protons, heavier ions and photon beams, see abstract; and entire document. These types of RT are ionizing radiation.
One of ordinary skill in the art would have been motivated to administer the therapeutic agents in combination and in the manner set forth to arrive at a successful and effective treatment for the purpose of achieving the desired treatment outcome as established in Michel and Trikha, see both, Michel and Trikha in their entireties. Further, one of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings well known in the art, the manner at which the administration of any pharmaceutical composition may be adjusted and optimized.
"[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Conclusion
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- Zhang et al. The neuroprotective effect and possible therapeutic application of xenon in neurological diseases. Journal of Neuroscience Research 99:3274-3283, first published 29 October 2021.
8. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however can normally be reached between 8AM-8PM, Monday through Friday.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached on 571-272-0859. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
December 2, 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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