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 amendment
The amendment filed 6/27/2025 has been entered. Claim 2 has been canceled. New claims 33-36 have been added.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 7, 9-16 and 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ichim et al. (US20180303871A1; in IDS dated 10/25/2018), for the reasons set forth in the office action mailed 3/27/2025.
It is noted that new claims 33-35 are just the alternate limitations set forth in claim 3. All three conditions Alzheimer’s, MS and ALS (now set forth in separate claims 33-35) were addressed in the previous office action, thus no new grounds of rejection are needed to meet these newly added claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, and 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ichim et al. (US20180303871A1; in IDS dated 10/25/2018), for the reasons set forth in the office action mailed 3/27/2025.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ichim et al. (US20180303871A1; in IDS dated 10/25/2018) as applied to claims 1-3, and 7-16 above, and further in view of Boche et al. (Boche et al. European Journal of Nuclear Medicine and Molecular Imaging, 46(13), 2831-2847. (2019); Publication date: 08/08/2019), for the reasons set forth in the office action mailed 3/27/2025.
New grounds of rejection
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Ichim et al. (US20180303871A1; in IDS dated 10/25/2018) as applied to claim 4-6 and claims 1, 3 and 7-16 above, and further in view of Boche et al. (Boche et al. European Journal of Nuclear Medicine and Molecular Imaging, 46(13), 2831-2847. (2019); Publication date: 08/08/2019).
New claim 36 adds the limitation that the TSPO is measured in the brain.
The rejection of claims 4-6 above failed to specifically address the new limitation of claim 36 that the TSPO is measured in the brain of the subject. The rejection above clearly addressed measuring the expression of TSPO in microglial cells, but failed to specifically discuss measuring in the brain.
However, microglial cells are located in the brain. This is taught by Boche on page 2832.
It would have been obvious to one of ordinary skill in the to measure the TSPO in the brain of a subject because it is known that TSPO is a marker of microglial cells and that microglial cells are located in the brain as taught by Boche. Since microglial cells/TSPO are specifically located in the brain as taught by Boche, one or ordinary skill in the art would have had a reasonable expectation of success using the brain to measure this marker.
Response to Arguments
Applicant argues that Ichim fails to enable methods of treating neurodegenerative disease and provides some reasoning pertaining to PBMCs not being the standard for treating such diseases. Applicant further assert that the instant specification enables the claimed methods due to mouse models.
This is not found persuasive. The Ichim reference specifically discloses treating neurodegenerative diseases by the administration of xenon gas. While not required, the reference even provides examples of suppression of Alzheimer’s protein by the administration of xenon gas, e.g., examples 2-3. Enablement requires how to make and/or use. Clearly, Ichim teaches that xenon gas can be made and used by administration of the gas to a patient for treating neurodegenerative diseases. These are the same steps and instantly claimed. It is unclear how, as applicant asserts, that the method of Ichim of administering xenon to treat neurodegenerative disease is not enabled but the instant claims having the same steps are enabled. As to applicant’s reliance on mouse models, it is noted that mouse models are not required to show enablement. One could even argue that mouse models are not always indicative of human results. However, such arguments are not relevant in this situation. Clearly, throughout the Ichim reference, various teachings of mechanisms of action are taught for treating neurodegenerative diseases by the administration of xenon gas, see for example, pages 1-2 and the examples. Therefore, Ichim clearly teaches how to make and use the invention. Furthermore, a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; “proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” Impax Labs. Inc. v. Aventis Pharm.Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See also MPEP § 2122. Clearly, Ichim provides more than sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention.
Applicant further asserts that Boche doesn’t even mention xenon and fails to provide a reasonable expectation of success.
This it not found persuasive because Boche is only used as a secondary reference to teach the methods of identifying markers associated with neurodegenerative disease set forth in the claims, i.e., identifying patient populations. It is Ichim that teaches the treatment by the administration of xenon gas for treating neurodegenerative disease.
Conclusion
No claims are allowed at this time.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20170333473 A1 is made of record for teaching of augmentation in amyotrophic lateral sclerosis using xenon and noble gas combinations but was not relied upon herein since it was viewed as cumulative to the references cited herein.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael G Hartley whose telephone number is (571)272-0616. The examiner can normally be reached 10-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener, can be reached at 5712721424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618