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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 9/29/25. Claims 1-45 are pending. Claims 19-45 are withdrawn. Claims 1-18 are considered on the merits.
Election/Restriction Requirement
Applicant’s election, without traverse, of Group I, claims 1-18, in the reply filed on 9/29/25 is acknowledged. It is regretted that claims 46-48 were not expressly included in the restriction. These claims are now cancelled so no further action is required. However it is noted that the method of Group I would cover claims 46-48 as well.
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.
Claim(s) 1-13, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 2008/0193566, in IDS7/4/22) and Wang et al. (Annals of Biomedical Engineering, 2003).
Miller et al. teach inhibiting tumor growth by administering gaseous nitric oxide (gNO) to a mammal at 1,000 to 50,000 ppm for at least 10 mins (Miller 0033-0038) or preferably 6-9 mins (Miller 0037). This gNO can be administered continuously or pulsed (Miller, 0076) to one or more administration sites (Miller, 0115). They also teach that the amount administered can be adjusted based on the detrimental effects to adjacent healthy tissues (Miller, 0117). Adjusting the amount based on the effects of a previous treatment renders obvious pulsed administration of gNO at least 2 times since a previous treatment was performed, then another treatment based on the results of prior treatment was applied.
They teach the gNO can be administered with the device of Fig 10A and B (Miller 0129-131) which is intended as an attachment of a endoscope or bronchoscope. This device delivers gNO to the tumor through ports #12 and leftover gas salvaged in port #15. The gNO ports #12 are spaced in a circumference to expose the tumor to streams of gNO at different administrations sites. The hole #11 at the center is 0.5-1.5 cm in diameter. While Miller et al. does not disclose that the ports #12 are spaced 0.25-.5 cm or 1-2.5 cm apart, this would be a matter of routine optimization based on the size of the of the device and the amount of gNO to deliver. A larger device could space the ports out to deliver the gNO. Also looking at Fig 10B, the hole #11 is 0.5-1.5 cm in diameter, and that diameter seems to be slightly smaller than the distance of ports #12 in the drawing. The Examiner has included Fig 10B below, with a lines of equal length between two #12 ports and through the diameter of #11 to illustrate the distances are similar. Based on the scale provided in Fig 10, it would be obvious to have ports #12 about 0.5-2.5 cm apart.
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Alternatively Miller et al. teach the NO can be delivered with an NO releasing particle that can be injected transcutaneous (Miller 0107). One of ordinary skill would recognize transcutaneous delivery to a skin tumor as taught by Miller et al. would be a intratumoral injection (Miller 0031).
While Miller et al. does not teach the dose per cm3 of tumor as limited in claims 7 and 8, this could be met via a matter of routine optimization. Miller et al. teach that gNO at various concentrations and various times to treat or prevent cancer (Miller 0117-118). One of ordinary skill would realize that bigger tumors would require more gNO than smaller tumors based conventional dose-response knowledge. Furthermore the time between administering the dose is not expressly stated by Miller et al. but the frequency of doses is also a matter of routine optimization base on the effect of the treatment to the tumor, the effect on the adjacent healthy cells, and dose of gNO applied. One of ordinary skill would recognize that these variables would be optimized based on the success of tumor growth or disappearance.
Also Miller et al. teach many cancers can be treated/inhibited with their method including primary tumors and metastatic tumors (i.e. secondary tumors) (Miller 0111). While Miller et al. does not expressly state this inhibition/treatment is an immunological response, this is an intended result of the method and since Miller et al. executes the same steps, then they obviously produce the same results.
While Miller et al. teach controlling the flow of gNO with either small volumes with precise control to avoid damage to adjacent cells (Miller, 0110, 0120, 0133). However they do not teach these flow rates. This would be obvious in view Wang et al., who teach delivering gNO to cells at a rate of 200 sccm, which converts to 0.2 L/min. Therefore one of ordinary skill would recognize that applying the gNO flow of Wang et al. to Miller et al. would be obvious since this appears to be an acceptable flow rate to expose cells to gNO. Therefore one of ordinary skill would recognize this as simply applying a known method step for exposing cells to gNO. (MPEP 2141 III (B) and (D)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim Rejections - 35 USC § 103
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 2008/0193566) and Wang et al. (Annals of Biomedical Engineering, 2003) as applied to claims 1-13, and 15-18 above, and further in view of Huerta et al. (Future Sci. OA 2015 in IDS 7/4/22).
Miller et al. and Wang et al. render obvious administering gNO to treat a tumors as limited in claim 1. They do not teach co-administering an anti-cancer therapy. However this would be obvious in view of Huerta et al. who teach administering NO to treat cancer as either a single agent or in combination with other antineoplastic compounds (Huerta, abstract). Therefore it would be obvious to add a antineoplastic compound to the method of Miller et al. to treat cancer since Huerta et al. teach this is an option in cancer therapy. One of ordinary skill would recognize this as simply combining two treatments known for cancer (MPEP 2114 III (D) and 2144.06 I).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699