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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/5/26, 6/8/26, 7/29/26 and 9/18/26 was filed after the mailing date of the Non-Final Action on 4/3/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 1-3, 19-21, 23, 34, 27, 29-31 and 39-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Vinit et al (WO 2019/030024 A1 hereafter Vinet) in view of Dadachova et al (US 2006/0018827 A hereafter Dadachova) and Hong et al (Brown adipose tissue 18F-FDG uptake in pediatric PET/CT imaging, Pediatric Radiol, 41: 759-768, 2011 hereafter Hong).
Vinet discloses a method PET/CT imaging method for discriminating tumor tissues from brown or beige adipose tissue in human cancer patients comprising administering an iodinated fatty acid of Formula I
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where R1 is H or I where the number of iodine is 1 to 6, R2 is H, unsaturated or saturated (pg. 8, lin. 19-25; pg. 12, lin. 10-21), meeting element a) of claims 1. 18FDG can be applied as a standard contrast agent to visualize brown or beige adipose tissue the where CT images are taken up to 24 hours later (pg. 16, lin. 16-30; pg. 20, lin. 1-5; Figure 3, Example 4), meeting some elements of parts b) and c) of claim 1. The contrast agent is an emulsion comprising biocompatible emulsifier such as lecithin, polyethylene glycol where the excipients can be present about 20% (pg. 15, lin. 25-32, Example 3), meeting limitations 23, 24, 42 and 43. The PET-CT agent is orally delivered and delivers about 0.5-1.6 mg of iodine per kg of body weight (pg. 19, lin. 1-5, Example 4), meeting limitations of claim 27, 39, 40 and 44. The contrast compound is useful for in vivo visualization and monitoring of tumors in the liver (claims), meeting limitations of claim 41.
While the reference discloses a method of in vivo imaging tissues by administering an iodized fatty acid nano emulsion and an additional tracer compound, the reference does not explicitly recite the diagnostic and monitoring limitations of claim 3. The reference discloses that adipose tissue can be imaged non-invasively measured (Example 4). CT images are taken before and 7 hours after oral ingestion as a comparison before and after. The specifics of cancer diagnosis using these compounds are known int eh art as seen in the Dadachova patent.
Dadachova discloses a PET/CT treatment method comprises administration of 18F-FDG to image and diagnose malignant tissues like tumors [0023, 0043]. The tumors can be liver, breast [0043, 0058]. The tracer is administered, and images are taken to observe the build up to the tracer in the tissues [0013]. These areas would be identified positive contrast enhancement, and these areas are seen as malignant [0054]. The method can further comprise an iodized compound [0038-0039, 0042]. These steps would meet limitations d, e and f in step II of claim 3. The efficacy of treatment methods are determined through imaging he tumors and measuring their size/volume over timer [0054], mee=ting limitations of claim 19. It would have been obvious to include the 18F-FDG tracer and diagnostic steps of Dadachova into the similar method of Vinit as they solve the same problem of in vivo diagnostics using iodine compound and 18F PET/CT tracers.
The combination, while disclosing a method for in vivo imaging and diagnosing, is silent to the age of the human patient. However, the use of 18F-FDG tracers in juvenile cancer patient is known in the art as seen in the Hong study.
Hong discloses the use of 18F-FDG tracers for PET/CT imaging of activated Brown adipose tissue in juvenile patients (abstract). Juvenile patients have more activated BAT and thus have better imaging outcomes for 18F-FDG (Conclusion). Hong establishes the level of skill in the art regarding the use of the tracers in distinguishing anatomy, malignant and healthy tissues and the factors useful in that endeavor. As such, it would have been obvious to use the combination of Vinit and Dadachova on juvenile patients.
With these aspects in mind it would have been obvious to combine the prior art would have been with an expected result of a non-invasive, in vivo diagnostic and treatment method of juvenile cancers. It would have been obvious to administer a combination of iodized fatty acids as seen in the Vinit patent and follow the suggestions to further include an 18F-FDG in order to refine the images over time. It would have been obvious to apply this combination, for children as they possess more activated BAT and would lead to more preces images as seen in Hong. It would have been obvious to use these imaging procedures to assess and diagnosis tumor sizes and monitor treatments as seen in Vinit and Dadachova as they solve the same problem. One of ordinary skill in the art would have been obviated to follow these disclosures, teachings and suggestions with an expected results of a non-invasive, and accurate diagnosing method.
Response to Arguments
Applicant's arguments filed 7/6/26 have been fully considered but they are not persuasive. Applicant argues that the combination of the prior art does not render the claims obvious because the combination of Vinit, Dadachova and Hong does not teach or render obvious a method that distinguishes between BAT and tumor tissue.
Regarding this argument, it remains the position of the Examiner that the combination of Vinit, Dadachova and Hong continues to render obvious the methods of the instant claims. The instant method for discriminating primary tumor from brown adipose tissue comprising administering to the human cancer patient a contrast agent comprising an iodinated fatty acid agent, administering a 18FDG PET tracer at least 3 hours after administration of the PET-CT contrast agent and performing a scan on the human patient. While Vinet performs a CT scan, the compounds administered are the same as the instant claims. They are administered in the same form and for the same purpose, specifically to visualize tumors amongst BAT tissues, just like the instant claims. Dadachova discloses a method comprising administration of a 18F-FDG agent and performing a PET-CT scan afterwards. Hong discloses the use of 18F tracers for PET-CT imaging and determination between adipose tissue and tumor tissue when using 18F-FDG tracers, similar to those used in Vinit and Dadachova. Applicant argues that the prior art does not achieve the distinction between tumor tissue and adipose tissue, however the prior art combination completes the same active steps as the instant claims. The same materials and compounds are applied to the same patient population. Vinit specifically indicates that the method results in tumor visualization. The determining, identifying and assigning steps of the instant claims are achieved by Vinet by identifying tumors. It would have been obvious to administer a combination of iodized fatty acids as seen in the Vinit patent and follow the suggestions to further include an 18F-FDG in order to refine the images over time. It would have been obvious to apply this combination, for children as they possess more activated BAT and would lead to more preces images as seen in Hong. It would have been obvious to use these imaging procedures to assess and diagnosis tumor sizes and monitor treatments as seen in Vinit and Dadachova as they solve the same problem. One of ordinary skill in the art would have been obviated to follow these disclosures, teachings and suggestions with an expected results of a non-invasive, and accurate diagnosing method. For theses reason, the claims remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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