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 .
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/06/2025 has been entered.
Status of the Application
Claims 1, 75-81 and 83 are pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 75-79, 83 and elected species are rejected under 35 U.S.C. 103 as being unpatentable over Gunton (US 2014/0336230 A1; on record).
Determining the scope and contents of the prior art
Gunton teaches treating and preventing obesity (i.e., delaying the onset of obesity; the subject is healthy and does not have an obesity) encompassed by the instant claims and thus prolonging life by increasing metabolism in human subject by daily oral administration of effective amount of DTPA in combination with components, such as magnesium for several months or years (abstract, paragraphs 0003-0008, 0011-0026, 0223-0225, 0227, 0231, 0235, 0236, figures and claims). The cited prior art further teaches that (1) obesity causes other diseases, such as stroke, cancer, diabetes etc.; (2) obesity is attributed to 280,000 deaths each year; and (3) obesity reduces life span (paragraphs 0003-0005) (thus, preventing obesity does increases life span).
PNG
media_image1.png
707
388
media_image1.png
Greyscale
PNG
media_image2.png
117
414
media_image2.png
Greyscale
PNG
media_image3.png
109
390
media_image3.png
Greyscale
Ascertaining the differences between the prior art and the claims at issue
Gauton teaches applicants process of using DTPA in treating obesity. However, the cited prior art provide example with DFS and fails to provide with DTPA.
Resolving the level of ordinary skill in the pertinent art
With regard to the above difference-Since the cited prior art teaches practicing method with compounds, such as DFS, DTPA etc., and example with DFS, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that the method may be practiced with DTPA as taught by the cited prior art.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
Based on the above established facts, it appears that the above cited prior art read applicants’ process.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have modified the elements as claimed by known methods with no change in their respective functions, and would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Gunton teach treating and preventing obesity (i.e., delaying the onset of obesity; the subject is healthy and does not have an obesity) encompassed by the instant claims and thus prolonging life by increasing metabolism in human subject by oral administration of effective amount of DTPA in combination with components, such as magnesium for several months or years.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that the process may be practiced with DTPA and can be made by teachings of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed process with a reasonable expectation of success.
Response to Arguments
Applicant’s remarks and affidavit, filed on 06/06/2025 and 08/06/2025, have been fully considered but not found persuasive.
Applicants argue that affidavit demonstrates that iron chelators DTPA and DFO do not affect obesity.
This is not found persuasive and the instant claims are found obvious in view of the cited prior art. This is because Gunton specifically teaches preventing and/or reducing obesity and therefore prolonging life using iron chelator, such as DFS, DTPA etc., and specific example with DFS:
PNG
media_image4.png
315
391
media_image4.png
Greyscale
PNG
media_image5.png
544
661
media_image5.png
Greyscale
PNG
media_image6.png
674
1020
media_image6.png
Greyscale
PNG
media_image7.png
662
1011
media_image7.png
Greyscale
Since the cited prior art teaches practicing method with compounds, such as DFS, DTPA etc., and example with DFS, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that the method may be practiced with DTPA as taught by the cited prior art. Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
With respect to affidavit, which is not found persuasive- (1) the office notice that the affidavit did not provide true comparison and have several discrepancies.
PNG
media_image8.png
600
933
media_image8.png
Greyscale
For instance, a) why DFO (compound different from DFS used by the cited prior art) is used to show comparison with DTPA b) why different doses of compared compound DFO and DTPA were used in the data, 25mg/Kg and 15mg/Kg respectively c) most importantly, why the data was collected from 150 days and missing data before 150 days. For accurately presenting if DTPA has any effect on obesity, data should be presented starting from 0 time point in manner similar to Exhibit 6 (applicant’s work US 20140378424 A1), such as:
PNG
media_image9.png
761
775
media_image9.png
Greyscale
or similar to Gunton, starting from 0 time point.
PNG
media_image7.png
662
1011
media_image7.png
Greyscale
Further, contrary to applicant’s argument and affidavit, the data presented in the affidavit (even though missing data before 150 days) in fact shows that there is a reduction in weight with DTPA. Thus, POSA would have reasonably expected DTPA to prevent or treat obesity based on the disclosure of Gunton.
Allowable Subject Matter
Claims 80 and 81 presents allowable subject matter over the cited prior art.
Objection
Claim 80 and 81, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
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, Milligan Adam can be reached on 571-2707674. 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.
/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623