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 .
Status of the Application
Claims 1, 75-81, 83-91 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
Applicants’ remarks, filed on 07/29/2026, have been fully considered but not found persuasive.
Applicant argued that Gunton does not demonstrate using DTPA in a healthy subject who does not have obesity to extend their lifespan.
This is not found persuasive, and the instant claims are found obvious in view of the cited prior art. This is because (1) 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 oral administration of effective amount of DTPA in combination with components, such as magnesium for several months or years. Gunton also specifically provides how preventing and treating obesity is a risk factor for other diseases, such as cardiovascular, stroke etc., and therefore increase in lifespan; (2) If Gunton would have provided specific example with DTPA, the rejection would have been anticipation and not obvious; (3) 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 regards to Applicants’ argument that Gunton relates to metabolic effects on mice fed a high fat diet, i.e., different patient population and there is no teaching in Gunton that DFS or DTPA are capable of reducing obesity in a healthy subject and prolonging life- This is again not found persuasive because (1) Gunton specifically teaches reducing obesity and therefore prolonging life:
PNG
media_image4.png
315
391
media_image4.png
Greyscale
PNG
media_image5.png
544
661
media_image5.png
Greyscale
; (2) High fat diet is a mouse model to show that even on high fat diet, mice gained less weight compared to control mice on high fat diet, i.e., prevention. Mouse models are frequently used to determine effect of compounds, drugs, medications etc. and mouse model is also used in the instant specification.
Applicants argue that Examiner’s dismissal of Applicant’s declaration is legally and factually insufficient
This is not found persuasive and the instant claims are found obvious in view of the cited prior art. This is because the Examiner in detail provided why affidavit is not persuasive and the deficiencies in the provided results. If the affidavit was not able to result any allowable subject matter in the rejected claims does not mean that affidavit was dismissed. Specifically, (1) the office notices that the affidavit did not provide true comparison and have several discrepancies.
PNG
media_image6.png
600
933
media_image6.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_image7.png
761
775
media_image7.png
Greyscale
or similar to Gunton, starting from 0 time point.
PNG
media_image8.png
662
1011
media_image8.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.
Instead of providing true comparative data and giving the necessary evidence for which the Examiner raised question, the applicant only argued. Applicants’ argument with no true comparative data and suggestion that the Examiner needs to provide proof or Examiner’s suggestion on data, dose etc., is legally insufficient is again just an argument. Further, if the data and evidence provided by applicants is not persuasive, it does not imply that the Examiner and the office will start conducting experiments to make it persuasive. It is the responsibility of the applicant to provide true comparative data and result that office can glean to get insight what applicant is arguing.
Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art.
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c) for examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration.
Applicants argue that the Examiner has not provided legally sufficient motivation to substitute DTPA for DFS
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_image9.png
674
1020
media_image9.png
Greyscale
PNG
media_image8.png
662
1011
media_image8.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).
Allowable Subject Matter
Claims 80, 81 and 84-91 are allowed.
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.
Conclusion
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
Prosecution Insights