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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
Priority
The instant application is a 371 of PCT/GB2018/053203 filed on 11/05/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/03/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The response filed on 12/03/2025 is acknowledged. Claims 1-33 are cancelled. No claims are amended or new.
Accordingly, claims 34-38 are pending and being examined on the merits herein.
The following grounds of rejection are maintained from the previous Office Action dated 07/03/2025.
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) 34-38 are rejected under 35 U.S.C. 103 as being unpatentable over Westman et al. (WO 2011004162; cited in IDS filed on 05/05/2012).
Westman et al. discloses the following compound shown below (page 51, lines 1-5):
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The above compound disclosed by Westman et al. is the same compound recited in claim 34. Westman et al. discloses their compound can be orally administered (see page 33, lines 16-19 and page 34, lines 27-34), which reads on claim 38. Westman et al. discloses that their compounds can be used to treat a disorder or condition ameliorated by AMPK activation such as diabetes and hyperinsulinemia and associated conditions (see page 32 lines 27-30). Westman et al. further discloses that "treatment of hyperinsulinemia or an associated condition" will be understood by those skilled in the art to include type 2 diabetes … obesity (see page 32 lines 32-33 and page 32 lines 35-36 through page 33, lines 1-9).
The difference between Westman and the claimed invention is that Westman does not expressly disclose a method of reducing bodyweight and increasing energy expenditure in a subject in need thereof.
However, the claimed features of “reducing bodyweight” and “increasing energy expenditure” by administering the recited compound to a subject in need thereof would be necessarily present in the teachings of Westman et al. because Westman et al. discloses that this recited compound can be used to treat the same patient population who are obese and/or have diabetes MPEP 2112 section I recites "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Response to Arguments
Applicant’s arguments filed on 12/03/2025 have been fully considered but were not persuasive.
Applicant states that Westman merely suggests or speculates a possibility of using the compounds for the treatment of obesity. Applicant states that Westman teach several other uses such as cancer treatment for their compounds and that Westman does not provide any examples to link the recited compound for treating obesity. Applicant also indicates that “obesity” is only mentioned once in the disclosure along with a long list of other disorders and conditions.
Applicant’s argument described was also not found persuasive because MPEP 2143.02 I states that “Conclusive proof of efficacy is not required to show a reasonable expectation of success … "To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.” … "This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." … reasoning that "the expectation of success need only be reasonable, not absolute". Therefore, the teachings of Westman do not need to demonstrate the use of the recited compound for treating obesity or diabetes to establish a reasonable expectation of success, and since Westman suggests the treatment of obesity or diabetes using the recited compound, an ordinary skilled artisan would have a reasonable expectation of success. Furthermore, the examples of Westman, which do not demonstrate treatment of obesity and/or diabetes, are exemplary and do not teach away from the whole disclosure of Westman et al.. Lastly, MPEP 2141 states the guidelines for determining obviousness under 35 USC 103, which recites “A patent for a claimed invention may not be obtained … 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.” Therefore, the basis for the 35 USC 103 rejection is not determined by how many times a limitation is disclosed in the prior art. Instead, the claimed invention is prima facie obvious over the disclosure of Westman et al. taken as a whole as described above.
Applicant further states that their previous argument regarding lack of predictability in the state of the art and no reasonable expectation of success were improperly dismissed. Applicant points to several other references which show that not all AMPK activating compounds result in reducing bodyweight and/or increasing energy expenditure. Therefore, Applicant states that, in light of the state of the prior art, there is no predictability or reasonable expectation that the compound of Westman would result in reducing bodyweight and increasing energy expenditure.
Applicant’s argument described was not found persuasive because it is noted that the link between AMPK activation and the claimed “reducing bodyweight” and “increasing energy expenditure” is not relied upon to arrive at the claimed invention in the current rejection of record. Instead, the claimed features of “reducing bodyweight and “increasing energy expenditure” would be necessarily present in Westman because Westman indicates that this compound can be administered to treat the same patient populations (obesity and diabetes) as described above. MPEP 2112.02 states that “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Applicant further states that the disclosure of Westman, which suggests administering the recited compound to the same patient population (diabetes and obesity), will not inherently result in reducing bodyweight because not all instances of administering the recited compound will result in reducing bodyweight. Applicant points to FIG. 4I and FIG.7 in the drawings and shown below:
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Here, Applicant states that FIG. 4I shows that switching the diet of a diet-induced obese mice at 9 weeks from a high fat diet (HFD) to a combination diet of the recited compound and HFD at 0.8 mg / g did not result in the reduction of bodyweight. In contrast, Applicant states that FIG. 7 shows that switching the diet at around 2 weeks or 8 weeks to 2.0 mg recited compound / g HFD resulted in bodyweight reduction.
Applicant’s arguments described above was not found persuasive because the data in FIG. 4I does appear to show a decrease in bodyweight initially before an increase in bodyweight. Therefore, Applicant has not appeared to establish that not all instances of administering the recited compound will result in bodyweight reduction. It is noted that the data in FIG. 4I is in weeks and not in days as shown in FIG. 7A, making it difficult to compare the bodyweight data. Additionally, it is noted that the data in Fig. 7A is stopped at around 75 days or around 11 weeks, whereas the data in FIG. 4I is extended to 16 weeks. Therefore, it is also not clear if the higher amount of the recited compound added to HFD in FIG. 7A will result in further reduction of bodyweight or a similar initial decrease then increase in bodyweight as seen in FIG. 4I within the same timespan (around 16 weeks).
Furthermore, it is difficult to determine the true dosage difference of the recited compound between the two sets of experiments because it is unclear if the amount of the recited compound plus HFD consumed per day by the mice was consistent between the two experiments. Applicant demonstrates in FIG. 7B the amount of food consumed by the mice in the experiments shown in FIG. 7A, however this food intake data for the experiment in FIG. 4 cannot be found. Therefore, while a lower amount of the recited compound is added into the HFD in the data of FIG. 4 compared to the data in FIG. 7, the dosage per day of the recited compound cannot be determined.
Because Applicant has not provided evidence that not all instances of administering the recited compound to the patient population (obesity and diabetes) disclosed in Westman will result in bodyweight reduction, the rejection over Westman is maintained.
Lastly, if Applicant were to provide evidence that not all instance of administering the recited compound to the patient population will result in bodyweight reduction, then the instant claims would not be commensurate in scope because the instant claims do not recite an amount / dosage for the recited compound, and furthermore, instant claim 34 does not recite the patient population that is being administered to.
Conclusion
No claim is found allowable.
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 DAVID H CHO whose telephone number is (571)270-0691. The examiner can normally be reached M-F 8AM-5PM.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693