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 Application
The Amendments and Remarks filed on 01/23/26 are acknowledged.
Claims 2-6, 14, and 17-43 were cancelled.
Claims 1, 12-13, and 15 were amended.
Claims 1, 7-13, and 15-16 are pending and are included in the prosecution.
Response to Amendments/Arguments
Rejection of claims under 35 USC § 103
Applicant amended claim 1 as follows:
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In light of this amendment, Applicants’ arguments (Pages 4-7, filed 01/23/26) regarding the rejection of claims 1-2 and 7-16 under 35 U.S.C. 103 as being unpatentable over Durkee et al. (US 2017/0151300 A1 – “Durkee”), as evidenced by NIH (“Are You At A Healthy Weight?” NIH, December 2013, 2 pages), in view of Sugita et al. (British Journal of Nutrition (2013), 110, 733-738) and Fernandez et al. (Flavour Fragr. J. 2006; 21: 162-165) have been fully considered and are persuasive. Since the primary reference, Durkee, teaches a composition comprising not only Aframomum melegueta seed extract, but also other fat-burning ingredients ([0049]), it does not meet the newly added transitional phrase of “consisting of” which is closed language and does not allow the inclusion of additional components.
Therefore, the obviousness rejection based on Durkee is withdrawn.
However, upon further consideration of the amended claims, a new ground(s) of rejection is made under 35 U.S.C. 103 as being unpatentable over Sugita et al. (British Journal of Nutrition (2013), 110, 733-738 – “Sugita”) in view of Fernandez et al. (Flavour Fragr. J. 2006; 21: 162-165 – “Fernandez”).
Since the new grounds of rejection were necessitated by Applicant’s amendment, this action is made FINAL.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 7-13, and 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1, lines 2-3, recites “… an effective amount of a composition consisting of an extract of Aframomum melegueta …” (emphasis added).
It is unclear if the composition consists only of an extract of Aframomum melegueta or if a delivery vehicle and the corresponding required components are required, for example, a tablet and tabletting excipients such as bulk filler or diluent, lubricant, disintegrant, etc.
Instant claim 1, last two lines, also recites “wherein administering the composition to the subject at a dose of 500 mg per day for 12 weeks reduces body weight in the subject by about four kilograms” (emphasis added). Regarding the “wherein” clause, MPEP 2144.04(I) states that: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.”
In the instant specification, Example 3 discloses that subjects received oral doses of 250 mg capsules twice daily (before breakfast and dinner) for 12 weeks. However, instant claim 1 does not positively recite any form of the composition (tablet or capsule), any administered dosage amount or dosage range, or any dosage regimen to achieve the claimed method of promoting weight loss.
It is suggested that instant claim 1 positively recite the form of the composition (incorporate the subject matter of claim 11), the components corresponding with the composition (incorporate the subject matter of claim 12), and the administered dose and regimen (incorporate the subject matter of claim 13).
Claim 8, lines 1-2, recites “… wherein said person has a healthy body weight …” Claim 8 is dependent on claim 1, and claim 1 recites a method of promoting weight loss. It is unclear why a person who has a healthy body weight would want to have weight loss promoted. Clarification and/or amendment are required.
Claim 12, lines 1-2, recites “The method of claim 1, wherein said composition includes at least one of an excipient …” (emphasis added). Claim 12 is dependent on claim 1, and claim 1, line 3, recites “composition consisting of an extract of Aframomum melegueta …” (emphasis added). The transitional phrase “consisting” is considered closed language. Please see MPEP 2111.03(II). It is unclear how claim 1 can be closed to additional components but claim 12 includes additional components such as excipients etc. It is suggested that the limitations of claim 12 be included in claim 1 so that all the components for the composition are recited along with the transitional phrase “consisting of.”
Similarly, claim 15, lines 1-2, recites “The method of claim 1, wherein said composition includes at least one of a vitamin …” (emphasis added). Claim 15 is also dependent on claim 1, and claim 1, line 3, recites “composition consisting of an extract of Aframomum melegueta …” (emphasis added). The transitional phrase “consisting” is considered closed language. Please see MPEP 2111.03(II). It is unclear how claim 1 can be closed to additional components but claim 15 includes additional components such as vitamins etc. It is suggested that the limitations of claim 15 be included in claim 1 so that all the components for the composition are recited along with the transitional phrase “consisting of.”
Claims 7, 9-13, and 16 are included for not correcting the defects of the claims from which they depend.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
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 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 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.
Claims 1, 7-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sugita et al. (British Journal of Nutrition (2013), 110, 733-738 – “Sugita”) in view of Fernandez et al. (Flavour Fragr. J. 2006; 21: 162-165 – “Fernandez”).
The claimed invention is a method of promoting weight loss, comprising administering to a person in need thereof an effective amount of a composition consisting of an extract of Aframomum melegueta having 15% 6-paradol, 8% 6-shoagol, and 17% 6-gingerol, wherein administering the composition to the subject at a dose of 500 mg per day for 12 weeks reduces body weight in the subject by about four kilograms.
Sugita teaches that oral ingestion of GP or Aframomum melegueta extract (40 mg) activates brown adipose tissue (BAT) and increases whole-body energy expenditure (EE) in men (Abstract). The GP extract is a potential tool for increasing BAT thermogenesis and decreasing body fat (Page 737, Col. 1, last ¶, lines 1-3). In human subjects, daily ingestion of GP extract for 4 weeks resulted in slight but significant reduction in visceral fat (Page 737, Col. 1, last ¶, lines 7-14). HPLC analysis of the extract revealed 12.5% of 6-paradol, 1.7% of 6-shogaol, and 15.2% of 6-gingerol (Page 734, Col. 1, last ¶ under “Test substances”).
Sugita does not expressly disclose 15% 6-paradol, 8% 6-shoagol, and 17% 6-gingerol.
Fernandez teaches that the major components of a supercritical CO2 extract or supercritical fluid extraction (SFE) product of Aframomum melegueta includes 13.3% ± 2 or 11.3% - 15.3% of 6-paradol, 6.1% ± 0.3% or 5.8% to 6.4% of 6-shogaol, and 10.0% ± 0.9% or 9.1% to 10.9% of 6-gingerol (Abstract and Page 164 - Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of using an extract of GP or Aframomum melegueta extract that activates BAT, increases whole-body EE, decreases body fat, and contains 12.5% of 6-paradol, 1.7% 6-shogao, and 15.2% of 6-gingerol as taught by Sugita, in view of the SFE product of Aframomum melegueta that includes 15.3% of 6-paradol and 6.4% of 6-shogaol, as taught by Fernandez, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because both references disclose extracts of Aframomum melegueta, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141 (III) (A). One of ordinary skill in the art would have had a reasonable expectation of success in increasing metabolic rate and promoting weight and fat loss by combining the teachings of the cited prior art references.
One of ordinary skill in the art would have found it obvious to combine the extracts of Aframomum melegueta as taught by Sugita and Fernandez because these extracts are equivalents which are known to be useful for the same purpose, i.e., for activating BAT, increasing whole-body EE (Abstract), decreasing body fat, (Page 737, Col. 1, last ¶, lines 1-14), as taught by Sugita. MPEP § 2144.06 states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine said extracts with a reasonable expectation of success because each extract is taught to be useful for the same purpose and it is prima facie obvious to combine said actives to form a third composition to be used for the very same purpose.
Also, the claimed concentration of 15% 6-paradol would have been obvious over the 12.5% 6-paradol taught by Sugita (Page 734, Col. 1, last ¶ under “Test substances”). The claimed concentration of 8% 6-shogaol would have been obvious over the 6.4% 6-shogaol taught by Fernandez (Table 1). The claimed concentration of 17% 6-gingerol would have been obvious over the 15.2% 6-gingerol taught by Sugita (Page 734, Col. 1, last ¶ under “Test substances”). According to MPEP 2144.05(I), a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). Furthermore, MPEP § 2144.05(I) also states: “A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004).”
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of a method of promoting weight loss, comprising administering to a person in need thereof an effective amount of a composition consisting of an extract of Aframomum melegueta would have been obvious over the method of oral ingestion of GP or Aframomum melegueta extract that activates BAT) and increases whole-body EE (Abstract), where the GP extract is a potential tool for increasing BAT thermogenesis and decreasing body fat, (Page 737, Col. 1, last ¶, lines 1-3), and in human subjects, daily ingestion of GP extract for 4 weeks resulted in slight but significant reduction in visceral fat (Page 737, Col. 1, last ¶, lines 7-14), as taught by Sugita. The extract of Aframomum melegueta taught by Sugita does not contain any additional components, thereby meeting the claimed requirement of a composition consisting of an extract of Aframomum melegueta. The limitation of an extract of Aframomum melegueta having 15% 6-paradol would have been obvious over the 12.5% 6-paradol taught by Sugita (Page 734, Col. 1, last ¶ under “Test substances”). The claimed concentration of 8% 6-shogaol would have been obvious over the 6.4% 6-shogaol taught by Fernandez (Table 1). The claimed concentration of 17% 6-gingerol would have been obvious over the 15.2% 6-gingerol taught by Sugita (Page 734, Col. 1, last ¶ under “Test substances”). According to MPEP 2144.05(I), a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
Regarding instant claim 7, the limitation of an extract of Aframomum melegueta seeds would have been obvious over the aqueous seed extract of GP or Aframomum melegueta and the GP seeds which are very rich in 6-paradol, 6-gingerol, and 6-shogaol (Page 734, Col. 1, 2nd ¶).
Regarding instant claim 8, the limitation of the person having a healthy body weight or being overweight would have been obvious over the nineteen healthy male volunteers that were used in the study (Page 734, Col. 1, “Subjects”) and the subjects’ profiles (Page 735, Col. 2, Table 1), as taught by Sugita.
Regarding instant claims 9-11, the limitations of the composition being administered systemically (instant claim 9), orally (instant claim 10), and in a capsule form (instant claim 11), would have been obvious over the oral ingestion of GP extract (Abstract) and the daily oral ingestion of the test capsules (Page 734, ¶ bridging Col. 1 and Col. 2), as taught by Sugita.
Regarding instant claim 12, the limitation of at least one of an excipient, pharmaceutical carrier, bulking agent, binding agent, filler and diluent would have been obvious over the 10 mg of GP in a mixture of 158 mg rapeseed oil and 32 mg beeswax in a capsule which consisted of 97.9 mg gelatin, 34.3 mg glycerol and 7.8 mg caramel which read on all the listed components (Page 734, ¶ bridging Col. 1 and Col. 2), as taught by Sugita.
Regarding instant claim 13, the limitation of the composition administered at a dose of 250 mg two times per day would have been obvious over the daily oral ingestion of the test capsules (Page 734, ¶ bridging Col. 1 and Col. 2), and the 10 mg of GP in a mixture of 158 mg rapeseed oil and 32 mg beeswax in a capsule which consisted of 97.9 mg gelatin, 34.3 mg glycerol and 7.8 mg caramel which read on all the listed components (Page 734, ¶ bridging Col. 1 and Col. 2), as taught by Sugita. One of ordinary skill in the art would have found it obvious to adjust the dosage of the capsule, the dosage of the extract of GP or Aframomum melegueta, the number of capsules, and the dosing regimen based on the patient’s underlying condition and the desired therapeutic efficacy related to weight loss. The recited dose would have been an obvious variant absent evidence of criticality or unexpected results.
Regarding instant claim 15, the limitation of the composition including a protein would have been obvious over the gelatin; the limitation of a lipid would have been obvious over the rapeseed oil; the limitation of a carbohydrate would have been obvious over the glycerol, and the limitation of a flavoring would have been obvious over the caramel (Page 734, ¶ bridging Col. 1 and Col. 2), as taught by Sugita.
Regarding instant claim 16, the limitation of the composition combined with a beverage would have been obvious over the capsules (Page 734, ¶ bridging Col. 1 and Col. 2) which are given with 100 ml water, which is a beverage (¶ bridging Pages 734 and 735), as taught by Sugita.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615