DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed January 29, 2025 has been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1, 2, 4, 8, 9, 11-14, and 16-19 are pending.
Election/Restrictions
4. In the reply filed on October 28, 2024, applicant elected Group I, now claims 1, 4, 8, 9, 12 and 20, and 15, pulse protein for species A and sarcopenia for species B without traverse.
5. Claims 2, 11, 13, 14 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
6. Claims 1, 4, 8, 9, 12 and 20 are examined on the merits in regards to the elected species.
Claim Rejections - 35 USC § 103
7. Claim(s) 1, 4, 8, 9, 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bueno Vargas (WO 2016/029113 A1).
This reference teaches a method for treating sarcopenia by administering a composition comprising inulin and a protein. The reference teaches that the protein can be pea protein. The reference teaches that the inulin is obtained from Jerusalem artichokes or chicory and has an average degree of polymerization of 25 or 10-12. In addition, the reference teaches that the inulin (as the prebiotic ingredient) in used in a concentration between 1 to 20% and the protein is used in a concentration between 5 to 40% (see page 4, lines 2, 16, 17; page 12, lines 12-17; page 14, lines 26-33; page 16, lines 16 and 34; page 27, line 16 – page 28, line 24; page 30, lines 13-19; and page 45).
The reference does not explicitly teach a composition with the combination of inulin and pea protein. However, as discussed above, the reference does state that pea protein is a useful type of protein for addition to the composition and includes both inulin and pea protein in the claims. Thus, the combination of these two ingredients is well within the teachings of the reference and would be an obvious combination for an artisan to employ given these teachings. The artisan would reasonably expect that pea protein and inulin could be combined into a single composition, and the artisan would be motivated to make this combination based on this reasonable expectation of success.
The reference does not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The reference teaches the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Response to Arguments
Applicant's arguments filed January 29, 2025 have been fully considered but they are not persuasive. Applicant argues that the reference does not teach the claimed invention because the reference teaches that whey protein, rather than pea protein, is the preferred protein. However, as discussed above, the reference explicitly teaches, and claims, that pea protein is a useful ingredient in the composition. Thus, an artisan of ordinary skill would reasonably expect that this protein could be successfully utilized in the composition taught by the reference.
In addition, applicant argues that the claimed invention is patentable based on the evidence in the specification that shows that pea protein is superior to whey protein when combined with inulin. However, as discussed in MPEP section 716.02, “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected… The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.’…”. Figures 1-4 do demonstrate a distinction between the whey protein and pea protein groups; however, it is not clear why this distinction is considered to be unexpected rather than a reasonable difference that would be expected between two distinct compositions. Thus, applicant’s claim for patentability based on unexpected results is not persuasive.
8. Claim(s) 1, 4, 8, 9, 12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barron (US 2012/0288588) in view of Bueno Vargas (WO 2016/029113 A1).
Barron reference teaches a method for reducing muscle wasting in senior citizens (sarcopenia) by administering a composition comprising pea protein and inulin. The reference teaches using the pea protein and inulin in a 3:1 ratio (see paragraphs 2 and Table 4). The reference does not teach the degree of polymerization of the inulin.
However, Bueno Vargas teaches that inulin with an average degree of polymerization of 25 is a “high performance inulin” and is useful in treating muscle wasting (see claim 33). Thus, the artisan of ordinary skill would reasonably expect that inulin with this degree of polymerization would be useful as the inulin ingredient in the composition taught by Barron. This reasonable expectation of success would have motivated the artisan to modify Barron to include the use of the inulin ingredient taught by Bueno Vargas.
The references do not specifically teach adding the ingredients together in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Response to Arguments
Applicant's arguments filed January 29, 2025 regarding the previous rejections based on Barron have been fully considered but they are not persuasive. Applicant argues that Barron does not teach the claimed invention because Barron requires the use of additional proteins in combination with the pea protein. However, applicant’s claims use the broad transitional phrase “comprising.” As discussed in MPEP section 2111.03, “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps…”. Thus, the reference properly teaches the stated claims because applicant’s claims encompass unrecited elements.
Applicant also argues that the Barron does not explicitly teach that the combination of pea protein and inulin in useful for treating muscle loss. However, Barron specifically states that the composition is useful for treating muscle wasting in senior citizen (see paragraph 2). Thus, this argument is not persuasive.
9. 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 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 Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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