DETAILED ACTION
America Invents Act
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 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.
Election/Restrictions
Applicants elected group I (hydrolyzed protein formulations), hydrolyzed beef protein and transfer factor without traverse in the reply filed on 23 Jan, 2017. Applicants have since amended the claims so they no longer read on applicant’s elected species.
Applicants argue that “hydrolyzed beef protein” reads on whey hydrolysate, so all claims should be examined. There are two issues with this argument. Applicants were required to elect a single, distinct, and disclosed protein. Nowhere did they elect whey hydrolysate, and the wording of the restriction requirement means that they are not to elect a genus of compounds, but a specific compound. Second, beef hydrolysate is a term of use in the art, note the webpage for xtreme beef amino (first cited in office action of 27 Feb, 2017). As such, a person of skill in the art would not read it to include whey protein hydrolysate.
Claims Status
Claims 1, 11, 12, 46, 47, 56, 58, and 65-103 are pending.
Claims 1 and 71 have been amended.
Claims 1, 22, 12, 46, 47, 56, 58, 65, 66, 67-70, 80-87, and 89-103 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claims 71-79, and 88 under 35 U.S.C. 103 as being unpatentable over Manninen (Nut. Metabol. (2009) 6 (38) p1-5, previously cited) in view of Moorhead (Gardian, issue of 24 June, 2012, previously cited), and Grimble et al (Gastroenterology (1987) 92 p136-142) with evidentiary support from Lisonbee et al (US 20080081076, previously cited) is hereby withdrawn due to amendment.
The rejection of claims 71-79, and 88 under 35 U.S.C. 103 as being unpatentable over Manninen (Nut. Metabol. (2009) 6 (38) p1-5, previously cited) in view of Moorhead (Gardian, issue of 24 June, 2012, previously cited), Grimble et al (Gastroenterology (1987) 92 p136-142, previously cited), Gunzer et al (Nutrients (2012) 4 p1187-1212, previously cited), and Lisonbee et al (US 20080081076, previously cited) is hereby withdrawn due to amendment.
New Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 71-79 and 88 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 71 has been amended so it, and all claims that depend on it, has a limitation that the amounts of the whey protein and hydrolyzed egg white provide a dose of leucine that promotes muscle growth without suppressing degradation of proteins in skeletal muscle. There is no support for this limitation. The only mention of leucine in the disclosure as filed is paragraph 25 on p7, which states that leucine increases muscle synthesis, promotes muscle growth, and may suppress degradation of skeletal muscle proteins, but high amounts lead to a loss of appetite. Nowhere does the disclosure mention increasing muscle synthesis separate from suppressing degradation of skeletal muscle proteins, much less that there is a dose that will do one rather than the other. Thus, this limitation constitutes new matter.
Claim Rejections - 35 USC § 112(b)
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 71-78 and 88 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 71 has been amended so that it, and every claim dependent on it, requires a dose with a sufficient amount of leucine to promote muscle growth without suppressing degradation of proteins in skeletal muscle. The issue is that the patient is not defined in the claim. A human subject with kwashiorkor, a disorder caused by protein deficiency (Palm et al, BMJ Case Rep. (2016), 1st page, 1st column, 1st paragraph) will likely benefit from a different leucine dose than a human subject on the Atkin’s diet, a high protein diet (Mahdi, Ann. Saudi Med. (2006) 26(3) p244-245, p244, 3d column, 3d paragraph, continues to p245) taking a variety of supplements for body building. And it is unlikely that the dose of either subject would be similar to one that would benefit a mouse or a whale.
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 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.
First rejection
Claims 71-79, and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Manninen (Nut. Metabol. (2009) 6 (38) p1-5, previously cited) in view of Moorhead (Gardian, issue of 24 June, 2012, previously cited), and Grimble et al (Gastroenterology (1987) 92 p136-142) with evidentiary support from Lisonbee et al (US 20080081076, previously cited).
Manninen discusses protein hydrolysates in sports nutrition (title). The rate of uptake for longer polypeptides is limited by hydrolysis of the peptides from whey, egg, and casin in the intestine, this step is not necessary for smaller peptides (p1, 2nd column, 2nd paragraph, continues to p2). This leads to the kinetics of absorption of a protein hydrolysate is determined by the proportion of smaller peptides in the mix (p2, 1st column, 1st paragraph). This more rapid uptake leads to more effective stimulation of skeletal muscle protein synthesis (3d page, 1st column, 2nd paragraph). Hydrolyzed whey protein provides for greater gains in muscle strength and lean body mass in bodybuilders vs. intact proteins (p3, 1st column, 3d paragraph), improved recovery time (p3, 2nd column, 1st paragraph), and improves the effect of carbohydrate ingestion on post exercise muscle glycogen resynthesis (p4, 1st column, 4th paragraph).
The difference between this reference and the instant claims is that this reference does not discuss bovine colostrum, including transfer factors and immune modulators, or egg white protein hydrolysate.
Moorhead discusses how colostrum helps athletes (title). This material strengthens the gut lining, reducing its permeability (2nd page, 5th paragraph). In athletes, this can be a problem causing serious effects on performance (2nd page, 3d paragraph), which is completely eliminated by bovine colostrum (2nd page, 4th paragraph). A convenient format is a powder which can be added to drinks and shakes (2nd page, 2nd paragraph). This reference teaches that athletes could benefit from treatment with bovine colostrum.
Grimble et al discuss the effect of chain length on the absorption of egg protein hydrolysates in humans (title). Commercially available deglycosylated egg white was enzymatically digested (p137, 1st column, 3d paragraph). Three different preparations were made, which differed in their extent of hydrolysis (table 1, p137, 2nd column, bottom of page). The more extensively hydrolyzed materials had better absorption than the formulation with the longer peptides, even though the difference was only a few amino acids (p141, 1st column, 3d paragraph), indicating that, as described by Mannninen, the smaller peptides are more rapidly taken up (;141, 2nd column, 1st paragraph). This reference teaches that egg white hydrolysate peptides of around 2-3 amino acids in length are more rapidly absorbed, which would be expected to lead to the benefits described by Manninen.
Therefore, it would be obvious to include the bovine colostrum to the formulations of Manninen, to prevent the runner’s trots described by Moorhead et al. As Moorhead teaches that this material is very effective for this purpose, an artisan in this field would attempt this addition with a reasonable expectation of success.
Furthermore, it would be obvious to add the hydrolyzed egg white protein of Grimble et al, as those peptides have more rapid uptake than the longer proteins, which suggests that they will provide the benefits described by Manninen. As Manninen expressly states that this effect occurs for egg proteins, an artisan in this field would add this component with a reasonable expectation of success.
Manninen teaches whey protein hydrolysates for athletes. Moorhead teaches bovine colostrum (including powder forms) to prevent intestinal issues. Note that the powdered form has had water removed, i.e. has been fractionated. Grimble et al renders obvious adding egg white hydrolysate. While none of the references discuss the ratio of egg white hydrolysate with whey protein hydrolysate, differences in concentration, absent secondary considerations, is not a patentable distinction (MPEP 2144.05 (II)(A)). Manninen discusses use of the compounds for increased skeletal muscle synthesis, this indicates that the dosage for the patient is appropriate for this purpose, meeting the leucine dosage requirement. Alternatively, for a reasonable dose, there exists a patient for which the dose would be appropriate. Thus the combination of references renders obvious claims 71. 73, 74 and 79.
The colostrum contains a fraction of less than 5 kDa, which, as evidenced by Lissonbee et al, comprises the nanofraction immune modulators (abstract), rendering obvious claims 72, 78, and 79.
Moorhead discusses powdered formulations that are mixed into drinks, rendering obvious claims 56 and 75-77.
None of the references mention soy protein, so there is no motivation in the references to add it, rendering obvious claim 88.
second rejection
Claims 71-79, and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Manninen (Nut. Metabol. (2009) 6 (38) p1-5, previously cited) in view of Moorhead (Gardian, issue of 24 June, 2012, previously cited), Grimble et al (Gastroenterology (1987) 92 p136-142, previously cited), Gunzer et al (Nutrients (2012) 4 p1187-1212, previously cited), and Lisonbee et al (US 20080081076, previously cited).
Manninen discusses protein hydrolysates in sports nutrition (title). The rate of uptake for longer polypeptides is limited by hydrolysis of the peptides from whey, egg, and casin in the intestine, this step is not necessary for smaller peptides (p1, 2nd column, 2nd paragraph, continues to p2). This leads to the kinetics of absorption of a protein hydrolysate is determined by the proportion of smaller peptides in the mix (p2, 1st column, 1st paragraph). This more rapid uptake leads to more effective stimulation of skeletal muscle protein synthesis (3d page, 1st column, 2nd paragraph). Hydrolyzed whey protein provides for greater gains in muscle strength and lean body mass in bodybuilders vs. intact proteins (p3, 1st column, 3d paragraph), improved recovery time (p3, 2nd column, 1st paragraph), and improves the effect of carbohydrate ingestion on post exercise muscle glycogen resynthesis (p4, 1st column, 4th paragraph).
The difference between this reference and the instant claims is that this reference does not discuss bovine colostrum, including transfer factors and immune modulators, or egg white protein hydrolysate.
Grimble et al discuss the effect of chain length on the absorption of egg protein hydrolysates in humans (title). Commercially available deglycosylated egg white was enzymatically digested (p137, 1st column, 3d paragraph). Three different preparations were made, which differed in their extent of hydrolysis (table 1, p137, 2nd column, bottom of page). The more extensively hydrolyzed materials had better absorption than the formulation with the longer peptides, even though the difference was only a few amino acids (p141, 1st column, 3d paragraph), indicating that, as described by Mannninen, the smaller peptides are more rapidly taken up (;141, 2nd column, 1st paragraph). This reference teaches that egg white hydrolysate peptides of around 2-3 amino acids in length are more rapidly absorbed, which would be expected to lead to the benefits described by Manninen.
Gunzer et al discuss nutritional intervention to help ameliorate exercise induced immunodepression in athletes (title). Athletes have more upper respiratory tract infections than non-athletes (p1188, 3d paragraph); while some exercise helps the immune system, going beyond that will decrease its effectiveness (p1188, 4th paragraph). There is a transient window after exercise where cellular immunity is impaired (p1198, 6th paragraph), but prolonged intense exercise can result in chronically impaired immune function (p1190, 2nd paragraph). Inadequate nutrition can play a role (p1190, 4th paragraph), but evidence for single macronutrients on athlete health is scarce and what results there are often inconsistent (p1200, 2nd paragraph). Use of a mixture of several supplements is likely to be more effective than a single supplement (abstract). This reference teaches that athletes (the users of the whey protein hydrolysate described in a prior reference) can have suppressed cellular immunity, which can be mediated to some extent via the diet.
Lisonbee et al discuss immune modulators (title). Sources of these compounds include mammalian colostrum, including bovine colostrum (paragraph 7). Various fractions of beef colostrum were isolated, including the fractions that comprise transfer factors, 4-8 kDa (paragraph 6). These fractions stimulated metabolic activity of CD4+ white blood cells (paragraph 31), and CD3+ white blood cells (paragraph 38), some of the same types of cells that Gunzer et al teach are impaired in athletes. Similar results were found with the fraction of less than 4 kDa (nanofraction immune modulators)(paragraph 33). Administration of these compounds can mediate a subject’s cell mediated immunity (paragraph 43). The material can be administered in many forms, such as a powder, which may include ingredients to provide a desirable flavor, a drink, a gel, or any other suitable form (paragraph 48). This reference discusses compounds that can counteract the immune system depression discussed by Gunzer et al.
Therefore, it would be obvious to add the hydrolyzed egg white protein of Grimble et al, as those peptides have more rapid uptake than the longer proteins, which suggests that they will provide the benefits described by Manninen. As Manninen expressly states that this effect occurs for egg proteins, an artisan in this field would add this component with a reasonable expectation of success.
Furthermore, it would be obvious to add the bovine colostrum fractions of Lisonbee et al, to the formulation of Manninen and Grimble et al, to counteract the immune system depression discussed by Gunzer et al. As the two references discuss much the same cell populations, an artisan in this field would make this modification with a reasonable expectation of success.
Manninen teaches whey protein hydrolysates for athletes. Manninen discusses use of the compounds for increased skeletal muscle synthesis, this indicates that the dosage for the patient is appropriate for this purpose, meeting the leucine dosage requirement. Alternatively, for any reasonable dosage form, there exists a patient for which the dose would be appropriate. Grimble et al renders obvious adding egg white hydrolysate. While none of the references discuss the ratio of egg white hydrolysate with whey protein hydrolysate, differences in concentration, absent secondary considerations, is not a patentable distinction (MPEP 2144.05 (II)(A)). Gunzer et al and Lissonbee et al together render obvious adding bovine colostrum fractions. Thus the combination of references renders obvious claims 71, 73, 74.
Lissonbee et al discuss colostrum fractions of less than 4 kDa (nanofraction immune modulator), and 4-8 kDa, rendering obvious claims 72, 78, and 79.
Moorhead discusses powdered formulations that are mixed into drinks, rendering obvious claims 56 and 75-77.
None of the references mention soy protein, so there is no motivation in the references to add it, rendering obvious claim 88.
Conclusion
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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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