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 .
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 (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.
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.
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.
Claim(s) 1-9, and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0240180 (Li) in view of WO 2021/126159 (Jewell II) (relying on the international filing date of 12/16/2019) as evidenced by WO 2014/149434 (Zemel).
Regarding claims 1 and 13, Li discloses a cat feed [0023] that may comprise 0.5-60 wt% MCTs [0034] and a preferred range of 2-10wt%. Li further discloses that carnitine may be present [0012] and gives an example (Table 1) where MCTs are present at 7wt% and carnitine is present at 750 mg/kg (0.075wt%) resulting in a ratio of 1:93 (0.011) which is outside of the claimed ratio of 1:70 – 1:80 (0.0125-0.014). The disclosure of Li is not limited to this example and Li does not give a range of creatine. Jewell II discloses a cat feed comprising betaine, carnitine and coconut oil (Table 7) and amounts of 0.05-0.1 wt% creatine which provides an overlapping ratio when combined with 2-10wt% MCTs of Li [Jewell II 0051]. One of ordinary skill would have found it reasonable to adjust the relative amounts of carnitine and MCTs as it is well within the purview of one of ordinary skill to adjust the amounts of the ingredients dependent upon the recipient and characteristics thereof.
Further, Table 1 of Li is a single example and one of ordinary skill would have found it obvious to optimize the amounts of the ingredients through routine experimentation.
Li does not expressly disclose the addition of betaine. Jewell II discloses effective amounts of betaine and carnitine of 700-10000ppm (0.07-1wt%) and 50-1000ppm (0.005-0.1wt%), respectively, which results in reduction in basal inflammation and enhanced response to bacterial stimulation [0121, claim 1]. It would have been obvious to add betaine to Li with a reasonable expectation of reducing basal inflammation as demonstrated by Jewell II.
Regarding claims 2-4, Li discloses C8, C10 and C12 can be derived from palm oil and coconut oil [0034].
Regarding claims 5 and 6, Jewell II discloses effective amounts of betaine and carnitine of 700-10000ppm (0.07-1wt%) and 50-1000ppm (0.005-0.1wt%), respectively. It would have been obvious to further provide carnitine in amounts suggested by Jewell II as Li is not limited to the single example of carnitine at 750ppm and one of ordinary skill would reasonably look to Jewell II for disclosure of the effective amounts for health benefits of both betaine and carnitine.
Regarding claim 7, Li discloses a range of 0.5-60wt% and a preferred range down to 2-10w% of MCTs [0034].
Regarding claims 8 and 11, Jewell II discloses a ratio of betaine to carnitine is from about 5:1 to about 25:1 [0012].
Regarding claims 9 and 12, Li discloses 0.5-60wt% and 2-10wt% MCTs which overlaps the claimed range (1-4wt%) and Jewell II discloses 0.07-1 wt% betaine which also overlaps the claimed range (0.03-1wt%), thereby providing an overlapping ratio.
Regarding claim 14, the total amount of betaine and carnitine in Jewell II is 0.075-1.1 wt% which overlaps the claimed range.
Regarding claim 15, the total amount of betaine in Jewell II and MCTs in Li is 0.57-61wt% of 2.07-11wt% which overlaps the claimed range.
Regarding claim 16, a total of carnitine of Jewell II and MCTs in Li is 0.505-61wt% or 2.05-10.1 wt% which overlaps the claimed range.
Regarding claim 17, a total of betaine, carnitine and MCTs of Jewell II and Li is 0.575-61.1 wt% or 2.075-11.1 wt% which overlaps the claimed range.
Regarding claim 18, Zemel discloses that carnitine is a functional ingredient that modulates metabolism and builds lean body mass, thus the pet food of Li as modified by Middleton is expected to possess the same properties due to the presence of carnitine [0100].
Claim(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0240180 (Li) in view of US 2008/0108548 (Luyer) and alternatively Luyer in view of Li, as evidenced by WO 2014/149434 (Zemel).
Li discloses a cat feed [0023] that may comprise 0.5-60 wt% MCTs [0034]. Li further discloses that carnitine may be present [0012] and gives an example (Table 1) where MCTs are present at 7wt% and carnitine is present at 750 mg/kg (0.075wt%) resulting in a ratio of 1:93 which is outside of the claimed ratio of 1:70 – 1:80 (0.0125-0.014). The disclosure of Li is not limited to this example and Li does not give a range of creatine. Further, Table 1 of Li is a single example and one of ordinary skill would have found it obvious to optimize the amounts of the ingredients through routine experimentation. Li does not disclose the addition of betaine.
Luyer discloses a pet food comprising betaine and carnitine where the betaine may be present in an amount of 0.5-5wt% and carnitine in an amount of 0.1-2g/L (0.01-2wt%) and up to 20wt% MCTs [0020, 0028, 0029, 0041] of the lipid fraction of 40-90wt%. It would have been obvious to one of ordinary skill to add betaine to the pet food of Li as disclosed by Luyer with a reasonable expectation of optimizing vagal stimulation [abstract of Luyer].
With regard to Li in view of Luyer or Luyer in view of Li, one of ordinary skill would have found it reasonable to adjust the relative amounts of carnitine and MCTs as it is well within the purview of one of ordinary skill to adjust the amounts of the ingredients dependent upon the recipient and characteristics thereof. Moreover, absent a showing of unexpected results, one of ordinary skill would have found it obvious to adjust the amounts to optimize the amounts, thus relative ratios, based upon the desire to balance the effects of each ingredient through routine experimentation.
Regarding claims 2 and 3, the lipid fraction of Luyer may include up to 20wt% MCTs with chain length of 8, 10, or 12 carbon atoms. Li discloses C8, C10 and C12 can be derived from palm oil and coconut oil [0034].
Regarding claim 4, Li discloses coconut oil as the source of MCTs and it would have been obvious to use a similar known source in Luyer.
Regarding claim 5, the amount of betaine of Luyer overlaps the claimed range.
Regarding claim 6, the amount of carnitine of Luyer overlaps the claimed range. Li does not expressly disclose a range of carnitine, however, one of ordinary skill would look to Luyer for teaching an exemplary amount of carnitine relative to betaine and would have found it obvious to use the amounts disclosed with a reasonable expectation of successfully providing a pet food ready for consumption. Moreover, one of ordinary skill would not be limited to the sole example of the amount of carnitine in Li, but would reasonably look to other amounts found to be useful in the art and adjust ratios accordingly.
Regarding claim 7, the amounts of MCTs in Luyer overlap the claimed range based on the teaching that up to 20wt% of the 40-90wt% lipid fraction may be MCTs. Taking a suggested range of 1-20% provides a range of about 0.4-18wt% MCTs. Li discloses a range of 0.5-60wt% and a preferred range down to 2-10w% of MCTs.
Regarding claims 8, 9, 11, 12 and 13, the amounts of betaine, carnitine and MCTs Li as modified by Luyer, and Luyer as modifed by Li overlaps the claimed ranges. Moreover, absent a showing of unexpected results, one of ordinary skill would have found it obvious to adjust the amounts to optimize the amounts, thus relative ratios, based upon the desire to balance the effects of each ingredient through routine experimentation
Regarding claim 14, the combined amount of betaine and carnitine disclosed by Luyer is 0.51-7wt% which overlaps the claimed range.
Regarding claim 15, the combined amount of betaine and MCTs in Luyer is 0.9-23wt% which overlaps the claimed range.
Regarding claim 16, the amount of carnitine and MCTs in Luyer is 0.41-20wt% which overlaps the claimed range.
Regarding claim 17, the total of carnitine, betaine and MCTs in Luyer is 0.91-25wt% which overlaps the clamed range.
Regarding claim 18, Zemel discloses that carnitine is a functional ingredient that modulates metabolism and builds lean body mass, thus the pet food of Li as modified by Middleton is expected to possess the same properties due to the presence of carnitine [0100].
Response to Arguments
Applicant’s amendment to the specification has overcome the rejections under 103 over Li in view of Middleton, and over Jewell in view of Li.
Applicant's arguments filed 04/30/2026 regarding the rejections of Li in view of Jewell II, Li in view of Luyer, and Luyer in view of Li, each as evidenced by Zemel, have been fully considered but are not persuasive.
Applicant amended claim 1 to incorporate the limitations of claim 10 which was cancelled. The rejections over Li in view of Jewell II, Li in view of Luyer, and Luyer in view of Li are maintained for reasons of record. Regarding Li in view of Jewell II, applicant argues that Li fails to disclose the ratio of carnitine to MCTs as claimed and Jewell II fails to remedy the deficiency. Li was modified to add betaine as disclosed by Jewell II. This position does not appear to be challenged in the record. The claimed ratio is considered obviated due to the provision of overlapping ranges of the MCTs and carnitine based upon the disclosures of Li (2-10wt% MCTs) and Jewell II (0.05-0.1wt% carnitine) absent a showing of unexpected results. Applicant argues that the instant specification provides unexpected results for the ratio of carnitine to MCTs of 1:70-1:80 based upon the sole example in the specification. However, the data is not commensurate in scope as the data is directed to a single data point of a ratio of 0.013, a precise betaine amount of 5000 ppm betaine, as well as a source of MCTs limited to coconut oil. There is no data to support the range of ratio claimed (0.0125-0.014) and any amounts of betaine and any source of MCTs. Moreover, the claims are open to any amounts of carnitine and MCTs so long as the ratio is achieved but the example is limited to 2.3wt% MCTs and 0.03wt% carnitine. Thus, the alleged unexpected results are not commensurate in scope with the breadth of the claim scope. See MPEP 716.02(d) which states in part, “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. “See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium).” “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).”
Applicant further argues a synergistic combination of betaine and carnitine. A synergistic relationship is recognized by Jewell II which discloses a ratio of betaine to carnitine of 25:1 to 5:1 [0012] which overlaps the claimed ratio range of betaine to carnitine of 20:1 to 13:1. Moreover, Luyer discloses the presence of betaine, carnitine and MCTs together in a single composition.
Conclusion
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 JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tong Guo can be reached at 5712723066. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1723
/Jennifer McNeil/Primary Examiner, Art Unit 1723
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