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 .
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) 1-5, 7-9, 12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0239941 (Jewell) in view of US 2019/0240180 (Li) as evidenced by WO 2014/149434 (Zemel).
Regarding claims 1-4, Jewell teaches a cat feed comprising betaine, carnitine, and coconut oil (Table 7). As indicated in instant claim 2, coconut oil is a source of MCTs. Coconut oil inherently provides hexanoic acid.
Jewell discloses an example where betaine, carnitine and MCTs (coconut oil) are present together, but does not give a ratio of carnitine to MCTs.
Li discloses a cat feed [0023] that may comprise 0.5-60 wt% MCTs [0034] which is consistent with Jewell’s disclosure of 0.5-60wt% (claim 2). 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 1:60 – 1:90 but is considered so close as to be patentably indistinct as one would reasonably expect a ratio of 1:90 in the feed to have the same properties as one with a ratio of 1:93. One of ordinary skill would have found it obvious to provide a similar ratio to that disclosed by Li based upon the express disclosure of an effective relative amount of each ingredient. Further, Table 1 of Li is a single example and one of ordinary skill would have found it obvious to optimize the ingredient amounts through routine experimentation.
Regarding claim 5, Jewell teaches a range of 0.25-1 wt% of betaine which falls within the claimed range. Moreover, Table 7 indicates an amount of 0.5wt%.
Regarding claim 7, as indicated in Table 7 of Jewell, coconut oil may be present in an amount of 4wt%.
Regarding claim 8, a ratio of the betaine of Jewell to the exemplified amount in Li provides a ratio of 3.33:1 to 13.33:1 which overlaps the claimed range.
Regarding claim 9, Jewell teaches a range of betaine of from 0.25-1wt% and gives an example of coconut oil at 4wt% (Table 7). This amounts to a ratio of 0.0625-0.25 (0.25:4 – 1:4) which overlaps the claimed range of 0.143-0.333 (1:3 – 1:7). See MPEP 2144.05(I) which states in part “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”.
Regarding claim 12, a value of 1:4 (betaine: coconut oil) is considered to meet the claimed value of “about 1:4.6”. See MPEP 2144.05(I) citing In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.). Also, 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."). Here, a value of 1:4 is considered to overlap with “about 1:4.6” or alternatively is so close as to not be patentably distinct and one of ordinary skill would reasonably expect the ratio of 1:4 to possess similar properties to a ratio of about 1:4.6.
Regarding claim 14, according to the value of 0.5wt% for betaine and 0.3wt% for carnitine in Table 7, the range of about 0.3-1wt% for the total of betaine and carnitine is met.
Regarding claim 15, according to the value of 0.5wt% for betaine and 4% for coconut oil in Table 7, the range of about 1-5wt% for the total of betaine and MCT source is met.
Regarding claim 16, according to the value of 0.3wt% for carnitine and 4wt% for coconut oil in Table 7, the range of about 1-5wt% for the total of carnitine and MCT source is met.
Regarding claim 17, according to the value of 0.5wt% betaine, 0.3wt% for carnitine and 4wt% for coconut oil in Table 7, the range of about 1-5wt% for the total of betaine, carnitine and MCT source is met.
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.
Claim(s) 1-18 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).
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 1:60 – 1:90 but is considered so close as to be patentably indistinct as one would reasonably expect a ratio of 1:90 in the food to have the same properties as one with a ratio of 1:93. 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 and 50-1000ppm, 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 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 as Li is not limited to the single example of carnitine at 750ppm and one of ordinary skill would reasonably look to Jewell 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 claims 10 and 13, Jewell II discloses 0.05-0.1 wt% creatine and 2-10wt% MCTs which provides an overlapping ratio. Further, 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.
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 1:60 – 1:90 but is considered so close as to be patentably indistinct as one would reasonably expect a ratio of 1:90 in the food to have the same properties as one with a ratio of 1:93. 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, 28, 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].
For Luyer in view of Li, one of ordinary skill would have modified Luyer which combines betaine, carnitine and MCTs to provide a ratio of carnitine to MCTs as exemplified by Li as it is demonstrative of a known and useful relative ratio of carnitine to MCTs for a pet food. As noted above, the ratio of Li is not seen to be patentably distinct from the claimed range and is considered to obviate the claimed range.
Moreover, 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.
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 8-13, 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].
Claim(s) 1-5, 7, 9, 12, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0240180 (Li) in view of US 10,624,370 (Middleton) as evidenced by WO 2014/149434 (Zemel).
Regarding claims 1 and 5, 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 1:60 – 1:90 but is considered so close as to be patentably indistinct as one would reasonably expect a ratio of 1:90 in the food to have the same properties as one with a ratio of 1:93. 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.
Middleton teaches a composition that modulates digestibility in pets (companion animals) and that a metabolite that modulates fat digestibility such as betaine can be added. Examples of betaine added in an amount of 0.61 and 0.69 wt% (Table 3) are given. It would have been obvious to add betaine in the claimed amounts to the pet food of Li with a reasonable expectation of modulating fat digestibility which is beneficial to the pet recipient.
Regarding claims 2 and 3, 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.
Regarding claim 7, Li discloses a range of 0.5-60wt% and a preferred range down to 2-10w% of MCTs which is consistent with and overlaps with the claimed range of about 1 to about 4wt%.
Regarding claims 9 and 12, the ratio of the betaine to coconut oil is considered to be optimizable based upon the desired effect of weight loss and improved digestibility. In other words, optimizing the amounts of coconut oil to provide the desired MCTs for weight loss and optimizing the amount of betaine as disclosed by Middleton to provide the effect of improved digestibility in pets is within the purview of one of ordinary skill in the art. Moreover, the amount of MCTs present in Li (2-10 wt%) and the example of 0.61wt% betaine in Middleton results in a ratio of betaine : MCTs of 0.061-0.305 which overlaps the range of 1:3 to 1:7 (0.143-0.333).
Regarding claim 15, as indicated above, amount of MCTs in Li (2-10wt%) and the examples from Middleton for betaine are 0.61 and 0.69wt%, thus falling within the claimed range of 1-5wt%.
Regarding claim 16, the amount of carnitine in Li (0.075wt%) and the amount of MCTs in the range of Li is 0.05-60wt% or 2-10wt%. Li is not limited to the example given; thus, one would reasonably look to the entire disclosure for the range of MCTs. The sum of carnitine and MCTs overlaps the claimed range.
Regarding claim 17, the sum of the amounts of carnitine, betaine and MCTs overlap 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].
Response to Arguments
Applicant’s amendment to the specification has overcome the rejection.
Applicant’s amendments to claims 14-17 have overcome the objections.
Applicant's arguments filed 12/03/2025 have been fully considered and are persuasive. Claim 1 was amended to incorporate limitations from claim 10 which has altered the scope of several dependent claims, thus necessitating new rejections above. The amendment also overcame the 102 over Jewell ‘941 and the 103 over Jewell ‘941. The amendment overcomes the 103 rejection over Pan in view of Maniga as evidenced by Haghighi.
New grounds of rejection are made above.
Conclusion
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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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793