DETAILED ACTION
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 the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 24 April 2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 5-8, 10, 12-13, 16, 18, 20-21, 23, and 25-26
Withdrawn claims: 13 and 26
Previously canceled claims: 2-4, 9, 11, 14-15, 17, 19, 22, 24, and 27
Newly canceled claims: None
Amended claims: 1, 6-8, 10, 16, 20, and 23
New claims: None
Claims currently under consideration: 1, 5-8, 10, 12, 16, 18, 20-21, 23, and 25
Currently rejected claims: 1, 5-8, 10, 12, 16, 18, 20-21, 23, and 25
Allowed claims: None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-8, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over MacKinnon (WO 2004/075653 A1, cited on the IDS filed on 30 October 2024) in view of Kuehl Jr. et al. (Kuehl Jr, F. A. & Egan, R. W. (1980). Prostaglandins, Arachidonic Acid, and Inflammation. Science, 210(4473), 978-984.).
Regarding claim 1, MacKinnon discloses a pet food composition (“Hill’s Science Diet Canine Adult Maintenance”, p. 8, lines 3-4; “fatty acid composition of the canine diet”, p. 11, Table 1) comprising, based on the dry matter of the pet food composition:
oleic acid present in an amount of about 4 to about 12 weight % – oleic acid (18:1) is present in an amount of 4.520 weight % (gm/100 gm) (p. 11, Table 1).
arachidonic acid present in an amount of about 0.02 to about 1 weight % – in the modified pet food described regarding claim 1, arachidonic acid is present in an amount of 0.052 weight % (gm/100 gm).
one or more omega-3 fatty acids present in an amount of about 0.1 to about 1 weight % – omega-3 fatty acids are present in an amount of 0.424 weight % (gm/100 gm) (p. 11, Table 1).
one or more omega-6 fatty acids present in an amount of about 1 to about 10 weight % – omega-6 fatty acids are present in an amount of 3.332 weight % (gm/100 gm) (p. 11, Table 1).
MacKinnon does not discuss that the weight ratio of oleic acid to arachidonic acid is from 160:1 to 190:1.
However, Kuehl teaches that free arachidonic acid is oxidized to yield potent pathological agents by the prostaglandin pathway and the lipoxygenase pathway. Kuehl teaches that both prostaglandins, such as prostaglandin E2 (PGE2), from the prostaglandin pathway and leukotrienes from the lipoxygenase pathway are inflammatory mediators that are biosynthesized from arachidonic acid (p. 979, “Summary”). Therefore, taken in the context of a pet food composition, Kuehl teaches one of ordinary skill in the art to reduce the arachidonic acid content in the food to avoid causing inflammation.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the pet food composition of MacKinnon with the teachings of Kuehl to reduce the amount of arachidonic acid in the pet food. One of ordinary skill in the art would have been motivated to do so in order to provide a pet food that does not include unnecessary amounts of the pro-inflammatory agent arachidonic acid. It is recognized that fatty acids in pet food formulations are obtained, at least in part, from the fats in the ingredients used to prepare the pet food. As such, it is recognized that one may not be able to reduce the amount of arachidonic acid in the pet food to zero. However, it is within reason to expect that the amount of fat-containing ingredients could be adjusted to reduce the amount of arachidonic acid in the pet food by about half. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in reducing the amount of arachidonic acid in the pet food composition of MacKinnon from 0.052% to 0.026%. In doing so, the weight ratio of oleic acid to arachidonic acid of the modified pet food would be 4.520:0.026, or 173.8:1. This ratio lies inside the claimed range of 160:1 to 190:1. It is noted that in reducing the amount of arachidonic acid to 0.026%, the modified pet food would comprise 3.306 weight % omega-6 fatty acids, which lies inside the claimed range.
Claim 1 is therefore rendered obvious.
Regarding claim 5, MacKinnon and Kuehl teach the pet food composition according to claim 1.
As described regarding claim 1, modified MacKinnon teaches a pet food with a weight ratio of oleic acid to arachidonic acid of 173.8:1. As evidenced by the instant specification at paragraph [0028], “According to the present application, use of the term "about" in conjunction with a numeral value refers to a value that may be +/- 5% of that numeral.” Therefore, the claimed ratio of “about 172:1” equates to 163.4:1 to 180.6:1. The ratio of 173.8:1 lies inside the claimed ratio.
Therefore, claim 5 is rendered obvious for the same reasons and with the same expectation of success as described regarding claim 1. It is further noted that one of ordinary skill in the art would not necessarily be limited to reducing the amount of arachidonic acid by exactly half of that disclosed in MacKinnon, and could easily arrive at an amount of arachidonic acid in the pet food higher or lower than 0.026% by routine experimentation within the range of 0% (as an undesirable ingredient per the teachings of Kuehl) to 0.052% (per the disclosure of MacKinnon).
Regarding claim 6, MacKinnon and Kuehl teach the pet food composition according to claim 1.
MacKinnon also teaches that the oleic acid is present in an amount of about 4 to about 9 weight %, based on the dry weight of the pet food composition – oleic acid (18:1) is present in an amount of 4.520 weight % (gm/100 gm) (p. 11, Table 1).
Claim 6 is rendered obvious.
Regarding claim 7, MacKinnon and Kuehl teach the pet food composition according to claim 1.
Modified MacKinnon also teaches that the arachidonic acid is present in an amount of about 0.02 to about 0.04 weight%, based on the dry weight of the pet food composition – in the modified pet food described regarding claim 1, arachidonic acid is present in an amount of 0.026 weight % (gm/100 gm).
Therefore, claim 7 is rendered obvious for the same reasons and with the same expectation of success as described regarding claim 1.
Regarding claim 8, MacKinnon and Kuehl teach the pet food composition according to claim 1.
MacKinnon also teaches that the pet food composition further comprises one or more omega-3 fatty acids, wherein the omega-3 fatty acids are present in an amount of about 0.1 to about 0.8 weight %, based on the dry weight of the pet food composition – omega-3 fatty acids are present in an amount of 0.424 weight % (gm/100 gm) (p. 11, Table 1).
Claim 8 is therefore rendered obvious.
Regarding claim 10, MacKinnon teaches the pet food composition according to claim 8.
MacKinnon also teaches that the omega-6 fatty acids are present in an amount of about 2 to about 5 weight %, based on the dry weight of the pet food composition – MacKinnon teaches that the pet food composition comprises omega-6 fatty acids in an amount of 3.332 weight % (gm/100 gm) (p. 11, Table 1). In reducing the amount of arachidonic acid to 0.026%, the modified pet food would comprise 3.306 weight % omega-6 fatty acids.
Claim 10 is therefore rendered obvious for the same reasons and with the same expectation of success as described regarding claim 1.
Regarding claim 12, MacKinnon teaches the pet food composition according to claim 10.
MacKinnon also teaches that the weight ratio of omega-3 fatty acid to omega-6 fatty acid is from about 1:5 to about 1:10 – the weight ratio of omega-3 fatty acid to omega-6 fatty acid in the pet food composition disclosed by MacKinnon on p. 11, Table 1 is 0.424 : 3.332, which equates to 1:7.86. In reducing the amount of arachidonic acid to 0.026%, the modified pet food would comprise 3.306 weight % omega-6 fatty acids. The weight ratio of omega-3 fatty acid to omega-6 fatty acid of the modified pet food would therefore be 0.424 : 3.306, which equates to 1:7.80.
Claim 12 is therefore rendered obvious for the same reasons and with the same expectation of success as described regarding claim 1.
Claims 16, 18, 20-21, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over MacKinnon (WO 2004/075653 A1, cited on the IDS filed on 30 October 2024) in view of Brockman et al. (US 2016/0296486 A1).
Regarding claim 16, MacKinnon discloses a pet food composition (“Hill’s Science Diet Canine Adult Maintenance”, p. 8, lines 3-4; “fatty acid composition of the canine diet”, p. 11, Table 1) comprising, based on the dry matter of the pet food composition:
oleic acid present in an amount of about 2 to about 8 weight % – oleic acid (18:1) is present in an amount of 4.520 weight % (gm/100 gm) (p. 11, Table 1).
arachidonic acid present in an amount of about 0.05 to about 2 weight % – in the modified pet food described regarding claim 1, arachidonic acid is present in an amount of 0.052 weight % (gm/100 gm).
one or more omega-6 fatty acids present in an amount of about 1 to about 10 weight % – MacKinnon teaches that omega-6 fatty acids are present in an amount of 3.332 weight % (gm/100 gm) (p. 11, Table 1).
MacKinnon does not discuss that the weight ratio of oleic acid to arachidonic acid is about 38.0:1 to about 60:1.
However, Brockman teaches regulation of cat hydration by administration of a pet food comprising a ratio of arachidonic acid to eicosapentaenoic acid (EPA) of 3:1 or greater ([0009]) and arachidonic acid in an amount from 0.05 to 0.5 % dry weight ([0007]). Brockman teaches that a high AA to EPA ratio increases urine flow in young and adult cats without dehydrating the animal, and the animals have increased hydration, most likely due to increased water intake ([0005]). These features correspond to a reduced risk of urinary tract complications ([0006]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the pet food disclosed by MacKinnon with the teachings of Brockman to increase the amount of arachidonic acid in the pet food beyond the disclosed 0.052%, and up to an amount of 0.5%. One of ordinary skill in the art would have been motivated to do so in order to provide a pet food with improved capability of reducing the risk of urinary tract complications in cats. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed weight ratio of oleic acid to arachidonic acid of about 38.0 to about 60:1 in doing so because the composition of MacKinnon comprises a ratio of 4.520 : 0.052, or 86.9:1, and in adding arachidonic acid in an amount of up to 0.5%, the ratio becomes 9.04:1. Therefore, the disclosed ratio is in a range of 9.04:1 to 86.9:1. The claimed range of 38.0:1 to 60:1 lies inside the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
It is noted that in the modified pet food, arachidonic acid is present in an amount of 0.05 to 0.5 weight %, which lies inside the claimed range of about 0.05 to about 2 weight %. Additionally, MacKinnon as modified by Brockman teaches the addition of arachidonic acid, an omega-6 fatty acid to an amount up to 0.5%. This would increase the amount of omega-6 fatty acids to up to 3.78%. This amount lies inside the claimed range of about 1 to about 10 weight %.
Claim 16 is therefore rendered obvious.
Regarding claim 18, MacKinnon and Brockman teach the pet food composition according to claim 16.
As described regarding claim 16, modified MacKinnon teaches a pet food with a weight ratio of oleic acid to arachidonic acid in a of range of 9.04:1 to 86.9:1. As evidenced by the instant specification at paragraph [0028], “According to the present application, use of the term "about" in conjunction with a numeral value refers to a value that may be +/- 5% of that numeral.” Therefore, the claimed ratio of “about 43:1” equates to 40.85:1 to 45.15:1. The claimed range of 40.85:1 to 45.15:1 lies inside the disclosed range of 9.04:1 to 86.9:1. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Therefore, claim 18 is rendered obvious for the same reasons and with the same expectation of success as described regarding claim 16. It is further noted that during routine experimentation within the disclosed range of 0.05% to 0.5% arachidonic acid, one of ordinary skill in the art would reasonably think to test the range in 0.05 or 0.1% increments. In doing so, one of ordinary skill in the art would arrive at a pet food with a ratio of oleic acid to arachidonic acid of 4.52 : 0.1, or 45.2:1, which lies inside the claimed range. It is also considered that in the course of routine experimentation, one of ordinary skill in the art would simply double the amount of arachidonic acid disclosed by MacKinnon to 0.104%, which would result in a ratio of 4.52 : 0.104, or 43.5:1, which is essentially 43:1.
Regarding claim 20, MacKinnon and Brockman teach the pet food composition according to claim 16.
Modified MacKinnon also teaches that the arachidonic acid is present in an amount of about 0.07 to about 0.3 weight %, based on the dry weight of the pet food composition – in the modified pet food described regarding claim 16, arachidonic acid is present in an amount of 0.05 to 0.5 weight %. The claimed range of about 0.07 to about 0.3 weight % overlaps the disclosed range of 0.05 to 0.5 weight %. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Therefore, claim 20 is rendered obvious for the same reasons and with the same expectation of success as described regarding claim 16.
Regarding claim 21, MacKinnon and Brockman teach the pet food composition according to claim 16.
MacKinnon also teaches that the pet food composition further comprises one or more omega-3 fatty acids, wherein the omega-3 fatty acids are present in an amount of about 0.05 to about 1 weight %, based on the dry weight of the pet food composition – MacKinnon teaches that omega-3 fatty acids are present in an amount of 0.424 weight % (gm/100 gm) (p. 11, Table 1).
Claim 21 is therefore rendered obvious.
Regarding claim 23, MacKinnon teaches the pet food composition according to claim 21.
MacKinnon also teaches that the omega-6 fatty acids are present in an amount of about 2 to about 5 weight %, based on the dry weight of the pet food composition – MacKinnon teaches that omega-6 fatty acids are present in an amount of 3.332 weight % (gm/100 gm) (p. 11, Table 1). MacKinnon as modified by Brockman teaches the addition of arachidonic acid, an omega-6 fatty acid to an amount up to 0.5%. This would increase the amount of omega-6 fatty acids to up to 3.78%. This amount lies inside the claimed range.
Claim 23 is therefore rendered obvious for the same reasons and with the same expectation of success as described regarding claim 16.
Regarding claim 25, MacKinnon teaches the pet food composition according to claim 23 as described above.
MacKinnon does not teach that the weight ratio of omega-3 fatty acids to omega-6 fatty acids is from about 1:10 to about 1:20.
However, Brockman teaches regulation of cat hydration ([0009]) by administration of a pet food comprising a ratio of arachidonic acid to eicosapentaenoic acid (EPA) of 3:1 or greater and arachidonic acid in an amount from 0.05 to 0.5 % dry weight ([0006]), and an omega-6 fatty acid to omega-3 fatty acid ratio of between 10:1 and 20:1 ([0009]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the pet food disclosed by MacKinnon with the teachings of Brockman to achieve a ratio of omega-3 fatty acids to omega-6 fatty acids of between 1:10 and 1:20 as claimed. The pet food of MacKinnon comprises arachidonic acid in an amount of 0.052% and an arachidonic acid: EPA ratio of 17.33:1, and an omega-3 to omega-6 fatty acid ratio of 1:7.86 (p. 11, Table 1). One of ordinary skill in the art would have been motivated to obtain an omega-3:omega-6 ratio of 10:1 to 20:1 because Brockman specifies that an omega-3:omega-6 ratio of 10:1 to 20:1 in combination with an arachidonic acid:EPA ratio of 3:1 or greater confers kidney-protective effects through increased hydration ([0001] – [0002], [0005] – [0006], [0009]), and the omega-3:omega-6 ratio of the composition of MacKinnon is outside of this range. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Brockman teaches that a cat food composition comprising an AA:EPA ratio of 3:1 or greater and an omega-3 to omega-6 ratio of 1:10 to 1:20 increases water intake in cats and thereby prevents or ameliorates risk factors for kidney disease in cats ([0001] – [0002], [0005] – [0006], [0009]).
Claim 25 is therefore rendered obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 24 April 2026 have been fully considered, but they are not persuasive.
Applicant first argued that the amendments to claim 1 bring the claims into commensurate scope with the data in Example 1, “Composition 1” of the instant specification, and asserted that inventors observed unexpected results when feeding dogs Composition 1 (p. 6, ¶ 3 – p. 7, ¶ 2). Applicant’s assertion that animals fed a diet containing an OA:AA ratio of about 172.2 showed a positive shift in the fatty acid moieties associated with a reduction in inflammation as compared to animals fed diets containing an OA:AA ratio of 64.8 (which showed a significant increase in AA conjugated metabolites) or 87.6 (which showed no significant effect) was surprising and unexpected is acknowledged.
Applicant’s argument has been considered, but it is not found to be persuasive. MPEP § 2145 states, “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc)”, and “[r]ebuttal evidence may include evidence of ‘secondary considerations,’ such as ‘commercial success, long felt but unsolved needs, [and] failure of others.’ Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 4459, 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997)”. However, as provided by MPEP § 2145(II), “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”, and “‘[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’ Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. Furthermore, “[e]vidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP § 716.02(c)(I). “‘Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.; In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”. See MPEP § 716.02(c)(II).
“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 MPEP § 716.02(d).
In the present case, Applicant’s evidence is not commensurate in scope with the claimed invention. The examples are not commensurate in scope with the claimed invention because it cannot be ascertained whether the alleged unexpected result occurs over the entire claimed ranges and combinations of the claimed ingredients from the examples provided, and none of the claims are directed toward the specific embodiment provided by any of the examples. The instant claim 1 is toward a pet food composition comprising about 4 to about 12 weight % of oleic acid, about 0.02 to about 1 weight % of arachidonic acid, about 0.1 to about 1 weight % of omega-3 fatty acids, and about 1 to about 10 weight % of omega-6 fatty acids, wherein the weight ratio of oleic acid to arachidonic acid is from 160:1 to 190:1. Composition 1 of Example 1 comprises 8.61 weight % of oleic acid, 0.05 weight % of arachidonic acid, 0.67 weight % of omega-3 fatty acids, and 4.87 weight % of omega-6 fatty acids, wherein the weight ratio of oleic acid to arachidonic acid is 172.2:1. The ranges recited in claims 6-8 and 10 are also broader in scope than the amounts disclosed by Example 1. One cannot ascertain whether the alleged unexpected results would be observed or likely over the entire claimed ranges from the data provided. Indeed, one cannot ascertain from the data provided at what ratio of OA:AA between 87.60 and 172.2 the observed transition in metabolite amounts occurs, and whether it would be observed at the claimed ratio of 160:1.
Applicant further argued that the amendments to claim 16 bring the claims into commensurate scope with the data in Example 3, “Composition 3” of the instant specification, and asserted that inventors observed unexpected results when feeding animals Composition 3 (p. 8, ¶ 4 – p. 9, ¶ 2). Applicant’s assertion that animals fed a diet containing an OA:AA ratio of about 43.5 showed a significant increase of serum OA conjugated metabolites compared with AA conjugated metabolites and that an OA:AA ratio greater than 38.0 decreases serum AA conjugated metabolites, as compared to lower ratios (e.g., 38.0 or 22.4), which either have no effect or show an opposite effect, was surprising and unexpected is acknowledged.
Applicant’s argument has been considered, but it is not persuasive. In the present case, Applicant’s evidence is not commensurate in scope with the claimed invention. The examples are not commensurate in scope with the claimed invention because it cannot be ascertained whether the alleged unexpected result occurs over the entire claimed ranges and combinations of the claimed ingredients from the examples provided, and none of the claims are directed toward the specific embodiment provided by any of the examples. The instant claim 16 is toward a pet food composition comprising about 2 to about 8 weight % of oleic acid, about 0.05 to about 2 weight % of arachidonic acid, and about 1 to about 10 weight % of omega-6 fatty acids, wherein the weight ratio of oleic acid to arachidonic acid is from about 38.0:1 to about 60:1. Composition 3 of Example 3 comprises 4.18 weight % of oleic acid, 0.11 weight % of arachidonic acid, and 2.8 weight % of omega-6 fatty acids, wherein the weight ratio of oleic acid to arachidonic acid is 43.5:1. The ranges recited in claims 20 and 23 are also broader in scope than the amounts disclosed by Example 3. One cannot ascertain whether the alleged unexpected results would be observed or likely over the entire claimed ranges from the data provided. Indeed, one cannot ascertain from the data provided at what ratio of OA:AA between 38.0 and 43.5 the observed transition in metabolite amounts occurs.
Applicant further argued that although the animals were fed an identical amount of food, each animal consume a different amount of total g/kcal based on the individual animal’s unique nutritional requirements, e.g., based on its individual metabolism, weight, activity level, etc., and therefore, the dog food compositions disclosed in Table 1 of Example 1 and fed to 24 different dogs naturally provided 24 separate data points per composition for g/kcal consumed on an as-fed basis for each nutrient, which data points can then be converted to a weight % of the nutrients using formulae known in the art to cover a wt % range (p. 7, ¶ 3). Likewise, the cat food compositions disclosed in Table 2 of Example 3 provided 30 data points per composition for each of the cats (Id.). Applicant submitted that, accordingly, the values reported in the Examples, depicting the metabolomic data after feeding the compositions to the animals, report a single average value for the 24 dogs in the study of Example 1 and the 30 cats in Example 3, and therefore cover a range of amounts of nutrients, when considered on an as-fed basis for each animal, rather than the single weight % values reported (pp. 7-8, bridging ¶). Applicant argued that, as such, the claimed weight % ranges are supported by evidence based on unexpected results from the tested ranges, as “one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof.” per MPEP § 716.02 (Id.).
Applicant’s argument has been considered, but it is not persuasive. “To be of probative value, any objective evidence should be supported by actual proof. Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence.” “[A]ppellants have not presented any experimental data showing that prior heat-shrinkable articles split. Due to the absence of tests comparing appellant' s heat shrinkable articles with those of the closest prior art, we conclude that appellant' s assertions of unexpected results constitute mere argument.”). See also In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991).” See MPEP § 716.01(c)(I).
“Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.” See MPEP § 716.01(c)(II).
In the present case, Applicant' s assertion that the weight % ranges can be calculated from data from the individual animals, and that those ranges are commensurate with the claimed ranges is based on argument, and not on objective evidence. “Argument does not replace evidence where evidence is necessary”. MPEP § 2145(I). Objective evidence of unexpected results must be submitted in an appropriate affidavit or declaration. MPEP § 716.01(c) §§ (I)&(II). Therefore, Applicant's assertion cannot be found persuasive. To support this assertion, Applicant must provide evidence that the claimed weight percentages were fed to the animals, and that the alleged unexpected results were observed in the corresponding animals. It is recognized that the presently presented data are averages. However, one cannot determine the spread of the data to gain any insight as to whether the claimed ranges are sufficiently represented. Additionally, the data were produced using a food containing chicken, wheat, barley, sorghum, corn, corn gluten meal, chicken meal, pork fat, beet pulp, soybean meal, vitamins and minerals (see instant specification [0075]) and a food containing chicken, wheat, corn gluten meal, pork fat, chicken meal, beet pulp, rice, soybean oil, vitamins, and minerals (see instant specification [0082]). None of these ingredients, or even amounts of macronutrients, are required by the instant claims. One cannot ascertain whether the alleged unexpected results would be observed in a food comprising different relative amounts of macronutrients. It is to be noted that these are examples, and not an exhaustive list of deficiencies between the scope of the claims and the supporting data. It is recommended that Applicant narrow the scope of the claims to be commensurate with the data provided, or to provide additional supporting data.
For at least these reasons, the rejections of claims 1, 5-8, 10, 12, 16, 18, 20-21, 23, and 25 under 35 U.S.C. § 103 are maintained.
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 James Shellhammer whose telephone number is (703) 756-5525. The examiner can normally be reached Monday - Thursday 7:30 am - 5:00 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
Prosecution Insights