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 .
This office action was written in response to the Applicants Remarks filed 6/2/26. Claims 11-14, 16-30 are pending and have been examined on the merits. Claim 15 was previously cancelled.
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 11-14, 16, and 22-30 are rejected under 35 U.S.C. 103 as being unpatentable over Janssens et al. (KR 2009/0005020) in view of Rademacher-Heilshorn et al. (US 2017/0007562), Miura et al. (US 2004/0043105).
Regarding Claims 11, 14, 16, and 22-25: Janssens discloses a method of feeding a composition to poultry to increase growth rates [3rd page; Disclosure]. Janssens discloses a feed composition containing a glycine compound and salts thereof [4th page, 1st two lines]. Janssens discloses that the feed composition contains a crude protein content of about 12% to 25% crude protein [5th page, 6th paragraph]. Janssens discloses administering the feed composition to poultry when the poultry is 10 to 35 days old and administered for 14 days or more [7th page, 2nd paragraph]. Janssens discloses glycine present at least about 0.001% [4th page, lines 1 and 2]; 0.001% to 0.5% [claim 8]. Janssens discloses that the method reduces the amount of fed required to produce a predetermined amount of meat; meaning the meat produced is predictable [3rd page Disclosure].
Janssens does not disclose guanidinoacetic acid; administered in an amount of from 0.01 to 0.20%.
Janssens does not explicitly disclose glycine as a free acid or in the form of a salt of glycine and present at 0.01% to 0.2% in the feed.
Rademacher-Heilshorn discloses a poultry feed containing guanidinoacetic acid which, when fed to parent chickens, improves chick growth and improves weight gain [abstract; 0015]. Rademacher-Heilshorn discloses including guanidinoacetic acid and/or its salts at 0.06% to .2%; .04% to .2% [0015; 0032; 0056]. Rademacher-Heilshorn discloses crude protein in the feed at 10 to 30% or 12 to 25% [0051].
Miura discloses a glycine enriched feed for layer chickens containing 0.05% to 0.5% glycine based on the weight of the feed [abstract; 0016; 0017; 0045]. Miura discloses glycine as aiding in the mitigating stress in poultry [abstract; 0011].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Janssens to include guanidinoacetic acid or its salts as in Rademacher-Heilshorn in order to improve the growth promoting ability. Further it would have been obvious to modify Janssens to include glycine as a free acid as in Miura in order to aid in mitigating stress caused by heat in poultry.
Regarding the crude protein content, although Janssens does not explicitly disclose 14% to 18.5% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Janssens overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding the age of the poultry, although Janssen does not explicitly disclose the 11th to the 39th day of life of the poultry one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Janssen overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding the amount of guanidinoacetic acid, although Rademacher-Heilshorn does not explicitly disclose 0.02% to .15% (claim 22); 0.04% to 0.1% (claim 23) one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Rademacher-Heilshorn overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding the amount of glycine, although Miura does not explicitly disclose 0.01% to .2%, 0.02% to .15% (claim 24); 0.04% to 0.10% (claim 25) one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Miura overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding Claim 12: Janssens as modified discloses as discussed above in claim 11. Janssens discloses composition as solid and mixed with low protein poultry feed [3rd page 6th paragraph 7th page “Methodology and Materials”]. It would have been obvious to administer as a solid in order to easily mix with other solid feed ingredients/formulations.
Regarding Claim 13: Janssens as modified discloses as discussed above in claim 11. Janssens discloses composition as mixed with drinking water [3rd page 6th paragraph; claim 21]. It would have been obvious to administer as a liquid in order to easily mix with drinking water and other liquid feed ingredients/formulations.
Regarding Claim 26: Janssens as modified discloses as discussed above in claim 11. Janssens discloses composition as mixed with drinking water [3rd page 6th paragraph; claim 21]. It would have been obvious to administer as a liquid in order to easily mix with drinking water and other liquid feed ingredients/formulations. Janssens discloses glycine present at least about 0.001% [4th page, lines 1 and 2]; 0.001% to 0.5% [claim 8].
Rademacher-Heilshorn discloses guanidinoacetic acid in acidic aqueous (water) solutions and its increased stability [0071]. Rademacher-Heilshorn discloses including guanidinoacetic acid and/or its salts at 0.06% to .2%; .04% to .2% [0015; 0032; 0056].
Miura discloses a glycine enriched feed for layer chickens containing 0.05% to 0.5% glycine based on the weight of the feed [abstract; 0016; 0017; 0045].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Janssens to include the formulation as an aqueous/water containing solution as in Rademacher-Heilshorn in order to increase the stability of at least the guanidinoacetic acid.
Regarding the amount of guanidinoacetic acid, although Rademacher-Heilshorn does not explicitly disclose 0.05 to 1.2 g per liter water one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Rademacher-Heilshorn overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding the amount of glycine, although Miura does not explicitly disclose 0.05 to 1.2 g per liter water one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Miura overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding Claim 27: Janssens as modified discloses as discussed above in claim 11. Janssens and Rademacher-Heilshorn disclose guanidinoacetic acid and glycine in overlapping amounts and it would have been obvious to use them in equal amounts based on the disclosed amounts above. It would have been obvious that the guanidinoacetic acid and glycine would have been used at a ratio of 1:1.
Regarding Claim 28: Janssens as modified discloses as discussed above in claim 11. Janssens and Rademacher-Heilshorn disclose poultry that are chickens, broilers and young chickens, males and females [Janssens 4th page, last page Rademacher-Heilshorn; 0022; 0074].
Regarding Claim 29: Janssens as modified discloses as discussed above in claim 11. Janssens discloses that the method reduces the amount of fed required to produce a predetermined amount of meat; meaning the meat produced is predictable [3rd page Disclosure].
However, claim 29 is a recitation of the intended use of the claimed invention and in order to patentably distinguish the claimed invention from the prior art, the recitation must result in a structural difference between the claimed invention and the prior art. MPEP 2103 states that intended use language "does not limit a claim to a particular structure does not limit the scope of a claim". The above mentioned phrase does not limit the claim to any particular structure, so it is not interpreted to limit the scope of the claims. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding Claim 30: Janssens as modified discloses as discussed above in claim 11. Janssens discloses that the feed has a caloric value of 11.5 MJ/kg or more; or less than 14 MJ/kg [6th page 2nd paragraph].
Although Janssens does not explicitly disclose 8 to 20 MJ/kg one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Janssens overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
7. Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Janssens et al. (KR 2009/0005020) in view of Rademacher-Heilshorn et al. (US 2017/0007562), Miura et al. (US 2004/0043105) as applied to claim 16 above and in further view of KR101443226 2014.
Regarding Claims 17 and 18: Janssens as modified discloses as discussed above in claim 16. Janssens does not disclose wherein the salt of the guanidinoacetic acid is selected
from the group of alkali metal or alkaline earth metal salts of the guanidinoacetic acid (claim 17); wherein the alkali metal or alkaline earth metal salts of the guanidinoacetic acid comprise sodium guanidinoacetate, potassium guanidinoacetate, magnesium guanidinoacetate or calcium guanidinoacetate (claim 18).
KR 226 discloses an animal foodstuff containing alkaline earth metal salts of the guanidinoacetic acid comprise sodium guanidinoacetate, potassium guanidinoacetate, or calcium guanidinoacetate [5th page; paragraphs 8 and 9].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Janssens to include the guanidinoacetic acid comprising sodium guanidinoacetate, potassium guanidinoacetate, or calcium guanidinoacetate of KR 226 since they are alkali metal salts of guanidinoacetic acid and Janssens calls for the inclusion of salts of guanidinoacetic acid in its formulation.
8. Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Janssens et al. (KR 2009/0005020) in view of Rademacher-Heilshorn et al. (US 2017/0007562), Miura et al. (US 2004/0043105) as applied to claim 11 above and in further view of Hong et al. CN201811117993 Machine Translation Sept 2018.
Regarding Claims 19-21: Janssens as modified discloses as discussed above in claim 11. Janssens does not disclose w wherein the glycine is used in the form of a salt of the glycine (claim 19); wherein the salt of the glycine is selected from the group of alkali metal or alkaline earth metal salts of the glycine (claim 20); wherein the alkali metal or alkaline earth metal salts of the glycine comprise sodium glycinate, potassium glycinate, magnesium glycinate or calcium glycinate (claim 21).
Hong discloses a poultry feed containing calcium glycine [abstract]. Hong discloses improving weight gain and the immune system of the poultry through the administration of the poultry feed.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Janssens to include the salts of glycine, namely calcium glycine as in Hong in order to aid the guanidinoacetic acid in improving weight gain and immunity in the poultry.
Response to Arguments
9. On pages 1-2, the Applicants assert that Janssens fails to disclose glycine or salts thereof and that glycine derivatives are not functional equivalents of glycine or salts of glycine. The Applicants also assert that Janssens does not disclose administering guanidinoacetic acid (GAA). The Applicants assert that Janssens only discloses protein at a content of at least 18.5 and that the disclosure of 12-25% protein was broad and generally stated.
The Examiner disagrees with the Applicants assertions. The Examiner notes that the glycine derivatives of Janssens was not considered in the rejection to be an equivalent. Janssens was modified by Miura to include glycine in the formulation of Janssens. The Examiner agrees that Janssens did not disclose GAA but notes that the limitation concerning the presence of GAA was modified by Rademacher-Heilshorn. The Examiner disagrees with the characterization of Janssens disclosure of protein. Janssens clearly states that glycine can be incorporated into any conventional poultry feed and discloses conventional diets as containing 12% to 25% crude protein. [pg. 5]. Janssens does disclose 18.5% protein as preferable, however, MPEP 2123 states that “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Further Janssens discloses in an example, 18.05% crude protein which is within the range recited by Applicant.
10. On pages 2-3, the Applicants assert that in Rademacher-Heilshorn, the inclusion of GAA is directed toward administering the feed to parent animals and that there is no direct feeding of GAA to the progeny. The Applicants assert that there is no teaching of the administration of the GAA for the purpose of fattening or increasing slaughter weight. The Applicants assert that Rademacher-Heilshorn is non-analogous art.
The Examiner notes that feeding poultry to progeny was disclosed and relied upon in the primary reference Janssens. There is nothing in Rademacher-Heilshorn that would dissuade one from adding GAA to young poultry/chick feed. One of ordinary skill in the art would have been motivated to add it to young poultry feed. Rademacher-Heilshorn discloses that GAA is a known additive for fattening animals [0007]. Rademacher-Heilshorn indirectly discloses that one would or could feed chicks/young poultry GAA, by stating that feeding parents with GAA improves chicks’ feed conversion “even if the chicks themselves are not fed GAA” [0011].
In response to applicant's argument that Rademacher-Heilshorn is non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Rademacher-Heilshorn is analogous art because it is relevant to feeding poultry a composition that contains GAA for the purpose of increasing growth. Rademacher-Heilshorn is further drawn to compositions containing crude protein at 10% to 30% or 12 to 25% which are amounts overlapping with the instant claims.
11. On page 3, the Applicants assert Miura fails to teach a low protein, GAA containing composition for poultry feed.
The Examiner disagrees and notes that although Miura was not relied upon for a teaching of the protein content, it discloses a crude protein content of 15.5% to 19.5% [0017] which overlaps with the instant claims. Further, for the teaching of GAA Rademacher-Heilshorn was relied upon as discussed above.
12. On page 3, the Applicants assert the Examiner as relied on deficient hindsight reasoning.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
13. On pages 3-5, the Applicants assert surprising and unexpected results.
First, in regards to the obviousness rejections, in order 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).
Further, Applicant is using known components to obtain expected results. There is nothing patentable unless the applicant, by a proper showing, further establishes a coaction or cooperative relationship between the selected ingredients, which produces a new, unexpected, and useful function. It is not seen where Applicant has provided support for unexpected results. In the absence of a showing of unexpected results, the amounts claimed are merely a matter of choice and well within the skill of the art. At most the amounts are seen merely as optimization.
In the absence of unexpected results, it is not seen how the claimed invention differs from the teachings of the prior art. Applicant's claims are drawn to a combination of known components which produces expected results.
14. On page 5, regarding claims 17 and 18, the Applicants assert that Gastner is non-analogous art because it drawn to pet feed as opposed to poultry feed.
Although KR ‘226 does not disclose poultry feed it does disclose animal feed generally. Further, secondary reference Rademacher-Heilshorn already established GAA for use in poultry feed. KR’226 was incorporated for its teaching of types of salts of GAA.
In response to applicant's argument that Gastner?/KR ‘226 is non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, animal feed and its incorporation of GAA is pertinent to the claimed invention.
15. On page 5, the Applicants assert that Hong using a premix that contains more than 0.2% glycine which is the maximum recited in claims 19-21.
The Examiner notes that the amounts of glycine were established in the Janssens and Miura references. Hong was relied upon for its teachings of the forms of glycine as salts of glycine.
For the reasons above the rejections are maintained.
Conclusion
16. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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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.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
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