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 .
DETAILED ACTIONContinued Examination under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/19/2025 has been entered.
Status of the application
3. Claims 13-23 are pending in this application.
Claims 13-20 have been withdrawn.
Claim 24 is further cancelled.
Claims 21-23 have been rejected.
Claim Rejections - 35 USC § 103
4. 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.
5. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
7. Claims 21, 23 are rejected under 35 U.S.C. 103 (a) as being unpatentable over Roman EA et al. (US 2009/0252833) in view of NPL Ran et al. (in J Animal Sci., 96 (10): pp 4385-4397, 2018) in view of Zimmer et al. USPN 5501857 and further in view of NPL Oyetayo et al. (in African Journal of Biotechnology Vol. 2 (11), pp. 448-452, November 2003) and further in view of Xiping et al. CN 107912535 A
8. Regarding claims 21, 23, Roman EA et al. discloses a sustained release formulation of a feed supplement for ruminants capable of transporting biologically active agents to the post-ruminal digestive system without suffering degradation. Roman EA et al. also discloses that (Paragraph [0034]) the formulation comprises a central nucleus containing a mixture of one or more active agents, a fatty acid salt and a metal salt, inter alia, wherein the addition of one or more external coatings is optional. The biologically active agents include amino acids, vitamins, trace elements, enzymes, proteins, non- protein nitrogenous compounds, medicaments etc. (at least in [0020]).
Roman EA et al. also discloses that (at least in Example IX) the preparation of a pellet of L- lysine*HCL mixed with Megapak (a commercial product based on calcium salt of palmitic acid), which is coated with a mixture that comprises 50% of a palmitic acid distillate and 50% of the calcium salt of said acid at a temperature of 240°F (116°C) by spraying in a drum at 38 rpm.
It is to be note that Roman EA et al. describes a mixture of a coating of functional additives which comprises a mixture of saponified fatty acid (calcium palmitate) and fatty acid (palmitic acid) in a 1:1 ratio. Therefore, 1:1 ratio is encompassed by the claimed ratio between 0.05 to 19 as claimed in claims 21, 23. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It is to be noted that Roman EA et al. discloses the hydrophobic fatty acid coating includes stearic acid and palmitic acid (/its salt) (encapsulation) ([0049], [0056]).
Regarding independent claims 21, 23, it is to be noted that both the claims 21, 23 are similar except claim 21 claims “with a hydrophobic encapsulating matrix” and Claim 23 claims “with an encapsulating matrix” which can broadly include ‘hydrophobic encapsulating matrix’ also. Therefore, the disclosed hydrophobic fatty acid coating includes stearic acid and palmitic acid (/its salt) (encapsulation) as disclosed by Roman EA et al. meet claims 21, 23.
It would have been obvious that the disclosed hydrophobic fatty acid coating includes stearic acid and palmitic acid (encapsulation) as disclosed by Roman EA et al. is identical to the claimed stearic and palmitic acid of claims 21 and 23, therefore, it would have the identical claimed property of claim 21 to serve as encapsulating formulation components to provide protection to the active ingredient of claimed probiotic including S. cerevisiae as claimed in claims 21 and 23.
Roman EA et al. does not specifically mention the active ingredient to be encapsulated is probiotic as claimed in independent claims 21 and 23.
However, additionally, NPL Ran et al.is used who discloses that the protection of microorganism in feed supplements for livestock to coat with stearic acid and palm oil (in NPL Ran et al., at least on third page, under “Encapsulation of Yeast’) to increase their viability and stability to the animal's gastrointestinal conditions, thereby can serve as an alternative to the use of antibiotics and greatly benefiting the improvement of feed digestibility, enhance feed efficiency, reduce risk of intestinal infection, and restore gut microflora etc. of the livestock (at least under Introduction, first paragraph and page 3, Under at least on third page, under “Encapsulation of Yeast’).
It is also to be noted that NPL Ran et al. discloses that equal amounts of active dry yeast (ADY) and capsule material with stearic acid and palm oil (i.e. claimed encapsulating matrix) are effective to protect and increase the viability and stability of ADY to the animal's gastrointestinal conditions to meet claim limitation of “the percent by weight of the hydrophobic encapsulating matrix…………between 40% and 60%” as claimed in claims 21 and 23. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Roman EA et al. to include the teaching of NPL Ran et al. to consider living microorganism e.g. probiotic can be used as an encapsulated (coated) form encapsulated by using stearic acid and palm oil -based capsule material in order to increase their viability and stability to the animal's gastrointestinal conditions and yeast provides the benefit to serve as probiotic having its great beneficial effect for the improvement of feed digestibility, enhance feed efficiency, reduce risk of intestinal infection, and restore gut microflora etc. of the livestock , therefore, it serves as an alternative to the use of antibiotics and (at least under Introduction, first paragraph and page 3, Under at least on third page, under “Encapsulation of Yeast’).
It is to be noted that even if NPL Ran et al. does not specifically coat claimed microorganisms, however, NPL Ran et al. discloses that the method can coat microorganisms. Therefore, according to MPEP 2143.01, “Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis)”.
Roman EA et al. and NPL Ran et al. are silent about the “a mixture” of probiotic species and the mixture of probiotic species includes L. acidophilus and L. casei as claimed in claims 21, 23.
With respect to (i), Zimmer et al. discloses that the probiotic microorganisms include Lactobacillus acidophilus, L. casei, as nutritional supplement (at least in claims 1, 10 of Zimmer et al.), S cerevisiae (Under Ex 8).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Roman EA et al. in view of NPL Ran et al. to include the teaching of Zimmer et al. who discloses that the probiotic microorganisms may include Lactobacillus acidophilus, L. casei, as nutritional supplement (at least in claims 1, 10 of Zimmer et al.).
However, they do not specifically teach the motivation of including combinations of claimed probiotics together.
NPL Oyetayo et al. discloses that L acidophilus protects from infection from unwanted organism and L casei has better effect to protect liver and helps for liver function improvement and, therefore, both the L acidophilus and L casei are valuable probiotic and can be considered together to protect gastrointestinal tract (GIT) (at least in Abstract and page 451, col 2 paragraph above “Acknowledgement).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Roman EA et al. in view of NPL Ran et al. and Zimmer et al. to include the teaching of NPL Ovetayo et al. who discloses that the reasons for the motivation to include both the L acidophilus and L casei are because both the L acidophilus and L casei are valuable probiotic and can be considered together to protect gastrointestinal tract (GIT) because L. acidophilus protects from infection with unwanted organism and L. casei has better effect to protect liver and helps for liver function improvement as disclosed by NPL Ovetayo et al. (at least in Abstract and page 451, col 2 paragraph above “Acknowledgement).
Roman EA et al. in view of NPL Ran et al. and Zimmer et al. and NPL Ovetayo et al. are silent about specific CFU/g as claimed in claims 21 and 23.
Xiping et al. discloses that the number of viable cells in the probiotic powder can be 106-109 cfu/gm in order to have an effective probiotic effect when used to feed animal (at least in page 7 first paragraph and in claims 3 and 4 of Xiping et al.).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Roman EA et al. in view of NPL Ran et al. and Zimmer et al. and NPL Ovetayo et al. to include the teaching of Xiping et al. to consider the number of viable cells in the probiotic powder can be 106-109 cfu/gm in order to have an effective probiotic effect when used to feed animal (at least in page 7 first paragraph and in claims 3 , 4 of Xiping et al.).
However, it is also variable. The reason is the viability of the final product depends on many factors including the method of encapsulation, type of probiotic etc. It is within the skill of one of ordinary skill in the art to optimize the viable organisms at the end of the formulated product. Therefore, it is variable and optimizable.
Absent showing of unexpected results, the specific amount of concentration of the probiotic microorganism (s) is not considered to confer patentability to the claims. As the amount of CFU/g are variables that can be modified, among others, by adjusting the amount of moisture in the dried viable organism (i.e., degree of drying) which determines the CFU/g, and also the method of making encapsulated product etc., which determines the viability (i.e., CFU/g) etc., the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount viable probiotic microorganism in Roman EA et al. in view of Ryan et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired concentration of the probiotic microorganism in terms of CFU/g (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
It is also to be noted that the amended claim limitation of “Wherein the functional additive is added to a feed concentrate requiring resistance to extrusion, pelletizing, or baking processes at temperatures of 70 -120 degree C” etc. is interpreted as it indicates that the feed concentrates with the additive formulation containing microorganism meet the characteristics of heat resistance as is understood from specification (in PGPUB [0005]). It is to be noted that the disclosed microorganisms meet the claimed microorganisms which are identical. Therefore, their property will be identical including claimed “requiring resistance to extrusion, pelletizing, or baking” etc. as claimed in claims 21 and 23.
9. Claim 22 is rejected under 35 U.S.C. 103 (a) as being unpatentable over Roman EA et al. (US 2009/0252833) in view of NPL Ran et al. (in J Animal Sci., 96 (10): pp 4385-4397, 2018) in view of Zimmer et al. USPN 5501857 and further in view of NPL Oyetayo et al. (in African Journal of Biotechnology Vol. 2 (11), pp. 448-452, November 2003) and further in view of Xiping et al. CN 107912535 A as applied to claims 21, 23 and further in view of Kirejevas et al. (US 2011/0104327).
10. Regarding claim 22, Roman EA et al. in view of NPL Ran et al. are silent about the claim limitations of “feed concentrate in a proportion of 50g/ton to 3000 g/ton as claimed in claim 22.
Kirejevas et al. discloses that the count of at least one probiotic in the food product to be used can be 104-1016 CFU/Kg of complete food (at least in [0080], [0081]) and probiotic includes L. casei and L acidophilus (at least in [0080]).
Regarding claim 22, it is to be noted that the disclosed range values of L. casei and L. acidophilus meet the claimed amount of these two probiotics as claimed in claims 21, 23. For example, 3.7x108 cfu/g of viable microorganism, as claimed in claim 21 from which claim 22 depends will have 3.7x108x 50= 1.85 x1010 CFU/50 gm. One ton contains 50 gm probiotic (lower) as claimed in claim 22. Therefore, 1.85 x1010 CFU is within the disclosed 104-1016 CFU/kg (i.e. 10 7-1019 CFU/Ton) (at least in [0080], [0081]). Therefore, the disclosed range of 104-1016 CFU/kg it meets claimed CFU/gm of claim 21 from which claim 22 depends.
However, the amount of dry probiotic to be added as functional additive to a feed concentration is also variable. It depends on few factors including viable count (CFU/g) of the original dry probiotic microorganism, type of animal etc. Therefore, it is within the skill of one of ordinary skill in the art to optimize the amount based on the viable count of the dry probiotic microorganism, type of animal to be fed with the feed supplemented with this additive etc.
Absent showing of unexpected results, the specific amount of additive as dry probiotic microorganism is not considered to confer patentability to the claims. As the amounts are variables that can be modified, among others, by adjusting the amount of concentration of viable count /g of dry probiotic additive to be used as an additive, type of animal to be fed with the feed supplemented with this additive etc., the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of probiotic additive in Roman EA et al. in view of NPL Ran et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired viable probiotic microorganism (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Response to arguments
11. Applicant’s arguments and amendments have been considered. Applicant’s arguments and amendments overcome the rejections of record. Accordingly, examiner considered a new secondary prior art by NPL Oyetayo et al. (in African Journal of Biotechnology Vol. 2 (11), pp. 448-452, November 2003) to address the motivation for the combined use of two probiotics L acidophilus and L. casei. Applicant’s arguments and amendments are mainly based on unexpected result. These are not persuasive. The reasons are discussed below.
12. Applicants argued on section II (in Remarks, second page) that “mixing the two components e.g. long chain fatty acid and high melting point saponified fatty acids together, lower the melting point of the mixture, which allows for a coating process at temperatures that do not harm the probiotics”.
In response, it is to be noted that the disclosed combinations of prior arts disclose the identical components and the method of encapsulation which meet the claimed ingredients and the ratio of mixing them and the identical claimed method of encapsulation. Therefore, the disclosed encapsulated product will maintain the identical property because the identical matrix will have the identical extraordinary thermal and mechanical resistance , protecting the additives under the extreme condition of pelletizing or extrusion.
13. Applicants argued on section III (in Remarks pages 3-4) that applicants have claimed invention of unique “Matrix composition” which is based on the synergistic interaction between free fatty acid and high-melting metallic soaps which creates a thermo-mechanical barrier uniquely capable of protecting live probiotic during extrusion and it is achieved by using specific ratio window to achieve resistance to high-temperature feed processing.
14. Applicants further explained under “Ratio definition for encapsulation Matrix” (in Remarks, Last few pages after the attached Research Article and before the pictures).
Applicant’s arguments related to unexpected result as argued above under “Ratio definition for encapsulation Matrix” have been considered.
The examiner acknowledges the arguments based on unexpected results. However, the arguments are insufficient to overcome the final rejection because:
(1) Applicants’ have not compared the claimed invention to the teachings of the closest prior art reference. Roman Et al. is the closest prior art.
However, in this instance as Roman et al. discloses only comprises 50% of a palmitic acid distillate and 50% of the calcium salt of said acid (i.e. 1:1) at a temperature of 240°F (116°C) by spraying in a drum, therefore, it is to be noted that in an obviousness rejection, the combination of references must be considered as a whole to consider that functional additives are probiotics from Lactobacillus spp. at 1:1 ratio rather than the specific teaching of each reference. In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971); In re Simon, 461 F.2d 1387, 1390 (CCPA 1972).
(2) Evidence of unexpected results must be commensurate in scope with the subject matter claimed. In re Linder 173 USPQ 356. More importantly, the evidence of unexpected results must be clear and convincing. In re Lohr 137 USPQ 548. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside (i.e. as well as the upper and lower limits) the claimed range to show the criticality of the claimed range. In re Hill 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP 716.02.
In this instance, at least, Let us consider the arguments under “Ratio definition for encapsulation Matrix” and Factor X1 (Ratio R= Free Fatty acid : saponified FA) and Factor X2 (Matrix percentage w/w).
Factor X1: The arguments based on the presentation of “Experimental Design ” for Factor X1 considered only 0.1 (low), 5 (mild) and 19 (high). However, claims 21 and 23 claim range ratios between 0.05 to 19. Therefore, applicants have not compared a sufficient number of test results both inside and outside (i.e. as well as the upper and lower limits) the claimed range to show the criticality of the claimed range. In re Hill 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Therefore, the unexpected results as presented for Factor X1 does not commensurate in scope with the subject matter claimed. In re Linder 173 USPQ 356.
Factor X2: The arguments based on the presentation of “Experimental Design ” for Factor X2 considered only 40% (low), 50% (mid), 60% (high). Independent claims 21, 23 claim range ratio between 0.05 to 19. Therefore, the “Experimental Design” considers the claimed range of claims 21, 23 for Factor X2. However, as mentioned above; in order to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside (i.e. as well as the upper and lower limits) the claimed range to show the criticality of the claimed range. In this case, applicants should additionally consider and compare the result using the points below 40% (w/w) and above 60% (w/w) in addition to the range values including the points considered inside the claimed range. In re Hill 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Therefore, the unexpected results as presented for Factor X2 does not commensurate in scope with the subject matter claimed. In re Linder 173 USPQ 356.
It is also to be noted that applicants have stated that intermediate R values (4-8) combined with Matrix loading (i.e. percent encapsulated probiotic) between 48-56% produced the best survivability without showing any survival data within this range value ( Under Section 3.2,Table above section 3.2, same page and Section 5.0). Therefore, applicants are advised to consider further data to present the best survivability within the intermediate R values (4-8) and matrix loading range value as discussed above.
However, claims 21, 23 are broad. It does not specify what is the survival % to be considered to meet “Resistance to Extrusion”. Therefore, applicants are advised to consider what percent survival of probiotic is considered as “best survivability” range.
Accordingly, applicants may amend independent claims 21, 23 further in order to establish the criticality of the claimed range value which will commensurate with the scope of the independent claim.
Therefore, at this time, the unexpected result is not sufficient to overcome the rejections of record.
The rejection is made as non-final.
Conclusion
15. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792