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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 4 recites a use of a composition. Appropriate correction or cancellation of the claim is required.
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.
Claims 1-3, and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Teague et al. (WO 2018/013530) in view of Nathan et al. (WO 2015/197728) and Chung (EP 2647694).
Regarding Claim 1: Teague discloses a poultry probiotic vaccine composition [abstract]. Teague discloses that the probiotics are isolated from the guts/intestinal tract of chickens [abstract; Fig. 1; pg. 15, lines 15-19]. Teague discloses other probiotics included in the composition [pg. 6, lines 1-25]. Teague discloses probiotics including Weisella sp. Lactobacillus sp. Enterococcus sp., Streptococcus sp. [pg. 6, lines 1-9].
Teague does not disclose the species selected from the group consisting of Enterococcus faecium, Streptococcus thermophilus, Bifidobacterium bifidum, Lactobacillus reuteri, and Lactobacillus acidophilus.
Teague does not disclose that the intestinal content (probiotics) are lyophilized and tyndallized.
Regarding the recitation of lyophilization by spray drying technique and tyndallization by batch mode, these are process limitations and since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim ABC has been considered regarding its disclosure of lyophilized and tyndallized intestinal content extract. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Nathan discloses a composition containing probiotic bacteria derived from chicken and turkey [abstract; pg. 7, lines 11-15]. Nathan discloses that the probiotic bacteria can be Lactobacillus reuteri [pg. 7, lines 11-15]; L. acidophilus, Enterococcus faecium [pg. 6, lines 19-30; col. 4]. Nathan discloses preferably insolating the probiotic bacteria from poultry [pg. 4, lines 15-18].
Chung discloses lyophilized and tyndallized lactobacillus/lactic acid bacteria [abstract]. Chung discloses that the lactic acid bacteria can be Streptococcus sp., Lactobacillus sp., Lactococcus sp., Enterococcus sp., Bifidobacterium sp. [0014-0021].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Teague to include Lactobacillus reuteri, L. acidophilus, or Enterococcus faecium as in Nathan in order to further provide probiotics that are able to aid in establishing early immunity in chicks upon hatching and since Teague also anticipates the use of species of Streptococcus, Lactobacillus, an Enterococcus in its composition.
Further it would have been obvious to provide the chicken intestinal extract of Teague in a lyophilized and tyndallized form as in Chung, in order to stabilized the probiotic bacteria and in order to provide antibacterial properties [Chung abstract] and in order to provide the extract in sterile form.
Regarding Claim 2: Teague as modified discloses as discussed above in claim 1 and as modified discloses a tyndallized product as discussed above. Teague does not disclose wherein the tyndallization is performed by heating at a temperature comprised between 70-100°C and for a time comprised between 15-30 minutes followed by incubation at room temperature for a period of about 24 hours, repeated two or three times.
However, regarding the process steps of the claim, since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim 2 has been considered regarding its disclosure of tyndallized probiotics.
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Regarding Claim 3: Teague as modified discloses as discussed above in claim 1 and as modified discloses a lyophilized product as discussed above. Teague does not disclose wherein lyophilization by spray technique takes place in four subsequent steps wherein the starting liquid product is atomized into a spray form, then the droplets generated by the spray are contacted with heated air for moisture evaporation and formation of dry solid particles, then the dry solid particles are separated from the air flow and collected..
However, regarding the process steps of the claim, since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim 3 has been considered regarding its disclosure of lyophilized probiotics.
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Regarding Claim 5: Teague as modified discloses as discussed above in claim 1. Teague discloses the benefits of probiotics on immunity [pg. 2, lines 1-18]. However, claim 5 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 6: Teague as modified discloses as discussed above in claim 5. Teague discloses feeding to chickens [abstract].
Regarding Claim 7: Teague as modified discloses as discussed above in claim 5. Teague discloses that the composition is administered in ovo [abstract].
Regarding Claim 8: Teague as modified discloses as discussed above in claim 7. Teague discloses that the composition is administered to the embryo on the 15-22nd day in the egg [pg. 8, lines 8-10].
Although Teague does not explicitly disclose 12-18th day of incubation 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 Teague 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 9: Teague as modified discloses as discussed above in claim 7. Teague discloses that the composition further contains a vaccine for Marek’s disease [abstract].
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fauzi et al. ID 202100632 discloses probiotics isolated from the intestines of chickens and using the isolated for increasing immunity in chickens [pgs. 2 and 3].
Esko et al. CA 2058990 1990 discloses a bacterial preparation derived from the intestinal tract of an adult bird and used for treating bacterial infections in chickens [claims 1-8].
Gao et al. CN 110892939 Machine Translation March 2020 discloses Bacillus subtilis isolated from the intestinal tract of healthy chickens [abstract].
Chen et al. CN 112226389 Machine Translation Jan 2021 discloses cultivating probiotic bacteria derived from chicken intestinal tract to improve the immunity of chickens [abstract].
Thaxton US 5311841 discloses a method of administering vaccines and bacteria through the yolk sack of a newly hatched chicken [abstract]. Thaxton discloses improving the immunity of the chick [col. 4, lines 7-12].
Conclusion
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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/Felicia C Turner/Primary Examiner, Art Unit 1793