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 5/5/26. Claims 1-3, 6, 8-10 are pending and have been examined on the merits. Claims 4, 5, 7 have been cancelled. Claim 10 is new.
Withdrawn Rejections
The 101 rejection of claim 4 has been withdrawn due to the cancellation of the claim.
The 103(a) rejections of claims 4, 5, and 7 have been withdrawn due to the cancellation of the claims.
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 1-3, 6, 8, and 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 discloses the benefits of probiotics on immunity [pg. 2, lines 1-18].
However, the claim contains a recitation of the intended use “for stimulating an immune system, with probiotic, prebiotic, and/or postbiotic action” 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.
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 1 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 stabilize 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 6: Teague as modified discloses as discussed above in claim 1. Teague discloses feeding to chickens [abstract]. Teague discloses that the composition is administered in ovo [abstract].
Regarding Claim 8: Teague as modified discloses as discussed above in claim 1. 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 1. Teague discloses that the composition further contains a vaccine for Marek’s disease [abstract].
Claim 10 is 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) as applied to claim 1 above and in further view of Zółkiewicz et al. “Postbiotics - A step Beyond Pre-and Probiotics” Nutrients July 23, 2020 vol. 12.
Regarding Claim 10: Teague discloses as discussed above in claim 1. Teague does not disclose further comprising a prebiotic component derived from lysed cells.
Zółkiewicz discloses prebiotic/postbiotic compositions [abstract]. Zółkiewicz discloses bacterial lysates and cell fragments [pg. 5. 2.4. Cell fragments; pg. 6, 2.6. Bacterial lysates]. Bacterial lysates are, by definition, lysed. Zółkiewicz discloses using postbiotics to alter the microbiome of the gut [abstract]. Zółkiewicz discloses that postbiotics provide minimal risks because they do not contain live microorganisms [abstract].
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 Teague to include bacterial lysates as in Zółkiewicz since they are disclosed as an additional means for modulating microbiota, where prebiotics and probiotics are also used as ways for modulating microbiota.
Response to Arguments
The 101 rejection of claim 4 has been withdrawn due to the cancellation of the claim.
The 103(a) rejections of claims 4, 5, and 7 have been withdrawn due to the cancellation of the claims.
Applicant's arguments filed 5/5/26 have been fully considered but they are not persuasive.
The Applicants assert that the office’s treatment of the lyophilization and tyndallization as non-limiting process features does not apply to the claims are amended.
The Examiner notes that the terms lyophilized and tyndallized have been given weight. However it is the explicit method steps of the lyophilization and tyndallization that do not limit the product claims.
The Applicants assert that the office has not provided a motivation to combine Teague, Nathan, and Chung. The Applicants assert that the office has used hindsight reasoning.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may 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 found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, the Examiner maintains that it would have been obvious to modify the probiotics to include those of 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 and to provide the chicken intestinal extract of Teague in a lyophilized and tyndallized form as in Chung, in order to stabilize the probiotic bacteria and in order to provide antibacterial properties [Chung abstract] and in order to provide the extract in sterile form.
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).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Deaton et al. (US 2015/0297648) Deaton discloses prebiotic compositions and specific undesirable bacteria are lysed and their cellular material is available as nutrients for the probiotic organism or endogenous [0029].
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 FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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.\
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/Felicia C Turner/
Primary Examiner, Art Unit 1793
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