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 ACTION
Election/Restrictions
Applicant’s election of Group I, the subject matter of claims 1-12 and 14-22, without traverse filed on 12/19/2025 is acknowledged. Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no generic or linking claim.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The effective filing date of 07/11/2022 from the provisional was used for examination.
Claim Status
Claims 1-22 are pending. Claims 14-20 were amended. Claims 21, 22 were added. Claim 13 was withdrawn. Claims 1-12 and 14-22 were examined on their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, and unless struck-through, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on 7/11/2023 are objected to because they are in color.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 22 is objected to because of the following informalities: Correct spelling of “course foam” with a “coarse foam”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102 / §103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-12, 14-22 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Elliott (07/04/2022)(See PTO-892 Notice of References Cited).
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With his dissertation, Elliott teaches a novel foam vaccination system was designed and developed to deliver vaccines via edible foams (as recited in claims 1, 2). Using IBV [Infectious Bronchitis Virus] (as recited in claim 6) as a model, a vaccination trial took place with foam vaccination being compared to eyedrop and spray vaccination on account of uniformity of application and level of protection provided. Day-old chicks received IBV vaccine through eyedrop, spray, or foam application methods (as recited in claims 3, 5, 20). Foam mass application was found in/or on 85% of the eyes, 60% of the nares, 75% of the beaks, 95% of the down, 62.5% of the tongues, and 55% of the choanal clefts of the day-old chicks it was applied to (Section 4.4.4, p. 79)(as recited in claim 4). In Table 2.3. several foaming agent formulations are provided including a surfactant like sodium stearoyl lactylate (SSL) (as recited in claims 7, 8, and 14). Additionally, egg white (albumen containing albumin protein)(as recited in claim 8, 15), xanthan gum (a polysaccharide viscosity agent)(as recited in claims 9, 16) and distilled water (an aqueous solvent)(as recited in claim 10) are included, too. Elliott also teaches Table 2.5, Figure 2.9, and Figure 2.10. Expansion rates, bubble size, liquid drainage and deterioration rates as well as liquid: air (gas) ratios (as recited in claim 17) fall within the ranges recited in claims 11, 12, 18, 19 (see below for values).
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Claims 21 (a)(b) was addressed in sections 3.3.3 – 3.3.6 which cover apparatus 1-3 experimentation including mixing the foaming agent and the vaccine as well as mixing the liquid with the gas in order to arrive at a stable foam (p. 53-55). Part (c) of Claim 21 and Claim 22 which describe the filter steps were addressed in Elliott’s teaching in Section 2.4.2 Prototype Nozzle: The prototype nozzle was tested with formulation 1 for 17 combinations of filter capsule setups, eight filter combinations, three pump setups and two types of tips. Out of this testing, the setup using two pumps, a 1000-micron coarse filter, a 600- micron fine filter, a 0.25”ID, 0.825” in length top capsule, a 0.38” ID, 0.55” in length bottom capsule, with a cone tip produced good quality foam (p. 41).
Claims 21 and 22 are both interpreted as product-by-process claims for the foam. And as noted above, Elliott teaches a stable foam. As stated in MPEP 2113, I, "[E]ven 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 product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Therefore, based on Elliott’s teachings, the invention as a whole would have been anticipated by the teachings, or in the alternative prima facie obvious.
Claims 1-3, 5-11, 14-17, 19-22 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Andersen (2017)(See PTO-892 Notice of References Cited).
Andersen teaches that foam has the potential to be used as a vaccine administration method for chickens (p.21) (as recited in claim 1). Chicks vaccinated by foam vaccine administration could cause pecking or preening itself or another bird, leading to ingestion and development of immunity to the vaccine virus (p.21) (Claim 2 recites foam is ingestible; Claim 3 recites ingesting the foam by the one or more avians). The foam comprises a gas and a liquid, where the liquid comprises a foaming agent (See 2.3.2 Foam Generation Methods, p. 23). While Andersen did not directly test a vaccine in her experimentation, she does teach that [her] studies would help determine the optimal foams that could be used to deliver vaccines in hatcheries (p. 41)(as recited in claim 1).
Andersen utilizes nine, day-old Cobb 500 pullet chicks from a local hatchery (p. 47) (Claim 5 recites one or more day-old chicks; Claim 20 recites one or more avians comprise chickens…). Andersen lists Marek’s disease (MD), Newcastle disease (ND) and infectious bronchitis (IB), respective vaccinations available and the typical age of chicks when vaccinations are administered in Table 1.1 (p. 14). Andersen state proper vaccination can induce an immune response in poultry, create a protective immunity and protect the birds against the diseases, which is an effective means to prevent and reduce the adverse effects of specific diseases in poultry (p. 1) and the three major vaccinations in hatcheries include MD, ND, and IB (p. 2) (as recited in claims 1 & 6). Note: The specification of the invention defines “neutralizing immune response” broadly as an immune response (humoral or cellular) that renders an infectious pathogen unable to cause disease or damage in its host.
Andersen further teaches a foaming agent comprising a surfactant, such as sodium stearoyl lactylate (SSL)(p. 22)(as recited in Claims 7, 8 & 14); Egg White Guar Gum (Table 2.1, p. 22), a foaming agent, where the guar gum component is a polysaccharide viscosity agent (as recited by claims 9 & 16) and where the distilled water is the aqueous solvent (as recited by claim 10). Egg white, or the albumen, contains the protein “albumin” which acts as a surfactant (p. 22)(as recited in claim 15). Finally, Andersen’s whipping method used CO2 and N2O gases at 75 PSI (Abstract, p. xi)(as recited in claim 17). Andersen also reported an average liquid drainage of the foaming agent 50-75% at 10 minutes (p. 33). This percentage falls within the 50-95% range as recited in claim 11 and the 10-99% range as recited in claim 19.
Claims 21 and 22 are both interpreted as product-by-process claims for the foam and as noted above, Andersen teaches foam. As stated in MPEP 2113, I, "[E]ven 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 product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Therefore, based on Andersen’s teachings, the invention as a whole would have been anticipated by the teachings, or in the alternative prima facie obvious.
Conclusion
No claims allowable.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672