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
Status of Claims
Claims 1-3, 5-23 are pending.
Claim 4 was canceled.
Claim 13 was withdrawn.
Claims 1, 12, 22 are amended.
Claim 23 is a new claim.
Claims 1-3, 5-12 and 14-23 are considered.
Due to the new rejections below, this Action is a Non-Final Action.
Drawings
(previous objection; withdrawn) The drawings filed on 7/11/2023 are objected to because they are in color.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).
Applicant contends: Page three of the Office Action raises an objection against the drawings for being filed in color without a petition under 37 CFR 1.84(a)(2) being granted. In response, Replacement Sheets of the drawings in black-and-white have been filed alongside this Amendment. Respectfully, these Replacement Sheets successfully address the above objection and, for at least this reason, withdrawal of the objection is requested.
Office response: Based on substitution, the objection to the drawings is withdrawn.
Claim Objections
(previous objection; withdrawn) Claim 22 is objected to because of the following informalities: Correct spelling of “course foam” with a “coarse foam”.
Appropriate correction is required.
Applicant contends: To address this objection, claim 22 has been amended as proposed, i.e., the spelling of "course foam" has been changed to "coarse foam". Respectfully, the amendments made to claim 22 have resolved the above objection and, for at least this reason, withdrawal of the objection is requested.
Office response: Based on amendment, the objection to claim 22 is withdrawn.
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.
(previous rejection; withdrawn) 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).
See Claims 1-3, 5-12 and 14-22 as submitted 06/29/2026.
Applicant contends: Claims 1-12 and 14-22 are rejected under 35 U.S.C. 102(a)(1) as allegedly being anticipated by or, in the alternative, under 35 U.S.C. 103 as allegedly being obvious over a non-patent publication by Elliott (hereinafter, "Elliott"). Applicant respectfully traverses this rejection. Elliott was made publicly available in the summer of 2022 and is the thesis of Kenneth Craig Elliott, who is named as an inventor on the present application. The present application claims priority to US Provisional Application No. 63/359,962 which was filed on July 11, 2022.
Applicant respectfully reminds the Office that 35 U.S.C. §102 (b)(1)(A) states that "a disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor." Since the present application's effective filing date is July 11, 2022, any disclosure made by an inventor or joint inventor after July 11, 2021, cannot qualify as prior art under 35 U.S.C. §102(a)(1). Accordingly, Elliot does not qualify as prior art under 35 U.S.C. §102(a)(1).
Applicant also respectfully reminds the Office that 35 U.S.C. §102(a)(2) states that "a person shall be entitled to a patent unless the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention." Elliot is not a patent issued under section 151 and not an application for patent published or deemed published under section 122(b). Accordingly, Elliot also cannot qualify as prior art under 35 U.S.C. §102(a)(2).
For at least the foregoing reasons, the anticipation and alternative obviousness
rejections over Elliot are not proper and cannot be sustained. Withdrawal of these rejections is respectfully requested.
Office response: Applicant’s traversal of the rejection is acknowledged. Applicant’s arguments, see p. 1-2, filed 06/29/2026, with respect to claims 1-12, 14-22 have been fully considered and are persuasive. Claim 4 was canceled and so its rejection is moot. The rejection of claims 1-3, 5-12, 14-22 has been withdrawn.
(previous rejection; withdrawn) 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).
See claims 1-3, 5-11, 14-17, 19-22 as submitted 06/29/2026.
Applicant contends: Without acquiescing in the above rejection, claim 1 has been amended to recite the feature previously captured by claim 4, i.e., the administering of the stable foam by contacting the stable foam with an eye of one or more avians so that the vaccine is administered to the one or more avians via the eye. Andersen fails to disclose and teach methods that deliver a stable foam containing a vaccine through the eye of one or more avians. The Office Action effectively acknowledges this failure since claim 4 is not included in the art rejections over Andersen. For at least these reasons, Applicant respectfully requests that the above rejections over Andersen be withdrawn and the application advance further towards allowance.
Office response: Based on applicant’s amendment to claim 1, the rejection to claims 1-3, 5-11, 14-17, 19-22 is withdrawn.
Regarding the amended claim 12 and the new claim 23,
Applicant contends: As discussed above, Elliot cannot qualify as prior art against the present application since it was published by a co-inventor within the grace period proffered by 35 U.S.C. §102 (b)(1)(A) and is not a patent or patent application.
Office response: Applicant’s arguments regarding Elliot, see p. 3, filed 06/29/2026, with respect to claims 12 and 23 have been fully considered and are persuasive.
Applicant also contends:
Furthermore, the liquid-gas ratio feature originally captured in claim 12, i.e., wherein the ratio of the liquid to the gas in the stable foam is from 1:20 to 1:200, was not included in the art rejections over Andersen. Accordingly, the Office has effectively acknowledged that Andersen fails to disclose and teach methods for vaccinating one or more avians in need thereof that comprises administering a stable foam comprising a gas and a liquid in a ratio ranging from 1:20 to 1:200.
Andersen also fails to disclose and teach methods for vaccinating one or more avians in need thereof that include (i) producing a stable foam containing a vaccine by pumping the vaccine into a mixing chamber and pumping foaming agents into the mixing chamber, and (ii) administering the stable foam produced in the mixing chamber to the one or more avians via one or more foam nozzles located above the one or more avians. Andersen discloses creating foams via a foam whipping method and a sparging method. Neither of these methods involve first producing a stable foam containing a vaccine by pumping the vaccine into a mixing chamber and pumping foaming agents into the mixing chamber and then administering the stable foam produced in the mixing chamber to the one or more avians via one or more foam nozzles located above the one or more avians.
Office response: See new 35 U.S.C. 103 rejections below.
Claim Rejections - 35 USC § 103
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.
(new rejection) Claims 1-3, 5-11, 14-17, 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (previously cited) in view of Grant (EP2979689A1)(See PTO-892 Notice of References Cited).
See claims 1-3, 5-11, 14-17, 19-23 as submitted 06/29/2026.
Regarding claims 1 and 23, Andersen teaches that foam has the potential to be used as a vaccine administration method for chickens (p.21) and “[t]he overall objective was to design a new method to administer a foam vaccination to chicks in hatcheries”(p. 13). Andersen states “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). 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 (p. 6).
Andersen teaches “From preliminary studies conducted, whipping and sparging were generation methods used to form a stable foam. A 0.5-L whipping dispenser (Chef-Master Whipped Cream Dispenser, Mr. Bar-B-Q Inc., Old Bethpage, NY) produced foam by attaching carbon dioxide (CO2) gas source (reads on the gas component) to charge the dispenser and to rapidly releasing the pressure by dispensing the foam”. Andersen also teaches “Whipping and sparging methods were used to generate foams using egg white (EW) and sodium stearoyl lactylate (SSL) mixed with IBV vaccine Arkansas (Ark) AviPro”(p. 66) (reads on wherein the liquid comprises the vaccine and a foaming agent and reads on pumping the vaccine into a mixing chamber and pumping foaming agents into the mixing chamber)…A 10,000 dose IBV Ark vaccine was re-suspended in 30 ml of sterile diluent to create a more concentrated dose” (p. 66).
Regarding claims 2 and 3, Andersen teaches “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).
Regarding claims 5 and 20, Andersen utilizes nine, day-old Cobb 500 pullet chicks from a local hatchery (p. 47).
Regarding claim 6, 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). (as recited in claims 1 & 6).
Regarding claims 7, 8, 9, 10, 14, 15, 16, Andersen 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 and 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).
Regarding claim 17, Andersen teaches whipping method used CO2 and N2O gases at 75 PSI (Abstract, p. xi).
Regarding claims 11 and 19, 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 (see MPEP 2144.05, Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions).
Regarding claims 21 and 22, both are 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).
Regarding claim 23, and as noted above for claim 1, Andersen teaches that foam has the potential to be used as a vaccine administration method for chickens (p.21). Andersen states “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). 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 (p. 6).
Andersen teaches “From preliminary studies conducted, whipping and sparging were generation methods used to form a stable foam. A 0.5-L whipping dispenser (Chef-Master Whipped Cream Dispenser, Mr. Bar-B-Q Inc., Old Bethpage, NY)(reads on “mixing chamber”) produced foam by attaching carbon dioxide (CO2) gas source to charge the dispenser and to rapidly releasing the pressure by dispensing the foam. “Whipping and sparging methods were used to generate foams using egg white (EW) and sodium stearoyl lactylate (SSL) mixed with IBV vaccine Arkansas (Ark) AviPro (p. 66)(reads on wherein the liquid comprises the vaccine and a foaming agent)…A 10,000 dose IBV Ark vaccine was re-suspended in 30 ml of sterile diluent to create a more concentrated dose” (p. 66) (reads on pumping the vaccine into a mixing chamber and pumping foaming agents into the mixing chamber).
Andersen teaches administering a stable foam albeit without vaccine and with a spoon “so the chicks could see the foams”(p. 49)(implies above the one or more avians). Andersen does not teach administering the foam via one or more foam nozzles.
However, Andersen provides in her review information about coarse spray cabinets (xi, Abstract; p. 6-8) where “The automatic sprayer has the chick trays pass under the nozzles on a conveyer belt, reducing labor costs and chick tray handing (p. 7). Andersen also discusses general industrial uses of foam (p. 11). But more specifically, and within a veterinary context, Andersen teaches foams used as drug delivery methods as well as in the depopulation of poultry (p. 12). Andersen teaches the following: “In agriculture, foam has been utilized as an emergency depopulation method for poultry. Benson et al. investigated a water-based foam (WBF) as a depopulation method, which forms a blanket to block air and induces mechanical hypoxia of poultry. The WBF is a mixture of gas, water, and foam concentrate that ejects from nozzle systems produced by a foam generator”(p. 12)(reads on mixing chambers, foam nozzles, located above one or more avians).
While Andersen does teach within the context of mass vaccination of chicks using coarse spray which targets chicks’ mucous membranes (respiratory and ocular), “Absorption of the vaccine through the eye stimulates the Harderian gland, activating the immune system” (p. 46) and intraocular vaccination by way of absorption through the lacrimal duct (p. 8) as well as and “[t]he overall objective was to design a new method to administer a foam vaccination to chicks in hatcheries”(p. 13), Andersen does not specifically teach wherein the administering of the stable foam includes contacting the stable foam with an eye or “so the vaccine is administered to the one or more avians via the eye”.
Regarding claims 1 and 23, Grant, however, teaches an ophthalmic composition for topical application to the eye and to a system for the delivery of the same. Grant does not clarify type of eye, e.g., mammalian versus avian. However, the list of therapeutic agents on pages 4 and 9 includes agents used in humans as well as avians (e.g., vancomycin). Grant teaches reference claim 1, “A liquid ophthalmic composition including a foaming agent, adapted for topical administration to the eye from an applicator capable of dispensing a foam”. Grant also teaches “The present invention provides a liquid ophthalmic composition comprising a foaming agent. The foaming agent allows the liquid to form a foam when mixed with a gas, and typically increases the viscosity of the solution, thereby increasing stability, lubricating properties and bioavailability. The composition is delivered by a foam dispensing pump container or other device that is capable of dispensing a foam”[0004].
Grant further teaches “Thus the formulation of a topical eye medication is changed so that it is capable of being dispensed as a foam rather than as a liquid. By foaming the eye medication several benefits can be obtained, one of the most important of which is the reduction of wasted medication. This is achieved because the foam can reach a sufficient volume to form a drop and fall into the eye without exceeding the amount of fluid that they eye can actually hold. In other words, in using the present invention the actual volume of liquid medication that is administered per drop can match what the eye can actually hold, since the majority of the volume of the drop is comprised of gas. The reduction in volume dispensed to the eye will also reduce the rate at which the eye replaces the tear film. This will allow the medication to remain in contact with the eye for a longer amount of time and thus increase the bioavailability of the drug” [0005] and “By foaming the drop, the drop also becomes larger and easier to apply to the eye. Another significant advantage of the present invention is that the gas that is used to create the foam can be used to augment the effectiveness of the drop. The foaming drop also has the added benefits of comfort of use, ease of application, and higher patient compliance. The invention described here is a more effective and more efficient method of delivery of medication to the eye” [0006].
With respect to therapeutically active agent, Grant teaches in reference claim 7 “…or from a recombinant DNA antibody, protein, or biopharmaceutical for medicinal purposes” (which can read on a vaccine immunogen). Grant further teaches in reference claim 10, “an applicator capable of dispensing a foam and claim 11, “wherein said liquid ophthalmic composition [therapeutically active agent and foaming agent] is contained in said applicator, and forms a foam when mixed with a gas” and claim 14, “wherein the container is a foam dispensing pump container”. Grant additionally teaches “nozzles” [0025] and more generally, “The presented pharmaceutical composition can be used with any type of device that is capable of mixing a fluid and gas in order to produce a foam”[0025].
One or ordinary skill in the art would have been motivated to combine the teachings of Andersen (foam vaccines intended for avians, administering foam above avians, different foaming agents; vaccination targeting mucous membranes to include ocular ones; absorption of the vaccine through the eye stimulating the Harderian gland and activating the immune system; and intraocular vaccination techniques) with the teachings of Grant (foam with a therapeutic agent such as a protein which could be an immunogen; foam administration directly to an eye from an applicator or a dispensing pump container/mixing device or nozzle) for the benefit of making an ophthalmic vaccine formulation with an increased viscosity and increased stability, lubricating properties and bioavailability due to increased contact time, as taught by Grant above, to be administered to flocks with improved efficiency and efficacy (See MPEP 2143 Rationale A. Combining prior art elements according to known methods to yield predictable results and Rationale G. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention).
One of ordinary skill in the art would have had a reasonable expectation of success for combining the teachings of Andersen and Grant. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of avian vaccinology and flock health, ophthalmic therapeutics and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
(new rejection) Claims 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (as previously cited).
See claims 12 and 18 as submitted 06/29/2026.
Regarding claim 12, Andersen teaches that foam has the potential to be used as a vaccine administration method for chickens (p.21) and “[t]he overall objective was to design a new method to administer a foam vaccination to chicks in hatcheries”(p. 13)(reads on administering to the one or more avians a stable foam containing a vaccine). Andersen states “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)(reads on an amount effective for inducing a neutralizing immune response against an infectious pathogen). 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 (p. 6).
Andersen teaches “From preliminary studies conducted, whipping and sparging were generation methods used to form a stable foam. A 0.5-L whipping dispenser (Chef-Master Whipped Cream Dispenser, Mr. Bar-B-Q Inc., Old Bethpage, NY) produced foam by attaching carbon dioxide (CO2) gas source (reads on the gas component) to charge the dispenser and to rapidly releasing the pressure by dispensing the foam”. Andersen also teaches “Whipping and sparging methods were used to generate foams using egg white (EW) and sodium stearoyl lactylate (SSL) mixed with IBV vaccine Arkansas (Ark) AviPro”(p. 66) (reads on wherein the liquid comprises the vaccine and a foaming agent)…A 10,000 dose IBV Ark vaccine was re-suspended in 30 ml of sterile diluent to create a more concentrated dose” (p. 66).
Regarding claims 12 and 18, on the limitations of “the ratio of the liquid to the gas in the stable foam is from 1:20 to 1:200”(as recited in claim 12) and “the ratio of the liquid to the gas is from about 1:50 to about 1:100” (as recited in claim 18), Andersen teaches that she did not directly test a vaccine in her experimentation, but that [her] studies would help determine the optimal foams that could be used to deliver vaccines in hatcheries (p. 41). Regarding optimization, see MPEP 2144.05: II. ROUTINE OPTIMIZATION: A. Optimization Within Prior Art Conditions or Through Routine Experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In view of the foregoing, all the claimed limitations are found in one reference and are
taught to be optional variations to a base process they exemplify. As such, the claimed process recited in claims 12 and 18, is within the scope of Andersen’s invention, and thus Andersen’s invention renders claims 12 and 18 prima facie obvious. The rationale to support this conclusion of obviousness is that Andersen provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed process exhibits any unexpected results compared to the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Qiao et al. (WO2015044337A2)(See PTO-892 Notice of References Cited) teaches reference claim 25, “prior to drying the vaccine formulation is treated by a procedure selected from the group consisting of applying it to a membrane, freezing it into beads, freezing it in vials, spray drying, spray freeze drying, and inducing it to foam” and reference claim 33, “A vaccine comprising a dry formulation of Claims 1 to 15 combined with a dry formulation of Claims 26 to 32 and a liquid pharmaceutically acceptable carrier” and ultimately, a liquid vaccine (see reference claim 34 for an example), Qiao also teaches avian vaccines (p. 4) and “Following being mixed with a carrier the room temperature stable vaccines of the present invention also may be administered by mucosal administration, such as by intranasal, oral, intratracheal, rectal, and/or ocular administration”(p. 31). Qiao teaches a liquid vaccine rather than a foam, once reconstituted.
Vu (WO2003087327A2)(See PTO-892 Notice of References Cited) teaches methods and compositions to preserve bioactive materials in a dried foam matrix (Abstract). Vu also teaches “To provide convenient and stable dosage forms, formulations can be filled into suitable containers. Containers can be provided with etched bottoms, e.g., promote bubble formation at the bottom of the container and/or to generate an open cell foam during foam expansion process steps. The container can be aseptically sealed, e.g., with a stopper to retain a vacuum and/or inert gas environment over the stable compositions of the invention” [0025]. Vu further teaches “Compositions of the invention can be administered to mammals, such as humans, as vaccines, therapeutics, pharmaceuticals, and/or the like. The compositions can be administered, e.g., as ground powders by inhalation or as reconstituted liquids by injection. The dry foam compositions of the invention can be ground, e.g., to a stable powder compositions with any desired size range, for example, an average particle size from about 0.1 um to about 150 um, or about 10 um to about 100 um, for quick reconstitution or delivery by inhalation. Reconstituted liquid can be administered by, e.g., delivering the composition to the mammal by intravenous, intramuscular, intraperitoneal, intracerebrospinal, subcutaneous, intra-articular, intrasynovial, intrathecal, oral, topical, intranasal, and/or pulmonary routes” [0028]. Avians and ocular administration of foams is not recited.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Cornelius whose telephone number is (571)272-0860. The examiner can normally be reached M-F, 0930-1700.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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