DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
Claims 1-30, as originally filed 13 January 2023, are pending and under consideration.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-30 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claims 1-3, 5, 13, 16-17 and 23, each of the concentrations or ratios recited in these claims is unitless. This renders the claims indefinite.
Regarding claims 8, 10 and 11, there is no antecedent basis for the following limitation: dose. MPEP § 2173.05(e) (lack of antecedent basis). It is unclear what constitutes a dose of the formulation of claim 1. Is it a particular volume, such as 100 ml? In further regard to claim 11, the following limitation is unclear, in the context of the claim: “OD/dose.”
Regarding claim 13, do the concentrations enclosed by parentheses merely exemplify various species of the vaccine and, therefore, are not further limiting? Alternatively, does that language actually narrow the claim? MPEP § 2173.05(d) (“If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.”). Furthermore, do those percentages, if afforded patentable weight, mean that (i) the aqueous phase, itself, has a volume of 100 ml and (ii) the oil emulsion phase, itself, has a volume of 100 ml? Or, do they mean that the vaccine has a total volume of 100 ml?
Regarding claim 15, the limitation concerning “administered as a combination” extends beyond the scope of the preamble, thereby rendering the claim indefinite. This claim is not directed to a kit or to a method of treatment.
Regarding claims 15, 18 and 30, is a “standard fast release vaccine” or a “standard vaccine formulation” a vaccine formulation that does not comprise PGPR? Applicant is referred to page 2, lines 31-34, of the specification, as originally filed.
Regarding claims 22-24, do each of these claims actually require the presence of inactivated H9N2? This ambiguity renders the claims indefinite.
Regarding claim 29, neither the process of this claim nor the process of the claim on which it depends (claim 28) provides an antecedent basis for the presence of the recited constituents in the aqueous and oil phases, respectively. For example, what explains the presence of polysorbate 80 in the aqueous phase? How did it get there? Applicant is referred to MPEP § 2173.05(e) (antecedent basis).
Claim Rejections - 35 U.S.C. 112(d)
The following is a quotation of 35 U.S.C. 112(d):
Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) as being in improper dependent form.
Claim 19 recites as follows: “The combination according to claim 18 wherein the vaccines are administered separately in any order or simultaneously.” Thus, the limitation introduced in claim 19 is directed to a method of treatment. Claim 18, however, is directed to a combination. The limitation recited in claim 19, which is an active step relevant to a method of treatment, is not relevant to the combination of claim 18. Consequently, claim 19 does not actually further limit 18 and, therefore, fails to comply with 35 U.S.C. 112(d).
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 U.S.C. 102
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, 3-4, 14, 21, 25, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (“Construction of a stable w/o nano-emulsion as a potential adjuvant for foot and mouth disease virus vaccine.” Artificial cells, nanomedicine, and biotechnology 45.5 (2017): 897-906).
Chen is directed to “[a] stable and bio-compatible w/o nano-emulsion was developed as adjuvant for foot and mouth disease (FMD) vaccine with isopropyl myristate as oil phase, polyglycerol polyricinoleate [(PGPR)], and Tween 80 as surfactants.” Abstract.
Chen discloses: “Foot and mouth disease (FMD) is a highly contagious disease that affects cloven-hoofed animals causing great economic losses in livestock field. Vaccination with inactivated FMD virus is the most effective way to control and eradicate FMD during an outbreak.” Page 897, left column.
Chen discloses: “To prepare emulsions-containing antigens, certain amount of OVA or FMDV was added previously to water phase containing 5% Tween 80. Then the water phase containing antigens was added to the oil phase containing 5% PGPR at aqueous phase to oil phase weight ratio of 1:2. After stirring at the rate of 24 000 rpm for 5 min, w/o emulsion system was formed.” Page 898, right column. FMDV is inactivated foot-mouth disease virus. Page 898, left column.
The examiner notes that “Tween 80” is a common tradename for the following surfactant: polysorbate 80.
The specification of the present application evidences that PGPR “delays antigen release” and “also provides a controlled, slow release once antigen release is initiated.” Page 2, lines 31-32. “As a result, an immune response is delayed in a subject receiving the PGPR based vaccine formulation.” Page 2, lines 32-33. “This delay in an immune response is generally at least 7 days, and is more typically 21 - 35 days, after the PGPR vaccine is administered, relative to a subject receiving a substantially identical vaccine except that it does not include PGPR.” Pages 2-3 (bridging sentence). Therefore, the water-in-oil (w/o) emulsion disclosed in Chen qualifies as controlled release. MPEP § 2111 (“During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”).
Accordingly, claims 1, 3-4, 14, 21, 25, and 28 are anticipated by Chen.
Claims 1, 3-4, 7, 14, 16, 21, and 24-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu (CN 111358944 A).
Hu, which published in Chinese, is directed to “composite vegetable oil vaccine adjuvants” (abstract) and water-in-oil vaccine emulsions comprising them (claim 5). The examiner obtained an English machine translation of Hu from the European Patent Office. Unless otherwise indicated, all citations refer to that translation, which accompanies this Office action.
Hu discloses: “Experimental vaccine preparation method: mix the adjuvant in step 1.2 with the inactivated chicken Newcastle disease virus antigen (NDV) solution in a volume ratio of 2:1, and use an emulsifier (Beijing Zhuochuan Electronic Technology Co., Ltd., model: FF-ESB-300) Emulsify for 2 minutes (16000 rpm) to prepare the corresponding milky white vaccine emulsion.” Description at page 009 (Section 1.3). The adjuvant in step 1.2 is the adjuvant from Example 2 (Description at page 004), which composed of “3.5% oleic acid, 9.5% Span-85, 3.5% polyglyceryl ricinoleate; the balance is camellia oil.” Emphasis added. The foregoing vaccine is administered to 1-day-old three-yellow broilers. Description at page 010.
The examiner notes that “Span 85” is a common tradename for the following surfactant: sorbitan trioleate.
The specification of the present application evidences that PGPR “delays antigen release” and “also provides a controlled, slow release once antigen release is initiated.” Page 2, lines 31-32. “As a result, an immune response is delayed in a subject receiving the PGPR based vaccine formulation.” Page 2, lines 32-33. “This delay in an immune response is generally at least 7 days, and is more typically 21 - 35 days, after the PGPR vaccine is administered, relative to a subject receiving a substantially identical vaccine except that it does not include PGPR.” Pages 2-3 (bridging sentence). Therefore, the emulsion disclosed in Hu qualifies as controlled release. MPEP § 2111 (“During patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification.’”).
Accordingly, claims 1, 3-4, 7, 14, 16, 21, and 24-27 are anticipated by Hu.
Regarding claim 28, Applicant is referred to claim 5 of Hu.
Claim Rejections - 35 U.S.C. 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 2, 8, 15, 18-20, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 111358944 A).
Hu is discussed above, in the second rejection under 35 U.S.C. 102(a)(1). That discussion is incorporated by reference into this rejection under 35 U.S.C. 103.
Regarding claim 2, Hu discloses that the oil adjuvant, itself, comprises 2.50-3.50% PGPR. Description at page 010. The oil adjuvant is the mixed and emulsified with the antigen-containing aqueous phase at a ratio of 2:1, which results in a W/O vaccine emulsion having final PGPR concentration range of 1.67-2.33%. The minimum concentration of 1.67% is close enough to the corresponding maximum concentration recited in claim 2 (“1.25%”) to support a finding of prima facie obviousness. MPEP 2144.05(I) (“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”).
Regarding claim 8, a person having ordinary skill in the art — following a review of Hu — would have been able to determine the effective amount of NDV antigen per dose through routine experimentation. MPEP § 2141.03(I) (“‘A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton’”) and (“‘Office personnel may also take into account ‘the inferences and creative steps that a person of ordinary skill in the art would employ’”).
Regarding claims 15, 18-20 and 30, it is prima facie obvious to sequentially administer or combine two vaccines having similar utility. MPEP § 2144.06(I) (combining equivalents known for the same purpose). The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP § 2144.04(IV)(C) (changes in sequence of adding ingredients), citing In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results).
Claims 5, 6, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 111358944 A) in view of Stone (“Preparation of inactivated oil-emulsion vaccines with avian viral or mycoplasma antigens.” Avian diseases (1978): 666-674) and Chen (“Construction of a stable w/o nano-emulsion as a potential adjuvant for foot and mouth disease virus vaccine.” Artificial cells, nanomedicine, and biotechnology 45.5 (2017): 897-906).
Hu is discussed above, in the second rejection under 35 U.S.C. 102(a)(1). That discussion is incorporated by reference into this rejection under 35 U.S.C. 103.
Although Hu discloses that the W/O vaccine emulsion comprises SPAN-85, Hu is silent as to whether it can further comprise another surfactant. Consequently, Hu does not satisfy claims 5 and 6 of the present application. As explained below, Stone and Chen compensate for this deficiency.
Stone is directed to preparing inactivated water-in-oil (W/O) emulsion vaccines. Title/Summary.
In Table 1 (page 668), Stone discloses:
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Stone discloses: “The oil-phase emulsifiers Arlacel A (mannide monooleate, Sigma Chemical Co., Saint Louis, Missouri) and Arlacel 80 (sorbitan monooleate, ICI United States, Inc., Wilmington, Delaware) were used either alone or in combination with an aqueous-phase emulsifier, Tween 80 (polysorbate 80, ICI United States. Inc.).” Page 668 (emphasis added; internal citations omitted).
Stone discloses: “Of considerable practical significance is the markedly lower viscosity of emulsions containing Tween 80 in combination with Arlacel A or Arlacel 80.” (Emphasis added) Page 673.
Chen is directed to “[a] stable and bio-compatible w/o nano-emulsion was developed as adjuvant for foot and mouth disease (FMD) vaccine with isopropyl myristate as oil phase, polyglycerol polyricinoleate [(PGPR)], and Tween 80 as surfactants.” Abstract.
Chen teaches that the aqueous phases were prepared by adding the antigen to water having different amounts of Tween 80 (w/w: 0, 1, 2, 3, 4, and 5%) dissolved therein. Page 898.
Before the effective filing date of the claimed invention, the teachings of Stone and Chen would have motivated a person having ordinary skill in the art to modify Hu by adding polysorbate 80 (Tween 80) to the aqueous phase, in an effort to reduce the viscosity of the W/O vaccine emulsion. Persons having ordinary skill in the art would have readily recognized that a lower viscosity makes it easier to administer the vaccine via injection and/or mitigates pain at the injection site. In regard to the concentration ranges recited in claims 5 and 17, Table 1 of Stone teaches 0.8% polysorbate 80 (first surfactant) and 8.0% sorbitan monooleate (second surfactant), which is close enough to support a finding of prima facie obviousness. MPEP 2144.05(I) (“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”). In sum, claims 5-6 and 17 are prima facie obvious.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 111358944 A) in view of Stone (US 5,744,137).
Hu is discussed above, in the second rejection under 35 U.S.C. 102(a)(1). That discussion is incorporated by reference into this rejection under 35 U.S.C. 103.
Hu is silent regarding any of the antigens recited in claims 9 and 10. Stone, which is directed to oil emulsion vaccines for animals, teaches “[t]he antigen can be live or inactivated” (column 4, line 67) and identifies Salmonella as an exemplary antigen (column 4, line 3). See also column 6 at Example 2. Before the effective filing date of the claimed invention, the teachings of Stone would have motivated a person having ordinary skill in the art to modify Hu by substituting inactivated Salmonella for the NDV antigen, as part of an effort to formulate a Salmonella vaccine. A person having ordinary skill in the art would have been able to determine the effective amount of inactivated Salmonella per dose through routine experimentation. MPEP § 2141.03(I) (“‘A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton’”) and (“‘Office personnel may also take into account ‘the inferences and creative steps that a person of ordinary skill in the art would employ’”). Therefore, claims 9 and 10 are prima facie obvious.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 111358944 A) in view of Ma (“A review of fish vaccine development strategies: conventional methods and modern biotechnological approaches.” Microorganisms 7.11 (2019): 569).
Hu is discussed above, in the second rejection under 35 U.S.C. 102(a)(1). That discussion is incorporated by reference into this rejection under 35 U.S.C. 103.
Hu is silent regarding any of the antigens recited in claim 11. Ma, which is directed to vaccines for fish immunization, teaches “[m]ost licensed fish vaccines have traditionally been inactivated microorganisms that were formulated with adjuvants and delivered through immersion or injection routes.” Abstract. Table 1 of Ma teaches both inactivated Vibriosis spp. (page 3) and inactivated S. iniae (page 4). Before the effective filing date of the claimed invention, the teachings of Ma would have motivated a person having ordinary skill in the art to modify Hu by substituting either or both of those inactivated antigens for the NDV antigen, as part of an effort to formulate a vaccine to immunize fish. A person having ordinary skill in the art would have been able to determine the effective amount of inactivated Vibriosis spp. and inactivated S. iniae per dose through routine experimentation. MPEP § 2141.03(I) (“‘A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton’”) and (“‘Office personnel may also take into account ‘the inferences and creative steps that a person of ordinary skill in the art would employ’”). Therefore, claim 11 is prima facie obvious.
Claims 12 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 111358944 A) in view of Lee (“Inactivated H9N2 avian influenza virus vaccine with gel-primed and mineral oil-boosted regimen could produce improved immune response in broiler breeders.” Poultry science 90.5 (2011): 1020-1022).
Hu is discussed above, in the second rejection under 35 U.S.C. 102(a)(1). That discussion is incorporated by reference into this rejection under 35 U.S.C. 103.
Hu is silent regarding the H9N2 antigen recited in claims 9 and 10. Lee, which is directed an inactivated H9N2 avian influenza virus vaccine, teaches that a 2-dose regimen of inactivated H9N2 LPAI vaccine could enhance the immunologic response in chickens. Abstract; see also page 1022, left column. Before the effective filing date of the claimed invention, the teachings of Lee would have motivated a person having ordinary skill in the art to modify Hu by substituting H9N2 avian influenza virus for the NDV antigen, as part of an effort to formulate a vaccine against avian influenza. Therefore, claims 12 and 22-23 are prima facie obvious.
Conclusion
Claims 1-30 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
13 December 2025
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611