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
The response filed in 6-30-2026 is acknowledged. Claims 1-9 and 13-16 are pending. Claim13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-9 and 15-16 are currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 4-2-2026 has been considered. An initialed copy is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections Maintained
35 USC § 112
Claims 1-9 and 15-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant argues:
1. Claim 1 is directed to a specific combination of antigens in a specific formulation - that is - the claims are directed to a vaccine composition is defined structurally circumscribed class: non-replicating PCV2 and Mhyo immunogens in a submicron oil-in-water emulsion comprising squalane, vitamin E-acetate, and silica.
2. The specification identifies the common structural features of the claimed class-non-replicatingPCV2 and Mhyo immunogens, an oil-in-water emulsion, squalane, vitamin E-acetate, silica, and in preferred embodiments, polysorbate 80 and submicron droplet size-and confirms this through working Examples that this formulation provides safe and effective vaccination against both target pathogens.
3. The specification is not limited to a single species but exemplifies structural diversity across the claimed genus as Example 5 tests multiple Mhyo immunogen strains (strain 11 and
strain J) in the claimed adjuvant context (paragraphs [0151]-[0163], Tables 9-10); Example 6 confirms PCV2 challenge protection via intradermal administration (paragraphs [0164]-[0204], Table 11); and Example 7 demonstrates that multiple pharma-grade colloidal amorphous silicas are suitable for producing the combination vaccine (paragraphs [0205]-[0206], Table 12). These Examples, combined with detailed compositional disclosures for each component (paragraphs [0030]-[0068]), would convey to a person of ordinary skill that Applicants possessed the claimed genus.
4. The specification's discussion of the difficulty of the problem solved does not negate written description where the specification then discloses the solution with particularity. See MPEP § 2163; Capon v. Eshhar, 418 F.3d 1349, 1358-59 (Fed. Cir. 2005) (written description assessed in view of skilled artisans' knowledge, not by rigid demand for exhaustive exemplification). Here, [0009]-[0019] describe the formulation challenge; and then discloses the solution with the requisite particularity-a specific adjuvant system, immunogen classes, component ranges, emulsion properties, and working challenge data ( [0021]-[0034]).
5. Species-by-Species Exemplification is not required to satisfy Section 112(a), and the Silica Genus Is Adequately Described by Structural Definition and Formulation Data.
6. To the extent the rejection also implicates enablement, the Wands factors confirm enablement without undue experimentation. See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The specification provides working formulations with exact preparation steps, component ranges, immunogen amounts and objective efficacy assays ( [0046]-[0068], Example 1), as
well as extensive guidance on the immunogens, excipients, and emulsion properties ( [0030]- [0065]). Moreover, the Examples provide substantive description and working examples spanning the preparation, the assessment of efficacy (Mhyo challenge & PCV2 challenges), safety, and variants of silica for the formulation (Examples 1, 5, 6, and 7). Therefore, the claim scope is commensurate with the guidance in the specification, as the pending claims are limited to the non-replicating PCV2 and Mhyo immunogens in a defined squalane/vitamin E- acetate/silica submicron oil-in-water emulsion formulation, and not to all adjuvanted PCV2/Mhyo vaccines.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Point 1, contrary to Applicant’s the instant claims are not drawn to a specific formulation as they encompass any and all non-replicating PCV2 and Mhyo antigens in an undefined submicron oil-in-water emulsion comprising squalene, Vitamin E-acetate and silica. As acknowledged by Applicant in their response filed on 12-3-2025, antigen/adjuvant combinations are unpredictable that one needs to test each antigen/adjuvant combination empirically in vivo in order to determine their efficacy.
With regard to Points 2 and 3, the Examples are limited to the use of “undefined” immunogens and two compositions comprising very specific concentrations of Polysorbate 80, squalene, Vitamin E-acetate, Aerosil 380, water, PBS and immunogen. Moreover, all the “combination vaccines” were prepared following the detailed method set forth in Example 1. This limited disclosure cannot be extrapolated to the vast genus of “combination vaccines” encompassed by the instant claims since antigen/adjuvant combinations are unpredictable that one needs to test each antigen/adjuvant combination empirically in vivo in order to determine their efficacy. Finally, Applicant is reminded that the instant claims encompass not only whole cell immunogens and bacterins but also any and all subunit vaccines.
With regard to Point 4, The crux of the Capon decision is what is known in the art. In the Capon decision, the CAFC stated “In summary, the Board erred in ruling that §112 imposes a per se rule requiring recitation in the specification of the nucleotide of claimed DNA when that sequence is already known in the field. However, the Board did not explore the support for each of the claims of both parties in view of the specific examples and general teachings in the specifications and the known science with application of precedent guiding review of the scope of the claims.” The CAFC determined that the correlation between structure and function, required to meet the written description requirements, were known in the art. This is not the case with regard to the instant claims as (as argued by Applicant) antigen/adjuvant combinations are unpredictable that one needs to test each antigen/adjuvant combination empirically in vivo in order to determine their efficacy and hence are not known in the art. Consequently, the Capon decision is not germane to the instant rejection. The Office’s position is supported by the fact that Applicant’s own combination vaccines are limited to those produced in a very specific (and hence limiting) way.
With regard to Point 5, while Applicant is not required to provide a “species by species exemplification”, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively, describe a representative member of the claimed genus. The limited disclosure of the instant specification cannot be extrapolated to the vast genus of “combination vaccines” encompassed by the instant claims. As the specification is limited to the use of “undefined” immunogens and two compositions comprising very specific concentrations of Polysorbate 80, squalene, Vitamin E-acetate, Aerosil 380, water, PBS and immunogen. Moreover, all the “combination vaccines” were prepared following the detailed method set forth in Example 1. This limited disclosure cannot be extrapolated to the vast genus of “combination vaccines” encompassed by the instant claims since antigen/adjuvant combinations are unpredictable that one needs to test each antigen/adjuvant combination empirically in vivo in order to determine their efficacy. Consequently, the required structure/function correlation is lacking.
With regard to Point 6, “undue experimentation” is not a criteria when determining whether there is proper written description. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
As outlined previously, the instant claims are drawn combination vaccines comprising an immunologically effective amount of a non-replicating immunogen of porcine circo virus type 2 and an immunologically effective amount of a non-replicating immunogen of Mycoplasma hyopneumoniae, characterized in an oil-in-water submicron emulsion comprising squalane, vitamin E-acetate and silica (claim 1) and optionally wherein the squalane is in an amount of 1 to 15% w/v (claim 2); the vitamin E-acetate is in an amount of 2 to 20% w/v (claim 3); said vaccines further comprise an emulsifier with an HLB value of 8 to 20 (claim 4) generally or polysorbate 80 specifically (claim 5); the emulsifier is present in an amount of 0.5 to 10% w/v (claim 6); the silica is present in an amount of 0.02 to 2% w/v (claim 7); that the non-replicating immunogen of porcine circo virus type 2 is recombinantly expressed protein encoded by the ORF2 gene of porcine circo virus type 2; that the non-replicating immunogen of Mycoplasma hyopneumoniae comprises killed whole Mycoplasma hyopneumoniae (claim 9); or an aqueous phase and oil phases, wherein the aqueous phase comprises the non-replicating immunogen of porcine circo virus type 2, the non-replicating immunogen of Mycoplasma hyopneumoniae immunogen and silica, and the oil phase comprises the squalane and vitamin E-acetate (claim 16).
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of combination vaccines, Applicant must adequately describe which combination of antigens, emulsifiers and silica (and concentrations thereof) as well as the concentrations of the squalane and vitamin E acetate that give rise to a combination vaccine with efficacy against porcine circo virus type 2 and Mycoplasma hyopneumoniae. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of combination vaccines to which the claims are drawn, such as a correlation between the structure (i.e. identity and concentration of vaccine components) and its recited function (inducing a protective immune response against porcine circo virus type 2 and Mycoplasma hyopneumoniae), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of combination vaccines.
The specification clearly sets forth that a safe and efficient multivalent vaccine suitable for intradermal administration is difficult and not straightforward (see, e.g. page 3, line 25 - page 4, line 6). Moreover, the specification also stressed that the choice of the adjuvant (as well as all other components) is important (see, e.g. page 3, line 1 - 32). Additionally, the examples highlight the fact that every combination must be tested empirically for efficacy. The Examples demonstrate that the nature of the antigen, its concentration; the nature of the silica (see tables 5 and 6 of present application); and the concentrations of the various elements of the composition have an impact the efficacy of a given combination as a vaccine. Finally, the specification is limited to the demonstration that only two vaccine compositions had efficacy as a vaccine (see Examples 5 and 6) and that these two vaccine compositions are nearly identical as they comprise polysorbate 80 3.24%; squalane 6.75%; Vitamin E-acetate 7.94%; Aerosil 380 (and not any silica particles) 0.2%, in water with PBS as buffer and the particular immunogens (see table 1). Said vaccine compositions merely differ in whether Alhydrogel was present or not. Consequently, there is no support for the generalization regarding the silica; the antigen, the concentrations of the components or the size of the emulsion. While the specification discloses in Example 7 that different pharma grade silicas are suitable for use in their vaccine compositions, no data supporting such said claim is presented. Table 12 of Example 7 merely discloses data regarding the appearance, pH, osmolality, size and microscopic view of silica which cannot be extrapolated to their suitability in vaccine compositions and Tables 5 and 6 clearly demonstrates that the nature of the silica has an impact on the efficacy of a given vaccine composition. This unpredictability is acknowledged by Applicant who clearly set forth in their response filed on 12-3-2025, “Each antigen-adjuvant combination must be empirically tested in vivo, as interactions can be complex and unpredictable.” (see page 7 of said response).
Therefore, the specification fails to adequately describe at least a substantial number of members of the genus of combination vaccines to which the claims refer.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Therefore, because the art is unpredictable, in accordance with the MPEP, the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph has not been satisfied.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 September 5, 2026
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