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 12-3-2025 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 Claim13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Claim Objections Withdrawn
The objection to claim 4 for utilizing the acronym HLB without defining it upon its first recitation is withdrawn in light of the amendment thereto.
Claim Rejections Maintained Withdrawn
The rejection of claims 1-9 and 15-16 under 35 U.S.C. 103 as being unpatentable over Jansen et al. (WO 2018/115435 – IDS filed on 9-9-2022), Montane et al. (WO 2019/121916 – IDS filed on 9-9-2022) and Binks et al. (Physical Chemistry Chemical Physics Issue 12, 1999, pages 3007-3016) is withdrawn in lieu of the written description rejection set forth below. Applicant’s traversal is predicated on the unpredictability of antigen/adjuvant combinations and the need to test each antigen/adjuvant combination empirically in vivo in order to determine their efficacy. It should be noted that if said written description rejection is overcome this rejection may be reinstated and the action made final.
New Ground of Rejection
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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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, Daniel Kolker can be reached on 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 March 27, 2026