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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on 11 Feb 2026 and 5 Jan 2026 have been entered.
Claim Status
The amended claim set filed 5 Jan 2026 is acknowledged. Claims 7, 10-12, 14, and 17-21 are currently pending. Of those, claims 7, 10-12, 14, and 17 are currently amended, and claims 18-21 are new. Claims 1-6, 8-9, 13, and 15-16 are cancelled. Claims 7, 10-12, 14, and 17-21 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 5 Jan 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Final Office Action mailed 3 Nov 2025 will be referred to as “FOA.”
Objection(s) and Rejection(s) Withdrawn
The rejection of claims 7, 10-12, 14, 17 under 35 U.S.C. 112(b) (see FOA par. 29-30) is withdrawn in view of the claim amendments and arguments.
The rejection of claims 7, 10-12, and 14 under 35 U.S.C. 112(a) (see FOA par. 7-28) is withdrawn in view of the claim amendments. The specification reduces to practice one vaccine composition, comprising the serine protease with SEQ ID NO: 1 [Examples 2-3]. There is no disclosed correlation of subsets of the structure with the function of being a vaccine that can protect against disease to at least some extent. However, the art teaches that much of the claimed protein sequence is predicted to be immunogenic. You et al. (2015; PTO-892 mailed 21 Mar 2025), which performs bioinformatic analysis on the H. parasuis serine protease (referred to as espP) to predict linear B cell epitopes and a 3D structure (Abstract). You et al. found that predicted antigenic epitopes are distributed at positions 70-80, 118-134, 140-148, 193-202, 211-220, 253-270, 310-318, 328-341, 347-356, 397-405, 530-541, and 626-632 of the amino acid sequence (section 2.4 pg. 2633, Figure 5). Therefore, much of the SEQ ID NO: 1 (amino acids 1-520) or SEQ ID NO: 2 (amino acids 130-221) regions are potentially antigenic. Also, work in other vaccines shows that vaccine efficacy decreases with increasing amino acid dissimilarity but that small modifications can largely be tolerated by an antigen. Juraska et al. (2018; PTO-892) studied dengue virus vaccines and shows that vaccine efficacy decreases with degree of amino acid dissimilarity between the vaccine insert and disease-causing DENVs, but that a few mismatched residues do not have a large effect on efficacy (Figure 1). Also, Nordstrom et al. (2017; PTO-892) studied vaccine engineering using the M protein of S. pyogenes and produced 86 peptide variants where one amino acid is altered and that were designed to not impair immunogenicity by altering the α-helical structure (Abstract); although very few mutants had improved efficacy, the mutants largely were still bound by the antibody (Figure 1A). Therefore, when viewing the specification in view of the art at the time of filing, one of ordinary skill in the art at the time of filing would have concluded that the one vaccine that has been demonstrated to have the claimed effect is a representative number of species of the narrower genus of serine proteases currently claimed.
New Rejection(s)
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7, 10-12, 14, and 17-18 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. This is a new matter rejection.
The claims have been broadened from “a vaccine” to “an immunogenic composition”. The claims and specification use the term “vaccine” but this term is not defined in the specification. In A Dictionary of Biology, Martin and Hine (2008; PTO-892) define the term “vaccine” as “A liquid preparation of treated disease-producing microorganisms or their products used to stimulate an immune response in the body and so confer resistance to the disease” (pg. 1, emphasis added). Therefore, one of ordinary skill in the art at the time of filing would recognize that the use of the term “vaccine” in the claims requires the induced immune response have the functional effect of “confer[ing] resistance to the disease” to at least some extent. The term “immunogenic composition” is broader because it does not require the composition be capable of this function. The specification does not adequately describe the broader genus of immunogenic compositions and therefore these newly amended claim limitations constitute new matter.
Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”). Applicant pointed out “Support for the amendments to claim 7 are found throughout the original application as originally filed, e.g., at page 3 (lines 35-36), page 4 (lines 4-10), page 5 (lines 17-19), page 6 (line 11), page 7 (lines 8-20), Example 2 and Example 3.” (Remarks pg. 4). These sections, except for Examples 2-3, are copied below:
Pg. 3 ln. 35-36
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Pg. 4 ln. 4-10
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Pg. 5 ln. 17-19
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Pg. 6 ln. 11
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Pg. 7 ln. 8-20
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However, a careful review of these paragraphs reveals that the specification does not reference immunogenic compositions that are not vaccines in those locations. Examples 2 and 3 also do not fill this gap because they point out a specific composition that is described as and used as a vaccine. Instead, the specification as a whole consistently uses the term “vaccine” to refer to the compositions comprising the H. parasuis serine protease. Accordingly, the newly amended claim limitations constitute new matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 7, 10-12, 14, and 17-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (2012; hereafter Zhang; PTO-892 mailed 21 March 2025) as evidenced by Yue et al. (2014; hereafter GenBank No. ACL32961; PTO-892 mailed 21 March 2025).
Zhang teaches an extracellular serine protease-like (ESP-like) protein espP2 (Title) cloned from a serotype 5 strain of H. parasuis (Abstract), that has 100% identity with the espP2 gene sequence of H. parasuis SH0165 (GenBank No. ACL32961) (par. bridging pg. 984-985). This GenBank No. is the same as the one disclosed in the instant specification [0031], and the full sequence disclosed has 66.7% identity with SEQ ID NO: 1 due to the presence of a C-terminal region that was truncated to form SEQ ID NO: 1 (see alignment below). However, the full serine protease sequence comprises an amino acid sequence (specifically, residues 1-520) having 100% sequence identity (i.e. at least 69%, 90%, 95%, and 98% identity) with SEQ ID NO: 1 (see alignment below). Also, the sequence disclosed in Zhang comprises SEQ ID NO: 2 (highlighted in alignment below). Zhang teaches that the recombinant protein can be formulated into a vaccine with ISA206 emulsion adjuvant and the protein concentration of 100 ng/ml requires the presence of some pharmaceutically acceptable carrier; one of ordinary skill in the art would understand the carrier as being saline to match the negative control (pg. 984 col. 2 par. 2-3). Zhang teaches that this vaccine can be given to guinea pigs, which are an art-recognized animal model for Glasser’s disease, with the result that the espP2 protein induces an antibody response and prevents H. parasuis serotype 5 (HPS0819) infection and death (i.e. a clinical sign) (pg. 986 par. bridging cols., pg. 984 col. 2 par. 2).
Also, with regard to the intended uses of “immunogenic composition”, “vaccine”, and “induces an immune response”, Zhang teaches the use of a protein comprising SEQ ID NO: 1 (see alignment below). The instant specification teaches that the SEQ ID NO: 1 structure is capable of protecting against both serotypes [Tables 2-3]. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. By teaching the same structure (SEQ ID NO: 1) administered as a vaccine to the same population (use to prevent Glasser’s disease), the Zhang vaccine must inherently teach the intended use of preventing infection by both serotypes. "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also MPEP 2112.01.
Alignment 1: Instant SEQ ID NO: 1 and the Zhang/GenBank No. ACL32961 sequence. The full sequence has 66.7% identity, and residues 1-520 of the sequence have 100% identity of residues 1-520 of SEQ ID NO: 1. The residues that make up SEQ ID NO: 2 are highlighted.
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Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/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, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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