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
1. Applicant’s response filed on March 30, 2026 is acknowledged. Claims 2-8 have been amended. Claims 15-19 have been canceled. Claims 1-8 are currently pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 1-8 in the reply filed on March 30, 2026 is acknowledged. Claims 1-8 are currently under examination.
Priority
3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on October 2, 2025; May 21, 2025; and December 23, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Specification
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims are rendered vague and indefinite by the use of the phrase, for instance, “bacterium serotype 9, sequence type 16”. It is unclear what is meant by said phrase, as it is not explicitly defined in the specification. It is impossible to determine the metes and bounds of the claimed invention particularly as it pertains to the limitation “the sequence type 16” in conjunction with “having at least 90% sequence identity” or “comprises in its amino acid sequence less than four repeats” What core features/structures must be maintained? What specific sequence, identified by sequence identifier (SEQ ID NO) is required? If there are specific sequence identifiers, Applicant is encouraged to amend the claim to reflect such.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
7. Claim 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-28 of copending Application No. 18/293,380 (reference application US20240325514A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a vaccine comprising in combination an IgM protease antigen of Streptococcus suis serotype 7, Streptococcus suis bacterin serotype 9, sequence type 16, and a pharmaceutically acceptable carrier.
The claims of the co-pending application are drawn:
23. A vaccine comprising a whole IgM protease antigen of Streptococcus suis, the antigen comprising in its amino acid sequence less than four repeats, and a pharmaceutically acceptable carrier.
24. The vaccine of claim 23, wherein the antigen comprises in its amino acid sequence less than three repeats.
25. The vaccine of claim 23, wherein the antigen comprises in its amino acid sequence two repeats.
26. The vaccine of claim 23, wherein the IgM protease antigen is of Streptococcus suis serotype 7 or of Streptococcus suis serotype 1.
27. The vaccine of claim 23, wherein the IgM protease antigen is of Streptococcus suis serotype 7 sequence type 29, or of Streptococcus suis serotype 1, sequence type 13.
28. The vaccine of claim 23, wherein the vaccine further comprises a Streptococcus suis bacterin of serotype 9, sequence type 16.
The pending claims are anticipatory and/or obvious over the combination of co-pending claims 23, 27 and 28.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 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.
The following rejections are made in light of the 112(b) as set forth above
8. Claim(s) 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okwumabua, CA 2541701 A1; Published: 9/30/07.
Independent claim 1 is drawn to a vaccine comprising in combination an IgM protease antigen of Streptococcus suis serotype 7, Streptococcus suis bacterin serotype 9, sequence type 16, and a pharmaceutically acceptable carrier.
Okwumabua discloses immunogenic compositions (which is interchangeable with vaccine; see paragraph 0028) include an isolated 38 kDa polypeptide of Streptococcus suis and a suitable excipient. Said polypeptide may be derived from Streptococcus suis capsular type such as type 7, type 9, type 16, and type 29 (see paragraph 0007/0033; meets claim 1 and 8). Further, said composition may include at least one additional antigen and may include an adjuvant (see paragraph 0012 and 14; meets claim 1).
The isolated antibody may be of any suitable isotype (e.g., IgG, IgM, IgE, IgD, IgA, and mixtures thereof) (see paragraph 0017). One embodiment includes an immunogenic composition comprising an isolated polypeptide having at least about 95% amino acid sequence identity to 38 kDa protein of Streptococcus suis and a suitable excipient (see paragraph 0065). One embodiment includes an isolated polypeptide which includes at least a contiguous ten amino acid fragment. Said fragment comprises an amino acid sequence selected from the group consisting of amino acid sequence 1-10 of SEQ ID NO:1, amino acid sequence 2-11 of SEQ ID NO: 1, amino acid sequence 3-12 of SEQ ID NO:1, etc....amino acid sequence 336-445 of SEQ ID NO:1. (see paragraphs 0076-77).
As it pertains to claims 2-6, the Office takes the position that the combination of antigens of S. suis serotype 7 and 9, as required by the claims are identical and are whole antigens; thus, absent evidence to the contrary, said reference encompasses antigens having at least 90 and 95% and has an amino acid sequence less than four repeats, less than three repeats and two repeats.
Considering the 112 above, the Office further takes the position that the Streptococcus suis type 7 and type 9, encompasses the sequence type 16, recited in claim 1 as well as encompasses sequence type 29, recited in claim 7, absent evidence to the contrary.
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
9. Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seele et al., MY-178365-A; Published: 10/09/20.
Independent claim 1 is drawn to a vaccine comprising in combination an IgM protease antigen of Streptococcus suis serotype 7, Streptococcus suis bacterin serotype 9, sequence type 16, and a pharmaceutically acceptable carrier.
Seele discloses vaccine compositions against Streptococcus suis infection comprising IdeSsuis (IgM protease) of Streptococcus suis 7, a Streptococcus suis bacterin serotype 9, Streptococcus suis 16, and a pharmaceutically acceptable carrier (see Table 1, page 8-9 and 11; meets claim 1). In a preferred embodiment, the vaccine essentially consist of an rIdeSsuis protein which is at least 85% or 95% to said protein (see page 6, lines 11-14 and Page 8, lines 17-25; meets claims 2-3).
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Conclusion
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 April 23, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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