DETAILED ACTION
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 .
Status of Claims
Claims 1-8 and 15-19 are pending and under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements have been considered. Initialed copies are enclosed.
Specification
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. See specification at page 1, line 35.
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.
Claims 2, 3 and 8 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claims 2 and 3, the claims are prima facie indefinite as they define an antigen by sequence identity with an unknown undefined sequence. Additionally, the term “whole IgM protease” is unclear as the specification describes the “whole” protease antigen as less then the full length protein and in reference to undefined regions in the serotype 1 IgM protease antigen. As such, it is unclear what is being compared to arrive at the “at least 90% or at least 95% sequence identity” as recited in the claims. The corresponding regions for serotype 1 and 7 are not described. The regions are set forth with respect to serotype 2. (see Example 1, page 12). Given that the regions are not defined in relationship to the IgM protease of serotype 1 and 7, the skilled artisan to be not readily apprised of the metes and bounds of the scope of the claims.
As to claim 8, the claim is internally inconsistent. It states that it comprises no other Streptococcus suis antigens other than the IgM protease antigen of serotype 1 and the bacterin serotype 9 and then proceeds in a contradictory fashion “or at most an IgM protease antigen of Streptococcus suis serotype 7. It simply cannot have no other element and at the same time have another element. Correction is required.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 and 15-17 and are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,383,610 in view of Jacobs (WO 2019/115741; of record) and Seele et al (WO 2015/181356; of record). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The ‘610 patent claims methods for protecting pigs against a pathogenic infection comprising administering an IgM protease antigen of S. suis and a S. suis bacterin serotype 9, sequence type 16 to pigs of at most 35 days and before an age at which the pigs are weaned. The ‘610 patent differs by not claiming serotype 1 IgM protease antigen and compositions comprising such. The ‘610 application does not limit the strain source of the IgM protease antigen.
Jacobs discloses that serotypes 2, 9, 1, 9 and1/2 are the most prevalent serotypes in infection and exemplifies serotype 2 IgM protease antigen as a vaccine and in a method of immunization of pigs and neonates for the protection of infection.
Seele et al teach the sequences of the IgM protease antigens from serotypes 2, 9, 14, 1, 7, 16 and 8 (see pages 8-9) and the use of in vaccines (see pages 23-25) for prophylaxis. Seele et al teach the use of IgM protein antigens from S. suis for vaccination of pigs. Seele et al teach protein antigens form serotypes 1, 2, 3, 4, 7, 8, 9 and 14. (see pages 8-9 and second paragraph of page 9). Seele et al teach one or more of the polypeptides in a vaccine formulation for the immunization of pigs page 3, 2nd paragraph) and the Mac-1 domain of each (second paragraph page 9 and of serotype 1 in particular disclosed as SEQ ID NO:10). Serotype 7 is disclosed as SEQ IDNO:7 and Mac-1 domain as residues 80-414 of SEQ ID NO:7 (see page 7, fourth paragraph). Seele et al teach the preparation of a vaccine composition at the paragraph bridging page 11-12. Vaccination schedules and dosages are given at page 14, 3rd-5th paragraphs) and pages 17-18, “Trial 1” and “Trial 2” and page 19, bullet 3. Seele et al teach that the Mac-1 domain is sufficient to confer protection and that any one or more of the domains can be used in the vaccine. Use of the Mac-1 domain of serotype 1 would provide for a IgM protease antigen having less than 4 or less than 3 repeats. Use of the full-length protein would meet the limitation of having 2 repeats, absent factual evidence to the contrary.
It would have been prima facie obvious to one having ordinary skill in the art at the time of filing to include or substitute the IgM protease antigen obtained from any one of the prevalent serotypes of S. suis identified as prevalent by Jacobs including whole serotype 1 or Mac-1 fragment as a vaccine as identified in Seele et al. It is noted that the serotype source of the IgM serotype antigen of the ‘610 patent is not limited as claimed and the skilled artisan would reach to any of the known prevalent serotypes for the IgM protease antigens identified by Jacobs for inclusion in a vaccine as identified by Seele et al.
Claims 1-8 (vaccine) and 15-19 (method) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-28 (vaccine) and 13-21 (method) of copending Application No. 18/293,380 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘380 application claims a method for protecting pigs against a pathogenic infection by immunizing sows or pigs at an age of at most 35 days with a vaccine comprising a whole IgM protease antigen of Streptococcus suis comprising less than for repeats, wherein the antigen is serotype 7, sequence type 29 or serotype 1, sequence type 13, further comprising a Streptococcus suis bacterin of serotype 9, sequence type 16 (claims 17, 18, 27 and 28 of ‘380).
It would have been prima facie obvious to one of ordinary skill in the art to combine antigen is serotype 7, sequence type 29 and/or serotype 1, sequence type 13, with a Streptococcus suis bacterin of serotype 9, sequence type 16 to form a vaccine for protecting pigs as claimed because the ‘380 application claims the broad combination and specifically identifies serotype 1 and 7 as encompassed by the whole IgM protease antigen of Streptococcus suis. The instant application merely combines the claimed ‘380 vaccine elements for the same purpose of protecting pigs against a pathogenic infection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant should note that both the ‘380 and the instant application were filed on the same day, as such a terminal disclaimer would be necessary to overcome the rejection if Applicant cannot show that the inventions are patentably distinct.
Conclusion
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/Patricia Duffy/Primary Examiner, Art Unit 1645