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 .
Claims 1-21 are cancelled. Claims 22-28 are pending and under examination.
Election/Restrictions
Applicant’s election without traverse of Group II claims 22-28 in the reply filed on 3/3/2026 is acknowledged.
Claims 13-21 Group I is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/3/2026.
Information Disclosure Statement
The information disclosure statements filed 12/24/2024, 6/5/2025 and 3/3/2026 have been considered and initialed copies are enclosed.
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.
Claim(s) 22-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seele et al. WO 2015/181356 12/3/2015 cited in IDS.
Seele et al disclose a method of manufacturing a vaccine for protecting pigs against a pathogenic infection with Streptococcus suis comprising combining a whole IgM protease antigen called IdeSsuis (see abstract) of serotype 7 or serotype 1 Streptococcus suis with a pharmaceutically acceptable carrier, wherein the antigen comprises in its amino acid sequence less than 4 repeats. See p. 2 3rd paragraph and p. 3.
Seele et al disclose that IdeSsuis has the amino acid sequence of SEQ ID NO: 7 which is the IdeSsuis of serotype 7 (see Seele et al at p. 4 paragraph 4) and also IdeSsuis serotype 1 which comprises less than four repeats – according to the specification IdeSsuis IgM protease from serotype 1 and serotype 7 has 2 repeats.
Seele et al also disclose vaccines comprising other whole IdeSsuis sequences from serotype 1 and 7 and a pharmaceutically acceptable carrier . See p. 8 to 9, p. 11, p. 12-15.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seele et al. WO 2015/181356 12/3/2015 cited in IDS in view of Rieckmann et al. Vet. Res. 2018 Jun 15; 49:48 (12 pages) cited in IDS.
Seele et al disclose a method of manufacturing a vaccine for protecting pigs against a pathogenic infection with Streptococcus suis comprising combining a whole IgM protease antigen called IdeSsuis (see abstract) of serotype 7 or serotype 1 Streptococcus suis with a pharmaceutically acceptable carrier, wherein the antigen comprises in its amino acid sequence less than 4 repeats. See p. 2 3rd paragraph and p. 3.
Seele et al disclose that IdeSsuis has the amino acid sequence of SEQ ID NO: 7 which is the IdeSsuis of serotype 7 (see Seele et al at p. 4 paragraph 4) and also IdeSsuis serotype 1 which comprises less than four repeats – according to the specification IdeSsuis IgM protease from serotype 1 and serotype 7 has 2 repeats.
Seele et al also disclose vaccines comprising other whole IdeSsuis sequences from serotype 1 and 7 and a pharmaceutically acceptable carrier . See p. 8 to 9, p. 11, p. 12-15.
Seele et al does not disclose the IgM protease antigen of serotype 7 has the sequence type 29.
Rieckmann et al disclose that S. suis is an important pathogen causing meningitis, arthritis and septicemia and that S. suis cps7 emerged recently in Germany in association with severe herd problems. Rieckmann et al disclose that the cps7 isolates belonged to sequence type (ST) 29 and some of these isolates expressed the IgM specific protease and that these strains were found to be virulent. Rieckmann et al disclose that there is IgM mediated killing of S. suis in the blood of growing piglets and this underlines the relevance of IgM as an important host defense mechanism against S. suis.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the vaccine composition of Seele et al by substituting the IgM protease of serotype 7 with the IgM protease serotype 7 ST29, thus resulting in the instant motivation with a reasonable expectation of success. The motivation to do so is that Rieckmann et al disclose that S. suis cps7 serotype 7 ST29 emerged recently in Germany in association with severe herd problems and that these virulent isolates expressed the IgM specific protease. Rieckmann et al disclose that the importance of IgM mediated killing of S. suis in the blood of growing piglets in an experimental infection with the cps7 ST29 strains and this underlines the relevance of IgM as an important host defense mechanism against S. suis. Thus, vaccinating using the IgM protease of ST29 would be beneficial.
Claim(s) 23 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seele et al. WO 2015/181356 12/3/2015 cited in IDS in view of Estrada et al. J Clin Microbiol 57:e00377-19. https://doi.org/ 10.1128/JCM.00377-19 (16 pages).
Seele et al disclose a method of manufacturing a vaccine for protecting pigs against a pathogenic infection with Streptococcus suis comprising combining a whole IgM protease antigen called IdeSsuis (see abstract) of serotype 7 or serotype 1 Streptococcus suis with a pharmaceutically acceptable carrier, wherein the antigen comprises in its amino acid sequence less than 4 repeats. See p. 2 3rd paragraph and p. 3.
Seele et al disclose that IdeSsuis has the amino acid sequence of SEQ ID NO: 7 which is the IdeSsuis of serotype 7 (see Seele et al at p. 4 paragraph 4) and also IdeSsuis serotype 1 which comprises less than four repeats – according to the specification IdeSsuis IgM protease from serotype 1 and serotype 7 has 2 repeats.
Seele et al also disclose vaccines comprising other whole IdeSsuis sequences from serotype 1 and 7 and a pharmaceutically acceptable carrier . See p. 8 to 9, p. 11, p. 12-15.
Seele et al does not disclose the IgM protease antigen of serotype 1 has the sequence type 13.
Estrada et al disclose that there is a correlation between serotype 1 ST13 and virulence and that serotype 1 isolates are associated with the pathogenic pathotype. See p. 13 second to last paragraph.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the vaccine composition of Seele et al by substituting the IgM protease of serotype 1 with the IgM protease serotype 1 ST13, thus resulting in the instant motivation with a reasonable expectation of success. The motivation to do so is that Estrada et al disclose that there is a correlation between serotype 1 ST13 and virulence and that serotype 1 isolates are associated with the pathogenic pathotype. Thus, vaccinating using the IgM protease of serotype 1 ST13 would be beneficial since this strain is pathogenic.
Claim(s) 23 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seele et al. WO 2015/181356 12/3/2015 cited in IDS in view of Klaasen et al. WO 2010108977 09-30-2010 cited in IDS.
Seele et al disclose a method of manufacturing a vaccine for protecting pigs against a pathogenic infection with Streptococcus suis comprising combining a whole IgM protease antigen called IdeSsuis (see abstract) of serotype 7 or serotype 1 Streptococcus suis with a pharmaceutically acceptable carrier, wherein the antigen comprises in its amino acid sequence less than 4 repeats. See p. 2 3rd paragraph and p. 3.
Seele et al disclose that IdeSsuis has the amino acid sequence of SEQ ID NO: 7 which is the IdeSsuis of serotype 7 (see Seele et al at p. 4 paragraph 4) and also IdeSsuis serotype 1 which comprises less than four repeats – according to the specification IdeSsuis IgM protease from serotype 1 and serotype 7 has 2 repeats.
Seele et al also disclose vaccines comprising other whole IdeSsuis sequences from serotype 1 and 7 and a pharmaceutically acceptable carrier . See p. 8 to 9, p. 11, p. 12-15.
Seele et al does not disclose that the vaccine further comprises a Streptococcus suis bacterin of serotype 9.
Klaasen et al disclose a vaccine comprising inactivated whole cell of Streptococcus suis serotype 9. See p. 6 first paragraph. Klaasen et al disclose that vaccines comprising S. suis antigens can be formulated by using art known methods that basically comprise admixing suitable antigens of S. suis (live or inactivated, whole cell, extract, purified fraction or even subunit) with a pharmaceutically acceptable carrier.
See p. 6 2nd paragraph. See p. 12 claim 5.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have combined the vaccine of Seele et al with an inactivated whole cell (bacterin) of Streptococcus suis serotype 9, thus resulting in the instant invention with a reasonable expectation of success.
The suggestion to do so is that Klaasen et al disclose a vaccine comprising inactivated whole cell (bacterin) of Streptococcus suis serotype and disclose that vaccines comprising S. suis antigens can be formulated by using art known methods that basically comprise admixing suitable antigens of S. suis (live or inactivated, whole cell, extract, purified fraction or even subunit) with a pharmaceutically acceptable carrier. In addition, Klaasen et al disclose a vaccine comprising a combination of inactivated cells of S. suis bacteria (bacterin) and derivatives thereof which is stated to be a non-live component of S. suis bacteria that have lost their association with the cells and can be in recombinant form. See Klaasen et al p. 4 last paragraph to p. 5 first paragraph and p. 12 claim 5.
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.
Claims 22-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/293,378 (‘378). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘378 claims disclose a method for manufacturing a vaccine for protecting pigs against a pathogenic with S. suis, the method comprising combining a whole IgM protease antigen of serotype 7 comprising two amino acid sequence repeats and bacterin of serotype 9 sequence type 16 and a pharmaceutically acceptable carrier. The ‘378 claims disclose said vaccine composition. The ‘378 claims disclose the IgM protease antigen is of sequence type 29.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 22-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 15-19 of copending Application No. 18/293,007 (‘007). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘007 claims disclose a method for manufacturing a vaccine for protecting pigs against a pathogenic with S. suis, the method comprising combining a whole IgM protease antigen of serotype 1 comprising two amino acid sequence repeats and bacterin of serotype 9 sequence type 16 and a pharmaceutically acceptable carrier. The ‘007 claims disclose said vaccine composition. The ‘007 claims disclose the IgM protease antigen of serotype 1 is of sequence type 13. The ‘007 claims disclose the vaccine further comprises at most an IgM protease antigen of S. suis serotype 7 which according to the instant specification comprises two amino acid repeats.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 22-26 and 28 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 Seele et al (WO 2015/181356). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The '610 claims disclose a vaccine 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. The vaccine will necessarily comprise a pharmaceutically acceptable carrier.
The '610 patent vaccine composition does not comprise an IgM protease comprising in its amino acid sequence less than 4 repeats.
Seele et al disclose a method of manufacturing a vaccine for protecting pigs against a pathogenic infection with Streptococcus suis comprising combining a whole IgM protease antigen called IdeSsuis (see abstract) of serotype 7 Streptococcus suis with a pharmaceutically acceptable carrier, wherein the antigen comprises in its amino acid sequence less than 4 repeats. See p. 2 3rd paragraph and p. 3.
Seele et al disclose that IdeSsuis has the amino acid sequence of SEQ ID NO: 7 which is the IdeSsuis of serotype 7 (see Seele et al at p. 4 paragraph 4) which comprises less than four repeats – according to the specification IdeSsuis IgM protease has 2 repeats and also IdeSsuis serotype 1. Seele et al also disclose vaccines comprising other whole IdeSsuis sequences from serotype 1 and pharmaceutically acceptable carrier. See p. 8 to 9, p. 11, p. 12-15.
It would have been prima facie obvious to one having ordinary skill in the art as of the effective filing date of the invention to have included or substituted the IgM protease antigen in the ‘610 claim with the IgM protease serotype 7 or serotype 1 as identified in Seele et al. The motivation to do so is that Seele et al disclose that the IgM protease serotype 7 or serotype 1 are useful for protecting against S. suis.
Claims 22-28 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 Estrada et al. J Clin Microbiol 57:e00377-19. https://doi.org/ 10.1128/JCM.00377-19 (16 pages).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The '610 claims disclose a vaccine 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. The vaccine will necessarily comprise a pharmaceutically acceptable carrier.
The '610 patent vaccine composition does not comprise an IgM protease comprising in its amino acid sequence less than 4 repeats which is the IgM protease of serotype 1 ST13.
Estrada et al disclose that there is a correlation between serotype 1 ST13 and virulence and that serotype 1 isolates are associated with the pathogenic pathotype. See p. 13 second to last paragraph.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the vaccine composition of the ‘610 claims by substituting the IgM protease with the IgM protease serotype 1 ST13, thus resulting in the instant motivation with a reasonable expectation of success. The motivation to do so is that Estrada et al disclose that there is a correlation between serotype 1 ST13 and virulence and that serotype 1 isolates are associated with the pathogenic pathotype. Thus, vaccinating using the IgM protease of serotype 1 ST13 would be beneficial since this strain is pathogenic.
Claims 22-28 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 Rieckmann et al. Vet. Res. 2018 Jun 15; 49:48 (12 pages) cited in IDS.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The '610 claims disclose a vaccine 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. The vaccine will necessarily comprise a pharmaceutically acceptable carrier.
The '610 patent vaccine composition does not comprise an IgM protease comprising in its amino acid sequence less than 4 repeats which is the IgM protease of serotype 7 ST29.
Rieckmann et al disclose that S. suis is an important pathogen causing meningitis, arthritis and septicemia and that S. suis cps7 emerged recently in Germany in association with severe herd problems. Rieckmann et al disclose that the cps7 isolates belonged to sequence type (ST) 29 and some of these isolates expressed the IgM specific protease and that these strains were found to be virulent. Rieckmann et al disclose that there is IgM mediated killing of S. suis in the blood of growing piglets and this underlines the relevance of IgM as an important host defense mechanism against S. suis.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the vaccine composition of the ‘610 claims by substituting the IgM protease with the IgM protease serotype 7 ST29, thus resulting in the instant motivation with a reasonable expectation of success. The motivation to do so is that Rieckmann et al disclose that S. suis cps7 serotype 7 ST29 emerged recently in Germany in association with severe herd problems and that these virulent isolates expressed the IgM specific protease. Rieckmann et al disclose that the importance of IgM mediated killing of S. suis in the blood of growing piglets in an experimental infection with the cps7 ST29 strains and this underlines the relevance of IgM as an important host defense mechanism against S. suis. Thus, vaccinating using the IgM protease of ST29 would be beneficial.
Status of Claims
Claim 22-28 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645