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
Claims 1, 3-6, 8-15, and 17-30 are pending. Claims 3-6, 8-15, 22-24, and 26 are rejoined. Claim 29 is withdrawn from consideration.
Response to Amendment
Applicant canceled claims 2, 7, and 16. Applicant amended claim 1 and narrowed the scope of the construct to consist of two truncated T3SS bacterial effector polypeptides. Applicant amended claims 8, 17, 22, and 24 to depend from claim 1, and claim 19 to depend from claim 18.
The objection to the drawings is withdrawn in view of Applicant’s argument.
The objection to the specification is withdrawn in view of the amendment.
The objection to claim 17 is withdrawn in view of the amendment.
The rejection of claims 1-30 under 35 U.S.C. 112(a) is withdrawn in view of Applicant’s argument.
The rejection of claims 19-21 under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
The rejection of claims 1-2, 27, and 30 under 35 U.S.C. 102(a)(1) is withdrawn in view of the amendment.
The rejection of claims 1-2, 16-17, 25, 27-28, and 30 35 U.S.C. 102(a)(2) is withdrawn in view of the declaration under 37 CFR 1.130(a) filed on 08/05/2026.
The rejection of claims 1-2, 16-19, 25, 27-28, and 30 under 35 U.S.C. 103 is withdrawn in view of the declaration under 37 CFR 1.130(a) filed on 08/05/2026.
Claim Objections
Claims 1, 8-10, and 26 are objected to because of the following informalities:
In claims 1 and 8-10, NIeC in lines 11, 2, and 1, respectively should be replaced with NleC.
In claim 1, a comma after “linker” in line 6 should be added.
In claim 26, “where in” in line 1 should be replaced with “wherein”.
Appropriate correction is required.
Rejection Necessitated by the Amendment
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.
Claims 20-23 and 28 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 20 and 21 recite the limitation "IpaH4.5" in lines 2 and 1, respectively. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites OspZ polypeptide having an amino acid sequence as set forth in SEQ ID NO.: 5. However, claim 3 recites that OspZ polypeptide has an amino acid
sequence as set forth in SEQ ID NO.: 3. The specification discloses NleC polypeptide has an amino acid sequence as set forth in SEQ ID NO.: 5 ([0052]). The claim is indefinite because it is not clear which SEQ ID NO. the claim requires.
Claim 23 recites YopJ polypeptide having an amino acid sequence as set forth in SEQ ID NO.: 9; or the YopJ polypeptide comprises a point mutation at cysteine 172 of SEQ ID NO.: 9. SEQ ID NO.: 9 does not comprise a cysteine at position 172. Furthermore, claim 13 recites NleB polypeptide has an amino acid sequence as set forth in SEQ ID NO.: 9. The claim is indefinite because it is not clear which SEQ ID NO. the claim requires.
Claim 28 recites the two or more truncated T3SS bacterial effector polypeptides. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites only two truncated T3SS bacterial effector polypeptides.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-6, 9-15, 19-22, 25-28 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 3 and 6 recite the construct comprises. Claim 1, from which claims 3 and 6 ultimately depend, limits the construct to consist of two truncated T3SS bacterial effector polypeptides. Claims 3 and 6 have a broader scope than claim 1 and do not further limit the subject matter of the claim 1.
Claim 4 recites the OspZ polypeptide comprises an amino acid sequence at least 90% identical to amino acids 226-446 of SEQ ID NO.: 3. Claim 3, from which claim 4 depends, limits the OspZ polypeptide to a portion of SEQ ID NO: 3. Claim 4 has a broader scope and does not further limit the subject matter of the claim 3.
Claim 9 recites the NleC polypeptide comprises an amino acid sequence at least 90% identical to amino acids 2-187 of SEQ ID NO.: 5. Claim 8, from which claim 9 depends, limits the OspZ polypeptide to a portion of SEQ ID NO: 3. Claim 9 has a broader scope and does not further limit the subject matter of the claim 8.
Claims 11-12 recite the construct comprises. Claims 11-12 have a broader scope than claim 1, and do not further limit the subject matter of claim 1.
Claim 14 recites the NleB polypeptide comprises an amino acid sequence at least 90% identical to amino acids 2-226 of SEQ ID NO.: 9. Claim 13, from which claim 14 depends, limits the NleB polypeptide to a portion of SEQ ID NO: 9. Claim 14 has a broader scope and does not further limit the subject matter of the claim 13.
Claim 19 recites the IpaH9.8 polypeptide comprises an amino acid sequence at least 90% identical to amino acid 56-228 of SEQ ID NO.: 11. Claim 18, from which claim 19 depends, limits the IpaH9.8 polypeptide to a portion of SEQ ID NO: 11. Claim 19 has a broader scope and does not further limit the subject matter of the claim 18.
Claims 20 and 21 recites IpaH4.5 polypeptide. Claim 20 depends from claim 19, which depends from claim 18, which depends from claim 17, which depends from claim 1. Claim 1 does not recite IpaH4.5 polypeptide and limits the E3 ubiquitin ligase to be IpaH 7.8 or IpaH9.8. Claims 20 and 21 are not proper dependent claims because they fail to include all the limitations of the base claim from which they ultimately depend from.
Claim 21 recites the IpaH4.5 polypeptide comprises an amino acid sequence at least 90% identical to amino acid 62-270 of SEQ ID NO.: 13. Claim 20, from which claim 21 depends, limits the IpaH4.5 polypeptide to a portion of SEQ ID NO: 13. Claim 21 has a broader scope and does not further limit the subject matter of the claim 20.
Claim 22 recites the construct comprises. Claim 22 has a broader scope than claim 1 and does not further limit the subject matter of the claim 1.
Claim 23 recites the construct comprises. Claim 23 has a broader scope than claim 1 and does not further limit the subject matter of the claim 1.
Claim 25 recites the construct of claim 1 further comprising a protein transduction domain. Claim 1 limits to construct to consist of two truncated T3SS bacterial effector polypeptides and does not require a protein transduction domain. Claim 25 is not a proper dependent claim because it fails to include all the limitations of the base claim from which it depends.
Claim 26 recites the protein transduction domain is an IpaH9.8 protein transduction domain; and wherein the IpaH9.8 protein transduction domain has an amino acid sequence. Claim 25, from which claim 26 depends, requires the
protein transduction domain to be a YopM protein transduction domain with SEQ ID NO.: 11. Claim 26 is not a proper dependent claim because it fails to include all the limitations of the base claim from which it depends.
Claims 27 recites wherein the construct comprises a fusion protein. Claim 27 is not a proper dependent claim because it fails to include all the limitations of claim 1 from which it depends.
Claim 28 recites the two or more truncated T3SS bacterial effector polypeptides. Claim 1 limits the construct to only two truncated T3SS bacterial effector polypeptides. Claim 28 has a broader scope than claim 1 and does not further limit the subject matter of the claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 5, 10, 13, and 15 do not cure the deficiency of the claims and are also rejected.
Maintained Rejection
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 1, 17-21, 25, 27-28, and 30 remain rejected and claims 3-5, 8-10, 12-15, and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, and 12 of U.S. Patent No. 12,404,307 in view of Lubos and Rohde.
Regarding instant claims 1-2, 16-21, 25, 27-28, and 30, patent claim 1 recites a composition comprising a set of paired peptides wherein the set of paired peptides is linked to a protein transduction domain, and wherein the set of paired peptides comprises a first bacterial effector polypeptide linked to a second bacterial effector polypeptide, wherein the protein transduction domain is a YopM protein transduction domain, an SspHl protein transduction domain, or an lpaH protein transduction domain wherein the protein transduction domain and the set of paired peptides comprise a fusion protein and the amino acid sequence of the fusion protein is at least 85% identical to the sequence set forth in SEQ ID NO. 10, 13, 16, 19, 22, or 24. Patent claim 2 recites the first bacterial effector polypeptide and second bacterial effector polypeptide are different. Patent claim 3 recites first bacterial effector polypeptide and the second bacterial effector polypeptide are immunomodulatory. Patent claim 6 recites a linker is positioned between the first bacterial effector polypeptide and the second bacterial effector polypeptide. Patent claim 7 recites the protein transduction domain is a YopM protein transduction domain. Patent claim 8 recites the protein transduction domain comprises SEQ ID NO: 5 (i.e., instant SEQ ID NO: 17). Patent claim 12 recites a composition comprising a protein transduction domain polypeptide linked to a first bacterial effector polypeptide and at least one additional bacterial effector polypeptides wherein the first bacterial effector polypeptide is a polypeptide having 90% sequence identity to an amino acid sequence set forth in the group consisting of SEQ ID NOs 3, 89,42,44,46,48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, and 79 and the at least one additional effector polypeptide is a polypeptide having 90% sequence identity to an amino acid sequence set forth in the group consisting of SEQ ID NOs. 3, 89, 42, 44,46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, and 79. Patent claims 1-3, 6-8, and 12 do not recite a pharmaceutical composition with carrier, truncated IpaH9.8, or truncated IpaH4.5.
However, Lubos teaches a pharmaceutical composition comprising one or more (i.e., two) of effector proteins or fragment thereof (i.e., truncated) and a carrier ([0263]), and teaches the effectors or their fragments are capable of down-regulating cytokines (i.e., effector polypeptides retain one or more activities of the corresponding full length-T3SS bacterial effector polypeptides) ([0205)]. Lubos teaches the effector protein is a bacterial effector protein of the selected from the group consisting of SspHl, SspH2, SlrP, IpaHl.4, IpaH2.5, IpaH3, IpaH4.5, IpaH7.8, and IpaH9.8 (i.e., E3 ubiquitin ligase). Lubos teaches IpaH4.5 is 100% identical to instant SEQ ID NO: 13 (See Appendix A pages 3-4 for alignment). Lubos teaches the effector is fused to cleavable linker ([0182]).
Lubos does not teach IpaH9.8 with SEQ ID NO: 11.
However, Rohde teaches IpaH9.8 from Shigella flexneri with 100% sequence identity to instant SEQ ID NO: 11 (See Appendix A pages 1-2 for alignment).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claims 1-3, 6-8, and 12 by fusing truncated IpaH9.8 and IpaH4.5 with SEQ ID NO: 11 and 13 respectively, as suggested by Lubos and Rohde. One of ordinary skill in the art would be motivated to do so in order to form and anti-inflammatory composition. MPEP 2144.06 II states that it is obvious to substitute equivalents know for the same purpose.
Response to Arguments
Applicant's arguments filed 08/05/2026 have been fully considered but they are not persuasive.
Applicant argues the claimed invention and the invention claimed in U.S. Patent No. 12,404,307 were made by or on behalf of parties to a joint collaboration that was in effect on or before the effective filing date of the claimed invention. Accordingly, U.S. Patent No. 12,404,307 does not constitute prior art and cannot form the basis of a nonstatutory double patenting rejection.
In response to the argument, claims of U.S. Patent No. 12,404,307 and instant claims are patentably indistinct as explained above, and the applications share at least one common inventor with this patent so even with a Joint Research Agreement a provisional non-statutory double patenting rejection is required. See MPEP 804 Chart II-A_AIA . Thus, the double patenting rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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