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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 6-22-2026 has been entered.
The amendment filed on 6-26-2026 is acknowledged. Claims 4 and 23 have been amended. Claims 2, 7 and 22 have been canceled. Claims 4-6, 20-21 and 23 are pending and currently under examination.
Priority
In light of the amendment to the specification, Applicant's claim for receiving the benefit of an earlier filing date under 35 U.S.C. 120 and 119 (e) is deemed perfected. It should be noted that the date used for the availability of art regarding the instant claims is as follows:
For claims drawn to the use of Dirofilaria immitis antigens the effective filing date of Application 16/790,277 (2-13-2020) will be used.
For claims drawn to the use of fusion proteins comprising four Brugia malayi antigens; fusion proteins comprising Abundant Larval Transcript, Tetraspanin, Small heat shock protein (HSP) 12.6, and Thioredoxin Peroxidase 2 generally; and fusion proteins comprising the sequences of SEQ ID NO:37, SEQ ID NO:49, SEQ ID NO:63 and SEQ ID NO:71, specifically, the effective filing date of Application 14/798,945 (7/14/2015) will be used.
Claim Rejections Withdrawn
The rejection of claims 7 and 20-21 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of the amendment to amendment thereto and the cancellation of claim 7.
The rejection of claims 22-23 under 35 U.S.C. 103 as being unpatentable over Grieve et al. (WO 94/15593 – IDS filed on 9-7-2022) and Dakshinamoorthy et al. (Vaccine Vol. 32, pages 19-25) is withdrawn in light of the amendment thereto.
Claim Rejections Maintained
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 4-6, 20-21 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-12 of U.S. Patent No. 12,419,939. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to methods of inducing various immune response through the administration of compositions comprising an Abundant Larval Transcript antigen, a HSP 12.6 antigen and a Thioredoxin Peroxidase and two or more adjuvants. It should be noted that while the patented claims do not explicitly disclose that the various antigens are covalently attached it is an obvious option as evidenced by patented claim 4.
It should be noted that Applicant asked for this rejection to be held in abeyance which technically is non-responsive. Applicant is advised that this rejected must traversed or a Terminal disclaimer be file in any response to this action in order to be considered fully responsive.
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 rejection of claims 4-6, 20-21 and 23 under 35 U.S.C. 103 as being unpatentable over Samykutty et al. (Procedia in Vaccinology Vol. 3, pages 8-12 – IDS filed on 5-25-2022); Chandrashekar (WO 98/52971 – IDS filed on 9-7-2022) and Dakshinamoorthy et al. (Vaccine Vol. 32, pages 19-25) is maintained for reasons of record. Cancellation of claims 2 and 22 has rendered the rejection of those claims moot.
Applicant argues:
1. Amended includes recitations of the limitations of claim 7 which was not part of the rejection.
2. The cited recited do not teach or suggest a thioredoxin peroxidase 2 having the amino acid of SEQ ID NO:71 or SEQ ID NO:95.
With regard to Point 1, the ability to induce an antigen-specific antibody response or an antigen specific memory T cell will response is deemed to be an inherent characteristic of the fusion protein arising from the combination of the recited references. Given the fusion protein arising from the combination of the cited references and the rejected claims have the same component antigens they would necessarily possess the same immunological characteristics.
With regard to Point 2, while Samykutty et al. do not specifically disclose the sequence of the Thioredoxin peroxidase 2 (TPx-2) proteins, given they and the claimed proteins are the same they would necessarily have the same sequences (and immunological characteristics).
As outlined previously, Samykutty et al. disclose a multivalent vaccine form lymphatic filariasis comprising Brugia malayi BmALT-2 and BmHSP proteins (see abstract).
Samkutty et al. differs from the rejected claims in that they don’t explicitly disclose: the sequence of the Thioredoxin peroxidase 2 (TPx-2) proteins; the use of the Thioredoxin peroxidase 2 (TPx-2) protein; that their antigens are covalently linked to form a fusion protein; or the use of multiple adjuvants.
Chandrashekar discloses vaccine compositions comprising the Brugia malayi Thioredoxin peroxidase 2 (TPx-2) protein (see abstract and page 4, lines 21-22). Chandrashekar further discloses that their compositions can comprise an adjuvant (see page 5, lines 15-17); that said adjuvants can be an aluminum salt, a calcium salt, silica, a saponin, toxoids, cytokines, chemokines, viral coat proteins or a block polymer (see page 30, line 15 to page 31, line 4); that their compositions can be administered more than once (see page 32 lines 11-30); and that their compositions induce antigen specific responses (see page 35, line 6-9).
Dakshinamoorthy et al. disclose the use of fusion proteins comprising Brugia malayi antigens Hsp12.6, ALT-2 and TSP LEL (see abstract). Dakshinamoorthy et al. further disclose the use of their fusion proteins in vaccine compositions comprising a combination of adjuvants (i.e. AL007 and TLR4 agonist AL019)[see section 2.3 on page 20) and that said vaccine compositions were greater than 95% effective (see abstract).
Consequently, it would have been obvious for the skilled artisan to use the Brugia malayi BmALT-2 and BmHSP proteins of Samykutty et al. and the Brugia malayi Thioredoxin peroxidase 2 of Chandrashekar in a single fusion protein for use in a nematode vaccine composition in order to take advantage of the increased immunogenicity of fusion proteins (as disclosed by demonstrated by Dakshinamoorthy et al.).
With regard to the specific sequences recited in claims 4 and 23, it is deemed in absence of the contrary, that given the disclosed proteins and the claimed proteins are the same they would necessarily have the same sequences.
The rejection of claims 4-6, 20-21 and 23 under 35 U.S.C. 103 as being unpatentable over Dakshinamoorthy et al. (Vaccine Vol. 32, pages 2013) and Chandrashekar (WO 98/52971 – IDS filed on 9-72022) is maintained for the reasons of record. Cancellation of claims 2 and 22 has rendered the rejection of those claims moot.
1. Amended includes recitations of the limitations of claim 7 which was not part of the rejection.
2. The cited recited do not teach or suggest a thioredoxin peroxidase 2 having the amino acid of SEQ ID NO:71 or SEQ ID NO:95.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Point 1, the ability to induce an antigen-specific antibody response or an antigen specific memory T cell will response is deemed to be an inherent characteristic of the fusion protein arising from the combination of the recited references. Given the fusion protein arising from the combination of the cited references and the rejected claims have the same component antigens they would necessarily possess the same immunological characteristics.
With regard to Point 2, while Samykutty et al. do not specifically disclose the sequence of the Thioredoxin peroxidase 2 (TPx-2) proteins, given they and the claimed proteins are the same they would necessarily have the same sequences (and immunological characteristics).
As outlined previously, Dakshinamoorthy et al. disclose the use of fusion proteins comprising Brugia malayi antigens Hsp12.6, ALT-2 and TSP LEL (see abstract). Dakshinamoorthy et al. further disclose the use of their fusion proteins in vaccine compositions comprising a combination of adjuvants (i.e. AL007 and TLR4 agonist AL019)[see section 2.3 on page 20) and that said vaccine compositions were greater than 95% effective (see abstract).
Chandrashekar discloses vaccine compositions comprising the Brugia malayi Thioredoxin peroxidase 2 (TPx-2) protein (see abstract and page 4, lines 21-22). Chandrashekar further discloses that their compositions can comprise an adjuvant (see page 5, lines 15-17); that said adjuvants can be an aluminum salt, a calcium salt, silica, a saponin, toxoids, cytokines, chemokines, viral coat proteins or a block polymer (see page 30, line 15 to page 31, line 4); that their compositions can be administered more than once (see page 32 lines 11-30); and that their compositions induce antigen specific responses (see page 35, line 6-9).
It would have been obvious for the skilled artisan to use the Brugia malayi Thioredoxin peroxidase 2 of Chandrashekar in the fusion protein of Dakshinamoorthy et al.) to form a single multimeric fusion protein for use in a nematode vaccine composition in order to take advantage of the increased immunogenicity of multimeric fusion proteins (as disclosed by demonstrated by Dakshinamoorthy et al.).
With regard to the specific sequences recited in claims 4 and 22, it is deemed in absence of the contrary, that given the disclosed proteins and the claimed proteins are the same they would necessarily have the same sequences.
New Grounds of Rejection
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 4-6, 20-21 and 23 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.
Claim 4 is rendered vague and indefinite by the use the phrase “…comprising four antigens isolated from Brugia malayi or Dirofilaria immitis…”. It is unclear what is meant to be engendered by said phrase as all the recited antigens are from Brugia malayi. The aforementioned phrase suggests that said fusion protein contains antigens from Dirofilaria immitis though none are recited. As written, it is impossible to determine the metes and bounds of the claimed invention.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 September 25, 2026
