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 .
Preliminary Amendment
The preliminary amendment dated 11/24/2025 has been entered. Claims 1-25 are pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest possible effective filing date for the instant claims is December 16, 2021 based on the filing date of the provisional application 63/290,156
Election/Restriction
Applicant’s election without traverse of Group I in the reply filed on 11/24/2025 is acknowledged.
Claims 17 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, linking claims 1-14 and 18-22.
Applicant’s species election in the reply filed on 11/24/2025 is acknowledged. Applicant elected a myeloproliferative disease associated with the elected method is polycythemia vera (PV). . Claims 1-15 and 18-23 are readable on these species. Claims 16, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species.
Therefore, Claims 1-15 and 18-23 are under examination.
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 3-6, 8, 14, 19-20 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 3-6, 8, 14, 19-20 all recite the limitation "….vaccines comprising the GAd20 virus, …. comprising the MVA virus, or ….. comprising the GAd20 virus and …. vaccines comprising the MVA virus..”. It is unclear if this recited vaccine GAd20 virus comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1. It is unclear if this recited vaccine MVA virus comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1. If the recited vaccine GAd20 virus does not comprise a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1 and if the recited vaccine MVA virus does not comprise a nucleotide sequence encoding the amino acid sequence of SEQ ID NO:1, there is insufficient antecedent basis for the GAd20 virus and the MVA virus recitation. For the purpose of compact prosecution, it has been interpreted that the recited “vaccine GAd20 virus” means the “vaccine GAd20 virus comprising a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1” and that the recited “vaccine MVA virus” means the “vaccine MVA virus comprising a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1”.
Appropriate correction is required for all the claims reciting the vaccines only as GAd20 virus or as MVA virus .
Claim 18 is 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 18 recite “…a vaccine comprising the GAd20….., a vaccine comprising the MVA virus…..”. It is unclear if this recited vaccine GAd20 virus comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1. It is unclear if this recited vaccine MVA virus comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1. If the recited vaccine GAd20 virus does not comprise a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1 and if the recited vaccine MVA virus does not comprise a nucleotide sequence encoding the amino acid sequence of SEQ ID NO:1 there is insufficient antecedent basis for the GAd20 virus and the MVA virus recitation. For the purpose of compact prosecution, it has been interpreted that the recited “vaccine GAd20 virus” means the “vaccine GAd20 virus comprising a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1” and that the recited “vaccine MVA virus” means the “vaccine MVA virus comprising a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1”.
Appropriate correction is required.
Claims 6 and 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.
Claim 6 recites the limitation "….the anti-CTLA-4 antibody….”. Claim 8 recites the limitation " ….the anti-PD-1 antibody …”. There is insufficient antecedent basis for the “the antibody” limitations in claims 6 and 8. Both claims depend on claim 1 and there is no mention of any antibody in claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 and 10 are 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 10 are dependent on claim 1. Claim 1 is drawn to a method….., comprising administering a treatment regimen comprising: two or more vaccines comprising a GAd20 virus that, in turn, comprises a nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 1 ….” Claims 3 and 10 fail to further limit the subject matter of the claim upon which it depend. Instead, the claim recitation “….one or more GAd20 virus, …...” is broader in scope. 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.
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.
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.
Claims 1-15 and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bachman (US 2020/0222478 A1 published July 16, 2020; issued patent No. US 11,793,843 B2) in view of Attar (US 2021/0222133 A1 filed November, 13, 2020, publication date July 22, 2021) and Tang (Drug Discovery Today Volume 26, Number 8 d August 2021).
Bachman teaches vectors, host cells, recombinant virus particles, vaccines comprising antigens and methods of making and using them (abstract). The method of using (in this case the use is treatment of prostate cancer) comprises administering a) a first vaccine derived from GAd20 and b) a second vaccine derived from MVA (Bachman’s claim 51, 70 and 71) as required by instant claims 1, 3 and 18.
Bachman also teaches that each vaccine can be administered one or more times to the subject (claims 76 and 77) which encompasses the required two or more times of instant claim 2. The GAd20 vaccine may be administered in an amount of about 1x109 to about 1x1012 viral particles (vp) to a human subject during one administration [4602] and this range is similar to the required range of GAd20 VP as required in instant claim 4 and includes the dose of 1x1011 of instant claim 18. The MVA vaccine comprises about 1x107 to 1x109 TCID50 (50% Tissue Culture Infective Dose) or IFU [4603] similar to the required range for MVA IFU required by instant claim 5 and includes the dose of 1x108 of instant claim 18. Bachman also teaches the administration of an additional cancer therapeutic agent being a CTLA-4 antibody and a PD-1 axis inhibitor, PD-1 antagonist that can be an antibody (claims 35, 36 72, 74, 76 and [4743]) as required by instant claims 6-9, 19 and 20).
Bachman also teaches boosting compositions that may be administered two or more times (instant claim 2), weeks or months after administration of the priming composition, for example, about 1 or 2 weeks or 3 weeks, or 4 weeks, or 6 weeks, or 8 weeks, or 12 weeks, or 16 weeks, or 20 weeks, or 24 weeks, or 28 weeks, or 32 weeks or one to two years after administration of the priming composition. Additional boosting compositions may be administered 6 weeks to 5 years after the boosting step (b), such as 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 weeks, or 7, 8, 9, 10, 11 or 12 months, or 2, 3, 4 or 5 years, after the initial boosting inoculation. Optionally, the further boosting step (c) can be repeated one or more times as needed ([4604] Boosting compositions). These boosting steps encompass the administration of the vaccines as recited in the instant claims 14 and 18.
Bachman also teaches that a polynucleotide inserted into the vaccine vector can encode a T cell enhancer (TCE) for the GAd20 vaccine ([4764] [4769]) and for the MVA vaccine ([4779] [4784]) (instant claims 11 and 13).
Bachman does not teach either the vaccine insert comprising SEQ ID NO: 1 or SEQ ID NO: 2 to be use for treatment of myeloproliferative disease or the doses for the CTLA-4 (instant claims 7 and 19) or the PD-1 (instant claims 9, and 20) antibodies
Attar teaches the insert for the for treatment of myeloproliferative disease, including polycythemia vera (PV) (claim 29) (instant claim 23), comprising the amino acid SEQ ID NO: 12 which is 100% identical to instant application SEQ ID NO; 1. See alignments below. In addition, Attar teaches the same vaccine vectors GAd20 (claim 14) and MVA (Attar claim 15) that are taught by Bachman and recited in the instant application.
Attar does not teach the doses for the CTLA-4 (instant claims 7 and 19) or the PD-1 (instant claims 9 and 20) antibodies.
Tang teaches that the dose/response relationships for pembrolizumab (a PD-1 inhibitor antibody), and several other checkpoint inhibitors, are quite flat as seen for instance in the case of pembrolizumab in the dose range of 2–10 mg/kg (page 1984 second column). Table S3 (supplementary material) summarizes the first-in-human (FIH) dose, MAD (Maximum Administered Dose), and P2D (Phase II dose) of pembrolizumab ranging from 1 to 10 mg/kg). These doses overlap the range of 0.5 to 5 mg/kg required by instant claim 9 and 1 to 3 mg/kg required by instant claim 20. Table S1 also lists the 3 mg/kg maintenance dose for Ipilimumab (a CTLA-4 antibody), which is within the range of 0.5 to 5 mg/kg required by instant claim 7 and 1 to 3 mg/kg required by instant claim 19.
SEQUENCE ALIGMENT (Attar SEQ ID NO: 12 and Instant application SEQ ID NO: 1)
Title: US-18-080-639-1
Sequence: 1 MKDKQDEEQRTRRMMRTKMR..........LNYGVCFCAAYFCGDENILV 95
US-17-097-458-12
Sequence 12, US/17097458
Publication No. US20210222133A1
APPLICANT: JANSSEN BIOTECH, INC.
TITLE OF INVENTION: VACCINES BASED ON MUTANT CALR AND JAK2 AND THEIR USES
FILE REFERENCE: JBI6177USNP1
CURRENT APPLICATION NUMBER: US/17/097,458
CURRENT FILING DATE: 2020-11-13
PRIOR APPLICATION NUMBER: 62/936,841
PRIOR FILING DATE: 2019-11-18
PRIOR APPLICATION NUMBER: 62/936,846
PRIOR FILING DATE: 2019-11-18
NUMBER OF SEQ ID NOS: 54
SEQ ID NO 12
LENGTH: 95
Query Match 100.0%; Score 511; Length 95;
Best Local Similarity 100.0%;
Matches 95; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKDKQDEEQRTRRMMRTKMRMRRMRRTRRKMRRKMSPARPRTSCREACLQGWTEAAYEEA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKDKQDEEQRTRRMMRTKMRMRRMRRTRRKMRRKMSPARPRTSCREACLQGWTEAAYEEA 60
Qy 61 EDNCRRMMRTKAAYVLNYGVCFCAAYFCGDENILV 95
|||||||||||||||||||||||||||||||||||
Db 61 EDNCRRMMRTKAAYVLNYGVCFCAAYFCGDENILV 95
It would be obvious to one of ordinary skill in the art to combine the teachings of Bachman and Attar to generate vaccines comprising Attar’s SEQ ID NO 12 (SEQ ID NO: 1 of the instant application) inserted into the GAD20 and MVA vaccine vectors taught by Bachman. Since these amino acid sequences are identical, it would further be obvious to determine the nucleotide sequence of SEQ ID NO: 12, see [0134] (instant claim SEQ ID NO: 2, instant claims 10-13 and 21-22). When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (See MPEP 2112.01. I). The nucleotide sequence would also further comprise a TCE as taught by Bachman (instant claims 11 and 13).
It would also be obvious to follow the method of using these vaccine vectors taught by Bachman and administer to the subject a treatment of myeloproliferative disease, including polycythemia vera (PV) comprising two or more recombinant GAd20 virus comprising SEQ ID NO: 12 and one or more MVA virus comprising SEQ ID NO: 12 as taught by Attar (or its corresponding nucleotide sequence). The artisan would be motivated to combine the vaccine vectors with the insert for treatment of myeloproliferative disease because both Bachman and Attar teach the same vaccine vectors. There would be a reasonable expectation of success when combining Bachman with Attar because the vaccine vectors as described by Bachman have shown promising results using other inserts, such a prostate cancer antigens.
It would further be obvious to combine Bachman and Attar with Tang and use the vaccine vectors with SEQ ID NO: 1 inserted in combination with a CTLA-4 antibody or a PD-1 antibody. The artisan would be motivated to do so because Bachman also teaches that the treatment further comprises a CTLA-4 antibody or a PD-1 antibody and Tang discloses the doses already tested in the clinic for a CTLA-4 antibody and a PD-1 antibody. There would be a reasonable expectation of success when combining Bachman, Attar and Tang because the vaccines and the antibodies have shown promising results in animal models and also in the clinic.
It would further be obvious that: (1) the number of vaccines (“two or more” or “one or more”) in the composition, (2) the number of VP for the recombinant GAd20 Virus or (3) the IFU for the recombinant MVA virus in a composition, or (4) the dose ranges for the antibodies or (5) the weekly schedule of the boosting composition administration after the priming composition are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 2.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-15 and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bachman (US 2020/0222478 A1 published July 16, 2020; issued patent No. US 11,793,843 B2) in view of Andersen et al (US 2019/0328857 A1 Published October 31, 2019), of Lim (Blood Cancer J, 2015, 5 1-4 12/05/2023 IDS citation NPL 12), Ayyagar (J Biomol Struct Dyn. 2020 Nov 30:1–15) and Tang (Drug Discovery Today d Volume 26, Number 8 d August 2021).
Bachman teachings have been discussed above and incorporated herein.
Tang teachings have been discussed above and incorporated herein.
Andersen teaches the use of peptides derived from mutated Janus kinase 2 (JAK2) and Calreticulin (CALR) genes for the treatment of myeloproliferative neoplasms via a pharmaceutical composition, wherein the pharmaceutical composition is a vaccine composition (Page 1, Lines 6-15; Page 84, Lines 24-28). The myeloproliferative neoplasms to be treated include polycythemia vera (claim 126) as required by instant claims 15 and 23. The peptides have 100% identity to areas within SEQ ID NO: 1 that correspond to one CALR epitope and two JAK2 epitopes (see alignments below).
[AltContent: connector]Lim teaches a CALR sequence that comprises the second CALR epitope of instant SEQ ID NO: 1 as depicted in the annotated Table 1A pasted below, wherein the outlined and enlarged sequence below the table is the CALR sequence, while the thick underlined portion indicates the epitope (Page 2, Table 1A).
Neither Andersen or Lim teach the use of a 3 amino acid sequence AAY to link the various epitopes within instant SEQ ID NO: 1.
Ayyagar teaches that the AAY (Ala-Ala-Tyr) linker is the cleavage site for the proteasomes in mammalian cells. Therefore, epitopes joined using AAY linker gets separated
effectively within the cells; thereby reducing the junctional immunogenicity. AAY linker also increases the immunogenicity of multi-epitope vaccines (page 7, second column, 6th paragraph).
The identification of the different epitopes in SEQ ID NO: 1 is supported in the instant specification. SEQ ID NO: 1 comprises the amino acid sequence of two CALR epitopes [epitope 1: MKDKQDEEQRTRRMMRTKMRMRRMRRTRRKMRRKMSPARPRTSCREACLQGWTE
(SEQ ID NO: 3); and epitope 2: EEAEDNCRRMMRTK (SEQ ID NO: 4)], two JAK2 epitopes [epitope 1: VLNYGVCFC (SEQ ID NO: 5); and epitope 2: FCGDENILV (SEQ ID NO: 6)], and AAY linkers (SEQ ID NO: 7) separating each epitope. The AAY linkers promote proteasomal cleavage of the peptide [0041].
SUMMARY SEQUENCE ALIGMENTS FOR SEQ ID: 1 (from instant application [0041]):
AA: 1 to 55 Andersen SEQ ID 10 (357-411); AA 56-58 Linker AAY (Ayyagar, see above)
AA: 59-72 ; Lim (see above); AA 73-75 Linker AAY (Ayyagar, see above)
AA- 76-83 Andersen SEQ ID: 7; AA 84-86 Linker AAY (Ayyagar, see above)
AA – 87-95 Andersen SEQ ID NO: 6
Title: US-18-080-639-1_f1_t95
Sequence: 1 MKDKQDEEQRTRRMMRTKMR..........LNYGVCFCAAYFCGDENILV 95
Database : US-16-308-164A-10.pep:*
SUMMARIES
Result Query
No. Score Match % Length DB ID Description
----------------------------------------------------------------------------
1 290 56.8 411 1 US-16-308-164A-10 CALR and JAK2 Vacc
ALIGNMENTS
US-16-308-164A-10
Query Match 56.8%; Score 290; DB 1; Length 411;
Best Local Similarity 100.0%;
Matches 55; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKDKQDEEQRTRRMMRTKMRMRRMRRTRRKMRRKMSPARPRTSCREACLQGWTEA 55
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 357 MKDKQDEEQRTRRMMRTKMRMRRMRRTRRKMRRKMSPARPRTSCREACLQGWTEA 411
Title: US-18-080-639-1_f1_t95
Sequence: 1 MKDKQDEEQRTRRMMRTKMR..........LNYGVCFCAAYFCGDENILV 95
Database : US-16-308-164A-7.pep:*
SUMMARIES
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 55 10.8 9 1 US-16-308-164A-7 CALR and JAK2 Vacc
ALIGNMENTS
US-16-308-164A-7
Query Match 10.8%; Score 55; DB 1; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 75 VLNYGVCFC 83
|||||||||
Db 1 VLNYGVCFC 9
Title: US-18-080-639-1_f1_t95
Sequence: 1 MKDKQDEEQRTRRMMRTKMR..........LNYGVCFCAAYFCGDENILV 95
Database : US-16-308-164A-6_f617_t625.pep:*
SUMMARIES
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 50 9.8% 9 1 US-16-308-164A-6_f617_t6
ALIGNMENTS
US-16-308-164A-6_f617_t625
Query Match 9.8%; Score 50; DB 1; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 87 FCGDENILV 95
|||||||||
Db 1 FCGDENILV 9
It would be obvious to one of ordinary skill in the art to combine the teachings of Bachman with Andersen, Lim and Ayyagar to generate vaccines comprising the combination of epitopes disclosed by Andersen and Lim linked by the AAY sequence to generate a 95 amino acid long insert for the GAD20 and MVA vaccine vectors taught by Bachman (SEQ ID NO: 1 of the instant application). The artisan would be motivated to do so because several epitope targeting CARL and JAK2 would be useful in the treatment of myeloproliferative diseases such as PV (Andersen). In addition, linking these epitopes with the AAY cleavage site for the proteasomes would help reducing the junctional immunogenicity and increasing the immunogenicity of multi-epitope vaccines as taught by Ayyagar. There would be a reasonable expectation of success creating these vaccine as the molecular biology techniques needed to generate them are commonly use in the lab.
Since these AAY-linked amino acid sequences encoding CALR and JAK2 epitopes are identical to instant SEQ ID NO: 1, it would further be obvious to identify the DNA sequence (Andersen: claim 122, [0086], [0093] and [0113]), (instant claim SEQ ID NO: 2, instant claims 10-13 and 21-22). When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (See MPEP 2112.01. I). The DNA sequence would also further comprise a TCE as taught by Bachman (instant claims 11 and 13).
It would also be obvious to follow the method of using these vaccine vectors taught by Bachman and administer to the subject a treatment of myeloproliferative disease, including polycythemia vera (PV) comprising two or more recombinant GAd20 virus comprising these AAY-linked amino acid sequences encoding CALR and JAK2 epitopes and one or more MVA virus comprising these AAY-linked amino acid sequences encoding CALR and JAK2 epitopes. The artisan would be motivated to combine the vaccine vectors with the insert for treatment of myeloproliferative disease because Andersen teaches that those epitopes can treat these diseases. There would be a reasonable expectation of success when combining Bachman with Andersen, Lim and Ayyagar because the vaccine vectors as described by Bachman have shown promising results using other inserts, such a prostate cancer antigens.
It would further be obvious to combine Bachman, Andersen, Lim and Ayyagar with Tang and use the vaccine vectors with the inserted AAY-linked amino acid sequences encoding CALR and JAK2 epitopes in combination with a CTLA-4 antibody or a PD-1 antibody. The artisan would be motivated to do so because Bachman also teaches that the treatment further comprises a CTLA-4 antibody or a PD-1 antibody and Tang discloses the doses already tested in the clinic for a CTLA-4 antibody and a PD-1 antibody. There would be a reasonable expectation of success when combining Bachman, Andersen, Lim, Ayyagar and Tang because the vaccines and the antibodies have shown promising results in animal models and also in the clinic.
It would further be obvious that: (1) the number of vaccines (“two or more” or “one or more”) in the composition, (2) the number of VP for the recombinant GAd20 Virus or (3) the IFU for the recombinant MVA virus in a composition, or (4) the dose ranges for the antibodies or (5) the weekly schedule of the boosting composition administration after the priming composition are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 2.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 2, 7, 9, 10-13, 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1. 4, 8, 12-16, 18, 20, 21, 23-29 of issued patent No. US 11,793,843 B2 (reference patent; Application number US 16/737,950 and PG Pub US 2020/0222478 A1) in view of Attar and Tang and also in view of Andersen, Lim, Ayyagar and Tang. The reference is not afforded safe harbor protection under 35 USC 121 because it does not share continuity with much less is it subject to a restriction/speciation with the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US 11,793,843 B2 and the instant claims are drawn to the same vaccines vectors (GAd20 and MVA). Whereas US 11,793,843 B2 teaches an insert related to prostate cancer, the instant application discloses an insert related to myeloproliferative diseases as taught by Attar but also by Andersen, Lim, and Ayyagar. Tang teaches the doses for the PD-1 and CTLA-4 antibodies. For a more in depth explanation please see Claim Rejections - 35 USC § 103 above. In addition, Attar teaches a method of treating or preventing a myeloproliferative disease (including PV) in a subject comprising administering a composition comprising a polynucleotide encoding the epitopes that comprise SEQ ID NO: 12 (instant SEQ ID NO: 1) wherein the administration comprises one or more administrations of the composition (Attar claims 9, 28 and 29) and the method, further comprising administering a second therapeutic agent selected from a CTLA-4 antibody or a PD-1 antibody ( Attar claim 34). The composition comprises a recombinant virus (Attar claim 35) an adenovirus (GAD20 is an recombinant adenovirus) or a poxvirus (MVA is a recombinant poxvirus), (Attar claim 36)
Claims 1-14 and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending application No. 18/080,634 (reference application). The reference is not afforded safe harbor protection under 35 USC 121 because it does not share continuity with much less is it subject to a restriction/speciation with the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 18/080,634 and the instant claims are drawn to the same vaccines vectors (GAd20 and MVA) and the same methods of using those vectors. Whereas 18/080,634 teaches an insert related to prostate cancer, the instant application discloses an insert related to myeloproliferative diseases as taught by Attar but also by Andersen, Lim, and Ayyagar.
It would be obvious to combine 18/080,634 with Attar and Tang to develop a method of treating or preventing a myeloproliferative disease, the method comprising administering to the subject a treatment regimen comprising: two or more vaccines comprising a GAd20 vector comprising SEQ ID NO: 12 (Instant SEQ ID NO: 1) and one or more vaccines comprising a MVA vector comprising SEQ ID NO:12 (Instant SEQ ID NO: 1) to treat myeloproliferative disease, including PV. There would be a reasonable expectation of success creating these vaccine as the molecular biology techniques needed to generate them are commonly use in the lab.
It would be obvious to combine 18/080,634 with Andersen, Lim, Ayyagar and Tang.to develop a method of treating or preventing a myeloproliferative disease, the method comprising administering to the subject a treatment regimen comprising: two or more vaccines comprising a GAd20 vector comprising an inserted AAY-linked amino acid sequence encoding CALR and JAK2 epitopes (Instant SEQ ID NO: 1) and one or more vaccines comprising a MVA vector comprising an inserted AAY-linked amino acid sequence encoding CALR and JAK2 epitopes (Instant SEQ ID NO: 1) to treat myeloproliferative disease, including PV. There would be a reasonable expectation of success creating these vaccine as the molecular biology techniques needed to generate them are commonly use in the lab.
For a more in depth discussion about the insert and the obviousness requirement please see Claim Rejections - 35 USC § 103 above
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 15-16, 24 of copending application No. US 18/663,981 in view of Bachman. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 18/663,981 are drawn to a method of treating or preventing a myeloproliferative disease, the method comprising administering a vector (GAd20 and MVA) comprising SEQ ID NO: 31 (instant SEQ ID NO: 1) see alignment below.
Bachman teachings regarding instant claim 1 have been described above and incorporated herein.
It would be obvious to combine Bachman and US 18/663,981 to develop a method of treating or preventing a myeloproliferative disease, the method comprising administering to the subject a treatment regimen comprising: two or more vaccines comprising a GAd20 vector comprising SEQ ID NO: 31 (Instant SEQ ID NO: 1) and one or more vaccines comprising a MVA vector comprising SEQ ID NO: 31 (Instant SEQ ID NO: 1) to treat myeloproliferative disease, including PV. There would be a reasonable expectation of success creating these vaccine as the molecular biology techniques needed to generate them are commonly use in the lab.
Title: US-18-080-639-1
Perfect score: 511
Sequence: 1 MKDKQDEEQRTRRMMRTKMR..........LNYGVCFCAAYFCGDENILV 95
Sequence 31, US/18663981
Publication No. US20240294884A1
GENERAL INFORMATION
APPLICANT: JANSSEN BIOTECH, INC.
TITLE OF INVENTION: VACCINES BASED ON MUTANT CALR AND JAK2 AND THEIR USES (en)
CURRENT APPLICATION NUMBER: US/18/663,981
CURRENT FILING DATE: 2024-05-14
SEQ ID NO 31
LENGTH: 123
Query Match 100.0%; Score 511; Length 123;
Best Local Similarity 100.0%;
Matches 95; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKDKQDEEQRTRRMMRTKMRMRRMRRTRRKMRRKMSPARPRTSCREACLQGWTEAAYEEA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 29 MKDKQDEEQRTRRMMRTKMRMRRMRRTRRKMRRKMSPARPRTSCREACLQGWTEAAYEEA 88
Qy 61 EDNCRRMMRTKAAYVLNYGVCFCAAYFCGDENILV 95
|||||||||||||||||||||||||||||||||||
Db 89 EDNCRRMMRTKAAYVLNYGVCFCAAYFCGDENILV 123
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/JANET L ANDRES/Supervisory Patent Examiner, Art Unit 1671