DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of species (isoform/protein): CD1d in the reply filed on April 2, 2026 is acknowledged.
3. Claims 12-26 and 30-37 are pending.
Claims 1-11 and 27-29 have been cancelled.
Claims 12, 13, 15 and 19 have been amended.
Claims 12-26 and 30-37 are examined on the merits with the species (isoform/protein): CD1d.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 12-26 and 31-37 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.
a. Claims 12 (line 8), 31 (lines 2 and 4) and 33 (line 2) recite “…all or a portion of X…”. It is not clear what part or piece of the parental receptor region, the transmembrane domain or antigenic payload should be retained from the entire component and still capable of rendering the required properties, maintain function, as well as structure to facilitate the required function. Accordingly, the metes and bounds cannot be determined.
Claim Rejections - 35 USC § 102
6. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claim(s) 12-15, 17-19, 22, 24-26, 30, 31 and 34-37 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pakyari et al., WO 2021/076887 A1 (effectively filed 18 October 2019). Pakyari discloses a composition “…comprising components of multi-component [chimeric antigen ligands] CALs or [chimeric antigen receptors] CARs, e.g., a [T cell receptor] TCR recognition domain”, see Abstract on 1st page; and sequence alignments at close of instant rejection. The composition comprises: “a) a TCR recognition domain; and one or both of: b) an intracellular signaling domain; and c) a biomolecular interaction domain (e.g., a first-type biomolecular interaction domain).”, see page 3, section 0011.
“In some embodiments, a nucleic acid encoding a CAL, CAR, a multi-component CAL and/or CAR or portion thereof as described herein is comprised by a vector. In some of the aspects described herein, a nucleic acid sequence encoding a multi-component CAL and/or CAR, or portion thereof as described herein, or any module thereof, is operably linked to a vector. The term “vector”, as used herein, refers to a nucleic acid construct designed for delivery to a host cell or for transfer between different host cells.”, see page 135, section 00265. The wherein clauses cited in claim 30 reads on characteristics and function of the disclosed nucleic acid encoding a CAL, CAR, multi-component CAL and/or CAR or portion thereof.
As evidenced by the instant specification, “the Signal/Leader encodes a signal sequence, a leader sequence, or a sorting sequence from the same isoform or protein as the [transmembrane domain] TMD, the [cytoplasmic domain] CYD, or both. In one aspect, the TMD encodes the sequence MGLIALAVLACLLFLLIVGFT (SEQ ID NO:2).”, see page 3, section 0013; page 5, section 0025; page 8, sections 0049 and 0050; and sequence alignment herein.
As evidenced by the instant specification, “the CYD encodes the sequence SRFKRQTSYQGVL (SEQ ID NO:3).”, see page 3, section 0013; page 5, section 0025; and sequence alignment herein.
As evidenced by the instant specification, “the encoded antigenic payload comprises the sequence SIINFEKL (SEQ ID NO:1).”, see page 5, section 0025; and sequence alignment herein. The taught signal/leader, payload and PRM components read on the same formula recited in claim 12.
“In one embodiments of any aspect, a cell comprising and/or expressing a comprising a composition comprising a TCR recognition domain and an intracellular signaling domain further comprises a TCR signaling-responsive promoter operatively linked to a payload transgene. Such embodiments permit transgene payload expression [specifically] to and/or in the vicinity of a targeted T cell. Suitable promoters and transgene are known in the art, e.g., those promoters and transgenes used in “TRUCK CAR” technology. An exemplary promoter is a NFAT-sensitive promoter. Exemplary transgene payloads can include checkpoint inhibitors (e.g., CTLA-4, [Ipilimumab, Tremelimumab] or PD-1 [Nivolumab, Pembrolizumab, Pidilizumab]) or proinflammatory cytokines (e.g., IL-2, IL-12, etc). In our case this will be used for in-situ targeting of a patient’s anticancer T-cells to very specifically and locally deliver activating agents like one or more checkpoint inhibitors (CTLA-4, [Ipilimumab, Tremelimumab] or PD-1 [Nivolumab, Pembrolizumab, Pidilizumab]) and/or proinflammatory cytokines, (e.g. IL-2, IL-12, etc.) that can push them to expansion and effector phenotype.’, see para. 00236 bridging pages 43 and 44.
As evidenced by the instant specification, the “[parental receptor molecule] PRM refers to all or a portion of at least one parental receptor molecule region from one or more proteins selected from one or more CD1 isoform,”, which reads on the elected species, CD1d, see page 8, section 0055. “Human CD1d (MGCLLFLLLWALLQAWGSA; SEQ IDNO:4)”, see protein spanning pages 8 and 9 of the instant specification. Pakyari teaches the TCR recognition domain comprises a CD1 domain that is CD1d, see page 4, section 0016.
“In some embodiments, the technology described herein relates to a pharmaceutical composition comprising a CAL and/or CAR, or a multi-component CAL and/or CAR (or portion thereof, or cell comprising a CAL and/or CAR, or a multi-component CAL and/or CAR) as described herein, and optionally a pharmaceutically acceptable carrier. In some embodiments, the active ingredients of the pharmaceutical composition comprise a CAL and/or CAR or a multi-component CAL and/or CAR (or portion thereof, or cell comprising a CAL and/or CAR or a multi-component CAL and/or CAR) as described herein. In some embodiments, the active ingredients of the pharmaceutical composition consist essentially of a CAL and/or CAR or a multi-component CAL and/or CAR (or portion thereof, or cell comprising a CAL and/or CAR or a multi-component CAL and/or CAR) as described herein. In some embodiments, the active ingredients of the pharmaceutical composition consist of a CAL and/or CAR or a multi-component CAL and/or CAR (or portion thereof, or cell comprising a multi-component CAL and/or CAR) as described herein.”, see page 122, section 00204; and page 139, section 00279.
“Pharmaceutically acceptable carriers and diluents include saline, aqueous buffer solutions, solvents and/or dispersion media. The use of such carriers and diluents is well known in the art. Some non-limiting examples of materials which can serve as pharmaceutically-acceptable carriers include: (1) sugars, such as lactose, glucose and sucrose; (2) starches, such as corn starch and potato starch; (3) cellulose, and its derivatives, such as sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, microcrystalline cellulose and cellulose acetate; (4) powdered tragacanth; (5) malt; (6) gelatin; (7) lubricating agents, such as magnesium stearate, sodium lauryl sulfate and talc; (8) excipients, such as cocoa butter and suppository waxes; (9) oils, such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; (10) glycols, such as propylene glycol; (11) polyols, such as glycerin, sorbitol, mannitol and polyethylene glycol (PEG); (12) esters, such as ethyl oleate and ethyl laurate; (13) agar; (14) buffering agents, such as magnesium hydroxide and aluminum hydroxide; (15) alginic acid; (16) pyrogen-free water; (17) isotonic saline; (18) Ringer's solution; (19) ethyl alcohol; (20) pH buffered solutions; (21) polyesters, polycarbonates and/or polyanhydrides; (22) bulking agents, such as polypeptides and amino acids (23) serum component, such as serum albumin, HDL and LDL; (22) C2-C12 alcohols, such as ethanol; and (23) other non- toxic compatible substances employed in pharmaceutical formulations. Wetting agents, coloring agents, release agents, coating agents, sweetening agents, flavoring agents, perfuming agents, preservative and antioxidants can also be present in the formulation. The terms such as "excipient", "carrier", "pharmaceutically acceptable carrier" or the like are used interchangeably herein. The terms such as "excipient", "carrier", "pharmaceutically acceptable carrier" or the like are used interchangeably herein.”, see section 00205 bridging pages 122 and 123.
“Suitable vehicles that can be used to provide parenteral dosage forms of a multi- component CAL and/or CAR (or portion thereof, or cell comprising a multi-component CAL and/or CAR) as disclosed within are well known to those skilled in the art.”, see page 123, section 00207.
RESULT 5 from (SIGNAL/LEADER)4.align450.rag.
BJG06744
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BJG06744 standard; protein; 242 AA.
XX
AC BJG06744;
XX
DT 24-JUN-2021 (first entry)
XX
DE Human CD1d protein isoform 2, SEQ ID 6.
XX
KW CD1d protein; T-cell surface glycoprotein CD1d; antigen;
KW antiinflammatory; autoimmune disease; cell therapy;
KW graft versus host disease; immunosuppressive; immunotherapy;
KW inflammatory disease; prophylactic to disease; recombinant protein;
KW t-lymphocyte; therapeutic; transplant rejection.
XX
OS Homo sapiens.
XX
CC PN WO2021076887-A1.
XX
CC PD 22-APR-2021.
XX
CC PF 16-OCT-2020; 2020WO-US055980.
XX
PR 18-OCT-2019; 2019US-0916924P.
XX
XX
CC PI Pakyari M, Cetrulo C, Wong W, Okuma A;
CC PT Composition used cell for treating or preventing an autoimmune disease or
CC PT condition, T cell mediated inflammation or immune response, comprises T-
CC PT cell receptor recognition domain, and intracellular signaling domain.
XX
CC PS Disclosure; SEQ ID NO 6; 235pp; English.
XX
CC The present invention relates to a novel composition comprising a TCR
CC recognition domain; and one or both of an intracellular signaling domain;
CC and a first-type biomolecular interaction domain. The invention further
CC provides: (1) a composition comprising: (a) a first polypeptide
CC comprising at least a portion of a TCR recognition domain and a first-
CC type biomolecular interaction domain; and (b) a polypeptide comprising a
CC second-type biomolecular interaction domain and an intracellular
CC signaling domain; wherein the first-type and second-type biomolecular
CC interaction domains bind specifically to each other; (2) a cell
CC comprising and/or expressing the composition; (3) a chimeric antigen
CC receptor (CAR) comprising an anti-CD127 and/or anti-CD45RO recognition
CC domain, and an intracellular signaling domain; and (4) a method for
CC treating or preventing an autoimmune disease or condition; T cell
CC mediated inflammation or immune response; malignant T cell condition;
CC transplant rejection; or GvHD in a subject, which comprises administering
CC to the subject a composition and/or cell.
SQ Sequence 242 AA;
Query Match 100.0%; Score 103; Length 242;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGCLLFLLLWALLQAWGSA 19
|||||||||||||||||||
Db 1 MGCLLFLLLWALLQAWGSA 19
BJG08511 from (PAYLOAD)1.align450.rag database.
ID BJG08511 standard; peptide; 8 AA.
XX
AC BJG08511;
XX
DT 24-JUN-2021 (first entry)
XX
DE Ovalbumin peptide, SEQ 2750.
XX
KW Ovalbumin; antiinflammatory; autoimmune disease; cell therapy; epitope;
KW graft versus host disease; immunosuppressive; immunotherapy;
KW inflammatory disease; prophylactic to disease; recombinant protein;
KW t-lymphocyte; therapeutic; transplant rejection.
XX
OS Gallus gallus.
XX
CC PN WO2021076887-A1.
XX
CC PD 22-APR-2021.
XX
CC PF 16-OCT-2020; 2020WO-US055980.
XX
PR 18-OCT-2019; 2019US-0916924P.
XX
CC PI Pakyari M, Cetrulo C, Wong W, Okuma A;
XX
XX
CC PT Composition used cell for treating or preventing an autoimmune disease or
CC PT condition, T cell mediated inflammation or immune response, comprises T-
CC PT cell receptor recognition domain, and intracellular signaling domain.
XX
CC PS Disclosure; SEQ ID NO 2750; 235pp; English.
XX
CC The present invention relates to a novel composition comprising a TCR
CC recognition domain; and one or both of an intracellular signaling domain;
CC and a first-type biomolecular interaction domain. The invention further
CC provides: (1) a composition comprising: (a) a first polypeptide
CC comprising at least a portion of a TCR recognition domain and a first-
CC type biomolecular interaction domain; and (b) a polypeptide comprising a
CC second-type biomolecular interaction domain and an intracellular
CC signaling domain; wherein the first-type and second-type biomolecular
CC interaction domains bind specifically to each other; (2) a cell
CC comprising and/or expressing the composition; (3) a chimeric antigen
CC receptor (CAR) comprising an anti-CD127 and/or anti-CD45RO recognition
CC domain, and an intracellular signaling domain; and (4) a method for
CC treating or preventing an autoimmune disease or condition; T cell
CC mediated inflammation or immune response; malignant T cell condition;
CC transplant rejection; or GvHD in a subject, which comprises administering
CC to the subject a composition and/or cell.
XX
SQ Sequence 8 AA;
1 SIINFEKL 8
RESULT 2 from (PRM/CD1d, cytoplasmic)3.align450.rag database.
BJG06745
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID BJG06745 standard; protein; 231 AA.
XX
AC BJG06745;
XX
DT 24-JUN-2021 (first entry)
XX
DE Human CD1d protein isoform 3, SEQ ID 7.
XX
KW CD1d protein; T-cell surface glycoprotein CD1d; antigen;
KW antiinflammatory; autoimmune disease; cell therapy;
KW graft versus host disease; immunosuppressive; immunotherapy;
KW inflammatory disease; prophylactic to disease; recombinant protein;
KW t-lymphocyte; therapeutic; transplant rejection.
XX
OS Homo sapiens.
XX
CC PN WO2021076887-A1.
XX
CC PD 22-APR-2021.
XX
CC PF 16-OCT-2020; 2020WO-US055980.
XX
PR 18-OCT-2019; 2019US-0916924P.
CC PI Pakyari M, Cetrulo C, Wong W, Okuma A;
XX
XX
CC PT Composition used cell for treating or preventing an autoimmune disease or
CC PT condition, T cell mediated inflammation or immune response, comprises T-
CC PT cell receptor recognition domain, and intracellular signaling domain.
XX
CC PS Disclosure; SEQ ID NO 7; 235pp; English.
XX
CC The present invention relates to a novel composition comprising a TCR
CC recognition domain; and one or both of an intracellular signaling domain;
CC and a first-type biomolecular interaction domain. The invention further
CC provides: (1) a composition comprising: (a) a first polypeptide
CC comprising at least a portion of a TCR recognition domain and a first-
CC type biomolecular interaction domain; and (b) a polypeptide comprising a
CC second-type biomolecular interaction domain and an intracellular
CC signaling domain; wherein the first-type and second-type biomolecular
CC interaction domains bind specifically to each other; (2) a cell
CC comprising and/or expressing the composition; (3) a chimeric antigen
CC receptor (CAR) comprising an anti-CD127 and/or anti-CD45RO recognition
CC domain, and an intracellular signaling domain; and (4) a method for
CC treating or preventing an autoimmune disease or condition; T cell
CC mediated inflammation or immune response; malignant T cell condition;
CC transplant rejection; or GvHD in a subject, which comprises administering
CC to the subject a composition and/or cell.
XX
SQ Sequence 231 AA;
Query Match 100.0%; Score 65; Length 231;
Best Local Similarity 100.0%;
Matches 13; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SRFKRQTSYQGVL 13
|||||||||||||
Db 219 SRFKRQTSYQGVL 231
Qy 1 SRFKRQTSYQGVL 13
|||||||||||||
Db 230 SRFKRQTSYQGVL 242
RESULT 2 from (LEADER, PRM/CD1d, transmembrane)2.align450.rag database.
BJG06745
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID BJG06745 standard; protein; 231 AA.
XX
DT 24-JUN-2021 (first entry)
XX
DE Human CD1d protein isoform 3, SEQ ID 7.
XX
KW CD1d protein; T-cell surface glycoprotein CD1d; antigen;
KW antiinflammatory; autoimmune disease; cell therapy;
KW graft versus host disease; immunosuppressive; immunotherapy;
KW inflammatory disease; prophylactic to disease; recombinant protein;
KW t-lymphocyte; therapeutic; transplant rejection.
XX
OS Homo sapiens.
XX
CC PN WO2021076887-A1.
XX
CC PD 22-APR-2021.
XX
CC PF 16-OCT-2020; 2020WO-US055980.
XX
PR 18-OCT-2019; 2019US-0916924P.
XX
(GEHO ) GEN HOSPITAL CORP.
XX
CC PI Pakyari M, Cetrulo C, Wong W, Okuma A;
XX
CC PT Composition used cell for treating or preventing an autoimmune disease or
CC PT condition, T cell mediated inflammation or immune response, comprises T-
CC PT cell receptor recognition domain, and intracellular signaling domain.
XX
CC PS Disclosure; SEQ ID NO 7; 235pp; English.
XX
CC The present invention relates to a novel composition comprising a TCR
CC recognition domain; and one or both of an intracellular signaling domain;
CC and a first-type biomolecular interaction domain. The invention further
CC provides: (1) a composition comprising: (a) a first polypeptide
CC comprising at least a portion of a TCR recognition domain and a first-
CC type biomolecular interaction domain; and (b) a polypeptide comprising a
CC second-type biomolecular interaction domain and an intracellular
CC signaling domain; wherein the first-type and second-type biomolecular
CC interaction domains bind specifically to each other; (2) a cell
CC comprising and/or expressing the composition; (3) a chimeric antigen
CC receptor (CAR) comprising an anti-CD127 and/or anti-CD45RO recognition
CC domain, and an intracellular signaling domain; and (4) a method for
CC treating or preventing an autoimmune disease or condition; T cell
CC mediated inflammation or immune response; malignant T cell condition;
CC transplant rejection; or GvHD in a subject, which comprises administering
CC to the subject a composition and/or cell.
XX
SQ Sequence 231 AA;
Query Match 100.0%; Score 99; Length 231;
Best Local Similarity 100.0%;
Matches 21; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGLIALAVLACLLFLLIVGFT 21
|||||||||||||||||||||
Db 198 MGLIALAVLACLLFLLIVGFT 218
Qy 1 MGLIALAVLACLLFLLIVGFT 21
|||||||||||||||||||||
Db 209 MGLIALAVLACLLFLLIVGFT 229
Claim Rejections - 35 USC § 103
8. 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.
9. Claim(s) 12-26 and 30-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pakyari et al., WO 2021/076887 A1 (effectively filed 18 October 2019), and further in view of McKinlay, Colin James, WO 2020/069445 A1 (effectively filed 27 September 2019). Pakyari teaches a composition “…comprising components of multi-component [chimeric antigen ligands] CALs or [chimeric antigen receptors] CARs, e.g., a [T cell receptor] TCR recognition domain”, see Abstract on 1st page; and sequence alignments at close of instant rejection. The composition comprises: “a) a TCR recognition domain; and one or both of: b) an intracellular signaling domain; and c) a biomolecular interaction domain (e.g., a first-type biomolecular interaction domain).”, see page 3, section 0011. Components can either be assembled together as separate sequences (e.g., by intramolecular binding of multiple peptide molecules) or can be expressed as fusion proteins with intervening linker sequences”, see page 20, section 0081.
“In some embodiments, a nucleic acid encoding a CAL, CAR, a multi-component CAL and/or CAR or portion thereof as described herein is comprised by a vector. In some of the aspects described herein, a nucleic acid sequence encoding a multi-component CAL and/or CAR, or portion thereof as described herein, or any module thereof, is operably linked to a vector. The term “vector”, as used herein, refers to a nucleic acid construct designed for delivery to a host cell or for transfer between different host cells.”, see page 135, section 00265. The wherein clauses cited in claim 30 reads on characteristics and function of the disclosed nucleic acid encoding a CAL, CAR, multi-component CAL and/or CAR or portion thereof.
“[A] composition described herein can comprise multiple copies or instances of a TCR recognition domain(s), e.g. the TCR recognition domain can be a mulitmer, or oligomer. In some embodiments, a composition described herein can comprise multiple copies or instances of a first polypeptide as described herein. In some embodiments, the first polypeptide comprises the entire TCR recognition domain. In some embodiments, the TCR recognition domain comprises at least two separate polypeptide sequences, the first polypeptide comprises at least one of the separate polypeptide sequences of the TCR recognition domain, and the first polypeptide is bound to or complexed with a second or further polypeptide sequences of the TCR recognition domain to form a TCR recognition domain.”, see page 128, lines 1-9.
As evidenced by the instant specification, “the Signal/Leader encodes a signal sequence, a leader sequence, or a sorting sequence from the same isoform or protein as the [transmembrane domain] TMD, the [cytoplasmic domain] CYD, or both. In one aspect, the TMD encodes the sequence MGLIALAVLACLLFLLIVGFT (SEQ ID NO:2).”, see page 3, section 0013; page 5, section 0025; page 8, sections 0049 and 0050; and sequence alignment herein.
As evidenced by the instant specification, “the CYD encodes the sequence SRFKRQTSYQGVL (SEQ ID NO:3).”, see page 3, section 0013; page 5, section 0025; and sequence alignment herein.
As evidenced by the instant specification, “the encoded antigenic payload comprises the sequence SIINFEKL (SEQ ID NO:1).”, see page 5, section 0025; and sequence alignment herein. The taught signal/leader, payload and PRM components read on the same formula recited in claim 12.
“In one embodiments of any aspect, a cell comprising and/or expressing a comprising a composition comprising a TCR recognition domain and an intracellular signaling domain further comprises a TCR signaling-responsive promoter operatively linked to a payload transgene. Such embodiments permit transgene payload expression [specifically] to and/or in the vicinity of a targeted T cell. Suitable promoters and transgene are known in the art, e.g., those promoters and transgenes used in “TRUCK CAR” technology. An exemplary promoter is a NFAT-sensitive promoter. Exemplary transgene payloads can include checkpoint inhibitors (e.g., CTLA-4, [Ipilimumab, Tremelimumab] or PD-1 [Nivolumab, Pembrolizumab, Pidilizumab]) or proinflammatory cytokines (e.g., IL-2, IL-12, etc). In our case this will be used for in-situ targeting of a patient’s anticancer T-cells to very specifically and locally deliver activating agents like one or more checkpoint inhibitors (CTLA-4, [Ipilimumab, Tremelimumab] or PD-1 [Nivolumab, Pembrolizumab, Pidilizumab]) and/or proinflammatory cytokines, (e.g. IL-2, IL-12, etc.) that can push them to expansion and effector phenotype.’, see para. 00236 bridging pages 43 and 44.
As evidenced by the instant specification, the “[parental receptor molecule] PRM refers to all or a portion of at least one parental receptor molecule region from one or more proteins selected from one or more CD1 isoform,”, which reads on the elected species, CD1d, see page 8, section 0055. “Human CD1d (MGCLLFLLLWALLQAWGSA; SEQ IDNO:4)”, see protein spanning pages 8 and 9 of the instant specification. Pakyari teaches the TCR recognition domain comprises a CD1 domain that is CD1d, see page 4, section 0016.
“In some embodiments, the technology described herein relates to a pharmaceutical composition comprising a CAL and/or CAR, or a multi-component CAL and/or CAR (or portion thereof, or cell comprising a CAL and/or CAR, or a multi-component CAL and/or CAR) as described herein, and optionally a pharmaceutically acceptable carrier. In some embodiments, the active ingredients of the pharmaceutical composition comprise a CAL and/or CAR or a multi-component CAL and/or CAR (or portion thereof, or cell comprising a CAL and/or CAR or a multi-component CAL and/or CAR) as described herein. In some embodiments, the active ingredients of the pharmaceutical composition consist essentially of a CAL and/or CAR or a multi-component CAL and/or CAR (or portion thereof, or cell comprising a CAL and/or CAR or a multi-component CAL and/or CAR) as described herein. In some embodiments, the active ingredients of the pharmaceutical composition consist of a CAL and/or CAR or a multi-component CAL and/or CAR (or portion thereof, or cell comprising a multi-component CAL and/or CAR) as described herein.”, see page 122, section 00204; and page 139, section 00279.
“Pharmaceutically acceptable carriers and diluents include saline, aqueous buffer solutions, solvents and/or dispersion media. The use of such carriers and diluents is well known in the art. Some non-limiting examples of materials which can serve as pharmaceutically-acceptable carriers include: (1) sugars, such as lactose, glucose and sucrose; (2) starches, such as corn starch and potato starch; (3) cellulose, and its derivatives, such as sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, microcrystalline cellulose and cellulose acetate; (4) powdered tragacanth; (5) malt; (6) gelatin; (7) lubricating agents, such as magnesium stearate, sodium lauryl sulfate and talc; (8) excipients, such as cocoa butter and suppository waxes; (9) oils, such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn oil and soybean oil; (10) glycols, such as propylene glycol; (11) polyols, such as glycerin, sorbitol, mannitol and polyethylene glycol (PEG); (12) esters, such as ethyl oleate and ethyl laurate; (13) agar; (14) buffering agents, such as magnesium hydroxide and aluminum hydroxide; (15) alginic acid; (16) pyrogen-free water; (17) isotonic saline; (18) Ringer's solution; (19) ethyl alcohol; (20) pH buffered solutions; (21) polyesters, polycarbonates and/or polyanhydrides; (22) bulking agents, such as polypeptides and amino acids (23) serum component, such as serum albumin, HDL and LDL; (22) C2-C12 alcohols, such as ethanol; and (23) other non- toxic compatible substances employed in pharmaceutical formulations. Wetting agents, coloring agents, release agents, coating agents, sweetening agents, flavoring agents, perfuming agents, preservative and antioxidants can also be present in the formulation. The terms such as "excipient", "carrier", "pharmaceutically acceptable carrier" or the like are used interchangeably herein. The terms such as "excipient", "carrier", "pharmaceutically acceptable carrier" or the like are used interchangeably herein.”, see section 00205 bridging pages 122 and 123.
“Suitable vehicles that can be used to provide parenteral dosage forms of a multi- component CAL and/or CAR (or portion thereof, or cell comprising a multi-component CAL and/or CAR) as disclosed within are well known to those skilled in the art.”, see page 123, section 00207.
“[C]ontrolled-release formulations are designed to initially release an amount of drug (active ingredient) that promptly produces the desired therapeutic effect, and gradually and continually release other amounts of drug to maintain this level of therapeutic or prophylactic effect over an extended period of time. In order to maintain this constant level of drug in the body, the drug must be released from the dosage form at a rate that will replace the amount of drug being metabolized and excreted from the body.”, see para. bridging pages 124 and 125.
Pakyari does not teach the pharmaceutical composition comprising the taught therapeutic polynucleotide is in a form of a vaccine, wherein the polynucleotide is encapsulated with the delivery vehicle. Nor, does Pakyari teach the delivery vehicle is a tertiary amino lipidated and/or PEGylated cationic peptide compounds and the payload is a detectable agent.
McKinlay teaches “…lipidated cationic peptide compounds, such as tertiary amino lipidated and/or PEGylated cationic peptide compounds or lipitoids, for nucleic acid delivery. More specifically, the present disclosure relates to lipid nanoparticle formulations comprising lipidated cationic peptide compounds and other lipid components including structural lipid, phospholipid and shielding lipids.”, see abstract; page 64, sections 0217 and 0218; and entire document. “Additional components may also be added to the complexes to facilitate high encapsulation of polyanionic cargoes and/or targeted, controlled release thereof. Such additional components may include, for example, polymers and surface- active components.”, see page 64, section 0216.
“[T]he compositions described herein facilitate the delivery of polyanionic compounds to cells, particularly endocellular environments. As such, the compositions may find use in a number of clinical applications as well as research applications. The delivery of a polyanionic compound to a cell may be used for clinical applications such as those related to prophylactic, diagnostic, and/or therapeutic methods. For example, in some embodiments, suitable clinical applications may include vaccination, cancer immunotherapy, protein replacement therapy, and/or in vivo gene editing, ex vivo cell therapy transfection, ex vivo stem cell induction.”, see page 67, section 0230; and entire document.
It would have been obvious to one of ordinary skill in the art at the
effective filing date of the claimed invention was made to combine the teachings of both references to package the polynucleotide that encodes a therapeutic polypeptide in a vaccine for clinical treatment and with multiple payload regions, see both documents in their entirety.
One of ordinary skill in the art would have been motivated to do so
with a reasonable expectation of success by teachings in both references to
implement the combination of the components to manufacture a delivery therapeutic for the treatment of maladies because both documents teach successful implementation of multi-component therapeutic agents, see all documents in their entirety.
RESULT 5 from (SIGNAL/LEADER)4.align450.rag.
BJG06744
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BJG06744 standard; protein; 242 AA.
XX
AC BJG06744;
XX
DT 24-JUN-2021 (first entry)
XX
DE Human CD1d protein isoform 2, SEQ ID 6.
XX
KW CD1d protein; T-cell surface glycoprotein CD1d; antigen;
KW antiinflammatory; autoimmune disease; cell therapy;
KW graft versus host disease; immunosuppressive; immunotherapy;
KW inflammatory disease; prophylactic to disease; recombinant protein;
KW t-lymphocyte; therapeutic; transplant rejection.
XX
OS Homo sapiens.
XX
CC PN WO2021076887-A1.
XX
CC PD 22-APR-2021.
XX
CC PF 16-OCT-2020; 2020WO-US055980.
XX
PR 18-OCT-2019; 2019US-0916924P.
XX
XX
CC PI Pakyari M, Cetrulo C, Wong W, Okuma A;
XX
DR WPI; 2021-417447/047.
DR REFSEQ; NP_001306074.1.
XX
CC PT Composition used cell for treating or preventing an autoimmune disease or
CC PT condition, T cell mediated inflammation or immune response, comprises T-
CC PT cell receptor recognition domain, and intracellular signaling domain.
XX
CC PS Disclosure; SEQ ID NO 6; 235pp; English.
XX
CC The present invention relates to a novel composition comprising a TCR
CC recognition domain; and one or both of an intracellular signaling domain;
CC and a first-type biomolecular interaction domain. The invention further
CC provides: (1) a composition comprising: (a) a first polypeptide
CC comprising at least a portion of a TCR recognition domain and a first-
CC type biomolecular interaction domain; and (b) a polypeptide comprising a
CC second-type biomolecular interaction domain and an intracellular
CC signaling domain; wherein the first-type and second-type biomolecular
CC interaction domains bind specifically to each other; (2) a cell
CC comprising and/or expressing the composition; (3) a chimeric antigen
CC receptor (CAR) comprising an anti-CD127 and/or anti-CD45RO recognition
CC domain, and an intracellular signaling domain; and (4) a method for
CC treating or preventing an autoimmune disease or condition; T cell
CC mediated inflammation or immune response; malignant T cell condition;
CC transplant rejection; or GvHD in a subject, which comprises administering
CC to the subject a composition and/or cell.
XX
SQ Sequence 242 AA;
Query Match 100.0%; Score 103; Length 242;
Best Local Similarity 100.0%;
Matches 19; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGCLLFLLLWALLQAWGSA 19
|||||||||||||||||||
Db 1 MGCLLFLLLWALLQAWGSA 19
BJG08511 from (PAYLOAD)1.align450.rag database.
ID BJG08511 standard; peptide; 8 AA.
XX
AC BJG08511;
XX
DT 24-JUN-2021 (first entry)
XX
DE Ovalbumin peptide, SEQ 2750.
XX
KW Ovalbumin; antiinflammatory; autoimmune disease; cell therapy; epitope;
KW graft versus host disease; immunosuppressive; immunotherapy;
KW inflammatory disease; prophylactic to disease; recombinant protein;
KW t-lymphocyte; therapeutic; transplant rejection.
XX
OS Gallus gallus.
XX
CC PN WO2021076887-A1.
XX
CC PD 22-APR-2021.
XX
CC PF 16-OCT-2020; 2020WO-US055980.
XX
PR 18-OCT-2019; 2019US-0916924P.
XX
CC PI Pakyari M, Cetrulo C, Wong W, Okuma A;
XX
XX
CC PT Composition used cell for treating or preventing an autoimmune disease or
CC PT condition, T cell mediated inflammation or immune response, comprises T-
CC PT cell receptor recognition domain, and intracellular signaling domain.
XX
CC PS Disclosure; SEQ ID NO 2750; 235pp; English.
XX
CC The present invention relates to a novel composition comprising a TCR
CC recognition domain; and one or both of an intracellular signaling domain;
CC and a first-type biomolecular interaction domain. The invention further
CC provides: (1) a composition comprising: (a) a first polypeptide
CC comprising at least a portion of a TCR recognition domain and a first-
CC type biomolecular interaction domain; and (b) a polypeptide comprising a
CC second-type biomolecular interaction domain and an intracellular
CC signaling domain; wherein the first-type and second-type biomolecular
CC interaction domains bind specifically to each other; (2) a cell
CC comprising and/or expressing the composition; (3) a chimeric antigen
CC receptor (CAR) comprising an anti-CD127 and/or anti-CD45RO recognition
CC domain, and an intracellular signaling domain; and (4) a method for
CC treating or preventing an autoimmune disease or condition; T cell
CC mediated inflammation or immune response; malignant T cell condition;
CC transplant rejection; or GvHD in a subject, which comprises administering
CC to the subject a composition and/or cell.
XX
SQ Sequence 8 AA;
1 SIINFEKL 8
RESULT 2 from (PRM/CD1d, cytoplasmic)3.align450.rag database.
BJG06745
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID BJG06745 standard; protein; 231 AA.
XX
AC BJG06745;
XX
DT 24-JUN-2021 (first entry)
XX
DE Human CD1d protein isoform 3, SEQ ID 7.
XX
KW CD1d protein; T-cell surface glycoprotein CD1d; antigen;
KW antiinflammatory; autoimmune disease; cell therapy;
KW graft versus host disease; immunosuppressive; immunotherapy;
KW inflammatory disease; prophylactic to disease; recombinant protein;
KW t-lymphocyte; therapeutic; transplant rejection.
XX
OS Homo sapiens.
XX
CC PN WO2021076887-A1.
XX
CC PD 22-APR-2021.
XX
CC PF 16-OCT-2020; 2020WO-US055980.
XX
PR 18-OCT-2019; 2019US-0916924P.
CC PI Pakyari M, Cetrulo C, Wong W, Okuma A;
XX
XX
CC PT Composition used cell for treating or preventing an autoimmune disease or
CC PT condition, T cell mediated inflammation or immune response, comprises T-
CC PT cell receptor recognition domain, and intracellular signaling domain.
XX
CC PS Disclosure; SEQ ID NO 7; 235pp; English.
XX
CC The present invention relates to a novel composition comprising a TCR
CC recognition domain; and one or both of an intracellular signaling domain;
CC and a first-type biomolecular interaction domain. The invention further
CC provides: (1) a composition comprising: (a) a first polypeptide
CC comprising at least a portion of a TCR recognition domain and a first-
CC type biomolecular interaction domain; and (b) a polypeptide comprising a
CC second-type biomolecular interaction domain and an intracellular
CC signaling domain; wherein the first-type and second-type biomolecular
CC interaction domains bind specifically to each other; (2) a cell
CC comprising and/or expressing the composition; (3) a chimeric antigen
CC receptor (CAR) comprising an anti-CD127 and/or anti-CD45RO recognition
CC domain, and an intracellular signaling domain; and (4) a method for
CC treating or preventing an autoimmune disease or condition; T cell
CC mediated inflammation or immune response; malignant T cell condition;
CC transplant rejection; or GvHD in a subject, which comprises administering
CC to the subject a composition and/or cell.
XX
SQ Sequence 231 AA;
Query Match 100.0%; Score 65; Length 231;
Best Local Similarity 100.0%;
Matches 13; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SRFKRQTSYQGVL 13
|||||||||||||
Db 219 SRFKRQTSYQGVL 231
Qy 1 SRFKRQTSYQGVL 13
|||||||||||||
Db 230 SRFKRQTSYQGVL 242
RESULT 2 from (LEADER, PRM/CD1d, transmembrane)2.align450.rag database.
BJG06745
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID BJG06745 standard; protein; 231 AA.
XX
AC BJG06745;
XX
DT 24-JUN-2021 (first entry)
XX
DE Human CD1d protein isoform 3, SEQ ID 7.
XX
KW CD1d protein; T-cell surface glycoprotein CD1d; antigen;
KW antiinflammatory; autoimmune disease; cell therapy;
KW graft versus host disease; immunosuppressive; immunotherapy;
KW inflammatory disease; prophylactic to disease; recombinant protein;
KW t-lymphocyte; therapeutic; transplant rejection.
XX
OS Homo sapiens.
XX
CC PN WO2021076887-A1.
XX
CC PD 22-APR-2021.
XX
CC PF 16-OCT-2020; 2020WO-US055980.
XX
PR 18-OCT-2019; 2019US-0916924P.
XX
CC PA (UBOS ) UNIV BOSTON.
CC PA (GEHO ) GEN HOSPITAL CORP.
XX
CC PI Pakyari M, Cetrulo C, Wong W, Okuma A;
XX
DR WPI; 2021-417447/047.
DR REFSEQ; NP_001358690.1.
XX
CC PT Composition used cell for treating or preventing an autoimmune disease or
CC PT condition, T cell mediated inflammation or immune response, comprises T-
CC PT cell receptor recognition domain, and intracellular signaling domain.
XX
CC PS Disclosure; SEQ ID NO 7; 235pp; English.
XX
CC The present invention relates to a novel composition comprising a TCR
CC recognition domain; and one or both of an intracellular signaling domain;
CC and a first-type biomolecular interaction domain. The invention further
CC provides: (1) a composition comprising: (a) a first polypeptide
CC comprising at least a portion of a TCR recognition domain and a first-
CC type biomolecular interaction domain; and (b) a polypeptide comprising a
CC second-type biomolecular interaction domain and an intracellular
CC signaling domain; wherein the first-type and second-type biomolecular
CC interaction domains bind specifically to each other; (2) a cell
CC comprising and/or expressing the composition; (3) a chimeric antigen
CC receptor (CAR) comprising an anti-CD127 and/or anti-CD45RO recognition
CC domain, and an intracellular signaling domain; and (4) a method for
CC treating or preventing an autoimmune disease or condition; T cell
CC mediated inflammation or immune response; malignant T cell condition;
CC transplant rejection; or GvHD in a subject, which comprises administering
CC to the subject a composition and/or cell.
XX
SQ Sequence 231 AA;
Query Match 100.0%; Score 99; Length 231;
Best Local Similarity 100.0%;
Matches 21; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGLIALAVLACLLFLLIVGFT 21
|||||||||||||||||||||
Db 198 MGLIALAVLACLLFLLIVGFT 218
Qy 1 MGLIALAVLACLLFLLIVGFT 21
|||||||||||||||||||||
Db 209 MGLIALAVLACLLFLLIVGFT 229
Conclusion
10. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however can normally be reached between 8AM-8PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video
conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached on 571-272-0859. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
20 June 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
Prosecution Insights