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 .
Applicant’s amendment and argument of 11/3/25 are entered.
Claims 1, 65, 68-69, 71-73, 75-77, 81-83 are amended.
Claims 64, 66-67, and 70, are canceled.
Claims 1 and 65, 68-69, and 71-83 are pending, and are considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claims 64, 66-67, and 70, all objections and rejections thereto, are withdrawn.
Drawings
In light of the amended drawings, the objections to the same, are withdrawn.
Claim Objections
Claims 65, 68-69, 76-77, and 80-81 are objected to because of the following informalities:
The objections to Claims 65, 68, 69, and 81 for the wording “which”, are withdrawn.
Claims 76, 77, and 80 are withdrawn in light of further consideration by the Examiner. It is felt that in these claims, the term “which” is acceptable and does make clear the intended scope.
In light of the amendment to Claim 72, removing two species, the advisory that should claim 72 be found allowable, claim 73 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof, is withdrawn.
Applicant is advised that should claim 71 be found allowable, claim 73 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 73 requires the CD45/CD148/CD43 to be present on the surface of a cytotoxic cell. However, Claim 1 requires the cell to be inhibit formation of a functional synapse with a cytotoxic cell. Thus, Claim 71, which depends from Claim 1, also has such, and it as is taught in the specification, it does so by binding the CD45/CD148/CD43 on the surface of the cell, thereby localizing the protein into the synapse location. Thus, the cytotoxic cell necessarily already has such expression.
Applicant is advised that should claim 71 be found allowable, claim 74 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 74 requires the transmembrane protein that binds to the CD45/CD148/CD43, to be capable of retinaing the CD45/CD148/CD43 in a developing immune synapse, thereby preventing immunological synapse formation. However, Claim 1 (from which Claim 71 depends) requires the binding, and the binding itself causes it to localize to the synapse and stop functional synapse formation. Thus, these claims have substantially the same scope.
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 77-80 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 77 recites “a nonautologous cell”. All cells are autologous to one subject or another. Thus, it is not clear if Applicant is claiming the cell, or the cell in the context of subject. Therefore, it is not clear if the claim is to a subject, or a cell.
Claims 78-80 also recite “nonautologous cell”, and thus, it is not clear if Applicant is claiming the cell, or the cell in the context of subject. Therefore, it is not clear if the claim is to a subject, or a cell.
Claim 79 recites the term “preferably”. However, the specification fails to define the embodiments where it is “preferable” or not preferable, for each element. Thus, the scope of the claim is not clear, as it is not defined, but one of opinion, presumably the inventor’s opinion.
Response to Argument – Clarity Rejections
Applicant’s argument of 11/3/25 has been considered but is not found persuasive.
Applicant argues broadly that the amendment addresses each rejection and/or renders them moot, by cancelation (p. 7, paragraphs 4-5).
Such is not persuasive. The language remains the same.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
In light of the amendment, the rejections of Claims 1, 65, 68-69, 71-74, and 76 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, for the aspect of a generic “modultation” of the functional synapse formation, are withdrawn.
Claims 1, 65, 68-69, and 71-83 are again rejected 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, as necessitated by amendment. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is amended to a therapeutic agent of a cell and a transmembrane protein that binds CD45/CD148/CD43, inhibiting the formation of a functioning immune synapse. Claim 73 indicates the CD45/CD148/CD43 is present on the surface of a cytotoxic cell, indicating the claims are broad for targeting non-cytoxic cells in the formation of the immune synapse. Further Claim 74 indicates that CD45/CD148/CD43 is retained in the synapse by the binding, and thereby disrupts functional synapse formation, indicating the broad claims do not require the CD45/CD148/CD43 to be retained in the synapse, and also do not require inhibition of the functional synapse formation. Finally, Claim 76 teaches the configuration of the transmembrane proteins may be distinct for a Markush of disorders.
Claim 75 teaches that the engager is present, bound to the CD45/CD148/CD43, which is on a T or NK cell, and does not require the engager to be on a cell surface, i.e., in solution. Such also appears to encompass different configurations that do not inhibit or do inhibit functional synpase formation, and could be separately configured for a plethora of diseases, as also implied in Claim 74 (SUPRA).
Claim 77 and depending claims are drawn to a non-autologous cell (which has no context, see rejection for clarity above) comprising an engager on its surface, configured to avoid synapse formation (which is distinct from inhibiting functional synapse formation) with one or more host cytotoxic cells (presumably not autologous with the non-autologous cell) configured to avoid synapse formation (again, which is distinct from inhibiting functional synapse formation). Claims 78 and 79 require the cytotoxic cells to be NK, T, or macrophage, or specific T cells. Claim 80 requires these non-autologous cells to be free of genetic modification.
Claim 81 and depending claims are drawn to a generic recombinant protein that links an antibody’s binding region, to a cell surface, through binding CD45/CD148/CD43 on the cell..
The specification provides antecedent basis for the claimed limitation (e.g., paragraph 15). Explains that the molecules are configured to retain the CD45/CD148/CD43 on the surface of a second cell in an incomplete immunological synapse (e.g., paragraph 17). Claims 82-83 limit various aspects of the components. Similar to Claim 75 these engagers are not required to be on the surface of a cell, but may be in solution.
The specification teaches that the CD45/CD148/CD43 are excluded from the inner portion of the synapse due to their bulky glycosylated extracellular portions (paragraph 13). The specification teaches that the phosphatases of CD45/CD148/CD43, by being brought into the inner portions of the synapse, allow for a squelching of the signaling via the synapse, and reducing cytotoxicity (e.g., paragraphs 13-15). In order to bring these proteins into the core region of the synapse, it is taught to have the APC target express CD45/CD148/CD43-binding molecules on their surface (e.g., Figures 2-3). In such instance, the CD45/CD148/CD43 binds to the binding-molecule on the surface of the APC, allowing it into the core region of the synapse (e.g., Id.).
As was discussed in the rejection SUPRA, these three phosphatases are also known in the art to turn down the immune response from the immunological synapse (e.g., Lin, et al. (2003) “The tyrosine phosphatase CD148 is excluded from the immunologic synapse and down-regulates prolonged T cell signaling”, Journal of Cell Biology, 162(4): 673-82, e.g., ABSTRACT). Thus, the Art agrees with Applicant’s demonstration in the Examples of several instances of shutting down the immune response at the synapse.
Thus, these molecules that are “configured”, must be so-configured by being on the APC surface, tethered to the cell membrane. If they were simply molecules in solution, they would not cause the CD45/CD148/CD43 to be localized to the cSMAC or pSMAC or dSMAC. If they were on the inner side of the membrane of the cell, they would not bind, and similarly would not cause inclusion into the core of the synapse.
Similarly, the complex so-capable of acting to prevent lysis, must necessarily be on the surface of the APC, otherwise it would just be further bulk bound to the CD45/CD148/CD43, and cause continued exclusion from the inner regions of the SMAC.
Further, with regard to the configuration to avoid synapse formation, this is simply not what happens, the signaling from the recruited CD45/CD148/CD43 into the synapse, does not block synapse formation, its squelches the cytotoxic affect which occurs due to the synapse formation.
Further elaborating, the various disorders listed do not limit any aspect of the protein structure, but are simply to the use of the same, and thus, configurations are still in question, e.g., in solution or otherwise, and thus, the Artisan would not understand how the claims to disorders alter the structure.
As regards the generic antibody’s binding domain, if it does not bind one of CD45/CD148/CD43, it will not work to squelch the immune synapse caused cytotoxicity.
Therefore, the Artisan would not have understood applicant to have been in possession of other than configurations that are a CD45/CD148/CD43 binding entity, linked to the surface of an APC, which cause recruiting of the CD45/CD148/CD43 to the synapse inner regions, thereby squelching synapse-induced cytotoxicity from T and NK cells.
Response to Argument – Description: overall configurations of protein/cells/etc
Applicant’s argument of 11/3/25 is addressed here, and not found fully persuasive.
Applicant argues the Examiner made a clerical error, and notes Claims 2-63 were previously canceled (p. 8, paragraph 4).
Such is persuasive. The Examiner apologizes and notes that present claims are corrected to those that are presently pending.
Applicant argues that the amendment overcomes the rejection, and a sufficient number of engagers were provided in SEQ ID NOS 1, 3, 5, … or 224, citing the specification paragraph 16, and examples (Id., paragraph 5).
Such is not fully persuasive. The issues have been further emphasized in an attempt to help Applicant, but for example, Claim 73 requires the targeted protein to be on a cytotoxic cell, and yet, from the specification, that is exactly why it is to be bound, thereby blocking the functional synapse formation. Applicant has not described non-immune-synapse inhibition, or other. Another example: Claim 74 teaches the protein retains the target CD45, etc., to be retained in the synapse during formation, and this indicates the broad claims do not require it be retained in the synapse during formation, but the whole invention is the same retention. Claim 76, indicating different disorders, indicate the configuration differs between these diseases, and others for the broad claims, which also brings into play the various configuration/function/etc issues. If Applicant reviews the claim explanation in this updated rejection above, Applicant can see that the depending claims are to structure/function which is required in the independent claims, and not a separate, narrower or severable scope, but being written in depending form, and comparing to the other claims, each claim must have a distinct scope. This causes the issues with written description above.
Applicant argues that the Examiner’s issues with configurations of the agent being in solution and argues that the genus is not as large as the assertions set forth by the Examiner as Claim 1 is to a therapeutic agent comprising a cell (p. 8, last paragraph).
Such is not persuasive. The Examiner doesn’t have an issue with the solution form for Claim 1 and dependent claims, but this aspect of in solution molecules is found in.e.g, Claim 75 and 77-80. For example, Claim 75 is the engager, bound to the target CD molecule on a T or NK cell. In this instance, it is not required to be on a cell, but could be in solution. For Claim 77 requires avoiding synapse formation altogether, and requires the engager on the surface of the cell, which is non-autologous (which still has clarity issues) and Claim 80 requires it to be genetic-modification free, which is the only way to get the transmembrane protein expressed, but also implies it was put in solution with the cell, to attach to the cell, and there is no description how this is done.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 64-83 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are generic for agents and molecules that bind CD45, CD148, or CD43 (e.g., The claims require that they interfere with immune synapse function, and as has been discussed above, this means binding of the CD45/CD148/CD43, to allow it to be drawn into the inner portions of the immune synapse). Claim 64 elaborates that these molecules or cells comprise a protein, aptamer, peptide, PNA, or nanoparticle. Claim 65 elucidates that the protein may be an antibody, scab, or VHH nanobody. Claim 66 elucidates that the protein may be viral or bacterial, including ULL or E3/49k, or fragments thereof. Claim 69 teaches several protein sequences, and all proteins with 80% identity may be used. Claims 72-73 teach that the protein may be a transmembrane protein that binds CD45/CD148/CD43, and the cell may be a graft cell (i.e., the APC). Claim 74 requires the transmembrane protein to retain CD45/CD148/CD43 on the surface of the synapse and disrupt functional synapse formation (i.e., disrupt the cytotoxic response). Claim 75 is drawn to the complex of the engager of Claim 69, bound to CD45/CD148/CD43 expressed on the surface of the T or NK cell. Claim 76 teaches it is configured for use in several conditions (adjusting the APC which would display the engager). Claim 77 teaches the cell with the engager on the surface (the Markush of 80% identity SEQ ID NOs, as in Claim 69 and 75). Claim 81 teaches the membrane-anchored protein, which has an scAB that binds CD45/CD148/CD43.
The specification provides antecedent basis for the claimed limitations (e.g., paragraph 15). The specification teaches that antibodies, nanobodies, and single chain antibodies binding to CD45/CD148/CD43 may be used (e.g., paragraphs 25 and 32), and demonstrates the use of the CD45-binding single chain antibody (e.g., Example 2), as well as the making of several nanobodies and single chain antibodies to CD45/CD148/CD43 (Examples 3-5), along with the use of UL11 and E3/49k binding regions (e.g., Example 2). However, even with all these disclosures, the same does not provide the essential structure required for the generic molecule that binds one of CD45/CD148/CD43, does not provide the essential structure required for an antibody/scAb/nanobody/aptamer/PNA/nanoparticle, which binds to the appropriate portion of the CD45/CD148/CD43. To wit, expressed within the context of antibodies, but the same issue arises with any molecule that binds to CD45/CD148/CD43:
For a claim to a genus, a generic statement that defines a genus of substances
by only their functional activity does not provide an adequate written description of the
genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC
1997). The recitation of a functional property alone, which must be shared by the
members of the genus, is merely descriptive of what the members of the genus must
be capable of doing, not of the substance and structure of the members. The Federal
Circuit has cautioned that, for claims reciting a genus of antibodies with particular
functional properties (e.g., high affinity, neutralization activity, competing with a
reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an
antibody that binds to human TNF-α with A2 specificity, can result in a claim that does
not meet written description even if the human TNF-α protein is disclosed because
antibodies with those properties have not been adequately described." Centocor
Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“[A] sufficient description of a genus . . . requires the disclosure of either a
representative number of species falling within the scope of the genus or structural
features common to the members of the genus so that one of skill in the art can
‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting
Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that
those species that are adequately described are representative of the entire genus.
AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir.
2014) (“The ’128 and ’485 patents, however, only describe species of structurally
similar antibodies that were derived from Joe-9. Although the number of the
described species appears high quantitatively, the described species are all of the
similar type and do not qualitatively represent other types of antibodies encompassed
by the genus.”). Thus, when there is substantial variation within the genus, one must
describe a sufficient variety of species to reflect the variation within the genus to
provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one
of skill in the art to ‘visualize or recognize’ the members of the genus takes into
account the state of the art at the time of the invention. For antibodies, the Federal
Circuit has found that possession of a mouse antibody heavy and light chain variable
regions provides a structural "stepping stone" to the corresponding chimeric antibody,
but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only
provides amino acid sequence information (a molecular description of the antibody)
for a single mouse variable region, i.e., the variable region that the mouse A2
antibody and the chimeric antibody have in common. However, the mouse variable
region sequence does not serve as a stepping stone to identifying a human variable
region within the scope of the claims.”). A chimeric antibody shares the full heavy
and light chain variable regions with the corresponding mouse antibody; that is, the
structure shared between a mouse and chimeric antibody would generally be
expected to conserve the antigen binding activity.
Lastly, even if a selection procedure is disclosed that was, at the time of the
invention, sufficient to enable the skilled artisan to identify antibodies with the recited
functional properties, the written description provision of 35 U.S.C § 112 is severable
from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The
fact that a fully-human antibody could be made does not suffice to show that the
inventors of the '775 patent possessed such an antibody.”)
In applicant’s case, Applicant has used known binding regions (e.g., UL11 and E3/49k), and made antibodies (e.g., a-CD45-sc and VHH), that bind to the appropriate CD45/CD148/CD43, and it is possible to use selex to design aptamers that bind to CD45/CD148/CD43, but this fails to provide the structure required for the scope of a generic molecule (or cell) that binds to CD45/CD148/CD43, thereby entering the synapse and squelching the immune response through localizing CD45/CD148/CD43 to the synapse and it’s subsequent phosphatase activity. It is noted that Applicant’s functional activity is merely descriptive of what the members be capable of doing, not the substance and structure of the members. The large variety of binding species described also fails to meet the representative number of species, as the species bind the CD45/CD148/CD43 but do not qualitatively represent other types of molecules/antibodies/aptamers/etc., in the genus. Lastly, even with selection procedures, while enabling of making the embodiments, the written description is severable from the enablement provision, and again, the generic structure required for the generas claimed is not sufficiently demonstrated.
The Art does not provide more with regard to any of these molecules or cells displaying the molecules.
Thus, aside from the specific embodiments made and disclosed, the Artisan would understand applicant to have been in possession of the generic molecule (or cell comprising the molecule) that binds CD45/CD148/CD43 and localizes it to the synapse, thereby squelching the immune response.
Response to Argument – Generic CD45/CD148/CD43 binding transmembrane proteins
Applicant’s argument of 11/3/25 has been considered but is not found persuasive.
Applicant argues that they have amended the claims to “inhibits the formation of a functional synapse with a cytotoxic cell, thereby prevening cytotoxicity” (p. 9, paragraphs 3-6).
Such is not persuasive. This doesn’t provide the generic structure required to bind one of CD45/CD148/CD43.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
In light of the amendment to Claims 81 and 82, the rejections of Claims 1 , 56, 68-69, and 71-83 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, are withdrawn.
To wit, Claim 82 now requires all elements to be present, and Claim 81 now requires the elements listed to be the order of N to C termini.
The claims are generic, as seen from depending claim 82, for random inclusions of elements (i) through (viii), and including orientations of element i-vii being present from carboxyl to amino terminus, of the proteins.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
In light of the amendments, the rejections of Claim(s) 1, 63, 65, 68 and 76 under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent No. 7,941,792 to Delcayre, et al., are withdrawn.
To wit, the molecule of Delcayre is soluble.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
In light of the amendment, the rejections of Claim(s) 1, 64-65, 68, and 70-74 under 35 U.S.C. 102(a)(1) as being anticipated by Park, et al. (1991) “Enhancement of T-cell activation by the CD43 molecule whose expression is defective in Wiskott-Aldrich syndrome”, Nature, 350: 706-09, are withdrawn.
To wit, Daudi cells are B cells that naturally express the molecule to bind CD43.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
In light of the amendments, the rejections of Claim(s) s 1, 64, 66, and 71-74 under 35 U.S.C. 102(a)(2) as being anticipated by WO 2014/0079725 to Kay-Fedorov, et al., are withdrawn.
To wit, the claims now exclude UL11 or portions thereof.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim(s) 1, 65, 67, 71-74, and 76 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent No. 10,550,183 to Png, et al., as necessitated by amendment.
Claim 1: Png teaches a chimeric antigen receptor, such receptor being able to bind CD45 (e.g., paragraph 47). It is taught to express the same in T cell recombinantly, as a CAR is well known to be done (e.g., paragraph 154). The structure being present, such would necessarily sequelch immune synapse function when another T cell binds.
Claim 65: Png teaches scFV (e.g., paragraph 76).
Claim 67: the molecule is not E3/49k, or a fragment.
Claim 71: the cells are to be placed in a recipient (e.g., paragraph 84).
Claim 72: the molecule is to bind CD45.
Claim 73: CD45 is well known to be on B and T cells.
Claim 74: as the structure is present, it is so-expected to capable of retaining CD45 in a developing immune synapse and disrupt functional immune synapse formation.
Claim 76: the cells are designed to treat t cell malignancy (e.g., paragraph 87).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
65 are withdrawn
In light of the amendments the rejections of Claims 1, 68, and 71-74 under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more. The claim(s) recite(s) cells configured to modulate the ability of CD45/CD148/CD43 to form functional immune synapse, thereby preventing cytotoxicity, are withdrawn.
To wit, the compositions are not found in nature, as amended.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638