DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The claim listing filed September 1, 2022 is pending.
Claims 2, 3, 9, 10, 12-14, 16-20, 23, 26, 28, 29, 31, 32, 34, and 37-79 are canceled.
Claims 1, 4-8, 11, 15, 21, 22, 24, 25, 27, 30, 33, 35, and 36 are pending.
Claim 1 is an independent claim.
Election/Restriction
Applicant’s election without traverse to the species of P9-11 as the clone for the first ABS, P9-24 as the clone for the second ABS, ECA42 as the anti-GAL9 control antibody clone, and stimulation by a plurality of peptides known to induce an immune response as the means to activate the immune cells in the reply filed on March 13, 2026 is acknowledged.
Claims 1, 4-8, 11, 15, 21, 22, 24, 25, 27, 30, 33, 35, and 36 are currently under consideration.
Upon further consideration, the species election requirement with respect to the specific clones for the first and second ABS in the office action mailed on 01/14/2026 is withdrawn.
In view of the withdrawal of the species election requirement, the Applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the species election requirement with respect to the specific clones for the first and second ABS is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Accordingly, all of the clones for the first and second ABS species are rejoined.
Claim Objections
Claim 22 recites “TNF-a” and “IFN-g” where it should recite “TNF-
α
” and “IFN-
γ
” in line 2.
Claim Rejections - 35 USC § 112
Indefinite Language
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 1, 4-8, 11, 15, 21, 22, 24, 25, 27, 30, 33, 35, and 36 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 1, 4, 11, 15, and 35 recite antibody clone names such as “P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, and P9-57” in claim 1 and “ECA42 clone” in claim 35.
The claims are indefinite in the recitation of “P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, and P9-57” and “ECA42 clone” because the characteristics of the recited clones are not known. The use of “P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, and P9-57” and “ECA42 clone” as the sole means of identifying the claimed antibodies renders the claim indefinite because “P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, and P9-57” and “ECA42 clone” are merely laboratory designations which do not clearly define the claimed product, since different laboratories may use the same designations to define completely distinct biological materials.
Amending claims 1, 4, 11, 15, and 35 to recite the appropriate Deposit Accession Number or SEQ ID NOs would obviate this rejection. See the rejection under the first paragraph of 35 U.S.C. 112, enablement for the deposit of biological materials below.
For the purposes of applying prior art, the terms “P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, and P9-57” and “ECA42 clone” are being used as the names of the claimed antibodies.
Claim 5 recites “wherein the first antigen binding site (ABS) further comprises a first IgG heavy chain polypeptide and a first light chain polypeptide” in lines 1 and 2. Claim 5 is dependent on claims 1 and 4 which recite that the first ABS comprises a VH and a VL, therefore, the first ABS of claims 1 and 4 already comprise first heavy chain light chain polypeptides. Thus, it is unclear if the first heavy and light chain polypeptides of the first ABS of claim 5 are in addition to or are the first heavy chain light chain polypeptides of the first ABS of claims 1 and 4. Amending claim 5 to recite “wherein the first antigen binding site (ABS) further comprises a first IgG heavy chain constant region polypeptide and a first light chain constant region polypeptide” would obviate this part of the rejection.
Claim 11 recites “another ABS clone” in lines 3 and 5. Claim 11 is dependent on claims 1 and 7. Claim 1 recites “from any one of the ABS clones” in line 3. It is unclear what the “another ABS clone” in claim 11 exactly is because there is no reference to the first ABS clone. Amending claim 1 to recite “an ABS clone other than the ABS clone of the first ABS” instead of “another ABS clone” in lines 3 and 5 would obviate this part of the rejection.
Claim 21 contains the trademarks/trade names “DARTs,” “tandAbs,” and “B-bodies” in lines 3 and 4. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
In the present case, the trademarks/trade names are used to identify/describe antibody formats and, accordingly, the identification/description is indefinite.
Amending claim 21 to delete the terms trademarks/trade names “DARTs,” “tandAbs,” and “B-bodies” would obviate this part of the rejection.
Claims 22, 24, 25, and 27 recite “activated immune cells.” It unclear what these activated cells are or how they become activated. Therefore, the phrase “activated immune cells” renders the claims indefinite. Amending 22, 24, 25, and 27 to replace “activated immune cells” with “immune cells activated by stimulation by a peptide or plurality of peptides known to induce an immune response, anti-CD3, or dendritic cells” would obviate this part of the rejection.
Claims 22, 24, 25, 27, 30, and 33 are further indefinite since the controls are not defined. Without a specific control, each fold change is meaningless and indefinite and so the claim are rejected here. Said another way, controls encompassed are open to multiple structural interpretations and this set of multiple interpretations gives the actual efficacies recited different interpretations, rendering the claims indefinite. Each control should be recited as a specific antibody by name or structure. Calling out the control by its target, such as anti-PD1 antibody is useless as the art is full of such with varying efficacies and thus rendering the fold changes required by the claims indefinite. It is recommended that claims 22, 24, 25, 27, 30, and 33 be amended to specifically define the controls.
Enablement
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, 4-8, 11, 15, 21, 22, 24, 25, 27, 30, 33, 35, and 36 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1, 4, 11, 15, and 35 recite antibody clone names, such as, “P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, and P9-57” in claim 1 and “ECA42 clone” in claim 35.
It is apparent that the hybridomas that produce the P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 antibodies are required to practice the claimed invention. As a required element, the P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 hybridomas must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. If it is not so obtainable or available, the enablement requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the cell lines/hybridomas which produce the P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42. See 37 CFR 1.1801-1.1809.
If the deposit has been made under the terms of the Budapest Treaty, an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 hybridomas have been deposited under the Budapest Treaty and that the P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 hybridomas will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. See 37 CFR 1.808.
Further, the record must be clear that the deposit will be maintained in a public depository for a period of 30 years after the date of deposit or 5 years after the last request for a sample or for the enforceable life of the patent whichever is longer. See 37 CFR 1.806.
If the deposit has not been made under the Budapest treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature must be made, stating that the deposit has been made at an acceptable depository and that the criteria set forth in 37 CFR 1.801-1.809, have been met.
If the deposit was made after the effective filing date of the application for a patent in the United States, a verified statement is required from a person in a position to corroborate the fact, and should state, that the P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 hybridomas, which are deposited, are biological material specifically identified in the application as filed, except if the person is an attorney or agent registered to practice before the Office, in which case the statement need not be verified. See MPEP 1.804(b). Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Further, amendment of the specification to disclose the date of deposit and the complete name and address of the depository (ATCC.10801 University Boulevard, Manassas, VA 20110-2209) is required as set forth in 37 C.F.R. 1.809(d). As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
It is apparent that the P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 are required to practice the claimed invention. It is noted that the Applicant has provided the CDR, VH and VL, and heavy and light chain amino acid sequences of the P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 antibody clones (e.g. see Tables 3, 4, and 6).
It is noted that the sequence of an entire immunoglobulin satisfies the enablement requirements under 35 USC 112, first paragraph as well. Note that satisfaction for the enablement of biological deposit of the specific P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 antibody clones requires the disclosure and recitation of their entire amino acid sequence and not based upon partial sequences.
Applicant is invited to make the record clear whether satisfaction of the requirements under 35 USC 112, first paragraph, enablement for biological materials has been satisfied in a current U.S. Patent for P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, P9-57, and ECA42 in order to make the record of the instant application complete.
Written Description
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, 6-8, 11, 15, 21, 22, 24, 25, 27, 30, 33, 35, and 36 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 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 instant claims are drawn to a Galectin-9 (GAL9) antigen binding molecule, comprising: a first antigen binding site (ABS) specific for a first epitope of a first GAL9 antigen, wherein the first antigen binding site comprises all three VH CDRs and/or all three VL CDRs from any one of the ABS clones selected from the group consisting of P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, and P9-57.
Regarding the claimed antibodies and antigen-binding molecules of claims 1, 8, 11, 15, 35, and 36, the Applicant has disclosed 30 anti-human GAL6 antibodies and their CDR, VH and VL, and HC and LC amino acid sequences (e.g. see Tables 3, 4, and 6). The Applicant has also disclosed the following anti-Gal9 control antibodies: ECA42, RG9.1, RG9.35, and 108A2 (e.g. see claim 35 and [0043]) and Nivolumab as an anti-PD-1 antibody (e.g. see [0333]). The Applicant has also disclosed that the anti-CD3 antibody BV510, PerCP/Cy5.5, and 145.2C11 (e.g. see Tables 1 and 2; and [0298]).
Regarding the claimed peptide or plurality of peptides known to induce an immune response of claim 36, the Applicant has disclosed the HCMV PepMix (pp65) (>90%) Protein ID: P06725 (Cat. No. PM-PP65-2, JPT Peptide Technologies) which was used to prime (or activate) an antigen specific response (e.g. see [0264] and [0333]). PepMixTM HCMVA (pp65) are complete protein-spanning mixtures of overlapping 15mer peptides through 65 kDa phosphoprotein (pp65) (Swiss-Prot ID: P06725) of Human cytomegalovirus (HHV-5), used for immunostimulation of immune cell responses (e.g. see [0264]).
When given the broadest reasonable interpretation in light of specification, the GAL9 antigen binding molecules of the instant invention are defined broadly to be any antigen binding molecule that binds to GAL9.
It is noted that the broadest claim (claim 1) does not indicate sufficient structure for the genus of GAL9 antigen binding molecules the comprise a first ABS with less than 6 CDRs.
Dependent claims 8 and 11 do not recite sufficient structure for the second ABS. Claim 8 does not recite any structure for the second ABS and claim 11 recites that the second ABS may comprise less than 6 CDRs.
Dependent claim 15 also recites that the first ABS may comprise less than 6 CDRs.
Dependent claim 35 does not recite any structure for the anti-PD1 antibody or the non-GAL9 binding isotype control antibody.
Dependent claim 36 does not recite any structure for the peptide or plurality of peptides known to induce an immune response or the anti-CD3.
It is noted that only claims 4 and 5 recite sufficient structure for the claimed GAL9 antigen binding molecules.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, January 5, 2001, see especially page 1106 column 3). In The Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412) 19 F. 3d 1559, the court held that disclosure of a single member of a genus (rat insulin) did not provide adequate written support for the claimed genus (all mammalian insulins). In this same case, the court also noted:
“A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what achieves that result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.”
Artisans are well aware that knowledge of a given antigen (for instance GAL9, PD-1, or a non-GAL9 antigen) provides no information concerning the sequence/structure of antibodies or antigen binding molecules that bind the given antigen. For example, Edwards et al. (J. Mol. Biol., 2003, 334:103-118) teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences spanning almost the entire heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lambda and V-kappa light chain germlines, and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well, see entire document).
As such, it does not seem possible to predict the sequence/structure of an antibody or antigen binding molecules that binds a given antigen, as there does not appear to be any common or core structure present within all antigen binding molecules that gives rise to the function of antigen binding. Further, given data, such as that of Edwards et al., indicating the diversity of sequences in a population of antibodies that bind to a given antigen, no number of species appears to reasonably representative of the breadth of the genus of antibodies or antigen binding molecules that bind the given antigen.
It should be pointed out that it is well established in the art that the formation of an intact antigen-binding site requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three different complementarity determining regions, CDR1, 2 and 3, which provide the majority of the contact residues for the binding of the antigen binding molecule to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (Janeway Jr et al., Immunology, 3rd Edition, 1997 Garland Publishing Inc., pages 3:1-3:11.see entire selection).
Thus, based upon the prior art, skilled artisans would reasonably understand that it is the structure of the CDRs within an antibody or antigen binding molecule which gives rise to the functional property of antigen binding, the epitope to which said CDRs bind is an inherent property which appears to necessarily be present due to conservation of critical structural elements, namely the CDR sequences themselves.
This applies to the instant invention which is drawn to genera of anti-GAL9 antigen binding molecules, anti-PD-1 antibodies, and non-GAL9 binding isotype control antibodies.
The same logic applies to the limitations in claim 36 that recite “peptide or plurality of peptides known to induce an immune response” and “anti-CD3” in lines 2 and 3. Claim 3 must recite the critical structural elements for the peptide or plurality of peptides and anti-CD3 which gives rise to their functional properties of inducing an immune response and binding CD3, respectively.
As noted above, the Applicant has disclosed 30 anti-human GAL6 antibodies with their CDR, VH and VL, and HC and LC amino acid sequences, the anti-Gal9 control antibodies ECA42, RG9.1, RG9.35, and 108A2; the anti-PD-1 antibody nivolumab; the anti-CD3 antibodies BV510, PerCP/Cy5.5, and 145.2C11; and the PepMixTM HCMVA (pp65) as the peptide or plurality of peptides known to induce an immune response. Such a disclosure does not serve to provide sufficient written description of the claimed genera of anti-GAL9 antigen binding molecules, anti-PD-1 antibodies, and non-GAL9 binding isotype control antibodies.
The disclosure does not identify sufficient structural features or combination of features which give rise to the function of GAL9, PD-1, non-GAL9, CD3 binding, or inducing an immune response. Additionally, there does not appear to be any reasonable shared structure present in the genera of recited antibodies, antigen binding molecules, or peptides or plurality of peptides which gives rise to their functional activity. Ultimately, identifying an antibody or antigen binding molecule on the basis of binding to GAL9, PD-1, non-GAL9, or CD3 rather than by identifying the sequence/structure, namely a complete set of six CDRs, of the anti-GAL9 antigen binding molecules, anti-PD-1 antibodies, non-GAL9 binding isotype control antibodies, or anti-CD3 in question is generally insufficient to provide written description. Similarly, identifying a peptide or plurality of peptides on the basis of inducing an immune response rather than by identifying the sequence/structure of the peptide or plurality of peptides in question is generally insufficient to provide written description.
The claims are drawn to broad genera of anti-GAL9 antigen binding molecules, anti-PD-1 antibodies, non-GAL9 binding isotype control antibodies, anti-CD3, peptides, and pluralities of peptides which are functionally defined by their ability to bind to GAL9, PD-1, non-GAL9, or CD3, or to induce an immune response, respectively, without reciting a corresponding structure expected to correlate with this ability as supported by Applicant’s disclosure.
Thus, there is insufficient written description for the breadth of anti-GAL9 antigen binding molecules, anti-PD-1 antibodies, non-GAL9 binding isotype control antibodies, anti-CD3, peptides and pluralities of peptides known to induce an immune response as currently claimed, which are distinct and diverse and do not share a common structure that contributes to a common ability to bind to GAL9, PD-1, non-GAL9, or CD3, or induce an immune response, respectively.
Therefore, in view of the breadth of the claims and the limited disclosure, artisans would reasonably conclude that applicant was not in possession of the full breadth of anti-GAL9 antigen binding molecules, anti-PD-1 antibodies, non-GAL9 binding isotype control antibodies, anti-CD3, and peptides or pluralities of peptide known to induce an immune response as encompassed by the claims at the time the instant application was filed.
Amending the claims as follows would obviate this part of the rejection:
Claim 1 to recite “wherein the first antigen binding site comprises all three VH CDRs and all three VL CDRs” in lines 2 and 3 and to recite the SEQ ID NOs for each of the respective CDRs;
Claim 8 to recite sets of six CDRs, their respective SEQ ID NOs, and their corresponding antigens for the second ABS;
Claim 11 to recite “wherein the second ABS comprises all three VH CDRs and all three VL CDRs” in lines 2 and 3 and to recite the SEQ ID NOs for each of the respective CDRs;
Claim 15 to recite “wherein the first antigen binding site comprises all three VH CDRs and all three VL CDRs” in lines 2 and 3 and to recite the SEQ ID NOs for each of the respective CDRs;
Claim 35 to recite sets of six CDRs and their respective SEQ ID NOs for the anti-PD-1 antibody and non-GAL9 binding isotype control antibody; and
Claim 36 to recite a specific structure for the peptide or a plurality of peptides and a complete set of six CDRs for the anti-CD3 and their respective SEQ ID NOs.
Improper Markush Grouping
Claims 1, 6-8, 11, 15, 21, 22, 24, 25, 27, 30, 33, 35, and 36 are rejected on the judicially-created basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial structural feature and a common use that flows from the substantial structural feature for the following reasons:
MPEP 803.02 provides guidance on the analysis of a proper Markush group. Members of a proper Markush group are disclosed in the specification to possess at least one property in common which is mainly responsible for their function in the claimed relationship, and it is clear from their very nature or from the prior art that all of them possess this property. The MPEP further provides that in the members of a proper Markush group there should be (1) a common utility, and (2) a substantial structural feature essential to that utility.
In the instant case, all claims above recite a Markush group of antigen binding molecules defined by at least a partial CDR set. However, as discussed above in the written description rejection, all incorporated here, it is the full CDR set that provides antigen binding function of an antigen binding molecules and so it is this set that is the substantial structural feature necessary to define a proper Markush group. Since this full set varies for each antigen binding molecules species recited (see Table 5) the Markush group is improper and the claims are rejected here.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. For example, a complete set of six CDRs for teach ABS clone as defined by their respective SEQ ID NOs.
This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
Allowable Subject Matter
It is noted that a Galectin-9 (GAL9) antigen binding molecule, comprising all three VH CDRs and/or all three VL CDRs from any one of the ABS clones selected from the group consisting of P9-01, P9-02A, P9-03, P9-06, P9-07, P9-11, P9-12, P9-14, P9-23, P9-24, P9-25, P9- 29, P9-30, P9-34, P9-37, P9-38, P9-40, P9-41, P9-42, P9-43, P9-44, P9-45, P9-46, P9-50, P9-51, P9-52, P9-53, P9-56, and P9-57, wherein the VH and VL CDRs are defined in Tables 3 and 4, respectively, is free of the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Grace H. Lunde whose telephone number is (703)756-1851. The examiner can normally be reached Monday - Thursday 6:00 a.m. - 3:00 p.m. (EST).
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/GRACE H LUNDE/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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