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 .
Claims Status
The remarks filed 02/09/2026 are acknowledged.
Claims 1-7, 12, 15-23, and 26-28 are pending.
Claims 8-11, 13-14, and 24-25 are canceled.
Claims 3-7, 12, 15, 17, 20-23, and 26-28 are amended.
Applicant’s election without traverse of Group I, claims 1-7, 17-20, 22, 23, and 26, in the reply filed on 02/09/2026 is acknowledged. Applicant’s election without traverse of the following species in the reply filed 02/09/2026 is acknowledged: SEQ ID NO: 21 for the VHH domain, SEQ ID NOs: 60-62, 63-65, and 66-68 corresponding to the IMGT, Kabat, and Chothia number schemes for the CDRs1-3, respectively.
Claims 12, 15-16, 21, and 27-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/09/2026.
Therefore, claims 1-7, 17-20, 22, 23, and 26 are under examination.
Priority
The instant application is a 371 of PCT/CN2021/136637 and claims priority to People’s Republic of China Applications CN202011437242.9 and CN202111353420.4 Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C.
119 (a)-(d) and receipt is acknowledged of certified copies of papers required by 37
CFR 1.55. Priority is given with the earliest effective filing date of 12/10/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/09/2023 and 08/31/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code (see page 12, lines 30-32; page 16, lines 9, 13, and 33; page 28, lines 1-2 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “a CDR1, a CDR2, and a CDR3 comprising an HCDR1, an HCDR2, and an HCDR3 selected from a VHH domain.” The Examiner recommends amending the claim to recite “a CDR1, a CDR2, and a CDR3 comprising a HCDR1, a HCDR2, and a HCDR3, respectively, selected from a VHH domain” to be grammatically correct and to clarify that the HCDRs 1-3 correspond to CDRs 1-3, respectively. Appropriate correction is required.
Claims 1, 7, and 19 are objected to because of the following informalities: Claims 1, 7, and 19 recite an acronym (i.e. GPC3, CDR1, CDR2, CDR3, HCDR1, HCDR2, HCDR3, VHH, FR, CHO). The first time an acronym is used, it must be accompanied by the definition of the abbreviation. Appropriate correction is required.
Claims 2, 3, 6, 7, 12, 19, and 23 are objected to because of the following informalities: Claims 2, 3, 6, 7, 12, 12, 19, and 23 include the limitation “preferably” and claim 19 further includes the limitation “such as.” MPEP 2173.05(d) states, “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim.” The “preferably” should be removed entirely. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-7, 17-20, 22, 23, and 26 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 1 recites an antibody or an antigen-binding fragment specifically binding to
GPC3, wherein the antibody or the antigen-binding fragment comprises a CDR1, a CDR2, and a CDR3 comprising an HCDR1, an HCDR2, and an HCDR3 selected from a VHH domain set forth in any one of SEQ ID NOs: 17-23 and 87. The numbering scheme for the CDRs is not explicitly defined in the claim. It is well known to those skilled in the art that antibodies utilize various numbering schemes to facilitate comparison and analysis of their variable regions. The most commonly used schemes include Kabat, Chothia, and IMGT. These schemes differ in their approach to defining regions, particularly the hypervariable regions (CDRs) that are crucial for antigen binding. Specifically, these different CDR identification methods may often identify radically different stretches as CDRs, indicating that CDRs are not well defined [Sela-Culang et al., 2013; instant PTO-892, see Conclusion]. For example, Sela-Culang et al. shows in Table 3 below, a comparison of CDR regions using different numbering methods demonstrating the significant difference between the amino acid sequences depending on what numbering scheme is utilized.
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The instant specification fails to clarify the issue, disclosing that CDRs may be labeled and defined by any numbering scheme well known in the art, including but not limited to, Kabat numbering scheme, Chothia numbering scheme, or IMGT numbering scheme [page 2, lines 22-23 of the instant specification]. The CDRs herein include overlaps and subsets of amino acid residues defined in different ways.
Therefore, without the amino acid sequences of each CDR region defined by SEQ ID NO or numbering scheme, one of ordinary skill in the art would not know the boundaries of the CDR regions set forth in the recited VHH domains of SEQ ID NOs: 17-23 and 87.
Claims 3-7, 17-20, 22, 23, and 26, which depend from claim 1, are therefore indefinite for the same reasons as set forth above.
Note: Claim 2 is not included in this rejection because it does explicitly define the CDRs by numbering scheme.
Claim 2 recites the limitation “e.g., selected from Table 1” and “for example”. First, regarding the “e.g.” and “for example”, description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim.” See MPEP 2173.05(d). Therefore, it is unclear if what succeeds the “e.g.” and “for example” are required limitations or not. Second, regarding the reference to Table 1, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP 2173.05(s). Therefore, the scope of this claim is indefinite.
Claim 6 recites the limitation “comprises a sequence set forth in any one of SEQ ID NOs: 17-23 and 87”. It is unclear if the term “a sequence” refers to the entire amino acid sequence shown in the recited SEQ ID NOs, or if the term refers to any two amino acids that are connected within the larger polypeptide. Therefore, this claim is indefinite.
Claim 6 further recites the limitation “wherein the single domain antibody comprises a sequence set forth in any one of SEQ ID NOs: 17-23 and 87; optionally, the single domain antibody comprises a sequence having at least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identity to the sequence set forth in any one of SEQ ID NOs: 17-23 and 87; or the single domain antibody comprises a sequence having at most 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 mutation compared with the sequence set forth in any one of SEQ ID NOs: 17-23 and 87.” The claim seems to require that the antibody comprise a sequence of SEQ ID NOs 17-23 or 87 but the limitations succeeding “optionally” only require, at a minimum, 80% sequence identity to the sequence. These limitations contradict each other and make the claim unclear as to what the actual limitations are. If the claim does not require 100% sequence identity to these sequences, then this would necessitate a rejection under 112(d) [see 112(d) rejections below]. Therefore, the scope of this claim is indefinite.
Claim 7 recites the limitation wherein the single domain antibody comprises an FR region in a VHH domain set forth in any one of SEQ ID NOs: 17-23 and 87; optionally, the single domain antibody comprises a sequence having at least 80%, 85%, 90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identity to the FR region in the VHH domain set forth in any one of SEQ ID NOs: 17-23 and 87; or the single domain antibody comprises a sequence having at most 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 mutation compared with the FR region in the VHH domain set forth in any one of SEQ ID NOs: 17-23 and 87.” The claim seems to require that the antibody comprise an FR region in the sequence of SEQ ID NOs 17-23 or 87 but the limitations succeeding “optionally” only require, at a minimum, 80% sequence identity to the sequence. These limitations contradict each other and make the claim unclear as to what the actual limitations are. Additionally, the reference to “the FR region” makes it unclear as to which FR region is being referenced as there are four FR regions in each of the listed sequences.
Claim 7 also recites the limitation “the single domain antibody”. There is insufficient antecedent basis for the limitation in this claim. The lack of antecedent basis arises from claim 7’s dependence on claim 1. Claim 1 does not reference a “single domain antibody”, and is rather broadly drawn to “an antibody or an antigen-binding fragment.”
Further, claim 7 recites the limitation “may be”. The “may be” sets forth alternatives but is an open list without knowing what the other options may be. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. See MPEP 2173.05(h). It is unclear what other alternatives are intended to be encompassed by the claim, and therefore, the scope of this claim is indefinite.
Claim 23 recites the limitation “a method for treating a GPC3-positive tumor or cancer, comprising: administering to a subject an effective amount of the antibody or the antigen-binding fragment according to claim 1”. It is unclear how the antibody or antigen-binding fragment can treat a tumor or cancer in any subject (i.e. one that does not have a tumor or cancer). Therefore, the scope of this claim is indefinite.
This rejection can be overcome by amending the claim to recite “a subject in need thereof”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 4, and 26 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 3 and 4, which depend from claim 1, recite variable sequence identities to the CDRs of the SEQ ID NOs listed in claim 1. Claim 1 requires that the antibody comprise a HCDR1, HCDR2, and a HCDR3 selected from a VHH domain set forth in any one of SEQ ID NOs: 17-23 and 87, but the limitations of claims 3 and 4 broaden the scope of the base claim because if the CDRs only have a % identity to the CDRs, then they do not comprise the CDRs of the listed SEQ ID NOs as required by claim 1. Claim 26 recites a kit comprising the antibody or antigen binding fragment according to claim 1. Claim 26 does not require anything in addition to the antibody or antigen binding fragment of claim 1. Therefore, claims 3-4, 6, and 26 do not further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
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 1-4, 6-7, 17-20, 22, 23, and 26 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.
Claim 1 is drawn to an antibody or antigen binding fragment that binds to GPC3 that comprises a CDR1, a CDR2, and a CDR3 comprising a HCDR1, a HCDR2, and a HCDR3 selected from a VHH domain set forth in any one of SEQ ID NOs: 17-23 and 97. Claim 3 further limits the CDR1, the CDR2, and/or the CDR3 to comprise amino acid sequences having at most 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 mutation on the HCDR1, the HCDR2, and/or the HCDR3; the mutation is selected from an insertion, a deletion, and/or a substitution, and the substitution is preferably a substitution of conserved amino acids. Claim 4 further limits the CDR1, the CDR2, and/or the CDR3 to comprise sequences having at least 80%, 85%, 90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identity to the HCDR1, the HCDR2, and/or the HCDR3, respectively. Claim 6 is drawn to the antibody being a single domain antibody, wherein the single domain antibody comprises a sequence having at least 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identity to the sequence set forth in any one of SEQ ID NOs: 17-23 and 87; or the single domain antibody comprises a sequence having at most 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 mutation compared with the sequence set forth in any one of SEQ ID NOs: 17-23 and 87; the mutation is selected from an insertion, a deletion, and/or a substitution, and the substitution is preferably a substitution of conserved amino acids.
The specification teaches VHH antibodies comprising the HCDRs 1-3 set forth in SEQ ID NOs: 17-23 and 87 [see pages 13-14; Table 1] with 100% sequence identity. However, the specification does not teach a functional antibody containing anything less than 6 CDRs (claim 1 is not limited to a VHH antibody) and does not teach a functional antibody or a VHH antibody containing anything less than 100% sequence identity to the CDRs of SEQ ID NOs: 17-23 and 87.
One means of providing adequate written description and evidence of possession of a claimed genus is through providing sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the genus is defined entirely by a desired function: specifically binds to GPC3. Claim 1 only requires three CDRs of a VHH domain set. However, the claim is to an antibody or an antigen-binding fragment and is not limited to a VHH antibody. One of skill in the art could not envisage such a structure that would bind the target epitope with anything less than 6 CDRs.
In this case, the claim is dawn to a variable number of CDRs, e.g. comprises only a CDR1, a CDR2, and a CDR3 comprising an HCDR1, an HCDR2, and an HCDR3, and is also drawn to a variable sequence for each of the CDRs with up to 10 mutations for each of the recited HCDRs 1-3. The art recognizes that a complete set of six CDRs comprise the binding region of an antibody [see Sela-Culang et al., 2013; instant PTO-892], and that even a single amino acid change to these regions can completely abrogate the binding specificity of an antibody [see Kussie et al., 1994; instant PTO-892). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held
that:
...To fulfill the written description requirement, a patent specification must
describe an invention and does so in sufficient detail that one skilled in the art can
clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re
Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed."). Thus, an applicant complies with the written
description requirement "by describing the invention, with all its claimed limitations, not
that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
A "representative number of species" means that the species, which are
adequately described, are representative of the entire 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. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if
the disclosure "indicates that the patentee has invented species sufficient to constitute
the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v.
Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir.
2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus
after only describing a limited number of species because there may be unpredictability
in the results obtained from species other than those specifically enumerated."). "A
patentee will not be deemed to have invented species sufficient to constitute the genus
by virtue of having disclosed a single species when ... the evidence indicates ordinary
artisans could not predict the operability in the invention of any species other than the
one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir.
2004).
Thus, based on the teachings of the instant specification and the art, applicant has failed to meet the written description of antibodies that are able to bind GPC3 that comprise less than a full set of six CDRS or a VHH antibody that comprise less than 100% sequence identity to the CDRs of SEQ ID NOs: 17-23 and 87. Therefore, one of skill in the art would not conclude that Applicant was in possession of the claimed invention.
Claims 1-2, 7, 17-20, 22, 23, and 26, which depend from claim 1, are therefore deficient for the same reasons above and do not meet the written description requirement.
Note: Applicant does have written description for a VHH domain antibody comprising SEQ ID NOs: 17-23 and 87 and the HCDRs 1-3 thereof, respectively, with 100% sequence identity. However, to reiterate, Claim 1 is drawn to any antibody or antigen-binding fragment and does not limit the antibody to being a single domain antibody (i.e. a VHH antibody). Claim 5, however, does set forth that at least some portion of the antibody or antigen-binding fragment is a single domain antibody where the VHH is not paired with anything. Therefore, claim 5 is not included in this rejection.
Claim 7 is 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.
Claim 7 is drawn to an antibody or an antigen-binding fragment specifically binding to GPC3, wherein the antibody or the antigen-binding fragment comprises a CDR1, a CDR2, and a CDR3 comprising an HCDR1, an HCDR2, and an HCDR3 selected from a VHH domain set forth in any one of SEQ ID NOs: 17-23 and 87, wherein the antibody or the antigen-binding fragment is: (1) a chimeric antibody or a fragment thereof (2) a humanized antibody or a fragment thereof or (3) a full human antibody or a fragment thereof.
The claim encompasses human antibodies. However, the specification teaches that the antibodies of the invention were produced in alpacas [see page 25, Example 2 of the instant specification].
There is no disclosure of a fully human antibody nor any expectation that a
human antibody would comprise the same complementary determining regions (CDRs)
as those disclosed in the instant application because the antibodies were made in alpacas. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian fibroblast growth factors (FGFs) were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. In the same manner, disclosure of an alpaca antibody sequence provides no salient information regarding the sequences produced in a human.
Accordingly, as applicant does not appear to be in possession of a fully human
antibody with the claimed sequences, the disclosure as a whole fails to adequately
describe a human antibody. Thus, a claim to such an antibody fails to meet the written
description requirements.
Allowable Subject Matter
The sequences of SEQ ID NOs: 17-23 and 87 for a VHH antibody and the HCDRs 1-3 thereof, respectively, are free of the prior art. Additionally, the Examiner completed a reverse translation search of the sequences to a nucleotide sequence. The art also does not teach an isolated nucleic acid fragment encoding SEQ ID NOs: 17-23 and 87 for a VHH antibody.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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