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 .
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 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.
DETAILED ACTION
Claims 1-16, 18-20, and 23 are pending in the instant application.
Priority
This application is a 371 of PCT/US21/29216, filed on 4/26/2021 which claims priority to the provisional applications 63131599 filed on 12/29/2020 and 63016268 filed on 4/27/2020.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/016268, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The provisional application 63/016268 discloses SEQ ID NOs: 1-96, but fails to discuss SEQ ID NOs: 97-242.
The provisional application 63/131599 presents the earliest disclosure of SEQ ID NOs: 1-242. Thus:
SEQ ID NOs: 1-96 have a priority date of 4/27/2020.
SEQ ID NOs: 97-242 have a priority date of 12/29/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 10/25/2022 complies with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Notice
Applicant is advised that should claim 1 be found allowable, claim 20 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 20, 1
In the instant case, claim 20 differs from claim 1 solely in the terms “composition” and “antigen-binding fragment thereof”. Because (i) it is unclear what structural differences distinguish “a derivative thereof” and “an antigen-binding fragment thereof” and (ii) the composition of claim 20 includes no other ingredients other than the antibody or fragment/derivative, these claims are considered substantial duplicates. There is no suggestion in the specification that delineates “derivative” from “antigen-binding fragment thereof”. Please see 112(b) rejection below regarding interpretations of the term “derivative of”. All the remaining limitations are identical between the claims. As such, despite a difference in wording, claims 1 and 20 are substantial duplicates.
Objections to the Claims
Claim 20, line 10, should include a semi-colon to differentiate between the list and sub-list. Please replace “239, and 241 and a light chain variable domain” with “239, and 241; and a light chain variable domain”.
Claim 20, line 11, should include a semi-colon to differentiate between the list and sub-list. Please replace “239, and 241 and a light chain variable domain” with “239, and 241; and a light chain variable domain”.
Correction is required. See MPEP § 608.01(m).
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 1-16, 18, 20, and 23 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.
All except 19
Claims 1-12, 14-15, 18, and 20 are drawn to “a derivative thereof” wherein it is unclear what this is referring to. The instant specification recites:
“In some embodiments, the antibody is a monoclonal antibody or a fragment or derivative thereof In some embodiments, the antibody or a derivative thereof is isolated. In some embodiments, the amino acid sequence of the heavy chain variable domain (VH) is represented by SEQ ID NO: N and the amino acid sequence of the light chain variable domain (VL) is represented by SEQ ID NO: N+ 1” (instant spec pg 3, para 1).
Because in this described embodiment, the “derivative” is separate from “a fragment” it is unclear what this derivative could be referring to. One artisan may conclude it is referring to an antibody with the same function but not the same structure, whereas another artisan might conclude derivative is synonymous with “fragment thereof.” Because of these conflicting interpretations, these claims are rendered indefinite. Examiner recommends the language “An antibody or fragment thereof” so that it is clear what applicant is claiming. Dependent claims 13, 16, and 23 fail to cure these deficiencies, thus are also rendered indefinite.
Claim 18
Claim 18 is drawn to treating “a subject at risk” wherein it is unclear (i) what the subject is at risk for and (ii) if they are presumed “at risk” of being susceptible of contracting SARS-CoV-2, it is unclear how this could be definitively measured or defined. One artisan might presume “a subject at risk” refers to an immuno-compromised individual, whereas another artisan would presume “at risk” requires the subject to be exposed to the virus within a certain time window. Applicant did not provide a definition of “a subject at risk”. Because of these multiple interpretations and the lack of any time-constraints (e.g. does qualifying as “at risk” at any point in their lifetime result in infringement?), this claim is rendered indefinite.
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.
Claim 11 is 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.
Claim 11
Claim 11 is drawn to a composition comprising no other ingredients other than the antibody by virtue of the term “optionally”. As a result, claim 11 fails to provide a further limitation over parent claim 1. Examiner recommends deleting the word “optionally” from this claim.
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)
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 1-3, 5-9, 11-16, 18, 20, and 23 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.
All except 4, 10, 19
Claims 1 and 20 are drawn to mixing and matching VH and VL fragments wherein all of the VH fragments do not share the same set of three HCDRs and the VL fragments do not share all of the same LCDRs. The art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody (Kussie 1994 and Chen 1995). Thus, making changes to the set of six CDRs by mixing and matching the VH and VL fragments of different 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. Thus applicant has failed to meet the written description of any antibody comprising a combination of mixed and matched VH and VL regions, save for the pairs described by SEQ ID NO: n and SEQ ID NO: n+1. Dependent claims 2-3, 5-9, 11-16, 18, and 23 fail to cure these deficiencies, thus also fail to meet the written description requirement.
Claim Rejections – 35 USC § 102
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.
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lippincott (US20180258175).
Claim 19
Regarding claim 19, Lippincott teaches a sequence with 100% sequence identity with instant SEQ ID NO: 2 (SEQ ID NO: 402), shown below with the CDR regions underlined (as defined by Lippincott).
instant_2 QSVLTQPPSASGTPGQRVTISCSGSSSNIGSNTVNWYQQLPGTAPKLLIYSNNQRPSGVP 60
Lippincott_402 QSVLTQPPSASGTPGQRVTISCSGSSSNIGSNTVNWYQQLPGTAPKLLIYSNNQRPSGVP 60
************************************************************
instant_2 DRFSGSKSGTSASLAISGLQSEDEADYYCAAWDDSLNGPVFGGGTKLTVL 110
Lippincott_402 DRFSGSKSGTSASLAISGLQSEDEADYYCAAWDDSLNGPVFGGGTKLTVL 110
**************************************************
Lippincott teaches this amino acid sequence is encode by the following nucleotide sequence, shown below (SEQ ID NO: 294; Table 2: pg 12, entry CCL-255A).
>Lippincott_294
CAGTCTGTGCTGACTCAGCCACCCTCAGCGTCTGGGACCCCCGGGCAGAG
GGTCACCATCTCTTGTTCTGGAAGCAGCTCCAACATCGGAAGTAATACTG
TAAACTGGTACCAGCAGCTCCCAGGAACGGCCCCCAAACTCCTCATCTAT
AGTAATAATCAGCGGCCCTCAGGGGTCCCTGACCGATTCTCTGGCTCCAA
GTCTGGCACCTCAGCCTCCCTGGCCATCAGTGGGCTCCAGTCTGAGGATG
AGGCTGATTATTACTGTGCAGCATGGGATGACAGCCTGAATGGTCCGGTA
TTCGGCGGAGGGACCAAGCTGACCGTCCTAG
Relevant Prior Art
Zhou (CN202010184358) discusses a method of detecting CoV-2 using immunofluorescence techniques that employ a rabbit anti-covid antibody marked with europium microspheres. The structure of this antibody used different CDRs than the ones instantly claimed. Alternatively, Zhou teaches this rabbit antibody could be detected using a secondary anti-rabbit antibody with a fluorescent label.
Allowable Subject Matter
The VH regions denoted by odd-numbered “SEQ ID NO: n” when paired with the appropriate even-numbered “SEQ ID NO: n + 1” were found to be allowable over the prior art. The VH regions described in claim 20 were not found in the prior art. The specific sets of HCDRs within the VH regions were not found in the prior art.
The closest prior art is that of Lippincott (US20180258175, SEQ ID NO: 183), shown below with the HCDRs regions underlined (as defined by Lippincott).
instant_1 QVQLQESGPGLVKPSETLSLTCTVSGYSISSGYYWGWIRQPPGKGLEWIGSIYHSGSTYY 60
Lippincott_186 QVQLQESGPGLVKPSETLSLTCTVSGGSIS-SYYWSWIRQPPGKGLEWIGYIYYSGSTNY 59
************************** *** .***.************** **:**** *
instant_1 NPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARTPLSLRLRYNWYFDLWGRGTLV 120
Lippincott_186 NPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARGRLT------GHFDYWGQGTLV 113
************************************** *: :** **:****
instant_1 TVSS 124
Lippincott_186 TVSS 117
****
Lippincott teaches a sequence with 100% sequence identity to the corresponding VL region of instant SEQ ID NO: 2 (SEQ ID NO: 402), shown below with the CDR regions underlined (as defined by Lippincott). (See Lippincott Table 2: pg 12, entry CCL-255A).
instant_2 QSVLTQPPSASGTPGQRVTISCSGSSSNIGSNTVNWYQQLPGTAPKLLIYSNNQRPSGVP 60
Lippincott_402 QSVLTQPPSASGTPGQRVTISCSGSSSNIGSNTVNWYQQLPGTAPKLLIYSNNQRPSGVP 60
************************************************************
instant_2 DRFSGSKSGTSASLAISGLQSEDEADYYCAAWDDSLNGPVFGGGTKLTVL 110
Lippincott_402 DRFSGSKSGTSASLAISGLQSEDEADYYCAAWDDSLNGPVFGGGTKLTVL 110
**************************************************
Notably, the antibodies of Lippincott target CD115, a wholly different antigen than instantly claimed. It is understood in the art that changes to CDRs are unpredictable, thus there was no guidance to arrive at the specific pairs of VH and VL described, given the art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675