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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 06/02/2026 is acknowledged. Applicant’s election does not indicate with or without traverse and instead states the election was made “without acknowledging the merits of the Examiner’s requirements.” Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant elected Group I, drawn to a protein with antigen binding site(s). Within Group I, applicant elected the following species for the protein with antigen binding site(s): (i) SEQ ID NO: 102, SEQ ID NO: 104, SEQ ID NO:105, SEQ ID NO:107, SEQ ID NO:108, and SEQ ID NO:109, corresponding to CDRH1, CDRH2, CDRH3, CDRL1, CDRL2, and CDRL3; and (ii) one VH and one VL, corresponding to SEQ ID NO:715 and SEQ ID NO:716, respectively.
Claim Status
Claims 1-52 and 58-91 are cancelled. Claims 53-57 and 92-116 are pending and currently under consideration for patentability under 37 CFR 1.104.
Priority
This application claims benefit of Provisional U.S. Application No. 63/396,910 filed on 08/10/2022. 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.
Claims 53-57 and 92-116 have an effective filing date of 08/10/2022 corresponding to Provisional U.S. Application No. 63/396,910.
Information Disclosure Statement
The information disclosure statements filed on 02/21/2024 and 10/22/2024 have been considered. All references considered unless marked with strikethrough. Signed copies are enclosed.
Notably, the disclosure statement filed on 02/21/2024 lists Search Reports. 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.
Claim Interpretation
Claim 115 recites “cultivating the host cell in a medium under conditions suitable for expressing the protein” (line 3). The instant specification does not delineate what conditions are suitable for expression, merely stating the host cell can be “cultured under conditions suitable for bio-reactor scale-up and maintained expression of the multi-specific protein” (¶ 0301). However, it is well known in the prior art how to express anti-CEACAM5 antibodies. For example, Baek et al. (A highly-specific fully-human antibody and CAR-T cells targeting CD66e/CEACAM5 are cytotoxic for CD66e-expressing cancer cells in vitro and in vivo, Cancer Letters, Volume 525, 28 Jan 2022, Pages 97-107) teach an “anti-CEACAM5 monoclonal antibody” (Pg. 97, Abstract, line 6), delineating conditions necessary for expression in different cell lines (Pg. 98, column 2, entire ¶ 2, discusses expression in E. coli and HEK cells).
Therefore, claim 115 is not deemed indefinite under 35 USC § 112(b) because a person having ordinary skill in the art would understand how to select suitable conditions for expression. For the purposes of claim interpretation, the phrase “cultivating the host cell in a medium under conditions suitable for expressing the protein” will interpreted in light of the teachings in the prior art.
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 53-54, 56, 94, 96-97, and 99-116 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 MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application, including “the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention” (MPEP 2163[II][A][2]).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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 Applicants were in possession of the claimed genus.
Claim 53 is drawn to “[a] protein comprising an antigen-binding site that binds CEACAM5, wherein the antigen-binding site comprises a VH comprising a CDRH1, CDRH2, and CDRH3, and a VL comprising a CDRL1, CDRL2, and CDRL3, wherein:
CDRH1 comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 3 and 102;
CDRH2 comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 37, 104, and 718;
CDRH3 comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 6, 38, and 105;
CDRL1 comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 7, 40, and 107;
CDRL2 comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 8, 41, and 108; and
CDRL3 comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 9, 42, and 109” (lines 1-15).
Claim 53 recites multiple options for the heavy chain CDRs (SEQ ID NOs: 3 and 102 for CDRH1; SEQ ID NOs: 37, 104, and 718 for CDRH2; SEQ ID NOs: 6, 38, and 105 for CDRH3) and light chain CDRs (SEQ ID NOs: 7, 40, and 107 for CDRL1; SEQ ID NOs: 8, 41, and 108 for CDRL2; SEQ ID NOs: 9, 42, and 109 for CDRL3), leading to 486 unique combinations of 6 CDRs.
Claim 54 is drawn to the protein wherein
“(a) the CDRH1, CDRH2, and CDRH3 are:
SEQ ID NOs: 3, 37, and 38, respectively;
SEQ ID NOs: 3, 718, and 6, respectively; or
SEQ ID NOs: 102, 104, and 105, respectively; and
(b) the CDRL1, CDRL2, and CDRL3 are:
SEQ ID NOs: 7, 8, and 9, respectively;
SEQ ID NOs: 40, 41, and 42, respectively; or
SEQ ID NOs: 107, 108, and 109, respectively” (lines 2-9).
Claim 54 recites multiple sets of HCDRs and LCDRs, leading to 9 unique combinations of 6 CDRs.
Claim 56 is drawn to the protein wherein “the VH comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 704, 708, 711, and 715; and the VL comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 591, 705, 712, and 716” (lines 2-5). Claim 56 recites multiple VHs and VLs, leading to 16 unique combinations of 1 VH and 1 VL.
Claim 97 is drawn to the protein “wherein the protein comprises an antibody Fc domain or a portion thereof that binds CD16” (lines 1-2). It is unclear what portion (e.g. a fragment of the Fc domain) retains the ability to bind CD16.
Claim 104 is drawn to the protein “wherein the antibody Fc domain or the portion thereof comprises an amino acid sequence at least 90% identical to SEQ ID NO: 531” (lines 1-2). In addition, the use of “an amino acid sequence” (line 2) includes fragments of SEQ ID NO: 531. Claims 105-107 are drawn to polypeptide chains of the Fc domain comprising “one or more mutations, relative to SEQ ID NO: 531” (claim 105, line 2). These recitations include a large number of variations to SEQ ID NO: 531 for the Fc domain, in either one or both polypeptide chains comprising said Fc domain, and fragments thereof.
Thus, as instantly claimed, the claims read on a genus of variants of proteins comprising the antigen-binding site that binds CEACAM5 wherein (i) the antigen-binding site can comprise numerous CDR and VH/VL combinations (claims 53-54 and 56), (ii) Fc domain that binds CD16 can comprise fragments (claim 97), nor (iii) SEQ ID NO: 531 or fragments thereof can have up to 10% variation or include all recited mutations (claims 104-107).
Table 15 of the instant specification delineates the 6 CDRs, VH, and VL for the protein comprising the antigen-bind site that binds CEACAM5 as:
SEQ ID NOs: 102, 104, and 105 for HCDRs 1-3, SEQ ID NOs: 107-109 for LCDRs 1-3, and SEQ ID NOs: 704 and 705 for VH and VL respectively (¶ 0397, Table 15, antibody named AB0264);
SEQ ID NOs: 102, 104, and 105 for HCDRs 1-3, SEQ ID NOs: 107-109 for LCDRs 1-3, and SEQ ID NOs: 715 and 716 for VH and VL respectively (¶ 0397, Table 15, antibody named AB0621);
SEQ ID NOs: 3, 37, and 38 for HCDRs 1-3, SEQ ID NOs: 40-41 for LCDRs 1-3, and SEQ ID NOs: 708 and 591 for VH and VL respectively (¶ 0397, Table 15, antibody named AB0411); and
SEQ ID NOs: 3, 718, and 6 for HCDRs 1-3, SEQ ID NOs: 7, 8, and 27 for LCDRs 1-3, and SEQ ID NOs: 711 and 712 for VH and VL respectively (¶ 0397, Table 15, antibody named AB0466).
It is noted that SEQ ID NO: 27 is interchangeable with SEQ ID NO: 9 (¶ 0198, Table 2, shows SEQ ID NOs: 7-9 instead of SEQ ID NOs: 7, 8, and 27 for LCDRs 1-3 of an exemplary antigen-binding site that binds CEACAM5). SEQ ID NOs: 9 and 27 differ by one amino acid at position 5 (SEQ ID NO: 9 is QQYNSYSYT and SEQ ID NO: 27 is QQYNAYSYT).
Therefore, the instant specification, with respect to the instant claims, teaches the protein wherein the CDRH1, CDRH2, CDRH3, CDRL1, CDRL2, and CDRL3 are (i) SEQ ID NOs: 3, 37, 38, 40, 41, and 42, respectively; (ii) SEQ ID NOs: 3, 718, 6, 7, 8, and 9, respectively; or (iii) SEQ ID NOs: 102, 104, 105, 107, 108, and 109, respectively (applicable to claims 53-54). In addition, the instant specification, with respect to the instant claims, teaches the protein wherein the VH and VL are: (i) SEQ ID NOs: 704 and 705, respectively; (ii) SEQ ID NOs: 708 and 591, respectively; (iii) SEQ ID NOs: 711 and 712, respectively; or (iv) SEQ ID NOs: 715 and 716, respectively (applicable to claim 56). The instant specification does not suggest or disclose that all CDR, VH, and VL combinations as recited in claims 53-54 and 56 would retain binding to CEACAM5.
The instant specification states “[t]he term ‘Fc domain’ or ‘Fc region’ as used herein refers to a C-terminal region of an immunoglobulin heavy chain derived from the second and third constant domains. The term includes native sequence Fc regions and variant Fc regions.” (¶ 0131, emphasis added). The instant specification also states: “[i]n each exemplary TriNKET [a multispecific antibody containing a CEACAM5-binding site and CD16-binding site], the Fc domain linked to an scFv comprises the mutations of Q347R, D399V, and F405T, and the Fc domain linked to a Fab comprises matching mutations K360E and K409W for forming a heterodimer. The Fc domain linked to the scFv further includes an S354C substitution in the CH3 domain, which forms a disulfide bond with a Y349C substitution on the Fc linked to the Fab” (¶ 0260); these mutations are relative to SEQ ID NO: 531.
Therefore, the instant specification tested proteins comprising the antigen-binding site that binds CEACAM5 with Fc domain mutations Q347R, D399V, F405T, K360E, K409W, S354C, and Y349C relative to SEQ ID NO: 531 (applicable to claims 97 and 104-107). These mutations represent ~3% variation in SEQ ID NO: 531. The instant specification does not suggest or disclose (i) fragments of the Fc domain that binds CD16 (claim 97), (ii) up to 10% variation of SEQ ID NO: 531, or fragments thereof (claim 104), nor (iii) including all recited mutations of SEQ ID NO: 531 (claims 105-107) retain Fc domain function (i.e. ability to bind CD16).
The instant specification contemplates proteins comprising the antigen-binding site that binds CEACAM5 wherein ((i) the antigen-binding site can comprise numerous CDR and VH/VL combinations (claims 53-54 and 56), (ii) Fc domain that binds CD16 can comprise fragments (claim 97), and (iii) SEQ ID NO: 531 or fragments thereof can have up to 10% variation or include all recited mutations (claims 104-107). However, the instant specification does not teach that these combinations, variations, and/or fragments are tested and retain their correlated functions. There is insufficient evidence of possession of invention regarding structure of the protein with (i) all possible CDR and VH/VL combinations and (ii) up to 10% variation, numerous mutations, or fragments of SEQ ID NO: 531 of the Fc domain as claimed.
Regarding claims 53-54 and 56, the antigen-binding site can comprise numerous CDR and VH/VL combinations. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al. (Proc. Natl. Acad. Sci. USA, 79(6):1979-1983, March 1982). Rudikoff et al. teach that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function. Colman (Research in Immunology, 145:33-36, 1994) teaches that even a very conservative substitution within the interface of the antigen-binding region of the antibody, i.e. anywhere in the VH and VL, may abolish binding or may have very little effect on the binding affinity (Pg. 35, top of left column; Pg. 33, right column). These teachings indicate amino acid substitutions within CDRs alone can completely change the antigen recognition of the antibody; this problem would be further exacerbated when replacing entire CDRs.
Regarding claims 97 and 104-107, the protein can comprise (i) fragments of the Fc domain that binds CD16 (claim 97), (ii) up to 10% variation of SEQ ID NO: 531, or fragments thereof (claim 104), and (iii) all recited mutations of SEQ ID NO: 531 (claims 105-107). Vafa et al. (An engineered Fc variant of an IgG eliminates all immune effector functions via structural perturbations, Methods, Volume 65, Issue 1, 2014, Pages 114-126) state teach a single amino acid substitution to an Fc domain can cause repositioning of key residues responsible for interacting with FcγRs, resulting in loss of function (Pg. 124, column 1, entire ¶ 2). This teaching indicates amino acid substitutions within Fc domains can inhibit their interactions with their receptors and lead to loss of function; removing key residues responsible for Fc-receptor interactions would also have disastrous effects.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common the genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.” The Federal Circuit has recently clarified that a DNA molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristic, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613”.
The court has since clarified that this standard applies to compounds other than cDNAs. See University of Rochester v. G.D. Searle & Co., Inc., F.3d,2004 WL 260813, at *9 (Fed.Cir.Feb. 13, 2004). The instant specification fails to provide sufficient descriptive information in the broadly claimed variants of the protein comprising the antigen-binding site that binds CEACAM5. The specification does not provide specific or detailed structural characteristics of the variants wherein (i) the antigen-binding site can comprise numerous CDR and VH/VL combinations (claims 53-54 and 56), (ii) Fc domain that binds CD16 can comprise fragments (claim 97), nor (iii) SEQ ID NO: 531 or fragments thereof can have up to 10% variation or include all recited mutations (claims 104-107) and the functions of said variants are retained. Thus, one of skill in the art would reasonably conclude that the inventor(s), at the time the application was filed, did not have possession of the claimed invention.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided: The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the 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.
As stated in the Written Description Guideline (2008), the levels of the skill and knowledge in the art would not be able to identify without further testing which of these variants could perform the same function (i.e. binding to CEACAM5 and CD16) as the sequences for the protein as recited in claims 53-54, 56, 97, and 104-107. Based on the lack of knowledge and predictability in the art those of ordinary skill in the art would not conclude that the applicant was in possession of the claimed genus of protein variants having the functions listed in the claims based on the limited examples given in the instant specification.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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). As discussed above, the skilled artisan cannot envision the detailed chemical structure(s) and functional attribute(s) of the encompassed genus of variants of the protein as claimed, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, only the proteins comprising the antigen-binding site that binds CEACAM5 with the following, but not the full breadth of the claims, meets the written description provision of 35 U.S.C. §112, first paragraph:
the CDRH1, CDRH2, CDRH3, CDRL1, CDRL2, and CDRL3 are (i) SEQ ID NOs: 3, 37, 38, 40, 41, and 42, respectively; (ii) SEQ ID NOs: 3, 718, 6, 7, 8, and 9, respectively; or (iii) SEQ ID NOs: 102, 104, 105, 107, 108, and 109, respectively (applicable to claims 53-54);
the VH and VL are: (i) SEQ ID NOs: 704 and 705, respectively; (ii) SEQ ID NOs: 708 and 591, respectively; (iii) SEQ ID NOs: 711 and 712, respectively; or (iv) SEQ ID NOs: 715 and 716, respectively (applicable to claim 56); and
Fc domain has mutations Q347R, D399V, F405T, K360E, K409W, S354C, and Y349C relative to the full-length amino acid sequence of SEQ ID NO: 531 (applicable to claims 97 and 104-107).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
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 USPQ2datl966.
The specification does not reasonably convey possession of the subject matter of claims 53-54, 56, 97, and 104-107. Claim 53-54, 56, 97, and 104-107 fails to comply with the written description requirement of 35 U.S.C. 112(a) as a person having ordinary skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed. Claims 94, 96, 99-103, and 108-116 are included in this rejection as they incorporate and/or depend on claims 53-54, 56, 97, and/or 104-107.
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 97 and 103-109 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.
Regarding claim 104, the phrase "an amino acid sequence at least 90% identical to SEQ ID NO: 531" renders the claims indefinite because it is unclear the exact identity of the protein as this recitation includes a large number of fragments. Claims 107-109 are included in this rejection as they incorporate and/or depend on claim 104.
For the purposes of claim interpretation, the phrase "an amino acid sequence at least 90% identical to SEQ ID NO: 531" will not include fragments.
Regarding claim 97, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 103-109 are included in this rejection as they incorporate and/or depend on claim 97.
For the purposes of claim interpretation, limitations following the phrase "optionally" will not hold patentable weight.
Art-Free Subject Matter
All species were searched, not just the elected species (see Election/Restriction section for more information), as the elected species did not have prior art. The closest prior art to 53-57 and 92-116 is US 20150125386 A1 (referred to as US ‘386; filed 2014-10-16, published 2015-05-07).
Regarding instant claim 53, US ‘386 teaches an “anti-CEA antibody” (Abstract) wherein CEA refers to CEACAM5 (¶ 0003, “CEACAM5 [carcinoembryonic antigen, ‘CEA’]”). This teaching reads on a protein comprising an antigen-binding site that binds CEACAM5 (instant claim 53).
Regarding instant claim 94, US ‘386 further teaches “antibody, as used herein, refers to… an antibody fragment” (¶ 0042) such as an “scFv” (¶ 0043). This teaching reads on the antigen-binding site that binds CEACAM5 is an scFv (instant claim 94).
Regarding instant claim 97, US ‘386 further teaches the anti-CEA antibody can be multispecific and “comprise a second antibody or fragment thereof… [such as] CD16” (¶ 0025). This teaching reads on the protein comprising a portion that binds CD16 (instant claim 97).
Regarding instant claim 103, US ‘386 further teaches anti-CEA “antibodies include but are not limited to IgG1” (¶ 0042) and includes “the Fc portions of antibodies” (¶ 0073) that are human (¶ 0046, anti-CEA can be a “human antibody”). This teaching reads on the protein comprising an Fc domain that is a human IgG1 antibody Fc domain (instant claim 103).
Regarding instant claim 110, US ‘386 further teaches “fragments may be constructed in different ways to yield multivalent and/or multispecific binding forms” (¶ 0043). This teaching reads on a protein comprising a second antigen-binding site that binds CEACAM5 (instant claim 110).
Regarding instant claims 111-113, US ‘386 further teaches “antigen binding proteins (scFv) are prepared by constructing a structural gene comprising DNA sequences encoding the VH and VL domains… the structural gene is inserted into an expression vector that is subsequently introduced into a host cell,” (¶ 0070). As VH and VL comprising 6 CDRs, this teaching reads on an isolated nucleic acid (i.e. DNA) encoding the protein (instant claim 111), a vector comprising the nucleic acid (instant claim 112), and a host cell comprising the vector (instant claim 113).
Regarding instant claim 115, US ‘386 further teaches “[m]ethods for producing scFvs are well-known in the art” (¶ 0070). This teaching reads on a method of producing the protein (instant claim 115).
Regarding instant claim 116, US ‘386 further teaches “antibodies or conjugates thereof can be formulated according to known methods to prepare pharmaceutically useful compositions” (¶ 0154). This teaching reads on a pharmaceutical composition comprising the protein (instant claim 116).
US ‘386 does not teach the SEQ ID NOs for the protein comprising the antigen-binding site that bind CEACAM5 nor the structural arrangement of the protein.
In summary, US ‘386 teaches parts of instant claims 53, 94, 97, 103, 110-113, and 115-116 as described above. However, US ‘386 does not teach the SEQ ID NOs for the SEQ ID NOs for the protein comprising the antigen-binding site that bind CEACAM5 nor the structural arrangement of the protein.
It is noted that instant SEQ ID NOs of instant claims 53-57, 92-93, 95, and 109 were thoroughly searched corresponding to the limitations of the claims and are free of prior art. All claims incorporate the SEQ ID NOs of instant claim 53.
Therefore, instant claims 53-57 and 92-116 are not anticipated by the prior are because the prior art fails to disclose each and every element of the claimed invention. In addition, instant claims 53-57 and 92-116 cannot be rendered obvious. While US ‘386 teaches a multivalent and bispecific anti-CEACAM5/anti-CD16 antibody, the prior art does not provide a teaching, suggestion, or motivation to modify the sequences of said antibody to arrive at the claimed invention.
Allowable Subject Matter
Claims 55, 57, 92-93, 95, and 98 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 53-57 and 92-116 are pending. Claims 53-54, 56, 94, 96-97, and 99-116 are rejected. Claims 55, 57, 92-93, 95, and 98 are objected to. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Priest whose telephone number is (571)272-8469. The examiner can normally be reached Mon-Fri 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.P./Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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