DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2 Applicant's amendment, filed on 01/30/2026, is acknowledged.
3. Claims 1-11 and 14-20 are pending.
4. Applicant’s election with traverse of Group I, claims 1-7, 14 and 16 (now claims 1-7, 14, 16 and 18-20) directed to an anti-ANGPTL3 antibody or an antigen-binding fragment thereof, filed on 01/30/2026, is acknowledged. 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 § 818.03(a)).
5. Claims 8-11, 15 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
6. Claims 1-7, 14, 16 and 18-20 are under examination as they read on an anti-ANGPTL3 antibody or an antigen-binding fragment thereof.
7. Applicant’s IDS, filed 05/29/2023, is acknowledged.
8. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
9. Claims 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a pharmaceutical composition comprising the anti-ANGPTL3 antibody, 5E5F6, for the treatment of proteinuria, hypoalbuminemia or hypercholesterolemia, does not reasonably provide enablement for the pharmaceutical composition recited in claims 18-20. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The intended use of the claimed antibody for treatment of a broad genus of diseases mediated by the FLD of ANGPTL3 and/or integrin αvβ3 including diseases related to podocyte damages.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The issue whether claimed composition would function as pharmaceutical composition for a broad genus of diseases mediated by the FLD of ANGPTL3 and/or integrin αvβ3 including diseases related to podocyte damages. The claims encompass diseases that are mediated by integrin αvβ3 such as angiogenesis, tissue remodeling and fibrosis and diabetes which do not involve FLD-ANGPTL3. Further, besides proteinuria, hypoalbuminemia and hypercholesterolemia the specification fails to discloses diseases mediated by FLD of ANGPTL2. In view of the absence of a specific and detailed description in Applicant’s specification of how to effectively use the pharmaceutical composition as claimed, and absence of working examples providing evidence which is reasonably predictive that the claimed pharmaceutical composition are effective for in vivo use of the broad genus of diseases, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed pharmaceutical composition with a reasonable expectation of success.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
10. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
11. Claims 1-6 14, and 18-20 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by CN 110938144 (IDS).
The `144 publication teaches anti-ANGPTL3 monoclonal antibody, 5E5F6, comprising published heavy chain SEQ ID NO: 1 comprising the CDRs of claimed SEQ ID NOS: 1-3 and light chain comprising published SEQ ID NO: 2 comprising the CDRs of claimed SEQ ID NOs: 4-6 (see published claim 1). The `144 publication teaches anti-ANGPTL3 monoclonal antibody is useful for preparing medicaments capable of treating nephrotic syndrome (see published claim 3). The anti-ANGPTL3 monoclonal antibody of the invention can be used for detecting the ANGPTL3 protein. The `144 teaches that the diluting 5E5F6 with buffer (i.e., composition with carrier) (see section 2 under Affinity detection). Also, the `144 publication teaches anti-ANGPTL3 monoclonal antibody group (100ng/ml): 100ng/ml anti-ANGPTL3 monoclonal antibody pre-intervention for 1 hour, followed by 50ug/ml PAN intervention for 48 hours (see Experimental method).
The `144 publication teaches that the monoclonal antibody against FLD of ANGPTL3, which can specifically recognize ANGPTL3, block the functional domain FLD of ANGPTL3, and antagonize the damage of ANGPTL3 to podocytes, thereby achieving the effect of protecting podocytes. The invention can be applied to detect ANGPTL3, and is expected to be used for the treatment of proteinuria in nephrotic syndrome (see Summary of the invention and Validation of monoclonal antibodies).
Alignment of published SEQ ID NO: 1 with claimed SEQ ID NOS: 1-3, 7-10, 15 and 17.
Qy 1 MAVLALLLCLVTFPSCVLSQVQLKESGPGLVAPSQSLSITCTVSGFSLTTYGVSWVRQPP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAVLALLLCLVTFPSCVLSQVQLKESGPGLVAPSQSLSITCTVSGFSLTTYGVSWVRQPP 60
Qy 61 GKGLEWLGVIWGDGNTNYHSALISRLSISKDNSKSQVFLKLNSLQTDDTATYYCAKGGPY 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GKGLEWLGVIWGDGNTNYHSALISRLSISKDNSKSQVFLKLNSLQTDDTATYYCAKGGPY 120
Qy 121 GNYVPFDYWGQGTTLTVSSAKTTPPSVYPLAPGSAAQTNSMVTLGCLVKGYFPEPVTVTW 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GNYVPFDYWGQGTTLTVSSAKTTPPSVYPLAPGSAAQTNSMVTLGCLVKGYFPEPVTVTW 180
Qy 181 NSGSLSSGVHTFPAVLQSDLYTLSSSVTVPSSTWPSETVTCNVAHPASSTKVDKKIVPRD 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 NSGSLSSGVHTFPAVLQSDLYTLSSSVTVPSSTWPSETVTCNVAHPASSTKVDKKIVPRD 240
Qy 241 CGCKPCICTVPEVSSVFIFPPKPKDVLTITLTPKVTCVVVDISKDDPEVQFSWFVDDVEV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 CGCKPCICTVPEVSSVFIFPPKPKDVLTITLTPKVTCVVVDISKDDPEVQFSWFVDDVEV 300
Qy 301 HTAQTQPREEQFNSTFRSVSELPIMHQDWLNGKEFKCRVNSAAFPAPIEKTISKTKGRPK 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 HTAQTQPREEQFNSTFRSVSELPIMHQDWLNGKEFKCRVNSAAFPAPIEKTISKTKGRPK 360
Qy 361 APQVYTIPPPKEQMAKDKVSLTCMITDFFPEDITVEWQWNGQPAENYKNTQPIMDTDGSY 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 APQVYTIPPPKEQMAKDKVSLTCMITDFFPEDITVEWQWNGQPAENYKNTQPIMDTDGSY 420
Qy 421 FVYSKLNVQKSNWEAGNTFTCSVLHEGLHNHHTEKSLSHSPGK 463
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Db 421 FVYSKLNVQKSNWEAGNTFTCSVLHEGLHNHHTEKSLSHSPGK 463
Alignment of published SEQ ID NO: 2 with claimed SEQ ID NOS: 4-6, 11-14 and 16 and 18.
Qy 1 METDTLLLWVLLLWVPGSTGDIVLTQSPASLAVSLGQRATISCRASESVDSYGNSFMHWY 60
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Db 1 METDTLLLWVLLLWVPGSTGDIVLTQSPASLAVSLGQRATISCRASESVDSYGNSFMHWY 60
Qy 61 QQKPGQPPKLLIYRASNLESGIPARFSGSGSRTDFTLTINPVEADDVATYYCQQSDEEPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 QQKPGQPPKLLIYRASNLESGIPARFSGSGSRTDFTLTINPVEADDVATYYCQQSDEEPP 120
Qy 121 TFGGGTNLEIKRADAAPTVSIFPPSSEQLTSGGASVVCFLNNFYPKDINVKWKIDGSERQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TFGGGTNLEIKRADAAPTVSIFPPSSEQLTSGGASVVCFLNNFYPKDINVKWKIDGSERQ 180
Qy 181 NGVLNSWTDQDSKDSTYSMSSTLTLTKDEYERHNSYTCEATHKTSTSPIVKSFNRNEC 238
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 NGVLNSWTDQDSKDSTYSMSSTLTLTKDEYERHNSYTCEATHKTSTSPIVKSFNRNEC 238
The reference teachings anticipate the claimed invention.
12. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
13. Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over CN 110938144 in view of Bird et al (1988).
The teachings of CN 110938144 reference have been discussed, supra.
The claimed invention differs from the reference teaching only by the recitation of a single chain antibody in claim7.
Bird et al teach a single chain antigen binding proteins composed of an antibody variable light –chain amino acid sequence (VL) tethered to a variable heavy –chain sequence (VH) by a designed peptide that links the carboxyle terminus of the VL sequence to the amino terminus of the VH sequence. Bird et al further teach that the single chain antibodies have significant advantages over monoclonal antibodies in a number of applications such as lower back ground in imaging applications since the single chain antibody lack the Fc portion (see the entire document and page 426, left column, 2nd paragraph in particular)).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to produce the monoclonal antibody taught by CN 110938144 as a single chain antibody as taught by the Bird et al.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because single chain antibodies have significant advantages over monoclonal antibodies in a number of applications such as lower back ground in imaging applications since the single chain antibody lack the Fc portion as taught by Bird et al.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expection of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
14. Claims 1 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over CN 110938144 in view of Zuk et al (U.S. Patent No. 4,281,061 issued July 28, 1981).
The teachings of CN 110938144 reference have been discussed, supra.
Zuk et al. teach that reagents for an immunoassay can be provided as kits as a matter of convenience and to optimize the sensitivity of the assay in the range of interest (col 22, line 62 - col 23, line 4).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to include the necessary reagents to perform the immunodiagnostic assay in a kit format for the convenience and economy of the user. One would have been motivated to assemble the reagents in a kit format to standardize the reagents for the optimization the assay for use in a clinical diagnostic laboratory or physician's office.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
15. No claim is allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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February 20, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644