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 with traverse of group II (claims 8-13) with species breast cancer in the reply filed on 8/14/2025 is acknowledged. The traversal is on the ground(s) that the reference by Ames used for lack of unity disclosed CA IX facilitating cancer growth and an antibody M75 to CA IX that binds to different epitope and Ames teaches that facilitation of tumor growth is different from treatment of a cancer. This is not persuasive. Ames teaches neutralizing M75 antibody binding to the same PG domain of the antigen CA IX as instantly claimed antibody, which could perform the same effect to neutralize/inhibit the activity of CA IX, which would result in the same therapeutic effect. For the reason the requirement is still deemed proper and is therefore made FINAL.
Claim 7 has been cancelled, claims 17-21 have been added, and claims 1-6 and 8-21 are currently pending.
Claims 1-6 and 14-16, withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 8-13 and 17-21, drawn to a method of treating a condition (elect breast cancer) comprising administering an antibody or variant with amino acid alternations binding to CA IX, are examined on merits.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 5/3/2022 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
Claim Objection(s)
1. Claim 10 is objected to for depending on the non-elected claim 1 reciting different subject matter (antibody). The objection can be obviated by rewritten the claim in a right dependent form.
2. Newly added claims 17-18 recite sequences for VH and VL that contain CDR sequences that are underlined. The underline in claims is an indication of amendment added to the claims. Correction is required. Using other way to emphasize the CDRs in VH and VL in the claims would be appreciated.
Claim Rejections - 35 USC § 112
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.
Written Description: all CDR sequences differing in 1 or 2 amino acids
Claims 8-13 and 21 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown. For claimed product the specification must provide sufficient distinguishing identifying characteristics of the genus, including disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, level of skill and knowledge in the art, and predictability in the art or any combination thereof.
The claims are broadly drawn to
A method of treating a condition comprising proliferation disease, cancers etc. comprising administering therapeutically effective amount of a humanized antibody specifically recognizing the proteoglycan domain of
human CA IX containing
a heavy chain variable region sequence comprising CDR sequences identical to or differing in 1 or 2 amino acids from the sequences GFTFNTNAMH (SEQ ID NO.1), and RIRSKSNNYTTYYADSVKD (SEQ ID NO. 2), and VCGSWFAY (SEQ ID NO. 3): and
a light chain variable region sequence comprising the CDR sequences identical to or differing in 1 or 2 amino acids from the following sequences: KSSQSLLNSSNQKNYLA (SEQ ID NO. 4), and FTSTRQS (SEQ ID NO. 5), and QQHYSIPLT (SEQ ID NO. 6),…..
Thus, the claimed method of using variant of antibodies with 1-2 amino acid alternations in each of the six SEQ ID NOs: 1-6 of 6 CDRs without further defining the sequences of CDRs or VH and VL domain.
Claim 10 is included in this rejection because it is interpreted as depending on claim 8.
The specification teaches that humanized antibodies from murine monoclonal antibody IV/18 (IgG2a) binding to the proteoglycan (PD-G)-like domain of CA IX are generated in CA-IX deficient mice (page 21, line 26+), wherein the VHCDR1-3 comprise the sequences of SEQ ID NOs: 1-3 and VLCDRs comprise the sequences of SEQ ID NOs:4-6. The specification teaches that the claimed humanized antibodies have the same CDRs as the murine antibody with framework changed to human’s and listed numbers sequences for humanized VH domains, SEQ ID NOs: 9-13, and VL domains, SEQ ID NOs: 14-18, as recited in claims 17-18.
However, the specification does not teach any variant(s) having amino acid alternations in any of the CDR regions and do not teach which or where the amino acid substitutions occurred, which could perform the same function or affinity for the antigen CA IX domain binding as the parental antibody.
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 antibody with the amino acid alternations in CDRs. The specification does not provide a specific or detail structural characteristics of the variants with amino acid substitutions in the sequence of the antibodies. 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 variant antibodies could perform the same function as parental antibody. Based on 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 variants having the functions listed in the claims based on the teaching of the murine monoclonal antibody having the VHCDR comprising the sequences of SEQ ID NOs: 1-3 and VLCDRs comprising the sequences of SEQ ID NOs:4-6.
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 variants of antibodies 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 antibodies comprising the VHCDRs having the sequences of SEQ ID NOs: 1-3 and VLCDRs having the sequence of SEQ ID NOs: 4-6, but not the full breadth of the claims, meets the written description provision of 35 U.S.C. §112, first paragraph. 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).
Applicant may also refer to Written Description Guideline at USPTO website:
http://www.uspto.gov/web/patents/guides.htm
Example 9 and 10 in particular.
Scope of enablement:
Claims 8-13 and 17-21 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating a proliferative condition comprising a cancer associated with abnormally expressed CA IX comprising administering the antibody or antigen binding fragment comprising VHCDR1-3 having the sequences of SEQ ID NOs: 1, 2, and 3 and VLCDR1-3 having the sequences of SEQ ID Nos 4, 5, and 6, does not reasonably provide enablement for claimed method of treating any conditions comprising cancers without indicating status of CA IX on the cancer cells with the antibody variants with amino acid alternations in CDRs. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to us the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the nature of the invention, (2) the relative skill of those in the art, (3) the breadth of the claims, (4) the amount or direction or guidance presented, (5) the presence or absence of working examples, (6) the quantity of experimentation necessary, (7) the state of the prior art, and (8) the predictability or unpredictability of the art.
Although the quantity of experimentation alone is not dispositive in a determination of whether the required experimentation is undue, this factor does play a central role. For example, a very limited quantity of experimentation may be undue in a fledgling art that is unpredictable where no guidance or working examples are provided in the specification and prior art, whereas the same amount of experimentation may not be undue when viewed in light of some guidance or a working example or the experimentation required is in a predictable established art. Conversely, a large quantity of experimentation would require a correspondingly greater quantum of guidance, predictability and skill in the art to overcome classification as undue experimentation. In Wands, the determination that undue experimentation was not required to make the claimed invention was based primarily on the nature of the art, and the probability that the required experimentation would result in successfully obtaining the claimed invention. (Wands, 8 USPQ2d 1406). Thus, a combination of factors which, when viewed together, would provide an artisan of ordinary skill in the art with an expectation of successfully obtaining the claimed invention with additional experimentation would preclude the classification of that experimentation as undue. A combination of Wands factors, which provide a very low likelihood of successfully obtaining the claimed invention with additional experimentation, however, would render the additional experimentation undue.
The nature of the invention
A method of treating a condition comprising proliferation disease, cancers etc. comprising administering therapeutically effective amount of a humanized antibody specifically recognizing the proteoglycan domain of
human CA IX containing
a heavy chain variable region sequence comprising CDR sequences identical to or differing in 1 or 2 amino acids from the sequences GFTFNTNAMH (SEQ ID NO.1), and RIRSKSNNYTTYYADSVKD (SEQ ID NO. 2), and VCGSWFAY (SEQ ID NO. 3): and
a light chain variable region sequence comprising the CDR sequences identical to or differing in 1 or 2 amino acids from the following sequences: KSSQSLLNSSNQKNYLA (SEQ ID NO. 4), and FTSTRQS (SEQ ID NO. 5), and QQHYSIPLT (SEQ ID NO. 6),…..
The invention is in a class of invention which the CAFC has characterized as ''the unpredictable arts such as chemistry and biology.'' Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
Level of skill in the art
The level of skill in the art is deemed to be high, generally that of a PhD or MD.
The breadth of the claims
For all the claims, Applicant broadly claims a method of treating any conditions comprising proliferative diseases and cancers with antibody having the VHCDR comprising the sequences of SEQ ID NOs: 1-3 and VLCDRs comprising the sequences of SEQ ID NOs: 4-6 OR variants of the antibody with amino acid alternations in CDRs.
Guidance in the specification and Working Examples
The specification teaches that humanized antibodies from murine monoclonal antibody IV/18 (IgG2a) binding to the proteoglycan (PD-G)-like domain of CA IX are generated in CA-IX deficient mice (page 21, line 26+), wherein the VHCDR1-3 comprise the sequences of SEQ ID NOs: 1-3 and VLCDRs comprise the sequences of SEQ ID NOs:4-6. The specification teaches that the antibodies have the same CDRs as the murine antibody with framework changed to human’s and listed numbers sequences for humanized VH domains, SEQ ID NOs: 9-13, and VL domains, SEQ ID NOs: 14-18, as recited in claims 17-18.
In the application, applicant does not provide any antibody that could be used for treating any condition without having detectable CA IX protein expression and not teach using any antibody variants for the claimed method.
Quantity of experimentation
The quantity of experimentation in the areas of cancer therapy is extremely large given the unpredictability associated with the treatment of any diseases/conditions with antibody binding to one protein and the lack of correlation found for predicting the treatment without detectable the expression of antigen based on levels of antibody or antibody variants binding to it.
The unpredictability of the art and the state of the prior art
Those of skill in the art recognize that what may be "preferable" in the lab is only suggestive and does not qualify as a reasonable expectation of success, especially in a highly unpredictable art such as inhibition of CA IX activity for treating any conditions including proliferative diseases. For example, Zatovicova et al teach a method of using an antibody binding to proteoglycan (PG)-like domain of CA-IX protein to inhibit the activity of protein. Zatovicova et al first test and compare binding ability to the cell expressing CA-IX protein among numbers of antibodies and state that the future experiment to examine biological activity of the antibodies will be required to show any significance for antibody-mediated anti-cancer therapy in order to development and improve clinically relevant detection of CA IX in biological materials (entire document, page 131-132 in particular).
Yamaguchi et al teach a method of anti-tumor efficacy of an antibody by inhibition of CA IX activity with the antibody. The reference indicates that many anti-CAIX antibodies have been reported but few have been shown to possess inhibition activity. Yamaguchi et al have shown one antibody having effect on CA IX expressing cell in vitro and in vivo effect of CA IX inhibition in xenograft tumor growth (page 2000-2002 and figure 2).
As such, the references clearly suggest that only CA-IX expressed proliferative cell can be treated with some, but not all the antibodies binding to CA-IX. Thus, one skilled in the art would understand that the antibodies inhibiting CA IX can be only used for treating CA IX associated condition, but not all the condition that is not related to CA IX activity.
Conclusion
Thus, given the claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the lack of guidance provided in the specification and the negative teachings in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue quantities of experimentations for one of skill in the art to perform the method of the claim as written.
Claim Rejections - 35 USC § 103
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim 8-13 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi et al (Anticancer Res 35:1997-2004, 2015) in view of Pastorek et al (WO03/10029 published Dec 2003, IDS) evidenced by sequence alignment.
The specification teaches that disclosed humanized antibody are derived from parental IV/18 mAb comprising VH and VL domains having the sequences of SEQ ID NOs: 19 and 25 respectively, which have the same full set of six CDRs as the instantly claimed humanized antibody (page 21-25).
Yamaguchi et al teach methods of inhibiting CA IX activity with antibody for anti-tumor effect. Specifically, Yamaguchi et al show that an antibody binding and effect on CA IX expressing cells in vitro and xenograft-bearing mice for tumor growth in vivo (page 2001-2, figure 2).
Yamaguchi et al do not teach the antibody comprising VHCDR1-3 and VLCDR1-3 set forth in claim 8.
Pastorek et al first teach a hybridoma cell producing mouse monoclonal antibody IV/18 that recognizes PG domain of CA IX protein expressed on human cells (HT-29 and Hela) and the CA IX protein extracted or shredded from human breast, colon, renal, bladder etc. cultured cells and/or cancer cells from patients, which are detected by numbers of immunoassays. The antibody could immune-precipitate the full-length CA IX protein as well (page 100, table 4, examples 3-8). Pastorek et al also teach correlation of the expression of CA IX with cancer status (example 11-12). Pastorek et al do not disclose the sequences of the IV/18 antibody from hybridoma, but suggest that the antibodies being humanized to reduce antigenicity are preferred in vivo use for therapeutic purpose and provide references for making humanized antibody (page 58, 74, 122+).
Thus, according to the instant specification as referred above, antibody IV/18 taught by Pastorek has the same VHCDR1-3 (SEQ ID NOs: 1, 2, and 3) and VLCDR1-3 (SEQ ID NOs 4, 5, and 6), which are also evidenced by the sequence alignment.
QY= fuse SEQ ID NOs 1-2-3 VH):
Sequence 19, US/17774111
Publication No. US20220396633A1
GENERAL INFORMATION
APPLICANT: MABPRO a.s.
TITLE OF INVENTION: HUMANIZED ANTI-CA IX ANTIBODIES AND METHODS OF THEIR USE
FILE REFERENCE: P1791PC01
CURRENT APPLICATION NUMBER: US/17/774,111
SEQ ID NO 19
LENGTH: 117
OTHER INFORMATION: murine IV/18, VH domain
ALIGNMENT:
Query Match 88.2%; Score 182.6; Length 117;
Best Local Similarity 45.7%;
Matches 37; Conservative 0; Mismatches 0; Indels 44; Gaps 2;
Qy 1 GFTFNTNAMH--------------RIRSKSNNYTTYYADSVKD----------------- 29
|||||||||| |||||||||||||||||||
Db 26 GFTFNTNAMHWVRQAPGKGLEWVARIRSKSNNYTTYYADSVKDRFTISRDDSQSMLYLQM 85
Qy 30 -------------VCGSWFAY 37
||||||||
Db 86 NNLKTEDTAMYYCVCGSWFAY 106
QY-fuse SEQ ID NOs: 4-5-6 (VL):
Sequence 25, US/17774111
Publication No. US20220396633A1
GENERAL INFORMATION
APPLICANT: MABPRO a.s.
TITLE OF INVENTION: HUMANIZED ANTI-CA IX ANTIBODIES AND METHODS OF THEIR USE
FILE REFERENCE: P1791PC01
CURRENT APPLICATION NUMBER: US/17/774,111
CURRENT FILING DATE: 2022-05-03
NUMBER OF SEQ ID NOS: 36
SEQ ID NO 25
LENGTH: 113
OTHER INFORMATION: murine IV/18, VL domain
Query Match 84.9%; Score 139.3; Length 113;
Best Local Similarity 41.2%;
Matches 33; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 KSSQSLLNSSNQKNYLA---------------FTSTRQS--------------------- 24
||||||||||||||||| |||||||
Db 24 KSSQSLLNSSNQKNYLAWFQQKPGQSPKLLVYFTSTRQSGVPDRFIGSGSGTDFTLTISS 83
Qy 25 -----------QQHYSIPLT 33
|||||||||
Db 84 VQAEDLADYFCQQHYSIPLT 103
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine teaching to derive the murine IV/18 antibody to a humanized form for the therapeutic purpose in human with expected result. One of ordinary skill in the art before the effective filing date of was made would have been motivated to combine the teachings of Yamaguchi et al with the teachings of Pastorek et al in order to benefit of treatment for CA IX expressing cancer by inhibiting the protein activity. One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success to do so because Yamaguchi et al have shown a method of using anti CA IX antibody for treating a cancer and Pastorek et al have shown an murine antibody IV/18 having advantages for recognizing the naturally expressed CA IX on or from tumor cells and suggest humanized the murine monoclonal antibody for therapeutic purpose. Therefore, the references in combination teach every limitation of the claims and the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention was made, absent unexpected results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13 (MPEP 9th Ed, Feb 2023).
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 8-13 and 17-21 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-6, 8-15 and 17-27 of copending Application No. 17/772980. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are directed to an antibody to recognize human CA IX and a method of treating a proliferative condition comprising a breast cancer comprising administering the same antibody.
The instant claims are drawn to
A method of treating a condition comprising proliferation disease, cancers etc. comprising administering therapeutically effective amount of a humanized antibody specifically recognizing the proteoglycan domain of
human CA IX containing
a heavy chain variable region sequence comprising CDR sequences identical to or differing in 1 or 2 amino acids from the sequences GFTFNTNAMH (SEQ ID NO.1), and RIRSKSNNYTTYYADSVKD (SEQ ID NO. 2), and VCGSWFAY (SEQ ID NO. 3): and
a light chain variable region sequence comprising the CDR sequences identical to or differing in 1 or 2 amino acids from the following sequences: KSSQSLLNSSNQKNYLA (SEQ ID NO. 4), and FTSTRQS (SEQ ID NO. 5), and QQHYSIPLT (SEQ ID NO. 6),…..
wherein the VH comprise the sequence of SEQ ID NO: 9, 10, 11, 12 or 13, and VL comprises sequence of SEQ ID NO: 14, 15, 16, 17 and 18.
The claims of application ‘980 are drawn to
A humanized antibody comprising one heavy chain variable region comprising
X32VQLVESGGGX33VQPGX34SLX35LSCAASGFTFNTNAMHWVRQAX36GX37GLEWV X38RIRSKSNNYTTYYADSVKDRFTISRDX39SKX40TX41YLQX42NSLX43X44EDTAVYYC VCGSWFAYWGQGTX45VTVSS (SEQ ID NO. 35), and
one light chain variable region comprising
DX46X47MTQSPDSLAVSLGERX48TINCKSSQSLLNSSNQKNYLAWX49QQKPGQX50PX5 1X52X53IYFTSTRQSGVPDRFX54GSGSGTDFTLTIX55SLQAEDVAVYX56CQQHYSIPLTF GQGTX57X58EIK (SEQ ID NO. 36)
wherein the VH comprise the sequence of SEQ ID NO: 20, 21, 22, 23, or 24, and
VL comprises sequence of SEQ ID NO: 28, 29, 30, 31 or 32.
A method of treating a condition comprising proliferative disease comprising a cancer comprising administering the step of administering the humanized antibody of the pharmaceutical composition.
Both sets of the claims encompass the same antibodies and same method of using the antibodies for treating a condition comprising a cancer, wherein the antibodies have the same sequences of VHCDRs and the same sequences of VLCDRs within the sequences of VH and VL as sequence alignment below (see details in supplemental contents viewer).
QY= fuse VHCDR1-3, SEQ ID NOs: 1-2-3, for heavy chain variable region:
PNG
media_image1.png
436
850
media_image1.png
Greyscale
QY= fuse VLCDR1-3, SEQ ID NOs: 4-5-6, for light chain variable region:
PNG
media_image2.png
352
928
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Both sets of claims encompass the same methods of treating the same cancers, e.g. breast cancer, with the same treatment schedules (1-10 administration cycles and 2-5 infusion/doses every 1-4 weeks…) and dose ranges (0.001-15 mg/kg body weight) of the humanized antibody to CA-IX. Thus, the claims of instant application and the claims of ‘980 application are anticipated and obvious over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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/LEI YAO/Primary Examiner, Art Unit 1642