Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
The preliminary claim amendments filed 07/06/2023 are acknowledged.
Claims 1-9, 12, and 15 are pending.
Claims 3-9 and 12 are amended.
Claims 10-11 and 13-14 are canceled.
Claim 15 is new.
Claims 1-9, 12, and 15 are under examination.
Priority
The instant application is a 371 of PCT/CN2022/070627 and claims priority to People’s Republic of China application CN202110025248.3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Therefore, priority is given with the earliest effective filing date of 01/08/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/06/2023, 10/31/2024, and 06/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code (see page 26, lines 19-20 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 4, 8, and 15 are objected to because of the following informalities: Claims 4, 8, and 16 include the limitation “preferably” and claim 15 also includes the limitation “more preferably.” MPEP 2173.05(d) states, “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim.” The “preferably” and “more preferably” should be removed entirely. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “An isolated anti-human 4-1BB antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof comprises three complementarity determining region LCDRs of the light chain variable region set forth in SEQ ID No. 7, and three complementarity determining region HCDRs of the heavy chain variable region set forth in SEQ ID No. 8.” The numbering scheme for the CDR regions is not explicitly disclosed.
It is well known to those skilled in the art that antibodies utilize various numbering schemes to facilitate comparison and analysis of their variable regions. The most commonly used schemes include Kabat, Chothia, and IMGT. These schemes differ in their approach to defining regions, particularly the hypervariable regions (CDRs) that are crucial for antigen binding. Specifically, these different CDR identification methods may often identify radically different stretches as CDRs, indicating that CDRs are not well defined [Sela-Culang et al., 2013 (instant PTO-892); see Conclusion]. For example, Sela-Culang shows in Table 3 below, a comparison of CDR regions using different numbering methods demonstrating the significant difference between the amino acid sequences depending on what numbering scheme is utilized.
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730
680
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Greyscale
The instant specification fails to clarify the issue, disclosing that CDRs may be numbered by IMGT or Kabat [see page 11, lines 12-13 of the instant specification]. The CDR herein includes overlaps and subsets of amino acid residues defined in different ways.
Therefore, without the amino acid sequences of each CDR region defined by SEQ ID NO or numbering scheme, one of ordinary skill in the art would not know the boundaries of the CDR regions set forth in the recited VL SEQ ID NO: 7 and VH SEQ ID NO: 8.
Claim 8 recites the limitation “wherein the antigen-binding fragment is one or more selected from the group consisting of F(ab')2, Fab', Fab, Fd, Fv, scFv, diabody, camelid antibody, CDR and antibody minimal recognition unit (dAb), preferably, the antigen-binding fragment is a Fab, F(ab')2 or scFv.” It is unclear how the antigen-binding fragment can be one or more of a F(ab')2, Fab', Fab, Fd, Fv, scFv, diabody, camelid antibody, or CDR and antibody minimal recognition unit (dAb). Further, it is unclear what is encompassed by a “CDR and antibody minimal recognition unit (dAb)”.The referenced “dAb” in parentheticals is understood in the art to be defined as a single-domain antibody and “a CDR and antibody minimal recognition unit” is not an art accepted term. Therefore, (1) it is unclear, due to the presence of the parentheses, if a “CDR and antibody minimal recognition unit” is the same as a “dAb” or not, and (2), if the terms are not the same, it is unclear what the structure of a “CDR and antibody minimal recognition unit” is because it is not defined in the specification and is not an art accepted term.
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-9, 12, and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 is drawn to an isolated anti-human 4-1BB antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof comprises a light chain variable region and/or a heavy chain variable region, wherein, the light chain variable region comprises a LCDR1 of the amino acid sequences set forth in SEQ ID No. 1, a LCDR2 of the amino acid sequences set forth in SEQ ID No. 2, and a LCDR3 of the amino acid sequences set forth in SEQ ID No. 3; and/or the heavy chain variable region comprises a HCDR1 of the amino acid sequences set forth in SEQ ID No. 4, a HCDR2 of the amino acid sequences set forth in SEQ ID No. 5, and a HCDR3 of the amino acid sequences set forth in SEQ ID No. 6.
The specification teaches sequences of the 3 CDRs for the light chain and the 3 CDRs for the heavy chain variable regions for the 4-1BB antibody named mAb-33-83, and further teaches the corresponding sequences for the whole light chain and heavy chain variable regions of the 4-1BB antibody [see Example 2 of the instant specification]. However, the specification does not teach a functional antibody containing only the light chain variable region or only the heavy chain variable region.
In this case, claim 2 is drawn to a variable number of CDRs, e.g. either the three CDRs of light chain variable region or the three CDRs of the heavy chain variable region. The art recognizes that a complete set of six CDRs comprise the binding region of an antibody (see Sela-Culang, et al., 2013; instant PTO-892), and that even a single amino acid change to these regions can completely abrogate the binding specificity of an antibody (see Kussie et al., 1994; instant PTO-892 and Chen et al., 1995; instant PTO-892). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. Therefore, has failed to meet the written description of antibodies that bind to 4-1BB and comprise less than the full set of six CDRs of SEQ ID NOs: 1-3 for the light chain variable region and SEQ ID NOs: 4-6 for the heavy chain variable region.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held
that:
...To fulfill the written description requirement, a patent specification must
describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
A "representative number of species" means that the species, which are adequately described, are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if
the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A
patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
Thus, based on the teachings of the instant specification and the art, Applicant has failed to meet the written description of antibodies that are able to bind to 4-1BB and comprise less than the full set of six CDRs of instant SEQ ID NOs: 1-3 for the light chain variable region and SEQ ID NOs: 4-6 for the heavy chain variable region. Therefore, one of skill in the art would not conclude that Applicant was in possession of the antibodies that are able to bind 4-1BB that comprise less than the full set of six CDRs.
Claims 3-9, 12, and 15, which depend from claim 2, are therefore deficient for the same reasons above and do not meet the written description requirement.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim is drawn to the anti-human 4-1BB antibody or antigen-binding fragment thereof according to claim 2, wherein the 4-1BB antibody or antigen-binding fragment thereof is a chimeric antibody, a humanized antibody, or a fully human antibody.
The claim encompasses human antibodies. However, the specification teaches that the antibody of the invention was produced in Balb/c mice that generated anti-human 4-1BB antibodies [see Example 1, page 29 of the instant specification].
There is no disclosure of a fully human antibody nor any expectation that a human antibody would comprise the same complementary determining regions (CDRs) as those disclosed in the instant application because the antibodies were made in mice. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian fibroblast growth factors (FGFs) were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. In the same manner, disclosure of a mouse antibody sequence provides no salient information regarding the sequences produced in a human.
Accordingly, as applicant does not appear to be in possession of a fully human antibody with the claimed sequences, the disclosure as a whole fails to adequately describe a human antibody. Thus, a claim to such an antibody fails to meet the written description requirements.
Enablement
Claim 15 is 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 method of treating 4-1BB mediated diseases or disorders does not reasonably provide enablement for preventing 4-1BB mediated diseases or disorders. 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.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and
Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v.
Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(1) The nature of the invention and (5) The breadth of the claims:
The claim is drawn to a method of preventing and/or treating 4-1BB-mediated diseases or disorders, including administering to a subject in need thereof the anti-human 4-1BB antibody or antigen-binding fragment thereof according to claim 2, preferably, the diseases or disorders are tumors; more preferably, the tumors are one or more selected from the group consisting of leukemia, lymphoma, myeloma, brain tumor, head and neck squamous cell carcinoma, non-small cell lung cancer, nasopharyngeal cancer, esophageal cancer, gastric cancer, pancreatic cancer, gallbladder cancer, liver cancer, colorectal cancer, breast cancer, ovarian cancer, cervical cancer, endometrial cancer, uterine sarcoma, prostate cancer, bladder cancer, renal cell carcinoma, and
melanoma.
The term "prevention" is generally understood in the art to encompass a total protection from disease or injury. Thus, given the high level of required effect, a high level of evidence showing prevention is also required. However, there are no working examples in the specification directed to the palliative, preventative, or curative treatment of any 4-1BB mediated disease or disorder, let alone the listed tumors and/or cancers encompassed by the instant claim. Applicant has provided evidence of anti-tumor activity of the claimed anti-human 4-1BB monoclonal antibody [see Example 6 of the instant specification]. However, Applicant provides no substantive evidence of preventing any 4-1BB mediated disease or disorder, or any of the listed tumors and/or cancers using the claimed anti-human 4-1BB monoclonal antibody. A demonstration of treatment does not provide support for prevention. Therefore, the instant specification does not provide evidence or substantial guidance commensurate in scope with the combination medicament and how to use the claimed anti-human 4-1BB monoclonal antibody to prevent any 4-1BB mediated disease or disorder, let alone the listed tumors and/or cancers in the instant claim.
In conclusion, the claimed invention does not provide enablement for preventing any 4-1BB mediated disease or disorder encompassed by the instant claim. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to use the claimed invention as the amount of experimentation required is undue, due the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claim and the specification is not fully enabled for the instant claim. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4, 6, 7-9, 12, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 11, and 15 of copending Application No. 18/260,435 (‘435; reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 2 of the instant application, claim 1 of ‘435 teaches a bispecific antibody comprising a first antigen-binding functional region that specifically binds to PD-L1 and a second antigen-binding functional region that specifically binds to 4-1BB, wherein the first antigen-binding functional region that specifically binds PD-L1 comprises: (A) a heavy chain variable region, comprising (a) HCDR1, which comprises the amino acid sequence set forth in SEQ ID NO: 15, (b) HCDR2, which comprises the amino acid sequence set forth in SEQ ID NO: 16, and (c) HCDR3, which comprises the amino acid sequence set forth in SEQ ID NO: 17; and (B) a light chain variable region, comprising (a) LCDR1, which comprises the amino acid sequence set forth in SEQ ID NO: 18, (b) LCDR2, which comprises the amino acid sequence set forth in SEQ ID NO: 19, and (c) LCDR3, which comprises the amino acid sequence set forth in SEQ ID NO: 20, and claims 2 and 3 of ‘435 teach wherein the second antigen-binding functional region that specifically binds to 4-1BB comprises (A) a heavy chain variable region, comprising (a) HCDR1, which comprises the amino acid sequence set forth in SEQ ID NO: 21, (b) HCDR2, which comprises the amino acid sequence set forth in SEQ ID NO: 22, and (c) HCDR3, which comprises the amino acid sequence set forth in SEQ ID NO: 23; and (B) a light chain variable region, comprising (a) LCDR1, which comprises the amino acid sequence set forth in SEQ ID NO: 24, (b) LCDR2, which comprises the amino acid sequence set forth in SEQ ID NO: 25, and (c) LCDR3, which comprises the amino acid sequence set forth in SEQ ID NO: 26.
SEQ ID NOs: 21-23 for the HCDRs 1-3 and SEQ ID NOs: 24-26 for the LCDRs 1-3 of ‘435 have 100% sequence identity to SEQ ID NOs: 4-6 for the HCDRs 1-3 and SEQ ID NOs: 1-3 for the LCDRs 1-3 of instant claim 2. Further, SEQ ID NOs: 21-23 for the HCDRs 1-3 and SEQ ID NOs: 24-26 for the LCDRs 1-3 of ‘435 have 100% sequence identity to the corresponding CDRs as set forth in SEQ ID NOs: 8 and 7 of instant claim 1.
Regarding claim 4 of the instant application, claim 11 of ‘435 teaches the bispecific antibody of claim 1, comprising a first Fc chain and a second Fc chain, wherein the Fc chains are IgG Fc fragments.
Regarding claims 6 and 7 of the instant application, claims 5 and 6 of ‘435 teach that the second antigen-binding functional region that specifically binds to 4-1BB comprises a heavy chain variable region comprising the amino acid sequence set forth in SEQ ID NO: 12, and a light chain variable region comprising the amino acid sequence set forth in SEQ ID NO: 10.
SEQ ID NO: 12 of ‘435 has 100% sequence identity to SEQ ID NO: 12 of the instant claim and SEQ ID NO: 10 of ‘435 has 100% sequence identity to SEQ ID NO: 11 of the instant claim.
Regarding claim 8 of the instant application, claims 7 and 8 of ‘435 teach that the second antigen-binding functional region [that specifically binds to 4-1BB] is a Fab fragment.
Regarding claim 9 of the instant application, claim 15 of ‘435 teaches an isolated polynucleotide encoding the bispecific antibody of claim 1.
Regarding claim 12 of the instant application, claim 19 of ‘435 teaches a composition comprising the bispecific antibody of claim 1 and a pharmaceutically acceptable carrier.
Regarding claim 15 of the instant application, claim 27 of ‘435 teaches a method of preventing and/or treating diseases, including administering to a subject in need thereof the bispecific antibody of claim 1, and claim 29 of ‘435 teaches wherein the diseases are selected from the group consisting of leukemia, lymphoma, myeloma, brain tumor, head and neck squamous cell cancer, non-small cell lung cancer, nasopharyngeal cancer, esophageal cancer, gastric cancer, pancreatic cancer, gallbladder cancer, liver cancer, colorectal cancer, breast cancer, ovarian cancer, cervical cancer, endometrial cancer, uterine sarcoma, prostate cancer, bladder cancer, renal cell cancer, melanoma, small cell lung cancer and bone cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 7-9, 12, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 11, and 15 of copending Application No. 18/260,435 (‘435; reference application), as applied to claims 1-2, 4, 6, 7-9, 12, and 15 above, and further in view of Jolliffe, 1992 (instant PTO-892).
The teachings of ‘435 are above.
However. ‘435 does not specifically teach that the 4-1BB antibody or antigen-binding fragment thereof is a humanized antibody.
Regarding claim 3 of the instant application, Jolliffe teaches that by humanizing an antibody, the antibody can retain the specificity and biological effects but can be nonimmunogenic in humans, and additionally, the antibody effector functions can be improved through manipulation of the antibody constant region genes [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the antibody of ‘435 to specifically be a humanized antibody. One would have been motivated to create a humanized antibody because Jolliffe teaches that by humanizing an antibody, the antibody can retain the specificity and biological effects but can be nonimmunogenic in humans, and additionally, the antibody effector functions can be improved through manipulation of the antibody constant region genes.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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