Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-18 are pending.
Claims 1-18 are under examination on the merits.
Priority
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 1-18 have an effective filing date of 03/30/2012, corresponding to EP12162615.4.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/27/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Objection to the Claims
Claim 1 is objected to because of the following informalities: The claim appears to contain a typographical error. The claim recites “CDR3 has an amino acid selected from…” which should read “CDR3 has an amino acid sequence selected from” Appropriate correction is required.
Claim 3 is objected to because of the following informalities: The claim appears to contain a typographical error. The claim recites “aVHH,” which should include a space between “a” and “VHH” to read “a VHH.” Appropriate correction is required.
Claim 7 is objected to because of the following informalities: The claim appears to contain a typographical error in the last line. The claim recites “aminon” which should read “amino.” Appropriate correction is required.
Claim Rejections
35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 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.
Claims 1 and 2 recite the following:
1. An Ang2-binding molecule comprising an immunoglobulin single variable domain, wherein said immunoglobulin single variable domain comprises three complementarity determining regions CDR1, CDR2 and CDR3, wherein CDR1 has an amino acid sequence selected from amino acid sequences shown in SEQ ID Nos: 168 to 170, CDR2 has an amino acid sequence selected from amino acid sequences shown in SEQ ID Nos: 171 to 173 and CDR3 has an amino acid selected from amino acid sequences shown in SEQ ID NOs: 174 to 177.
2. The Ang2-binding molecule according to claim 1, wherein (a) CDR1 has an amino acid sequence shown in SEQ ID NO: 168, CDR2 has an amino acid sequence shown in SEQ ID NO: 171 and CDR3 has an amino acid sequence shown in SEQ ID NO: 174…
The recitation of “an amino acid sequence…” is problematic with respect to 35 U.S.C. 112(b), because, for example, the recitation of an amino acid sequence selected from amino acid sequences shown in SEQ ID Nos: 168 to 170 from claim 1 encompasses sequences that comprise only a fragment of SEQ ID Nos: 168 to 170, which renders the claim indefinite. This issue could be remedied by amending to the recitation of “an” to “the.” Applicant is informed that claim 5, which recites “a sequence selected from…,” suffers from a similar indefiniteness issue, and it is recommended that “a sequence selected from…” be amended to recite “the sequence selected from…”
It is further noted that claims 1 and 2 recite the phrase “has an amino acid sequence…,” and claim 5 recites the phrase “having a sequence….” It is unclear if the terms has and having are intended to read “comprising” or “consisting of.”
35 U.S.C. 112, First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 4, and 8-18 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.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. 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. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 1 is drawn to an Ang2-binding molecule comprising an immunoglobulin single variable domain, wherein said immunoglobulin single variable domain comprises three complementarity determining regions CDR1, CDR2 and CDR3, wherein CDR1 has an amino acid sequence selected from amino acid sequences shown in SEQ ID Nos: 168 to 170, CDR2 has an amino acid sequence selected from amino acid sequences shown in SEQ ID Nos: 171 to 173, and CDR3 has an amino acid selected from amino acid sequences shown in SEQ ID NOs: 174 to 177. The claimed Ang2-binding molecules represent a genus that comprises numerous CDR combinations, and even though Applicant has adequately described four species comprised within said genus, see claim 2, the specification does not provide adequate written description for the entire claimed genus, because absent empirical determination, one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genus claimed, specifically, which of the recited CDR sequences may be paired with one another such that the resultant VHH is capable of binding Ang2. Therefore the specification does not sufficiently describe the claimed genus such that the skilled artisan would conclude that Applicant was in possession of the claimed genus at the time of the invention.
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, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., 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 applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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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. In the instant case, Applicant appears to have disclosed four species within the genus claimed; however given the possible CDR variation within the genus, as well as the high level of unpredictability in the art, the disclosure of four species comprised within the claimed genus is not sufficiently representative of the entire genus.
Furthermore Applicant has not disclosed relevant, identifying characteristics of CDR region combinations that confer upon a VHH molecule the ability to bind Ang2, because the instant specification does not provide structural antibody features that correlate with a functional ability to bind Ang2. Absent a description of the at least minimal structural features correlating with a functional ability to bind Ang2 which are shared by members of a genus of VHH molecules commonly sharing this function, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish which CDR amino acid sequences may be combined such that the resultant VHH possesses the ability to bind Ang2. Therefore it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish at least most of the members of the genus to which the claims are directed, and therefore the specification would not reasonably convey to the skilled artisan that Applicant had possession of the claimed invention at the time the application was filed.
Claim 18 is drawn to a method of treating a disease comprising administering to a patient in need, an effective amount of one or more Ang2-binding single variable domains. One skilled in the art would appreciate that the Ang2-binding single variable domains recited in the claims could be used to treat a disease that is associated with Ang2-mediated effects on angiogenesis; however the claims are drawn to a method of treating any disease by administering one or more Ang2-binding single variable domains. Absent empirical determination one skilled in the art would be unable to envision which diseases that are not associated with Ang2-mediated effects on angiogenesis could be treated using the claimed Ang2-binding single variable domains. Applicant is informed that this written description issue may be overcome by amending the claim to specifically recite a method of treating a disease that is associated with Ang2-mediated effects on angiogenesis.
35 U.S.C. 102(e)
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-18 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Gschwind et al. (US PG PUB 2013/0078247, filing date 03/29/2012, IDS from 04/27/2023).
With respect to claims 1-6, Gschwind et al. disclose an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that consists of the sequence of SEQ ID NO: 487, and SEQ ID NO: 487 of Gschwind et al. shares 100% sequence homology with the instant SEQ ID NO: 166, which comprises CDRs 1-3 of SEQ ID NO(s): 168, 171, and 175 respectively.
Gschwind et al. further disclose an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that shares 100% sequence homology with the instant SEQ ID NO: 166, wherein said VHH has a modification or exchange on N terminus, wherein said modification is a deletion of a first amino acid and said exchange is a replacement of the first amino acid by another amino acid, as recited in claim 7, see Sequence Listing below.
Sequence Listing
Query Match - 99.5%; Matches - 123; Mismatches - 0
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFDDYALGWFRQAPGKEREGVSCIRCSGGSTYY 60
:|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVQLVESGGGLVQPGGSLRLSCAASGFTFDDYALGWFRQAPGKEREGVSCIRCSGGSTYY 60
Qy 61 ADSVKGRFTISSDNSKNTVYLQMNSLRPEDTAVYYCAASIVPRSKLEPYEYDAWGQGTLV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISSDNSKNTVYLQMNSLRPEDTAVYYCAASIVPRSKLEPYEYDAWGQGTLV 120
Qy 121 TVSS 124
||||
Db 121 TVSS 124
With respect to claims 8-13, at [0243], Gschwind et al. disclose methods for the recombinant production of polypeptides, comprising selecting suitable expression vectors, transfection of cells, culturing, and protein isolation/purification. At [0248], Gschwind et al. disclose pharmaceutical compositions comprising Ang2-binding molecules and a pharmaceutically acceptable carrier. At [0268], Gschwind et al. disclose that molecules comprising an Ang2-binding moiety may be administered in combination with additional therapeutic agents, in particular chemotherapeutic agents, such as DNA damaging agents.
With respect to claims 14-18, at [0102]-[103], Gschwind et al. teach that bispecific binding molecules comprising a binding site for DLL4 and Ang2 may be used in the treatment of pancreatic cancer, breast cancer, age-related macular degeneration, diabetic and other proliferative retinopathies, as well as kidney cancer, which is a form of chronic kidney disease.
Therefore all of the limitations of claims 1-18 are met by Gschwind et al.
Claims 1-6 and 8-18 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Gschwind et al. (US PG PUB 2013/0078248, filing date 03/29/2012, hereafter referred to as “Gschwind II, IDS from 04/27/2023).
With respect to claims 1-6, Gschwind II discloses an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that consists of the sequence of SEQ ID NO: 222, and SEQ ID NO: 222 of Gschwind II shares 100% sequence homology with the instant SEQ ID NO: 166, which comprises CDRs 1-3 of SEQ ID NO(s): 168, 171, and 175 respectively.
With respect to claims 8-13, Gschwind II discloses methods for the recombinant production of polypeptides, comprising selecting suitable expression vectors, transfection of cells, culturing, and protein isolation/purification. At [0252], Gschwind II discloses pharmaceutical compositions comprising Ang2-binding molecules, and at [0274], Gschwind II discloses that molecules comprising an Ang2-binding moiety may be administered in combination with additional therapeutic agents, in particular chemotherapeutic agents, such as DNA damaging agents.
With respect to claims 14-18, at [0106]-[107], Gschwind et al. teach that bispecific binding molecules comprising a binding site for VEGF and Ang2 may be used in the treatment of pancreatic cancer, breast cancer, age-related macular degeneration, diabetic and other proliferative retinopathies, as well as kidney cancer, which is a form of chronic kidney disease.
Therefore all of the limitations of claims 1-6 and 8-18 are met by Gschwind et al.
35 U.S.C. 103(a)
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gschwind et al. (US PG PUB 2013/0078248, filing date 03/29/2012, hereafter referred to as Gschwind II, IDS from 04/27/2023) in view of Gschwind et al. (US PG PUB 2013/0078247, filing date 03/29/2012, IDS from 04/27/2023).
With respect to claims 1-6, Gschwind II discloses an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that consists of the sequence of SEQ ID NO: 222, and SEQ ID NO: 222 of Gschwind II shares 100% sequence homology with the instant SEQ ID NO: 166, which comprises CDRs 1-3 of SEQ ID NO(s): 168, 171, and 175 respectively.
With respect to claims 8-13, Gschwind II discloses methods for the recombinant production of polypeptides, comprising selecting suitable expression vectors, transfection of cells, culturing, and protein isolation/purification. At [0252], Gschwind II discloses pharmaceutical compositions comprising Ang2-binding molecules, and at [0274], Gschwind II discloses that molecules comprising an Ang2-binding moiety may be administered in combination with additional therapeutic agents, in particular chemotherapeutic agents, such as DNA damaging agents.
With respect to claims 14-18, at [0106]-[107], Gschwind et al. teach that bispecific binding molecules comprising a binding site for VEGF and Ang2 may be used in the treatment of pancreatic cancer, breast cancer, age-related macular degeneration, diabetic and other proliferative retinopathies, as well as kidney cancer, which is a form of chronic kidney disease.
Gschwind II does not teach an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that comprises a modification or exchange on N terminus, wherein said modification is a deletion of a first amino acid and said exchange is a replacement of the first amino acid by another amino acid, as recited in claim 7. This deficiency is remedied by Gschwind et al.
Gschwind et al. teach an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that consists of the sequence of SEQ ID NO: 487, and SEQ ID NO: 487 of Gschwind et al. shares 100% sequence homology with the instant SEQ ID NO: 166, which comprises CDRs 1-3 of SEQ ID NO(s): 168, 171, and 175 respectively.
Gschwind et al. further teach an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that shares 100% sequence homology with the instant SEQ ID NO: 166, wherein said VHH has a modification or exchange on N terminus, wherein said modification is a deletion of a first amino acid and said exchange is a replacement of the first amino acid by another amino acid, as recited in claim 7, see Sequence Listing below.
Sequence Listing
Query Match - 99.5%; Matches - 123; Mismatches - 0
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFDDYALGWFRQAPGKEREGVSCIRCSGGSTYY 60
:|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVQLVESGGGLVQPGGSLRLSCAASGFTFDDYALGWFRQAPGKEREGVSCIRCSGGSTYY 60
Qy 61 ADSVKGRFTISSDNSKNTVYLQMNSLRPEDTAVYYCAASIVPRSKLEPYEYDAWGQGTLV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISSDNSKNTVYLQMNSLRPEDTAVYYCAASIVPRSKLEPYEYDAWGQGTLV 120
Qy 121 TVSS 124
||||
Db 121 TVSS 124
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the time of the invention to combine the teachings of Gschwind II and Gschwind et al. to develop an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that comprises a modification or exchange on N terminus, wherein said modification is a deletion of a first amino acid and said exchange is a replacement of the first amino acid by another amino acid. One of ordinary skill in the art would have been motivated to do so, because there would have been a reasonable expectation that such a modification to the invention of Gschwind II would result in an Ang2-binding molecule that is capable of treating Ang2-related diseases.
Therefore the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time of the invention, as evidenced by the references.
Nonstatutory 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 15 of U.S. Patent No. 9,527,925.
The instant claims and those of U.S. Patent No. 9,527,925 are not identical; however the claims are not patentably distinct, because the conflicting claims recite an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that consists of the sequence of SEQ ID NO: 222, and SEQ ID NO: 222 of the conflicting claims shares 100% sequence homology with the instant SEQ ID NO: 166, which comprises CDRs 1-3 of SEQ ID NO(s): 168, 171, and 175 respectively.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 15 of U.S. Patent No. 9,527,925 in view of Gschwind et al. (US PG PUB 2013/0078247, filing date 03/29/2012, IDS from 04/27/2023).
Claim 1-6 and those of U.S. Patent No. 9,527,925 are not identical; however the claims are not patentably distinct, as indicated above. The conflicting claims do not recite methods of producing Ang2-binding molecules or the use of Ang2-binding molecules in treating the diseases recited in claims 14-18; however these deficiencies are remedied by the teachings of Gscwind et al., which are detailed above.
Gschwind et al. further disclose an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that shares 100% sequence homology with the instant SEQ ID NO: 166, wherein said VHH has a modification or exchange on N terminus, wherein said modification is a deletion of a first amino acid and said exchange is a replacement of the first amino acid by another amino acid, as recited in claim 7.
With respect to claims 8-13, at [0243], Gschwind et al. disclose methods for the recombinant production of polypeptides, comprising selecting suitable expression vectors, transfection of cells, culturing, and protein isolation/purification. At [0248], Gschwind et al. disclose pharmaceutical compositions comprising Ang2-binding molecules and a pharmaceutically acceptable carrier. At [0268], Gschwind et al. disclose that molecules comprising an Ang2-binding moiety may be administered in combination with additional therapeutic agents, in particular chemotherapeutic agents, such as DNA damaging agents. Based upon these teachings, one of ordinary skill in the art would have been motivated to use the methods of Gschwind et al. in order to produce the claimed Ang2-binding molecules of the conflicting claims, which may be used in the treatment of diseases associated with Ang2 expression.
With respect to claims 14-18, at [0102]-[103], Gschwind et al. teach that bispecific binding molecules comprising a binding site for DLL4 and Ang2 may be used in the treatment of pancreatic cancer, breast cancer, age-related macular degeneration, diabetic and other proliferative retinopathies, as well as kidney cancer, which is a form of chronic kidney disease. Based upon these teachings, one of ordinary skill in the art would have been motivated to use the Ang2-binding molecule of the instant claims to treat these conditions, thus meeting the limitations of claims 14-18.
Therefore the instant claims are prima facie obvious over the conflicting claims in view of Gschwind et al.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. 10,414,828.
The instant claims and those of U.S. Patent No. 10,414,828 are not identical; however the claims are not patentably distinct, because the conflicting claims recite an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that consists of the sequence of SEQ ID NO: 222, and SEQ ID NO: 222 of the conflicting claims shares 100% sequence homology with the instant SEQ ID NO: 166, which comprises CDRs 1-3 of SEQ ID NO(s): 168, 171, and 175 respectively.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. 10,414,828 in view of Gschwind et al. (US PG PUB 2013/0078247, filing date 03/29/2012, IDS from 04/27/2023).
Claim 1-6 and those of U.S. Patent No. 10,414,828 are not identical; however the claims are not patentably distinct, as indicated above. The conflicting claims do not recite methods of producing Ang2-binding molecules or the use of Ang2-binding molecules in treating the diseases recited in claims 14-18; however these deficiencies are remedied by the teachings of Gscwind et al., which are detailed above.
With respect to claims 8-13, at [0243], Gschwind et al. disclose methods for the recombinant production of polypeptides, comprising selecting suitable expression vectors, transfection of cells, culturing, and protein isolation/purification. At [0248], Gschwind et al. disclose pharmaceutical compositions comprising Ang2-binding molecules and a pharmaceutically acceptable carrier. At [0268], Gschwind et al. disclose that molecules comprising an Ang2-binding moiety may be administered in combination with additional therapeutic agents, in particular chemotherapeutic agents, such as DNA damaging agents. Based upon these teachings, one of ordinary skill in the art would have been motivated to use the methods of Gschwind et al. in order to produce the claimed Ang2-binding molecules of the conflicting claims, which may be used in the treatment of diseases associated with Ang2 expression.
Gschwind et al. further disclose an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that shares 100% sequence homology with the instant SEQ ID NO: 166, wherein said VHH has a modification or exchange on N terminus, wherein said modification is a deletion of a first amino acid and said exchange is a replacement of the first amino acid by another amino acid, as recited in claim 7.
With respect to claims 14-18, at [0102]-[103], Gschwind et al. teach that bispecific binding molecules comprising a binding site for DLL4 and Ang2 may be used in the treatment of pancreatic cancer, breast cancer, age-related macular degeneration, diabetic and other proliferative retinopathies, as well as kidney cancer, which is a form of chronic kidney disease. Based upon these teachings, one of ordinary skill in the art would have been motivated to use the Ang2-binding molecule of the instant claims to treat these conditions, thus meeting the limitations of claims 14-18.
Therefore the instant claims are prima facie obvious over the conflicting claims in view of Gschwind et al.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11,161,916.
The instant claims and those of U.S. Patent No. 11,161,916 are not identical; however the claims are not patentably distinct, because the conflicting claims recite an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that consists of the sequence of SEQ ID NO: 222, and SEQ ID NO: 222 of the conflicting claims shares 100% sequence homology with the instant SEQ ID NO: 166, which comprises CDRs 1-3 of SEQ ID NO(s): 168, 171, and 175 respectively.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 15 of U.S. Patent No. 11,161,916 in view of Gschwind et al. (US PG PUB 2013/0078247, filing date 03/29/2012, IDS from 04/27/2023).
Claim 1-6 and those of U.S. Patent No. 11,161,916 are not identical; however the claims are not patentably distinct, as indicated above. The conflicting claims do not recite methods of producing Ang2-binding molecules or the use of Ang2-binding molecules in treating the diseases recited in claims 14-18; however these deficiencies are remedied by the teachings of Gscwind et al., which are detailed above.
With respect to claims 8-13, at [0243], Gschwind et al. disclose methods for the recombinant production of polypeptides, comprising selecting suitable expression vectors, transfection of cells, culturing, and protein isolation/purification. At [0248], Gschwind et al. disclose pharmaceutical compositions comprising Ang2-binding molecules and a pharmaceutically acceptable carrier. At [0268], Gschwind et al. disclose that molecules comprising an Ang2-binding moiety may be administered in combination with additional therapeutic agents, in particular chemotherapeutic agents, such as DNA damaging agents. Based upon these teachings, one of ordinary skill in the art would have been motivated to use the methods of Gschwind et al. in order to produce the claimed Ang2-binding molecules of the conflicting claims, which may be used in the treatment of diseases associated with Ang2 expression.
Gschwind et al. further disclose an Ang2-binding molecule comprising an immunoglobulin single variable domain VHH that shares 100% sequence homology with the instant SEQ ID NO: 166, wherein said VHH has a modification or exchange on N terminus, wherein said modification is a deletion of a first amino acid and said exchange is a replacement of the first amino acid by another amino acid, as recited in claim 7.
With respect to claims 14-18, at [0102]-[103], Gschwind et al. teach that bispecific binding molecules comprising a binding site for DLL4 and Ang2 may be used in the treatment of pancreatic cancer, breast cancer, age-related macular degeneration, diabetic and other proliferative retinopathies, as well as kidney cancer, which is a form of chronic kidney disease. Based upon these teachings, one of ordinary skill in the art would have been motivated to use the Ang2-binding molecule of the instant claims to treat these conditions, thus meeting the limitations of claims 14-18.
Therefore the instant claims are prima facie obvious over the conflicting claims in view of Gschwind et al.
Conclusion
No claims are allowed.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642