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 .
Claim Status
Claims 20-22 have been cancelled.
Claims 1-19 are currently pending.
Claims 1-19 are being examined in this application.
Priority
This application is filed under 35 U.S.C 371 of PCT/KR2022/015064 (filed on 10//2001), which claims priority to US provisional applications 60/228,420 (filed on 8/29/200) and 60/306,457 (filed on 07/20/2001).
Information Disclosure Statement
The IDS filed on 11/20/2025, 10/14/2025 and 4/5/2024 have been considered. See the attached PTO 1449 forms.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01.
Claim Objections
Claim 4 is objected to because of the following informalities: the claim recites KD values as “10-8 M, 10-9 M…” which are not formatted properly with the appropriate superscripts such as “10-8 M.”
Claim 5 is objected to because of the following informalities: the claim recite the abbreviation SCF, which should be fully spelled out.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
112(b) Rejection
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 6-11 and 17 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 6-8 recite SEQ ID NO: 5 in the claims, however, the instant Sequence Listing has “000” as residues. The instant specification recites SEQ ID NO: 5 has “LGS” as its sequence. Thus, it is creating inconsistency and confusion as what specific sequence is encompassed by SEQ ID NO: 5. For the purpose of the below art rejection, SEQ ID NO: 5 is interpreted to contain “LGS” as its sequence.
Regarding claim 17, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
112(a) Rejection(s)
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 Rejection
Claims 7 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims recite a method of treating various diseases using antibody or any “variant” thereof, and/or antibodies with sequences that have at least 95% identity as SEQ ID NOs: 7 and 8.
To satisfy the written description requirement, applicants may convey reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
Applicants may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d at 1118.
The written description requirement of 35 U.SC. 112 exists independently of enablement requirement, and the requirement applies whether or not the case involves questions of priority. The requirement applies to all inventions and includes chemical inventions. The fact that the patent is directed to method entailing use of compounds, rather than to compounds per se, does not remove patentee’s obligation to provide a description of the compound sufficient to distinguish infringing methods from non-infringing methods. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ 2d 1886, 1890-93 (Fed. Cir. 2004).
With regard to the description requirement, applicants’ attention is invited to consider the decision of the Court of Appeals for the Federal Circuit, which holds that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it form other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)].
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species or 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.
Each of claims 7 and 9 is drawn to a genus of antibodies with numerous amino acid sequences. Claim 9 recites “… an amino acid sequence having at least 95% …” of SEQ ID NOs: 7-8. Claim 7 recites “variants” of an antibody or fragments thereof. Neither the instant specification nor the claims have demonstrated common structure and/or function for the claimed genus of amino acid sequences that would have the same function as the c-Kit antibodies. In addition, no representative numbers of species for each claimed genus of sequence are provided to show possession of the claimed genus of antibodies, variants or fragments thereof that can bind to c-Kit protein and provide the function of treating various diseases.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. (see MPEP 2163 II). In this case, the instant application did not provide the core sequences that would provide the c-Kit binding capability and further the treatment functionality. The only examples are the sequences with the 100% matching sequences to the SEQ ID NOs 7-8. The instant specification has not provided any examples where proteins that share 95% or more identity with SEQ ID NOs: 7-8 would still have the same binding affinity and function.
Therefore, applicants are not in possession of the entire claimed genus of antibody sequences.
Scope of Enablement Rejection
Claims 1-19 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for using anti-c-Kit antibody for treating, managing, or ameliorating certain mast cell related disorder in a subject, does not reasonably provide enablement for preventing and or treating any mast cell related disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
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 re Wands, 8 USPQ2d 1400(1988). They are:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The predictability or lack thereof in the art
5. The level of skill in the art;
6. The amount of direction or guidance present;
7. The presence or absence of working examples;
8. The quantity of experimentation needed.
The breadth of the claims / The nature of the invention
The breadth of the claims are drawn to any antibodies or fragments that have can bind to c-Kit protein and methods of using such a genus of pharmaceutical composition for treating and/or preventing any diseases that are related to mast cells. The nature of the invention in the instant claims are methods of treating and preventing any mast cell related diseases, which are enormous genus of diseases.
The state of the prior art/ The predictability or lack thereof in the art
Treating various type of mast cell related disease such as leukemia, any respiratory diseases, etc. using c-Kit antibody is highly unpredictably, let alone preventing these diseases using the antibody. Currently there is no known method of total “prevention” of most of the diseases that can be deemed to be mast cell related. Further, treating various mast cell related diseases using c-Kit antibody is also not proven or routine in the art.
The level of one of ordinary skill
The level of skill would be high, most likely at the Ph.D. level.
The amount of direction or guidance present / The presence or absence of working examples
The only guidance present in the instant specification is using the c-Kit antibody inhibiting mast cell in vitro. There are no working examples of using the antibody to treat any patients. Further, there is no example of showing “preventing” any mast cell related diseases using the antibody.
The quantity of experimentation needed
Due to the unpredictabilities of using the c-Kit antibodies to treat and/or prevent any mast cell related diseases in vivo, undue experimentation would be required. The art has not demonstrated anti-c-Kit antibody can be used to prevent any mast cell related diseases or even treat certain types of mast cell related diseases. Because the instant specification only provides guidance for in vitro (i.e. cell based assay) assay, undue experimentation would be required to practice claimed method of preventing any mast cell related diseases or even treating some diseases.
Conclusion
Therefore based on the evidences as a whole regarding each of the above factors (e.g. factors 1-8), the specification, at the time the application was filed, does not satisfy the enablement requirement for the instant claimed method.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Park et al
Claims 1-17 and 19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Park et al (WO2020076105; 4/16/2020; filed on 10/10/2019 or earlier; cited in IDS; English equivalent CA3116154, cited in IDS, published on 4/16/2020, is relied upon for the below rejection).
The instant claims recite “a method of treating, preventing, managing or ameliorating one or more mast cell related disorders in a subject, comprising administering to a subject in need thereof a therapeutically effective amount of an anti-c-Kit antibody which specifically binds to human c-Kit epitope comprising an amino acid sequence of SEQ ID No: 13, or an antigen binding fragment thereof.”
Park et al, throughout the publication, teach anti-c-Kit antibody, and method of using the antibody for treating various diseases (e.g. Abstract).
For claims 1, 17, the reference teaches treating various diseases including rheumatoid arthritis and others (e.g. p.10; claim 10), which diseases read on the mast cell related diseases of the instant claims 1 and 17. The reference also teaches treatment is by administering an anti-c-Kit antibody (e.g. p.10; claims 9+; p.11). The reference teaches various anti-c-Kit antibody that binds to human c-Kit protein or fragment thereof (e.g. p.6, para 3; pp.14-15 bridging para; p.22, para 3), which the antibody reads on the instant claimed antibody that would bind to the human c-Kit protein (of SEQ ID NO:13).
For claims 2, 3, the reference teaches the anti-c-Kit antibody binds to “domain II” of C-KIT (e.g. p.15, ll.1+; claim 1), which the domain II encompass sequence of SEQ ID NO:11 and the SEQ ID NO:14 residues as evidenced by Yuzawa et al (Cell. Vol.130: 323-334; 2007).
For claims 4, 5, since the reference teach the same antibody as the instant claimed, and thus would necessarily possess the inherent property of the equilibrium dissociation constant and binding strength.
For claims 6-11, the reference teaches antibodies comprising SEQ ID NOs 7 (LC) and 8 (HC) (e.g. p.5, para 2+), which sequences are 100% matching to the instant SEQ ID NO:8 (LC) and 7 (HC) respectively. The instant claimed SEQ ID NOs 1-6 are CDRs within SEQ ID NO:7 and 8. The antibodies comprising SEQ ID NOs 7 and 8 would be capable of cross-competes for binding with antibodies with CDRs of SEQ ID NOs 1-6. The reference also teaches an antibody comprising SEQ ID NOs:25(LC) and 26 (HC) (e.g. p.5, para 4+), which matches to the instant SEQ ID NOs 10 and 9 respectively.
For claim 12, the antibody taught by the reference reads on a bivalent and monospecific antibody as evidenced by the instant specification that states the antibody comprising SEQ ID NOs 7 and 8 is bivalent and monospecific (Instant spec., p.6, para 43).
For claim 13, the reference teaches humanized antibody (e.g. p.6, para 4+; p.21, para 2+).
For claim 14, the reference teaches monoclonal antibody that is not conjugated or linked to other molecules (e.g. p.21, para 3+).
For claim 15, the reference teaches treating human diseases (e.g. p.7, para 1; p.12, para 1; claims 10-11).
For claim 16, the reference teaches the amount of administration can be 100 mg/kg (e.g. p.13, para 2).
For claim 19, the reference teaches various methods of administration including oral, subcutaneous etc. (e.g. p.12, para 1).
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, 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.
Park, Chang and Picard
Claims 1-17, 18 and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Park et al (WO2020076105; 4/16/2020; filed on 10/10/2019 or earlier; cited in IDS; English equivalent CA3116154, cited in IDS, published on 4/16/2020, is relied upon for the below rejection), in view of Chang et al (The Journal of Allergy and Clinical Immunology. Vol.135(2): 337-342; 2015) and Picard et al (Clinical Therapeutics. Vol.35(5): 548-562; 2013).
Park et al, throughout the publication, teach anti-c-Kit antibody, and method of using the antibody for treating various diseases, as discussed supra.
Park et al do not explicitly teach the subjects being treated have urticaria as recited in claim 18.
However, Chang et al., throughout the publication, teach using antibody containing drug, omalizumab (an anti-IgE antibody) to treat chronic spontaneous urticaria (e.g. Abstract; p.337). The Chang reference also teaches urticaria is related to mast cell activation through IgE activation (e.g. Abstract), and inhibition of IgE through antibody binding can reduce mast cell activation, and thus treating urticaria (e.g. p.337-338; p.340).
In addition, Picard et al., throughout the publication, teach mast cell activation syndrome (MCAS) including urticaria, and treatment approaches (e.g. Abstract; p.555). The Picard reference also teaches that c-Kit protein activates mast cells, and leads to MCAS (e.g. p.549, left col.). The reference also teaches using antibodies such as omalizumab to treat these MCAS diseases (e.g. p.558, right col.). The reference also teaches other therapies including inhibitors against the KIT protein (e.g. p.558, right col., para 2+).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to treat patients with MCAS related diseases such as urticaria with anti-C-Kit antibody to decrease mast cell activation, since Picard and Chang teach that urticaria is related to mast cell activation via the c-Kit protein signaling pathway, and that an inhibitor of the c-Kit protein such as an antibody would inhibit c-Kit protein and thus reduce mast cell activation. In addition, because Park et al., teach treating diseases that are caused by c-Kit protein pathway using the c-Kit antibody, and the Picard reference teach c-Kit protein association with urticaria, it would have been obvious to one skilled in the art to apply the same c-Kit antibody treatment to patients with urticaria.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Picard has demonstrated using c-Kit inhibitors for treating urticaria and Park has demonstrated treating c-Kit related diseases using c-Kit antibodies.
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.
‘180 Patent
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12540180 (hereinafter referred to as ‘180 patent) in view of Park et al (WO2020076105; 4/16/2020; filed on 10/10/2019 or earlier; cited in IDS; English equivalent CA3116154, cited in IDS, published on 4/16/2020, is relied upon for the below rejection), Chang et al (The Journal of Allergy and Clinical Immunology. Vol.135(2): 337-342; 2015) and Picard et al (Clinical Therapeutics. Vol.35(5): 548-562; 2013).
The reference patent claims the followings:
1. An antibody binding to c-kit or antigen-binding fragment thereof, comprising:
a heavy-chain CDR1 comprising the sequence of SEQ ID NO: 1,
a heavy-chain CDR2 comprising the sequence of SEQ ID NO: 2,
a heavy-chain CDR3 comprising the sequence of SEQ ID NO: 3,
a light-chain CDR1 comprising the sequence of SEQ ID NO: 4,
a light-chain CDR2 comprising the sequence of SEQ ID NO: 5, and
a light-chain CDR3 comprising the sequence of SEQ ID NO: 6.
10. A method for treating an angiogenic disease of a patient in need thereof, comprising administering an effective amount of the antibody or antigen-binding fragment thereof according to claim 1, a nucleic acid encoding the antibody or antigen-binding fragment thereof, or a vector comprising the nucleic acid thereof to the patient.
11. A method for treating cancer, comprising administering an effective amount of the antibody or antigen-binding fragment thereof according to claim 1, a nucleic acid encoding the antibody or antigen-binding fragment thereof or a vector comprising the nucleic acid thereof to a patient in need thereof.
16. A method for inhibiting an abnormal angiogenesis of a patient in need thereof, comprising administering an effective amount of an antibody or antigen-binding fragment thereof according to claim 1 binding to the domain I and domain II of c-kit, a nucleic acid encoding the antibody or antigen-binding fragment thereof, or a vector comprising the nucleic acid thereof to the patient.
The reference patent does not explicitly claim treating mast cell related diseases including urticaria.
However, Park et al, throughout the publication, teach anti-c-Kit antibody, and method of using the antibody for treating various diseases including rheumatoid arthritis and others (e.g. p.10; claim 10), which diseases read on the mast cell related diseases of the instant claims.
Chang et al., throughout the publication, teach using antibody containing drug, omalizumab (an anti-IgE antibody) to treat chronic spontaneous urticaria (e.g. Abstract; p.337). The Chang reference also teaches urticaria is related to mast cell activation through IgE activation (e.g. Abstract), and inhibition of IgE through antibody binding can reduce mast cell activation, and thus treating urticaria (e.g. p.337-338; p.340).
In addition, Picard et al., throughout the publication, teach mast cell activation syndrome (MCAS) including urticaria, and treatment approaches (e.g. Abstract; p.555). The Picard reference also teaches that c-Kit protein activates mast cells, and leads to MCAS (e.g. p.549, left col.). The reference also teaches using antibodies such as omalizumab to treat these MCAS diseases (e.g. p.558, right col.). The reference also teaches other therapies including inhibitors against the KIT protein (e.g. p.558, right col., para 2+).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to treat patients with MCAS related diseases such as urticaria with anti-C-Kit antibody to decrease mast cell activation, since Picard and Chang teach that urticaria is related to mast cell activation via the c-Kit protein signaling pathway, and that an inhibitor of the c-Kit protein such as an antibody would inhibit c-Kit protein and thus reduce mast cell activation. In addition, because Park et al., teach treating diseases that are caused by c-Kit protein pathway using the c-Kit antibody, and the Picard reference teach c-Kit protein association with urticaria, it would have been obvious to one skilled in the art to apply the same c-Kit antibody treatment to patients with urticaria.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Picard has demonstrated using c-Kit inhibitors for treating urticaria and Park has demonstrated treating c-Kit related diseases using c-Kit antibodies.
‘646 Patent
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12134646 (hereinafter referred to as ‘646 patent) in view of Park et al (WO2020076105; 4/16/2020; filed on 10/10/2019 or earlier; cited in IDS; English equivalent CA3116154, cited in IDS, published on 4/16/2020, is relied upon for the below rejection), Chang et al (The Journal of Allergy and Clinical Immunology. Vol.135(2): 337-342; 2015) and Picard et al (Clinical Therapeutics. Vol.35(5): 548-562; 2013).
The reference patent claims the followings:
An anti-C-KIT antibody or antibody fragment thereof, specifically binding to domain II of C-KIT, wherein the anti-C-KIT antibody or antibody fragment thereof comprises a light chain variable region comprising a light chain CDR1 of SEQ ID NO: 1, a light chain CDR2 of SEQ ID NO: 2, and a light chain CDR3 of SEQ ID NO: 3; and a heavy chain variable region comprising a heavy chain CDR1 of SEQ ID NO: 4, a heavy chain CDR2 of SEQ ID NO: 5, and a heavy chain CDR3 of SEQ ID NO: 6.
8. A method for treating an angiogenesis-related disease, comprising administering the anti-C-KIT antibody or antibody fragment thereof of claim 1 to a patient in need thereof, wherein the angiogenesis-related disease is selected from the group consisting of cancer, leukemia, ophthalmic vascular diseases, rheumatoid arthritis, psoriasis, chronic wounds, chronic inflammation, hemangioma, hemangiofibroma, vascular malformations, arteriosclerosis, vascular adhesions, vasculitis, pyogenic granuloma, blister diseases, pulmonary hypertension, asthma, nasal polyps, infectious diseases, inflammatory bowel disease, periodontal disease, peritoneal adhesions, endometriosis, uterine bleeding, ovarian cysts, osteomyelitis, osteitis, sepsis and autoimmune diseases.
The reference patent does not explicitly claim treating mast cell related diseases including urticaria.
However, Park et al, throughout the publication, teach anti-c-Kit antibody, and method of using the antibody for treating various diseases including rheumatoid arthritis and others (e.g. p.10; claim 10), which diseases read on the mast cell related diseases of the instant claims.
Chang et al., throughout the publication, teach using antibody containing drug, omalizumab (an anti-IgE antibody) to treat chronic spontaneous urticaria (e.g. Abstract; p.337). The Chang reference also teaches urticaria is related to mast cell activation through IgE activation (e.g. Abstract), and inhibition of IgE through antibody binding can reduce mast cell activation, and thus treating urticaria (e.g. p.337-338; p.340).
In addition, Picard et al., throughout the publication, teach mast cell activation syndrome (MCAS) including urticaria, and treatment approaches (e.g. Abstract; p.555). The Picard reference also teaches that c-Kit protein activates mast cells, and leads to MCAS (e.g. p.549, left col.). The reference also teaches using antibodies such as omalizumab to treat these MCAS diseases (e.g. p.558, right col.). The reference also teaches other therapies including inhibitors against the KIT protein (e.g. p.558, right col., para 2+).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to treat patients with MCAS related diseases such as urticaria with anti-C-Kit antibody to decrease mast cell activation, since Picard and Chang teach that urticaria is related to mast cell activation via the c-Kit protein signaling pathway, and that an inhibitor of the c-Kit protein such as an antibody would inhibit c-Kit protein and thus reduce mast cell activation. In addition, because Park et al., teach treating diseases that are caused by c-Kit protein pathway using the c-Kit antibody, and the Picard reference teach c-Kit protein association with urticaria, it would have been obvious to one skilled in the art to apply the same c-Kit antibody treatment to patients with urticaria.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since Picard has demonstrated using c-Kit inhibitors for treating urticaria and Park has demonstrated treating c-Kit related diseases using c-Kit antibodies.
Conclusion and Correspondence
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUE LIU whose telephone number is (571)272-5539. The examiner can normally be reached M-F 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor (director), Jennifer Michener can be reached at 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
Prosecution Insights