DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. The amendments filed 06/05/2023 have been acknowledged. Claims 4-5. 9-16, 21, 23, and 31 are amended. Claims 17-20, 22, and 24-30 are cancelled. Claims 1-16, 21, 23, and 31-32 are pending.
Priority
3. The instant application was effectively filed on 06/05/2024, is a 371 of PCT/US21/61755 filed 12/03/2021, which claims benefit of Provisional Application No. 63/121629 filed on 12/04/2020.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 04/24/2023 is in compliance
with the provisions of 37 CFR 1.91. Accordingly, the information disclosure statement is being
considered by the examiner.
Claim Rejections - 35 USC § 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.
5. The term “about” in claims 1, 2, 4, and 23 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The word about introduces a range of possibilities and even wider in some interpretations which causes ambiguity. The rationale for avoiding such phrasing comes down to accuracy, reproducibility and the proper representation of uncertainty.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1 and 6 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 MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed 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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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 Applicants were in possession of the claimed genus.
The instant claims are drawn to a method of treating an ocular disease comprising administering an anti-C1q antibody, and said antibody is a monoclonal antibody, a humanized antibody, a human antibody, a chimeric antibody, an antibody fragment, or antibody derivative thereof.
The specification teaches the antibody is a monoclonal antibody, a polyclonal antibody, a recombinant antibody, a humanized antibody, a human antibody, a chimeric antibody, a monovalent antibody, a multi-specific antibody, or an antibody fragment, or antibody derivative thereof. Although the claims are inclusive of a specifically disclosed anti-C1q antibody, the claims are not limited to the specific antibody and instead are inclusive analogs and derivatives of the recited antibody. For example, claim 6 recites “antibody derivative thereof”. This is interpreted as encompassing any antibody with a structure similar to anti-C1q antibody with modified or engineered properties. The specification recites “antibody derivatives may also be prepared by the use of recombinant DNA engineering techniques involving the manipulation and re-expression of DNA encoding antibody variable and constant regions” and “Examples of antibody derivatives include single-chain antibody molecules, monovalent antibodies and multispecific antibodies formed from antibody fragments”. Standard molecular biology techniques may be used to modify, add or delete further amino acids or domains as desired. Any alterations to the variable or constant regions are still encompassed by the terms 'variable' and 'constant' regions as used herein”. This indicates, hundred, if not thousands, of possible molecules encompassed by the claims. The claim require that the anti-C1q antibody exhibit specific functions, but the specification provides no guidance regarding which protein, small molecules, nucleic acids, or other molecules are capable of the required function. Therefore, the specification does not provide adequate written description to identify the broad and variable genus of antibody derivatives because, inter alia, the specification does not disclose a correlation between the necessary structure of the antibody and the function(s) recited in the claims; and thus, the specification does not distinguish the claimed genus from others, except by function.
For example, Stojan, et al. teach patients with anti-C1q were three times more likely to have Proteinuria and 2.6 times more likely to have urinary red cell casts. Stojan, et al. further teach anti-C1q are strongly associated with proliferative lupus nephritis. (Stojan, G, and M Petri. “Anti-C1q in systemic lupus erythematosus.” Lupus vol. 25,8 (2016): 873-7. doi:10.1177/0961203316645205).
Accordingly, the specification does not define any structural features commonly possessed by members of the genus, because while the description of an ability of the claimed antibody derivative may generically describe the antibody’s function, it does not describe the antibody itself. A definition by function does not suffice to define the genus because it is only an indication of what the antibody does, rather than what it is; therefore, it is only a definition of a useful result rather than a definition of what achieves that result. In addition, because the genus of agents is highly variable (i.e., each antibody derivative would necessarily have a unique structure; see MPEP 2434), the generic description of the substance is insufficient to describe the genus. Thus, the encompassed antibody derivatives have no correlation between their structure and function.
Furthermore, Applicant have not shown possession of a representative number of species that have the claimed function(s). While the specification clearly sets forth a correlation between the fully described anti-C1q antibody, and the claimed function(s), this correlation does not appear to be clearly present in the breadth of the claims. As noted above, the claims are not limited to the disclosed anti-C1q antibody and encompass a vast genus of compounds of varying biological genera. Thus, the genus has substantial variation because of the numerous alternatives and combinations permitted. There is no description of the structure common to the members of the genus such that one of skill in the art can visualize or recognize the members of the genus. Given the vast number of antibody’s that are encompassed by the claims, the disclosure of a few species is not sufficiently representative of the broad genus of compounds encompassed by the claims. Therefore, the specification provides insufficient written description to support the genus encompassed by the claim.
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.)
The skilled artisan cannot envision the detailed chemical structure of the encompassed agents, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601,1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481,1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
Finally, 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 USPQ2dl961,1966 (1997); In re Gosteli, 872 F.2dl008,1012,10 USPQ2dl614, 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 variety of compounds are known in the art and may be identified by their effects. Examples include proteins, small molecules, or nucleic acids. The instant claims thereby encompass many genera of chemical and biological molecules, without any described structure that is required for the molecules to perform required functions.
Applicant is reminded that generally, in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus (Enzo Biochem, Inc. v. Gen- Probe Inc., 323 F.3d 956 (Fed. Cir. 2002); Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004); Regents of the University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)). A patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017) at page 1358). An adequate written description must contain enough information about the actual makeup of the claimed products — “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
Adequate written description requires more than a mere statement that is part of the invention. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chungai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
The 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 USPQ2dat1966.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, ‘does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the “written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
7. Claims 2 and 4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 recites the CDR’s for the light chain and heavy chain of the antibody. Claim 2 and 4 further recite heavy and light chains, however, the light and heavy chains are at least about 95% homologous. Having about 95% homologous amino acid sequence of the heavy and light chain is broader than what is recited in claim 1 and fails to further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
8. Claims 1-16, 21, 23, and 31-32 are rejected under 35 U.S.C 102(a)(1) as being anticipated over Annexon, et al. (Annexon Biosciences Reports Top-line Phase 1b Results for Novel C1q Inhibitor ANX007 in Glaucoma. (https://ir.annexonbio.com/node/6131/pdf available Oct 9, 2019).
The instant claims are drawn to a method of treating an ocular disease in a human patient, comprising administering to the patient a composition comprising about 1 mg to about 10 mg of an anti-C1q antibody via intravitreal injection.
Annexon, et al. teach ANX007, which is an monoclonal antibody antigen-binding fragment (Fab) which inhibits C1q formulated for intravitreal administration to treat glaucoma and geographic atrophy which is well-tolerated at all dose levels for at least 4 weeks, as recited in instant claims 1, 6, 7, 23, 31 and 32.
Regarding instant claims 1, 2, 3, 4, 5, and 8 that recite “wherein the antibody comprises a light chain variable domain comprising an HVR-L1 having the amino acid sequence of SEQ ID NO: 5, an HVR-L2 having the amino acid of SEQ ID NO: 6, and an HVR-L3 having the amino acid of SEQ ID NO: 7; and a heavy chain variable domain comprising an HVR-H1 having the amino acid sequence of SEQ ID NO: 9, an HVR-H2 having the amino acid of SEQ ID NO: 10, and an HVR-H3 having the amino acid of SEQ ID NO: 11 (instant claim 1)”, “wherein the antibody comprises a light chain variable domain comprising an amino acid sequence with at least about 95% homology to the amino acid sequence selected from SEQ ID NO: 4 and 35-38 and wherein the light chain variable domain comprises an HVR-L1 having the amino acid sequence of SEQ ID NO: 5, an HVR-L2 having the amino acid of SEQ ID NO: 6, and an HVR-L3 having the amino acid of SEQ ID NO: 7 (instant claim 2)”, “wherein the light chain variable domain comprising an amino acid sequence selected from SEQ ID NO: 4 and 35-38 (instant claim 3)”, “wherein the antibody comprises a heavy chain variable domain comprising an amino acid sequence with at least about 95% homology to the amino acid sequence selected from SEQ ID NO: 8 and 31-34 and wherein the heavy chain variable domain comprises an HVR-H1 having the amino acid sequence of SEQ ID NO: 9, an HVR-H2 having the amino acid of SEQ ID NO: 10, and an HVR-H3 having the amino acid of SEQ ID NO: 11 (instant claim 4)”, “wherein the heavy chain variable domain comprising an amino acid sequence selected from SEQ ID NO: 8 and 31-34 (instant claim 5)”, and “wherein the Fab fragment comprises a heavy chain Fab fragment of SEQ ID NO: 39 and a light chain Fab fragment of SEQ ID NO: 40 (instant claim 8)”, such structures would be inherent properties of ANX007, because Annexon, et al. teach administering the same antibody (ANX007), at multiple dosages to the same patient population and therefore, the prior method would necessarily possess the same results claimed by the Applicant. Annexon, et al. teach the monoclonal antibody antigen-biding fragment anti-C1q that accumulates on photoreceptor cell synapses with normal age or disease that may lead to aberrant synapse removal and neuronal loss in disease. Annexon, et al. further teach ANX007 is designed to potently bind and inhibit C1q and all downstream components of the classical complement cascade, including C3 and C5, but to not interfere with the normal function of C3 and C5 as part of other complement pathways. Instant specification teaches the anti-C1q antibody disclosed are potent inhibitors of C1q and recognize complement factor C1q and/or C1q in the C1 complex of the classical complement activation pathway (page 34, line 15). Instant specification further teaches the antibody recognizes C1q, showing no binding to the other complement components (C3b and C5) (page 6, line 15). It is well settled that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (emphasis added); see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368. Additionally, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
9. Claims 1-7, 9-16, 21, 23, and 31-32 are rejected under rejected under 35 U.S.C 102(a)(1) as being anticipated over Rosenthal, et al. (US Patent No: US 10,316,081 B2, issued 06/11/2019).
Rosenthal, et al. teach a humanized anti-C1q antibody, wherein the antigen-binding fragment is a Fab, F(ab’)2 or Fab’ fragment (claim 10), wherein the antibody comprises a heavy chain variable domain comprising a HVR-H1, HVR-H2, and HVR-H3, having the amino acid sequence of SEQ ID NO: 23, 24, and 25 (claim 1) which is 100% identical to the instant heavy variable domain comprising a HVR-H1, HVR-H2, and HVR-H3 having the amino sequence of instant SEQ ID NO: 9, 10 and 11. Rosenthal, et al. further teach the antibody comprises a light chain variable domain comprising an amino acid sequence of SEQ ID NO: 7 (claim 8, 19 and 20), which is 100% identical to the instant light variable domain comprising a HVR-L1, HVR-L2, and HVR-L3 having the amino sequence of instant SEQ ID NO: 5, 6, and 7. Rosenthal, et al. also teach a method of treating or preventing a disease such as glaucoma, age-related macular degeneration (AMD), and geographic atrophy by administering anti-C1q antibody at a dosage ranging from 10 ng/kg to 100mg/kg with a dosing frequency of three times per day, twice per day, once per day, once every other day, once weekly, once every two weeks, once every four weeks, once every five weeks, once every six weeks, once every seven weeks, once every eight weeks, once every nine weeks, once every ten weeks, or once monthly, once every two months, once every three months, or longer (paragraphs 24, 25, 218, and 219). This recites the limitations of instant claim 1, 6-7, 9-16, 21, 23, and 31-32.
Rosenthal, et al. teaches the antibody comprising a light chain variable domain comprising an amino acid sequence of SEQ ID NO: 7 (claim 8, 19 and 20), which is 100% identical to the instant light variable domain comprising a HVR-L1, HVR-L2, and HVR-L3 having the amino sequence of instant SEQ ID NO: 5, 6, and 7 of instant claim 1.
Rosenthal, et al. SEQ ID NO: 7 is 100% duplicate of instant SEQ ID NO: 5:
Query Match 100.0%; Score 52; Length 107;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RASKSINKYLA 11
|||||||||||
Db 24 RASKSINKYLA 34
Rosenthal, et al. SEQ ID NO: 7 is 100% duplicate of instant SEQ ID NO: 6:
Query Match 100.0%; Score 32; Length 107;
Best Local Similarity 100.0%;
Matches 7; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SGSTLQS 7
|||||||
Db 50 SGSTLQS 56
Rosenthal, et al. SEQ ID NO: 7 is 100% duplicate of instant SEQ ID NO: 7:
Query Match 100.0%; Score 52; Length 107;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QQHNEYPLT 9
|||||||||
Db 89 QQHNEYPLT 97
Rosenthal, et al. teach the antibody comprising a heavy chain variable domain comprising a HVR-H1, HVR-H2, and HVR-H3, having the amino acid sequence of SEQ ID NO: 23, 24, and 25 (claim 1) which is 100% identical to the instant heavy variable domain comprising a HVR-H1, HVR-H2, and HVR-H3 having the amino sequence of instant SEQ ID NO: 9, 10 and 11 of instant claim 1.
Rosenthal, et al. SEQ ID NO: 23 is 100% duplicate of instant SEQ ID NO: 9:
Query Match 100.0%; Score 67; Length 10;
Best Local Similarity 100.0%; Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GYHFTSYWMH 10
||||||||||
Db 1 GYHFTSYWMH 10
Rosenthal, et al. SEQ ID NO: 24 is 100% duplicate of instant SEQ ID NO: 10:
Query Match 100.0%; Score 91; Length 17;
Best Local Similarity 100.0%;
Matches 17; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VIHPNSGSINYNEKFES 17
|||||||||||||||||
Db 1 VIHPNSGSINYNEKFES 17
Rosenthal, et al. SEQ ID NO: 25 is 100% duplicate of instant SEQ ID NO: 11:
Query Match 100.0%; Score 63; Length 12;
Best Local Similarity 100.0%;
Matches 12; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ERDSTEVLPMDY 12
||||||||||||
Db 1 ERDSTEVLPMDY 12
Rosenthal, et al. teach the light chain variable domain comprising an amino acid sequence of SEQ ID NO: 5 (claim 1) and the heavy chain variable domain comprising an amino acid sequence of SEQ ID NO: 1 (claim 1), which is about 95% homologous to instant SEQ ID NO: 4 and 35-38 and to instant SEQ ID NO: 8 and 31-34. The limitation “about 95% homologous” allows for +/- 10% variability.
See MPEP 2173.05(b)
In determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). In W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as "exceeding about 10% per second" is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
Rosenthal, et al. SEQ ID NO: 5 is 93.9% duplicate of instant SEQ ID NO: 4:
Query Match 93.9%; Score 526; Length 107;
Best Local Similarity 93.5%;
Matches 100; Conservative 3; Mismatches 4; Indels 0; Gaps 0;
Qy 1 DVQITQSPSYLAASPGETITINCRASKSINKYLAWYQEKPGKTNKLLIYSGSTLQSGIPS 60
|||||||||||||| || ||||||||||||||||||:|||||||||||||||||||||:
Db 1 DVQITQSPSYLAASLGERATINCRASKSINKYLAWYQQKPGKTNKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGAGTKLELK 107
||||||||||||||||||||||||||||||||||||||| |||||:|
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Rosenthal, et al. SEQ ID NO: 1 is 94.6% duplicate of instant SEQ ID NO: 8:
Query Match 94.6%; Score 608; Length 121;
Best Local Similarity 94.2%;
Matches 114; Conservative 3; Mismatches 4; Indels 0; Gaps 0;
Qy 1 QVQLQQPGAELVKPGASVKLSCKSSGYHFTSYWMHWVKQRPGQGLEWIGVIHPNSGSINY 60
|||| | |||| |||||||:||||||||||||||||||| ||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESKATLTVDKSSSTAYMQLSSLTSEDSAVYYCAGERDSTEVLPMDYWGQGTSVTVS 120
|||||||||:|||||:||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFESKATITVDKSTSTAYMQLSSLTSEDSAVYYCAGERDSTEVLPMDYWGQGTSVTVS 120
Qy 121 S 121
|
Db 121 S 121
Rosenthal, et al. SEQ ID NO: 1 is 100% duplicate of instant SEQ ID NO: 31:
Query Match 100.0%; Score 640; Length 121;
Best Local Similarity 100.0%;
Matches 121; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESKATITVDKSTSTAYMQLSSLTSEDSAVYYCAGERDSTEVLPMDYWGQGTSVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFESKATITVDKSTSTAYMQLSSLTSEDSAVYYCAGERDSTEVLPMDYWGQGTSVTVS 120
Qy 121 S 121
|
Db 121 S 121
Rosenthal, et al. SEQ ID NO: 1 is 96.9%% duplicate of instant SEQ ID NO: 32:
Query Match 96.9%; Score 622; Length 121;
Best Local Similarity 95.9%;
Matches 116; Conservative 4; Mismatches 1; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESRATITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
||||||:||||||||||||||:|||| |||:||||||||||||||||||||||||:||||
Db 61 NEKFESKATITVDKSTSTAYMQLSSLTSEDSAVYYCAGERDSTEVLPMDYWGQGTSVTVS 120
Qy 121 S 121
|
Db 121 S 121
Rosenthal, et al. SEQ ID NO: 1 is 96.3%% duplicate of instant SEQ ID NO: 33:
Query Match 96.3%; Score 618; Length 121;
Best Local Similarity 95.0%;
Matches 115; Conservative 4; Mismatches 2; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
||||||: |||||||||||||:|||| |||:||||||||||||||||||||||||:||||
Db 61 NEKFESKATITVDKSTSTAYMQLSSLTSEDSAVYYCAGERDSTEVLPMDYWGQGTSVTVS 120
Qy 121 S 121
|
Db 121 S 121
Rosenthal, et al. SEQ ID NO: 1 is 96.3% duplicate of instant SEQ ID NO: 34:
Query Match 99.5%; Score 639; Length 229;
Best Local Similarity 99.2%;
Matches 120; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVRQAPGQGLEWIGVIHPNSGSINY 60
|||||||||||||||||||||||||||||||||||||:||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
Qy 121 S 121
|
Db 121 S 121
Rosenthal, et al. SEQ ID NO: 5 is 100% duplicate of instant SEQ ID NO: 35:
Query Match 100.0%; Score 558; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVQITQSPSYLAASLGERATINCRASKSINKYLAWYQQKPGKTNKLLIYSGSTLQSGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVQITQSPSYLAASLGERATINCRASKSINKYLAWYQQKPGKTNKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Rosenthal, et al. SEQ ID NO: 5 is 97.7% duplicate of instant SEQ ID NO: 36:
Query Match 97.7%; Score 541; Length 107;
Best Local Similarity 97.2%;
Matches 104; Conservative 1; Mismatches 2; Indels 0; Gaps 0;
Qy 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKANKLLIYSGSTLQSGIPA 60
||||||||| |:|||||||||||||||||||||||||||||| |||||||||||||||||
Db 1 DVQITQSPSYLAASLGERATINCRASKSINKYLAWYQQKPGKTNKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Rosenthal, et al. SEQ ID NO: 5 is 96.0% duplicate of instant SEQ ID NO: 37:
Query Match 96.0%; Score 533; Length 107;
Best Local Similarity 96.3%;
Matches 103; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
||||||||| |:|||||||||||||||||||||||||||||| ||||||||||||||||
Db 1 DVQITQSPSYLAASLGERATINCRASKSINKYLAWYQQKPGKTNKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Rosenthal, et al. SEQ ID NO: 5 is 95.5% duplicate of instant SEQ ID NO: 38:
Query Match 95.5%; Score 530; Length 107;
Best Local Similarity 94.4%;
Matches 101; Conservative 3; Mismatches 3; Indels 0; Gaps 0;
Qy 1 DIQLTQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
|:|:||||| |:|||||||||||||||||||||||||||||| ||||||||||||||||
Db 1 DVQITQSPSYLAASLGERATINCRASKSINKYLAWYQQKPGKTNKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
10. Claims 1-16, 21, 23, and 31-32 are rejected under rejected under 35 U.S.C 102(a)(1) as being anticipated over Yednock, et al. (Patient Application Publication No: US 2017/0152309 A1, issued 06/1/2017).
Yednock, et al. teach an antibody fragment that binds to C1q, with the heavy chain variable domain comprising SEQ ID NO:1 (claim 1), that is 100% duplicate with the instant heavy variable domain comprising instant SEQ ID NO: 9, 10, and 11. Yednock, et al. teach the antibody fragment that binds to C1q, with the light chain variable domain comprising SEQ ID NO: 2 (paragraph 18), that is 100% duplicate with the instant light variable domain comprising instant SEQ ID NO: 5, 6, and 7. Yednock, et al. further teach a method of treating or preventing a disease by comprising administering antibody Fab fragment (claim 37) via an intravitreal administration (paragraph 222) , and such disease are defined as glaucoma, age-related macular degeneration (AMD), and geographic atrophy (paragraph 29). This recites the limitations of instant claims 1, 6, 7, 31 and 32.
Yednock, et al. teach an antibody fragment that binds to C1q, with the heavy chain variable domain comprising SEQ ID NO:1 (claim 1), that is 100% duplicate with the instant heavy variable domain comprising instant SEQ ID NO: 9, 10, and 11 of instant claim 1.
Yednock, et al. SEQ ID NO: 1 is 100% duplicate with instant SEQ ID NO: 9:
Query Match 100.0%; Score 67; Length 229;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GYHFTSYWMH 10
||||||||||
Db 26 GYHFTSYWMH 35
Yednock, et al. SEQ ID NO: 1 is 100% duplicate with instant SEQ ID NO: 10:
Query Match 100.0%; Score 91; Length 229;
Best Local Similarity 100.0%;
Matches 17; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VIHPNSGSINYNEKFES 17
|||||||||||||||||
Db 50 VIHPNSGSINYNEKFES 66
Yednock, et al. SEQ ID NO: 1 is 100% duplicate with instant SEQ ID NO: 11:
Query Match 100.0%; Score 63; Length 229;
Best Local Similarity 100.0%;
Matches 12; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ERDSTEVLPMDY 12
||||||||||||
Db 99 ERDSTEVLPMDY 110
Yednock, et al. teach the antibody fragment that binds to C1q, with the light chain variable domain comprising SEQ ID NO: 2 (paragraph 18), that is 100% duplicate with the instant light variable domain comprising instant SEQ ID NO: 5, 6, and 7 on instant claim 1.
Yednock, et al. SEQ ID NO: 2 is 100% duplicate with instant SEQ ID NO: 5:
Query Match 100.0%; Score 52; Length 214;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RASKSINKYLA 11
|||||||||||
Db 24 RASKSINKYLA 34
Yednock, et al. SEQ ID NO: 2 is 100% duplicate with instant SEQ ID NO: 6:
Query Match 100.0%; Score 32; Length 214;
Best Local Similarity 100.0%;
Matches 7; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SGSTLQS 7
|||||||
Db 50 SGSTLQS 56
Yednock, et al. SEQ ID NO: 2 is 100% duplicate with instant SEQ ID NO: 7:
Query Match 100.0%; Score 52; Length 214;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QQHNEYPLT 9
|||||||||
Db 89 QQHNEYPLT 97
Yednock, et al. teach the antibody Fab fragment comprising a light chain of amino acid sequence provided in SEQ ID NO: 2, which is about 95% homologous to the amino acid sequence of the light chain variable domain of instant SEQ ID NO: 4, and 35-38.
Yednock, et al. teach the antibody Fab fragment comprising a heavy chain of amino acid sequence provided in SEQ ID NO: 1, which is about 95% homologous to the amino acid sequence of the light chain variable domain of instant SEQ ID NO: 8 and 31-34.
The limitation “about 95% homologous” allows for +/- 10% variability.
See MPEP 2173.05(b)
In determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). In W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as "exceeding about 10% per second" is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
Yednock, et al. SEQ ID NO: 2 is 89.5% duplicate with instant SEQ ID NO: 4:
Query Match 89.5%; Score 501; Length 214;
Best Local Similarity 89.7%;
Matches 96; Conservative 4; Mismatches 7; Indels 0; Gaps 0;
Qy 1 DVQITQSPSYLAASPGETITINCRASKSINKYLAWYQEKPGKTNKLLIYSGSTLQSGIPS 60
||||||||| |:|| || ||||||||||||||||||:|||| |||||||||||||||:
Db 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGAGTKLELK 107
||||||||||||||||||||||||||||||||||||||| |||||:|
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Yednock, et al. SEQ ID NO: 2 is 95.5% duplicate with instant SEQ ID NO: 35:
Query Match 95.5%; Score 533; Length 214;
Best Local Similarity 96.3%;
Matches 103; Conservative 1; Mismatches 3; Indels 0; Gaps 0;
Qy 1 DVQITQSPSYLAASLGERATINCRASKSINKYLAWYQQKPGKTNKLLIYSGSTLQSGIPA 60
||||||||| |:|||||||||||||||||||||||||||||| ||||||||||||||||
Db 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Yednock, et al. SEQ ID NO: 2 is 98.6% duplicate with instant SEQ ID NO: 36:
Query Match 98.6%; Score 546; Length 214;
Best Local Similarity 99.1%;
Matches 106; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKANKLLIYSGSTLQSGIPA 60
||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||
Db 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Yednock, et al. SEQ ID NO: 2 is 100% duplicate with instant SEQ ID NO: 37:
Qy 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Yednock, et al. SEQ ID NO: 2 is 99.5% duplicate with instant SEQ ID NO: 38:
Query Match 99.5%; Score 552; Length 214;
Best Local Similarity 98.1%;
Matches 105; Conservative 2; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQLTQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
|:|:||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIK 107
Yednock, et al. SEQ ID NO: 1 is 91.1% duplicate with instant SEQ ID NO: 8:
Qy 1 QVQLQQPGAELVKPGASVKLSCKSSGYHFTSYWMHWVKQRPGQGLEWIGVIHPNSGSINY 60
|||| | |||| |||||||:||||||||||||||||||| ||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESKATLTVDKSSSTAYMQLSSLTSEDSAVYYCAGERDSTEVLPMDYWGQGTSVTVS 120
||||||: |:|||||:|||||:|||| |||:||||||||||||||||||||||||:||||
Db 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
Qy 121 S 121
|
Db 121 S 121
Yednock, et al. SEQ ID NO: 1 is 96.6% duplicate with instant SEQ ID NO: 31:
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESKATITVDKSTSTAYMQLSSLTSEDSAVYYCAGERDSTEVLPMDYWGQGTSVTVS 120
||||||: |||||||||||||:|||| |||:||||||||||||||||||||||||:||||
Db 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
Qy 121 S 121
|
Db 121 S 121
Yednock, et al. SEQ ID NO: 1 is 99.4% duplicate with instant SEQ ID NO: 32:
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESRATITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
||||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
Qy 121 S 121
|
Db 121 S 121
Yednock, et al. SEQ ID NO: 1 is 100% duplicate with instant SEQ ID NO: 33:
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
Qy 121 S 121
|
Db 121 S 121
Yednock, et al. SEQ ID NO: 1 is 99.5% duplicate with instant SEQ ID NO: 34:
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVRQAPGQGLEWIGVIHPNSGSINY 60
|||||||||||||||||||||||||||||||||||||:||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
Qy 121 S 121
|
Db 121 S 121
Yednock, et al. teach the Fab fragment comprising amino acid sequence of SEQ ID NO: 2 which is 100% identical to instant SEQ ID NO: 39 and 40.
Yednock, et al. SEQ ID NO: 2 is 100% duplicate with instant SEQ ID NO: 39:
Query Match 100.0%; Score 1205; Length 229;
Best Local Similarity 100.0%;
Matches 229; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAELKKPGASVKVSCKSSGYHFTSYWMHWVKQAPGQGLEWIGVIHPNSGSINY 60
Qy 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFESRVTITVDKSTSTAYMELSSLRSEDTAVYYCAGERDSTEVLPMDYWGQGTTVTVS 120
Qy 121 SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS 180
Qy 181 SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHT 229
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHT 229
Yednock, et al. SEQ ID NO: 2 is 100% duplicate with instant SEQ ID NO: 40:
Query Match 100.0%; Score 1108; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DVQITQSPSSLSASLGERATINCRASKSINKYLAWYQQKPGKAPKLLIYSGSTLQSGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAMYYCQQHNEYPLTFGQGTKLEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
Yednock, et al. teach dosage of the antibody will depend on the treatment, route of administration, the nature of the therapeutics, sensitivity of the patient to the therapeutics, etc. A clinician can determine the maximum safe dose for an individual, depending on the route of administration. Utilizing ordinary skill, the competent clinician will be able to optimize the dosage of a particular therapeutic composition in the course of routine clinical trials (paragraph 182).
Based on the application disclosure on page 56, line 9, optimization is reasonable of dosages and dosage administration as different dosages are recited in instant claims 1, 9-16, 21 and 23. The time of dosage and measuring clinical endpoints can clearly be a result effective parameter that a person having ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient, i.e., the dosage and dosing regimen, needed to achieve the desired results. The principle of law states from MPEP §§ 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages," (see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," (See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Conclusion
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM.
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/SYED J ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674