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 .
1. Claims 1, 6, 18, 26 and 28-32 are pending in the instant patent application.
Claims 1, 6, 18, 26 and 28-32 are under examination.
Claim Objections
2. Claims 1, 6, 18, 26 and 28-31 are objected to because of the following informalities:
The claims recite “LOX-1” without first providing the full name of the term. It is suggested that the term be spelled out at its first use and in all independent claims so that it is clearly understood what it stands for. Appropriate correction is suggested.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
3. Claims 1, 6, 18 and 28-32 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.
4. Claim 1 is vague and indefinite insofar as it employs the term “disease associated with vascular inflammation, coronary inflammation and/or atherosclerosis” as a limitation. This term is not known in the relevant prior art of record as being associated with well-defined genus of pathological conditions. Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of a “disease associated with vascular inflammation, coronary inflammation and/or atherosclerosis”, an artisan cannot determine if a disease which meets all of the other limitations of a claim would then be included or excluded from the claimed subject matter by the presence of this limitation.
5. The term “reduced” in claim 1 is a relative term which renders the claim indefinite. The term “reduced” 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. Providing a point of reference or comparison would obviate this ground of rejection.
6. Similarly, the term “low” in claim 1 is a relative term as well.
7. Claim 31 is vague and ambiguous for reasons that follow. The claim further defines the antibody of claim 30 by reference to “a mutation at position 234, 235 and 331;” however, the antibody of claim 30 has been already fully defined by SEQ ID NO: 8 and SEQ ID NO:10. Thus, if positions 234, 235 and 331 are the same as within SEQ ID NOS: 8 and 10, then claim 31 is a duplicate claim of claim 30. If amino acids at positions 234, 235 and 331 are different, mutated, then claim 31 is not further narrowing for reciting subject matter outside the base claim from which it depends. This renders the claim indefinite.
8. Claims 6, 18, 28-30 and 32 are indefinite for being dependent from indefinite claim.
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.
9. Claims 1, 6, 18, 28 and 29 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.
Claims 1, 6, 18, 26, 28 and 29 specifically require possession of LOX-1 binding proteins suitable for clinical administration. In case of claims 28 and 29, the LOX-1 protein is anti-LOX-1 antibody defined by reference to amino acid sequences of at least 80% similarity to SEQ ID NO: 8 and SEQ ID NO: 10. The claims do not require that the LOX-1 binding proteins possess any particular conserved structure or other disclosed distinguishing feature. Thus, the claims are drawn to a genus of polypeptides that is defined only by their ability to specifically bind and neutralize human LOX-1, see specification at p. 46, or by reference to the sequence identity. However, the instant specification fails to describe the entire genus of proteins, which are encompassed by these claims.
MPEP §2163(I)(A) states:
“The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim "A gene comprising SEQ ID NO:1." The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements).”
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. For example, the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein, but the same information would not place the inventor in possession of the naturally-occurring DNA or mRNA encoding the protein. See In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C 103).”
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. From the specification, it is clear that Applicant has possession of an anti-LOX-1 antibody MEDI6570, identified by SEQ ID NOS: 1-6, 8 and 10. The claims are drawn to any protein that binds and neutralizes human LOX-1 or has at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 8 or 10. The specification only describes one antibody and fails to teach or describe any other protein which lacks the structure of MEDI6570 and has the activities necessary to practice the claimed methods.
To provide adequate written description and 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. In this case, the only factor present in the claims is a reference to the partial structure in the form of a recitation of percent identity, or general requirement to bind and neutralize human LOX-1 protein. There is not even identification of any particular portion of the structure that must be conserved. The specification does not provide a complete structure of those LOX-1 binding proteins and anti-LOX-1 antibodies that are currently in claims, and fails to provide a representative number of species for the recited genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of LOX-1 binding proteins, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, only anti-LOX-1 antibody MEDI6570 but not the full breadth of the claims meets the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
10. Claims 1, 6, 18, 26 and 28-32 are further rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of treatment of diabetes type II by administration of anti-LOX-1 antibody MEDI6570, does not reasonably provide enablement for the full scope of the claimed methods. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Claims 1, 6, 18, 26 and 28-32 are directed to methods of treating and preventing diseases in general and treating diseases associated with vascular inflammation, coronary inflammation and/or atherosclerosis by administration of a LOX-1 binding protein. However, the specification does not provide sufficient guidance to enable practice the full scope of the claimed invention without undue experimentation.
The enablement requirement is met when one skilled in the art, having read the specification, could practice the invention without “undue experimentation.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d at 1336 (Fed. Cir. 2013). The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The specification discloses a role of a lectin-like oxidized low density lipoprotein receptor-1 (LOX-1), a scavenger receptor for oxidized LDL in the endothelial arterial wall, in etiology of inflammation and atherogenesis in particular, p. 1. The specification goes on to describe the structure of the anti-LOX-1 antibody MEDI6570, pp. 50-52. The working examples, relevant to the instant claimed subject matter, see pp. 76-89, demonstrate benefits of administration of MEDI6570 to patients with Type 2 Diabetes Melitus (T2DM). The instant specification does not provide neither further guidance for a method of prevention or treatment of any disease in general or for any other disease in particular, nor working examples, which would show that the claimed method was successfully achieved, thus, requiring undue experimentation on part of one skilled in the art to discover how to practice the claimed invention.
The nature of the invention involving biological molecules and their effect on a physiological system is complex and unpredictable. As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology", Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991).
The MEDI6570 antibody, Golocdacimab, is not novel. The prior art recognizes clinical use of MEDI6570 antibody, see art rejection at section 11 below. However, finding of the association of LOX-1 with every pathology or disease has not been reported.
With respect to claim breadth, the standard under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the enablement scope of the claims, the teachings of the specification are to be taken into account because the claims are to be given their broadest reasonable interpretation that is consistent with the specification (see MPEP 2111 [R-1], which states that claims must be given their broadest reasonable interpretation“During patent examination, the pending claims must be "given *>their< broadest reasonable interpretation consistent with the specification." In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).”
As such, the broadest reasonable interpretation of the claimed method is that it allows the prevention and treatment of any disease, claim 26, and treatment of any pathology that meets the limitation of a disease associated with vascular inflammation, coronary inflammation and/or atherosclerosis by administration of any protein that binds and neutralizes human LOX-1. Thus, the claims encompass an unreasonable number of pathological conditions to be prevented and treated by administration of a broad range of drugs, which the skilled artisan would not know how to evaluate. As opposed to the claims, what is disclosed about the claimed method is narrow: a set of experiments limited to one antibody, MEDI6570, and no other obvious specific examples of LOX-1 binding proteins or meaningful guidance on prevention and treatment of any disease, as currently claimed.
A mere wish or plan of obtaining the claimed invention is not sufficient. The standard of an enabling disclosure is not the ability to make and test if the invention worked but one of the ability to make and use with a reasonable expectation of success.
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. In the decision of Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that:
“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure.” The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art,” “[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.”
The instant specification is not enabling because one cannot follow the guidance presented therein and practice the claimed methods without first making a substantial inventive contribution to perfect the method and complete the invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
11. Claim(s) 1 and 28-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/050889, reference 2 of IDS filed on 03/01/2024, the ‘889 document hence forth.
Claims 1 and 28-32 broadly encompass a method of treatment of atherosclerosis by administration of LOX-1 binding protein, and MEDI6570 antibody in particular. The ‘889 document fully teaches MEDI6570 antibody, see the instant specification at p. 50, and its use to treat atherosclerosis, p. 1 of the ‘889, thus fully anticipating the instant claimed method.
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.
12. Claims 1, 26 and 28-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-20 of U.S. Patent No. 10,117,889 and claims 15-19 of U.S. Patent No. 11,078,284. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims, broadly drawn to methods of administration of MEDI6570 antibody to treat various diseases associated with vascular inflammation, coronary inflammation and atherosclerosis, recite the same product to treat the same pathology as in claims for which patent protection has been already granted.
Conclusion
13. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
June 17, 2026
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