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 .
Election/Restrictions
Applicant’s election with traverse of Group III (claims 1-2, 5-7, and 9-12) and species of disease: arthroplasty, in the reply filed on 2/17/2026 is acknowledged. The traversal is on the grounds that all of the Groups are based on the same special technical feature, if and when the examiner makes a formal rejection of the elected claims, applicant will show that the claims define over the prior art, at which time the restriction requirement will have to be withdrawn and all of the claims examined and allowed. Applicants arguments have been considered but are non-persuasive because a method of preventing post-operative pain in an individual, comprising administering an effective amount of an anti-IL6 agent, of Group III lacks a special technical feature, which defines a contribution over the prior art. The claimed method fails to recite a special technical feature absent in the prior art because US 2004/121958 teaches peptides for the prevention of post-operative pain in a patient (paragraph 15, 51-54, 93; table 5; claims 9, 13, 18) including a peptide of human interleukin-6 (hIL6) (paragraph 51; table 5). Furthermore, WO2010/088444 teaches an anti-IL6 antibody for the treatment or prevention of post-operative pain (paragraph 255; claims 20, 38). Since the claimed invention lacks a special technical feature, the other claimed inventions cannot share a special technical feature with the first claimed invention. Furthermore, contrary to Applicant’s arguments, claim 1 recites “…comprising administering an effective amount of an anti-IL-6 agent”. IL-6 and IL-6R are very disparate in amino acid sequence and immunogenic conjugates of these proteins would be separate and patentably distinct. Also, there is absence of a recitation of the amino acid sequence for anti-IL-6 agent in independent claim 1, and in the absence of recitation of the amino acid sequence of the anti-IL-6 agent administered in the claimed method, the product of Group III lacks a special technical feature over the prior art reference . Therefore, Applicants are arguing limitations absent from the claims.
The test for propriety of restriction is not whether the inventions are related but rather whether they are distinct and whether it would impose a burden on the examiner to search and examine multiple inventions in a single invention. The claimed methods are independent and distinct, each from the other, requiring separate searches, which would be unduly burdensome. Furthermore, separate search terms would be required for searching the literature, e.g. a search of the literature for a method of treatment of an autoimmune bullous disease would not necessarily reveal art for an association of the method with a kit or with the polypeptide to be administered.
The Groups as delineated in the restriction requirement of 10/14/2025 are patentably distinct one from the other such that each invention could, by itself, in principle, support its own separate patent (as shown by the arguments put forth in the written restriction requirement).
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-4, and 8, are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Amended claims 1-2, 5-7, 9-12, (2/17/2026), are under consideration by the Examiner.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 6/30/2022, is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
Claim Rejections - 35 USC § 112(a), lack of written description
4. 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.
4a. Claims 1-2, 5-7, and 9-12, 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 claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention.
The claims require administration of “an IL-6 agent”. The claims, however, do not require that the “agent” recited in claim 1 possess any particular conserved structure, or other distinguishing feature. The specification on page 3, lines 17-24, discloses:
“As intended herein, an anti-IL-6 agent is an agent capable of blocking, in part or completely, the action of IL-6 in vivo or in the body. The anti-IL-6 agent according to the invention may be of any type. In particular, it may be a protein, a nucleic acid or a small molecule. Preferably, the anti-IL-6 agent according to the invention is specifically directed against IL-6 or against the IL-6 receptor in order to block the IL-6 pathway. Preferably, the anti-IL-6 agent according to the invention is an immunotherapeutic agent.”
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, and any combination thereof. In this case, the only factor present in the claim that is sufficiently disclosed is a recitation of a desired activity. The specification does not identify any particular portion of the structure, nor does it provide a disclosure of structure/function correlation. The distinguishing characteristics of the claimed genus for the antigens or the targeting means are not described. Accordingly, the specification does not provide adequate written description of the claimed genus of antigens or targeting means.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the 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.
See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 (DC WNY 2003) and University of Rochester v. G.D. Searle & Co. et al. CAFC [(03-1304) 13 February 2004]. In University of Rochester v. G.D. Searle & Co. a patent directed to method for inhibiting prostaglandin synthesis in human host using an unspecified compound, in order to relieve pain without side effect of stomach irritation, did not satisfy written description requirement of 35 U.S.C. §112, since the patent described the compound's desired function of reducing activity of the enzyme PGHS-2 without adversely affecting PGHS-1 enzyme activity, but did not identify said compound, since invention consists of performing “assays” to screen compounds in order to discover those with desired effect. The patent did not name even one compound that assays would identify as suitable for practice of invention, or provide information such that one skilled in art could identify suitable compound. And since specification did not indicate that compounds are available in public depository, the claimed treatment method cannot be practiced without compound. Thus the inventors cannot be said to have “possessed” claimed invention without knowing of a compound or method certain to produce compound. Thus, said patent constituted an invitation to experiment to first identify, then characterize, and then use a therapeutic a class of compound defined only by their desired properties.
Therefore the full breadth of the claims fails to meet the written description provision of 35 U.S.C. §112, first paragraph. In the instant case, for example, Applicants have failed to describe which “IL-6 agent” has the property of preventing post-operative pain in an individual.
To demonstrate possession of a method of treatment one must provide substantially more than the description of a compound or collection of related compounds having an in vitro activity, in combination with a hypothesis that the administration of a compound having that activity to an individual suffering from a particular disease or disorder might produce a beneficial effect. What is required is an established nexus between the administration of such a compound to an individual and a beneficial result consequent thereto. Such a nexus can be established by the presentation of evidence demonstrating clinical efficacy of the claimed method in the treatment of a particular disease or disorder, demonstrating efficacy of that method in the treatment of an art accepted animal model of a disease or disorder wherein that model is known to be reasonably predictive of the efficacy of a treatment protocol in the treatment of that disease or disorder, or providing evidence of an in vitro activity for the recited compound in combination with a showing that other compounds possessing that activity (mode of action) have been shown to have clinical efficacy in the treatment of the recited disease or disorder. The instant specification fails to show possession of the claimed method as of the effective filing date of the instant application because it provides none of these.
As stated in M.P.E.P. § 2163(II)(A)(3), a specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) (“[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim.”); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) (“[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose.”); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves).
Whereas a reduction to practice of an uncomplicated invention such as a simple mechanical or electrical device can be achieved by merely providing a diagram of the device wherein one skilled in the relevant art can predict the likely operability of the device by reviewing the diagram, the operability of the claimed invention cannot be predicted by merely reviewing diagrams or illustrations. To demonstrate the reduction to practice of a method of treating a subject afflicted with a particular condition requires either a working embodiment, a demonstration of operability in the treatment of an art accepted animal model of the condition to be treated, wherein that animal model has been shown to be reliably predictive of efficacy in the treatment of the condition, or a demonstration that the therapeutic agent employed therein possesses an activity in which the majority of compounds possessing that activity have been shown to be effective in the treatment of that condition in the absence of further inventive contribution. In the instant case, Applicant has provided none of these. Consequently, Applicant has failed to demonstrate possession of the claimed method with respect to claim 1, as of the earliest effective filing date of the instant application.
With respect to the demonstration of a reduction to practice of a generic invention, MPEP 2163(II)(A)(3)(ii) states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus, above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
The above position is further supported by In re Clarke, 148 USPQ 665, (CCPA 1966), which held that;
“It appears to be well settled that a single species can rarely, if ever, afford support for a generic claim. In re Soll, 25 C.C.P.A. (Patents) 1309, 97 F.2d 623, 38 USPQ 189; In re Wahlforss et al., 28 C.C.P.A. (Patents) 867, 117 F.21 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of a small genus such as halogens, consisting of four species, a reduction to practice of three, or perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably large number of reductions to practice would probably be necessary.”
In the instant case, Applicant has failed to demonstrate a reduction to practice of a method of preventing post-operative pain in an individual, by administration of an “IL-6 agent” as recited in claim 1.
Independent claim 1 recites “a method of preventing or treating post-operative pain in an individual, comprising administering an effective amount of an anti-IL-6 agent”. Dependent claim 2 recites “the method according to claim 1, wherein the anti-IL-6 agent is an immunotherapeutic agent”. Dependent claim 6 recites “the method according to claim 1, wherein the anti-IL-6 agent comprises, or consists of, a polypeptide derived from IL-6 or the IL-6 receptor (IL-6R), optionally bound to a carrier protein”. Dependent claim 7 recites “the method according to claim 6, wherein the polypeptide comprises, or consists of, a sequence of at least 6 amino acid residues of IL-6 or IL-6R or a sequence having at least 90% identity thereto.” Claim 11 recites “the method according to claim 1, wherein said anti IL-6 agent is a polypeptide comprising at least the sequence ALAENNL (SEQ ID NO:3) or a sequence having at least 90% sequence identity with SEQ ID NO:3.” Claim 12 recites “the method according to claim 1, wherein said anti IL-6 agent is a polypeptide comprising or consisting of CMNNDDALAENNLKLPECY (SEQ ID NO: 2), CESSKEALAENNLNLPKC (SEQ ID NO: 5), CESSKEALAENNLNLPKCY (SEQ ID NO: 6), or a sequence having at least 90% sequence identity with SEQ ID NO: 2, 5 or 6.”
Claim 1, for example, as recited would represent a large pool of variant peptides that must have similar functional activity to IL-6 and have at least 90% identity to the IL-6 polypeptide that has at least “6 amino acids”. Furthermore, with respect to the “at least 90% identity” limitation, the specification fails to recite which amino acids may be added, deleted, substituted, or otherwise mutated anywhere throughout the entire length of the polypeptide of IL-6. There is no limit in the claims, as written, that the variance be contiguous. Moreover, there is no limitation stating that the substitution, for example, be a conservative substitution. As a result, there are potentially thousands of variant permutations that could be made. Applicants have not described which portions of the polypeptide are critical to the function of the protein. The specification provides limited guidance regarding which amino acids can be modified in the genus of peptides, while maintaining the desired function. Therefore, these structures (i.e., sequence variants) are claimed only by their functional characteristics and the specification fails to provide sufficient correlation between the claimed functional characteristics and the necessary structural components (i.e., critical domains within the sequences).
Thus, the genus of claimed peptides is extremely broad because the claims recite generic and incompletely described peptides. One of ordinary skill in the art would not be reasonably apprised of the structure of the claimed peptides without adequate descriptions of its component parts or overall makeup. The claims as recited do not impart enough structural information to permit one of ordinary skill in the art to reasonably recognize or understand that Applicant was in possession of the full scope of the genus of variant peptides recited in the claims. The specification does not provide adequate written description to identify the broad and variable genus of peptides because, inter alia, the specification does not disclose a correlation between the necessary structure of the peptide and the function(s) of the peptide; and thus, the specification does not distinguish the claimed genus from others. Accordingly, the specification does not define any structural features commonly possessed by members of the genus of variant peptides. In addition, because the genus of claimed polypeptide is highly variable (i.e., each variant peptide would necessarily have a unique structure; see MPEP 2434), the generic description of the variant peptide is insufficient to describe the genus.
Further, Applicants have not shown possession of a representative number of species of the claimed peptides. As noted above, the claims are generic for the components of the peptide. The disclosure of only a few species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.") (MPEP 2163).
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.)
Protein chemistry is probably one of the most unpredictable areas of biotechnology. Consequently, the effects of sequence dissimilarities upon protein structure and function cannot be predicted. Bowie et al. (Science, 1990, 247:1306-1310) teach that an amino acid sequence encodes a message that determines the shape and function of a protein and that it is the ability of these proteins to fold into unique three-dimensional structures that allows them to function and carry out the instructions of the genome and further teaches that the problem of predicting protein structure from sequence data and in turn utilizing predicted structural determinations to ascertain functional aspects of the protein is extremely complex (column 1, page 1306). Bowie et al. further teach that while it is known that many amino acid substitutions are possible in any given protein, the position within the protein's sequence where such amino acid substitutions can be made with a reasonable expectation of maintaining function are limited. Certain positions in the sequence are critical to the three-dimensional structure/function relationship and these regions can tolerate only conservative substitutions or no substitutions at all (column 2, page 1306). The sensitivity of proteins to alterations of even a single amino acid in a sequence are exemplified by Burgess et al. (J. Cell Biol. 111:2129-2138, 1990) who teach that replacement of a single lysine reside at position 118 of acidic fibroblast growth factor by glutamic acid led to the substantial loss of heparin binding, receptor binding and biological activity of the protein and by Lazar et al. (Mol. Cell. Biol., 8:1247-1252, 1988) who teach that in transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen. These references demonstrate that even a single amino acid substitution will often dramatically affect the biological activity and characteristics of a protein.
Additionally, Bork (Genome Research, 2000, 10:398-400) clearly teaches the pitfalls associated with comparative sequence analysis for predicting protein function because of the known error margins for high-throughput computational methods. Bork specifically teaches that computational sequence analysis is far from perfect, despite the fact that sequencing itself is highly automated and accurate (page 398, column 1). One of the reasons for the inaccuracy is that the quality of data in public sequence databases is still insufficient. This is particularly true for data on protein function. Protein function is context dependent, and both molecular and cellular aspects have to be considered (page 398, column 2). Conclusions from the comparison analysis are often stretched with regard to protein products (page 398, column 3). Further, although gene annotation via sequence database searches is already a routine job, even here the error rate is considerable (page 399, column 2). Most features predicted with an accuracy of greater than 70% are of structural nature and, at best, only indirectly imply a certain functionality (see legend for table 1, page 399). As more sequences are added and as errors accumulate and propagate it becomes more difficult to infer correct function from the many possibilities revealed by database search (page 399, paragraph bridging columns 2 and 3). The reference finally cautions that although the current methods seem to capture important features and explain general trends, 30% of those features are missing or predicted wrongly. This has to be kept in mind when processing the results further (page 400, paragraph bridging cols 1 and 2).
The state of the art regarding the structure-function correlation cannot be relied upon because functional characteristics of any peptide/protein are determined by its structure as evidenced by Greenspan et al. 1999 (Defining epitopes: It's not as easy as it seems; Nature Biotechnology, 17:936-937). Greenspan et al. teach that as little as one substitution of an amino acid (e.g., alanine) in a sequence results in unpredictable changes in the 3-dimenstional structure of the new peptide sequence which, in turn, results in changes in the functional activity such as binding affinity of the peptide sequence (page 936, 1st column). Greenspan et al. teach that contribution of each residue (i.e., each amino acid) cannot be estimated with any confidence if the replacement affects the properties of the free form of the molecule (page 936, 3rd column).
Given not only the teachings of Bowie et al., Lazar et al., Burgess et al., and Greenspan et al., but also the limitations and pitfalls of using computational sequence analysis and the unknown effects of alternative splicing, post translational modification and cellular context on protein function as taught by Bork, the claimed peptides could not be predicted as claimed.
Applicant has provided little or no descriptive support beyond the mere presentation of generic or partially named structures to enable one of ordinary skill in the art to determine the actual structural composition of the claimed genus of peptides in the conjugate. Although the prior art outlines art-recognized procedures for producing and screening for recombinant proteins this is not sufficient to impart possession of the genera of variant proteins to Applicant. Even if a few structurally identifiable composition components were described in the specification, they may not be sufficient, as the ordinary artisan would not necessarily immediately recognize how to put them together in such a way as to form a completely constructed peptide such that one would be able to distinguish it from the peptides of the prior art. Without an adequate structural description of the claimed components and descriptive support on how to put them together, one of ordinary skill in the art would not be reasonably apprised that Applicant was in possession of the genus of IL-6 proteins as claimed.
While "examples explicitly covering the full scope of the claim language" typically will not be required, a sufficient number of representative species must be included to "demonstrate that the patentee possessed the full scope of the [claimed] invention." Lizard tech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724,1732 (Fed. Cir. 2005).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the claimed IL-6 conjugate. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features (see, Univ. of Rochester v. G.D. Searle& Co., 358 F.3d 916,927, 69 USPQ2d 1886, 1895 (Fed. Cir. 2004); accord Ex Parte Kubin, 2007-0819, BPAI 31 May 2007, opinion at p. 16, paragraph 1). 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).
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).
Therefore, the full breadth of the claims fails to meet the written description provision of 35 U.S.C. §112, first paragraph. In the instant case, for example, Applicants have failed to describe which “IL-6 polypeptide sequences have at least 90% identity” to IL-6 as claimed.
Claim Rejections - 35 U.S.C. § 112(b)
5. 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.
5a. Claims 1-2, 5-7, 9-12, 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 pre-AIA the applicant regards as the invention.
Claim 1, line 3, is vague and indefinite because it recites “anti IL-6 agent” rather than an “anti-IL-6 agent” for consistency with claim 2. Furthermore, the metes and bounds of the term “IL-6 agent” is unclear.
Claim 6 is vague and indefinite for several reasons.
Claim 6, lines 2-3, is vague and indefinite because it recites “a polypeptide derived from IL-6” and it is unclear how similar the polypeptide is to IL-6. Is it 50%, 75% or 90% similar? Therefore, the metes and bounds of the claim are unclear.
Claims 6-7 are improper because they recite non-elected subject matter. It is suggested that the claims be amended to delete recitation of “IL-6R” to obviate this rejection.
Claim 7, line 2, is vague and indefinite because it fails to recite that “at least 6 amino acids” are contiguous.
Claim 7, lines 2-3, is vague and indefinite because it recites “…having at least 90% identity thereto”, and it is unclear which amino acids sequences in IL-6 are encompassed by the limitation because no amino acid sequence has been recited in the claim. Furthermore, it is unclear which species of IL-6 is encompassed by the claim because IL-6 species are very disparate in amino acid sequence. Human and mouse IL-6 share only about 42% amino acid identity.
Claim 9 is vague and indefinite because it is unclear if the limitation “not immediate” encompasses 15 minutes, 30 minutes or an hour after the operation. On page 2, lines 29-32, the specification discloses “Preferably, the post-operative pain according to the invention is not immediate, i.e. it does not appear as soon as the operation is over, in particular as soon as the individual who underwent the operation wakes up if the individual was put to sleep for the
operation.” Therefore, the metes and bounds of the term “not immediate” are unclear.
Regarding claim 10, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2, 5, and 11-12, are rejected as vague and indefinite insofar as they depend on the above rejected claims for their limitations.
Claim rejections-35 U.S.C. 102
6. 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 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.
(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.
6a. Claims 1-2, 5, 9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by
WO2010/088444 teaches an anti-IL6 antibody for the treatment or the prevention of post-operative pain (paragraph [255]; claims 20, 38). The reference also discloses that the anti-IL6 antibody is administered as a post-surgery analgesic for treatment of inflammatory osteoarthritic pain and rheumatoid arthritic pain (paragraph [255]). Therefore, the prior art anticipates claims 1-2, 5 and 9.
6b. Claims 1-2, 5-7, 9-11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2004/0121958 A1.
US 2004/121958 teaches peptides for the prevention of pain in a patient (paragraph [15], [51-54], [93]; page 6, Table 5; claims 9, 13, 18) including a peptide of human interleukin-6 (hIL6) EALAENNLNLPKMAG which encompasses ALAENNL (SEQ ID NO:3) recited in claim 11 of the instant (paragraph [51]; page 6, [Table 5]). The same active agent is administered in both, the method of the instant claims and the method of the prior art reference for alleviating pain. The fact that applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Therefore, although the reference is silent about post-operative pain it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). “(i)t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Therefore, the method disclosed in the reference anticipates claims 1-2, 5-7, and 9-11.
Claim rejections-35 U.S.C. 103
7. 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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
7a. Claims 1-2, 5-7, and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0121958 A1 in view of Lucille Desallais et al (2016).
The teachings of US 2004/0121958 A1 have been set forth above in paragraph 6b. The reference is silent with respect to administering an IL-6 peptide consisting or comprising C78ESSKEALAENNLNLPK94CY (SEQ ID NO:6) for the treatment of post-operative pain.
Lucille Desallais et al (2016) describes a peptide of human interleukin-6 (hIS200) which comprises the sequence 78-94 of human interleukin-6: Acetyl + C78ESSKEALAENNLNLPK94CY (SEQ ID NO:6 in the instant application) which is administered as an active immunotherapy agent for the induction of high levels of anti-IL-6 antibodies as well as neutralizing antibodies to treat inflammation in cynomolgus monkeys (See abstract; page 2, first full paragraph, Methods). The inflammatory score for the hIS200-immunized monkeys was significantly lower compared to the control group (page 5, first paragraph; page 6, Figure 5). Furthermore, the IL-6 peptide of SEQ ID NO:6 disclosed in the reference, encompasses the IL-6 peptide of SEQ ID NO:3 recited in instant claim 11.
Therefore, it would have been obvious to a person skilled in the art at the time of the instant invention to modify the method of US 2004/0121958 A1 and administer the anti-IL-6 peptide disclosed by Lucille Desallais et al because Lucille Desallais et al teaches that the peptide of SEQ ID NO:6 is an active peptide-based immunotherapeutic agent for the induction of anti-IL-6 antibodies. Therefore, a person skilled in the art could be motivated from the teachings of the references to administer the polypeptide disclosed by Lucille Desallais et al in the method of pain treatment of US 2004/0121958 A1 because Lucille Desallais et al teaches that C78ESSKEALAENNLNLPK94CY peptide is an active immunotherapy agent for the induction of anti-IL-6 antibodies in the treatment of inflammation. Therefore, the combination of references renders obvious claims 1-2, 5-7, and 9-12 in the absence of evidence to the contrary.
Conclusion
No claim is allowable.
Claims 1-2, 5-7, 9-10, and 11-12, are rejected.
Advisory Information
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1646
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