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 .
Election/Restrictions
2. Applicant’s election without traverse of invention Group VI (claim 22, drawn to a method for inhibiting or reducing menstruation comprising administration of an agent capable of binding to IL-11 or IL-11RA and inhibiting or antagonizing IL-11 mediated signaling) in the reply filed on 07/31/2026 is acknowledged. Claims 1 and 6-16, and 19-21 are previously presented-withdrawn. Claims 17-18 are withdrawn.
3. The election without traverse filed 07/31/2026 is acknowledged. Claim 22 is pending and under examination.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted 08/16/2023, 12/19/2025, and 08/05/2026 and the references cited therein have been considered, unless indicated otherwise.
5. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
6. The use of the term Genetex (Table E30), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Please review the specification for other trademarks and correction is required.
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.
7. Claim 22 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.
The term/phrase “capable of” in claim 22 is a relative term which renders the
claims indefinite. The term “capable of” 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/phrase 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.
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.
8. Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method for inhibiting or reducing menstruation comprising administration of an agent capable of binding to IL-11 and/or IL-11RA and inhibiting, or antagonizing IL-11 mediated signaling.
The specification teaches the present invention provides agents in form of inhibitors and antagonists of interleukin-11 (IL-11) and/or interleukin-11 receptor alpha (IL-11RA) including allosteric inhibitors and antagonists for the treatment and/or prevention of abnormal uterine bleeding. The specification further teaches inhibitors or antagonists in the form of antibodies, fragments and derivatives thereof, antibody mimetics, nucleic acids, aptamers, or small molecules.
The claims a method for inhibiting or reducing menstruation comprising administration of an agent capable of binding to IL-11 and/or IL-11RA and inhibiting, or antagonizing IL-11 mediated signaling. However, the specification provides only general description of IL-11 and IL-11RA as biological targets and identifies the inhibitors by name without providing any data, working examples, or experimental evidence demonstrating that these compounds are effective in treating any of the claimed cardiovascular diseases.
The specification does not provide any disease specific mechanistic reasoning, pharmacological data or therapeutic guidance linking inhibition of IL-11 and IL-11RA to a beneficial effect in inhibiting and reducing menstruation. The disclosure amounts to a mere recitation of the claimed subject matter in narrative form, which is insufficient to satisfy the written description requirement. See Ariad Pharms., Inc V. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (end banc) (“[A] description that merely restates the claim language… does not satisfy the written description requirement.”); see also MPEP §2163.
The specification fails to describe the structural features common to members of the genus that would allow the skilled artisan to distinguish agents encompassed by the claims from other agents, and disclose any correlation between the structure and function of the agents encompassed by the claims. While the specification teaches that the IL-11 and IL-11RA is antibodies, fragments and derivatives thereof, antibody mimetics, nucleic acids, aptamers, or small molecules, generically stating the type of agent that can be IL-11 and ILRA inhibitors is not a description of the agent itself. That is because knowing the broad class to which the IL-11 and/or IL-11RA inhibiting, or antagonizing IL-11 mediated signaling belongs does not provide any information regarding the specific structure that yields the required function(s). Although those of ordinary skill in the art could prepare the claimed agents, it is the specification itself that must demonstrate possession. “A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence”. Thus, the specification fails to describe the agents required to practice the claimed method in a manner that reasonably conveys to those skilled in the art that Applicant was in possession of the claimed method.
Furthermore, the specification does not disclose a representative number of species to describe the genus. The specification clearly sets forth the correlation between IL-11 and/or IL-11RA inhibition, or antagonizing IL-11 mediated signaling and the function of inhibiting or reducing menstruation. However, the correlation between the aforementioned agent(s) and the corresponding function(s) set forth above do not appear to be clearly present in the breadth of the claims. The claims are generic for the IL-11 and/or IL-11RA inhibiting, or antagonizing IL-11 mediated signaling and the term encompasses any number of different types of agents that vary in their structure. Additionally, the claims are generic for the modifying effect that IL-11 and/or IL-11RA inhibiting, or antagonizing IL-11 mediated signaling agents have on the generically recited subject and/or cell and immune response. Thus, the genus has substantial variation because of the numerous options and combinations permitted. However, the species disclosed are not deemed to be representative of the genus because the few species disclosed do not reflect the variation within the genus. There is no indication in the specification that other species encompassed by the genus that differ from the few species disclosed will have the same functional characteristics and one of skill in the art would not be able to predict the operability of any species other than the ones disclosed. When there is substantial variation within the genus, the specification must describe a sufficient variety of species to reflect the variation within the genus. Thus, the specification does not adequately reflect the structural diversity of the claimed genus, either by the establishment of "a reasonable structure-function correlation or through the disclosure of sufficient number of species that are "representative of the full variety or scope of the genus”. Therefore, the specification provides insufficient written description to support the genus of compositions 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.)
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing 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.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559,1569, 43 USPQ2d 1398,1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(l), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
In Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336,1351 (Fed. Cir. 2010), the court held that a "sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Ariad, 598 F.3d at 1350. "[A]n adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials." Id. Although "functional claim language can meet the written description requirement when the art has established a correlation between structure and function," "merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Id.
Furthermore, regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886,1890-93 (Fed. Cir. 2004).
The specification and claims teach that IL-11 and/or IL-11RA inhibiting, or antagonizing IL-11 mediated signaling agents include antibodies, fragments and derivatives thereof, antibody mimetics, nucleic acids, aptamers, or small molecules. Thus, the claims broadly encompass an indeterminate number of agents that are inhibitors of IL-11 and/or IL-11RA. The instant claims thereby encompass many genera of chemical and biological molecules, without any described structure that is required for the molecules to perform the required functions.
Regarding the encompassed proteins, protein chemistry is 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 (p. 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 (p. 398, column 2). Conclusions from the comparison analysis are often stretched with regard to protein products (p. 398, column 3). Further, although gene annotation via sequence database searches is already a routine job, even here the error rate is considerable (p. 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 (p. 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 (p. 400, paragraph bridging cols 1 and 2). Given not only the teachings of Bowie et al., Lazar et al. and Burgess 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 proteins could not be predicted based on sequence identity.
Regarding the encompassed antibodies, the functional characteristics of antibodies, including binding specificity and affinity, are dictated on their structure. Amino acid sequence and conformation of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. For example, Vajdos et al. (J Mol Biol. 2002 Jul 5;320(2):415-28 at 416) teaches that, “ … Even within the Fv, antigen binding is primarily mediated by the complementarity determining regions (CDRs), six hypervariable loops (three each in the heavy and light chains) which together present a large contiguous surface for potential antigen binding. Aside from the CDRs, the Fv also contains more highly conserved framework segments which connect the CDRs and are mainly involved in supporting the CDR loop conformations, although in some cases, framework residues also contact antigen. As an important step to understanding how a particular antibody functions, it would be very useful to assess the contributions of each CDR side-chain to antigen binding, and in so doing, to produce a functional map of the antigen-binding site." The art shows an unpredictable effect when making single versus multiple changes to any given CDR. For example, Brown et al. (J Immunol. 1996 May; 156(9):3285-91 at 3290 and Tables 1 and 2), describes how the VH CDR2 of a particular antibody was generally tolerant of single amino acid changes, however the antibody lost binding upon introduction of two amino changes in the same region.
Recently, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself even when preparation of such an antibody would be routine and conventional. Amgen, 872 F.3d at 1378-79. A key role played by the written description requirement is to prevent "attempts] to preempt the future before it has arrived." Ariad at 1353, (quoting Fiers v. Revel, 984 F.2d at 1171). Upholding a patent drawn to a genus of antibodies that includes members not previously characterized or described could negatively impact the future development of species within the claimed genus of antibodies. In the instant application, neither the art nor the specification provide a sufficient representative number of antibodies or a sufficient structure-function correlation to meet the written description requirements.
Regarding small molecule inhibitors of a particular protein target, the prediction of binding to a target, much less the inhibitory activity, is highly unpredictable. According to Guido et al (Curr Med Chem. 2008; 15(1):37-46), accurately predicting the binding affinity of new drug candidates remains a major challenge in drug discovery (see page 37). There are a vast number of possible compounds that may function as an inhibitor of a cytokine or cytokine receptor, many of which have likely not been discovered. Relying on virtual screening also lends unpredictability to the art regarding identification of molecules that would be capable of the required functions of the instant claims. Guido et al. teach that there are two main complex issues with predicting activity for a small molecule: accurate structural modeling and/or correct prediction of activity (see page 40). As taught by Clark et al (J. Med. Chem., 2014, 57 (12), pp 5023–5038), developing selective JAK inhibitors is difficult. Even when guided by structure, JAK structure-activity relationships has been challenging owing to the similarities of the enzymes (see page 5028). Therefore, it is impossible for one of skill in the art to predict that any particular encompassed small molecule therapeutic would function to inhibit a particular protein, or treat disease.
Regarding nucleic acid based agents, the efficacy of any possible RNA interference therapeutic modality is highly unpredictable. This unpredictability stems from an inability to predict the effects of any particular sequence the expression or function of any target. As taught by Aagaard et al. (Advanced Drug Delivery Reviews 59 (2007) 75-86), the development of RNAi based therapeutics faces several challenges, including the need for controllable or moderate promoter systems and therapeutics that are efficient at low doses (see page 79), the ability of an unpredictable number of sequences to stimulate immune responses, such as type I interferon responses (see page 79), competition with cellular RNAi components (see page 83), the side effect of suppressing off targets (see page 80), and challenging delivery (see page 83). The success of antisense strategies, including anti-RNA and anti-DNA strategies are also highly unpredictable. Warzocha et al. (Leukemia and Lymphoma, 1997; 24(3-4): 267-281) teach that the efficacy of antisense effects varies between different targeted sites of RNA molecules and three dimensional RNA structures (see page 269), while DNA- targeting strategies have numerous problems including a restricted number of DNA sequences that can form triple helices at appropriate positions within genes and the inaccessibility of particular sequences due to histones and other proteins (see page 269). These references demonstrate that variation in RNA or DNA based therapeutics will often dramatically affect the biological activity and characteristics of the intended therapeutic. Given the teachings of Aagaard et al. and Warzocha et al., the claimed RNA and DNA therapeutics could not be predicted based on the targets selected or similarities to the disclosed example therapeutics. Therefore, it is impossible for one of skill in the art to predict that any particular encompassed RNA or DNA based therapeutic, such as RNAi molecules and antisense oligonucleotides, would function to decrease expression or function of a target gene or protein, or treat disease.
The state of the art regarding an antibody to treat menstruation is discussed by Wong, et al.. Wong, et al. teach monoclonal antibody to IL-11 can treat woman suffering or susceptible to endometriosis which include the same symptoms as menstruation such as irregular period, heavy bleeding and abnormal uterine flow.
Menkhorst, et al. (Menkhorst E, Salamonsen L, Robb L, Dimitriadis E. IL11 antagonist inhibits uterine stromal differentiation, causing pregnancy failure in mice. Biol Reprod. 2009 May;80(5):920-7. doi: 10.1095/biolreprod.108.073601. Epub 2009 Jan 14. PMID: 19144959; PMCID: PMC2849829.) teach the effect of administering a PEGylated IL11 antagonist, PEGIL11A (where PEG is polyethylene glycol), on pregnancy outcomes in mice and IL11 signaling in human endometrial epithelial cells (HES). Menkhorst, et al. further demonstrate that PEGIL11A blocked IL11 action in the decidua during early decidualization, which totally abolished pregnancy and which is equivalent to the Il11ra−/− mouse.
Both Wong, et al. and Menkhorst, et al. provide examples of different agents under the genus of inhibiting or antagonizing IL-11. Wong establishes that a type of agent inhibiting IL-11 to treat menstruation is an antibody, whereas, Menkhorst establishes that a type of agent inhibiting IL-11 to treat menstruation is a PEGylated IL-11 antagonist. Thus, the broad genus of agent as claimed encompasses multiple inhibitors and antagonists that does not meet the requirement of written description.
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." Lizardtech 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 genus. 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).
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.
9. Claim 22 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Wong, et al. (WO 03/039455 A3, published 15 May 2003) as evidenced by Laux-Biehlmann (Alexis Laux-Biehlmann, Menstruation pulls the trigger for inflammation and pain in endometriosis, https://doi.org/10.1016/j.tips.2015.03.004.
(https://www.sciencedirect.com/science/article/pii/S0165614715000449)
The instant claim is drawn to a method for inhibiting or reducing menstruation comprising administration of an agent capable of binding to IL-11 and/or IL-11RA and inhibiting, or antagonizing IL-11 mediated signaling.
Wong teaches endometriosis is a disease affecting woman in their reproductive years. Wong teaches endometriosis affects the tissue that lines the inside of the uterus, which builds up and sheds each month in the menstrual cycle. Wong teach the most common location of endometrial growths include the ovaries, and uterus (page 1, 1st and 2nd paragraphs). Wong teaches symptoms worsen with time. Wong further teach the symptoms of endometriosis as pain before and during periods, infertility, and heavy or irregular bleeding. Wong teaches a method of treating a woman suffering or susceptible to endometriosis (claim 1), inter alia characterized heavy or irregular bleeding (page 2, symptoms section), by administering a cytokine antagonist selected from the group consisting of monoclonal antibodies to IL-11.
Endometriosis encompasses menstruation as evidenced by Laux-Biehlmann. Laux-Biehlmann establishes endometriosis is characterized as heavier menstruation, longer flow duration, and abnormal uterine bleeding (paragraph 2 and 3). Thus, instant claim 22 is anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
10. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Laux-Biehlmann (Alexis Laux-Biehlmann, Menstruation pulls the trigger for inflammation and pain in endometriosis, https://doi.org/10.1016/j.tips.2015.03.004.
(https://www.sciencedirect.com/science/article/pii/S0165614715000449) in view of Wong, et al (WO 03/039455 A3, published 15 May 2003).
The instant claim is drawn to a method for inhibiting or reducing menstruation comprising administration of an agent capable of binding to IL-11 and/or IL-11RA and inhibiting, or antagonizing IL-11 mediated signaling.
Laux-Biehlmann establishes endometriosis is characterized as heavier menstruation, longer flow duration, and abnormal uterine bleeding (paragraph 2 and 3).
Laux-Biehlmann does not teach a method for inhibiting or reducing menstruation comprising administration of an agent capable of binding to IL-11 and/or IL-11RA and inhibiting, or antagonizing IL-11 mediated signaling.
Wong teaches a method of treating a woman suffering or susceptible to endometriosis (claim 1), inter alia characterized heavy or irregular bleeding (page 2, symptoms section), by administering a cytokine antagonist selected from the group consisting of monoclonal antibodies to IL-11.
It would have been prima facie obvious for a person with ordinary skill in the art to apply the method of Wong to arrive at the instant invention and as evidenced by Laux, which discloses that endometriosis is characterized by heavier menstruation. Therefore, an artisan of ordinary skill would reasonably expect that the application of IL-11 to endometriosis would necessarily decrease menstruation. Applying a known technique to a known method ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Conclusion
11. No claims 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
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