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 .
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The instant abstract utilized implied phrases see “The present invention relates to”. This language should be avoided.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1-13 are objected to because of the following informalities: The pages containing claims 1-13 also have line numbers to the left of the claims which can cause confusion. For instance, line 15 has the number the beside it. It is recommend to delete the page line numbers from the listing of claims. Appropriate correction is required.
Claims 4-13 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and cannot depend rom any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 4-13 have not been further treated on the merits.
Status of the claims
Claims 1-13 are pending. Claims 4-13 have not been further treated on the merits (see Claim Objections above). Thus, claims 1-3 are under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 1 describes an abstract idea, law of nature, or natural phenomenon in the preamble of the claim by requiring a method of determining the disease status of a subject that has been diagnosed with an antibody-associated autoimmune disease or an antibody-mediated autoimmune disease and determining the likelihood or relapse or treatment. The claims are directed to a naturally occurring correlation between the levels or presence of the recited biomarkers in a subject with the disease status of relapse or treatment
Step 2A, Prong 2
The additional elements of providing a biological sample and determining the level of presence of IgM or CXCL13 does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “determining whether the subject is in a relapse, determining the likelihood of a relapse, determining whether the subject is to be treated, or determining whether a subject is likely to benefit from treatment”. The “determining” statement at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the recited markers being correlated with relapse or need of treatment. No active method steps are invoked or clearly required; the “determining” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by the art below it is well known routine and conventional in the art to provide a sample and determine the level or presence of IgM or CXCL13.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-3 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to a method of determining any and all disease status of any and all subjects that has been diagnosed with any and all antibody-associated autoimmune diseases or any and all antibody-mediated autoimmune disease by providing any and all biological samples from any possible subject and detecting the mere presence or level of IgM antibodies to any possible antigen or detecting the mere presence or level of CXCL13. The limitation ‘disease status’ represent a genus and encompasses disease stages e.g. 1, 2, 3 or prevalence/activity such as endemic or outbreak and also encompasses categorizing a subject as having or not having a disease to name a few. The limitation ‘antibody-associated autoimmune disease or antibody-mediated disease’ is a genus and encompasses Myasthenia gravis, Lupus (SLE), Graves’ disease, Hashiomoto’s thyroiditis, Rheumatoid arthritis, Celiac disease and Sjogren syndrome to name a few. The limitation ' biological sample’ is a genus and encompasses tears, semen, liver, serum, plasma, urine, kidney, brain, peritoneal fluid, sputum, synovial fluid, lung tissues or stool. The limitation 'subject’ represents a genus and encompasses human and non-human including monkey, dog, pig, kangaroo, horse, canine and feline to name a few. Also, the current claims appear to allow for any level or even the mere presence of the recited biomarkers being correlated with any and all possible disease status of antibody-associated autoimmune disease or antibody-mediated autoimmune disease. However, there is inadequate written description in the instant specification for a method(s) of such broad scope as claimed currently.
In order to fulfill the written description requirements set forth under 35 U.S.C § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, each member correlated with the requisite function, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicants have possession the claimed invention. Applicants have not described and established structure-function correlation for a representative number of species within the broad genus of at least the recited ‘disease status’, ‘antibody-associated autoimmune disease or antibody-mediated disease’ ‘subject’, and “biological sample’ and expression level such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the full scope of the claimed invention at the time the application was filed.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). 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 University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. When there is substantial structural variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
A review of the instant specification indicates the following. The specification on pages 19-20 discloses serological association with relapses and RTX administration in patients with Neuromyelitis Optical spectrum disorders (NMOSD) and discloses AQP4-IgM levels in patients with administer RTX or naïve to RTX. The specification on page 23 discloses a ROC curve showing sensitivity and specificity of different cut-off of AQP4 IgM titres. The specification on page 24 discloses the proportion of relapse samples and APQ4-IgM. The specification on page 25 discloses that CXCL13 levels were significantly higher in sera from relapsing versus non-relapsing LGl1-autoantibody patients and relapsing patients more frequently showed CSCL13 levels above a sera cut-off. The specification on page 25 the detection of AQP4-IgM in serum with the use of anti-human IgM (specifically for human). The specification of page 27, lines 29-30 the visualization of human antibodies. The examples in the specification appear to be limited to the detection of IgM antibodies specific for AQP4 or measurement of CXCL13 in the blood or serum of human patients having NMOSD and comparing the levels to that of a control to correlate with relapse of the NMOSD. The specification does not teach that the detection of any and all IgM with any and all antigens or CXCL13 level from any and all subjects that have been diagnosed with any and all antibody-mediated or antibody-associated autoimmune disease and correlating with any and all possible disease status. The specification appear to be limited to the detection of IgM antibodies specific for AQP4 or measurement of CXCL13 in the blood or serum of human patients having NMOSD and comparing the levels to that of a control to correlate with relapse of the NMOSD.
Further, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract).
The only examples utilized in the specification appear to be limited to the detection of IgM antibodies specific for AQP4 or measurement of CXCL13 in the blood or serum of human patients having NMOSD and comparing the levels to that of a control to correlate with relapse of the NMOSD. The specification does not disclose that the recited biomarkers which appear blood or serum also appear in samples such as ileal tissue, lung, brain, sputum, or stool or that such biomarkers would be expected to be shed, excreted into or found in these samples and correlated with any and all aneurysms. As stated supra the specification appear to be limited to the detection of IgM antibodies specific for AQP4 or measurement of CXCL13 in the blood or serum of human patients having NMOSD and comparing the levels to that of a control to correlate with relapse of the NMOSD.
The specification also fails to provide for a correlation of the recited biomarkers in all subjects such as dogs, cats, cows, monkey, horse, rabbit and squirrel (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease) The specification also fails to provide that the recited biomarkers exist in samples such as lung tissue, kidney tissue, stool, sputum, CSF or liver tissue or that a correlation of the biomarkers exist in such subjects with aneurysm. Further, it is not well known in the art that these samples provide for the biomarkers and that a correlation exists between such biomarkers in the samples to assess any and all aneurysms. The examples in the specification appear to be limited the detection of IgM antibodies specific for AQP4 or measurement of CXCL13 in the blood or serum of human patients having NMOSD and comparing the levels to that of a control to correlate with relapse of the NMOSD. The purpose of the ‘written description; requirement is broader than to merely explain how to ‘make and use’, 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.
It must be noted that "[t]he applicant must . . . convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir.1991). The invention, is for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the claimed invention at the time of filing. The Written Description Guidelines state: There is an inverse correlation between the level of predictability in the art and the amount of disclosure necessary to satisfy the written description requirement. For example, if there is a well-established correlation between the structure and function in the art, one skilled in the art will be able to reasonably predict the complete structure of the claimed invention from its function. Furthermore, the written description provision of 35 U.S.C § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ‘Written Description’ Requirement (66 FIR 1099-1111, January 5,2001) state, ‘[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention’ (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. Factual evidence of an actual reduction to practice has not been disclosed in the instant specification, nor has Applicant shown the invention was ‘ready for patenting’. The Guidelines further state, ‘[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus' (Id. at 1106). For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Instant claims are viewed as not meeting the written description provision of 35 U.S.C § 112, first paragraph. The specification does not provide for the detection of any and all IgM with any and all antigens or CXCL13 level from any and all subjects that have been diagnosed with any and all antibody-mediated or antibody-associated autoimmune disease and correlating with any and all possible disease status.
Scope of Enablement
Claims 1-3 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of determining relapse in a human subject that has been diagnosed with Neuromyelitis Optical spectrum disorders (NMOSD), wherein IgM antibodies are specific for AQP4 by obtaining a blood or serum sample from the subject and detecting the level of the IgM antibodies or the level of CXCL13 and comparing to a control wherein a higher level of the antibodies or the CXCL13compared to the control determines a relapse in the subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. The factors that must be considered in determining undue experimentation are set forth in In re Wands USPTQ2d 14000. Factors to be considered in determining whether a disclosure would require undue experimentation include (1) the nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the quantity of experimentation necessary, (7) the relative skill of those in the art, and (8) the breadth of the claims.
The claims are directed to a method of determining any and all disease status of any and all subjects that has been diagnosed with any and all antibody-associated autoimmune diseases or any and all antibody-mediated autoimmune disease by providing any and all biological samples from any possible subject and detecting the mere presence or level of IgM antibodies to any possible antigen or detecting the mere presence or level of CXCL13.
One cannot extrapolate the teachings of the specification to the enablement of the claims because other than measuring the level of IgM antibodies specific to AQP4 or the level of CXCL13 in a human subject that has been diagnosed with NMOSD and comparing the level to that of a reference or control wherein a level higher than the reference or control determines relapse in the subject, the specification does not teach any and all samples from any and all subjects contain the recited biomarkers and particularly at levels for determining any and all disease status of a subject having been diagnosed with any and possible antibody-associated or antibody-mediated autoimmune disease. Further, the measurement of the recited biomarker(s) in such samples a lung tissue, feces, urine, tears, CSF, vomit etc is not well known and conventional. The specification only provides the measurement of the recited biomarkers in blood or serum samples from a human subject and assessing relapse of NMOSD.
The specification on pages 19-20 discloses serological association with relapses and RTX administration in patients with Neuromyelitis Optical spectrum disorders (NMOSD) and discloses AQP4-IgM levels in patients with administer RTX or naïve to RTX. The specification on page 23 discloses a ROC curve showing sensitivity and specificity of different cut-off of AQP4 IgM titres. The specification on page 24 discloses the proportion of relapse samples and APQ4-IgM. The specification on page 25 discloses that CXCL13 levels were significantly higher in sera from relapsing versus non-relapsing LGl1-autoantibody patients and relapsing patients more frequently showed CSCL13 levels above a sera cut-off. The specification on page 25 the detection of AQP4-IgM in serum with the use of anti-human IgM (specifically for human). The specification of page 27, lines 29-30 the visualization of human antibodies. The examples in the specification appear to be limited to the detection of IgM antibodies specific for AQP4 or measurement of CXCL13 in the blood or serum of human patients having NMOSD and comparing the levels to that of a control to correlate with relapse of the NMOSD. The specification does not teach that the detection of any and all IgM with any and all antigens or CXCL13 level from any and all subjects that have been diagnosed with any and all antibody-mediated or antibody-associated autoimmune disease and correlating with any and all possible disease status. The specification appear to be limited to the detection of IgM antibodies specific for AQP4 or measurement of CXCL13 in the blood or serum of human patients having NMOSD and comparing the levels to that of a control to correlate with relapse of the NMOSD.
Further, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract).
The only examples utilized in the specification appear to be limited to the detection of IgM antibodies specific for AQP4 or measurement of CXCL13 in the blood or serum of human patients having NMOSD and comparing the levels to that of a control to correlate with relapse of the NMOSD. The specification does not disclose that the recited biomarkers which appear blood or serum also appear in samples such as ileal tissue, lung, brain, sputum, or stool or that such biomarkers would be expected to be shed, excreted into or found in these samples and correlated with any and all aneurysms. Thus, for the reasons stated supra one cannot practice the claimed invention without undue experimentation.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 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.
Claim 1, step (a) the recitation “a subject” is vague and indefinite because it is unclear if the Applicant is referring to the subject recited in line 1 of the preamble or if the Applicant intends something else. See also deficiencies found in claim 2, line 3.
Claim 1, step (b) is indefinite in reciting “determining the level or presence of IgM isotype antibodies” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --detecting--.
Claim 3 is indefinite in reciting “or the absence of IgM isotype antibodies …” because claim 1 appears to specifically require determining a specific level or the presence of the antibodies and now claim 3 is determining an absence. Therefore, it is unclear if the applicant is changing the limitations from claim 1, if the applicant inadvertently left out the absence or if the applicant intends something else. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims.
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.
Claims 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pedreno et al (Multiple Sclerosis and Related Disorders 28, 2019, pages 230-234.
Pedreno et al discloses a method comprising providing a serum sample from a subject such as a subject suspected of NMOSD (e.g. page 231). Pedreno et al discloses determining the presence of IgM antibodies (e.g. Table 1, page 232).
Pedreno et al also discloses a method comprising providing a serum sample fro a subject having Myelin oligodendrocyte glycoprotein (MOG) and discloses detecting IgM antibodies for the MOG-associated IgG disease and teaches that these antibodies provide indication of the disease.
With respect to the recitation “of determining the disease status of a subject that has been diagnosed with an antibody-associated autoimmune disease or an antibody-mediated autoimmune disease wherein the antibody recognizes a specific antigen” as recited in claim 1. This recitation is not given patentable weight because the recitation appears in the preamble of the claim. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case Pedreno et al performs every active method step and when every active method step has been performed the prior art method is met.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al (Journal of Neuroimmunology 240-241, 2011, pages 104-108).
Zhong et al discloses a method of determining neuromyeltis optica (NMO) in a patient comprising obtaining a CSF sample (biological sample) from the patient and measuring the level of CXCL13 in the sample and comparing the sample to that of a control (e.g. abstract, pages 104 – 105). Zhong et al discloses thatCXCl13 levels were related to NMO disease activity indicated by relapse rate. Zhong et al discloses that patients with higher relapse have the higher CSCl13 concentrations (e.g. abstract).
With respect to the recitation “of determining the disease status of a subject that has been diagnosed with an antibody-associated autoimmune disease or an antibody-mediated autoimmune disease wherein the antibody recognizes a specific antigen” as recited in claim 1. This recitation is not given patentable weight because the recitation appears in the preamble of the claim. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case Pedreno et al performs every active method step and when every active method step has been performed the prior art method is met.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cohen et al (US 20160069896).
Cohen et al discloses a method of diagnosing (disease status) SLE (antibody-associated autoimmune disease) comprising obtaining a from a subject and detecting the presence of IgM antibodies to MOG and comparing the presence to that of a control sample and determining a difference to diagnose the subject with SLE (e.g. page 22, clm 13). Cohen et al discloses administering a treatment to the subject having SLE (thus, the presence of the IgM indicated the need for treatment).
With respect to the recitation “of determining the disease status of a subject that has been diagnosed with an antibody-associated autoimmune disease or an antibody-mediated autoimmune disease wherein the antibody recognizes a specific antigen” as recited in claim 1. This recitation is not given patentable weight because the recitation appears in the preamble of the claim. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). In the instant case Pedreno et al performs every active method step and when every active method step has been performed the prior art method is met. Regarless, Cohen et al reads on the limitations as currently recited.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GARY COUNTS/ Primary Examiner, Art Unit 1678