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 of Group III (claims 31-34) and the specifies at least one antigen in the reply filed on 05/13/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon further consideration the species restriction is withdrawn. Currently, claims 14-35 are pending. Claims 14-30 and 35 are withdrawn as being directed to non-elected inventions. Accordingly, claims 31-34 are under examination.
Information Disclosure Statement
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.
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 use of the term Tween-20 (e.g. page 23, line 16), 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.
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
Claim 32 is objected to because of the following informalities: the recitation “A fragment” should be --An antigenic fragment or peptide--. To avoid any possible ambiguity that the fragment or peptide does not possess an epitope. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitations is/are:
“means for the detection and/or quantification of at least one type of AGO-Abs” in claim 31.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 32-34 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. This is a written description rejection.
The instant claims are broadly drawn to a genus of variants of AGO1, AGO2, AGO3 and AGO4 which have the unique capability of binding to Argonaute autoantibodies.
The specification on page 10 discloses AGO1, AGO2, AGO3 and AGO4 and gives specific SEQ ID Nos: 5-8 for each of the argonautes. The specification on page 12 defines “fragments” as an antigenic fragment which is a portion of the whole AGO protein that contains at least one epitope allowing its binding with at least one anti-AGO antibody. The specification on page 23 discloses the use of HuProt 3.1 microarrays (which is proteome microarray which features 20,000 full-length human proteins). The specification on pages 23-24 discloses HEK 293 cells transfected with very specific AGO consisting of SEQ ID Nos 1-4. However, the specification does not teach give the structure of a single variant of the AGO proteins which possess the unique capability of specific affinity for binding to the AGO autoantibodies. There are no tables, data or evidence to provide that any and all variants are known in the art which possess this unique characteristic or capabilities.
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 by describing structural features common the genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, 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.” The Federal Circuit has recently clarified that a DNA molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristic, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613”.
The court has since clarified that this standard applies to compounds other than cDNAs. See University of Rochester v. G.D. Searle & Co., Inc., F.3d ,2004 WL 260813, at *9 (Fed.Cir.Feb. 13, 2004). The instant specification fails to provide sufficient descriptive information of any variant which possesses the unique capability of specifically binding to AGO autoantibodies. Thus, one of skill in the art would reasonably conclude that the inventor(s), at the time the application was filed, did not have possession of the broadly claimed genus of immobilization agents and the invention using such immobilization agents.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure(s) and functional attribute(s) of the encompassed genus of variants or derivatives used in the method, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Considering the potentially large numbers of variants encompassed by these claims, the disclosure is not sufficient to show that a skilled artisan would recognize that the applicant was in possession of the claimed invention (genus) commensurate to its scope at the time the application was filed. The specification appears to be limited to the full length proteins, antigenic fragments and specific cells expressing SEQ ID NOs: 1-4.
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 31-34 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 32, line 2 the recitation “means for the detection and/or quantification of at least one type of AGO-Abs ” is not clear because it is unclear what the means for are. The specification does not provide a specific definition and does not provide a specific scope because in addition antibodies it also appears to allow for any and all reagents, devices including buffers, controls, instructions etc. Thus, it is unclear what the applicant is trying to encompass. The metes and bounds of the claim cannot be ascertained as currently recited.
Claim 32 the recitation “for the implementation of the process according to claim 14” is vague and indefinite because the claim depends from a non-elected invention and thus it is unclear what applicant intends to encompass. Please clarify.
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 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MacVicar (US 2005/0014200).
MacVicar discloses a kit comprising a detecting enzyme linked, anti-human immunoglobulin antibody (same antibody as recited in claim 32) and an enzyme substrate (reactant useful for in vitro detection as recited in claim 32) (e.g. para 0027).
With respect to the recitation “for the implementation of the process according to claim 14” as recited in the preamble of the claim 31. This is intended use of the kit and a recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art and since MacVicar disclose the same components as the instantly recited claims, MacVicar reads on the instantly recited claims and is capable of being implemented for the process according to claim 14. Also, this recitation occurs in the preamble of the claim and thus has not been given patentable weight. 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).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Ogawa-Momohara et al (Clinica Chimica Acta 471, 2017, pages 304-307) in view of Boguslaski et al (US 5,420,016) in light of Muro et al (Clinical and Development Immunology, 2013, pages 1-7).
Ogawa-Momohara et al discloses a method and reagents for the detection of autoantibodies to Arogonaute 2 (AGO2) (e.g. abstract, pg 305). Ogawa-Momohara et al discloses recombinant Ago2 protein immobilized to plate (solid carrier) (means for detection) (e.g. pg 305). Ogawa-Momohara et al discloses horse radish peroxidase-conjugated goat anti-human IgG antibody (means for detection) (e.g. pg 305).
Ogawa-Momohara et al differs from the instant invention in failing to teach the components and reagents packaged into a kit.
Boguslaski et al teaches assembling various components into a kit and also discloses that by assembling these components into kits makes it more convenient and facile for the test operator (col 7).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to package the regents and components of Ogawa-Momohara et al into a kit format such as taught by Boguslaski et al because Boguslaski et al teaches that assembling components into kits makes it more convenient and facile for the test operator. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the plate, recombinant AGO2 and antibodies of Ogawa-Momohara et al into a kit such as taught by Boguslaski et al.
With respect to the recitation “for the implementation of the process according to claim 14” as recited in the preamble of the claim 31. This is intended use of the kit and a recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art and since the combination of Ogawa-Momohara et al and Boguslaski et al disclose the same components as the instantly recited claims, the combination of Ogawa-Momohara et al and Boguslaski et al reads on the instantly recited claims and is capable of being implemented for the process according to claim 14. Also, this recitation occurs in the preamble of the claim and thus has not been given patentable weight. 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).
With respect to claim 34 and a microtiter plate. Ogawa-Momohara et al discloses that the sera was tested following previously published protocols such as in Muro et al (Clinical and Development Immunology, 2013, pages 1-7). As shown in Muro et al the plate is a microplate (also known as a microtiter plate).
Claims 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeda et al (Journal of Immunological Methods, 317, 2006, pages 38-44) in view of Boguslaski et al (US 5,420,016).
Ikeda et al discloses methods and components for the detection of antibodies (e.g. page 39). Ikeda et al discloses recombinant Ago2 protein immobilized to a microtiter plate (e.g. page 39).
Ikeda et al differs from the instant invention in failing to teach the components and reagents packaged into a kit.
Boguslaski et al teaches assembling various components into a kit and also discloses that by assembling these components into kits makes it more convenient and facile for the test operator (col 7).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to package the regents and components of Ikeda et al into a kit format such as taught by Boguslaski et al because Boguslaski et al teaches that assembling components into kits makes it more convenient and facile for the test operator. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the microtiter plate and recombinant AGO2 of Ikeda et al into a kit such as taught by Boguslaski et al.
With respect to the recitation “for the implementation of the process according to claim 14” as recited in the preamble of the claim 31. This is intended use of the kit and a recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art and since the combination of Ikeda et al and Boguslaski et al disclose the same components as the instantly recited claims, the combination of Ikeda et al and Boguslaski et al reads on the instantly recited claims and is capable of being implemented for the process according to claim 14. Also, this recitation occurs in the preamble of the claim and thus has not been given patentable weight. 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).
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Luo et al (Genomics Proteomics Bioinformatics, 17, September 2019, pages 248-259) discloses arrays of recombinant proteins for the detection of autoantibodies such as AGO1 (e.g. pgs 250-251, 254, 257). Luo et al discloses AGO1 immobilized coated onto a plate (e.g. pg 257).
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.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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