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 .
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed steps, the process steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 1, the Examiner notes that the claim does not require endogenous vitamin D binding protein be present in the sample as the claim states that the sample "may contain" vitamin D binding protein (DBP). Additionally, the phrase "under binding conditions" is not a requirement that DBP and megalin bind to form a complex. The Examiner also notes that for samples that do not contain endogenous vitamin D binding protein, the limitations recited in steps b and c are negated. The Examiner also notes that the claim does not require DBP binding to megalin, and does not recite a relationship between megalin and DBP such that one can determine a vitamin D status of a subject.
For claim 1, the Examiner notes that the claimed vitamin D supplementation therapy is not defined or described in the specification. As such, the Examiner is unable to determine if adapting vitamin D supplementation therapy comprises a subject taking a medication, a physician prescribing a medication, or any other therapy that might affect a subject's vitamin D status.
For claim 11, the phrase "antibody complex recognizing the complex comprising DBP" does not require an antibody bound to a complex comprising DBP. The Examiner notes that the claimed 'recognizing' does not require the antibody complex to bind the complex comprising DBP, thus the Examiner will not interpretate the claim as requiring the antibody complex binding the complex comprising DBP.
For claim 12, the Examiner notes that the phrase "amino acid sequence of megalin" is sufficiently broad so as to read on the sequence of megalin printed on instructions within the kit. As such, the Examiner contends that any means by which an amino acid sequence of megalin is provided meets the claim limitation. Also, the Examiner notes that the carrier is optional, and therefore not a required component of the claimed kit.
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.
Claims 1-11 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.
For claim 1, it is unclear how one relates megalin bound DBP to a vitamin D status of a subject as the claim docs not provide a relationship between megalin bound DBP and vitamin D status. The Examiner points out that the claim does not require DBP binding to megalin, thus it is unclear how one of ordinary skill in the art would relate megalin bound DBP to vitamin D status as recited in the claim. Additionally, the phrase "its metabolites" is unclear as the Examiner is unable to determine if the claim is referring to specific metabolites of vitamin D, or all the metabolites of vitamin D. Also, for claim 1, the "higher amount of megalin-bound DBP" is unclear as the claim does not recite a threshold or concentration by which one can determine what is or is not a higher amount. As such, the metes and bounds of the phrase "higher amount" cannot be determined. Claims 2-11 depend directly or indirectly from claim 1 and are also indefinite.
For claim 1, it is unclear what Applicant regards as a vitamin D supplementation therapy as the specification does not define or describe a vitamin D supplementation therapy. Furthermore, it is unclear what Applicant regards as a therapy. For example, it is unclear if the therapy comprises taking a medication, stopping a medication regimen, or a change in diet.
For claim 11, the "higher amount" of antibody bound to the solid phase" is unclear as the claim does not recite a threshold or concentration by which one can determine what is or is not a higher amount. As such, the metes and bounds of the phrase "higher amount" cannot be determined.
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, 4-10, and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) a law of nature and an abstract idea. This judicial exception is not integrated into a practical application because the claims do not recite any additional elements that utilizes the judicial exceptions in a manner that imposes a meaningful limit on the exceptions. Independent claim 1 recites a method for adaptation of vitamin D supplementation therapy in a subject by measuring vitamin D and its metabolites in a sample of bodily fluid comprising contacting a sample with megalin and/or a fragment thereof to form a ternary complex comprising vitamin D binding protein, vitamin D metabolite, and megalin, determining the amount of vitamin D binding protein bound to megalin, relating the amount of megalin-bound vitamin D binding protein to the vitamin D status of the subject, and adapting a vitamin D supplementation therapy to the effective vitamin D status of the subject. The amount of vitamin D binding protein in the sample, and thereby the vitamin D status of the subject results from the disease state of the subject, thus the levels of vitamin D binding protein is nothing more than a law of nature as the levels of vitamin D binding protein reflect the disease state of the subject. The steps of relating the amount of bound vitamin D binding protein, and adapting a vitamin D supplementation therapy are an abstract idea in that the steps only require mental analysis based on the determined amount of vitamin D binding protein. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements are directed to determining a level of a biomarker in a biological sample utilizing routine and conventional techniques. As set forth in the MPEP, determining a level of a biomarker in blood by any means has been recognized as routine and conventional activity, or as insignificant extra-solution activity (MPEP 2106.05(d)). Additionally, the MPEP states that collecting information, analyzing the information, and displaying results is an abstract idea when the analysis steps are recited at a high level of generality such that they could be performed in the human mind (MPEP 2106.04(a)(2) III A). Furthermore, the step of adapting a supplementation therapy is not a particular treatment as it only applies the judicial exception in a generic way (see MPEP 2106.04(d)(2). As such, the additional elements recited in the claims do not recite eligible subject matter.
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.
Claim(s) 1-6 and 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saito et al., (US 2012/0040374).
For claims 1-6, Saito et al., teach a method for detecting renal disease comprising contacting a sample with megalin (paragraph 0092) having a sequence identical to that of SEQ ID 1 as recited in claims 2 and 3 (sequence 2, amino acids 1280-1295), and measuring the amount of megalin in the sample (paragraph 0092). The Examiner notes that because reference to Saito et al., comprises the megalin sequence presented in the claims, the binding properties of megalin taught by the prior art would be identical. The Examiner is interpreting claim 1 as not having endogenous vitamin D in the sample as the claim does not require vitamin D to be Page 8 present. As such, steps b-d are not required to occur. The Examiner notes that claim 1 is being read in light of the rejections under 35 U.S.C. 112(b) in which the limitations regarding DBP and megalin are indefinite. The Examiner also notes that the measurement of megalin taught by Saito et al., is being read on the claimed higher amount of megalin bound DBP as the metes and bounds of the phrase "higher amount" cannot be determined.
For claim 10, Saito et al., teach utilizing ELISA-Light to determine megalin (paragraph 0092).
For claim 11, Saito et al., teach providing an amount of megalin coupled to a microtiter plate (solid phase, paragraph 0092), contacting a sample with megalin in the microtiter plate (paragraph (0092), creating conditions to allow for megalin binding (paragraph 0092), contacting megalin with an antibody and determining an amount of antibody bound to the solid phase (paragraphs 0027-0029, 0074, 0075, 0092). The Examiner notes that the claim is being read in light of the rejection under 35 U.S.C. 112(b) in which the phrase "higher amount" is unclear.
For claims 12 and 13, Saito et al., teach a kit and composition comprising an antibody and megalin (Abstract, paragraphs 0011, 0027, 0028, 0089).
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.
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito et al., (US 2012/0040374) in view of Schering (EP 1,462,119).
Regarding claim 7, Saito et al., do not teach adding a known amount of DBP to the sample.
Schering teaches a method of monitoring megalin mediated uptake wherein a cofactor, including vitamin binding proteins are added to the sample (paragraph 0118). Schering teaches that it is advantageous to add a cofactor as a means of promoting binding of compounds to megalin receptors (paragraph 0072).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Saito et al., wherein DBP is added to the sample in order to promote binding of compounds to megalin receptors as taught by Schering.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito et al., (US 2012/0040374) in view of Ogasawara et al., (US 2009/0117594).
Regarding claim 8, Saito et al., do not teach adding cubilin to the sample.
Ogasawara et al., teach a method for measuring megalin wherein cubilin is taught as a ligand added to a sample to bind megalin (paragraphs 0032, 0065). Ogasawara et al., teach that it is advantageous to add cubilin to a sample as a means of inducing agglutination and measuring megalin based on the degree of agglutination (paragraph 0035).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Saito et al., wherein cubilin is added to the sample in order to induce agglutination and measure megalin based on the degree of agglutination as taught by Ogasawara et al.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saito et al., (US 2012/0040374) in view of Arthur et al., (US 2014/0038203).
Regarding claim 9, Saito et al., do not teach determining megalin by nephelometry.
Arthur et al., teach a method for detecting kidney disease wherein protein markers can be analyzed by various methodologies including nephelometry assays and that such assays would be known to a skilled artisan (paragraph 0075). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Arthur et al., teach that nephelometry would be known to a skilled artisan, thus combining the teachings of Saito et al., with those of Arthur et al., would have been an obvious variant to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Saito et al., to utilize nephelometry to determine megalin in a sample as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Conclusion
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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