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 .
Claims 1-20 are pending and under consideration.
Duplicate Claims Warning
Applicant is advised that should claim 10 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim 11 is 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 11 recites a step of detecting a level of expression of “the DSP” gene in the second biological sample, however reference to “the DSP gene” lack sufficient antecedent basis because claim 1 does not recite detection of a DSP gene. It is not clear if claim 11 was intended to be dependent from claim 10, instead.
Claim interpretation applicable to rejections below
It is noted that the claims recite “detecting an rs3778337 SNP…” and “detecting a level of expression of a DSP gene”. However, most of the claims do not require the detection of a particular allele of the rs numbers in the claims. The recitation of an rs number does not limit the claims to a particular allele because the rs number merely denotes a position within the genome that is polymorphic and sets forth the possible alleles that may be found at the position. Additionally, none of the claims require the detection of any particular level of DSP expression.
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.
(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, 3, 4, and 6-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharif (Sharif et al; Arthritis and Rheumatism, October 2011, vol 63, abstract number 2429) as evidenced by Assassi (Assassi et al; Arthritis Research & Therapy, vol 12, pages 1-11, 2010).
Sharif teaches obtaining samples from SSc patients enrolled in the GENISOS (Genetics versus Environment In Scleroderma Outcome Study) cohort (see abstract). Sharif teaches genotyping all patients by the Illumina Human 610-Quad BeadChip (see abstract). The Illumina Human 610-Quad BeadChip contains the necessary oligonucleotides for genotyping the alleles for rs3778337 and rs104848326. As evidenced by Assassi, patients in the GENISOS cohort included patients with interstitial lung disease (see abstract). Assassi further teaches that patients in the cohort included those who had been treated with cyclophosphamide (see page 4, col 2). Accordingly, Sharif inherently teaches “obtaining a first biological sample from said interstitial lung disease subject undergoing treatment for interstitial lung disease” and detecting in said sample, rs3778337 and/or rs104848326 SNP.
With regard to claims 3 and 4, although Sharif does not teach the allele detected for each SNP, the claims are dependent on claim 1, which encompasses detection in the alternative. Therefore, claims 3 and 4 do not actually require that the method only detect the allele in claim 3 or claim 4. With regard to claims 6 and 7, as evidenced by the Scleroderma foundation, the significant prevalence of ILD in SSc is reflected in the criteria of the diagnosis with the finding of predominantly basilar fibrosis being one of the three major criteria utilized for diagnosis (Scleroderma Foundation information titled “Pulmonary Fibrosis in Systemic Sclerosis”). With regard to claim 9, a thorough review of the specification reveals that the time frame for “undergoing treatment for interstitial lung disease” is not defined. For example, the specification teaches obtaining a sample after the treatment has been administered (para 0048), but does not define how long after treatment administration the sample collection is taken. Accordingly, the recitation of a sample “from an interstitial lung disease subject undergoing treatment for interstitial lung disease” is given its broadest reasonable interpretation to include sample collection from a subject who has been treated for interstitial lung disease, with no particular sample collection time frame required after treatment has been administered.
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.
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 8, 10-12, 14, 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sharif (Sharif et al; Arthritis and Rheumatism, October 2011, vol 63, abstract number 2429) as evidenced by Assassi (Assassi et al; Arthritis Research & Therapy, vol 12, pages 1-11, 2010), in view of Hsu (Hsu et al; Arthritis and Rheumatism, vol 63, March 2011, pages 783-794).
Sharif teaches obtaining samples from SSc patients enrolled in the GENISOS (Genetics versus Environment In Scleroderma Outcome Study) cohort (see abstract). Sharif teaches genotyping all patients by the Illumina Human 610-Quad BeadChip (see abstract). The Illumina Human 610-Quad BeadChip contains the necessary oligonucleotides for genotyping the alleles for rs3778337 and rs104848326. As evidenced by Assassi, patients in the GENISOS cohort included patients with interstitial lung disease (see abstract). Assassi further teaches that patients in the cohort included those who had been treated with cyclophosphamide (see page 4, col 2). Accordingly, Sharif necessarily teaches “obtaining a first biological sample from said interstitial lung disease subject undergoing treatment for interstitial lung disease” and detecting in said sample, rs3778337 and/or rs104848326 SNP.
Sharif does not teach detecting DSP expression in the subjects, however Hsu teaches analysis of gene expression using the Illumina HumanRef-8 v3.0 BeadChips (page 784, col 2) in samples from patients with SSc with pulmonary fibrosis. The Illumina HumanRef-8 v3.0 BeadChip contains the necessary oligonucleotides for detecting expression of DSP. Hsu teaches that microarray analysis demonstrated distinct gene expression profiles in tissues and fibroblasts from patient with SSc-associated lung disease (see abstract). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, to have conducted GWAS analysis using microarrays, as taught by Sharif, and gene expression analysis using microarrays, as taught by Hsu, in SSc patients with interstitial lung disease for the purpose of providing insight into the genetic and molecular profile of such patients to study pathogenesis and therapeutic targets of SSc lung disease as taught by both Sharif and Hsu.
In conducting the microarray analysis taught by Sharif and the microarray analysis taught by Hsu, the ordinary artisan would have necessarily conducted the active steps required by the claims. The rejected claims do not require detection of a particular allele or a particular level of expression of DSP. With regard to claims 14 and 15, although Sharif does not teach the allele detected for each SNP, the claims are dependent on claim 12, which encompasses detection in the alternative. Therefore, claims 14 and 15 do not actually require that the method only detect the allele in claim 14 or claim 15.
With regard to claim 8, Although neither Sharif nor Hsu teach analysis in blood samples, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date to have included SNP and gene expression analysis in blood samples because it is a less invasive biological sample for biomarker analysis.
With regard to claim 18, a thorough review of the specification reveals that the time frame for “undergoing treatment for interstitial lung disease” is not defined. For example, the specification teaches obtaining a sample after the treatment has been administered (para 0048), but does not define how long after treatment administration the sample collection is taken. Accordingly, the recitation of a sample “from an interstitial lung disease subject undergoing treatment for interstitial lung disease” is given its broadest reasonable interpretation to include sample collection from a subject who has been treated for interstitial lung disease, with no particular sample collection time frame required after treatment has been administered.
Conclusion
Claims 2, 5, 13, and 16 are objected to for being dependent on rejected claims.
Claims 1, 3-4, 6-12, 14-15, and 17-20 are rejected for the reasons set forth above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682