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 .
Status of Claims
Currently, claims 64, 66-69, and 72-83 are pending in the instant application. Claims 81-83 are withdrawn from consideration as being drawn to a non elected inventions. Claims 64, 66-69, and 72-80 are currently under examination. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant Application. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 112
112(a)
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.
Claims 64, 66-69 and 72-80 are rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention.
The claims have been amended to recite that the elution and qPCR occur in the same vessel “without transferring the biological sample or performing a concentration step”. As set forth in the MPEP at 2163IB:
While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure.
At 2163IIA, the MPEP states:
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims.
Furthermore, at 2163.04I(B), the MPEP states:
A simple statement such as "Applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘____’ in the application as filed." may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported.
See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that "[MPEP] § 2163.04 [subsection] (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description rejection.").
The response makes a general statement that the amendments are supported in the entire specification, however it does not state where the individual newly added limitations are supported. In response to this rejection, applicant should delete subject matter that is not supported in the disclosure as originally filed, or provide an explanation as to where the specification has express, inherent, or implied support for each of the newly recited claim limitations.
112(b)
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.
Claims 64, 66-69 and 72-80 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
The claims have been amended to recite that the elution and qPCR occur in the same vessel “without transferring the biological sample or performing a concentration step”. However, this recitation is vague because it is unclear which steps or manipulations are excluded by this recitation. The term “vessel” is not defined by either the specification or the claims, such that the recitation of “without transferring” is confusing because it is not clear if the biological sample can be transferred within the vessel or not. Additionally, it is not clear what is prohibited from being concentrated. It is known that as reactions are conducted, the concentrations of the reagents inherently change as they react with each other. Accordingly, the metes and bounds of the claims are unclear.
Claim Rejections - 35 USC § 103
Claims 64, 66-69, 72-74, and 76-80 are rejected under 35 U.S.C. 103 as being unpatentable over Tatnell (Tatnell et al; US 2016/0367986) in view of Hughes (Hughes et al; Blood, vol 88, 1996, pages 3242-3243) and Lefterova (Lefterova et al; The Journal of Molecular Diagnostics, vol 18, 2016, pp 267-282).
Tatnell teaches a microfluidic device (vessel) for direct PCR from dried blood spots (see abstract, para 0023, 0074). Tatnell teaches the device includes a receiving area for dried sample, as well as reagents for analysis. Tatnell teaches using lyophilized reagents in the vessel. Tatnell teaches that the vessel includes fluid processing areas and a reaction chamber for thermal cycling (para 0030-0031). Tatnell teaches an assay where DNA from a dried blood spot is successfully amplified using reagents carried out on board the microfluidic device and PCR reagents delivered to the reaction chamber, where thermal cycling and detection are carried out on board the device (para 0074). Additionally, Hughes exemplifies direct PCR of dried blood spots where no initial DNA extraction is required (see p 3242, col 1). Hughes teaches that the dried blood spot is added directly to a reaction chamber for PCR amplification. Neither Tatnell nor Hughes specifically teach a separate eluting step, however Lefterova teaches a method of quantitative PCR using DNA from dried blood spots where the DNA is eluted at a temperature of 99°C prior to PCR. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have modified the method and device of Tatnell to include a step of eluting DNA from the dried blood spot as taught by Lefterova for the benefit of increasing the yield of DNA from the sample for quantitative PCR. Given that Tatnell and Hughes exemplify the successful PCR analysis of DNA from dried blood spots, the artisan of ordinary skill would have had a reasonable expectation of success in arriving at a method of eluting DNA from a dried blood spot and performing PCR in a single microfluidic device.
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Tatnell in view of Hughes and Lefterova as applied to claims 64, 66-69, 72-74 and 76-80 above, and further in view of Kermekchiev (Kermekchiev et al; Nucleic Acids Research, vol 37, 2009, e40, pages 1-14).
The teachings of Tatnell in view of Hughes and Lefterova are set forth above. Tatnell in view of Hughes and Lefterova do not teach using an inhibitor resistant polymerase. However Kermekchiev teaches Taq polymerase mutants that allow DNA amplification in whole blood and are resistant to PCR inhibitors. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have used inhibitor resistant polymerases taught by Kermekchiev in the method of Tatnell in view of Hughes and Lefterova because Kermekchiev teaches that these polymerases allow DNA amplification in whole blood samples.
Conclusion
No claims are allowed herein.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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