DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 14-18 have been objected to as being in improper format. In particular, while those claims are directed to an apparatus, on the other hand, they also recite functionality construed as method steps and /or process limitations. However, a claim cannot be directed to mixed categories and must be formatted as pertaining to one category only [in this case, to an apparatus]. Correction is required.
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 2-21 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
With respect to claim 2, it is unclear from the claim language how the functionality intended for the test well, as recited, can be performed in the absence of a controller connected to at least one actuator and to the electrodes, as well as programmed accordingly [including software for determinations of the ‘after attenuation’ point]. . It is further unclear what structural features must configure the ‘sample introduction area’ for receiving the sample as recited.
In claim 3, it is unclear whether or not the recitation of the ‘sealed chamber’ means that the claimed apparatus must include some means for sealing the chamber.
In claim 4, it is unclear from the claim language what is meant by the ‘pneumatic interface’ and what structural features must define the interface as ‘pneumatic’. It is further unclear whether or not ‘the region of the device’ is the same as ‘the region of the device having an aperture leading into the fluid path’ recited in claim 3. Moreover, it is unclear what structural features of the pneumatic fluid path must configure it for applying pressure as intended.
In claim 5, it is not clear, again, what structural features must configure the ‘mixing chamber’ for the intended functionality.
In claim 6, it is unclear in what sense the first and second contact pads must be ‘leading’ as recited. It is assumed that the claimed structure must include current conductive connectors disposed between each electrode and respective contact pads.
In claim 7, it is unclear whether or not the circuit board with the electrodes must be position within the test well that contains the electrodes.
In claim 8, it is unclear whether or not the cover must be positioned over the ‘unitary piece’ set forth in claim 7.
Similarly, in claim 9, tit is not clear whether or not the test well must be a circular through-aperture formed within the ‘unitary piece’.
In claim 19. It is unclear whether or not the test well must include at least one heater.
Note that it is applicants’ responsibility to locate and correct all instances of the raised issues in other dependent claims as well. Further note that the features not positively included as part of the claimed apparatus [such as the ‘region’ with the ‘aperture’; the electrodes as recited in claims 2-6 and 12-13; the filter; the liquid and dried constituents; or the capture probe, including all associated details] are not accorded patentable weight when evaluated for patentability.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
These apparatus claims are is directed to steps and/or process limitations of intended use in a manner that does not further limit the structure set forth in claim 2.
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.
Claims 2-3, 11-18 and 20-21 are rejected un7-20 35 U.S.C. 102(a)(1) as being anticipated by Scurati et al., US 20040132059.
Referring to claims 2-3, Scurati discloses a sample testing device comprising, as shown in Figures 1-3, a sample introduction area 8, 17, configured to receive a sample; a test well 24 that can contain electrodes 30, 31, capable to function as recited;
and a fluid path 15 fluidically coupling the sample introduction area to the test well. Figure 3 further shows at least one sealed chamber 21 capable of containing liquid constituents as intended, the sealed chamber being positioned in a region of the device having an aperture at 17a leading into the fluid path, with the sample introduction area being positioned between the aperture and the test well, as recited.
Regarding claim 11, Figure 3 further shows vent 26, 23 that can be covered by impermeable filter 35, to function as recited.
With respect to claims 12-13, note that the claim language fails to positively include the electrodes as part of the claimed apparatus. As to claims 14-18, the claim language does not require any further structural limitations further limiting claim 2.
It is further emphasized that the features not positively included as part of the claimed apparatus [such as the ‘region’ with the ‘aperture’; the electrodes as recited in claims 2-6 and 12-13; the filter; the liquid and dried constituents; or the capture probe, including all associated details] are not accorded patentable weight when evaluated for patentability. Additionally, the process ‘constituents, pertain to materials to be worked upon, and, as such, do not impart patentability to apparatus claims.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a non-statutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 2-3 are rejected under the judicially created doctrine of obviousness-type double patenting s being unpatentable over claims 1-13 of US 11465141. Although the conflicting claims are not identical, they are not patentably distinct from each other because all positively recited structural features of the instant claims are entirely within the scope of claims 1-13 of US 11465141.
Claim 2 is rejected under the judicially created doctrine of obviousness-type double patenting s being unpatentable over claims 1-3 of US 12275007. Although the conflicting claims are not identical, they are not patentably distinct from each other because all positively recited structural features of the instant claims are entirely within the scope of claims 1-1 of US 12275007.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims, as well as any structural detail that is essential for a proper understanding of the disclosed invention. Therefore, the structural inter-relationships between the ‘region of the device having an aperture leading into the fluid path’ and the ‘sample introduction area’ fluidically coupled to the fluid path, as well as the ‘sharp’, the ‘portion of the fluid path formed in a unitary piece’, the ’ portion of the liquid impermeable material; to which the circuit board is adhered, the ’cap’ of the cover., as recited, must be clearly shown and properly referenced as such, or the feature(s) canceled from the claim(s). No new matter should be entered. Additionally, many figures fail to clearly show the boundaries of the recited components. Formal; drawing for at least Figures 1A,1B, are requested.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Natalia Levkovich whose telephone number is (571)272-2462. The examiner can normally be reached on Monday-Friday, 2.00 pm-10:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill A Warden can be reached on 571-272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATALIA LEVKOVICH/Primary Examiner, Art Unit 1798
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