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 .
Election/Restrictions
Applicant’s election of the Invention 1 [claims 1-6] made with traverse in the reply filed on 09/22/2025, has been acknowledged. Applicants assert that the prior restriction requirement is, allegedly, improper because the ‘present independent claims 1, 7, 8 and 9 have already recited the technical features which are not well known and routinely employed in the art, over the disclosure of Kellogg et al. Specifically, the above-mentioned technical features claimed in the present independent claims 1, 7, 8 and 9 are “at least one buffer valve 50”, “a valve body 52” and “a transient chamber 54”.
Applicants further assert that, in the present invention, ‘when the atmospheric pressure reaches equilibrium, it is inevitable that a small part of the testing sample will drop into the buffer valve 50 through the inlet channel 40 (microfluidic channel). At this time, the transient chamber 54 with an average radius greater than the average radius of the outlet channel can accommodate these testing samples to temporarily store said samples in the buffer valve 50. The valve body 52 can be hydrophobically modified or not be hydrophobically modified, and therefore the modified valve body 52 will increase the action of the surface tension to enhance the tolerance of the valve body 52 to the rotational speed. The disclosure of the paragraph [0029] of the present invention shows that the buffer valve 50, the valve body 52 and the transient chamber can prevent the testing sample of the first chamber 10 from flowing into the buffer valve 50 or the second chamber 20, therefore to minimize the risk of the cross-contamination of the reagents and deviation of the detection values.’
Based on the above, applicants further assert that ‘Kellogg et al. state that the function of the overflow capillary 121 and the overflow chamber 122 which are only for diverting excess test fluid.’
On this basis, applicants conclude that ‘the present independent 1, 7, 8 and 9 have already comprise the technical features which are obviously not well known and routinely employed in the art’, including the cited reference of Kellogg et al.
Examiner disagrees. Restrictions of national stage entry applications are based on the concept of the common [i.e., shared between inventions as claimed] technical feature that is [or is not] special, depending on whether or not it contributes novelty over the prior art. In this particular case [as was clearly explained in the prior action], the only shared technical feature recited in the claims, is a fluidic circuit [i.e., fluidly connected flow path components] with a valve [disclosed as a capillary one] having a valve body in fluid communication with chambers and channels, as recited. The cited reference, in particular, Figures 1 A-B of Kellogg show a capillary valve 111 with a valve body as recited, in fluid communication with channels and chambers as intended. Thus, the invention of Kellogg provides the evidence that the shared structure [technical feature] is known, i.e., does not contribute any novelty over the prior art. Therefore, the unity of invention is lacking. Upon further considerations, in view of the prior art searches, the Invention 2 [claim 7] has been re-joined with the elected Invention 1. Accordingly, claims 8-10 have been withdrawn from further consideration under 37 CFR 1.142(b), as being drawn to the non-elected inventions.
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 1-7 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 pre-AIA the applicant regards as the invention.
With respect to the independent claims 1 and 7, it is unclear from the claim language what structural features must configure the claimed detection channel / device as being a ‘centrifugal’ one. It is further unclear how the ‘connected’ components can be arranged as recited, in the absence of any supporting base, or platform, assumingly, configured for rotation. Furthermore, it is not clear from the claim language what structural features must configure the ‘buffer’ valve for the functionality implied by the name of the valve. Moreover, with respect to the ‘transient’ [that is, impermanent] chamber, the claim language fails to set forth any structural features that must define the chamber as such, as well as delimit it as a distinct and separate structure relative to the valve body. The same considerations apply to claim 7, with respect to the ‘dispensing’ channel; and to the dependent claim 5 including the recitations of the ‘background’ channel / chamber. Additionally, in claims 1 and 7, it is not clear whether or not the recitations of the upper and lower parts of the buffer valve, mean that the orientation of the claimed fluidic structure in space must be limited relative to some fixed relative points. Also note that, since the ‘transient’ chamber is assumed to be impermanent [that is, it may not be present at times], it is currently considered as being not positively included as part of the claimed structure and, as such, is not accorded patentable weight when evaluated for patentability.
Regarding claims 2-3, it is unclear how the intended contents of the chamber can further limit the claimed structure. Note that the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.
In claim 5, it is not clear how the ‘background’ channel and chamber must be inter-related with the channels and chambers recited in the preceding claim. Further note that it is applicants’ responsibility to locate and correct all instances of the raised issues.
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 1-4 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kellogg et al., US 6632399.
With respect to claims 1 -4 and 6-7, Kellogg discloses a centrifugal microfluidic detection channel and/or device, comprising, as illustrated in Figures 1 A-B, ‘first’ chamber 104; at least one microfluidic inlet channel 101 fluidly connected with the ‘first’ chamber; at least one buffer valve having body 111 and fluidly connected with the at least one inlet channel, the valve body being disposed at an upper part as recited, depending on a special orientation of the device; where a lower part of the valve can constitute a ‘transient’ chamber, when present, in view of the chamber name being interpreted as ‘impermanent’. The structure of Kellogg further includes at least one outlet channel 114 connected with the at least one buffer valve; and at least one second chamber 122, connected with the at least one outlet channel. Regarding claim 7, Figure 11A further shows that the detection device additionally includes dispensing channel 902 connected to a waste chamber 905. As to claim 6, Figure 11A also illustrates that the device of Kellogg can include an additional [‘second’] capillary [‘buffer’] valve 923 connected to a second inlet channel 921, second outlet channel 932 and ‘third’ chamber 922. It is further noted that the features not positively recited as part of the claimed invention such as the transient chamber, or the reagents, including all associated details, are not accorded patentable weight when evaluated for patentability.
Allowable Subject Matter
Claim 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 transient chamber, distinct from the valve body, as well as the upper and lower parts of the buffer valve, as recited, must be clearly illustrated and properly referenced as such, or the feature(s) canceled from the claim(s). Currently, in at least Figures 1 and 2, the reference characters 52 and 54 appear to point at two undelimited portions of the same component. Additionally, Figure 12 fails to clearly show the boundaries of the centrifugal detection device 100. Correction is required. Now new matter should be entered.
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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