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 .
DETAILED ACTION
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on August 24th, 2026. Claims 1, 11-18, and 21-27 are pending. Claims 11-18 are withdrawn from consideration. Claims 2-10, 19, and 20 are canceled. Claims 1 and 21-27 are under examination.
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 and 21-27 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.
The metes and bounds of the methodology and with respect to the electronic controller’s configuration as in the last paragraph of claim 1 to “…compare….with data obtained by a standard laboratory technique” are indefinitely understood.
The comparison “data” is not clearly understood in the context of data obtainable from a technique.
It is further noted that specification does not detail or define this data nor what amounts to “a standard laboratory technique” therefor.
It appears it may be Applicant’s intention that the actual data (the plot of kinetic aggregation) is compared against a reference/standard of some sort, such as in one that has no amount of acute phase proteins.
Clarification is required.
Claim 21 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.
The metes and bounds of what encompasses a “burst” of ultrasound waves are indefinitely defined herein and the specification does not make clear the metes and bounds. For purposes of examination, such “burst” will be construed as a relative increase of ultrasound waves from a prior point (i.e. from off as in ‘0’ to amount above ‘0’ or any other relative increase from a prior amount).
Claim 23 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 23 is recites the limitation "the determined concentration". There is insufficient antecedent basis for this limitation in the claim.
It appears Applicant intends to recite “the determined fibrinogen concentration.”
Claim 23-24 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.
The recitation “a numerical result comparable to a parameter used in a clinical laboratory” is indefinitely understood.
The disclosure does not set forth clear metes and bounds as to what sort of “equivalence” or correlation such numerical result has with a “parameter used in a clinical laboratory.”
For purposes of examination, the recitation will be read as necessitating a numerical result of the fibrinogen concentration, aggregation index, and sedimentation rate, in which such a numerical result is implicitly comparable in as much as recited herein.
Claim Rejections - 35 USC § 103
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.
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) 1 and 21-27, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sacchetti et al. (USPN 8,647,886), hereafter Sacchetti, in view of Higuchi (US 2020/0018677).
With regard to claim 1, Sacchetti discloses an apparatus as claimed, comprising a collection tube 12 configured to contain the whole blood sample, a mixer device 11configured as claimed, a reading cell container 16 equipped with two parallel windows, an aspiration needle 13, pump device 14, and hydraulic circuit 15 connecting the aspiration needle to the reading cell container and configured to transfer a portion of the whole blood sample from the collection tube to the reading cell container, a collimated light source 17 configured as claimed, electromechanical devices 110,111 coupled to the reading cell and activatable to disrupt RBC aggregates as claimed (column 3, fig. 1, for example). Sacchetti further discloses an electronic control device 112 coupled to the collimated light source and the optical detector and operatively coupled to the pump device and the electromechanical devices, wherein the electronic control device is configured as recited therein except for last clause of “compare…to determine an acute phase proteins concentration for the whole blood sample” (line 37, col. 3 – line 67, col. 4). With regard to claim 21, Sacchetti discloses that the control device is configured to evaluate a mean viscosity value of plasma as recited therein (lines 50-60, co. 4). With regard to claim 23, Sacchetti discloses providing the result of the evaluated phenomenon in the way of a numerical result comparable to the common used parameters in a clinical laboratory (lines 43-46, col. 3). With regard to claim 24, Sacchetti discloses the electronic control device is configured to provide the aggregation index and the subsequent erythrocyte sedimentation rate as numerical results comparable to parameters used in a clinical laboratory (lines 40-46, col. 3). With regard to claim 25, Sacchetti discloses the electronic control device is configured to active the electromechanical devices with a power that is initially ramped up until disruption as claimed (lines 12-17, col. 4; claims 13&16). With regard to claim 26, Sacchetti discloses the electronic control device is configured to acquire optical variation during the ramped activation and record a plot that expresses a disruption rate as claimed (lines 19-25, col. 4). With regard to claim 27, Sacchetti further discloses that fibrinogen as one of the plasma proteins important to rouleaux/RBC aggregation (lines 37-47, col. 1).
With regard to claims 1, 22, and 27, Sacchetti does not specifically disclose that the controller is configured to “compare…to determine an acute phase proteins concentration for the whole blood sample,” and wherein the acute phase proteins comprise fibrinogen, and the comparing comprises relating RBC aggregability to fibrinogen concentration.
Higuchi discloses inflammatory marker measurement methodology and apparatus therefor (abstract). Higuchi discloses producing a syllectogram that affords calculation of a parameter associated with the erythrocyte aggregation (i.e. ESR), in which Higuchi discloses a controller for carrying out the operations to develop the syllectogram and in which fibrinogen concentration, an acute phase protein, is measured as an inflammatory marker by using a nonlinear function having the aggregation parameter and a parameter associated with the erythrocyte density as variables. Higuchi discloses that when the fibrinogen concentration is increased in accordance with inflammation and thus when the fibrinogen concentration is increased erythrocyte aggregation becomes remarkable (pars.[0002,0046,0055-0059,0081-0085]). Higuchi further disclose comparing the data from the plot of kinetic aggregation (herein, syllectogram, and its regression based on the aggregation parameter, and as further seen in pars.[0046-0049]) with data obtained by a standard laboratory technique (herein, the Clauss method) to determine an acute phase proteins concentration, herein fibrinogen, for the whole blood sample (pars.[0086-0091]).
It would have been obvious to one of ordinary skill in the art to modify Sacchetti to provide the controller configured to “compare…to determine an acute phase proteins concentration for the whole blood sample” as recited in claim 1 such as suggested by the analogous art of Higuchi to a apparatus/method for plotting a syllectogram for erythrocyte aggregation and parameters related thereto in which Higuchi provides a measurement therewith to fibrinogen concentration, as an acute phase protein, that is a clinically relevant biomarker for inflammatory conditions to be utilized as likewise contemplated and concerned in Sacchetti (lines 37-47, col. ), and wherein it is noted that the determined concentration of Higuch is also a “numerical result” as claimed that is “comparable to parameters…” in as much as claimed and recited herein as it is numerical result comparable to a clinical inflammation marker.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 21-27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
As discussed above, in view of the amendments to the claims, claims 1 and 21-27 are rejected under 35 USC 112 b/2nd and under 35 USC 103a1 as being unpatentable over Sacchetti in view of Higuchi for the reasons discussed therien.
Conclusion
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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/ Primary Examiner, Art Unit 1798
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