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 February 6th, 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 Claims 11-18 are withdrawn from consideration.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 21-27 are newly added. Claims 1 and 21-27 are under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 6th, 2026 has been entered.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification lacks antecedent basis for a majority of the amended claims.
In claim 1-
“an optical detector…attenuated and backscatter…”
Items (i)-(iv) relating to the configuration of the electronic control device.
The recitation of claim 21 lacks antecedent basis in the specification.
The recitation of claim 22 lacks antecedent basis in the specification.
The recitation of claim 23 lacks antecedent basis in the specification.
The recitation of claim 24 lacks antecedent basis in the specification.
The recitation of claim 25 lacks antecedent basis in the specification.
The recitation of claim 26 lacks antecedent basis in the specification.
The recitation of claim 27 lacks antecedent basis in the specification.
The disclosure is objected to because of the following informalities: The optical detector and receiver are noted as item 18. These appear to be equivocal terms and should be corrected as a singular term to reference the element or otherwise provide for their equivalence in the specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1 and 21-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendments to the optical detector being configured to detect light attenuation and backscatter are drawn to new matter that is not supported by the disclosure.
Further, the amendments to the electronic control device and its configuration as in items (i)-(iv) in claim 1, and further recitations thereto in newly-added claims 21 and 23-26 are drawn to new matter that is not supported by the disclosure.
The recitations of newly-added claims 22 and 27 are drawn to new matter that is not supported by the disclosure.
Initially, with respect to the optical detector and its recited dual (“and”) configuration to detect both light attenuation and backscatter, Examiner notes that the disclosure provides support to an alternative of either one of these values. This can be seen as in par.[0016] of Applicant’s pre-grant publication US 2023/0091139, in which light attenuation is detected in the arrangement in which the light source and optical detector are on opposite sides of one another across the reading cell, and backscatter is detected in the arrangement in which the light source and optical detector are provided on the same side.
Secondly, with respect to the electronic control device and its recited configurations, support is not found within the disclosure and is not described in a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Examiner notes that Applicant points to pars.[0005,0018,0021-0026] and figure 1 of the specification as seen through US 2023/0091139, along with a general assertion that being read by a PHOSITA provides support for such amendments to the controller’s configuration as in claim 1.
Par.[0005] amounts to a general, background discussion of syllectometry and a syllectogram.
Par.[0018] provides discussion to the homogenization of a sample inside a tube by a vortex mixer.
Pars.[0021-0026] provides general discussion to the processing of the sample in providing initial disruption that is optically assessed (i.e. disruption achieved at lowest backscatter detected, or equivocally when light transmission detected is lowest).
As it pertains to step (ii), Applicant asserts that the specification, as read by PHOSITA provides sufficient support thereto. Applicant further cites pars.[0023-0026].
Examiner asserts that the general discussion provided herein to achieving a dispersion phase by activating ultrasonic electromechanical devices followed by cessation thereof to optically assess thereafter a plot of aggregation does not provide for the particular discussions herein to computing such characteristics and correlating such to aggregation index and/or aggregation rate index.
Pars.[0023-0026] generically discuss recording the signal for a predetermined amount of time as a plot of kinetic aggregation, without providing any further particulars thereto in its aspects and breakdown that inform such sought “slope, time constant, and amplitude of the subsequent aggregation phase” analysis of the syllectrogram and further, in correlation with the particular computation of aggregation index and/or aggregation rate index.
Further, Applicant’s discussion to the “inflection point” being marked as the transition where variation stops increasing is unfounded by way of par.[0023] as there is no such disclosure therein. The discussion in par.[0023] relates to the general optical assessment in which one realizes that the RBCs have been dispersed (i.e. completely disrupted), and does not pertain to particular data analytics related to information particularly gleaned from characteristics of a syllectogram.
This is likewise seen with Applicant’s offering to the disclosure of “amplitude” as given by mere mention of a “plot of kinetic aggregation,” in which such discussion to “captures the overall extend of the light attenuation/backscatter…from baseline to plateau” is wholly unfounded herein. This is further seen with respect to “time constant” wherein such general and vague term is without particular definition or discussion herein, let alone as it pertains to the syllectogram and the particularly computed aggregation index, aggregation rate index.
Applicant further points to fig. 1 as providing support to these recitations as it shows an optical detector and a control device for generating such a plot.
Examiner asserts that the schematic-type illustration of the physical architecture of the system does not provide such disclosure nor inform one of ordinary skill in the art of such particular data processing, analysis thereof and correlation to particular aggregation index and aggregation rate index as claimed.
The specification insufficiently and inadequately discusses such “computing…” as claimed and is absent particular steps/calculations/evaluations of the syllectogram so as to provide for the sought aggregation index and/or aggregation rate index as claimed.
With regard to step (iii) “quantitively…”, Applicant points to pars.[0002,0004] as providing support thereto.
Examiner asserts that the general, conclusory and prophetic statement within these sections to “analysis…compared with data observed…demonstrated the ability to quantitatively determine acute phase proteins presence effect in a quick and simple manner” does not provide a description 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
These sections offer a general, prophetic discussion to the claimed subject matter, without providing the particular basis that provides for achieving such quantitative determinations as claimed.
The sections generally offer that “analysis of syllectogram data obtained with the disclosed methods” demonstrate the recited ability as in par.[0004].
However, the specification is without particulars as to what analysis of syllectogram data is carried out so as to afford such, and is instead drawn to a general, prophetic discussion.
This is likewise seen with “the disclosed methods,” wherein such particular, active steps that constitute these offered “disclosed methods” and their correlation with quantitatively determining “acute phase proteins presence effect indicative of inflammation” are unfounded within the disclosure.
This is similarly seen with respect to the terminology “acute phase proteins presence effect” in which the disclosure does not provide sufficient disclosure thereto so as to apprise one of ordinary skill in the art the meaning of such term and in constitution with particular data analysis from a syllectogram, let alone with respect to its correlation with inflammation, in which the disclosure is also insufficient.
Lastly, the step (iii) itself is predicated on the computed aggregation parameter as in prior step (ii), which in and of itself is not supported by the disclosure as discussed above.
With regard to step (iv) “evaluate…” Applicant offers pars.[0015,0028,0029] as providing support thereto.
The disclosure of pars.[0015,0029] are drawn to general, proferred intended usages that do not support or provide adequate disclosure to the particular evaluation claimed.
With respect to par.[0028], the disclosure inadequately discloses determining mean viscosity value of plasma in the blood sample and derive, from analysis of the recorded syllectogram, one or more additional parameters including red blood cell deformability and red blood cell elasticity. Par.[0028] generally offers that “during the dispersion phase…the resultant signal is evaluated to extract a mean viscosity value of the sample plasma by considering the time needed by the sample to completely re-suspend.” The disclosure inadequately provides what constitutes “considering” as it is desired to extract a value (as in mean viscosity value of the plasma in the sample) and disclosure to mere consideration of time to re-suspend inadequately provides to one of ordinary skill in the art the ability to make/use the invention for this purpose.
The remainder of the disclosure is wholly absent sufficient disclosure to the evaluation of deformability and elasticity, wherein the prophetic discussions to the device having intended uses therewith do not suffice.
As it pertains to newly-added claims 21-27, Examiner initially asserts that as these are drawn to further delineations of already-insufficiently disclosed base claim 1, the newly claims 21-27 are thereby at least in adequately disclosed as given that the broader, genus-type recitations are unsupported it follows that the narrower, species-type recitations are likewise unsupported.
Claim 21 is not supported by pars.[0015,0028]. As likewise discussed above, the disclosure does not provide discussion to particular data analysis of a syllectogram let alone for the particular rheological parameters recited herein. The specification offers prophetic intended uses with the system as a whole.
Claim 22 is not supported by pars. [0004,0005,0015,0017]. These portions do not adequately disclose a “blood-protein assay” and what is meant by such a codified assay, nor is it seen what is meant by “protein-assay measurement values,” let alone discussion to particular analysis thereof that afford such correlation to the aggregation parameter.
Claim 23 is not supported by pars.[0004,0014,0015]. This is seen at least for the above-discussed reasons as it pertained to the broader “acute phase protein” in item (iii) of claim 1 that analogously follows with the species thereof in fibrinogen.
Claim 24 is not supported by pars.[0003,0017,0025]. Mere discussion to a general discussion of extracting “other factors” and general discussion to a “plot of kinetic aggregation” does not suffice for such particular recitation herein, wherein the “using…” is wholly unfounded in the disclosure as the disclosure does not provide sufficient disclosure to particular analysis of a syllectogram and with particular aspects thereof (i.e. slope, time constant, etc…).
Claim 27 is not supported by par.[0005] for at least the same reasons as applied above with respect to claim 22, and in which par.[0005] is drawn to general, background discussion of syllectometry not commensurate with that of claim 27.
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 sought apparatus for its recited configurations with respect to the electronic control device are indefinitely defined herein.
Initially, step (i) is recited in a narrative fashion with respect to a sought application of the electromechanical devices to disrupt/disperse the blood sample coincident with continuous optical detection of backscatter or attenuation, followed by cessation of the electromechanical devices and continuous measurement by the optical detector to assess aggregation thereafter with the inverse of the prior backscatter or attenuation.
As discussed above, step (i) largely codifies this procedure in a narrative sense, in which it appears that Applicant desires particular weight to these actions in which Applicant should set forth the various actuations carried out by the control device with the respective equipment (i.e. electromechanical devices, optical detector).
For example, Applicant may recite something on the order of –
1. electronic control device configured to actuate electromechanical devices at increasing power levels over time to provide a dispersion of RBCs.
2. control device configured to receive the backscatter/attenuation signals over time from the optical detector to assess RBC dispersion has been achieved.
3. control device configured to cease actuation of the electromechanical devices and continually receive backscatter/attenuation signals thereafter over time from the optical detector until an aggregation is indicated (i.e. inverse backscatter/attenuation from that of the dispersion).
4. control device configured to plot a syllectogram as the above optical signals over the time course from actuation of the electromechanical devices to the cessation thereof and at aggregation indication.
Further, as in step (i) the recitation dispersion/disruption is indefinitely defined in its metes and bounds. The use of the “/” renders the metes and bounds indefinite. Are these terms equivocal to one another? If not, what distinction is being drawn between them in terms of the optical signal that indicates dispersion as opposed to disruption? And if so, they should be recited individually. From the specification, it appears that such terms are equivocal, and a singular one of that matches with the usage in the specification should be utilized.
Further, in step (ii), the recitation to “time constant” is indefinitely understood herein. The specification is without particular definition and discussion thereto so as to apprise one of the metes and bounds of such value/constant in the syllectogram.
Further, in step (iii), the constitution of a quantitative assessment buttressed against a “presence effect” that is accomplished by a comparison is indefinitely understood herein.
Initially, it would appear that utilization of a “presence effect” determined by general comparison as claimed would provide, at best, a qualitative assessment.
Additionally, the specification is without particular discussion and definition with respect to “presence effect indicative of inflammation…” as recited herein in which its metes and bounds are indefinitely provided.
In step (iv), the metes and bounds are indefinitely defined as the recitation to “re-suspend” is not particularly defined in terms of the prior-established elements.
Previously, step (i) provides both creating and optically observing a dispersion/disruption followed by an aggregation phase.
Is the “re-suspend” drawn to a subsequent, additional dispersion/disruption process by the controller/electromechanical devices that provides for dispersion/disruption the aggregated RBCs in the second portion of step (i)? If so, Applicant should provide the additional active configuration to the controller/em devices to re-disperse/re-disrupt the RBC aggregate and correlate/make clear “re-suspend” therewith.
In claim 21, the recitation to “ultrasound bursts” is indefinitely defined as there is no such prior basis therefor. Does Applicant intend to initially provide that the electromechanical devices are ultrasound transducers and thereby link the functionality as in step (i) to that of claim 21 providing ultrasound waves for such dispersion/disruption?
In claims 22 and 27, the metes and bounds of the terms “blood-protein assay,” “fibrinogen assay,” and “protein-assay measurement values” are indefinitely defined. These are all Applicant’s own terminology that amount to codified “assays” and “values” wherein the specification does not make clear and define what assays (and as in their active steps as would be understood in terms of an “assay”) that constitute each, as well as what “values” are attributed to each of the codified “values” being protein-measurement.
In claim 23, the term “acute phase proteins presence effect,” as similarly discussed above is indefinitely defined herein, wherein the specification does not define or particularly discuss this terminology so as to render the metes and bounds clear.
In claim 24, the recitation is indefinitely defined as it provides a vague “using” application wherein it is unclear what constitutes such “using” in terms of actively provided steps/processing/calculation with respect to the cited slope, time constant, inflection point, amplitude that afford computation of the aggregation parameter.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 21-27 have been considered but are moot because in view of the new grounds of rejection applied in view of the amendments made to the claims.
Examiner acknowledges Applicant’s remarks as they pertain to both of the rejections under 35 USC 112 a/1st and 35 USC 112 b/2nd.
Examiner directs Applicant to the particular discussion above in the body of the action that address the remarks and amendments made herein to the claims in which claims 1 and 21-27 are rejected under 35 USC 112 a/1st and claims 1 and 21-27 are rejected under 35 USC 112 b/2nd for those reasons discussed therein.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NEIL N TURK/Primary Examiner, Art Unit 1798