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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on March 26th, 2026. Claims 1-4, 6, 7, 9, 11, 13-16, 20-25, 30-47, 49-70, 72-78, 80, 83-85, 87, 88, 90-101, 103-109, 116-130, 132-170, and 178-179 are pending. Claims 5, 8, 10, 12, 17-19, 26-29, 48, 71, 79, 81, 82, 86, 89, 102, 110-115, 131, 171-177, and 180 are canceled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 26th, 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 proper antecedent basis for the claim recitations of blood-cell-poor plasma region” and “blood-cell rich region.”
Examiner notes pars.[0070,0071] of Applicant’s pre-grant publication US 2020/0333322 provide discussion to a plasma region without any cells and a blood cell aggregation region, however, the present language lacks proper antecedent basis in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Detector capable of detecting or ascertaining...of the one or more images…as in cl. 1 and dependents thereof.
2) Aggregation reagent that causes or assists….as in claims 8 and 18-20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
1) Unclear from the disclosure, further clarification is required *see below under 35 USC 112 b, 2nd paragraph.
2) Those elements disclosed in pars. [0113,0280] of Applicant’s pre-grant publication and equivalents thereof, however, *further clarification is required as seen below under 35 USC 112 b/2nd.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-4, 6, 7, 9, 11, 13-16, 20-25, 30-47, 49-70, 72-78, 80, 83-85, 87, 88, 90-101, 103-109, 116-130, 132-170, and 178-179 is/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 recited “detector capable of detecting or ascertaining a signal of the analyte from the interference-elements poor region and interreference-elements rich region of the one or more images…” as in the claims are indefinitely defined.
This is likewise seen in the concordant method of claim 6 (and dependents thereof), which provides the apparatus of claim 1, and positively claimed steps of imaging, identifying, and measuring steps.
Par.[0021] of Applicant’s pre-grant publication US 2020/0333322 that provides an indefinite definition and discussion to what encompasses this “detector” for its recited functionality.
The definition given in par.[0021] is both non-definitive and overly vague/broad (providing it can be exemplifed by this or that generally described “device” for either of the general functionality of “detect or measure signals…”)
It is further noted that the definition given to the “detector” in par.[0021] is also self-referencing given the disclosure of “…the term “detector” as used herein refers to devices that are configured to detect and/or measure signals gathered by the detector and/or other devices/components…” which in and of itself provides an indefinite disclosure to the detector.
Additionally, the discussion to the detector “refers to a mobile device,” and “the detector is a “smart phone” is highly generalized and prophetic (see also as in claims 105-107).
A general “mobile device” and “smart phone” does not set forth clear metes and bounds to the claimed detector and does not afford the recited functionality.
Further, from the disclosure, it is seen that the “mobile device” and “smart phone” refer to particular software therein (such as seen through pars.[0112,0127,0157,0132]), the disclosure does not provide particular disclosure to such software that provides for the recited functionality of the detector (and as well as in the imager, in which the imager is also discussed as comprising such software; see above as well as in par.[0126,0146].
To this end, such recitation to the “detector capable of detecting…” as recited in claim 1 is construed under 35 USC 112 F, 6th as providing a computer-implemented means-plus-function recitation as “detector capable of detecting…” is drawn to a mobile device or smart phone having software, or software itself to the imager.
See MPEP 2181, Section II, B:
For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b). See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367, 88 USPQ2d 1751, 1757 (Fed. Cir. 2008). See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) (“[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.’”) (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999)).
In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function. See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239.
For a computer-implemented means-plus-function claim limitation invoking 35 U.S.C. 112(f) the Federal Circuit has stated that “a microprocessor can serve as structure for a computer-implemented function only where the claimed function is ‘coextensive’ with a microprocessor itself.” EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 622, 114 USPQ2d 1711, 1714 (Fed. Cir. 2015), citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1316, 97 USPQ2d 1737, 1747 (Fed. Cir. 2011). “‘It is only in the rare circumstances where any general-purpose computer without any special programming can perform the function that an algorithm need not be disclosed.’” EON Corp., 785 F.3d at 621, 114 USPQ2 at 1714, quoting Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1365, 102 USPQ2d 1122, 1125 (Fed. Cir. 2012). “‘[S]pecial programming’ includes any functionality that is not ‘coextensive’ with a microprocessor or general purpose computer.” EON Corp., 785 F.3d at 623, 114 USPQ2d at 1715 (citations omitted). “Examples of such coextensive functions are ‘receiving’ data, ‘storing’ data, and ‘processing’ data—the only three functions on which the Katz court vacated the district court’s decision and remanded for the district court to determine whether disclosure of a microprocessor was sufficient.” 785 F.3d at 622, 114 USPQ2d at 1714. Thus, “[a] microprocessor or general purpose computer lends sufficient structure only to basic functions of a microprocessor. All other computer-implemented functions require disclosure of an algorithm.” Id., 114 USPQ2d at 1714
To claim a means for performing a specific computer-implemented function and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239. In this instance, the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239; Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999); Rain Computing, Inc. v. Samsung Electronics America Co., 989 F.3d 1002, 1007-8, 2021 USPQ2d 284 (Fed. Cir. 2021).
The corresponding structure is not simply a general purpose computer by itself but the special purpose computer as programmed to perform the disclosed algorithm. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. Thus, the specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to the special purpose computer. See Aristocrat, 521 F.3d at 1338, 86 USPQ2d at 1241. (“Aristocrat was not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions in order to satisfy 35 U.S.C. § 112 ¶ 6. It was required, however, to at least disclose the algorithm that transforms the general purpose microprocessor to a ‘special purpose computer programmed to perform the disclosed algorithm.’” (quoting WMS Gaming, 184 F.3d at 1349, 51 USPQ2d at 1391.)) An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary, Microsoft Press, 5th edition, 2002. Applicant may express the algorithm in any understandable terms including as a mathematical formula, in prose, in a flow chart, or “in any other manner that provides sufficient structure.” Finisar, 523 F.3d at 1340, 86 USPQ2d at 1623; see also Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir. 2003); In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376, 1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); In re Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.
Applicant’s specification is devoid of the particulars of the software as in algorithm(s), programming, or the like required for performing the detecting or ascertaining a signal of the analyte from the rich/poor region of the one or more images.
The disclosure in pars.[0032,0055,0059,0112,0127,0132,0146,0172,0197,0202] is generalize and prophetic to the software that provides for such detection/image analysis. Therein, the disclosure speaks to “associated software,” but is without particular discussion to this “associated software” that affords the recited functionality.
The above-cited disclosure, and the remainder thereof, is without particular and definitive discussion to the software and its programming, algorithms, or the like that afford the cited functionality to the detector (and likewise with respect to the imager in those instances wherein the imager is disclosed to include the software).
Further, the functions in the claims go beyond a general purpose computer and are not coextensive with the computer as defined in the MPEP passages cited above. Therefore, the claims are indefinite and rejected under 35 USC 112b/2nd.
This is likewise seen in the concordant method of claim 6 (and dependents thereof), which provides the apparatus of claim 1, and positively claimed steps of imaging, identifying, and measuring steps.
Furthermore, as in claim 1 (and dependents thereof), the metes and bounds of what constitutes a “blood-cell poor plasma region” and “blood-cell rich region” are indefinitely defined herein.
The disclosure in pars.[0070,0071,0157] is vague and indefinite in setting forth the metes and bounds of such regions.
The disclosure is highly generalized and brief, and references “the figure,” which is assumed as fig. 6 which is drawn to an exemplary image (i.e. both non-definitive and highly-stylized without supporting disclosure thereto in actual experimental data/results to such “exemplary image”).
The remaining figures also “show” these regions in a stylized fashion (see fig. 2, for example) that do not provide clear metes and bounds to what defines the claimed regions.
Further, the generalized discussion of one region being marked as “blood cell aggregation region” (assumed as “blood-cell rich region” for sake of discussion) with “relative dark color,” and the other region is “plasma region without any cell” (assumed as “blood-cell poor plasma region” for sake of discussion) does not set forth clear metes and bounds so as to define each of the recited regions.
The only discussion is with respect to a generalized and vague statement that the blood cell aggregation region with relative dark color. This terminology is vague and indefinitely defined in and of itself, wherein the disclosure does not define what constitutes “relative dark color.”
The disclosure is absent any further discussion, data in showing and detailing the “relative dark color” utilized so as to allow for such image analysis/particular detection of the “blood-cell rich region” from that of the “blood-cell poor plasma region.” The disclosure is absent to discussion to particular optical parameters (i.e. absorbance, transmittance, reflectance, light scatter, fluorescence, etc..) utilized in defining these regions.
Further, the generalized discussion that the “software” (indefinitely defined as discussed above) separates the plasma region from the blood cell aggregation region is a results-based discussion without the means provided (i.e. image analysis related to some number of optical parameters/signals) to separate such particular regions.
The subsequent general discussion to “average the color intensity” of the plasma region and wherein the glucose level of the blood is directly correlated to the average color intensity in the plasma region is both not commensurate in scope with the recitation at-hand, and, as the plasma region itself is indefinitely defined herein, the ability to ascertain its color intensity is indefinitely defined and thereby precludes the correlated glucose level.
This is likewise seen in the concordant method of claim 6 (and dependents thereof), which provides the apparatus of claim 1, and positively claimed steps of imaging, identifying, and measuring steps.
Claims 44-47 and 49-66 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.
Amended claims 44-47 and 49-66 are indefinitely defined in terms of their correlation within the active steps of the recited method.
While it appears Applicant may intend to correlate such ‘average thickness compression” to the amended step of claim 1 to the “pressing…” step, the dependent claims are without clear connection therewith which calls into question the relation and what further step(s) are being set forth to the method in claims 44-47 and 49-66.
Claims 45 and 46 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 by claims 45 and 46 are indefinitely defined.
Both of claims 45 and 46 provide a conditional result of “wherein for a specific part that has an average thickness of X…only interference rich regions exist,” however, the claims themselves are without positively provided steps that necessitate such a specific part of the sample to be pressed/compressed to this thickness.
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 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.
Claims 1, 4, 6, 11-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-109, 116-130, 132-141, 145-147, 150-163, 168-170, and 179, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Bamford et al. (US 2016/0035100), hereafter Bamford, in view of Wardlaw (US 2011/0294198), and in view of Vermeiden et al. (USPN 6,551,554), hereafter Vermeiden.
With regard to claims 1, 21-23, Bamford teaches an apparatus for assaying a sample that contains an analyte and interference elements, comprising (Abstract - bio/chemical sensing, assays and applications):a sample holder that is configured to hold a sample (pars.[0011,0026] scanning a slide holding a sample), an imager that images one or more images of the sample, and a detector capable of detecting or ascertaining a signal of the analyte from at least one of interference-elements poor region and interference-elements rich region of the one or more images, and a non-transitory computer-readable medium storing an executable algorithm that when executed provides for identifying (i) and analyzing (ii) as recited therein (abstract, pars.[0007,0022-0026,0031,0032,0036,0051], figs. 1-5, for example, in which a source imager 101 as in a spectral camera, scanner, fluorescence microscope is associated with or including a spectral camera for imaging a slide containing a sample, detection module 113, and in communication with a plurality of processing modules or logical instruments that are executed by a processor 125 to computer 120, wherein such logical instruments include software/algorithm for recognizing region(s) of noise (the broadband signals designated as “interference-elements rich region as a blood-cell rich region” as recited herein) and regions of interest (the target signals designated herein as “interference-elements poor region is a blood-cell-poor plasma” as recited herein; see also pars.[0005-0007]).
Examiner further notes that “blood-cell-poor plasma region” with respect to the “poor region” and “blood-cell rich region” with respect to the “rich region” remain to be drawn to nominal regions of space as recited herein and wherein such regions of space images and detected herein are likewise constituted as a blood-cell-poor plasma region” and “blood-cell rich region,” wherein the claims do not necessitate a positive provision of particular optical parameters or otherwise defined boundaries that provide to particularly define such “blood-cell-poor plasma region” and “blood-cell rich region,” and wherein Bamford discusses detecting/ascertaining broadband signals from red blood cells (interference elements rich region) from that of target signal regions (interference elements poor region) (pars.[0005-0007], for example).
With regard to claim 11, Bamford discloses calculating a concentration as claimed (pars.[0007,0034,0039,0056], for example).
With regard to claim 6, and for likewise reasons as those discussed above with respect to claim 1, Bamford provides the application of such apparatus in a methodology as in claim 6 steps (i-v) (pars.[0011,0021-0026,0031,0036,0051], figs. 1-5, for example). With regard to claims 12 and 14, Bamford discloses that the sample is blood/whole blood and the interference elements are blood cells (pars.[0004,0005]) which details samples such as blood, and which is further given as whole blood, and that red blood cells have high broadband signals that are desired to be removed for diagnostic purposes. With regard to claim 66, an analyte is not a positively claimed element of the device and the sample holder (modified by Wardlaw below) is fully capable of holding a sample at an average thickness to about a minimum dimension of a prospective analyte in as much as claimed and required herein. With regard to claims 71-73, and 82, Bamford discloses an original or diluted sample such as in whole blood (par.[0004]). With regard to claims 75-79, Bamford disclose that the analyte is a biomarker, an environmental marker, or a foodstuff marker, a biomarker indicative of the presence or severity of a disease or condition, is a cell, protein, or nucleic acid, and as in those additional elements as in cls. 78 and 79, and wherein Examiner notes that an analyte is not a positive element of the method, wherein the method of Bamford is commensurate with the active steps provided and fully capable of realizing signals related to these prospective analytes in as much as recited and required herein(pars.[0004,0026,0049], which includes cells, cultures, blood, tissues, and proteins, for example, and wherein proteins are well understood as biomarkers and for the presence/severity of a disease or condition, and as typified in Bamford with cancer or other disease). With regards to claims 80-81, interference elements are not a positive element of the method, wherein the claims are drawn to image processing by an algorithm that identifies “interference-elements poor” and “rich” regions, wherein Bamford provides a commensurately claimed methodology with all of the actively recited steps as claimed and further positively disclose such interference elements that generate signals that interfere with the analyte as discussed above, and which includes cells such as in red blood cells as interference elements.
With regards to claims 28-43, the recitations are drawn to process recitations not afforded patentable weight in a device claim, and interference-elements poor and rich regions are not positively claimed structural aspects of the apparatus, wherein the claims are drawn to a non-transitory CRM for identifying one or more rich and poor regions, and analyzing the poor region.
With regards to claims 44-60, the recitations are drawn to process recitations not afforded patentable weight in a device claim. Likewise, with regards to claims 91-94,the recitations are drawn to process recitations not afforded patentable weight in a device claim.
With regards to claims 83, 84, Bamford disclose a sample as in whole blood or RBCs (pars. [0004,0005,0049]). With regard to claims 16, and 99-101, Bamford discloses that the imager comprises a camera and the imager is part of the detector and the imager is integrated with the detector(pars.[0026,0031], for example). With regard to claim 102, Bamford discloses that the imager is directed by the executable algorithm to capture one or more images and identify interference elements regions, free regions, and separate them (pars.[0036-0052], figs. 1-5, for example).
With regard to claim 103, Bamford discloses that the imager comprises a filter configured as claimed (par.[0028,0054]). With regard to claim 104, Bamford discloses a light source as claimed (par.[0028]). With regard to claim 108, Bamford disclose that the detector measures an amount and presence of the analyte and comprises a display configured to show the presence and/or amount as claimed (par.[0030]). With regard to claims 109-111, Bamford discloses that the detector is configured to transmit detection results to a third party (par.[0030] with connection over a network to a third party), the non-transitory CRM is in a storage unit that is a part of the detector, and that the non-transitory CRM is configured to direct the detector to display the presence and/or amount (pars.[0030,0035,0036]). With regard to claim 113, Bamford discloses that the algorithm is configured to direct the detector to disregard the signal of the analyte form the rich region (pars.[0005,0035,0056,0057], to removing the offending signals, leaving behind a refined set of target/desired signals). With regard to claim 114, Bamford discloses the algorithm is configured to direct the detector to increase signal contrast as claimed (pars.[0023,0035]).
With regards to claims 116-125, the recitations are drawn to intended use recitations not afforded patentable weight. With regard to claims 126-127, and 129, Bamford discloses that the signal related to the analyte is an electrical or an optical signal (i.e. Bamford provides for optical investigation by the light source in which a luminescence response is measured and such luminescence emission is converted to an electrical signal in the processing detector, or otherwise as in the imaging of the sample/analyte comprises optical and electrical signals related to the analyte) (pars.[0027,0028] and above discussion). Further, as in claims 128 and 129, the recitations are drawn to process recitations not afforded patentable weight.
With regards to claims 161-163, the recitations are drawn to a capability of the sample holder, and as modified below by Wardlaw to provide a commensurately structured and arranged sample holder as claimed, such sample chamber is fully capable of providing a variation of thickness to the sample layer within 5, 10, 30% in as much as recited and required herein.
With regard to claims 1 and 6 (and dependents thereof), Bamford does not specifically disclose that the sample holder comprises spacers fixed on one or both of the first and second plates, the spacers have substantially uniform height and a constant inter-spacer distance, and pressing the sample holder into the closed configuration to obtain a layer of the sample as in cls. 6, 44-47, 49-66. Likewise, Bamford does not specifically disclose the recitations to the sample holder as in cls. 4, 24, 25, 61-65 (and noting the recitation of cls. 61-65 are drawn to the functionality/capability of sample holder of claim 1 and does not specifically provide a sample holder with plates separated at the recited dimensions), 87, 88, 90-94, 129-141, 145-163, 168-170, and 179 (wherein such recitation in cl. 169 is drawn to a product-by-process recitation that is always directed to the product, which is drawn to spacers fixed on one or more of the plates).
With regard to claims 13 and 15, Bamford does not specifically disclose calculating the volume of the sample based on an area of the layer.
Wardlaw discloses a disposable chamber for analyzing biological fluids such as blood (abstract). Wardlaw discloses a chamber comprising a first 12 and second plate 14 (made of transparent plastic cl. 157, such as acrylic or polystyrene, as in cl. 170; and of thickness such as 23 microns for the first planar member and 50 microns for the second planar member as in cl. 94) wherein the plates 12/14 are movable relative to each other in an open configuration and a closed configuration as claimed including a closed configuration for compressing a sample therebetween into a layer of uniform thickness and (and as in 200 microns or less, and as in 4microns or less), wherein the sample holder is pressed into the closed configuration to obtain a layer of sample (pars.[0014,0036,0037,0046], for example), and wherein the first and second plates are separated by spacers 16 (e.g. polystyrene as in cl. 170; a ratio of 1 given their spherical nature and a pillar shape as they are upstanding, supporting structures as in cls. 150/154 (and commensurate with that provided by Applicant’s pre-grant publication see section B11.16), and as in cl. 151-153 wherein an analyte is drawn to a prospective workpiece in which such spacers meet the criteria for a given prospective analyte, and having a density as in cls. 155/156 given that the spacers are made of a likewise material of construction to that of Applicant’s disclosed materials in polystyrene; see par.[0063] of Applicant’s pre-grant publication) and fixed to one or more of the plates and have a substantially uniform height (and a height as in about 4 microns, for example), and wherein such first and second plates are fully capable of being moved into the recited open and closed configurations, and movable relative to each other, and includes an optical analysis system 44 including a light source and CCD camera movable in three dimensions to scan the examination area of the sample holder. Examiner further notes (and likewise with Vermeiden below) the recitation in claim 1 to “sample-contacting area…” is merely a designated area within the confines of the first and second plates and is appended with the intended-use type designation of being “sample-contacting;” the areas in which the spacers herein are provided are equivocally within the confines of first and second plates and exist in areas likewise designated as “sample-contacting areas of the first or second plates” as such areas are fully capable of receiving sample thereat in as much as recited and required herein. Wardlaw discloses that such a counting chamber has the advantage of provide a chamber thickness that approximates the mean dimension of the separators such that the height is readily ascertainable and thus having a volume that is accurately determinable, and such chamber can be manufactured in an inexpensive form and still provide the desired accuracy (pars.[0014-0016,0031-0042,0047-0049], figs. 1-8, for example). With regards to claims 137, 138, Wardlaw discloses at least one of the plates has a lateral area as claimed, such as in the range of 500 to 1000 square millimeters (par.[0039], for example). With regard to claims 158,139, 140, and 179, Wardlaw discloses that the top planar member may be flexible (pars.[0014,002,0023, and as Wardlaw discloses a likewise material of construction to that of the planar member as Applicant’s (see also above in cl. 170), and Wardlaw discloses likewise spacer elements constructed and arranged as in Applicant’s, and wherein Wardlaw’s flexible top planar member constructed of commensurate polystyrene and commensurately claimed arrangement to the spacers therebetween is said to provide for the recited Young’s module by the ISD of the spacers as in cl. 141 and 179, and the spacers providing a Young’s modulus and filling factor product as in cls. 139&140.
Further, as in cl. 89, as discussed above, from Applicant’s disclosure (see par.[0076] of Applicant’s pre-grant publication US 2020/0333322),the claimed “Q-card” is drawn to the top bottom plate and spacer arrangement disclosed by Wardlaw.
Vermeiden discloses a counting compartment for biological investigations (abstract). Vermeiden discloses spacers 8 that are arranged in the counting compartment at a regular distance (periodically arranged at a constant inter-spacer distance as claimed in cls. 1/6) from one another in order to ensure a uniform depth for the counting compartment over its entire surface, and wherein the sample holder is pressed into the closed configuration to obtain a layer of sample as in cl. 6 (lines 58-60, col. 1; lines 32-36, col. 2, lines 39-44, col. 3, for example).
It would have been obvious to one of ordinary skill in the art to modify Bamford to utilize a sample chamber comprising spacers and being configured to be placed in an open and closed configuration as recited in claims 1, 4, 6, 24, 25, 61-65, 86-88, 90-94, 129-141, 145-163, 168-170, and 179 such as taught by Wardlaw in order to provide a sample holder to the device/method of Bamford who similarly discloses a slide holder for scanning biological fluids such as blood, wherein provision of the sample chamber of Wardlaw comprising spacers of substantially uniform height offers the obvious benefit of providing a chamber in which the height is readily ascertainable and thus having a volume that is accurately determinable in order to offer more accurate optical scanning results of the fluid therein, and wherein such chamber may be made inexpensively while retaining a high degree of accuracy.
Further, it would have been obvious to one of ordinary skill in the art to modify Bamford/Wardlaw provide spacers equally spaced from one another as amended such as suggested by the analogous art of Vermeiden to counting compartments in order to assure a uniform depth for the counting compartment over its entire surface and would have a reasonable expectation of success therein, and wherein Wardlaw similarly discloses a desire for the chamber height to be controlled by that of the spacers/separators (see abstract and the mean chamber height being controlled by the mean heigh of the separators/spacers).
Further, it would have been obvious to one of ordinary skill in the art to modify Bamford to provide pressing the sample holder into the closed configuration to obtain a layer of sample and to an average thickness of a layer of sample as in cls. 44-47,49-66 such as suggested by Wardlaw, wherein Wardlaw provides disclosure to compressing the chamber height to 4 microns or less in a controller manner (par.[0037]) and doing so as to provide an optical imaging of the compressed sample by CCD camera/imaging analysis (pars.[0042,0048], for example), wherein modification suitably provides for a dynamic range of thicknesses to be applied for various samples, including whole blood, that may then be compressed into a layer that affords accurate and specific optical imaging and analysis thereof the cells.
Further, it would have been obvious to one of ordinary skill in the art to modify Bamford to calculate the volume of the sample based on an area of the layer such as taught by Wardlaw in order to provide a more accurate measure of the cell/analyte analysis per volume, or the more accurate concentration of the cell/analyte within the sample space.
As it pertains to amended claims 30-43, the combined prior art as discussed above provide a commensurate method to that of claim 6 and as such is said to equivocally form one or more microdomains of the recited dimensions in as much as claimed and required herein, wherein the claims do not provide particular, additional process step(s) thereto that correlate and particularly provide the recited microdomain and dimensioning thereof, such that the combined prior art discloses an equivocal method of the positive steps provided and thus form such microdomains in as much as claimed and required herein.
With regard to claim 159, the recitation is drawn to a process recitation wherein particular application of pressure is not required and as modified above by Wardlaw, a commensurately structured and arranged sample holder is provided and including in which one of the plates is a flexible polymer, and it is further seen that the spacers may be made rigid relative to the flexible plate so that a pressure that compresses the plates does not compress the spacers.
Claim(s) 2, 3, 7, 9, 20, 74, 95-98, and 178 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bamford in view of Wardlaw and Vermeiden as applied to claims 1, 4, 6, 10-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-111, 116-130, 132-141, 145-147, 150-163, 168-170, 179, and 180 above, and further in view of Ikeda (US 2005/0106552; and further evidenced through JPS 6421362A as referenced within Ikeda in par.[0020], and translation available through Google Patents).
Bamford/Wardlaw/Vermeiden does not specifically disclose an aggregation reagent, and application thereof as in claims 2, 3, 7, 9, 19, 20, 74, 95-98, and 178.
Examiner further notes that the amended recitation of claim 2 to “…the aggregation reagent is coated on the sample holder” is drawn to a process recitation not afforded patentable weight in a device claim.
Ikeda discloses an instrument and method for separating plasma or serum (abstract). Ikeda discloses that it is known to apply an aggregation reagent to blood cells, wherein an aggregration reagent such as thrombin or lectin is utilized (and as a dry reagent), such that in clinical tests it is necessary to use plasma or serum isolated so that red blood cells or an impurity in a blood sample may not interfere with the optical measurement, and such aggregation reagent is provided in a matrix layer on the sample holder providing that the aggregation reagent is coated on the sample holder in as much as required herein wherein “…is coated on…” is drawn to a process recitation not afforded patentable weight in a device claim (pars.[0003-0005,0020], for example).
It would have been obvious to one of ordinary skill in the art to modify Bamford/Wardlaw/Vermeiden to utilize an aggregation reagent in the sample holder, and as in thrombin or lectin, that causes or assists in formation of the interference-elements poor and rich regions such as taught by Ikeda wherein Bamford likewise acknowledges that unwanted signals, including those coming from red blood cells will interfere with the sought targeted signals from the analyte/target of interest, and application of such an aggregation reagent provides the added ability of aggregating and separating away the troublesome/interfering red blood cells so that a more accurate optical analysis can be achieved in viewing and assessing a target area/signals with respect to the target devoid of interfering red blood cells.
Further, while not explicitly disclosed, it would have been readily appreciated by one of ordinary skill in the art that disposition of the aggregation reagent in a coating to one or more of the plates of the chamber is an obvious engineering design choice as providing a relevant point of placement wherein intimate contact will be achieve between the blood sample and the aggregation reagent in order to affect the desired functionality of aggregating and separating away the red blood cells/unwanted debris from the sample.
Claim(s) 67-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bamford in view of Wardlaw and Vermeiden as applied to claims 1, 4, 6, 10-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-111, 116-130, 132-141, 145-147, 150-163, 168-170, 179, and 180 above.
Bamford/Wardlaw/Vermeiden does not specifically disclose the duration of the analysis as recited in claims 67-70.
However, it would have been obvious to one of ordinary skill in the art to optimize the analysis to be done as quickly as possible, and including the durations as claimed including 30 seconds or less, and wherein it is noted that Bamford discloses likewise-considered, sophisticated processing logic that has the capability to process data in a concordant timeframe, and wherein this is seen as an obvious engineering design choice absent a showing of a criticality or unexpected results arising otherwise.
Claim(s) 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bamford in view of Wardlaw and Vermeiden as applied to claims 1, 4, 6, 10-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-111, 116-130, 132-141, 145-147, 150-163, 168-170, 179, and 180 above, and further in view of Siegel.
Bamford/Wardlaw/Vermeiden does not specifically disclose that the sample holder comprises wells configured to hold the sample.
Siegel discloses blood samples places in a microtiter plate for optical imaging and analysis thereof (par.[0033]).
It would have been obvious to one of ordinary skill in the art to utilize an alternative form of a sample holder for a blood sample such as in a microtiter plate (plate having wells for holding samples) as a well-known sample holder with an array of wells for high-throughput sample analysis and for suitably and securably holding the samples to be stably imaged and analyzed that would have a reasonable expectation of success in Bamford/Wardlaw.
Claim(s) 105-107 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bamford in view of Wardlaw and Vermeiden as applied to claims 11, 4, 6, 10-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-111, 116-130, 132-141, 145-147, 150-163, 168-170, 179, and 180 above and in further view of Ozcan et al. (US 2012/0157160), hereafter Ozcan.
Bamford/Wardlaw/Vermeiden does not specifically disclose that the detector is a mobile phone, a smart phone, and the imager is a camera as a part of the smart phone.
Ozcan discloses utilizing a smart phone as a platform for fluorescent microscopy with imaging and detection of labeled whole blood samples, wherein the detector is the mobile device/smart phone and the imager is the camera of the smart phone that provides for an integrated device demonstrating ability for optical analysis of blood samples in a compact, light-weight, modular device that is relatively inexpensive (abstract, pars.[0007-0014,0078,0105-0108], figs., for example).
It would have been obvious to one of ordinary skill in the art to modify Bamford/Warldaw/Vermeiden to utilize mobile phone/smart phone as the detector and the camera of the smartphone as the imager such as taught by Ozcan in order to provide for for optical analysis of blood samples in a compact, light-weight, modular device that is relatively inexpensive and having the ability to be portable and have applications at dynamic fields of use on-site.
Claim(s) 142-144 /are rejected under 35 U.S.C. 103 as being unpatentable over Bamford in view of Wardlaw and Vermeiden as applied to claims 1, 4, 6, 10-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-111, 116-130, 132-141, 145-147, 150-163, 168-170, 179, and 180 and in further view of Coffman et al. (US 2001/0001644), hereafter Coffman, and Craig et al. (US 2002/0037092)
Bamford/Wardlaw/Vermeiden does not disclose that one or both of the plates comprise a location marker, a scale marker, or an image marker as in cls. 164-167.
Coffman discloses plate alignment and sample transfer indicia (location marker) for a multiwell multiplate (abstract). Coffman discloses that alignment indicia are provided on the multiwell plate and comprise positional indicia, as well as transfer indicia on the multiwell plate.
Craig discloses providing scale markers that provide both information of a lateral dimension of a structure of the sample or plate and provide information that assists an imaging of the sample (abstract; pars.[0011,0017-0021,0034], for example).
It would have been obvious to one of ordinary skill in the art to modify Bamford/Wardlaw to utilize a location marker, scale marker, and imaging marker such as taught by Coffman and Craig in order to provide indicia/marking to the plate that help inform the user and the applied equipment in helping track, focus, and align the sample to best optically interrogate and concordantly create images within the desired areas of interest in the sample chamber.
Claim(s) 148 and 149 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bamford in view of Wardlaw and Vermeiden as applied to claims 1, 4, 6, 10-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-111, 116-130, 132-141, 145-147, 150-163, 168-170, 179, and 180 above.
Bamford/Wardlaw/Vermeiden does not specifically disclose that the cross-sectional shape of the pillars is selected from polygonal, square, rectangular, or any combination of the same as in cl. 148, and Bamford/Wardlaw/Vermeiden does not specifically disclose that the spacers have a pillar shape with a substantially flat top surface for contacting each of the first and second plates as in cl. 149.
However, it would have been obvious to one of ordinary skill in the art through routine engineering design to utilize an alternative shape to the spacers of Bamford/Wardlaw/Vermeiden that likewise provide the desired functionality of supporting and separating as previously discussed, and wherein a choosing of a cross-sectional shape of polygonal, square, rectangular, or any combination of the same, and with a substantially flat top surface represents a mere engineering design choice, and is seen as an obvious alternative to the shape/cross-sectional shape of the spacers in Bamford/Wardlaw/Vermeiden absent a showing of evidence to a criticality to those claimed shapes. See also MPEP 2144 IV, B, and In reDaile, 357 F.2d 669, 149 USPQ (CCPA 1966).
Claim(s) 164-167 /are rejected under 35 U.S.C. 103 as being unpatentable over Bamford in view of Wardlaw and Vermeiden as applied to claims 1, 4, 6, 10-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-111, 116-130, 132-141, 145-147, 150-163, 168-170, 179, and 180 above, and in further view of Padmanabhan et al. (US 2003/0142291), hereafter Padmanabhan.
Bamford/Wardlaw/Vermeiden does not specifically disclose that the first and second plates are connected and configured to go from open to closed configuration by folding, and through a hinge, as in claims 164-167.
Padmanabhan discloses a portable scattering and fluorescence cytometer in which an analysis chamber is comprised of connected top and bottom plates that are to be folded with respect to one another from an open configuration to a closed configuration, and including a hinge for facilitating such movement from one configuration to the other (abstract; pars.[0047-0051], fig. 1, for example).
It would have been obvious to one of ordinary skill in the art to modify Bamford/Wardlaw/Vermeiden to utilize connected first and second plates, and with a hinge configured for the folding as claimed such as taught by Padmanabhan in order to provide an obvious alternative arrangement to the top and bottom plate arrangement that suitably affords a sample chamber that is securably held together while also facilitating an ease of transitioning from an open configuration to a closed configuration and vice versa.
Further, while not explicitly disclosed by Padmanabhan, it is asserted that making the first and second plates from a single piece of material represents an obvious engineering design choice so as to make integral two pieces that are already to be connected to one another. See also MPEP 2144.04 ,V-B.
Response to Arguments
Applicant's arguments filed March 26th, 2026 have been fully considered but they are not persuasive.
With regards to the rejection of the claims under 35 USC 112 b/2nd paragraph, Applicant traverses the rejection and asserts that the amendment provides a concrete implementation that is expressly described throughout the specification and examples.
To this, Examiner initially sets forth that the prior rejection has been removed, but a similar one thereto is herein provided in which claims 1-4, 6, 7, 9, 11, 13-16, 20-25, 30-47, 49-70, 72-78, 80, 83-85, 87, 88, 90-101, 103-109, 116-130, 132-170, and 178-179 are rejected under 35 USC 112 b/2nd for the particular reasons discussed above in the body of the claims.
The functionality to the imager, detector, and coincident with the provided device to the method of claim 6 and the positive steps of imaging, identifying, and measuring are indefinitely provided for herein.
Examiner refers Applicant to the body of the action which discusses the particular issues of clarity.
Furthermore, while Applicant asserts that “the amendment provides a concrete implementation that is expressly described throughout the specification and examples,” Examiner notes that Applicant has not identified any particular portion of the disclosure or particular example(s) thereof to provide for the purported “concrete implementation that is expressly described…”
Similarly to that discussed above with respect to the rejection of the claims under 35 USC 112 b/2nd paragraph, Examiner asserts that the specification is without disclosure that expressly describes the amended claims herein.
With regards to claims 1, 4, 6, 11-16, 21-25, 30-47, 49-66, 71-78, 80-85, 87, 88, 90-94, 99-101, 103, 104, 108-109, 116-130, 132-141, 145-147, 150-163, 168-170, and 179 rejected under 35 USC 103, as discussed above, Applicant traverses the rejection.
Applicant asserts that the claims (independent cls. 1 and 6) require spacers to be periodically arranged.
Examiner asserts that, as discussed above, Bamford has not been relied upon for such disclosure, and the modifying, secondary reference of Vermeiden provides the claimed periodically arranged spacers that afford an obvious modification for the reasons discussed above.
Applicant further asserts that the prior art does not teach or suggest the combination of claimed structural features whereby the apparatus is configured to analyze an analyte in a blood sample by identifying a blood-cell-poor plasma region and measuring an analyte signal from the plasma region within a spacer-controlled layer.
Examiner asserts that Bamford provides for such an apparatus configured as claimed and an applied methodology thereof in identifying the recited regions.
Bamford discloses a source imager 101 as in a spectral camera, scanner, fluorescence microscope is associated with or including the spectral camera for imaging a slide containing a sample, detection module 113, and in communication with a plurality of processing modules or logical instruments that are executed by a processor 125 to computer 120, wherein such logical instruments include software/algorithm for recognizing region(s) of noise (the broadband signals designated as “interference-elements rich region as a blood-cell rich region” as recited herein) and regions of interest (the target signals designated herein as “interference-elements poor region is a blood-cell-poor plasma” as recited herein; see also pars.[0005-0007,0026,0031,0032,0036]).
Examiner further notes that “blood-cell-poor plasma region” with respect to the “poor region” and “blood-cell rich region” with respect to the “rich region” remain to be drawn to nominal regions of space as recited herein and wherein such regions of space images and detected herein are likewise constituted as a blood-cell-poor plasma region” and “blood-cell rich region,” wherein the claims do not necessitate a positive provision of particular optical parameters or otherwise defined boundaries that provide to particularly define such “blood-cell-poor plasma region” and “blood-cell rich region,” and wherein Bamford discusses detecting/ascertaining broadband signals from red blood cells (interference elements rich region) from that of target signal regions (interference elements poor region) (pars.[0005-0007,0011,0023,0024,0031,0032,0036], for example).
Applicant asserts that the additional references including Ikeda, Siegel, Ozcan, Coffman, Craig, and Padmanabhan do not remedy the deficiencies of Bamford and Wardlaw (and assuming Vermeiden as it is presented in the rejection to independent claims 1 and 6).
As discussed above, there are no such deficiencies with respect to Bamford n view of Wardlaw and Vermedien, and thus the claims are maintained properly rejected as discussed above and in the body of the action.
Likewise, the remaining dependent claims that incorporate the features of claim 1 or 6 are also maintained as properly rejected for the reasons discussed above in the body of the action.
With regard to claims 65 and 133, Applicant asserts that the amended, claimed average thickness of 1.8 to 3.8 microns in cl. 65 and the spacers have a uniform height of 1.8 to 3.8 microns are patentable over the art of record.
Applicant asserts that these dimensions might compress cells into a very thin layer, potentially deforming RBCs, which help in reducing overlap, and, as such, this range enables the formation of a thin layer in which blood cells are spatially separated, thereby minimizing overlap and facilitating accurate imaging and measurement of analyte signals.
As discussed above, Examiner asserts that Wardlaw provides disclosure to compressing the chamber height to 4 microns or less in a controller manner (par.[0037]) and doing so as to provide an optical imaging of the compressed sample by CCD camera/imaging analysis (pars.[0042,0048], for example), wherein modification suitably provides for a dynamic range of thicknesses to be applied for various samples, including whole blood, that may then be compressed into a layer that affords accurate and specific optical imaging and analysis thereof the cells.
With regard to claim 179, Applicant asserts that the claim recites that “…the thickness of the flexible plate times the Young’s modulus of the flexible plate is in the range of 60 to 750 Gpa-micrometers, and that the fourth power…”
Applicant asserts that Wardlaw does not teach or suggest “the specific range of 60 to 750 GPa-micrometers and equal to or less than…” as in cl. 179.
Applicant asserts that Wardlaw discloses flexible materials such as acrylic or polystyrene, however, these materials encompass a large class having numerous members that can lead to various ranges or values of the thickness and Young’s modulus of the flexible plate, let alone the ISD of the spacers.
Examiner asserts that the recitation of claim 179 is not limited to any particular material, let alone a class or genus of materials, as the recitation of claim 179 itself is equivocally open-ended in terms of materials afforded as proffered by Applicant and provides for a broad scope of materials of construction.
Herein, Examiner provides that Wardlaw discloses polystyrene as materials to the plates as discussed in related claim 170 and in Applicant’s specification and equivocal thickness thereto the plates as discussed in Applicant’s specification, and providing equivocal spacers as claimed (as noted above with the added prior art reference to Vermeiden as discussed above in the body of the action).
Bamford/Wardlaw/Vermeiden provide that of the claimed resultant material property thereto as in cl. 179.
Examiner further notes that-
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. “The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.”). See MPEP 2112.01, II, for example.
As discussed above, Bamford/Wardlaw/Vermeiden provide a commensurately structured and arranged device in as much as provided herein, wherein such a commensurately structured and arranged device necessarily has a resultant material property in as much as recited in claim 179 as there is no structural difference presented between the claimed plates/beads and that of the cited prior art combination.
Further, in view of the amendments to the claims, Examiner notes that Claims 1-4, 6, 7, 9, 11, 13-16, 20-25, 30-47, 49-70, 72-78, 80, 83-85, 87, 88, 90-101, 103-109, 116-130, 132-170, and 178-179 are herein rejected under 35 USC 112 b/2nd for the reasons discussed above in the body of the action.
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
Prosecution Insights