DETAILED ACTION
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 .
Status of the Objections and Rejections pending since the
non-final Office Action mailed on April 17, 2026
The objection to claim 19 is withdrawn.
The rejection of claim 11 under 35 U.S.C 112(b) is withdrawn.
All of the double patenting rejections are maintained. They are presented again below for Applicant’s convenience.
The rejections of claims 1, 2, and 4-8 under 35 U.S.C. 103 are maintained. They are presented again below for Applicant’s convenience.
The rejection of claim 11 under 35 U.S.C. 103 is withdrawn, but has been rewritten in light of applicant’s latest Amendment.
5. The rejections of claims 15, 16, 19, and 22-26 under 35 U.S.C. 103 are withdrawn.
Response to Arguments
Applicant's arguments filed July 16, 2026 have been fully considered but they are not persuasive. The Examiner’s remarks below track Applicant’s presentation of arguments’ the latest Amendment.
Claim Rejections Under Double Patenting
Regarding the claims rejections under double patenting Applicant first argues
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The Examiner does not understand this argument. The Examiner’s double patenting rejection of claim 15 based on claim 21 of U.S. Patent No. 12,140,599 is reproduced below.
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The Examiner does not identify any material difference in claim 15 (of the application) from claim 21 because there is none nor has Applicant pointed out any material difference. Applicant mentions “the claimed electroscopic imaging methodology”. The claimed electroscopic imaging methodology in application claim 15 is the following
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The claimed electroscopic imaging methodology in claim 211 of U.S. Patent No. 12,140,599 is the following
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Applicant is invited to explain how these two electroscopic imaging methodologies are materially different.
Applicant next argues
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The Examiner respectfully disagrees as the purpose of the concept of nonstatutory double patenting rejections is to prevent unjustified extension of patent rights:
B. Nonstatutory Double Patenting
A rejection based on nonstatutory double patenting is based on a judicially created doctrine grounded in public policy so as to prevent the unjustified or improper timewise extension of the right to exclude granted by a patent. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969); In re White, 405 F.2d 904, 160 USPQ 417 (CCPA 1969); In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968); In re Sarett, 327 F.2d 1005, 140 USPQ 474 (CCPA 1964). A double patenting rejection also serves public policy interests by preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982).[AltContent: rect]
A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate. To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences. Then the examiner should determine whether those differences render the claims patentably distinct using an anticipation analysis and/or an obviousness analysis. See Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1363, 86 USPQ2d 1001, 1008 (Fed. Cir. 2008).
See MPEP 804(II)(B)
6. Nonstatutory Double Patenting Rejection Based on Equitable Principles
In some circumstances a nonstatutory double patenting rejection is applicable based on equitable principles. Occasionally the fundamental reason for nonstatutory double patenting – to prevent unjustified timewise extension of patent rights – is itself enforceable no matter how the extension is brought about. Examples of this occurred in In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968); and Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
In In re Schneller, 397 F.2d 350, 158 USPQ 210, 216 (CCPA 1968), the court affirmed a double patenting rejection after summing up the situation as follows:
[I]n appellant’s own terms: The combination ABC was old. He made two improvements on it, (1) adding X and (2) adding Y, the result still being a unitary clip of enhanced utility. While his invention can be practiced in the forms ABCX or ABCY, the greatest advantage and best mode of practicing the invention as disclosed is obtained by using both inventions in the combination ABCXY. His first application disclosed ABCXY and other matters. He obtained a patent claiming [a clip comprising] BCX and ABCX, . . . so claiming these combinations as to cover them no matter what other feature is incorporated in them, thus covering effectively ABCXY. He now, many years later, seeks more claims directed to ABCY and ABCXY. Thus, protection he already had would be extended, albeit in somewhat different form, for several years beyond the expiration of his patent, were we to reverse.
397 F.2d at 355-56, 158 USPQ at 216 (emphasis in original).
The court recognized that "there is no double patenting in the sense of claiming the same invention because ABCX and ABCY are, in the technical patent law sense, different inventions. The rule against ‘double patenting,’ however, is not so circumscribed. The fundamental reason for the rule is to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about. To . . . prevail here, appellant has the burden of establishing that the invention claimed in his patent is ‘independent and distinct’ from the invention of the appealed claims…. [A]ppellant has clearly not established the independent and distinct character of the inventions of the appealed claims." 397 F.2d at 354-55, 158 USPQ at 214-15 (emphasis in original). The court observed:
The controlling fact is that patent protection for the clips, fully disclosed in and covered by the claims of the patent, would be extended by allowance of the appealed claims. Under the circumstance of the instant case, wherein we find no valid excuse or mitigating circumstances making it either reasonable or equitable to make an exception, and wherein there is no terminal disclaimer, the rule against "double patenting" must be applied.
397 F.2d at 355, 158 USPQ at 215.
See MPEP 804(II)(B)(6). Underlining and highlighting in bold by the Examiner.
The Examiner does not argue that “any collection of limitations drawn from dependent claims sharing a common parent claim would become presumptively patentably indistinct, regardless of whether the patent provides any reason to select those particular limitations.” Clearly, for example, features to different embodiments are not necessarily presumptively combinable. The document patenting rejection of claim 7 is reproduced below
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The Examiner notes that all of the limitations combined from the dependent claims in this double patenting rejections are compatible with each other, non-overlapping2, and directed to the same base invention. So, it is reasonable to assume that they may be combined. According to Applicant’s argument (1) no reasonable combination of limitations of dependent claims in a patent may be assumed so perhaps hundreds of claims are necessary to prevent infringement, and (2) when Applicant’s patent term on a patent, such as U.S. Patent No. 12,140,599, is about to expire all Applicant has to do extend patent rights is combine any features from dependent claims in the patent to make a “new” claim in a new patent application. However, if Applicant files a Declaration disavowing any rights to any combination of features in the dependent claims of either U.S. Patent No. 12,140,599 and U.S. Patent No. 11,567,036 or if Applicant files a Declaration stating that one of ordinary skill in the art would never think of combining together features in the dependent claims of either U.S. Patent No. 12,140,599 and U.S. Patent No. 11,567,036, the Examiner will reconsider these double patenting rejections.
Applicant next argues
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The Examiner respectfully disagrees. The double patenting rejection of
claim 1 of the application based on U.S. Patent No. 12,140,599 is reproduced below.
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Claim 26 of U.S. Patent No. 12,140,599 is reproduced below.
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So, claim 26 of U.S. Patent No. 12,140,599 does meet the application claim 1 limitation “per pixel coverage of cell footprint area of between about 0.008% to about 12%; . . . .” As for “the functional relationship between sensor geometry and the footprint of a living cell that defines Applicant's invention…”, it is not clear what part of claim 1 of the application Applicant is referring to. This functional relationship appears in neither
claim 1 nor any other claim in the instant application.
As for claim 26 of the instant application, it is reproduced below.
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Claims 16, 17, 193, 20, 21, and 24 of U.S. Patent No. 12,140,599
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Clearly
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implies “selecting an area of interest of the ChemFET sensor array device, wherein the area of interest comprises at least one cell of interest; and displaying an electroscopic image for the area of interest, . . . .” of claim 26. As for “wherein the electroscopic image displayed includes an image and a temporal response curve of at least one cell in the area of interest…”, claim 18 requires
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Although claim 18 is not specifically mentioned in the claim 26 rejection this is an obvious oversight as claim 26 is otherwise rejected over at least immediately adjacent claims 16, 17, and 19. One would have to willfully ignore claim 18.
Last, regarding the double patenting rejections, Applicant argues
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As the Examiner stated above,” if Applicant files a Declaration disavowing any rights to any combination of features in the dependent claims of either U.S. Patent No. 12,140,599 and U.S. Patent No. 11,567,036 or if Applicant files a Declaration stating that one of ordinary skill in the art would never think of combining together features in the dependent claims of either U.S. Patent No. 12,140,599 and U.S. Patent No. 11,567,036, the Examiner will reconsider these double patenting rejections.”
Claim Rejections Under 25 U.S.C. 103
Independent claim 1
Applicant first argues the following
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The Examiner respectfully disagrees. The relevant portion of the claim 1 rejection is reproduced below.
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Nowhere here does the Examiner mention optimization. Nor does MPEP 2144.04(IV)(A), reproduced below, relate to optimization.
IV. CHANGES IN SIZE, SHAPE, OR SEQUENCE OF ADDING INGREDIENTS
A. Changes in Size/Proportion
In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.).
In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Applicant has the burden to show a material effect on the scaling down in size of the pixels over Duarte-Guervara.
Applicant next argues
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The Examiner does not understand how this “benefit” may be read into claim 1 as it stands. In any event, it is self-evident that the greater the pixel density, that is, sensor density, the greater the imaging resolution of the cell.
Applicant next argues
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Applicant’s own argument actually alludes to how Milgrew and Duarte-Guevara are analogous art – they both disclose FET sensor arrays. Duarte-Guevara is relied upon only to show that it was known how make, as acknowledged by Applicant, a higher-density BioFET device.
Applicant next argues
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As a first matter it is not clear why subcellular discrimination is to be read into claim 1. In any event, the rejection of claim 1 states,
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The Examiner respectfully disagrees that Applicant is the first one to recognize that pixel (sensor) density affects imaging resolution.
Applicant next argues
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In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., different sensor geometries) are not recited in the rejected claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In any event, as has already been stated, it is self-evident that the greater the pixel density, that is, sensor density, the greater the imaging resolution of the cell.
Applicant next argues
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In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “windowing”) are not recited in the rejected claim 1 (nor claim 7). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant next argues
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Applicant has not pointed out how the Examiner’s rejection of claim 1 does not the limitations of claim 1 as claimed. Also, the Examiner does provide motivation for turning to Lorenzelli and Schaffhauser:
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Applicant next argues
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The Examiner has provided motivation for each modification made to Milgrew. Applicant has not explained why these modifications, such as from Lorenzelli and Schaffhauser would not preserve the operation of Milgrew's extracellular sensing platform.
Applicant next argues
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As explained above the Examiner does not argue that pixel coverage is a result-effective variable. The Examiner has provided motivation for each modification made to Milgrew. Applicant seems to not accept the concept of obviousness rejections and only accepts anticipatory rejections.
Claims 2-13
Applicant here largely relies on the argument made against the rejection of
claim 1. Applicant further argues
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The Examiner respectfully disagrees. The Examiner has provided motivation for any modification made to Milgrew without using Applicant’s specification as a roadmap. Applicant is invited to show a specific example of where the Examiner uses reasoning from the specification to modify Milgrew. Indeed, in rejecting claim 2 the Examiner turns to Milgrew alone:
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Claims 4 and 5
Applicant here argues the following
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The Examiner has carefully reconsidered Applicant’s specification paragraphs [0073]-[0079]. Where is this inventive enabling detail Applicant refers to in his argument? In these paragraphs there is just mention of generic electronic components such as an array controller and analog supply. For example,
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Applicant’s Figure 5A is just a circuit block diagram:
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Applicant next argues
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The Examiner has established prima facie obviousness of duplication of parts. The burden is on Applicant to show otherwise. A mere assertion that it is not so, especially when Applicant’s own specification refer only to generic electronic components and drawings only show block circuit diagram, is not persuasive.
Applicant next argues
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This argument is very odd. Applicant argues that the electronics for the claimed cell analysis system are inventive, yet Applicant’s application only refers to genic electronic components and includes not a single circuit schematic. Put another way, Applicant argues, “General reference to electronic circuitry is insufficient to satisfy the requirement that every claim limitation be addressed. MPEP § 2143.03. ..“, yet Applicant’s original disclosure only makes general reference to electronic circuitry.
Claim 6
Applicant here argues
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Applicant has clearly misread the rejections of claim 6 and underlying claim 1 as they pertain to Lorenzelli. Motivation for turning to :Lorenzelli has certainly been articulated:
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(excerpted for the claim 1 rejection under 35 U.S.C. 103 on page 23 of the previous Office Action), and
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Moreover, Applicant has not provided any technical reason as to why the aspect of Lorenzelli relied upon by the Examiner is not compatible with the cell analysis system of Milgrew.
Claim 7
Applicant here argues the following
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Applicant’s specification paragraph [0123] is reproduced below
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Surely the finding that there is an “inverse relationship between an aera of interest selected and the rate at which data can be collected…” is not a discovery as it verges on common sense – the greater the area of interest, the more data to be collected. Will the inventors file a declaration declaring that one of ordinary skill in the art believed otherwise at the time the application was filed?
Applicant next argues here
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Applicant’s claim 7 is reproduced below
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First, nowhere in this claim is there expressed a mathematical relationship between sample area and acquisition frequency, the claim only states two ranges. Stating that a bag of marbles contains marbles that have a diameter between 1-2 cm and have a weight between 0.5 – 2.0 gm does not express a relationship as to how marble diameter varies with marble weight.
Second, not only is there no expression of a mathematical relationship between sample area and acquisition frequency in claim 7 there is no indication of any sort of optimization.
Third, the Examiner in the claim 7 rejection clearly establishes optimization without reference to Applicant’s specification. The rejection of claim 7 states in part, on page 27 of the previous Office Actin, the following
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Where are data compression, reducing noise, and enhancing or maximizing a signal mentioned in Applicant’s specification?
Last, Applicant is invited to provide a case or MPEP citation where it is held that an Examiner may not optimize the relationship between two claimed operational variables to achieve another benefit than Applicant allegedly found.
Claims 12 and 13
Applicant argues here the following
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All of these arguments are moot as the Examiner has not rejected either claim 12 or claim 13 under 35 U.S.C. 103, only double patenting rejections have been made against them.
Claims 8 and 11
Applicant argues here the following
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Applicant has perhaps read the wrong claim rejections. The rejections of claim 8 and 11 clearly do teach the suggested claimed surface treatment and adequate reason for one of ordinary skill in the art to rely upon the applied secondary references is clearly articulated:
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Claim 8
Applicant argues here the following
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In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant next argues
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Applicant has not provided reason as to why one of ordinary skill in the art would think the cited references to not be compatible. Surely it is self-evident that for the cell analysis system of Milgrew in which the cell or cells to analyzed are laid over the FET sensor array the better the cells adhere to the sensor surfaces the better more accurate or stringer the measurement signals. Put another way, any spacing between the cell bottom surface and the senor array top surface should be minimized or eliminated.
Applicant next argues
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The Examiner respectfully disagrees. Apparently, Applicant has overlooked a large portion of the rejection under 35 U.S.C 103, which is reproduced in part below
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Applicant next argues
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The Examiner does not understand why Applicant believes that when a poly-D-lysin and/or laminin coating are adopted from Bonk or Larramendy into the cell analysis system of Milgrew explicitly to enhance cell adhesion that this will not necessarily “permit stable cell attachment while maintaining the sensing capabilities of the device throughout repeated measurements.”
Claim 11
Applicant argues here
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While the Examiner agrees with Applicant’s characterization of Applicant's specification paragraphs [0061] and [0085], he declines to withdraw the rejection of
claim 11 under 35 U.S.C 103 as the claim itself identifies poly-D-lysin and/or laminin as an extracellular matrix preparation. To wit,
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Applicant is invited to explain how an extracellular matrix preparation coating can be something other than a poly-D-lysin and/or laminin coating and yet a poly-D-lysin and/or laminin coating at the same time.
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Applicant’s Amendment pages 24-30 argue against the rejections of claims 15, 16, 19, and 22-29 under 35 U.SC. 103. The Examiner has reconsidered these rejections and has decided to withdraw them mainly due to the discussion by Applicant under the heading
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,which is on pages 24-25 of the Amendment, and the discussion under the heading
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, which is on pages 25-26 of the Amendment and is tied to the electroscopic image discussion.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double Patenting Rejections based on US 12,140,559 B2
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 26 together of U.S. Patent No. 12,140,559 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 13 and 26 together of U.S. Patent No. 12,140,559 B2 meet all of the limitations of claim 1 of the instant application. Note that one of ordinary skill in the art would assume that that ChemFET sensor array used in the cell imaging method of claim 26 of U.S. Patent No. 12,140,559 B2 may be the ChemFET sensor array that is part of cell analysis system of claim 13 of the same patent.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 13, and 26 together of U.S. Patent No. 12,140,559 B2. Claim 1, from which claim 2 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 2 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim (such as claims 3 and 13 do) as they then clearly modify the same base invention.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 26 together of U.S. Patent No. 12,140,559 B2.
Claim 1, from which claim 4 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 13 (via claim 1) of U.S. Patent No. 12,140,559 B2 already meets the additional limitation of claim 4 of the instant application.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 13, and 26 together of U.S. Patent No. 12,140,559 B2. Claim 1, from which claim 5 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 4 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 5 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim (such as claims 4 and 13 do) as they then clearly modify the same base invention.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 26 together of U.S. Patent No. 12,140,559 B2.
Claim 1, from which claim 6 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 14 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 6 of the instant application.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 13, 23, and 26 together of U.S. Patent No. 12,140,559 B2. Claim 1, from which claim 7 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because
(1) claim 5 of U.S. Patent No. 12,140,559 B2 meets the additional claim 7 limitation of “. . . ., further comprising control circuitry coupled to the device and configured to provide a frame rate of between about 1.3 kHz to about 75 kHz . . . .”;
(2) claim 23 requires that “the ChemFET sensor array has a sensor pitch of between around 850 nm to about 3.36 µm.” Thus, to have to have the area of the frame rate be from 8000 µm2 to 20µm2 for the cell analysis system of claims 5, 13, and 26 together of U.S. Patent No. 12,140,559 B2, which is not specified and which has 20 million ChemFET sensors (claim 1 of the patent), is prima facie obvious as a change in size or proportion of the area of the frame rate with no material effect on the ChemFET measurements per se (MPEP 2144.04(IV)(A)), especially as the upper area limit of 8000 µm2 is four hundred times the lower limit of 20µm2; and
(30 it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim (such as claims 5 and 13 do, and 23 and 26 do) as they then clearly modify the same base invention.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 13, and 26 together of U.S. Patent No. 12,140,559 B2. Claim 1, from which claim 8 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 8 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 8 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim (such as claims 8 and 13 do) as they then clearly modify the same base invention.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 13, and 26 together of U.S. Patent No. 12,140,559 B2. Claim 1, from which claim 12 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 12 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim (such as claims 12 and 13 do) as they then clearly modify the same base invention.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 12, 13, and 26 together of U.S. Patent No. 12,140,559 B2. Claim 12, from which claim 13 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 13 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim (such as claims 10, 12, and 13 do) as they then clearly modify the same base invention.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12,140,559 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 21 of U.S. Patent No. 12,140,559 B2 meet all of the limitations of claim 15 of the instant application.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 15, from which claim 16 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 18 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 16 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 16, from which claim 18 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 19 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 18 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 15, from which claim 19 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 20 and 21 together of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 19 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23 and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 15, from which claim 22 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 23 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 22 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24 and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 15, from which claim 23 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 24 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 23 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25 and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 15, from which claim 24 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 25 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 24 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26 and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 15, from which claim 25 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 26 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 25 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 24, and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 15, from which claim 26 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 19 and 24 together of U.S. Patent No. 12,140,559 B2 meet or render obvious the additional limitations of claim 26 of the instant application. In particular, the claim 26 step of “. . . ., after performing the experiment: selecting an area of interest of the ChemFET sensor array device, wherein the area of interest comprises at least one cell of interest; . . . .” is obvious over claim 24 of U.S. Patent No. 12,140,559 B2, which requires “. . . ., wherein the footprint of a cell over the sensor array surface is between about 2 sensors to about 12,668 sensors…” as one of ordinary skill in the art would not have many thousands of sensors perform imaging of if only a few thousand or a few hundred or even a few dozen are sufficient, the rest just imaging space surrounding the cell. As for the claim 26 steps of “. . . ., and displaying an electroscopic image for the area of interest, wherein the electroscopic image displayed includes an image and a temporal response curve of at least one cell in the area of interest…”, these are met by claim 19 of U.S. Patent No. 12,140,559 B2. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28 and 21 together of U.S. Patent No. 12,140,559 B2.
Claim 15, from which claim 29 depends , has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 28 of U.S. Patent No. 12,140,559 B2 meets the additional limitation of claim 29 of the instant application. Note: (1) that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention; and (2) that claims 6-8 of U.S. Patent No. 12,140,559 B2 evidence that the coating compounds listed in claim 28 of the patent will promote cell adhesion.
Double Patenting Rejections based on US 11,567,036 B2
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,567,036 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 1 of the instant application.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,567,036 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 2 of the instant application.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11,567,036 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 13 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 4 of the instant application.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,567,036 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 5 of the instant application.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,567,036 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 6 of the instant application.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11,567,036 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 12 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 7 of the instant application. Note: (1) that the claim 12 frame rate range of “a frame rate per cell diameter of between about 1 kHz to about 75 kHz” includes and is, in fact almost the same as, the clam 7 frame rate range of “a fame rate of between about 1.3 kHz to about 75 Hz”5; and (2) that the claim 12 limitation ‘. . . . a frame rate per cell diameter of between about 1 kHz to about 75 kHz for a range of cells with a diameter of between about 100 μm to 5 μm, respectively…[italicizing by the Examiner]” implies the claim 7 of “configured to provide a frame rate of between about 1.3 kHz to about 75 kHz over an area of about 8000 µm2 to 20 µm2, respectively…“ as, assuming that the cells as substantially circular, a cell with a diameter of 100 μm will have an area of about 7854 µm2 and a cell with a diameter of 5 µm will have na area of about 20 µm2.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,567,036 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 6 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 8 of the instant application. As evidenced by the Bonk et al. article and the Larramendy et al. article cited on Applicant’s Information Disclosure Statement (non-patent literature 001 and 006, respectively), a coating of poly-D-lysine or lamin or both will inherently
promote cell adhesion. Bonk states,
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(see Bonk page 520), and Larramendy states,
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(see Larramendy page 7).
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,567,036 B2. Claim 8, from which claim 11 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of U.S. Patent No. 11,567,036 B2 meets all of the limitation of claim 11 of the instant application.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,567,036 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 6 of the instant application. Note that the claim 1 claim 1 of U.S. Patent No. 11,567,036 B2 limitation “each microwell structure having a height with a characteristic ratio to a width, and a bottom defined by a sensing surface; . . . “ the claim 12 limitation “herein each microwell structure is coupled to at least one sensor.”
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,567,036 B2. Claim 12, from which claim 13 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of U.S. Patent No. 11,567,036 B2 meets all of the limitations of claim 13 of the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Milgrew et al., “A Fully-Integrated CMOS Microsensor Array for Imaging the Hydrogen Ion Activity of Living Cells,” Twelfth International Conference on Miniaturized Systems for Chemistry and Life Sciences October 12 -16, 2008, San Diego, California, USA (hereafter “Milgrew”); and Lorenzelli et al., “Bioelectrochemical signal monitoring of in-vitro cultured cells by means of an automated microsystem based on solid state sensor-array,” Biosensors and Bioelectronics 18 (2003) 621-626 (hereafter “Lorenzelli”) and Schaffhauser et al., “Measurement of Rapid Amiloride-Dependent pH Changes at the Cell Surface Using a Proton-Sensitive Field-Effect Transistor,” Biosensors 2016,6, 11; doi:10.3390/bios6020011 (hereafter “Schaffhauser”), and Duarte-Guevara et al, “Characterization of a 1024 x 1024 DG-BioFET platform,” Sensors and Actuators B: Chemical 250 (2017) 100-110 (hereafter “Duarte-Guevara”).
Addressing claim 1, Milgrew discloses a cell analysis system (see the title) comprising:
a device including an array of chemical field effect transistor (ChemFET) sensors (see the first sentence of Theory, which is on page 1117, and Figures 2 and 3, noting therein “Pixel Array”).
Milgrew does not disclose “said array of sensors having a per pixel coverage of cell footprint area of between about 0.008% to about 12%”. However, Milgrew does disclose,“The array comprises of 16 x 16 pixels, with a size of 12.8 μm x 12.8 μm and a pitch of 1.2 μm.” See Experimental on page 1118. Duarte-Guevara discloses a sensor array of bioFETS including over a million transistors in a 7 x 7 mm2 array, the sensing area of each sensor being only 0.5 x 0.26 µm. See the title, Abstract, Figure 1, and Table 1, which is on page 103. So the dimensions of the sensor array and sensors within the array of Milgrew could be significantly reduced in size. Thus, this limitation about pixel coverage per cell footprint area is prima facie obvious as just a size or proportion change of the sensor array in light of Duarte-Guevara, with no material effect on the operation of the cell analysis system. See MPEP 2144.04 (IV)(A). One of ordinary skill in the art would know how to adjust the size each sensor of the sensor array depending on the expected size range of the sample cells and the analysis or experimental data of interest.
Milgrew also does not disclose “a flow cell mounted upon the device, wherein the flow cell is configured to provide a fluidic interface for the device with the cell analysis system; and a reference electrode in flow communication with the flow cell, wherein the reference electrode is configured to provide a stable reference potential to the array of sensors.”
Lorenzelli discloses a cell analysis system including a device comprising an ISFET array, a flow cell (Microchamber head together with Electrode compartment, and Ag/AgCl reference electrode shown in Figure 1B) mounted upon the device, wherein the flow cell is configured to provide a fluidic interface for the device with the cell analysis system; and a reference electrode in flow communication with the flow cell. See the title, Abstract, and Figure 1(B).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a flow cell as taught by Lorenzelli in the device of the cell analysis system of Milgrew as modified by Duarte-Guevara because (1) one of ordinary skill in the art could readily adapt the flow cell of Lorenzelli for use with device of the cell analysis system of Milgrew as modified Duarte-Guevara, (2) if the cells being analyzed are living, then, as disclosed by Lorenzelli, the flow cell will allow the culture medium to be replaced with fresh culture medium as needed without interrupting the analysis or disturbing the cells (see Lorenzelli first column on page 624, underneath Figure 3), and (3) regarding the reference electrode, although not specifically indicated by Lorenzelli, its benefit would be in grounding the culture medium (see Schaffhauser Figure 2(a) and note the following
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See Schaffhauser page 3 of 12.). One of ordinary skill in the art would recognize that grounding the culture medium, and so holding it at a fixed potential, will prevent it from adversely affect the ISFET pH measurements, which correlate gate or source voltage change with solution pH change (see Lorenzelli the last sentence on page 622, bridging to page 623, and see in Milgrew the second sentence of Experimental on page 1118).
Addressing claim 2, as for the additional limitation “wherein the ChemFET sensors are ion selective field effect transistor (ISFET) sensors . . . .” see Milgrew the Abstract and Figure 1. Also note that all of the secondary references used in rejection of claim 1, also disclose having ChemFET sensors that are ISFETs.
As for the additional limitation “wherein the ChemFET sensors are ion selective field effect transistor (ISFET) sensors selective for hydrogen ion. [italicizing by the Examiner]” see Milgrew the last sentence of Introduction, which is on page 1117, and Figure 1.
Addressing claim 4, for the additional limitation of this claim first see Milgrew
Figure 3, Pixel Array micrograph. Expanding the pixel array, that is adding more rows and/or columns of sensors, is prima facie obvious as just duplication of parts for a multiplied effect (see MPEP 2144.04(VI(B)), namely, increasing the population of cells that analyzed simultaneously by the sensor array. In this regard, note that while the pixel array in Milgrew is 16 x 16 ChemFETsensors, Duarte-Guevara discloses a 1024 x 1024 sensor pixel array, that is an array of 1,048,576 ChemFET sensors (see the title and Abstract).
Addressing claim 5, as for the claimed array controller, this array controller is implied by the electrical schematic shown on the right-side of Milgrew Figure 1, the photograph of the fabricated microchip in Milgrew Figure 2, and the following
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See Milgrew page 1118.
Addressing claim 6, as for the claimed fluidic system, recall the following from the rejection of underlying claim 1 above,
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide a flow cell as taught by Lorenzelli in the device of the cell analysis system of Milgrew as modified by Duarte-Guevara because (1) one of ordinary skill in the art could readily adapt the flow cell of Lorenzelli for use with device of the cell analysis system of Milgrew as modified Duarte-Guevara, (2) if the cells being analyzed are living, then, as disclosed by Lorenzelli, the flow cell will allow the culture medium to be replaced with fresh culture medium as needed without interrupting the analysis or disturbing the cells (see Lorenzelli first column on page 624, underneath Figure 3), . . . . [underlining added for emphasis]
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Milgrew in view of Lorenzelli, Schaffhauser, and Duarte-Guevara as applied to claims 1-6 above, and further in view of Davey et al. US 20120143531 A1 (hereafter “Davey”).
Addressing claim 7, although Milgrew as modified by Lorenzelli, Schaffhauser, and Duarte-Guevara does implicitly disclose that the cells analysis system comprises control circuitry coupled to the device (see Results and Discussion on page 1119), Milgrew as modified by Lorenzelli, Schaffhauser, and Duarte-Guevara does not disclose that control circuitry is “configured to provide a frame rate per cell diameter of between about 1 kHz to about 75 kHz over an area of about 8000 µm2 to 20 µm2, respectively.”
Davey discloses a cell analysis system (although the analysis system (see the title and Abstract) of Davey is exemplified in the Davey specification by discussing how it could be used for nucleic acid sequencing, Davey does state,
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In other words, that the analysis system of Davey is a cell analysis system is an intended use of the Davey system that it is inherently capable of being used for, as it is structurally and compositionally substantially the same as the claimed cell analysis system (see discussion below), and Davy itself, as noted above, discloses that the system may be used for cell analysis.) comprising:
a device (chip 132 in Figure 1B) including an array of chemical field effect transistor (ChemFET) sensors (note microwell array 107 in Figure 1A, which is part of the device. As shown in a detailed view of a single microwell in Figure 2A and discussed in paragraph [0039], each microwell comprises a chemFET sensor 214).
Davey further discloses control circuitry coupled to the device. This control circuitry is configured to perform frame averaging as a data compression technique, reduce noise, and enhance or maximize a signal about an event of interest. See Davey parapgrjhs [0142]-[0145]. Davey also discloses frame rates within the claimed range up tot 75 kHz. See Davey paragraph [0052]. Thus, in light of this disclosure of Davey, barring a contrary showing, such as unexpected results, to have the control circuitry in the cell analysis system of Milgrew as modified by Lorenzelli, Schaffhauser, and Duarte-Guevara be “configured to provide a frame rate per cell diameter of between about 1 kHz to about 75 kHz over an area of about 8000 µm2 to 20 µm2, respectively…” is just optimization of a known result effective variable (to balance data compression with reduce noise, and enhance signal related to an event of interest).
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Milgrew in view of Lorenzelli, Schaffhauser, and Duarte-Guevara as applied to
claims 1-6 above, and further in view of Bonk et al., “Design and Characterization of a Sensorized Microfluidic Cell-Culture System with Electro-Thermal Micro-Pumps and Sensors for Cell Adhesion, Oxygen, and pH on a Glass Chip,” Biosensors 2015, 5, 513-536; doi: 10.3390/bios5030513 (hereafter “Bonk”); Florian Larramendy, Amel Bendali, Marie-Charline Blatché, Fabrice Mathieu, Serge Picaud, et al. MISFET-based biosensing interface for neurons guided growth and neuronal electrical activities recording. Sensors and Actuators B: Chemical, Elsevier, 2014, 203, pp.375 -381. 10.1016/j.snb.2014.06.106. hal-01504965 (hereafter “Larramendy”),
Addressing claim 8, although Milgrew as modified by Lorenzelli, Schaffhauser, and Duarte-Guevara does disclose that “the device has a substantially planar surface” (see Milgrew Figures 1 and 2), Milgrew as modified by Lorenzelli, Schaffhauser, and Duarte-Guevara does not appear to disclose that this surface is treated with a coating to promote cell adhesion, the coating being selected from poly-D-lysine, laminin, and combinations thereof.
Bonk discloses a cell analysis system for cell monitoring in the form of a chip comprising pH measurement electrodes with connecting Pt structures passivated by silicon nitride and silicon nitride layers “used as the sensitive material of the pH electrodes”. See the title, Abstract, and Figure 3. Bonk further discloses coating the chips with poly-D-lysine. See Second experiment (IDES detection of cell proliferation):, which is on Bonk page 520.
Larramendy discloses a cell analysis system comprising a transistor-based chip having SiO2/Si3N4 pH-sensitive chemical field effect transistors. See the title, Abstract, and 2.1 Design and fabrication of biosensors, which is on page 3. Larramendy further discloses coating the chip with poly-D-lysine followed by laminin. See 2.3 Rat retina neuronal cell culture, which is on page 4.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to treat the substantially planar surface of the device in the cell analysis system of Milgrew as modified by Lorenzelli, Schaffhauser, and Duarte-Guevara with a coating of poly-D-lysine as taught by Bonk or a coating of poly-D-lysine followed by a coating of laminin as taught by Larramendy because Bonk states,
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(see Bonk page 520), and Larramendy states,
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(see Larramendy page 7).
So, with enhanced cell attachment as taught Bonk improved measurement accuracy would be expected with the cell analysis system of Milgrew due to better contact of the cell being measured with the sensor area and less likelihood of the cell shifting its position during the measurement. With cell expansion and neuronal differentiation as taught by Larramendy cell expansion is clearly desirable as it increases the contact area of the cell being measured with sensor area, and neuronal differentiation is clearly desirable because then the cell analysis system of Milgrew as modified by Lorenzelli, Schaffhauser, and Duarte-Guevara will be especially suitable for analyzing neurons (note here that Milgrew does not limit the cells that may be analyzed with the disclosed cell analysis system).
Addressing claim 11, it is not clear how claim 11 further limits claim 8 as claim 11 itself identifies poly-D-lysin and/or laminin as an extracellular matrix preparation. To wit,
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Applicant is invited to explain how an extracellular matrix preparation coating can be something other than a poly-D-lysin and/or laminin coating and yet a poly-D-lysin and/or laminin coating at the same time.
Final Rejection
Applicant's amendment necessitated the new ground 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.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 Claim 21 of U.S. Patent No. 12,140,599 depends from claim 20, which in turn depends from claim16. So, claim 21 of U.S. Patent No. 12,140,599 includes all of the limitations of claim 20 and also of claim 16.
2 That is, not different structures for performing the same function.
3 Claim 19 includes all of the limitations of claims 16 and 17; and claim 21 includes all of the limitations of claims 20 and 16.
4 Of Applicant’s preliminary Amendment of December 27, 2024.
5 ‘In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.’ See MPEP 2144.05(I).
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