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 9th, 2026. Claims 9-15 are pending. Claims 1-8 are canceled. Claim 15 is newly added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9th, 2026 has been entered.
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:
Detection unit for detecting the light emitted…as in cl. 9.
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.
A CMOS sensor, camera, photodetector, and equivalents thereof (pars.[0034,0076]).
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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2007/0099294), hereafter Yang, in view of Kato et al. (US 2017/0145370), hereafter Kato, and Gjerde et al. (US 2011/0042317), hereafter Gjerde.
Yang discloses materials and methods for cell-based assays (abstract). With regard to claim 9, Yang discloses providing a container comprising a reaction field (i.e. spanning the area constituted by the plurality of vessels 405 with cell support structures/scaffolds that are comprised of a plurality of pieces of porous nonwoven fibers 410 at which cultured cells preside and that constitutes a “cell culture substrate comprising cultured cells”, wherein each of cell support structure comprise nonwoven biocompatible fibrous porous material; this is likewise seen in figs. 1, 2, 23, 24, and 26/27 that likewise provide for a reaction field spanning a plurality of vessels with fibrous, porous cell supports therein(pars.[0010,0015,0034,0041-0049 ,0055,0083], figs. 1,2, 23-27, for example) and a detection unit (par.[0007,0018,0044], for example), the reaction field comprising a plurality of pieces of porous nonwoven fibers (see above as in the cell supports). Yang further discloses contacting the plurality of pieces of porous nonwoven fibers (and cultured cells thereat the support structures) with a solution comprising an analyte and a reagent to cause the reagent to be adsorbed and then gradually released by the plurality of pieces of porous nonwoven fibers and to cause light emission by a reaction between the analyte and the reagent (e.g. light-emitting protein as in EGFP as an analyte [the reporter for measurements of fluorescence therefrom the cultured cells] with a reagent as in fibronectin, pars. [0063,0064], or green fluorescent protein (GFP) as an analyte with a chemotherapy agents as a reagent as in par.[0074], for example), and detecting light emitted in the reaction field by the reaction between the analyte and the reagent (pars.[0007,0018,0030,0044,0063,0064,0074], for example). With regard to claim 11, Yang discloses treating the cell culture at one or more test conditions at one or more appropriate intervals and measuring optical responses therefrom, as in accumulation value of light emission intensity during a predetermined time of light emission in the reaction field to inform the test/assay (pars.[0007,0011,0013-0015,0023,0064], for example). With regards to claims 13 and 14, the recitations amount to conclusory statements in which no further, active step(s) are positively afforded to the method of independent claim 9, and wherein Yang, as modified below, provides to commensurately disclose the recited steps of the method and is thereby also said to provide “light emitted by the reaction…continues for a longer period of time…” and “…wherein the longer period of light emission increases…” in as much as recited and required herein. Further to this end, Examiner asserts that the base method of claim 9 generally provides contacting the plurality of pieces with a reagent and an analyte to cause light emission by a reaction between the analyte and the reagent, wherein Yang [as modified] commensurately provides such a contacting of a reagent and analyte as claimed. The claimed method does not specify a particular reaction, nor a more particular contacting, and wherein Yang [as modified] also commensurately as claimed provides a likewise medium in that of likewise plural pieces of porous nonwoven fibers having a random orientation, as well as commensurate “detecting with the detection unit the light emitted by…”. By this, it can be seen that the methodology of Yang [as modified] likewise provides provide “light emitted by the reaction…continues for a longer period of time…” and “…wherein the longer period of light emission increases…” in as much as recited and required herein claims 13 and 14.
With regard to claim 9, Yang discloses detecting optical emissions to inform various aspects of cell culturing assays, as well as biosensing, by radiation emitting, light transmission, fluorometric, and calorimetric means, and such as with a fluorescence microscope (pars.[0007,0018]), but does not specifically disclose a detection unit provided to the container as claimed.
With regard to claim 9, Yang does not specifically disclose that the plurality of porous sheet pieces that are non-woven fibers have a random orientation.
With regard to claim 12, Yang discloses continuous observation of the cultured cells as well as optically monitoring test conditions of the cells at one or more intervals, and monitoring growth kinetics (pars.[0005,0007,0015,0019,0020], for example), but does not specifically disclose that the predetermined time is from 3 seconds to 60 minutes.
Gjerde discloses a method and device for extracting an analyte in which the membrane can be a non-woven mesh of fibers that have a random orientated mat of fibers (par.[0100], for example).
It would have been obvious to one of ordinary skill in the art to modify Yang to provide the plurality of nonwoven fibers to have a random orientation such as suggested by Gjerde in the analogous art of biological sequestration and analysis in which a provision to utilizing a random orientation represents an obvious to try form to the plurality of porous non-woven fibers of Yang that would have a reasonable expectation of success for a similarly desired purpose.
Kato discloses a cell culture container, imaging method, and system thereof (abstract). Kato discloses providing an imaging sensor 140 (detection unit as in CCD or CMOS, for example) integrated with the container 100A to directly receive the transmitted light from the cell culture mixture and wherein such arrangement prevents light rays from crossing that aids in accurate measurements of the light intensity related to the culture (par.[0080]).
It would have been obvious to one of ordinary skill in the art to modify Yang to provide a detection unit to the container such as suggested by the analogous art of Kato in the field of cell culturing and imaging thereof in order to provide a compact device that has the detection unit on-board and integrated with the cell culture container so as to directly optically assess the cells under investigation and prevents light rays from crossing that aids in accurate measurements of the light intensity related to the culture.
Further, it would have been obvious to one of ordinary skill in the art to modify Yang to utilize a predetermined time from 3 seconds to 60 minutes such as implied in Yang given discussion to both continuous monitoring and monitoring at one or more intervals coincident with applied test conditions, and monitoring cell kinetics, and as would be appreciated by one of ordinary skill in the art so as to track dynamic cellular processes such as growth, migration, response to the various test conditions, and fluorescent signals over time to better inform the kinetics, wherein such modification is seen as one of routine engineering as informed through the teachings of Yang, and absent a showing of a criticality or unexpected results arising otherwise.
Claim(s) 10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Kato and Gjerde, as applied to claims 9 and 11-14 above , and in further view of Baeumner et al. (US 2014/0083859), hereafter Baeumner.
Yang/Kato/Gjerde does not specifically disclose an average diameter of the fibers is from 0.05 microns to 10 microns as in cls. 10 and likewise as in (b) of cl. 15 to the fibers constituting a sheet.
With regard to claim 15, Yang discloses the plurality of porous nonwoven fibers is a sheet comprising the porous nonowoven fibers (see pars.[0010,0048] wherein the support matrices/scaffolds made up of the plurality of porous nonwoven fibers is a disc that constitutes a sheet)
Baeumner discloses biofunctional nanofibers for analyte separation in microchannels, wherein fibers with diameters on the order of 100nm are formed by electrospinning and in nonwoven mats, wherein such fibers provide extremely large surface area to volume ratios and can be tailored to have different pore sizes and tensile strengths, and have application to be functionalized by adsorbing or covalently bonding antibodies to the fibers surfaces allowing for detection. (par.[0290]).
It would have been obvious to one of ordinary skill in the art to modify Yang/Kato/Gjerde to provide fibers having an average diameter from 0.05 microns (50nm) to 10 microns (10,000nm) such as suggested by Baeumner in order to provide fibers having desirable large surface area to volume ratio and being able to be tailored in their pore size and tensile strength, while having application in biological applications as likewise desired in Yang/Kato/Gjerde.
Response to Arguments
Applicant's arguments filed March 9th, 2026 have been fully considered but they are not persuasive.
With regards to the ‘Claim Interpretation’ of “detection unit configured to detect…” Applicant asserts that the claims have been amended to remove this recitation and thereby interpretation under 35 USC 112 F/6th does not apply.
Examiner asserts that the interpretation under 35 USC 112 F/6th is not solely predicated on the usage of “configured to…” and the recitation remains interpreted under 35 USC 112 F/6th.
The recitation meets the requirements 35 USC 112 F/6th as it remains to recite a generic placeholder by way of detection unit that is accompanied by functionality in that of “detecting light emitted…” without providing sufficient structure(s) in the recitation that affords basis for this functionality given to the unit.
With regard to claims 9 and 11-14 rejected under 35 USC 103 as being unpatentable over Yang in view of Kato and Gjerde, Applicant traverses the rejection.
Applicant asserts that Yang does not disclose “wherein the reaction field is a cell culture substrate comprising cultured cells and a plurality of pieces of porous nonwoven fibers having a random orientation” and “detecting with the detection unit the light emitted in the reaction by the reaction between the analyte and the reagent.”
Initially, Examiner asserts that Yang is noted for the deficiency in providing a detecting unit (Yang discloses detecting light emitted in the reaction field between the analyte and reagent absent explicit disclosure to the actual detection unit therefor), and Yang discloses a plurality of porous nonwoven fibers, but does not specifically disclose they have a random orientation.
These modifications are provided, as discussed above, by Gjerde and Kato.
Further, Yang discloses a reaction field comprising a cell culture substrate comprising cultured cells, such as in spanning the area constituted by the plurality of vessels 405 with cell support structures/scaffolds 410 at which cultured cells preside (see pars. [0010,0015,0034,0041-0049,0055,0083figs. 1, 2, 23, 24).
Additionally, Yang provides such a step of “contacting…with a solution of reagent and analyte…” as in claim 9 such as given by light-emitting protein as in EGFP as an analyte [the reporter for measurements of fluorescence therefrom the cultured cells] with a reagent as in fibronectin, pars. [0063,0064], or green fluorescent protein (GFP) as an analyte with a chemotherapy agents as a reagent as in par.[0074], and detecting light emitted in the reaction field by the reaction between the analyte and the reagent (pars.[0007,0018,0030,0044,0063,0064,0074], for example).
Applicant further assert that Yang does not disclose the recitation of amended claim 13.
Examiner asserts that Yang is not deficient here. The recitations of claim 13, as well as claim 14, amount to conclusory statements in which no further, active step(s) are positively afforded to the method of independent claim 9.
Yang [as modified] provides to commensurately disclose the recited steps of the method and is thereby also said to provide “light emitted by the reaction…continues for a longer period of time…” and “…wherein the longer period of light emission increases…” in as much as recited and required herein.
Further to this end, Examiner asserts that the base method of claim 9 generally provides contacting the plurality of pieces with a reagent and an analyte to cause light emission by a reaction between the analyte and the reagent, wherein Yang [as modified] commensurately provides such a contacting of a reagent and analyte as claimed. The claimed method does not specify a particular reaction, nor a more particular contacting, and wherein Yang [as modified] also commensurately as claimed provides a likewise medium in that of likewise plural pieces of porous nonwoven fibers having a random orientation, as well as commensurate “detecting with the detection unit the light emitted by…”.
By this, it can be seen that the methodology of Yang [as modified] likewise provides provide “light emitted by the reaction…continues for a longer period of time…” and “…wherein the longer period of light emission increases…” in as much as recited and required herein claims 13 and 14.
With regard to newly-added claim 15, Applicant asserts that Yang does not disclose this feature.
Examiner asserts that Yang discloses the plurality of porous nonwoven fibers is a sheet comprising the porous nonowoven fibers (see pars.[0010,0048] wherein the support matrices/scaffolds made up of the plurality of porous nonwoven fibers is a disc that constitutes a sheet).
This modification is provided as likewise provided above with respect to claim 10 and Baeumner.
For these reasons, claim 15 is also rejected under 35 USC 101 as being unpatentable over Yang/Kato/Gjerde and in further view of Baeumner, as likewise provided with respect to claim 10.
Further, Applicant arguments that Kato, Gjerde, and Baeumner do not disclose or suggest modifying the method of Yang are unpersuasive for the reasons discussed above and in the body of the action, and wherein Applicant’s argument is provided without substantive support thereto.
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.
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/NEIL N TURK/Primary Examiner, Art Unit 1798