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 .
Claim Interpretation
Independent claim 1 recites structural limitations of a chromatography plate followed by the manner to utilizing said plate with corresponding functional language including recitation of use of the plate structure to selectively form ligand complexes with ions, followed by separation of such complexes, while dependent claim 2 recites optionally present materials of construction and dependent claims 4-10 recite limitations to functional language regarding mixing of ligands or specific ligand materials which may be present within the plate, separation of ligands and complexes formed, or detection using a UV imaging device to quantify ion concentration.
It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.”
Hence, claims 1, 2 and 4-10 are interpreted as containing the positively recited chromatography plate structural features, absent the above recited claim language directed to functional recitations regarding the manner of operating the disclosed and claimed chromatography plate device or material or article worked by the plate device.
The following claim interpretations are also herein presented to clarify on the record limitations other than the above recited in each of the noted claims:
In independent claim 1, as well as claim 3, each recitation of “the channel” is interpreted as referring back to the initial recitation in the claim of “at least one channel”.
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.
Claims 1-12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
In claim 1, initial recitation of “at least one channel” (singular or plural) is inconsistent with plural subsequent recitations of “the channel” (singular), which thus lack antecedent basis (it is suggested that either “at least one channel” be replaced with “a channel” or that the recitations of “the channel” be replaced with “the at least one channel”);
“the ligands and their complexes formed” lacks antecedent basis, being inconsistent with preceding recitations of merely “ligands”; structural and functional recitation or ‘nexus of the “separating region” and “effluent well”, relative to each other and relative to the recited “sample well”, “ligand well” and “mixing region” is unclear; and
the ”characterized” clause is indefinite as to in what recited feature(s) of the “channel” or “at least one channel” does the selective formation of complexes occur.
In claim 2, “preferably silica or cellulose” is unclear as to whether or not material of the substrate being silica or cellulose is a positively recited or definitive plate feature.
In claim 3, “the channel” (plural recitations) is inconsistent with initial recitation in claim 1 of “at least one channel”.
In claim 4, the term “substantial mixing” is a vague, relative term, since no clear criteria is present regarding what amount of mixing is “substantial”.
In claim 6, recitation of “the ligands with ultraviolet chromophores” lacks antecedent basis, being inconsistent with recitation in claim 5 of “the ligands comprise ultraviolet chromophores, and is ambiguous as to whether “the ligands with ultraviolet chromophores” is reciting some or all of the ligands being such chromophores, or of some or all of the ligands including one or more such chromophores; and
it is additionally unclear whether “to form complexes with cadmium, potassium, beryllium, cesium, lead and radium ions respectively” is reciting there being a one-to-one correspondence of a given one of the 6 specific types of recited chromophores to the 6 types of ions.
In claim 7, the claim is ambiguous as to whether or not each of the recited two types or species of ligand chromophores are operative to form plural, respective complexes with lead ions, or if instead there is a one-to-one correspondence of types of chromophores and respective lead ion complexes.
In claim 8, the claim is ambiguous as to whether or not each of the recited two types or species of ligand chromophore are operative to form plural, respective complexes with arsenic ions, or if instead there is a one-to-one correspondence of types of chromophores and respective arsenic ion complexes.
Claim 9 is ambiguous as to whether the recited “single channel” refers back to the “at least one channel” or to “the channel” introduced in independent claim 1; and
ambiguous as to whether the recited “multiple ligands” refers back to the deposited or mixed ligands introduced in independent claim 1.
In claim 10, it is unclear whether the recited method step of detection of a material using an ultraviolet imaging device, following separation further defines, or introduces any plate structural feature, and unclear as to whether “separation” refers back to the “separation region” introduced in claim 1;
with each of “the concentration” and “the different ions” lacking in antecedent basis.
In claim 11, in the “positioning” clause, “the transfer” lacks antecedent basis, and “when ultraviolet light is utilized…” is indefinite as to whether or not such method step is a positively recited limitation;
in the “transfer” clause, the recitation “when ultraviolet light is utilized…” is indefinite, since it is unclear whether the recited transfer step utilizing ultraviolet light necessarily occurs;
in the “washing off” clause, “the uncured polymer mixture” lacks antecedent basis; and,
in the “depositing” clause, “the channel formed on the plate” also lacks antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 5-10 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 is not further limiting, since recitation of “porous substrate is preferably silica or cellulose” does not preclude the substrate being of any one or more of any other material.
None of claims 5-9, respectfully are further limiting, since recitation of presence of particular ligands or types of ligands residing in, or transiently moving through the separation region or any other feature of the chromatography plate does not further describe or limit the separation region or other feature of the plate.
Claim 10 does not appear to further limit the subject matter of claim 1 from which it depends, since it only describes an intended use of an ultraviolet imaging device for quantifying concentration of ions in a solution within the plate, the claim not positively reciting presence of such imaging device, nor further describing any new structural components or features of the chromatography plate.
In summary, Independent claim 1 recites structural limitations of a chromatography plate followed by the manner to utilizing said plate with corresponding functional language including recitation of use of the plate structure to selectively form ligand complexes with ions, followed by separation of such complexes, while dependent claim 2 recites optionally present materials of construction and dependent claims 4-10 recite limitations to functional language regarding mixing of ligands or specific ligand materials which may be present within the plate, separation of ligands and complexes formed, or detection using a UV imaging device to quantify ion concentration.
It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See in particular, Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.”
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Regarding the obviousness rejections which follow: Independent claim 1 recites structural limitations of a chromatography plate followed by the manner to utilizing said plate with corresponding functional language including recitation of use of the plate structure to selectively form ligand complexes with ions, followed by separation of such complexes, while dependent claim 2 recites optionally present materials of construction and dependent claims 5-10 recite limitations to functional language regarding specific ligand materials which may be present within the plate, separation of ligands and complexes formed, or detection using a UV imaging device to quantify ion concentration.
It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.”
Hence, claims 1, 2, and 4-10 are positively reciting and requiring the positively recited chromatography plate structural features, absent the above recited claim language directed to functional recitations regarding the manner of operating the disclosed and claimed chromatography plate device or material or article worked by the plate device.
Claims 1-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsey PGPUBS Document US 2002/0008030 (Ramsey) in view of Guttman et al PGPUBS Document US 2003/0135030 (Guttman.
Referenced paragraph numbers of the Descriptions of the applied PGPUBS Documents are identified with “[ ]” symbols.
For independent claim 1, Ramsey discloses: A chromatography plate (base or “plate” member 22 of microchip 20, see [0050]), as illustrated in figure 1, comprising: an etched glass substrate (base member 22 including channel-containing planar surface 26 [0050]) ; and
at least one channel on the substrate [0051-0052 and 0054-0057 regarding channel pattern or portions 24] wherein the channel further comprises;
a sample reservoir for the deposition of a solution ([0053 and 0059 re reservoir 32 supplied with buffer] and [0072 re the buffer being in a form of a solution] and [0118-0119 re pumping of different fluids including chemical solutions from different ports or reservoirs]) ;
a ligand reservoir for the deposition of ligands [0053 and 0059 re reservoir 30 being supplied with analyte];
a mixing region to allow mixing and interaction of the solution with the ligands (figures 1 and 9 re intersection 46 of channel portions 46 and 48 in communication with the reservoirs 30 and 32] and adjacent entry section of channel portion] and [0055, 0088, 0108, 0109 and 0118 re mixing of different chemical solutions and reagents in precise and known concentrations and at mixing tee 116] ;
an elongated separating region for the separation of the ligands and their complexes formed (figures 1, 2, 9 and 14 and [0055-0057, 0081 and 0118-0119 re part of channel portion 54 which may serve as a chromatographic separation column and [0102, 0105 and 0108] re separation channel 106]); and,
an effluent reservoir where excess solution from the channel collects (figures 1 and 12, [0059] and [0096] re waste reservoirs 34, 78 and 82);
characterized in that the channel is milli-fluidic [0056 re channel length and turn radius portion 54 of channel being in mm dimensions].
Claim 1, and claims dependent therefrom, differ by requiring wherein the substrate is porous.
Ramsey at [0108] describes the substrate as being of glass and having channels which are etched, however does not describe such substrate as being porous.
However, Guttman teaches a miniaturized, high-throughput, nanoporous structure integrated with means for performing thin-layer, i.e. “plate” chromatography for performing high throughput analysis of reaction products [0021-0024]; and teaches the structure being formed of glass or silicon materials which has pores, spaces, channels and networks.
Thus, it would have obvious to one of ordinary skill in the chromatography art, to have modified the Ramsey chromatography plate structure, by manufacturing the plate to be porous, or “microporous” as taught by Guttman, thus enabling formation of a larger number of channels and reservoirs, to enable high-throughput analysis of complex assays which form multiple reaction products
Claim 1, and claims dependent therefrom, also differ by requiring wherein the reservoirs comprise wells.
Guttman also teaches a nanoporous analysis structure which includes wells such as in “micro-well plates”, facilitating high-throughput analysis of samples or assays [0061].
It would have been further obvious to the skilled artisan to have modified the Ramsey structure to include or manufacturing the reservoirs to be in the form of wells, or to contain such wells, as taught by Guttman, to further facilitate high-throughput analysis of samples or assays.
Claim 1 and claims dependent therefrom, also differ by requiring the ligand reservoir or well is tailored for deposition of a ligands, and by requiring wherein the deposited ligands selectively form complexes with ions found in the solution and the mixture of ligands and their complexes then separate based on their interaction forces with the substrate along the separating region.
Guttman also teaches the nanoporous structure being equipped to perform receptor-ligand binding or reactions [0057], and for performing receptor-ligand binding reactions such as in the determination of receptor-specificity and determining affinity of the receptor for various ligands [0163-0166], including detection and quantification of receptor-ligand complexes [0164].
It would have been additionally obvious to the skilled artisan to have modified the Ramsey structure to be tailored for use with receptor-ligand binding reactions such as in the determination of receptor-specificity and determining affinity of the receptor for various ligands, as taught by Guttman, in order to facilitate analysis of a wide-range of types ligands, and including detection and quantification of receptor-ligand complexes.
Neither Ramsey or Guttman teaches or suggests, specifically, wherein the deposited ligands selectively form complexes with ions found in the solution and the mixture of ligands and their complexes then separate based on their interaction forces with the substrate along the separating region.
However, such claim clause or recitation is deemed to not further limit the chromatographic plate structure by introducing any one or more specific plate structural feature, or require any one or more structural property of chromatography plate feature, thus such limitations are deemed to be of little or no patentable weight, and as not further limiting the structural apparatus of the chromatography plate.
Additionally, the MPEP at Section 2114 provides Court Decisions where it has been ruled that functional limitations in apparatus claims and recitations of what a device does, instead of what a device is do not distinguish or make non-obvious apparatus claims if the prior art teaches all of the structural limitations of the claim.
For claim 2, Ramsey teaches in an embodiment wherein the porous substrate is may be silica [0111]. Optionally since presence of silica or cellulose with the porous substrate is only preferable, hence optional, such recitation is deemed to not further limit the structure of the chromatography plate.
For claim 3, Ramsey discloses or suggests wherein the depth of the channel is within the range of 10 to 20 µm [0057 re channel 54 having a depth of 10um, and teaches the width of the channel being about 70-90 um [0057].
Neither Ramsey or Guttman teaches the channel width being within the range of 1.5 mm to 3.0 mm. However, Guttman teaches that the nanoporous structure may be of various physical dimensions and geometric orientations [0061].
Such channel width dimension is deemed to constitute a results-effective variable for which it would have been obvious for one of ordinary skill in the prior art to have optimized by routine experimentation, so as to adapt the size of the channel to the size or dimensions of the particular chromatography plate, which may vary, depending upon particular application of the plate device. The MPEP, Section 2144.05 includes court rulings that have determined that such types of parameter values or ranges do not support the patentability of such subject matter, particularly where the prior art contains similar ranges, amounts or proportions, or suggests such similarity, absent a finding of unexpected criticality or achieving of unexpected results.
For claim 4, Ramsey discloses wherein the mixing region comprises at least two bends to enable substantial mixing of the solution with the ligands (figure 1 and [0081 re serpentine channel for initially mixing the solution and analyte in a mixing region, as these enter the separation zone.
Claim 4 differs from Ramsey by requiring the mixing region specifically, being to enable substantial mixing of solution with ligands.
Such limitation is deemed to not further limit the chromatographic plate structure by introducing any one or more specific plate structural feature, or require any one or more structural property of chromatography plate feature, thus such limitation is deemed to be of little or no patentable weight, and as not further limiting the structural apparatus of the chromatography plate.
Additionally, the MPEP at Section 2114 provides Court Decisions where it has been ruled that functional limitations in apparatus claims and recitations of what a device does, instead of what a device is do not distinguish or make non-obvious apparatus claims if the prior art teaches all of the structural limitations of the claim.
Claims 5-8 recite various respective specific ligands. Although none of the applied prior art teaches wherein the ligands comprise ultraviolet chromophores or other specific ligands or types of ligands.
Such limitations are deemed to not further limit the chromatographic plate structure by introducing any one or more specific plate structural feature, or require any one or more structural property of chromatography plate feature, thus such limitations are deemed to be of little or no patentable weight, and as not further limiting the structural apparatus of the chromatography plate.
Additionally, the MPEP at Section 2114 provides Court Decisions where it has been ruled that functional limitations in apparatus claims and recitations of what a device does, instead of what a device is do not distinguish or make non-obvious apparatus claims if the prior art teaches all of the structural limitations of the claim.
Claim 9 recites wherein a single channel is fabricated to allow the deposition of multiple ligands that are selective towards different ions found in the solution to enable simultaneous separation of the ligands and complexes formed various respective specific ligands.
Although none of the applied prior art teaches wherein the ligands comprise ultraviolet chromophores, such limitation is deemed to not further limit the chromatographic plate structure contains such specific ligands, such limitations are deemed to be of little or no patentable weight, and as not further limiting the structural apparatus of the chromatography plate.
Additionally, the MPEP at Section 2114 provides Court Decisions where it has been ruled that functional limitations in apparatus claims and recitations of what a device does, instead of what a device is do not distinguish or make non-obvious apparatus claims if the prior art teaches all of the structural limitations of the claim.
Claim 10 recites wherein after separation, detection using an ultraviolet imaging device is performed to quantify the concentration of the different ions present in the solution.
Although none of the applied prior art teaches utilization of such ultraviolet imaging device, such limitation as worded in the instant claim is deemed to pertain to a method step not directly associated with the chromatography plate, and thus to not further limit the chromatographic plate structure contains such specific ligands, such limitations are deemed to be of little or no patentable weight, and as not further limiting the structural apparatus of the chromatography plate.
Additionally, the MPEP at Section 2114 provides Court Decisions where it has been ruled that functional limitations in apparatus claims and recitations of what a device does, instead of what a device is do not distinguish or make non-obvious apparatus claims if the prior art teaches all of the structural limitations of the claim.
For claim 12, Ramsey in view of Guttmann teaches a chromatography plate and its use for separations including of ligands (see above discussion of claim 1))
For claim 12, Guttmann further teaches or suggests use of a chromatography plate, for the separation and detection of ion selective ligands and their complexes [0163 re performing receptor-ligan binding reactions for various ligands, hence inherently forming ligand binding complexes].
Allowable Subject Matter
Claim 11 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 11 is deemed to distinguish and be non-obvious in view of recitation of A method for producing a chromatography plate according to claim 1 comprising the steps
of:
coating a chromatography plate comprising a substrate with an ultraviolet curable polymer mixture (202);
placing the coated plate in a vacuum chamber to remove any air bubbles (204); and,
positioning the coated plate under a liquid crystal display screen mask to enable the transfer of at least one channel design onto the coated plate when ultraviolet light is utilized to cure the polymer mixture (206).
Neither the applied prior art, nor any other prior art now made of record teaches or suggests such steps to coat and then cure an ultraviolet curable polymer mixture onto a chromatography plate substrate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Of particular interest, Lebedev teaches providing of wells in a particular array pattern on a thin-layer or plate chromatography device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Primary Examiner Joseph Drodge at his direct government formal facsimile phone number telephone number of 571-272-1140. The examiner can normally be reached on Monday-Friday from approximately 8:00 AM to 1:00PM and 2:30 PM to 5:30 PM.
If attempts to reach the examiner are unsuccessful, the examiner' s supervisor, Benjamin Lebron, of Technology Center Unit 1773, can reached at 571-272-0475.
The telephone number, for official, formal communications, for the examining group where this application is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from the Patent Examiner. Unpublished application information in https:///www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https:///www.uspto.gov/patents/apply/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.
JWD
07/25/2026
/JOSEPH W DRODGE/ Primary Examiner, Art Unit 1773
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