DETAILED ACTION
In application filed on 02/09/2024, Claims 1-20 are pending. The claim set submitted on 02/09/2024 is considered because this is the most recent claim set with some preliminary amendments. Claims 1-9 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/10/2026 and 02/09/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 08/10/2026 is acknowledged. Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/10/2026.
Group I, Claims 1-9 are considered on the merits below.
Claim Rejections - 35 USC § 112
Claims 2, 6 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "a plurality of test zones".
Is the "a plurality of test zones thereon " in Claim 2 same as the “a plurality of test zones thereon” recited in Claim .
Applicant should provide clarification.
For the purpose of expedited prosecution, the limitation "a plurality of test zones" in Claim 2 is interpreted by the Examiner as "the plurality of test zones".
Moreover, Claim 9 is rejected by virtue of dependency on claim 2.
Claim 6 recites the limitation "a respective test zone".
Is the "a respective test zone" in Claim 6 same as one of the “a plurality of test zones thereon” in claim 1
Applicant should provide clarification.
For the purpose of expedited prosecution, the limitation "a respective test zone" in Claim 6 is interpreted by the Examiner as "a respective test zone of the plurality of test zones".
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Fletcher et al. (US20020115062A1).
Regarding claim 1, Fletcher teaches an apparatus for a cellulose-based vertical flow assay (See Abstract… device for conducting a rapid in vitro enzyme immunoassay test for the direct and qualitative detection of two or more viral antigens from specimens of symptomatic patients; See Para 0042…Suitable materials for membrane 50 are, for example, glass, nylon and cellulose), comprising:
a holder (referred to as base portion [Figs. 1, 3, ref. 12]) for supporting a cellulose substrate (See Para 0042; Fig. 3, ref. 50…suitable materials for membrane 50 are, for example, glass, nylon and cellulose) having a plurality of test zones thereon (referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58]) , the holder (referred to as base portion [Figs. 1, 3, ref. 12]) having a base plate (referred to as bottom wall [Figs. 1, 3, ref. 32]) and engaging members (referred to as projections [ Fig. 3, ref. 42]); and
a lid (referred to as lid[ Fig. 1, ref. 13]) for reversibly engaging with the engaging members (referred to as projections [ Fig. 3, ref. 42]) of the holder (referred to as base portion [Figs. 1, 3, ref. 12]) such that when engaged, the lid (referred to as lid[ Fig. 1, 3, ref. 13]) is disposed over the base plate (referred to as bottom wall [Figs. 1, 3, ref. 32]) and a gap exists (See Para 0038…projections 42 are separated from each other by spaces 44. When device 10 is assembled as shown in FIG. 1, top wall 14 of lid 13 rests on upper surfaces 46 of projections 42 so that the lower edge 48 of side wall 15 is preferably positioned slightly above horizontal shelf 38, thereby providing air communication from the external environment to chamber 40 through spaces 44; thereby teaching “gap exists”) between the lid (referred to as lid[ Fig. 1, ref. 13]) and the base plate (referred to as bottom wall [Figs. 1, 3, ref. 32]),
wherein the lid (referred to as lid [ Fig. 1, ref. 13]) comprises a plurality of openings (referred to as openings [ Fig. 1, ref. 26 and 28]) for allowing access to the test zones (referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58]) on the cellulose substrate (See Para 0042; Fig. 3, ref. 50…suitable materials for membrane 50 are, for example, glass, nylon and cellulose).
In addition, Claim 1 recites a holder and lid and then recites how these structures function. Claim 1 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 2, Fletcher teaches that the apparatus (See Claim 1 rejection for the apparatus) further comprises one or more layers of cellulose substrate (See Para 0042; Fig. 3, ref. 50…suitable materials for membrane 50 are, for example, glass, nylon and cellulose) disposed over the base plate (referred to as bottom wall [Figs. 1, 3, ref. 32]) of the holder (referred to as base portion [Figs. 1, 3, ref. 12]), and the cellulose substrate (See Para 0042; Fig. 3, ref. 50…suitable materials for membrane 50 are, for example, glass, nylon and cellulose) having a plurality of test zones thereon (referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58]).
Regarding Claim 3, Fletcher teaches that the apparatus (See Claim 1 rejection for the apparatus) further comprises one or more layers of an absorbent material (referred to as a pad 60 of absorbent material [Para 0043]) disposed over the base plate (referred to as bottom wall [Figs. 1, 3, ref. 32]).
Examiner submits that the claimed “and optionally wherein the absorbent material is disposed between a cellulose substrate and the base plate” is interpreted as optional, thus not required by the claim.
Regarding Claim 5, Fletcher teaches the engaging members (referred to as projections [ Fig. 3, ref. 42]) of the holder (referred to as base portion [Figs. 1, 3, ref. 12]) comprise slots (See Para 0038… the embodiment of the projections and spaces) for slidably engaging the lid (referred to as lid [ Fig. 1, ref. 13]).
In addition, Claim 5 recites “the engaging members of the holder” and cites how these structures function. Claim 4 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 6, Fletcher teaches the plurality of openings (referred to as openings [ Fig. 1, ref. 26 and 28]) of the lid (referred to as lid [ Fig. 1, ref. 13]) each aligns (See Figs. 1-3) to a respective test zone (interpreted as "a respective test zone of the plurality of test zones") (referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58]) of the cellulose substrate (See Para 0042; Fig. 3, ref. 50…suitable materials for membrane 50 are, for example, glass, nylon and cellulose).
Regarding Claim 7, Fletcher teaches the test zones (referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58]) of the cellulose substrate (See Para 0042; Fig. 3, ref. 50…suitable materials for membrane 50 are, for example, glass, nylon and cellulose) are relatively more permeable (See Para 0042…Membrane 50 may be of any material that wets readily with an aqueous assay solution) to a liquid sample (referred to as aqueous assay solution [Para 0042]) than areas of the cellulose substrate (See Para 0042; Fig. 3, ref. 50…suitable materials for membrane 50 are, for example, glass, nylon and cellulose) that are outside the test zones(referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58]).
The limitation “and optionally wherein the areas of the cellulose substrate that are outside the test zones are coated with a layer that is substantially impermeable to a liquid sample” interpreted by examiner as optional and thus not required by the claim.
In addition, Claim 7 recites the test zones of the cellulose substrate and how the structure functions with respect to the liquid sample. Claim 7 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fletcher et al. (US20020115062A1) in view of Kracun et al. (US20180133712A1).
Regarding Claim 4, Fletcher teaches that the gap (See Para 0038…projections 42 are separated from each other by spaces 44. When device 10 is assembled as shown in FIG. 1, top wall 14 of lid 13 rests on upper surfaces 46 of projections 42 so that the lower edge 48 of side wall 15 is preferably positioned slightly above horizontal shelf 38, thereby providing air communication from the external environment to chamber 40 through spaces 44; thereby teaching “gap”) is capable of accommodating a plurality of layers of a cellulose substrate (See Para 0053…in the membranes thereof to induce…, thereby teaching “a plurality of layers of a cellulose substrate”; See Para 0042… Membrane 50 may be of any material that wets readily with an aqueous assay solution) and a layer of an absorbent material (referred to as a pad 60 of absorbent material [Para 0043]) simultaneously (Fig. 1 for the simultaneous arrangement; See Para 0023… an absorbent pad between the device top and bottom and a membrane between the device top and the absorbent pad.)
Fletcher does not teach “a plurality of layers of an absorbent material”.
In the analogous art of an enzyme activity assay system and devices for determining biopolymer enzyme degrading activity in a liquid sample, Kracun teaches “a plurality of layers of an absorbent material” (See Para 0191… a plurality of membrane structure pads 15, 16 of porous material.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified an apparatus of Fletcher to include “a plurality of layers of an absorbent material”, as taught by Kracun for the benefit of allowing liquid to travel very fast in the solid support structure (Kracun, Para 0191), allowing for providing an enzyme activity assay system and device suitable for determination of biopolymer enzyme degrading activity in a liquid sample, which assay system and device is both fast and simple to use (Kracun, Para 0014).
In addition, Claim 4 recites a gap and cites how the gap function. Claim 4 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fletcher et al. (US20020115062A1) in view of Reed et al. (US20110220239A1).
Regarding Claim 8, Fletcher teaches that the lid (referred to as lid[ Fig. 1, ref. 13]) comprises no less than 60 openings (referred to as openings [ Fig. 1, ref. 26 and 28]) for allowing access to the test zones (referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58]) on the cellulose substrate (See Para 0042; Fig. 3, ref. 50…suitable materials for membrane 50 are, for example, glass, nylon and cellulose).
Fletcher does not teach “no less than 60 openings”.
In the analogous art of filling apparatus for filling a microplate, Reed teaches that “no less than 60 openings” (See Claim 10…a microplate comprising a plurality of openings for receiving one or more solutions, the openings defining a plurality of groups each including more than one of the openings).
While the combination of Fletcher and Reed does not explicitly teach ““no less than 60 openings”, Reed teaches the limitation “no less than 60 openings” using an overlapping range disclosure (See Claim 10…the openings defining a plurality of groups each including more than one of the openings).
As a result, since the claimed limitation overlap the range disclosed by the prior art, a prima facie case of obviousness exists. Please see MPEP 2144.05 (I) and In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976) for further details.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Fletcher to include “no less than 60 openings”, as taught by Reed for the benefit of receiving solutions (Reed, Claim 10) allowing for the provision of analysis may aid in developing diagnostics, medicines, and therapies for a wide variety of disorders (Reed, Claim 10).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fletcher et al. (US20020115062A1).
Regarding Claim 9, Fletcher teaches that the one or more layers of cellulose substrate (See Para 0042… Membrane 50 may be of any material that wets readily with an aqueous assay solution) comprises a plurality of layers of cellulose substrate (See Para 0053…in the membranes thereof to induce…, thereby teaching “a plurality of layers of a cellulose substrate”; See Para 0042… Membrane 50 may be of any material that wets readily with an aqueous assay solution) and wherein the diameter of the test zones (referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58] ; Examiner submits under BRI that the test areas have a diameter) of a cellulose substrate (See Para 0042… Membrane 50 may be of any material that wets readily with an aqueous assay solution) selected from the plurality of layers of cellulose substrate (See Para 0053…in the membranes thereof to induce…, thereby teaching “a plurality of layers of a cellulose substrate”; See Para 0042… Membrane 50 may be of any material that wets readily with an aqueous assay solution); the test zones (referred to as test areas [Para 0040; Fig. 3, refs. 56 and 58] ; Examiner submits under BRI that the test areas have a diameter) of another cellulose substrate (See Para 0053…in the membranes thereof to induce…, thereby teaching “another cellulose substrate”; See Para 0042… Membrane 50 may be of any material that wets readily with an aqueous assay solution) selected from the plurality of layers of cellulose substrate(See Para 0053…in the membranes thereof to induce…, thereby teaching “a plurality of layers of a cellulose substrate”; See Para 0042… Membrane 50 may be of any material that wets readily with an aqueous assay solution).
Fletcher does not explicitly teach the difference in the diameters of “test zones of a cellulose substrate” and of “test zones of another cellulose substrate”.
However, Fletcher does teach that the apparatus of Claim 1 is an apparatus where the only difference between the prior art and the claim is the difference in the diameters of “test zones of a cellulose substrate” and of “test zones of another cellulose substrate”.
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 (See MPEP § 2144.05, Part II, Subpart B; In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and fabricate an apparatus having a difference in the diameters of “test zones of a cellulose substrate” and of “test zones of another cellulose substrate” for the benefit developing the color indicating positive assay results (Fletcher,Para 0041), allowing for the provision of an improvement over previous flow-through diagnostic test devices (Fletcher, Para 0025).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
Prosecution Insights