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 Claims
Claims 1-10 remain pending in the application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/769,903, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The claims which were filed 01/22/2024 do not have support in the parent application and are therefore not entitled to the benefit of the filing date of the prior application. A detailed discussion of the claims are listed below under not having proper antecedent basis in the specification and is claims 4-5.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Please see at least paragraphs [0029], [0039], [0050], which list several patents.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 4 recites “wherein the test strip… or (b) is comprised or consists of non-nitrocellulose material.” where because claim 1 describes that the test strip is at least partially composed of nitrocellulose, in the instance where the test strip is comprised of non-nitrocellulose material, it is not seen in the instant specification where the test strip may be a combination of both nitrocellulose and non-nitrocellulose material.
The instant specification [0006] describes where the test strip is frequently comprised at least partially of nitrocellulose and “Alternatively the strip may be comprised or consist of non-nitrocellulose material”, [0008] recites “Frequently in such embodiments, the test strip is comprised at least partially of nitrocellulose. Alternatively, the test strip may be comprised or consists of non-nitrocellulose material.”, [0050] recites “accept a traditional test strip such as a nitrocellulose test strip to provide a hybrid device. In certain embodiments the test strip is not comprised of nitrocellulose, e.g., a non-nitrocellulose test strip…”, [0052] recites “a lateral flow test strip such as a traditional nitrocellulose test strip or a test strip comprised of, at least partially, nitrocellulose. Alternatively, the lateral flow test strip may comprise a non-nitrocellulose test strip.” [0054] and [0055] also describe that the test strip may be a nitrocellulose test strip or a non-nitrocellulose test strip.
From the paragraphs cited above, while there is support for a test strip at least partially comprised of nitrocellulose and a test strip that is comprised or consists of non-nitrocellulose material, it does not appear that there is support for a test strip that comprises both a nitrocellulose material and a non-nitrocellulose material.
Claim 5 describes the test strip is a lateral flow test strip and comprises a water-dispersible, flushable, or water-soluble material. However, in claim 1 the test strip is at least partially composed of nitrocellulose.
From the instant specification, it describes that nitrocellulose membranes are synthetic and non-water dispersible and not soluble (see [0003], [0031] and [0040] which describes “matrix material” to include water-soluble, water dispersible, biodegradable, compostable, and/or flushable material but excludes nitrocellulose, [0052] and [0053] which describes the diagnostic insert to be not water dispersible, not flushable, and not water-soluble and includes nitrocellulose as an example material with these qualities).
Therefore, the instant specification does not appear to provide antecedent basis for nitrocellulose being water-dispersible, flushable, or water-soluble.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 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 1 recites “wherein a single backing supports” on line 13, where it is unclear if this single backing is the same or different from the backing recited on line 2.
[0058] of the instant specification is the only place where “backing” is described, where it states that the devices of the present disclosure often eliminate the need for a plastic backing card traditionally used in test strip, where it further describes that a non-synthetic matrix material that is water dispersible or soluble is used as a backing material. [0043] describes that the diagnostic insert has an opening in the top surface for a sample pad.
For examination it will be interpreted that the backing of line 2 and the single backing of line 13 are the same component.
Claims 2-10 are rejected by virtue of being dependent on a rejected claim.
Claim 2 recites “wherein the diagnostic insert is adapted to removably receive the test strip.” where this is unclear because in claim 1, the diagnostic insert comprises a backing, sample pad, label zone, test strip, and downstream portion. In other words, if the test strip is a part of the diagnostic insert, how can it be removably received by the diagnostic insert itself?
In claim 1 it describes that a single backing supports the sample pad, the label zone, the test strip, and the downstream portion.
Therefore for examination, it will be interpreted that claim 2 is referring to the backing being adapted to removably receive the test strip.
Claims 3-5 are rejected by virtue of being dependent on a rejected claim.
Claim 4 recites “wherein the test strip (a) is comprised at least partially of nitrocellulose, or (b) is comprised or consists of non-nitrocellulose material.” where this is unclear because in claim 1 lines 9-10 it describes the test strip is at least partially composed of nitrocellulose. If claim 4 is (a), then this does not appear to further limit the claim. If claim 4 is (b) and “consists” of non-nitrocellulose material, this is unclear because claim 1 already describes the test strip to at least partially comprise nitrocellulose. The test strip cannot be at least partially nitrocellulose and consist of non-nitrocellulose material at the same time.
[0008] of the instant specification recites “the test strip is comprised at least partially of nitrocellulose. Alternatively, the test strip may be comprised or consists of non-nitrocellulose material.”
Claim 9 recites “wherein the downstream portion is integrated into or on top of the top surface of the diagnostic insert.” where for similar reasons described for claim 2 supra, it is unclear how the downstream portion would be integrated into or on top of the diagnostic insert, as the downstream portion is a part of the diagnostic insert.
Due to claim 1 describing that a single backing supports the sample pad, label zone, test strip, and downstream portion, for examination it will be interpreted that for claim 9 the downstream portion is integrated into or on top of the backing.
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(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US-2008/0286879-A1) in view of Gerdes (US-2004/0110167-A1), Witchel (WO-2005/116651-A2), and Mangold (US-5177022-A).
Regarding claim 1, Lee teaches diagnostic insert comprising:
a backing (flat bottom section 124) composed of non-synthetic cellulose matrix material ([0018] see housing 104 may be constructed of natural materials such as paper fiber, paper pulp products, cardboard, natural fibers, [0021] see generally flat bottom section 124 of housing 104, Figures 2-3);
a sample pad (first end 122) composed of a cellulose web material and providing a sample receiving zone ([0026] see first end 122 of test strip 132 extends from housing 104 to engage a test liquid, [0031] see first end 122 is made from cellulosic filters);
a downstream portion (absorbent pad 158) ([0031] see absorbent pad 158 provided in opposition to 122 to facilitate conduction of test liquid along length of test strip 132. Note that 158 is not seen in the Figures, however Figure 7 of Lee has “AB. PAD” labeled which is understood to be the absorbent pad),
Lee teaches that the components of the test strip are supported by the flat bottom section 124, as the test strip seen in Figures 2-3 will be housed on the flat bottom section 124. [0031] of Lee describes the test strip 132 seen in Figure 6 described as having a backing material 150 with a membrane 152 made of porous nitrocellulose overlaying it, having first end 122 being a wick made from cellulosic filters, a test site 136 being for example a conjugate pad made of cellulose, and a second end having an absorbent pad 158. However, Figure 6 of Lee does not have reference numbers referring to the backing 150, membrane 152, or absorbent pad 158 (from Figure 8, it appears that an absorbent pad is labeled). Therefore the structure of the test strip seen in Figure 6 is unclear. Further, Lee does not teach the material of the absorbent pad.
In the analogous art of lateral flow devices, Gerdes teaches a device with a sample receiving zone, a labeling zone, a capture zone and an absorbent zone (Gerdes; [0005], [0018]-[0021]).
Specifically, Gerdes teaches where a labeling zone 104 is in lateral flow contact with a sample receiving zone 102, where the labeling zone comprises a first visible moiety that is reversibly bound to the matrix and coupled to a first ligand that are specific for discrete binding partners coupled to or complexed with amplified or non-amplified target nucleic acids (Gerdes; [0089]). [0089] of Gerdes further describes that the labeling zone may include materials such as cellulose. [0090] of Gerdes describes the labeling zone may also comprise a second visible moiety. [0091] of Gerdes describes the capture zone membrane 106 that is in lateral flow contact with the labeling zone and may be made of nitrocellulose. [0091] and [0092] of Gerdes describe the test capture region 108 to comprise a first “test” capture moiety and a second “control” capture moiety. Finally, [0094] of Gerdes describes the absorbent pad or zone 112 that is in lateral flow contact with the capture zone at the distal end of the test strip that helps draw a test sample from the sample receiving zone to the distal end and may include materials such as cellulose.
Therefore, one skilled in the art would find it obvious to modify the test strip seen in Figure 6 of Lee such that the first end 122 (wick) is in lateral flow contact with a separate labeling zone (conjugate pad), where the labeling zone is in lateral flow contact with a nitrocellulose membrane that includes the test and control lines, and finally the absorbent pad that is in lateral flow contact with the nitrocellulose membrane as taught by Gerdes because Gerdes teaches that this is an effective configuration for a lateral flow assay test.
Additionally, because Lee is silent with regards to specific material for the absorbent pad, therefore, it would have been necessary and thus obvious to look to the prior art for conventional absorbent pad materials. Gerdes provides this conventional teaching showing that it is known in the art to use cellulose for an absorbent zone. Therefore, it would have been obvious to one having ordinary skill in the art to make the absorbent pad from cellulose because it is taught by Gerdes that cellulose is an effective material for drawing sample from a receiving zone to the distal end of the test strip by capillary action (Gerdes; [0094]).
Further, one skilled in the art would be motivated to make the conjugate pad of Lee a separate component from the nitrocellulose membrane because it is taught by Witchel that having a separate conjugate pad instead of pre-dosing the material on the carrier material that includes the detection zone has the following advantages: ease of manufacture, uniformity in test strip assembly, and enhancing the sensitivity of the test (Witchel; [0076]).
[0018] of Lee describes the materials of the housing (and thus the flat bottom section) being paper fiber, paper pulp products, cardboard, natural fibers, and [0025] describes that the device 102 is manufactured primarily or completely of biodegradable materials suitable for flushing into a sewer or septic systems. Further, the test strip is described to have materials such as nitrocellulose, cellulosic fibers in [0031] of Lee (where Gerdes is being used to modify the structure of the test strip as described above and teach the material of the absorbent pad to be cellulose). Therefore, the diagnostic insert is comprised of at least one water-dispersible, flushable, biodegradable material, or water-soluble material.
While Lee does not address if the materials are water-dispersible, flushable, biodegradable material, or water-soluble material, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the paper fiber, paper pulp products, cardboard and or natural fibers for the flat bottom section and/or the cellulose for the wick, label pad, and/or absorbent pad is different, the prior art is considered to have the same properties with respect to being water-dispersible, flushable, biodegradable material, or water-soluble. MPEP § 2112.01 (I-IV).
Please see [0039] of the instant specification that describes a water dispersible or soluble matrix comprising cellulose pulp fibers, and that other water dispersible or soluble materials include cellulose based non-wovens.
Lee does teach the material of the housing, and thus the flat bottom section, is made of materials listed in [0018], and it is further described that the material is made of a material that maintains its structural stability for a predetermined time and provides paper fiber that begins to degrade within 2 minutes of being subjected to a liquid as a specific example, Lee does not teach a coating with an agent adapted to limit, slow, or delay wettability of the backing when exposed to liquid.
In the same problem solving area of increasing the wet-strength of a porous carrier material, Mangold teaches wet-strength agents (Mangold; column 3 lines 4-15).
Specifically, Mangold teaches where a porous carrier material is treated with at least one wet-strength agent, or the wet-strength agents can already be added to the fiber pulp (Mangold; column 3 lines 4-15). It is further described in column 4 lines 46-60 that the carrier material can also be treated by having a machine impregnate the carrier material with the wet-strength agent.
It would have been obvious to one skilled in the art to modify the housing of Lee such that it includes the wet-strength agent as taught by Mangold because Mangold teaches that the wet-strength agent provides for better mechanical loading capacity of paper and it increases the wet strength of the paper (Mangold; column 3 lines 15-25).
Further, the process of Mangold where the porous material fibers have the wet-strength agents added will be coating the fibers, and thus be a coating. Additionally, the alternative method of Mangold where the carrier material is then impregnated with the wet-strength agent will be coating the material.
Regarding claim 2, modified Lee teaches the diagnostic insert of claim 1.
The limitations of claim 2 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Lee and the test strip of modified Lee is capable of being removably received in the flat bottom section of modified Lee. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Lee (see MPEP §2114).
As seen in Figure 3 of Lee, the flat bottom section 124 will removably receive the test strip 132 (Lee; [0021]).
Regarding claim 3, modified Lee teaches the diagnostic insert of claim 2. Lee has been modified by Gerdes such that the structure includes the wick connected to the labeling zone and the labeling zone connected to the nitrocellulose membrane with the test and control area.
While modified Lee does not address if the nitrocellulose is non-water dispersible, or non-water-soluble material, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the nitrocellulose is different, the prior art is considered to have the same properties with respect to being non-water-dispersible, or non-water-soluble as that is claimed. MPEP § 2112.01 (I-IV).
Please note due to “or”, only one of the material being non-water-dispersible, non-flushable, or non-water-soluble is required.
Regarding claim 4, modified Lee teaches the diagnostic insert of claim 3. Modified Lee further teaches wherein the test strip (a) is comprised at least partially of nitrocellulose (please see claim 1 supra).
Please note the limitation “or (b) is comprised or consists of non-nitrocellulose material.” is not required due to recitation of “or”.
Regarding claim 5, modified Lee teaches the diagnostic insert of claim 2.
Lee has been modified by Gerdes such that the first end 122 (wick) is in lateral flow contact with a separate labeling zone (conjugate pad), the lateral labeling zone is in contact with a nitrocellulose membrane with test and control lines, and finally the nitrocellulose membrane is in contact with the absorbent pad. Therefore, the nitrocellulose membrane with test and control lines (test strip) is a lateral flow test strip. Please note that [0031] of Lee does describe nitrocellulose as a material used for the test strip that is placed into the device 104 that is flushed.
Further, [0025] of Lee describes where the device 102 is made of biodegradable materials suitable for flushing into a sewer or septic system, where the user can flush the toilet once the results of testing are displayed.
Therefore, the nitrocellulose membrane with test and control lines (test strip) will comprise a flushable material.
Please note that due to “or”, only one of the material being water-dispersible, flushable, or water-soluble is required.
Regarding claim 6, modified Lee teaches the diagnostic insert of claim 1. Lee further teaches wherein the diagnostic insert is rigid (Lee; the housing bottom surface 124 will need to be at least somewhat rigid in order to support the test strip seen in Figure 3, further [0031] describes the test strip to have a backing material which will provide the test strip with rigidity).
Regarding claim 7, modified Lee teaches the diagnostic insert of claim 1. Lee further teaches wherein the diagnostic insert is flat (Lee; see Figures 4-5 which shows side views of the device where it can be seen that both the housing bottom surface and the test strip are flat).
Regarding claim 8, modified Lee teaches the diagnostic insert of claim 1.
The limitations of claim 8 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Lee and the flat bottom section of modified Lee is capable of including one or more perforations adapted to enhance dissolution or dispersion, and/or decrease sinking and dispersion timing. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Lee (see MPEP §2114).
Regarding claim 9, modified Lee teaches the diagnostic insert of claim 1. Lee further teaches wherein the downstream portion is on top of the top surface of the diagnostic insert (Lee; Figure 3 where it can be seen that the test strip 132 (including the absorbent pad) will be placed on a top surface of the housing bottom surface 124. In Figure 3, the housing 104 is understood to be made of a lid that is placed on top of the flat bottom section 124, where the bottom surface of the flat bottom section may be defined as the location of the lip 106 when the housing is oriented upside down).
Please note that the limitation “integrated into or” is not required due to recitation of “or”.
Regarding claim 10, modified Lee teaches the diagnostic insert of claim 1. Lee further teaches wherein the downstream portion comprises an absorbent zone (please see claim 1 supra).
Claim(s) 8 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Lee (US-2008/0286879-A1), Gerdes (US-2004/0110167-A1), Witchel (WO-2005/116651-A2), and Mangold (US-5177022-A), and in further view of Ryan (US-2005/0178515-A1).
Regarding claim 8, modified Lee teaches the diagnostic insert of claim 1. Lee has been modified with Mangold to include a wet-strength agent.
If it is determined that the housing of Lee is not capable of including one or more perforations to enhance dissolution or dispersion, and/or decrease sinking and dispersion timing, in the same problem solving area of dispersing a paper product, in the analogous art of flushable paper products, Ryan teaches where a dispersibility region of a paper product can include perforations, which may or may not be filled with a reacted cationic strength agent or a reacted nonionic strength agent, where the filled perforations function as additional strength regions and enhance dispersibility of the paper product (Ryan; abstract, [0032]).
It would have been obvious to one skilled in the art to modify the flat bottom section such that it includes perforations as taught by Ryan because Ryan teaches the perforations enhance dispersibility of the paper product, and that a combination of strength regions and dispersibility regions (perforations) allows a paper product to have enough strength to maintain its useful features without sacrificing the paper’s desired dispersibility (Ryan; [0032]).
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Avallin (US-2016/0152660-A1) teaches a distributor plate that is perforated with holes/openings that allows substantially uniform distribution of fluid (Avallin; [0005]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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