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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-21 in the reply filed on 5/13/2026 is acknowledged. Claims 22-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/13/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 12/20/2023 and 01/19/2024 are being considered by the examiner.
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:
“control member adapted to control passage of the fluid sample from the first layer into the second layer” in claim 17;
“the control member is configured to receive a first user action to release the passage of the fluid sample from the first layer into the second layer" in claim 18;
“the control member is configured to receive a first user action to release the passage of the fluid sample from the first layer into the second layer… wherein the first user action activates a first timer and allows the fluid sample to contact with the viral-lysis reagent for a first predetermined period” in claim 19;
“the control member is configured to receive a second user action and wherein the second user action activates a second timer and allows the nucleic acid in the nucleic acid-receiving area to contact with a detecting agent for a second predetermined period” in claim 20.
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.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 recites “control member adapted control passage of the fluid sample from the first layer into the second layer” in lines 2-3, wherein the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While the specification discloses that the control member can be a button (p. 16, ln. 27 and Fig. 9C) that can be activated by a user and start timers, but the specification does not disclose how the button structurally contribute to controlling the passage of the fluid sample from the first layer to the second layer. It raises the question whether the button is connected a mechanical or electronic structure that actually perform the function, and that the button merely triggers the structure that actually perform the function (e.g., does activation of the button triggers opening up a valve? in such case, the valve is the structure that actually perform the function. Or does the button comprise addition structural features that performs the function? If so, such features are not disclosed) Thus, the disclosure is devoid of the structure of "control member” that performs the function in the claim. Therefore, the specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary sill in the art can reasonably conclude that the invention had possession of the claimed invention.
Claims 18-20 are rejected by virtue of their dependent on claim 17. Furthermore, for the reasons discussed above, the disclosure is devoid of the structure that actually performs the functions of releasing the passage of the fluid sample from the first layer into the second layer in the claim 18, allowing the fluid sample to contact with the viral-lysis reagent for a first predetermined period in claim 19, and allowing the nucleic acid in the nucleic acid-receiving area to contact with a detecting agent for a second predetermined period.
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.
Claim 6 and 17-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite.
Claim 6 is rejected 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 6 recites “wherein the lysis-reagent pad or the incubation pad comprises an incubation channel having a starting end positioned at least in part in an overlapping manner with the lysis-reagent pad” in line 4. It is unclear how the incubation channel (which is a part of the lysis reagent pad) can overlap with the lysis reagent pad. Furthermore, it is unclear in the specification and the drawings whether (1) incubation pad 125a and incubation channel 125b are two separate components (Fig. 1C) or (2) incubation channel 125b is a part of incubation pad 125a (p. 19, referring to Fig. 1C, discloses the incubation pad 125a comprises an incubation channel 125b and the incubation pad 125a is labeled “incubation channel” in Fig. 1C). If incubation channel 125b is a part of incubation pad 125a, then it is unclear where the starting end of incubation channel 125b is. Consequently, it is difficult to tell whether the starting end of incubation channel 125b is overlapping with lysis pad (121) in Fig. 1C. . Therefore, this limitation is indefinite. Clarification is requested.
Regarding claim 17-20, claim limitations involving “control member” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Claim 17 recites “control member adapted to control passage of the fluid sample from the first layer into the second layer” in lines 2-3, wherein the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While the specification discloses that the control member can be a button (p. 16, ln. 27 and Fig. 9C) that can be activated by a user and start timers, but the specification does not disclose how the button structurally contribute to controlling the passage of the fluid sample from the first layer to the second layer. It raises the question whether the button is connected a mechanical or electronic structure that actually perform the function, and that the button merely triggers the structure that actually perform the function (e.g., does activation of the button triggers opening up a valve? in such case, the valve is the structure that actually perform the function. Or does the button comprises addition structural features that performs the function? If so, such features are not disclosed) Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 18-20 are indefinite by virtue of their dependent on claim 17. Furthermore, for the reasons discussed above, is it unclear what structure actually performs the functions of releasing the passage of the fluid sample from the first layer into the second layer in the claim 18, allowing the fluid sample to contact with the viral-lysis reagent for a first predetermined period in claim 19, and allowing the nucleic acid in the nucleic acid-receiving area to contact with a detecting agent for a second predetermined period. Therefore, claims 18-20 are indefinite.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-2, 4-12, 15 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mace et al. (WO 2019246207 A1) in view of Rolland et al. (US 20140295415 A1).
Regarding claim 1, Mace teaches a device for separating a nucleic acid of a virus from a fluid sample (Fig. 8), comprising
a first layer (layers 1, 2 and 3) having a sample-receiving area (the porous polymer mesh in layer 1, rightmost zone in layer 2 and layer 3, which is a porous polymer-based membrane) adapted to receive a fluid sample and retain cells in the fluid sample (p. 36, lns. 22-31);
a second layer (layers 4 and 5; alternatively, comprises only layer 4) stacked below the first layer (Fig. 8) and having a viral-lysis area (rightmost zone in layers 4 and 5; alternatively, only rightmost zone in layer 4) positioned at least in part in an overlapping manner with the sample-receiving area (Fig. 8),
a third layer (layers 7 and 8) stacked below the second layer and having a pH-adjusting area (rightmost zone in layers 7 and 8) in fluid connection with the viral-lysis area (Fig. 8), the pH-adjusting area comprising a pH-adjusting reagent (p. 37, ln. 13-14, immunoassay reagent, which comprises buffer components that affects/adjusts pH); and
a fourth layer (layer 9) stacked below the third layer and having a nucleic acid-receiving area (rightmost zone for product capture)(p. 37) in fluid connection with the pH-adjusting area (Fig. 8).
Mace teaches multilayered fluidic devices for blood analysis. Mace teaches, as an example in Fig. 8, a device for isolating and detecting C-reactive protein (CRP) from blood samples (rightmost pathway). Mace teaches that the plasma is separated from the whole blood through layers 1-3 (first layer), and the CRP in the plasma travels through layers 4 and 5 (second layer) and is assayed with the immunoassay assay reagent for detecting CRP stored in rightmost zone of layer 7 (a part of the third layer) for CRP detection (p. 37, lns. 15-17). Mace teaches detecting CRP protein, which does not required lysis, and thus fails to teach the viral-lysis area in the second layer (layers 4 and 5) comprising a viral-lysis reagent.
However, Mace further teaches, the multilayer devices can be can comprises reagents for immunoassay for not only CRP but also for viruses such HIV and Hepatitis C (Mace, p. 20, lns. 25-27). In addition, Rolland teaches a multilayer microfluidic device for detecting HIV and Hepatitis C from whole blood (para. 0077). Rolland further teaches the device comprises a filtration layer for isolating plasma, and immediately below the filtration layer, the device comprise a lysis reagent layer that comprises chaotropic agent, which is a reagent for lysing cell/denaturing viral coat proteins (Rolland, Fig. 1A-A and paras. 0112-0014) such that the viral nucleic acids can be isolated and captured for detection (Rolland, paras. 0107, 0112-0116).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified layer 4 of Mace’s device in Fig. 8 (the layer after plasma is isolated) to have chaotropic agent dried on the rightmost zone of the layer as taught by Rolland (Rolland, para. 0113) in order to denature viral coat proteins for the detecting viruses such as HIV and hepatitis C (Rolland, paras. 0107, 0112-0114) and to have modified the CRP immunoassay reagents and layer 9 taught Fig. 8 of Mace with HIV or Hepatitis C immunoassay reagent and for HIV or Hepatitis C capture, respectively, as taught by Mace (p. 20, lns. 25-27 and p. 37, ln. 18-19) and Rolland (paras. 0017) because such modifications allows for the multilayer device of Mace to detect HIV or Hepatitis (Rolland, para. 0077 and Mace, p. 20, lns. 25-27) with a reasonable expectation of success (MPEP 2143)(I)(G).
The teachings of Mace in view of Rolland teaches the second layer (layers 4 and 5, or alternatively only layer 4) stacked below the first layer (Fig. 8) and having a viral-lysis area (rightmost zone in layers 4 and 5, or alternatively rightmost zone in layer 4) positioned at least in part in an overlapping manner with the sample-receiving area (Fig. 8), the viral-lysis area comprising a viral- lysis reagent (Rolland, para. 0113, chaotropic agent dried on the rightmost zone of layer 4); the third layer (layers 7 and 8) stacked below the second layer and having a pH-adjusting area (rightmost zone in layers 7 and 8) in fluid connection with the viral-lysis area (Fig. 8), the pH-adjusting area comprising a pH-adjusting reagent (HIV or Hepatitis immunoassay reagents comprises buffer components which affects/adjusts pH) and a fourth layer (layer 9) stacked below the third layer and having a nucleic acid-receiving area (rightmost zone for product/viral nucleic acid capture)(p. 37) in fluid connection with the pH-adjusting area.
Regarding claim 2, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1. Mace further teaches the device further comprising a fifth layer (layers 10 and 11) having a wicking pad (layers 10 and 11 are paper).
Regarding claim 4, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Mace further teaches wherein the viral- lysis area comprises (iii) a lysis-reagent pad containing the lysing reagent (Rolland, para. 0113 and claim 1, lysis reagent dried on the rightmost zone of layer 4).
Regarding claim 5, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 4. Modified Mace further teaches wherein the viral-lysis area further comprises (iv) an incubation pad (the rightmost zone in layer 5) stacked below the lysis-reagent pad (the rightmost zone in layer 4 with dried chaotropic agent).
Regarding claim 6, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 5. Modified Mace further wherein
Regarding claim 7, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1.
Interpreting in the alternative of the second layer comprises only layer 4
wherein the viral- lysis area is separated from the third layer by a degradable film (layer 5, which is made of paper that is degradable).
Regarding claim 8, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Mace further teaches wherein the pH- adjusting area (rightmost zone of layers 7 and 8) comprises a pH channel holding the pH-adjusting reagent (p. 37, lns. 10-17) and having an inlet end in fluid connection to the viral-lysis area in the third layer and an outlet end in fluid connection to the nucleic acid-receiving area in the fourth layer (Fig. 8).
Regarding claim 9, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1. Mace teaches wherein the nucleic acid-receiving area (rightmost zone of layer 9) is functionalized (p. 37, ln. 18, functionalized for product capture, see also p. 20, ln. 31 - p.21, ln. 7 and claim 1).
If it is determined that Mace does not teach the nucleic acid-receiving area (rightmost zone of layer 9) is functionalized. Then the following obviousness rejection is put forth.
Modified Mace teaches the nucleic acid-receiving area is capturing product/target (viral nucleic acid) for readout, but does not explicitly teach the capturing is done by functionalizing the layer with complementary oligos. However, Rolland teaches capturing products/target using surface-bounded (functionalized) oligonucleotide (Rolland, para. 0017) in the oligo-capture layer (nucleic acid-receiving area).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nucleic acid-receiving area taught by modified Mace with complementary oligo to the product functionalized to the nucleic acid receiving area as taught by Rolland in order to capture the product/target analyte (para. 0017) with a reasonable expectation of success (MPEP 2143)(I)(G).
Regarding claim 10, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to the limitation “wherein the fluid sample comprises a blood sample, a sputum sample, a urine sample, a urinary swab sample, or a saliva sample,” the fluid sample is not positively recited. Since this limitation is directed to the fluid sample, this limitation does not further limit the structure of the invention. For the purpose of compact prosecution, Mace teaches the device is for blood sample (abstract)
Regarding claim 11, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to the limitation “wherein the nucleic acid comprises RNA or DNA,” the nucleic acid is not positively recited. Since this limitation is directed to the nucleic acid, this limitation does not further limit the structure of the invention.
Regarding claim 12, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to the limitation “wherein the virus is HIV, Dengue, SARS-CoV-2, or Ebola” the virus is not positively recited. Since this limitation is directed to the virus, this limitation does not further limit the structure of the invention.
Regarding claim 15, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 2. Mace further teaches wherein the fifth layer (layers 10 and 11) comprises cellulose (paper).
Regarding claim 21, modified Mace teaches a kit comprising the device of claim 1 (see claim 1).
Modified Mace teaches the device comprises reagents for performing immunoassay for HIV or Hepatitis C (see claim 1), but does not explicitly teach a probe having a sequence that is complementary to a target sequence of the nucleic acid.
However, Rolland teaches a multilayer device for detecting HIV and Hepatitis C. Rolland further teaches the device comprising detection reagent that include a probe comprised of a nucleotide sequence complementary to product, viral nucleic acid of HIV or Hepatitis C (Rolland, para. 0016, 0077).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit taught Mace to include a detection reagent that include a probe comprised of a nucleotide sequence complementary to the product, which is HIV or Hepatitis C nucleic acid (Rolland, para. 0016) in order to detect HIV and Hepatitis C with a reasonable expectation of success (MPEP 2143)(I)(G).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Mace et al. (WO 2019246207 A1) in view of Rolland et al. (US 20140295415 A1) as applied to claim 1 above, and further in view of Baillargeon et al. (“High-Yielding Separation and Collection of Plasma from Whole Blood Using Passive Filtration,” Analytical Chemistry 2020 92 (24), 16245-16252).
Regarding claim 3, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1. Mace further teaches wherein the sample-receiving area comprises (ii) a lower filter pad (layer 3, membrane for separating plasma, hereinafter “plasma filter”)(p. 36, lns. 29-31) and adapted to retain a second population of cells (blood cells).
Mace does not explicitly teach the sample-receiving area comprises (i) an upper filter pad adapted to receive the fluid sample and retain a first population of cells, and consequently fails to teach the lower filter pad stacked below the upper filter pad.
However, Baillargeon teaches a device for separating plasma from whole blood for HIV detection. Baillargeon teaches the device comprise a pre-filter and a plasma separation membrane PSM adhered with a double side adhesive ring (Fig. 1). More specifically, Baillargeon teaches the device comprises a sample-receiving area comprises the pre-filter (an upper filter pad) adapted to receive the fluid sample and retain a first population of cells (p. 16246, “Experimental Design”, prefilter removes majority of white blood cells) and (ii) the PSM (lower filter pad) stacked below the upper filter pad and adapted to retain a second population of cells (p. 16246, “Experimental Design” PSM removes remaining white blood cells and red blood cells). Baillargeon teaches the pre-filter reduces clogging of the PSM and minimizes hemolysis (p. 16246) and thus increase separation capacity of plasma from whole blood (abstract and conclusion).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plasma filter taught by Mace with the prefilter and the PSM adhered with a double side adhesive ring taught by Baillargeon (Fig. 1) in order to reduce clogging of the PSM and minimizes hemolysis (p. 16246) and thus increase separation capacity of plasma from whole blood (Baillargeon, abstract and conclusion) with a reasonable expectation of success (MPEP 2143)(I)(G).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mace et al. (WO 2019246207 A1) in view of Rolland et al. (US 20140295415 A1) as applied to claim 1 above, and further in view of Khodakov et al. (RU 2595374 C2).
Regarding claim 13, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Mace teaches the viral-lysis reagent that is dried on the second layer is a chaotropic agent (Rolland, para. 0113), but does not explicitly wherein the viral-lysis reagent comprises dried Triton X-100.
However, Khodakov teaches lysis of viral using a dry reaction mixtures containing a chaotropic agent and detergent representing Triton X-100 (para. 0052).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the viral-lysis reagent of a chaotropic agent to further include dry detergent representing Triton X-100 as taught by Khodakov because a dry reaction mixtures containing a chaotropic agent and detergent representing Triton X-100 for viral lysis is known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination yielded nothing more than predictable results (viral-lysis reagent). See MPEP 2143(I)(A).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Mace et al. (WO 2019246207 A1) in view of Rolland et al. (US 20140295415 A1) as applied to claim 1 above, and further in view of Chu et al. (US 20060269543 A1).
Regarding claim 14, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Mace teaches the immunoassay reagent for HIV or Hepatitis comprises a antibody (p. 20, ln. 20 – p. 21 ln. 1), but fail to explicitly teach the reagent comprises sodium acetate, and thus modified Mace fails to wherein the pH- adjusting reagent comprises sodium acetate.
However, Chu teaches stable formation of antibody, and the formulation include the sodium acetate buffer (abstract and claim 44).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the antibody in the immunoassay reagent taught by modified to include sodium acetate buffer as taught by Chu in order for the antibody (that is a part of immunoassay reagent) to be more stable (Chu, abstract, claim 44) with a reasonable expectation of success (MPEP 2143)(I)(G).
The teachings of modified Mace would yield wherein the pH- adjusting reagent comprises sodium acetate (the immunoassay reagent comprise antibody reagent that comprises sodium acetate).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mace et al. (WO 2019246207 A1) in view of Rolland et al. (US 20140295415 A1) as applied to claim 4 above, and further in view of Holmes (US 20180231533 A1).
Regarding claim 16, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 4.
Modified Mace teach lysis reagent is dried in the reagent pad comprises paper, and thus fails to teach wherein the lysis-reagent pad comprises fiberglass.
However, Holmes teaches a multilayer microfluidic device for analyzing blood samples that involves using lysing agents (paras. 0118-0119). Holmes further lysing agents may be impregnated and then dried into porous mats, glass fiber mats, sintered frits or particles such as Porex, paper, or other similar material (para. 0119).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the reagent pad comprises pad as taught by Mace with a glass fiber mat because one of ordinary skill in the art would accordingly have recognized the glass fiber mat would result in the predictable result of providing a material for lysing reagent to dried on (MPEP 2143)(I)(B).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mace et al. (WO 2019246207 A1) in view of Rolland et al. (US 20140295415 A1) as applied to claim 1 above, and further in view of Muir et al. (US 20120091008).
Regarding claim 17, modified Maces teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Mace does not teach the device further comprising a control member adapted to control passage of the fluid sample from the first layer into the second layer.
However, Rolland teaches the use of a micropipette to dispense samples and reagent on the to the appropriate inlet of the multilayer device (para. 0095).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mace to include a micropipette as taught by Rolland because dispensing samples and reagent using a micropipette on a multilayer microfluidic device is known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination yielded nothing more than predictable results (a device comprising a micropipette and a multilayer device, wherein reagent/sample is being dispensed by a micropipette onto the multilayer layer device). See MPEP 2143(I)(A).
In addition, Muir teaches teach a micropipette (Fig. 1). Muir further teaches the micropipette comprises a dispenser button for drawing and dispensing fluid.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the micropipette taught by modified Mace with the micropipette comprises a dispenser button taught by Muir because one of ordinary skill in the art would accordingly have recognized the micropipette comprising a dispenser button would result in the predictable result of providing a micropipette for dispensing fluid. See MPEP 2143(I)(B).
The teachings of modified Mace yields the device further comprising a control member (the dispenser button of the micropipette) adapted to control passage of the fluid sample from the first layer into the second layer (the dispenser button of the pipette dispenses and thus controls passage of the fluid sample from first to second layer).
Regarding claim 18, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 17. Modified Mace further wherein the control member (button of the micropipette) is configured to receive a first user action to release the passage of the fluid sample from the first layer into the second layer (the dispenser button of the micropipette is configured to be pressed by a user, and the pressing of the button leads to release the passage of fluid sample into the porous polymer mesh in layer 1 through which the sample fluid to the subsequent layers, p.36, lns. 22-28).
Regarding claim 19, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 18. Modified Mace further wherein the first user action activates a first timer (fluid flowing at a rate through the distance of the path from top layer 1 to layer 4, which measure the time it takes for the sample fluid to travel from layer 1 to layer 4, see also p. 37, ln 15) and allows the fluid sample to contact with the viral-lysis reagent for a first predetermined period (the first user action on the micropipette allows fluid sample to be injected and subsequently contact the viral-lysis reagent for a predetermined period, which is the duration that the sample fluid travels through layer 4, p.36, lns. 22- p. 37, ln. 6).
Regarding claim 20, modified Mace teaches all of the elements of the current invention as stated above with respect to claim 17. Mace further teaches wherein the control member is configured to receive a second user action and wherein the second user action activates a second timer and allows the nucleic acid in the nucleic acid-receiving area to contact with a detecting agent for a second predetermined period (the dispenser button of the micropipette is configured to be pressed by a user to dispense a reagent, e.g., detecting agent, into the rightmost cut-outs in the first layer through which the reagent flow to the subsequent layers which includes the nucleic acid-receiving area. The reagent is in the nucleic acid area for a predetermined period, which is the duration that the reagent travels through the area, p.36, ln. 22- p. 37, ln. 22).
Conclusion
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/M.L.C./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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