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 .
Response to Amendment
The Amendment filed 12/10/2025 has been entered. Claims 46, 48-50, 52-55, 59-60, 63, 66, 69-71 remain pending in the application. Claim 63 is withdrawn. New grounds of rejections necessitated by amendments are discussed below.
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 46, 53-55, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Naseri et al. (US 20190099166 A1) in view of Miller (US 20130331666 A1, cited in the IDS filed 10/30/2021).
Regarding claim 46, Naseri teaches a female hygienic device in the form of a sanitary pad (Figs. 7-8 and paragraph [0112] teaches a dried blood spot testing menstrual pad comprising a menstrual pad 700 with a blood collection device strip 800), comprising:
a. a carrier substrate layer (Figs. 8A-8E, interpreted as comprising bottom frame 830 and top frame 810);
b. a barrier layer (protective cover layer 801) complementary in size and shape to the carrier substrate layer (Figs. 8A-8E), the barrier layer being made of a material configured to prevent penetration of vaginal discharges therethrough (paragraph [0114] teaches the protective cover 801 is a material impermeable to liquid, therefore is structurally capable of preventing penetration of vaginal discharges therethrough), and comprising at least one orifice (inlet 802) configured to allow the penetration of the vaginal discharges therethrough (Figs. 8A-8E teaches the inlet 802 is structurally capable of allowing penetration of vaginal discharge through the protective cover layer 801);
c. at least one lateral flow test strip (Figs. 8A-8E, absorbent paper material 820; paragraph [0114] teaches fluid flows laterally from the inlet area of the absorbent paper material to the plasma window area; paragraph [0113] teaches a fluid collection test strip 800; therefore, the absorbent paper material 820 is interpreted as a lateral flow test strip) sandwiched between the carrier layer and the barrier layer (Fig. 8E shows element 820 sandwiched between elements 830 and 801; note that the carrier layer is interpreted as comprising bottom frame 830 and top frame 810, and the absorbent paper material 820 is between the bottom frame 830 of the carrier layer and the barrier layer 801), the lateral flow strip comprising at least one absorption zone aligned with the orifice for accumulating vaginal discharge (paragraph [0114] teaches fluid flows laterally from the inlet area of the absorbent paper material to the plasma window area, therefore, the area of the absorbent paper material 820 that absorbs fluid from the inlet area that is aligned with inlet 802 is interpreted as the absorption zone capable of accumulating vaginal discharge); and
wherein the carrier substrate layer (Figs. 8A-8E, interpreted as comprising bottom frame 830 and top frame 810) comprises a window (Fig. 8B and paragraph [0114], opening 811 that functions as a window) configured to enable visual inspection of an indication zone (interpreted as a functional limitation, see MPEP 2114; Fig. 8B and paragraph [0114], opening 811 that functions as a window, therefore is structurally capable of enabling visual inspection of an indication zone).
Naseri fails to teach: the lateral flow strip (Figs. 7-8) comprising at least one indication zone comprising at least one agent comprising a DNA probe, an RNA probe, or an antibody capable of reacting with a physiological marker associated with ovarian cancer in the vaginal discharge to provide a visual indication of the reacting; and d. recesses located over the carrier substrate, the recesses being sized and shaped to structurally cause the vaginal discharges to flow to the orifice in order to accumulate at the absorption zone of the lateral flow strip.
Naseri teaches embodiments where the fluids collection test strip can include an additive that is capable of diagnosing various health markers using colorimetric detection methods; wherein a color represents the presence or absence of a biomarker; wherein the results could be interpreted by a mobile device or similar especially if the biomarker is quantifiable; and the use of a colorimetric detection provides the additional flexibility on on-location diagnosis, and transport of the fluids collection test strip is not required for diagnosis (paragraph [0120]). Naseri teaches the fluids collection test strip includes a color indicator selected to provide a visual indication of the presence of a biomarker in a vaginal fluid (paragraphs [0041],[0051]). Naseri teaches detection of biomarkers or cancer markers, and of cancer types in blood (paragraphs [0120],[0129]). Naseri teaches a specific location of a detection card may be coated with a specific molecule, such as an antibody for a target antigen in vaginal fluid and a color change will be shown for colorimetric detection (paragraph [0132]). Naseri teaches biomarkers can be analyzed in vaginal fluids, such as RNA or DNA of interest (paragraph [0141]).
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 lateral flow strip of Naseri to incorporate the teachings of embodiments of the test strip including a color indicator of Naseri (paragraphs [0041],[0051],[0120]) and the teachings of analysis of DNA, RNA, antigens and cancer markers of Naseri (paragraphs [0120],[0129],[0132],[0141]) to provide: the lateral flow strip comprising at least one indication zone comprising at least one agent comprising a DNA probe, an RNA probe, or an antibody capable of reacting with a physiological marker associated with ovarian cancer in the vaginal discharge to provide a visual indication of the reacting. Doing so would have a reasonable expectation of successfully improving diagnosing of various health markers, such as DNA, RNA, and antigens, using colorimetric detection methods and therefore improve flexibility of on-location diagnosis (Naseri, paragraphs [0041], [0051], [0120], [0129], [0132], [0141]).
Modified Naseri fails to teach: d. recesses located over the carrier substrate, the recesses being sized and shaped to structurally cause the vaginal discharges to flow to the orifice in order to accumulate at the absorption zone of the lateral flow strip.
Miller teaches a disposable menstrual fluid fractionation apparatus comprising a sensor integrated into a disposable feminine hygiene product to detect a target analyte in the liquid component of menstrual fluid and indicate the presence/concentration of the target analyte (abstract). Miller teaches biological fluids are frequently assayed to monitor or diagnose medical conditions (paragraph [0002]). Miller teaches a holder for a disposable article with integrated analyte sensor components (Figs. 3a-3b; paragraph [0093]), wherein the disposable article is a sanitary napkin (300; paragraph [0094]) and includes a pre filter (Figs. 3a-3b, prefilter 302) located over a carrier substrate (304); wherein the prefilter includes surface channels, i.e. recesses (Fig. 3a, element 303), which are arranged to direct a flow of menstrual fluid toward the carrier substrate (paragraph [0100]; Fig. 3a). Miller teaches a detection matrix is in fluid communication with the sample collection matrix (paragraphs [0109]-[0110]).
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 female hygienic device of modified Naseri to incorporate the teachings of a disposable feminine hygiene product with surface channels over a carrier substrate of Miller (Figs. 3a-3b; paragraph [0100]) to provide: d. recesses located over the carrier substrate, the recesses being sized and shaped to structurally cause the vaginal discharges to flow to the orifice in order to accumulate at the absorption zone of the lateral flow strip. Doing so would have a reasonable expectation of successfully improving direction of flow of menstrual fluid towards the carrier substrate and absorption zone for analysis as taught by Miller (paragraph [0100]; Fig. 3a).
Regarding claim 53, modified Naseri fails to teach the said indication zone further comprises at least one second agent for visually reacting with a second physiological marker.
Naseri teaches an embodiment where it possible to treat the different areas of the paper absorbent material with different reagents to allow for more analysis from one strip (paragraph [0116]). Naseri teaches embodiments where the fluids collection test strip can include an additive that is capable of diagnosing various health markers using colorimetric detection methods; wherein a color represents the presence or absence of a biomarker; wherein the results could be interpreted by a mobile device or similar especially if the biomarker is quantifiable; and the use of a colorimetric detection provides the additional flexibility on on-location diagnosis, and transport of the fluids collection test strip is not required for diagnosis (paragraph [0120]). Naseri teaches the fluids collection test strip includes a color indicator selected to provide a visual indication of the presence of a biomarker in a vaginal fluid (paragraphs [0041],[0051]). Naseri teaches a specific location of a detection card may be coated with a specific molecule, such as an antibody for a target antigen in vaginal fluid and a color change will be shown for colorimetric detection (paragraph [0132]). Naseri teaches biomarkers can be analyzed in vaginal fluids, such as RNA or DNA of interest, vitamins, minerals, lipid profiles, hormone levels (paragraph [0141]), which are interpreted as a physiological marker not indicative of a cancerous condition.
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 indication zone of modified Naseri to incorporate the teachings of different areas with different reagents for multiple analyte analysis, and analytes including antigens, RNA or DNA of interest, vitamins, minerals, lipid profiles, and hormone levels of Naseri (paragraphs [0116],[0041],[0051],[0132],[0141]) to provide: the said indication zone further comprises at least one second agent for visually reacting with a second physiological marker. Doing so would have a reasonable expectation of successfully improving analysis of a sample for more than one analyte, such as multiple biomarkers, as taught by Naseri (paragraph [0116]).
Regarding claim 54, modified Naseri fails to explicitly teach wherein the second physiological marker is not indicative of a cancerous condition.
Naseri teaches an embodiment where it possible to treat the different areas of the paper absorbent material with different reagents to allow for more analysis from one strip (paragraph [0116]). Naseri teaches embodiments where the fluids collection test strip can include an additive that is capable of diagnosing various health markers using colorimetric detection methods; wherein a color represents the presence or absence of a biomarker; wherein the results could be interpreted by a mobile device or similar especially if the biomarker is quantifiable; and the use of a colorimetric detection provides the additional flexibility on on-location diagnosis, and transport of the fluids collection test strip is not required for diagnosis (paragraph [0120]). Naseri teaches the fluids collection test strip includes a color indicator selected to provide a visual indication of the presence of a biomarker in a vaginal fluid (paragraphs [0041],[0051]). Naseri teaches a specific location of a detection card may be coated with a specific molecule, such as an antibody for a target antigen in vaginal fluid and a color change will be shown for colorimetric detection (paragraph [0132]). Naseri teaches biomarkers can be analyzed in vaginal fluids, such as RNA or DNA of interest, vitamins, minerals, lipid profiles, hormone levels (paragraph [0141]), which are interpreted as a physiological marker not indicative of a cancerous condition.
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 indication zone of modified Naseri to incorporate the teachings of different areas with different reagents for multiple analyte analysis, and analytes including antigens, RNA or DNA of interest, vitamins, minerals, lipid profiles, and hormone levels of Naseri (paragraphs [0116],[0041],[0051],[0132],[0141]) to provide: wherein the second physiological marker is not indicative of a cancerous condition. Doing so would have a reasonable expectation of successfully improving analysis of a sample for more than one analyte, such as multiple biomarkers, as taught by Naseri (paragraph [0116]).
Regarding claim 55, while Naseri teaches a location may be coated with an antibody for a target antigen in vaginal fluid (paragraph [0132]), modified Naseri fails to teach the second physiological marker comprises at least one of the group consisting of albumin, actin, tubulin, a secondary antibody and any combination thereof.
Miller teaches a disposable menstrual fluid fractionation apparatus comprising a sensor integrated into a disposable feminine hygiene product to detect a target analyte in the liquid component of menstrual fluid and indicate the presence/concentration of the target analyte (abstract). Miller teaches biological fluids are frequently assayed to monitor or diagnose medical conditions (paragraph [0002]). Miller teaches target-specific aptamers, a capture reagent, a second detection reagent, and a second capture reagent (paragraph [0030]), where an aptamer-nanoparticle construct that binds to albumin may be included to provide an indication of the concentration of serum/plasma/menstrual fluid in the liquid received by the analyte sensor and the analyte sensor may be further provided with a sliding scale that is adjusted by the user based on the color/intensity of the control and is then used to determine the concentration of the target analyte (paragraph [0030]). Miller teaches a control assay may include an assay for a common component of blood and/or extracellular fluid, such as albumin, in order to determine whether the first assay result is unreliable due to sample dilution (e.g., with mucus, etc.) (paragraph [0131]).
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 at least one second agent of modified Naseri to incorporate the teachings of a second detection reagent and second capture reagent, such as an aptamer-nanoparticle construct, for use as a control and/or indication of non-target analyte concentration, such as albumin, of Miller (paragraph [0030]) to provide wherein the second physiological marker comprises at least one of the group consisting of albumin, actin, tubulin, a secondary antibody and any combination thereof. Doing so would have a reasonable expectation of successfully allowing for improved analysis of serum/plasma/menstrual fluid concentration of a liquid sample to improve analysis of a concentration of a target analyte based on the color/intensity of the control as taught by Miller (paragraph [0030]). Furthermore, doing so would have a reasonable expectation of successfully improving detection of reliability of an assay as taught by Miller (paragraph [0131]).
Regarding claim 60, modified Naseri further teaches wherein the visual indication comprises a color change and/or a color intensity change (see above claim 46; modified Naseri includes a color indicator as taught by Naseri, paragraphs [0041],[0051],[0120]; therefore, the visual indication comprises a color change and/or color intensity change from the color indicator).
Claims 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Naseri in view of Miller as applied to claim 46 above, and further in view of Schroeder et al. (US 20060140924 A1; cited in the IDS filed 03/28/2022).
Regarding claim 48, while Naseri teaches menstrual blood and vaginal discharge collection for the purpose of menstrual blood and vaginal discharge diagnostics (paragraph [0001]), modified Naseri fails to teach wherein the hygienic device further comprises at least one viscosity-reducing agent.
Schroeder teaches a composition to prevent viscoelastic fluids and aiding in reducing the viscoelastic properties of fluid so that the fluid can flow into absorbent articles, such as pads (abstract). Schroeder teaches failure of fluids from a vagina to reach absorbent articles due to the viscoelastic properties of the fluids (paragraph [0003]). Schroeder teaches the composition comprises at least one viscoelastant material, such as enzymes (paragraphs [0026]-[0027]), wherein if the viscoelastic fluid is mucus, the enzyme can be protease and/or glycosidase (paragraph [0028]). Schroeder teaches the composition allows for improved absorbency to the absorbent article and performance of the absorbent article (paragraph [0050]).
Since Naseri teaches collection and analysis of vaginal discharge with an absorbent pad (paragraph [0001]) and Schroeder teaches improving fluid absorbent articles by using compositions including enzymes for mucus (abstract; paragraph [0003], [0026]-[0028], [0050]), 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 hygienic device of modified Naseri to incorporate the teachings of compositions to reduce viscoelastic properties of fluids from the vagina (paragraph [0003], [0026]-[0028]) to provide wherein the hygienic device further comprises at least one viscosity-reducing agent (e.g. an enzyme for mucus). Doing so would have a reasonable expectation of successfully improving absorbency and performance of the device to absorb viscous fluid, such as from the vagina (Schroeder, paragraph [0050]).
Regarding claim 49, modified Naseri fails to teach wherein the at least one viscosity-reducing agent comprises an agent for targeting an enzymatic activity of mucin.
Schroeder teaches the composition comprises at least one viscoelastant material, such as enzymes (paragraphs [0026]-[0027]), wherein if the viscoelastic fluid is mucus, which is mucin and water, the enzyme can be protease and/or glycosidase (paragraph [0028]). Schroeder teaches the composition allows for improved absorbency to the absorbent article and performance of the absorbent article (paragraph [0050]).
Since Naseri teaches collection and analysis of vaginal discharge with an absorbent pad (paragraph [0001]) and Schroeder teaches improving fluid absorbent articles by using compositions including enzymes for mucus (abstract; paragraph [0003], [0026]-[0028], [0050]), 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 viscosity-reducing agent of modified Naseri to incorporate the teachings of compositions to reduce viscoelastic properties of mucus from the vagina (paragraph [0003], [0026]-[0028]) to provide wherein the at least one viscosity-reducing agent comprises an agent for targeting an enzymatic activity of mucin (e.g. an enzyme for mucus). Doing so would have a reasonable expectation of successfully improving absorbency and performance of the device to absorb viscous fluid, such as from the vagina (Schroeder, paragraph [0050]).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Naseri in view of Miller and Schroeder as applied to claim 49 above, and further in view of Carte et al. (US 20070065893 A1).
Regarding claim 50, modified Naseri fails to teach wherein the viscosity-reducing agent is selected from the group consisting of water beads, N- acetyl-L- cystein, N-acetylcytamine, Sodium thioglycollate, 2- mercaptoethanol, acetic acid, ammonium acetate, (NH4)2SO4, perchloric acid, NaOH, dithiothreitol (DTT), Urea, sodium dodecyl sulfate (SDS), Sodium Chloride and any combination thereof.
Schroeder the composition contains a viscoelastant material, such as enzymes, alkyl polyglycosides, bovine lipid extract surfactant, dextrans and dextran derivatives (paragraph [0010]). Schroeder teaches the composition comprises at least one viscoelastant material, such as enzymes (paragraphs [0026]-[0027]), wherein if the viscoelastic fluid is mucus, which is mucin and water, the enzyme can be protease and/or glycosidase (paragraph [0028]), i.e. viscosity reducing enzymes. Schroeder teaches the composition allows for improved absorbency to the absorbent article and performance of the absorbent article (paragraph [0050]).
Carte teaches detection of cancer or precancerous condition in a sample (abstract). Carte teaches detection of markers in mucous secretions such as vaginal fluid (paragraph [0002]). Carte teaches cancers can include vaginal cancer (paragraph [0043]). Carte teaches the consistency of mucous samples renders it immiscible with aqueous reagents, therefore sputum and other mucous samples are easily liquified using techniques known to persons skilled in the art, such as using reducing agents, oligosaccharides, sodium chloride, and enzymes; wherein commonly used reducing agents include NAC and DTT (paragraph [0059]).
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 viscosity-reducing agent of modified Naseri to incorporate the teachings of compositions to reduce viscoelastic properties of fluids from the vagina of Schroeder (paragraph [0003], [0026]-[0028]) and the teachings of liquifying mucous samples using sodium chloride, NAC, and DTT of Carte (paragraph [0059]) to provide: wherein the viscosity-reducing agent is selected from the group consisting of N- acetyl-L- cystein, dithiothreitol (DTT), Sodium Chloride and any combination thereof. Doing so would have a reasonable expectation of successfully improving absorbency and performance of the device to absorb viscous fluid (Schroeder, paragraph [0050]) and improving liquifying mucous samples for analysis with reagents as taught by Carte (paragraph [0059]).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Naseri in view of Miller as applied to claim 46 above, and further in view of Kouvonen et al. (US 5965458 A).
Regarding claim 52, modified Naseri fails to teach wherein the lateral flow strip comprises at least two areas comprising the at least one agent, wherein each of the at least two areas comprises a different amount of the at least one agent.
Naseri teaches an embodiment where it possible to treat the different areas of the paper absorbent material with different reagents to allow for more analysis from one strip (paragraph [0116]).
Kouvonen teaches a test strip for a rapid immunoassay containing specific reagent zones (abstract). Kouvonen teaches a strip comprising more than one zone each containing different reagents, and the strip may also contain several different concentrations of the same reagent or label in order to determine different analyte concentrations semiquantitatively (column 4, lines 2-9). Kouvonen teaches the test is based on lateral flow principle (column 5, line 37). Kouvonen teaches the number and positions of zones on test membrane can vary depending on the analyte to be tested, where the same membrane may contain several reagents for detecting different analytes or for detecting different concentrations of the same analyte (column 5, lines 54-58). Kouvonen teaches the sample can be a vaginal secretion sample to detect the presence of IGFBP-1 (column 8, lines 32-34), where if two different concentrations of an antibody against IGFBP-1 are used in the same test, it is possible to detect a low or high concentration of IGFBP-1 (column 8, lines 34-39).
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 device of modified Naseri to incorporate the teachings of a lateral flow strip comprising multiple zones of different concentrations of a same reagent of Kouvonen (abstract; column 4, lines 2-9; column 8, lines 34-39) to provide wherein the lateral flow strip comprises at least two areas comprising the at least one agent, wherein each of the at least two areas comprises a different amount of the at least one agent. Doing so would have a reasonable expectation of successfully improving functionality of the device and analysis of a sample by allowing for semiquantitative determination of analyte concentrations as taught by Kouvonen (column 4, lines 2-9; column 8, lines 34-39).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Naseri in view of Miller as applied to claim 46 above, and further in view of Tariyal et al. (US 20160324506 A1; cited in the IDS filed 10/30/2021).
Regarding claim 59, modified Naseri fails to teach wherein the at least one indication zone further comprises a detection enhancer, wherein said detection enhancer is selected from the group consisting of gold nanoparticles, gold microparticles, polystyrene beads, cellulose nanobeads and any combination thereof.
Tariyal teaches a medical kit for analysis of vaginal biological samples (abstract). Tariyal teaches detection methods include direction visual observation and colorimetric readout (paragraph [0145]). Tariyal teaches an assay based on gold-nanoparticles conjugated antibodies, which demonstrates improved stability over enzyme-based methods and in part eliminate the time-dependency problems of enzyme-linked antibody assays (paragraph [0152]). Tariyal teaches the gold-nanoparticle-based assays allows for signal amplification by polymerization to be conducted either immediately after capturing the antigen/antibody or at a later time, without affecting the diagnosis outcome and provides for a flexible diagnostic method which can be readily prepared, shipped, and stored, and testing procedures which can be flexibly conducted without rigid adherence to time limits or storage conditions (paragraph [0152]).
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 at least one indication zone of modified Naseri to incorporate the teachings of gold-nanoparticle-based assays of Tariyal (paragraph [0152]) to provide wherein the at least one indication zone further comprises a detection enhancer, wherein said detection enhancer is selected from the group consisting of gold nanoparticles, gold microparticles, polystyrene beads, cellulose nanobeads and any combination thereof. Doing so would have a reasonable expectation of successfully improving stability of the device and improving signal amplification of detection of a target while allowing for flexible diagnosis that can be readily prepared, shipped, and stored as taught by Tariyal (paragraph [0152]).
Claims 70, 66, 69, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Naseri in view of Miller as applied to claim 46 above, and further in view of Spetzler et al. (US 20140141986 A1; cited in the office action filed 04/25/2025).
Regarding claim 70, while Naseri teaches analysis of biomarkers in vaginal fluid (paragraph [0141]), and analysis of cancer markers (paragraph [0120]), modified Naseri fails to teach: the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is selected from the group consisting of CD 54 and FGF-1.
Spetzler teaches biomarkers can be assessed for diagnostic, therapy-related or prognostic methods to identify phenotypes, such as conditions or disease, or the stage or progression of a disease (abstract). Spetzler teaches a biological sample may comprise vaginal secretions (paragraph [0011]). Spetzler teaches a method for accessing a cancer by detecting a level of one or more circulating biomarkers, such as CD54 (paragraph [0432]-[0433]). Spetzler biomarkers can include CD54 (page 55, table 5). Spetzler teaches any of the types of biomarkers or specific biomarkers described herein can be assessed as part of a biosignature, such as biomarkers of table 5, which includes FGF-1 (paragraph [0447]; page 65). Spetzler teaches determining whether a subject is likely to respond or not to a tyrosine kinase inhibitor, the method comprising identifying one or more biomarker in a vesicle population in a sample from the subject, the biomarker including FGF1 (paragraph [1104]).
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 at least one agent of modified Naseri to incorporate Spetzler’s teachings of accessing a cancer by detecting a level of one or more circulating biomarkers, such as CD54 (paragraph [0432]-[0433]) and analysis of biomarkers such as FGF1 (paragraphs [0447], [1104]; page 65) to provide: the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is selected from the group consisting of CD 54 and FGF-1. Doing so would have a reasonable expectation of successfully improving analysis of bodily fluids of a subject and improving characterization, screening, and diagnosis of cancers, such as ovarian cancer, by employing agents for detecting known markers as taught by Spetzler.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. wherein the physiological marker is CD 54 or FGF-1) by known methods with no change in their respective functions (i.e. diagnosing and/or monitoring ovarian cancer), and the combinations yielded nothing more than predictable results (i.e. providing the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is CD 54 or FGF-1, would yield nothing more than the obvious and predictable result of improving analysis of bodily fluids of a subject and characterization, screening, and diagnosis of cancers, such as ovarian cancer). See MPEP 2143(A).
Regarding claim 66, modified Naseri fails to teach the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is CD 54.
Spetzler teaches biomarkers can be assessed for diagnostic, therapy-related or prognostic methods to identify phenotypes, such as conditions or disease, or the stage or progression of a disease (abstract). Spetzler teaches a biological sample may comprise vaginal secretions (paragraph [0011]). Spetzler teaches a method for accessing a cancer by detecting a level of one or more circulating biomarkers, such as CD54 (paragraph [0432]-[0433]). Spetzler biomarkers can include CD54 (page 55, table 5).
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 at least one agent of modified Naseri to incorporate the Spetzler’s teachings of accessing a cancer by detecting a level of one or more circulating biomarkers, such as CD54 (paragraph [0432]-[0433]) to provide: the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is CD 54. Doing so would have a reasonable expectation of successfully improving analysis of bodily fluids and improving characterization, screening, and diagnosis of cancers, such as ovarian cancer, by employing agents for detecting known markers as taught by Spetzler.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. wherein the physiological marker is CD 54) by known methods with no change in their respective functions (i.e. diagnosing and/or monitoring ovarian cancer), and the combinations yielded nothing more than predictable results (i.e. providing the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is CD 54 would yield nothing more than the obvious and predictable result of improving characterization, screening, and diagnosis of cancers, such as ovarian cancer). See MPEP 2143(A).
Regarding claim 69, modified Naseri fails to teach the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is FGF-1.
Spetzler teaches biomarkers can be assessed for diagnostic, therapy-related or prognostic methods to identify phenotypes, such as conditions or disease, or the stage or progression of a disease (abstract). Spetzler teaches a biological sample may comprise vaginal secretions (paragraph [0011]). Spetzler teaches a method for accessing a cancer by detecting a level of one or more circulating biomarkers (paragraph [0432]-[0433]). Spetzler teaches any of the types of biomarkers or specific biomarkers described herein can be assessed as part of a biosignature, such as biomarkers of table 5, which includes FGF-1 (paragraph [0447]; page 65). Spetzler teaches determining whether a subject is likely to respond or not to a tyrosine kinase inhibitor, the method comprising identifying one or more biomarker in a vesicle population in a sample from the subject, the biomarker including FGF1 (paragraph [1104]).
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 at least one agent of modified Naseri to incorporate the Spetzler’s teachings of accessing a cancer by detecting a level of one or more circulating biomarkers and analysis of biomarkers such as FGF1 (paragraphs [0447],[1104]; page 65) to provide: the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is FGF-1. Doing so would have a reasonable expectation of successfully improving analysis of bodily fluids and improving analysis of desired biomarkers to improve determination of whether a subject is likely to respond to an inhibitor as discussed by Naseri (paragraph [1104]).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. wherein the physiological marker is FGF-1) by known methods with no change in their respective functions (i.e. analysis of desired biomarkers of a subject), and the combinations yielded nothing more than predictable results (i.e. providing the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is FGF-1 would yield nothing more than the obvious and predictable result of improving analysis of desired biomarkers to improve determination of whether a subject is likely to respond to an inhibitor). See MPEP 2143(A).
Regarding claim 71, modified Naseri fails to explicitly teach wherein the device further comprises the vaginal discharge comprising the physiological marker.
Naseri teaches the present invention relates to menstrual blood and vaginal discharge collection for the purpose of menstrual blood and vaginal discharge diagnostics (paragraph [0001]). Naseri teaches colorimetric detection for bacteria or viruses and cancer markers (paragraph [0120]), such as endometrial cancer and other cancer types (paragraph [0129]).
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 device of modified Naseri to incorporate the teachings of collection of vaginal discharge for colorimetric detection of bacteria or viruses and cancer markers of Naseri (paragraphs [0001], [0120],[0129]) to provide: wherein the device further comprises the vaginal discharge comprising the physiological marker. Doing so would have a reasonable expectation of successfully allowing for collection and analysis of vaginal discharge and desired target physiological markers.
Response to Arguments
Applicant’s arguments, see pages 5-9, filed 12/10/2025, with respect to the rejection(s) of claims 46-47, 53-54, 58 and 60 under 35 U.S.C. 103, specifically regarding claim 46, and claims 48-50, 52, 55, 59, 70, 66-69, and 71 under 35 U.S.C. 103, specifically regarding claim 46, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Naseri et al. (US 20190099166 A1) in view of Miller (US 20130331666 A1, cited in the IDS filed 10/30/2021).
Applicant's arguments, see pages 8-9, filed 12/10/2025, with respect to claims 70, 66-69, and 71, have been fully considered but they are not persuasive.
In response to applicant’s argument that the prior art fails to teach the physiological marker is selected from CD54 and FGF-1 for detection of ovarian cancer, the examiner notes that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114.
As claimed, the device comprises at least one agent comprising a DNA probe, an RNA probe, or an antibody capable of reacting with a physiological marker associated with ovarian cancer; wherein the physiological marker is selected from the group consisting of CD 54 and FGF-1. Note that a method or process of detection of ovarian cancer is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, in response to applicant's arguments against the references individually (i.e. Spetzler), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as discussed above in the rejection of at least claim 70 under 35 U.S.C. 103, while Naseri teaches analysis of biomarkers in vaginal fluid (paragraph [0141]), and analysis of cancer markers (paragraph [0120]), modified Naseri fails to teach: the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is selected from the group consisting of CD 54 and FGF-1. Spetzler teaches a method for accessing a cancer by detecting a level of one or more circulating biomarkers, such as CD54 (paragraph [0432]-[0433]). Spetzler biomarkers can include CD54 (page 55, table 5). Spetzler teaches any of the types of biomarkers or specific biomarkers described herein can be assessed as part of a biosignature, such as biomarkers of table 5, which includes FGF-1 (paragraph [0447]; page 65). Spetzler teaches determining whether a subject is likely to respond or not to a tyrosine kinase inhibitor, the method comprising identifying one or more biomarker in a vesicle population in a sample from the subject, the biomarker including FGF1 (paragraph [1104]).
It would have been obvious to one of ordinary skill in the art to have modified the at least one agent of modified Naseri to incorporate Naseri’s teachings of analysis of biomarkers in vaginal fluids and cancer markers (paragraphs [0141],[0120]) and Spetzler’s teachings of accessing a cancer by detecting a level of one or more circulating biomarkers, such as CD54 (paragraph [0432]-[0433]) and analysis of biomarkers such as FGF1 (paragraphs [0447], [1104]; page 65) to provide: the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is selected from the group consisting of CD 54 and FGF-1. Doing so would have a reasonable expectation of successfully improving analysis of bodily fluids of a subject and improving characterization, screening, and diagnosis of cancers, such as ovarian cancer, by employing agents for detecting known markers as taught by Spetzler.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. wherein the physiological marker is CD 54 or FGF-1) by known methods with no change in their respective functions (i.e. diagnosing and/or monitoring ovarian cancer), and the combinations yielded nothing more than predictable results (i.e. providing the at least one agent capable of reacting with the physiological marker, wherein the physiological marker is CD 54 or FGF-1, would yield nothing more than the obvious and predictable result of improving analysis of bodily fluids of a subject and characterization, screening, and diagnosis of cancers, such as ovarian cancer). See MPEP 2143(A).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have modified the at least one agent to be capable of reacting with CD 54 or FGF-1 for improving analysis of bodily fluids of a subject and improving characterization, screening, and diagnosis of cancers.
Additionally, the apparatus of modified Naseri is identical to the presently claimed structure. Modified Naseri, see above rejection of claim 70 under 35 U.S.C. 103, discloses the at least one agent to be capable of reacting with CD 54 or FGF-1 as claimed and therefore, would have the ability to perform the use recited in the claim, i.e. capable of reacting with a physiological marker associated with ovarian cancer in the vaginal discharge. See MPEP 2112.01 (I). Additionally, CD 54 or FGF-1 is identical to the claimed CD 54 or FGF-1, and therefore is interpreted as a physiological marker associated with ovarian cancer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gray et al. (WO 2013148749 A1) teaches a system including a menstral pant and an absorbent article (abstract). Gray teaches an embodiment (Fig. 5) comprising a sanitary napkin comprising apertures 32 that can both help fluid acquisition as well as reduce stiffness in the middle zone (page 10, lines 24-25). Gray teaches a topsheet of a sanitary napkin can have optional characteristics, such as channels to direct fluid flow (page 8, lines 6-9).
Vijoen et al. (US 20100291536 A1) teaches a device for collecting, treating, and analysis of biological material (abstract). Vijoen teaches source material can include vaginal secretions (paragraph [0023]). Vijoen teaches source material samples having a higher viscosity may require contacting with a chemical processing agent that will assist the mixing function in breaking down the source material to reduce the viscosity, wherein a reducing agent may be used as a viscosity-reducing agent, wherein the reducing agent includes dithiothreitol (DTT), mercaptoethanol, mercaptoethylamine (paragraph [0035]).
Basu et al. (US 20150307947 A1) teaches systems of molecular profiling of cancer (abstract), including ovarian cancer (paragraph [0010]). Basu teaches genes and gene products that are known to play a role in cancer and can be assayed by any of the molecular profiling techniques of the invention include CD 54 (paragraph [0260]). Basu teaches molecular intelligence profiles for an ovarian cancer comprising assessment of FGFR1 (paragraph [0391]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758