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 Group I (Claims 1-7 and 11) in the reply filed on March 18, 2026 is acknowledged.
Claims 13, 14-18, and 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 18, 2026.
Claim Objections
Claim 6 is objected to because of the following informalities:
“comprising applied-field-reactive capture molecule conjugate” should read instead as “comprising an applied-field-reactive capture molecule conjugate”
“binds to and capture” should read as “binds to and captures”
Appropriate correction is required.
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:
“biomarker testing unit” in claim 1. The corresponding structure for a “biomarker testing unit is defined at Applicant’s Paragraph 0297 as “may be one or more electronic biosensors, one or more lateral flow assays or other microfluidic type testing systems, or a combination of the same.”
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 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, 5, and dependent claims thereof 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.
Re. Claim 1: Claim 1 recites the limitation “the lungs and airways of a test subject.” There is insufficient antecedent basis for this limitation in the claim.
Re. Claim 5: Claim 5 recites an acronym, “SAP,” which is not defined in the claims nor does it have clear antecedent basis. Examiner recommends amending the claim to instead recite “comprises a super absorbent polymer (SAP),” as best understood.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over:
Schindheim et al. (US 20140364758 A1) (hereinafter – Schindheim) in view of
Larson et al. (US 20210140956 A1) (hereinafter – Larson).
Re. Claim 1: Schindheim teaches an apparatus, comprising:
an exhaled breath condensate (EBC) collector for converting breath vapor received from the lungs and airways of a test subject into an EBC fluid biosample (Abstract: particularly “The apparatus may also include one or more collectors to accumulate a breath condensate over an extended period of time;” Paragraph 0002: “Example embodiments may be incorporated with components of respiratory treatment apparatus, such as a pressure treatment mask or other patient interface;” Paragraphs 0024, 0097: patient interface is coupled with sensing module including a collector).
Schindheim does not teach the invention further comprising:
a biomarker concentrator for concentrating a target biomarker portion in the fluid biosample to form a concentrated fluid biosample;
a biomarker testing unit for receiving the concentrated fluid biosample and testing the concentrated fluid biosample for a target biomarker.
Larson teaches analogous art in the technology of analyzing biofluids such as sweat, blood, or saliva (Paragraph 0004), akin to the breath condensate gathered by Schindheim. Larson further teaches the invention comprising:
a biomarker concentrator for concentrating a target biomarker portion in the fluid biosample to form a concentrated fluid biosample (Fig. 4; Paragraph 0054: “The channel 480 is configured to concentrate a sweat sample relative to a target analyte, and includes an optional pre-concentration filter 492, a selectively-permeable concentrator membrane 490 and a concentrator pump 494. When a sweat sample enters the channel through the inlet, it moves in the direction of the arrow 16, where it encounters the pre-filter. The filter removes solutes from the sweat sample based on size, electrical charge, or chemical property, or removes proteases or other solutes that may interfere with the device measurements. Once through the filter, the sweat sample is concentrated relative to the target analyte by the concentrator membrane 490, which could be a dialysis membrane, or other material that at least allows the passage of water and inorganic solutes, but prevents passage of the target analyte. The pump 494 is constructed of a material suitable for drawing water out of the channel through the membrane”);
a biomarker testing unit for receiving the concentrated fluid biosample and testing the concentrated fluid biosample for a target biomarker (Fig. 4: EAB sensors 421-424).
Schindheim teaches that the sensing module may include “one or more sensors of the following sensors: a peroxide sensor, a nitrous oxide sensor, an acetone sensor, a carbon dioxide sensor, a pH sensor, glucose sensor, and/or a lactate sensor” (Paragraph 0029). It would have been obvious to one having skill in the art before the effective filing date to have modified the sensing module of Schindheim to further include the biomarker concentrator and biomarker testing unit of Larson, the motivation being that doing so further expands the capabilities of the device to detect molecules and ions or other materials in a biofluid with high specificity (Paragraph 0003).
Re. Claim 2: Schindheim as modified by Larson teaches the invention according to claim 1. Schindheim further teaches the invention further comprising a testing system support for the EBC collector, wherein the testing system support is configured and dimensioned to fit inside a face mask (Paragraph 0097: “ Paragraph 0098: “While the sensors and housing may be cylindrical as illustrated in the figures, they may also be any other shape or size practical for use in the technology (e.g., fits within a patient interface, gas conduit, or tube)”),
wherein the face mask forms an exhaled breath vapor containment volume to hold the exhaled breath vapor in proximity to the EBC collector to enable the exhaled breath vapor to coalesce into the fluid biosample (Paragraph 0100: “…the sample collector of the mask allows an accumulation of breath gas or breath condensate”).
Re. Claim 3: Schindheim as modified by Larson teaches the invention according to claim 1. Larson, in teaching details of the modification, further teaches the invention wherein the biomarker concentrator comprises a selectively permeable barrier for allowing excess water in the fluid biosample to pass through the selectively permeable barrier and block the target biomarker in the fluid biosample from passing through the selectively permeable barrier (see citation of rejection of claim 1; Fig. 4: selectively-permeable concentrator membrane 490).
Re. Claim 4: Schindheim as modified by Larson teaches the invention according to claim 3. Larson, in teaching details of the modification, further teaches the invention wherein further comprising an excess water absorbing wick for absorbing the excess water passing through the selectively permeable material (Fig. 4: concentrator pump 494 draws water out of channel through the membrane 490).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over:
Schindheim et al. (US 20140364758 A1) (hereinafter – Schindheim) in view of
Larson et al. (US 20210140956 A1) (hereinafter – Larson) in further view of
Luxton et al. (US 20210405050 A1) (hereinafter – Luxton).
Re. Claim 5 (as best understood): Schindheim as modified by Larson teaches the invention according to claim 1. Larson, in teaching details of the modification, further teaches the invention
wherein the target biomarker is not absorbed by a filter and flows along with the EBC through the SAP and microfluidics structures of the diagnostic platform, wherein as the EBC flows along through the filter, the water content in the EBC is removed while the content of the target molecules remains constant, increasing the tested sample concentration of the target molecules (Paragraph 0054: “…the concentrator membrane 490, which could be a dialysis membrane, or other material that at least allows the passage of water and inorganic solutes, but prevents passage of the target analyte”).
Thus, the concentrator incorporated by Larson into Schindheim is absent only in reciting that it comprises a super absorbent polymer for preferentially absorbing water from the EBC. However, Larson states that the part of the concentrator which draws water away from the sample (i.e., Fig. 4: pump 494) is “constructed of a material suitable for drawing water out of the channel through the membrane (Paragraph 0054).
Luxton teaches analogous art in the technology of viral sensors (Abstract). Luxton teaches that a material which draws water through another layer is made of “cellulose, cotton linter fibres, wood pulp, and sodium polyacrylate super-absorbent polymers or mixtures thereof” (Paragraph 0032).
Thus, it would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include super-absorbent polymers to use as a water-drawing material as taught by Luxton in the system of Larson as modified by Schindheim, since the claimed invention is merely a combination of old elements (Schindheim as modified by Larson: requiring an fluid-drawing material to act as a pump 494; Luxton: teaching super-absorbent polymers as a suitable water-drawing material), and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., providing a concentrator having a fluid-absorbing material that is a super-absorbent polymer).
Claims 6, 7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over:
Schindheim et al. (US 20140364758 A1) (hereinafter – Schindheim) in view of
Larson et al. (US 20210140956 A1) (hereinafter – Larson) in further view of
Hu et al. (US 20180164302 A1) (hereinafter – Hu).
Re. Claim 6: Schindheim as modified by Larson teaches the invention according to claim 1, but does not teach the invention further comprising applied-field-reactive capture molecule conjugate provided for capturing the target biomarker,
the applied-field-reactive capture molecule conjugate having at least one applied-field-responsive end and a capture molecule end,
wherein the capture molecule end binds to and capture the target biomarker.
Hu teaches analogous art in the technology of biomolecule detection (Paragraph 0040). Hu further teaches the invention further comprising applied-field-reactive capture molecule conjugate provided for capturing the target biomarker (Paragraph 0076: magnetic immunosensor that have capture antibodies which produce electroactive species once bound),
the applied-field-reactive capture molecule conjugate having at least one applied-field-responsive end and a capture molecule end (Paragraph 0076: applied-field responsive end can be viewed as the magnetic bead portion; the capture molecule end can be viewed as the capture antibody end),
wherein the capture molecule end binds to and capture the target biomarker (Paragraph 0076: “The beads are coated with capture antibodies that are configured to bind to the target analyte bound to the antibody-enzyme conjugate…”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Schindheim as modified by Larson to include the structures and techniques of Hu, the motivation being that doing so provides the additional capability of detecting difficult to sense molecules with high resolution (Paragraphs 0030-0038), and allows the sensor to detect biomolecules such as “ionophores, cofactors, polypeptides, proteins, glycopeptides, enzymes, immunoglobulins, antibodies, antigens, lectins, neurochemical receptors, oligonucleotides, polynucleotides, DNA, RNA, or suitable mixtures” (Paragraph 0040).
Re. Claim 7: Schindheim as modified by Larson and Hu teaches the invention according to claim 6. Hu, in teaching further detail regarding the modification, teaches the invention further comprising a dissolvable adhesive for holding the applied-field-reactive capture molecule conjugate in a path of the fluid biosample, wherein water in the fluid biosample dissolves the dissolvable adhesive and allows the applied-field-reactive capture molecule conjugate to be free floating in the fluid biosample (Paragraph 0074: “The biological sample or a fluid may be passed at least once over the dry reagent, e.g., the reagent region 650 to dissolve the reagent within the biological sample or fluid. Reagents used to amend biological samples or fluid within the cartridge may include the antibody-enzyme conjugate, magnetic beads coated with capture antibodies, or blocking agents that prevent either specific or non-specific binding reactions among assay compounds. Within a segment of the biological sample or fluid, the reagent can be preferentially dissolved and concentrated within a predetermined region of the segment;” Paragraph 0076: “The beads are coated with capture antibodies that are configured to bind to the target analyte bound to the antibody-enzyme conjugate, e.g., the antibody-enzyme conjugate disposed in reagent region 650 and subsequently dissolved in the biological sample;” similarly recited in Paragraph 0083; Paragraph 0108: “At step 1515, a second dry reagent is dissolved into the biological sample. The second dry reagent may comprise magnetic beads or microspheres coated with capture biomolecules (e.g., capture antibodies immobilized on magnetic beads) configured to bind to the analyte. At step 1520, a second complex of the first complex (e.g., signal antibodies bound to the analyte) and the capture antibodies immobilized on the magnetic beads is formed in a second liquid phase comprising the biological sample;” Paragraph 0114).
Re. Claim 11: Schindheim as modified by Larson and Hu teaches the invention according to claim 6. Hu, in teaching further detail regarding the modification, teaches the invention wherein the applied-field-reactive capture molecule conjugate comprises a linker molecule disposed between the applied-field-responsive end and the capture molecule end (Paragraph 0074: “In some embodiments, the magnetically susceptible beads are coated with any suitable biomolecules that can either bind to an analyte of interest, or respond to the presence of such analyte by producing a change that is capable of measurement. Many methods of attachment exist in the art, including providing amine reactive N-hydroxysuccinimide ester groups for the facile coupling of lysine or N-terminal amine groups of proteins. In the instance of streptavidin-modified magnetically susceptible beads, the biomolecules may be modified to include a binder such as biotin to attach the biomolecules on the bead surfaces. For example, the biomolecules may be attached to biotin (e.g., Thermo Scientific—EZ-link Sulfo-NHS-LC-LC-biotin (Product#21338) or EZ-link Sulfo-NHS-LC-biotin (Product#21335))”),
the linker molecule providing the applied-field-reactive capture molecule conjugate with electro-chemical properties wherein when the capture molecule end binds with the target biomarker at least one of a polarity and a conductivity of the applied-field-reactive capture molecule conjugate changes (Paragraph 0084: measuring current changes generated by oxidation current from magnetic sensor 610; Paragraph 0107: “A change in current or potential generated by the production or destruction of the electroactive species at the first and second sensors, as appropriate to the mode of operation of the sensing device, is recorded as a function of time and determinative of the presence of a target analyte in the biological sample”).
Double Patenting
COPENDING APPLICATIONS:
Claims 1-7 and 11 of this application are patentably indistinct from claims 1, 9, and 16 of Application No. 18/443,194. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and dependent claims thereof are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, and 16 (i.e., each independent claim) of copending Application No. 18/443,194 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each independent claim of the reference claim recites
an apparatus, comprising:
an exhaled breath condensate (EBC) collector for converting breath vapor received from the lungs and airways of a test subject into an EBC fluid biosample (claims 1, 9, 16, with claims 1 and 16 reciting verbatim language);
a biomarker concentrator for concentrating a target biomarker portion in the fluid biosample to form a concentrated fluid biosample (claims 1, 9, 16, with claims 1 and 16 reciting verbatim language);
a biomarker testing unit for receiving the concentrated fluid biosample and testing the concentrated fluid biosample for a target biomarker (claims 1, 9, 16, with claims 1 and 16 reciting verbatim language).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
COPENDING PATENTS:
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over independent claims of each of US patents 12,369,816 B2, 12,533,047 B2, 12,442,726 B2 respectively in view of Larson et al. (US 20210140956 A1) (hereinafter – Larson).
Each of the patents listed recite limitations encompassing the present application, and differs in lacking a biomarker concentrator and biomarker testing unit which receives a concentrated fluid. This aspect is taught by Larson, as detailed in the prior art rejections above; motivation to modify claims of the patents would be identical to motivation to modify the primary reference utilized in the prior art rejections.
Conclusion
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/JUSTIN XU/ Primary Examiner, Art Unit 3791
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