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 .
Information Disclosure Statement
The Applicant should note that the large number of references in the attached information disclosure statement (IDS) filed on 2/19/2026. Each reference not struck-through has been considered by the Examiner in the same manner as other documents in Office search files are considered by the Examiner while conducting a search of the prior art in a proper field of search (See MPEP 609.05(b)). The following chart provides the reasons why selected references on the IDS were not considered.
Reference Entry on IDS
Reason
Foreign Patent Document 090
A full copy was not provided
Foreign Patent Document 108
No copy of the document was provided, only the translation was provided
Foreign Patent Document 109
No copy of the document was provided, only the translation was provided
Non-Patent Literature Document 172
No matching document with the indicated number of pages was provided
Non-Patent Literature Document 241
No matching document with the indicated date was provided
The IDS filed 7/25/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The struck-through references on this IDS do not seem to have a corresponding document in this application or the parent application that matches the description provided in their corresponding IDS entry. The struck-through references have not been considered.
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.
No claim limitation is 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 36, 38-39, 41-44, 46-47, 50, 59, 61, and 64 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 recites “the first state” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a flow state” of the first flow controller of claim 28, line 6. If they are the same, consistent terminology should be used. If they are different, the relationship between these two recitations should be made clear. Also, if they are different, there is insufficient antecedent basis for “the first state” in the claim.
Claim 36 recites “the second state” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a non-flow state” of the first flow controller of claim 28, lines 10-11. If they are the same, consistent terminology should be used. If they are different, the relationship between these two recitations should be made clear. Also, if they are different, there is insufficient antecedent basis for “the second state” in the claim.
Claim 38 recites “as a result of the first flow controller being to the second state” in lines 27-28, but is so grammatically awkward that its meaning is not clear. Clarification is required.
Claims 39, 41-44, 46-47, 50, 61, and 64 are rejected by virtue of their dependence from claim 38.
Claim 50 recites “portion of the negative pressure differential that is applied across the diaphragm” in lines 2-4, but it is not clear if this recitation is the same as, related to, or different from “a portion of the negative pressure differential that is applied across the diaphragm” of claim 38, lines 26-27. If they are the same, “portion of the negative pressure differential that is applied across the diaphragm” in claim 50 should be “the portion of the negative pressure differential that is applied across the diaphragm”. If they are different, the relationship between these two recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 59 recites “the unsealed state” in line 5, but it is not clear if this recitation is the same as, related to, or different from “a second position” of the barrier of claim 53, line 29. If they are the same, consistent terminology should be used. If they are different, the relationship between these two recitations should be made clear. Also, if they are different, there is insufficient antecedent basis for the unsealed state” in the claim.
Double Patenting
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 28, 31, 38, 43-44, 47, 53-55, 59, and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52, 54-55, 57, 59, and 62 of copending Application No. 17/591237 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 52 and 55 of the reference application have all features of claims 28 and 31 of the present application, respectively.
Claims 52, 54, 55, and 57 of the reference application have all features of claims 38, 43, 44, and 47 of the present application, respectively.
Claims 52, 54, 55, 59, and 62 of the reference application have all features of claims 53, 54, 55, 59, and 62 of the present application, respectively.
Claims 28-29, 31-32, 36, 38-39, 41, 43-44, 46-47, 53, 60-61, 64, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-29, 31-32, 36, 38-39, 42-43, 47, and 60-61 of copending Application No. 17/591237 (reference application) in view of U.S. Patent Application Publication No. 2018/0177445 (Rogers). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 28 or 38 of the reference application includes an inlet and outlet. Rogers teaches that such structures are connected in a housing with the elements of the device contained therein (FIGS. 24A-24C of Rogers). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a housing between the inlet and outlet and containing the elements of the device so as to make the device compact while providing protection to the elements of the device.
Claim 28 of the reference application as modified has all features of claims 28, 38, 46, 53, 64, and 66 of the present application.
Claims 29, 31, 32, and 36 of the reference application as modified have all features of claim 29, 31, 32, and 36 of the present application, respectively.
Claim 28 or 38 of the reference application as modified has all features of claim 38 of the present application.
Claims 29 of the reference application as modified has all features of claim 39 of the present application.
Claims 39, 42, and 43 of the reference application as modified have all features of claims 41, 43, and 44 of the present application, respectively.
Claims 47 of the reference application as modified has all features of claims 47 of the preset application, respectively.
Claims 60 and 61 of the reference application as modified has all features of claims 60 and 61 of the preset application, respectively.
Claims 28, 31-33, 36-38, 41-44, 50, 53-55, 57-59, and 67-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-38, 41-45, 47-48, 51, 53, 56, 58-59, and 62 of copending Application No. 17/516887 (reference application) in view of Rogers. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 36 of the reference application includes a housing, an inlet and outlet. Rogers teaches that such structures with the elements of the device contained in the housing (FIGS. 24A-24C of Rogers). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to contain the elements of the device in the housing so as to make the device compact while providing protection to the elements of the device.
Claim 44 of the reference application includes an inlet and outlet. Rogers teaches that such structures are connected in a housing with the elements of the device contained therein (FIGS. 24A-24C of Rogers). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a housing between the inlet and outlet and containing the elements of the device so as to make the device compact while providing protection to the elements of the device.
Claim 36 or 44 of the reference application as modified has all features of claims 28, 38, and 53 of the present application.
Claim 37 or 45 of the reference application as modified have all features of claims 36 and 41 of the present application, respectively.
Claim 38 or 47 of the reference application as modified have all features of claims 37 and 42 of the present application, respectively.
Claim 41, 42, 43, or 48 of the reference application as modified has all features of claims 31, 43, 44, 54, and 55 of the present application.
Claim 51 of the reference application as modified has all features of claims 32 and 57-58 of the present application.
Claim 53 or 58 of the reference application as modified has all features of claims 33, 50, 55, and 57-58 of the present application.
Claim 56 or 62 of the reference application as modified has all features of claims 67, 68, and 69 of the preset application, respectively.
Claim 59 of the reference application as modified has all features of claim 59 of the present application.
Allowable Subject Matter
Claims 36, 38-39, 41-44, 46-47, 50, 59, 61, and 64 would be allowable if
(1) rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action; and
(2) the double patenting rejections set forth in this Office action were overcome by filing a terminal disclaimer.
Claims 28-29, 31-33, 37, 53-55, 57-58, 60, 62, and 66-69 would be allowable if the double patenting rejections set forth in this Office action were overcome by filing a terminal disclaimer.
The following is a statement of reasons for the indication of allowable subject matter.
U.S. Patent Application Publication No. 2018/0177445 (Rogers) teaches a fluid control device (FIGS. 23A-23B or FIGS. 23C-23E of Rogers). Rogers discloses a valve 2308, 2326 so as to prevent the sampling blood from flowing to the outlet until the sequestration chamber is filled (paragraph 0135-0137 of Rogers). Rogers teaches that such a valve can be a clip or other enclosing device that can close off the sampling channel (paragraph 0136 of Rogers). U.S. Patent No. 3,848,579 (Villa-Real) discloses such a valve in the form of an elastically deformable membrane that opens when a predetermined pressure differential threshold is reached (col. 16, line 9 to col, 19, line 50 of Villa-Real; any of the elasto-valvular components 8, 8op in FIGS. 1-15 and 18-29 of Villa-Real). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use any of the elasto-valvular components 8, 8op in FIGS. 1-15 and 18-29 of Villa-Real as the valve 2308, 2326 of Rogers since (1) Rogers teaches other enclosing devices may be used and Villa-Real teaches one such enclosing device, (2) it is a simple substitution of one known element for another to obtain predictable results, and/or (3) it permits an automatic opening upon a predetermined pressure differential.
As to the operation of the elasto-valvular components 8, 8op of Villa-Real, Villa-Real teaches that the membrane remains closed as long as a predetermined pressure differential threshold is not reached. In the context of Villa-Real, the predetermined pressure differential threshold is reached when there is flow caused by the penetration into the subject’s vein on one side of the components 8, 8op and a vacuum pressure from the vacutainer on the other side of the components 8, 8op (col. 16, line 9 to col, 19, line 50 of Villa-Real). For example, when there is a pressure differential due to the penetration into the subject’s vein on one side of the components 8, 8op and no pressure differential due to any vacuum pressure, the components 8, 8op are closed. Once the two pressure differentials are obtained (one pressure differential due to the penetration into the subject’s vein and one pressure differential due to the vacuum from the vacutainer), the components 8, 8op is opened.
Rogers discloses that the valve prevents the sampling blood from flowing to the outlet until the sequestration chamber is filled (paragraph 0135-0137 of Rogers). With the incorporation of the elastically deformable component of Villa-Real in the device of Rogers, the elastically deformable component of Villa-Real opens when a predetermined pressure differential threshold acts across it. The predetermined pressure differential threshold acting across the elastically deformable component of Villa-Real so as to open the component would occur after the sequestration chamber is filled since the pressure differential acting across the elastically deformable component of Villa-Real would be low when the flow proceeds through the sequestration chamber, but rise to the predetermined pressure differential threshold after the sequestration chamber is filled. That is, after the sequestration chamber is filled, there is only one pressure differential due to the pressure caused by the penetration into the subject’s vein on one side of the deformable component and the pressure caused by the vacuum from the vacuum container on the other side of the deformable component in which this one pressure differential is now large enough to open the deformable component since the sequestration chamber is closed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the elastically deformable component of Villa-Real such that the elastically deformable component of Villa-Real opens when a predetermined pressure differential threshold acts across it in which this predetermined pressure differential threshold across the elastically deformable component occurs after the sequestration chamber is filled since it permits an automatic operation of the device of Rogers while fulfilling its requirement that the valve prevents the sampling blood from flowing to the outlet until the sequestration chamber is filled.
With respect to claim 28, the combination teaches or suggests a fluid control device, the device comprising:
a housing having an inlet (the inlet port 2302 and its corresponding structure in FIG. 23C-23E of Rogers) fluidically coupleable to a bodily fluid source and an outlet (the outlet port 2304 and its corresponding structure in FIG. 23C-23E of Rogers) fluidically coupleable to a fluid collection device, the housing defining at least partially each of a containment channel (the blood sequestration chamber 2306, 2320 of Rogers) and a sampling channel (the blood sampling channel 2308, 2322 of Rogers) between the inlet and the outlet;
a first flow controller (the hydrophobic plug of Rogers) in fluid communication with the containment channel, the first flow controller in a flow state configured to allow a gas but not a bodily fluid to flow through the containment channel and toward the outlet in response to a negative pressure differential between the inlet and the outlet via the containment channel that is generated by fluidically coupling the outlet to the fluid collection device such that a volume of the bodily fluid is drawn from the inlet to the containment channel, the first flow controller in a non-flow state configured to prevent the gas and the bodily fluid from flowing through the first flow controller from the containment channel to the outlet; and
a second flow controller (any of the elasto-valvular components 8, 8op in FIGS. 1-15 and 18-29 of Villa-Real) in fluid communication with the sampling channel, the second flow controller in a first state configured to prevent the gas and the bodily fluid from flowing from the inlet, through the sampling channel, and to the outlet (any of the elasto-valvular components 8, 8op in FIGS. 1-15 and 18-29 of Villa-Real before opening).
With respect to claim 38, the combination teaches or suggests a fluid control device, the device comprising:
a housing having an inlet (the inlet port 2302 and its corresponding structure in FIG. 23C-23E of Rogers) fluidically coupleable to a bodily fluid source and an outlet (the outlet port 2304 and its corresponding structure in FIG. 23C-23E of Rogers) fluidically coupleable to a fluid collection device, the housing defining at least partially each of a containment channel (the blood sequestration chamber 2306, 2320 of Rogers) and a sampling channel (the blood sampling channel 2308, 2322 of Rogers) between the inlet and the outlet;
a first flow controller (the hydrophobic plug of Rogers) fixedly disposed in the housing, the first flow controller configured to prevent a bodily fluid from flowing through the first flow controller, the first flow controller in a first state configured to allow a gas to flow, in response to a negative pressure differential introduced at the outlet, from the containment channel to the outlet, the first flow controller in a second state configured to prevent the gas and the bodily fluid from flowing from the containment channel to the outlet; and
a second flow controller (any of the elasto-valvular components 8, 8op in FIGS. 1-15 and 18-29 of Villa-Real) disposed in the housing, the second flow controller in a first state configured to prevent the bodily fluid from flowing from the inlet, through the sampling channel, and to the outlet (any of the elasto-valvular components 8, 8op in FIGS. 1-15 and 18-29 of Villa-Real before opening).
With respect to claim 53, the combination teaches or suggests a fluid control device, the device comprising:
a housing having an inlet (the inlet port 2302 and its corresponding structure in FIG. 23C-23E of Rogers) fluidically coupleable to a bodily fluid source and an outlet (the outlet port 2304 and its corresponding structure in FIG. 23C-23E of Rogers) fluidically coupleable to a fluid collection device, the housing defining at least partially each of a containment channel (the blood sequestration chamber 2306, 2320 of Rogers) and a sampling channel (the blood sampling channel 2308, 2322 of Rogers) between the inlet and the outlet;
a first flow controller (the hydrophobic plug of Rogers) fixedly disposed in the housing between the containment channel and the outlet, the first flow controller in a first state configured to allow a gas but not a bodily fluid to flow through the first flow controller from the containment channel and toward the outlet in response to a negative pressure differential introduced at the outlet such that a volume of the bodily fluid is drawn from the inlet to the containment channel (the unsaturated state of the plug of Rogers), the first flow controller configured to transition to a second state when the volume of the bodily fluid is in the containment channel, the first flow controller in the second state configured to prevent the gas and the bodily fluid from flowing therethrough (the saturated state of the plug of Rogers); and
a second flow controller (any of the elasto-valvular components 8, 8op in FIGS. 1-15 and 18-29 of Villa-Real) disposed within the housing between the inlet and the outlet, the second flow controller in a first state configured to prevent the gas and the bodily fluid from flowing through the sampling channel to the outlet (any of the elasto-valvular components 8, 8op in FIGS. 1-15 and 18-29 of Villa-Real before opening has this ability).
However, the above combination of Rogers and Villa-Real does not teach or suggest:
(1) “the second flow controller including a diaphragm and a barrier, the diaphragm defines a portion of the containment channel and is configured to transition from a first configuration to a second configuration as a result of an increase in a portion of the negative pressure differential between the inlet and the outlet that is applied across the diaphragm and caused by the first flow controller being in the non-flow state, and as a result of the diaphragm being transitioned to the second configuration, the diaphragm configured to move the barrier to transition the second flow controller from the first state to a second state in which the second flow controller facilitates the bodily fluid to flow through the sampling channel to the outlet” of claim 28 along with the other features of claim 28;
(2) “the second flow controller including a diaphragm and a barrier, the diaphragm defining at least a portion of the containment channel, the diaphragm configured to transition from a first configuration to a second configuration in response to an increase in a portion of the negative pressure differential that is applied across the diaphragm as a result of the first flow controller being to the second state, and the second flow controller further configured such that the diaphragm moves the barrier, as a result of the diaphragm being transitioned to the second configuration, to transition the second flow controller from the first state to the second state” of claim 38 along with the other features of claim 38; and
(3) “the second flow controller including a diaphragm defining at least a portion of the containment channel and a barrier, the diaphragm configured to transition from a first configuration to a second configuration as a result of an increase in a portion of the negative pressure differential that is applied across the diaphragm that causes an elastic deformation of the diaphragm, wherein the increase in the portion of the negative pressure differential that is applied across the diaphragm is a result of the first flow controller being in the second state, the barrier of the second flow controller configured to be moved by the diaphragm as a result of the diaphragm being transitioned to the second configuration between a first position in which the barrier is configured to prevent the gas and the bodily fluid from flowing from the inlet, through the sampling channel, and to the outlet, to a second position in which the barrier is configured to allow the bodily fluid to flow from the inlet, through the sampling channel, and to the outlet” of claim 53 along with the other features of claim 53.
U.S. Patent Application Publication No. 2011/0198221 (Angelescu) teaches a flow controller having a diaphragm configured to transition from a first configuration to a second configuration in response to an increase in pressure applied across the diaphragm when the first flow controller is in the non-flow state, the second flow controller further having a barrier configured to be transitioned, at least in part by the diaphragm due to the diaphragm transitioning, from a first state in which the barrier separates at least a portion of one flow path from another (FIGS. 2(a)-2(b) of Angelescu). Also, Angelescu teaches the steps of transitioning a diaphragm of a flow controller from a first configuration to a second configuration in response to an increase in a portion of pressure applied across the diaphragm and transitioning a barrier of the flow controller, at least in part by the diaphragm due to the diaphragm transitioning, from a first state in which the barrier separates a flow path of the fluid control device from another (FIGS. 2(a)-2(b) of Angelescu).
However, Angelescu, alone or in combination with Rogers or the combination of Rogers and Villa-Real, does not teach or suggest:
(1) “the second flow controller including a diaphragm and a barrier, the diaphragm defines a portion of the containment channel and is configured to transition from a first configuration to a second configuration as a result of an increase in a portion of the negative pressure differential between the inlet and the outlet that is applied across the diaphragm and caused by the first flow controller being in the non-flow state, and as a result of the diaphragm being transitioned to the second configuration, the diaphragm configured to move the barrier to transition the second flow controller from the first state to a second state in which the second flow controller facilitates the bodily fluid to flow through the sampling channel to the outlet” of claim 28 along with the other features of claim 28;
(2) “the second flow controller including a diaphragm and a barrier, the diaphragm defining at least a portion of the containment channel, the diaphragm configured to transition from a first configuration to a second configuration in response to an increase in a portion of the negative pressure differential that is applied across the diaphragm as a result of the first flow controller being to the second state, and the second flow controller further configured such that the diaphragm moves the barrier, as a result of the diaphragm being transitioned to the second configuration, to transition the second flow controller from the first state to the second state” of claim 38 along with the other features of claim 38; and
(3) “the second flow controller including a diaphragm defining at least a portion of the containment channel and a barrier, the diaphragm configured to transition from a first configuration to a second configuration as a result of an increase in a portion of the negative pressure differential that is applied across the diaphragm that causes an elastic deformation of the diaphragm, wherein the increase in the portion of the negative pressure differential that is applied across the diaphragm is a result of the first flow controller being in the second state, the barrier of the second flow controller configured to be moved by the diaphragm as a result of the diaphragm being transitioned to the second configuration between a first position in which the barrier is configured to prevent the gas and the bodily fluid from flowing from the inlet, through the sampling channel, and to the outlet, to a second position in which the barrier is configured to allow the bodily fluid to flow from the inlet, through the sampling channel, and to the outlet” of claim 53 along with the other features of claim 53.
Claims 29, 31-33, 36-37, 60, and 67-69 are allowable by virtue of their dependence from claim 28.
Claim 39, 41-44, 46-47, 50, 61, and 64 are allowable by virtue of their dependence from claim 38.
Claim 54-55, 57-59, 62, and 66 are allowable by virtue of their dependence from claim 52.
Response to Arguments
The Applicant’s arguments filed 2/19/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 2/19/2026, the previous claim objections have been withdrawn.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 2/19/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. have been withdrawn. However, there are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 2/19/2026.
Prior art rejections
In view of the claim amendments filed on 2/19/2026, the previous prior art rejections have been withdrawn.
Double patenting rejections
There are new grounds of double patenting rejections that were necessitated by the claim amendments filed on 2/19/2026.
Conclusion
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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