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 .
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.
Claim 6 and claims dependent thereon 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 pre-AIA the applicant regards as the invention.
Claim 6 recites the limitation "the dissolving process." There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-6, 8, and 11-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bullington et al (US 2019/0076074) (“Bullington”)
Regarding Claim 1, Bullington teaches a device (Abstract, Figs. 2-5, [0071]-[0094]) comprising:
an inlet port for receiving a blood sample (Figs. 2-5, [0072] inlet 231);
an outlet port (Figs. 2-5, [0072] outlet 236);
a chamber connected with the inlet port and the outlet port, and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable (Figs. 2-5, [0073] sequestration chamber 234, [0075] chamber includes material that is air permeable and blood impermeable);
a sample path connected with the inlet port and configured to convey a subsequent portion of the blood sample to the outlet port (Figs. 2-5. [0077] fluid flow path 233 to 254); and
a resistive plug configured to inhibit at least a part of the first portion of the blood sample from entering the sample path, and also having a structural feature configured to control a resistance of the resistive plug in allowing the subsequent portion of the blood sample into the sample path ([0078]-[0081] actuator 250 inhibits at least a first portion of the blood sample from entering the sample path with a structural feature that provides controlled resistance of the resistive plug / actuator 250 to enable subsequent portions of blood to flow to the outlet).
Regarding Claim 2, Bullington teaches the device of claim 1, wherein the resistive plug comprises a dissolvable material ([0081] the actuator blocking blood may have a dissolving characteristic) and the structural feature is a pilot hole through the resistive plug ([0058], [0066] flow controllers may have various structures, including an orifice and porous membranes, which both include openings that may be considered pilot holes) to allow blood to start the dissolving process (Examiner notes this limitation is intended use).
Regarding Claim 5, Bullington teaches the device of claim 1, wherein the resistive plug comprises a dissolvable material ([0081]) and the structural feature is a porous membrane that allows air but not blood to flow ([0058], [0066] flow controllers may have various structures, including a porous membrane) through the resistive plug.
Regarding Claim 6, Bullington teaches the device of claim 1, wherein the structural feature is an air path around the resistive plug ([0066] a structure for modulating pressure may be a porous membrane that exhibits an air path around the resistive plug) to allow blood to contact the resistive plug to start the dissolving process (Examiner notes this limitation is intended use).
Regarding Claim 8, Bullington teaches the device of claim 1, wherein walls of the chamber are coated with a hydrophilic coating to provide less resistance to fluid flow and facilitate filling of the chamber with the first portion of the blood sample ([0054]).
Regarding Claim 11, Bullington teaches the device of claim 1, and Bullington teaches a resistive feature is a elastomeric membrane and the structural feature comprises an aperture in the elastomeric membrane that is selectively opened ([0235]) and teaches that actuators may be dissolved ([0081]) thus teaching a resistive plug that is an elastomeric membrane and the structural feature comprises an aperture in the elastomeric membrane that is configured to increase in size to allow fluid flow to the outlet port as the actuator within the membrane dissolves.
Regarding Claim 12, Bullington teaches the device of claim 11, wherein the resistive plug is configured to be manually actuated to allow or prevent the fluid flow ([0081]).
Regarding Claim 13, Bullington teaches the device of claim 11, wherein the resistive plug is configured to be automatically actuated to allow or prevent the fluid flow ([0081]).
Regarding Claim 14, Bullington teaches the device of claim 13, wherein the resistive plug is configured to actuate based on a pressure exerted on the resistive plug ([0067], [0237]).
Regarding Claim 15, Bullington teaches the device of claim 11, wherein the structural feature further comprises a plug member shaped to cover the aperture and fall away once the aperture sufficiently increases in size ([0067], [0237]).
Regarding Claim 16, Bullington teaches a device (Abstract, Figs. 2-5, [0071]-[0094]) comprising:
an inlet port for receiving a blood sample (Figs. 2-5, [0072] inlet 231);
an outlet port (Figs. 2-5, [0072] outlet 236);
a chamber connected with the inlet port and the outlet port, and configured to collect a first portion of the blood sample, the chamber including a material that is air permeable and blood impermeable (Figs. 2-5, [0073] sequestration chamber 234, [0075] chamber includes material that is air permeable and blood impermeable);
a sample path connected with the inlet port and configured to convey a subsequent portion of the blood sample to the outlet port (Figs. 2-5. [0077] fluid flow path 233 to 254); and
wherein walls of the chamber and/or the sample path include one or more coatings that facilitate filing of the chamber with blood first ([0054] hydrophilic coating within the chamber).
Regarding Claim 17, Bullington teaches the device of claim 16, wherein the walls of the chamber are coated with a hydrophilic coating to provide less resistance to fluid flow and facilitate filling of the chamber with the first portion of the blood sample (See Claim 16 Rejection).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of Davis et al (US 2007/0031283) (“Davis”) as noted in Applicant IDS dated 4/22/2025.
Regarding Claim 3, while Bullington teaches the device of claim 1, wherein the resistive plug comprises a mechanically transformable material ([0081] the actuator blocking blood may have a transforming characteristic in response to a level of flow rate, flow velocity) and the structural feature is a pilot hole through the resistive plug ([0058], [0066] flow controllers may have various structures, including an orifice and porous membranes, which include openings that may be considered pilot holes) to allow blood to start the transforming process (Examiner notes this limitation as intended use), Bullington fails to teach wherein the mechanical transformation of the resistive plug is a tearing transformation based on the material being a tearable material.
However Davis teaches a fluid guiding architecture with valves (Abstract, Fig. 16, [0277]-[0278]) where a valve may be structured to open based on tearing ([0278]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to transform the material of Bullington by tearing as taught by Davis as a more specific way to identify how the transforming functionality in Bullington from fluid characteristics may be realized.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of Miller (US 2011/0118612).
Regarding Claim 4, while Bullington teaches the device of claim 1, and Bullington teaches wherein the structural feature is a transforming feature and allows blood flow into the sample path when a pressure is applied ([0081] transition may occur due to pressure differential and change in composition or configuration), Bullington fails to explicitly teach wherein the structural feature is a slit configured to open and allow blood flow into the sample path when a pressure is applied.
However Miller teaches a fluid guidance system using valves (Abstract, [0010]) where a valve function may be output by a slit configured to open and allow flow when a pressure is applied ([0010]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to transform the material of Bullington by a slit opened due to a pressure differential as taught by Miller as a more specific way to identify how the transforming functionality in Bullington from fluid characteristics may be realized.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of Phan et al (US 2005/0106713) (“Phan”).
Regarding Claim 7, while Bullington teaches the device of claim 1, wherein the resistive plug comprises a dissolvable material ([0081]), Bullington fails to teach the dissolvable material configured to be inert or non-reactive to one or more lab tests to be run on the blood sample.
However Phan teaches a fluid guidance system using valves (Abstract, [0010]) where a disintegrating plug can be a dissolvable plug or a melting plug of inert biocompatible material ([0105]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the dissolvable material of Bullington to be biologically inert as taught by Phan so that the dissolvable plug doesn’t contaminate a final blood sample received at the output.
Claim(s) 9-10 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of Krasnow et al (US 2016/0256095) (“Krasnow”).
Regarding Claim 9, while Bullington teaches the device of claim 1, their combined efforts fail to teach wherein walls of the sample path are coated with a hydrophobic coating to provide more resistance to fluid flow and facilitate filling of the chamber with blood first.
However Krasnow teaches a blood accessing system (Abstract) that teaches that hydrophilic coating and hydrophobic coatings can both be applied into blood accessing systems to guide blood as desired ([0047], [0055]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the sample path of Bullington be coated with a hydrophobic coating as Krasnow teaches that hydrophobic coatings can be applied as desired by a user to guide blood flow. And Bullington’s invention is directed to forwarding an initial sample away from the sample path and to a sequestration chamber so an initial repelling quality would be desirable for Bullington.
Regarding Claim 10, while Bullington teaches the device of claim 1, wherein walls of the chamber are coated with a hydrophilic coating ([0054]), Bullington fails to teach wherein walls of the sample path are coated with a hydrophobic coating.
However Krasnow teaches a blood accessing system (Abstract) that teaches that hydrophilic coating and hydrophobic coatings can both be applied into blood accessing systems to guide blood as desired ([0047], [0055]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the sample path of Bullington be coated with a hydrophobic coating as Krasnow teaches that hydrophobic coatings can be applied as desired by a user to guide blood flow. And Bullington’s invention is directed to forwarding an initial sample away from the sample path and to a sequestration chamber so an initial repelling quality would be desirable for Bullington.
Regarding Claim 18, while Bullington teaches the device of claim 16, their combined efforts fail to teach wherein walls of the sample path are coated with a hydrophobic coating to provide more resistance to fluid flow and facilitate filling of the chamber with blood first.
However Krasnow teaches a blood accessing system (Abstract) that teaches that hydrophilic coating and hydrophobic coatings can both be applied into blood accessing systems to guide blood as desired ([0047], [0055]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the sample path of Bullington be coated with a hydrophobic coating as Krasnow teaches that hydrophobic coatings can be applied as desired by a user to guide blood flow. And Bullington’s invention is directed to forwarding an initial sample away from the sample path and to a sequestration chamber so an initial repelling quality would be desirable for Bullington.
Regarding Claim 19, while Bullington teaches the device of claim 16, wherein walls of the chamber are coated with a hydrophilic coating ([0054]), Bullington fails to teach wherein walls of the sample path are coated with a hydrophobic coating.
However Krasnow teaches a blood accessing system (Abstract) that teaches that hydrophilic coating and hydrophobic coatings can both be applied into blood accessing systems to guide blood as desired ([0047], [0055]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the sample path of Bullington be coated with a hydrophobic coating as Krasnow teaches that hydrophobic coatings can be applied as desired by a user to guide blood flow. And Bullington’s invention is directed to forwarding an initial sample away from the sample path and to a sequestration chamber so an initial repelling quality would be desirable for Bullington.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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JAIRO H. PORTILLO
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
