DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/26/26 has been entered.
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 38, 40, and 42 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.
Claims 38 and 40 recite “wherein the subsequent amount of the blood is different blood from the amount of the blood” in lines 1-2. It is not clear what is meant by “the subsequent amount of blood is different blood”. Clarification requested. Suggested correction: “wherein the subsequent amount of the blood is different from the amount of the blood”.
Claim 42 recites “wherein the sample of blood is different blood from the first portion of the blood” in lines 1-2. However, according to claim 22, the first portion of the blood and the sample of the blood are both taken from the same received blood. Because the sample cannot simultaneously originate from the same received blood and be a different body of blood, the claim scope is internally inconsistent, confusing, and fails to particularly point out the invention.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-2, 4-9, 11-14, 16-17, 19, 21-23, 25, 27, 29, and 31-42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Desch (US 6050957) (cited by Applicant) in view of Ziv (US 6269704).
Regarding claim 1, Desch teaches a multiple-draw, variable suction syringe device, (Fig. 1) comprising: a housing (10) that defines an inlet port (22) for receiving blood (30); a chamber (20) connected with the inlet port, the chamber configured to collect a first portion of the blood responsive to a suction source (Col. 4, lines 7-9, plunger 42, piston 14); and a flow controller (Col. 4, lines 20-22 check valve 54) configured to prevent blood flow into the sampling channel (conduit 50) until the first portion of the blood is in the chamber. (Col. 2, lines 33-35).
However, Desch does not teach “a sampling channel connected with the inlet port and configured to convey, while the first portion of blood is contained in the chamber, a subsequent portion of the blood from the inlet port responsive to the suction source”.
Ziv teaches (Figs. 2A-2B) a blood sampling device (10) comprising a sampling channel (outlet 20) connected with the inlet port (sampling port 26) and configured to convey, while the first portion of blood is contained in the chamber (90), a subsequent portion of the blood (90’) from the inlet port (26) responsive to the suction source (Col. 4, lines 26-34 When it is desired to take a blood sample from the individual, said drawing member 30 is rotated in a counter-clockwise direction represented by arrow 98 in Fig. 2B by means of the displacing element 56 (not shown) whereby the confined volume 90 of FIG. 2A now moves to a new location indicated by 90' in Fig. 2B. Gradually, as the drawing member 30 is rotatably displaced in the position seen in Fig. 2B a vacuum is generated and liquid contained within tube portions 20 is drawn into confined volume 90'.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “a sampling channel connected with the inlet port and configured to convey, while the first portion of blood is contained in the chamber, a subsequent portion of the blood from the inlet port responsive to the suction source”, as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claim 2, Desch illustrates (Fig. 1) wherein the housing (10) defines at least a portion of the chamber (20) and at least a portion of the sampling channel (50).
Regarding claim 4, Desch teaches wherein the suction source (plunger 42, piston 14) is a dual seal suction source. (Col. 2, lines 17-19, piston and plunger are sealably engaging and slidable along an interior wall of the cylindrical body).
Regarding claim 5, Desch teaches wherein the chamber (20) is configured to collect the first portion of the blood (30) when the suction source applies a suction in the chamber (Col. 4, lines 7-9, plunger 42, piston 18), and the sampling channel (50) is configured to convey the subsequent portion of the blood when the suction source applies the suction in the sampling channel. (Col. 4, lines 14-19).
Regarding claim 6, Desch teaches wherein the flow controller (54) is configured, in a first position, to initially close off the sampling channel, (Fig. 2, check valve 54 in a closed position) and is further configured, in a second position, to facilitate a flow of the subsequent portion of the blood (30) through the sampling channel. (Fig. 3, check valve 54 in an open position).
Regarding claim 7, Desch teaches wherein the chamber (20) is configured to collect and sequester the first portion of the blood (30), the sampling channel (50) is configured to convey the subsequent portion of the blood past the chamber and the first portion of the blood sequestered therein. (See Figs. 2-3).
Regarding claim 8, Desch teaches a device, (Fig. 1) comprising: a housing (10) that defines an inlet port (22) for receiving blood (30); a chamber (20) connected with the inlet port and configured to collect an amount of blood when suction is applied via a suction source in the chamber (Col. 4, lines 7-9, plunger 42, piston 14); and a flow controller (Col. 4, lines 20-22 check valve 54), configured, in a first position, (Fig. 2) to prevent blood flow from flowing into the sampling channel (conduit 50), and further configured, in a second position, (Fig. 3), such that the subsequent amount of the blood flows past the chamber and through the sampling channel. (Col. 2, lines 33-35).
However, Desch does not teach “a sampling channel connected with the inlet port and configured to convey a subsequent amount of the blood from the inlet port when suction is applied, via the suction source and while the amount of blood is contained in the chamber, in the sampling channel.”
Ziv teaches (Figs. 2A-2B) a blood sampling device (10) comprising a sampling channel (outlet 20) connected with the inlet port (sampling port 26) and configured to convey, a subsequent amount of the blood (90’) from the inlet port when suction is applied, via the suction source and while the amount of blood is contained in the chamber (90). (Col. 4, lines 26-34).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “a sampling channel connected with the inlet port and configured to convey a subsequent amount of the blood from the inlet port when suction is applied, via the suction source and while the amount of blood is contained in the chamber, in the sampling channel”, as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claim 9, Desch illustrates (Fig. 1) wherein the housing (10) defines at least a portion of the chamber (20) and at least a portion of the sampling channel (50).
Regarding claim 11, Desch teaches wherein the suction source (plunger 42, piston 14) is a dual seal suction source. (Col. 2, lines 17-19, piston and plunger are sealably engaging and slidable along an interior wall of the cylindrical body).
Regarding claim 12, Desch teaches wherein a flow path (fluid flow through fluid outlet 24) is defined between the inlet port (22) and the chamber (20) when the flow controller (54) is in the first position. (Fig. 2).
Regarding claim 13, Desch teaches wherein the flow controller (54) is configured to occlude at least a portion of the sampling channel (50) before the amount of the blood is collected in the chamber. (See Fig. 2).
Regarding claim 14, Desch teaches (Fig. 3), wherein the flow controller (54) is configured to be moved after the amount of the blood is in the chamber. (Figs. 2-3, Col. 4, lines 40-47 check valve 54 comprises a ball 80 that is shiftable from a position in engagement with the conduit conical sidewall 76 whereby to close the conduit inlet, and a position supported by the stems 78 in spaced relationship from the conduit outlet 74 whereby to permit flow of fluid through the conduit chamber 70, out of the conduit outlet and into the enclosed fluid collection receptacle 52.)
Regarding claim 16, Desch teaches a device, (Fig. 1) comprising: a housing (10) that defines an inlet port (22) for receiving blood (30); a chamber (20) connected with the inlet port and configured to collect an amount of blood when suction source applies suction within the housing (Col. 4, lines 7-9, plunger 42, piston 14); and a flow controller (Col. 4, lines 20-22 check valve 54), configured, in a first position, (Fig. 2) to prevent blood flow from flowing into the sampling channel (50), and further configured, in a second position, (Fig. 3), such that the subsequent amount of the blood flows past the chamber (20) and through the sampling channel (50).
However, Desch does not teach “a sampling channel connected with the inlet port and configured to convey, while the first portion of blood is contained in the chamber, a subsequent amount of the blood from the inlet port under continued suction within the housing”.
Ziv teaches (Figs. 2A-2B) a blood sampling device (10) comprising a sampling channel (outlet 20) connected with the inlet port (26) and configured to convey, while the first portion of blood is contained in the chamber (90), a subsequent amount of the blood (90’) from the inlet port under continued suction within the housing. (Col. 4, lines 26-34).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “a sampling channel connected with the inlet port and configured to convey, while the first portion of blood is contained in the chamber, a subsequent amount of the blood from the inlet port under continued suction within the housing”, as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claim 17, Desch illustrates (Fig. 1) wherein the housing (10) defines at least a portion of the chamber (20) and at least a portion of the sampling channel (50).
Regarding claim 19, Desch teaches wherein the flow controller (54) is configured, in a first position, to initially close off the sampling channel, (Fig. 2, check valve 54 in a closed position) and is further configured, in a second position, to facilitate a flow of the subsequent portion of the blood (30) through the sampling channel. (Fig. 3, check valve 54 in an open position).
Regarding claim 21, Desch teaches wherein the chamber (20) is configured to collect and sequester the amount of the blood (30), the sampling channel (50) is configured to convey the subsequent portion of the blood past the chamber and the first portion of the blood sequestered therein. (See Figs. 2-3).
Regarding claim 22, Desch teaches a device, (Fig. 1) comprising: a housing (10) that defines an inlet port (22) for receiving blood (30); a chamber (20) connected with the inlet port; a sampling channel (conduit 50) connected with the inlet port; and a flow controller (Col. 4, lines 20-22 check valve 54), configured, in a first position, (Fig. 2), to close off the sampling channel (50) such that a suction source (Col. 4, lines 7-9, plunger 42, piston 14) draws a first portion of the blood into the chamber (20), the flow controller further configured, in a second position, (Fig. 3), to open the sampling channel such that a sample of the blood is drawn, via the suction source, from the inlet port (22) through the sampling channel (50).
However, Desch does not specifically teach the flow controller further configured, in a second position, to open the sampling channel such that a sample of the blood is drawn, via the suction source and “while the first portion of the blood is contained in the chamber”, from the inlet port through the sampling channel.
Ziv teaches (Figs. 2A-2B) a blood sampling device (10) comprising a sampling channel (outlet 20) connected with the inlet port (26) and configured to convey a subsequent amount of the blood (90’) from the inlet port when suction is applied, via the suction source while the first portion of the blood is contained in the chamber (90). (Col. 4, lines 26-34).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach the flow controller further configured, in a second position, to open the sampling channel such that a sample of the blood is drawn, via the suction source and “while the first portion of the blood is contained in the chamber”, as taught by Ziv, from the inlet port through the sampling channel. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claim 23, Desch illustrates (Fig. 1) wherein the housing (10) defines at least a portion of the chamber (20) and at least a portion of the sampling channel (50).
Regarding claim 25, Desch teaches wherein the flow controller (54) is configured to be moved to the second position (Fig. 3) after the first portion of the blood is in the chamber (Fig. 2).
Regarding claim 27, Desch teaches wherein the flow controller (54) is configured, in the second position, (Fig. 3), such that the sample of the blood flows past the chamber (20) and through the sampling channel (50).
Regarding claim 29, Desch contemplates a sealing member positioned in the housing and configured to facilitate the chamber collecting the first portion of the blood. (Col. 2, lines 17-19, piston and plunger are sealably engaging and slidable along an interior wall of the cylindrical body).
Regarding claims 31-34, Ziv teaches (Figs. 2A-2B) wherein the sampling channel (20) conveys the sample of the blood to a sample volume (confined volume 90’) separate from the chamber (confined volume 90). (Col. 4, lines 26-34).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the sampling channel conveys the sample of the blood to a sample volume separate from the chamber” as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claim 35, Desch does not teach “wherein the subsequent portion of the blood is different blood from the first portion of the blood”.
Ziv teaches wherein the subsequent portion of the blood (90’) is different blood from the first portion of the blood (90). (Col. 4, lines 26-34).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the subsequent portion of the blood is different blood from the first portion of the blood” as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claim 36, Desch does not teach “wherein the first portion of the blood is contained in the chamber separate from the sampling channel”.
Ziv teaches wherein the first portion of the blood (90) is contained in the chamber separate from the sampling channel (20). (See Figs. 2A-2B).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the first portion of the blood is contained in the chamber separate from the sampling channel” as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claims 37, 39, and 41, Desch does not teach “wherein the chamber is configured to collect and sequester the amount of the blood, the sampling channel is configured to convey the subsequent amount of the blood past the chamber and the amount of the blood sequestered therein”.
Ziv teaches wherein the chamber is configured to collect and sequester the amount of the blood (90), the sampling channel (20) is configured to convey the subsequent amount of the blood (90’) past the chamber (confined volume 90) and the amount of the blood sequestered therein.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the chamber is configured to collect and sequester the amount of the blood, the sampling channel is configured to convey the subsequent amount of the blood past the chamber and the amount of the blood sequestered therein” as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claims 38 and 40, Desch does not teach “wherein the subsequent amount of the blood is different blood from the amount of the blood”.
Ziv teaches wherein the subsequent amount of the blood (90’) is different blood from the amount of the blood (90). (Col. 4, lines 26-34).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the subsequent amount of the blood is different blood from the amount of the blood” as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Regarding claim 42, Desch does not teach “wherein the sample of blood is different blood from the first portion of the blood”.
Ziv teaches wherein the sample of blood (90’) is different blood from the first portion of the blood (90). (Col. 4, lines 26-34).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the sample of blood is different blood from the first portion of the blood” as taught by Ziv. Doing so provides sampling of subsequent fresh blood portion while a previous portion of collected blood is isolated to yield predictable fluid containment without risk of cross-contamination.
Claims 15, 20, 26, 28, and 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Desch in view Ziv, further in view of Phillips (US 20040124389) (previously cited).
Regarding claims 15, 20, 26, and 28, Desch does not teach “wherein the flow controller is a movable elastomeric seal configured to form a fluid tight seal with an inner surface of the housing.”
Phillips, in a related field of endeavor, teaches a blood collection device (Figs. 4-5) wherein the flow controller (valve plug 70) is a movable elastomeric seal configured to form a fluid tight seal with an inner surface of the housing (42). (Paragraph [0055] As such, the distal head 75 of the valve plug 70 is configured to seat against the shoulder so as to achieve a surface-to-surface seal when the valve plug is forced into contact with the shoulder by a biasing device such as elastomeric device 90; Paragraph [0057] elastomeric device 90 biases the valve plug distally so as to maintain a bias tending to maintain a seal between the valve plug head 75 and the flow passage distal shoulder 49).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the flow controller is a movable elastomeric seal configured to form a fluid tight seal with an inner surface of the housing”. Doing so minimizes risk of fluid escape. (Paragraph [0059]).
Regarding claim 30, Desch does not teach “wherein the sealing member is configured to transition from a first configuration to a second configuration as the first portion of blood is collected in the chamber.”
Phillips illustrates wherein the sealing member is configured to transition from a first configuration (Fig. 4) to a second configuration (Fig. 5) as the first portion of blood is collected in the chamber.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Desch to teach “wherein the sealing member is configured to transition from a first configuration to a second configuration as the first portion of blood is collected in the chamber” as taught by Phillips. Doing so enables the ability to selectively seal the flow passage. (Paragraph [0065]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 11/7/2025, with respect to the rejection of claims
1-2, 4-9, 11-17, 19-23 and 25-34 under 35 U.S.C. 103 have been fully considered. However, upon further consideration, a new ground of rejection was necessitated by the claim amendments made in view of Ziv.
Conclusion
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
Prosecution Insights