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.
Claims 1-19, 21 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 1 recites the limitation "a plunger having a proximal end and a distal end and …the proximal end of the plunger occludably received through the proximal end of the housing" in line 3-5. The directional terms are not consistent between the housing and the plunger see ¶0058 of the specification and Fig. 1. The end which located further from the caregiver “device holder” is a distal end and the one which is closest to the caregiver is a proximal end. For the housing:114 is a distal end and 112 is a proximal end. However, for the plunger 122 is a proximal end and 124 is distal end (should be switched so that end 122 is a distal and 124 is a proximal end). Note: the applicant needs to amended specification and the clams to be consistent with directional terms and/or the applicant may uses a structurally element such as "a plunger having an with a stopper and another with a flange portion and …the stopper of the plunger occludably received through the proximal end of the housing".
Claim Rejections - 35 USC § 102
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) 1-3, 7-8, 11-15 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Zinnanti (US. 20140114210A1).
Re claim 1, Zinnanti discloses an aspiration syringe device (Fig. 1-7, abstract), comprising: an elongated housing (122) having an open proximal end ( top end close to124) and an open distal end (lower end close to 110); a plunger (125) having a proximal end (close to 127) and a distal end (close to 125) and configured for axial sliding within the housing, the proximal end of the plunger occludably received through the proximal end of the housing (Fig. 1 and Fig. 2); a compression spring (123) disposed about a portion of the plunger external to the housing (Fig. 1), the compression spring configured to urge the distal end of the plunger away from the proximal end of the housing (Fig. 1 to Fig. 2, ¶0028); and a retention mechanism (126) configured to fixedly engage with the plunger so as to retain the plunger in position relative to the housing with the compression spring in an at least partially compressed state (Fig. 1).
Re claim 2, Zinnanti discloses wherein removal of the retention mechanism from fixed engagement with the plunger (Fig, 2) causes the compression spring to transition to an uncompressed state and urge the distal end of the plunger away from the proximal end of the housing (Fig. 2, ¶0028).
Re claim 3, Zinnanti discloses wherein the retention mechanism is configured to fixedly engage with the plunger adjacent the distal end of the plunger (Fig. 1, close to 125).
Re claim 7, Zinnanti discloses wherein the compression spring is disposed in circumferential relationship about the portion of the plunger external to the housing and extends from the distal end of the plunger toward the proximal end of the plunger (Figs. 1-2).
Re claim 8, Zinnanti discloses wherein the compression spring has a first end (lower end) and a second end (upper end), the first end of the compression spring abutting a lateral extension (124) at the proximal end of the housing (Fig. 1) and the second end of the compression spring abutting a flange portion at the distal end of the plunger (125, Fig. 1).
Re claim 11, Zinnanti discloses wherein the plunger includes a compressible stopper (seal 127, the seal can be compressible ) at the proximal end thereof, the stopper configured to provide a wiping action along an inner wall of the housing and to prevent the plunger from being completely removed from the housing (¶0025).
Re claim 12, Zinnanti discloses wherein the housing has a volume of at least 100 mL ( the syringe can be selected with sufficient size ¶0027).
Re claim 13, Zinnanti discloses wherein the housing has a volume of at least 300 mL ( the syringe can be selected with sufficient size ¶0027).
Re claim 14, Zinnanti discloses wherein the compression spring has a preselected tension configured to provide a desired suction pressure for the aspiration syringe device (¶0025, ¶0027).
Re claim 15, Zinnanti discloses wherein the compression spring has a preselected tension (spring has specific tension ) configured to provide a suction pressure for the aspiration syringe device of from about -10 cmH2O to about -40 cmH2O ( the spring is capable to create suction ¶0020) .
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.
Claim(s) 4-6, 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinnanti in view of Oosterhof (US.5957864).
Re claim 4, Zinnanti fails to disclose wherein the retention mechanism passes through an opening defined in the housing.
However, Oosterhof discloses an aspiration syringe (Fig, 1-2) and a syringe housing (2, 3) and a plunger (18, 6, 8) and wherein the retention mechanism (10) passes through an opening defined in the housing (opening around 10, Col. 3, lines 53-60).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the housing of Zinnanti to include an opening so that the retention mechanism passes through an opening defined in the housing as taught by Oosterhof for the purpose of locking the plunger with the housing as preferable retention mean (Oosterhof , Col..3, lines 14-22).
Re claim 5, Zinnanti fails to disclose wherein the opening is defined in a side wall of the housing and adjacent the proximal end of the housing.
However, Oosterhof discloses an aspiration syringe (Fig, 1-2) and a syringe housing (2, 3) and a plunger (18, 6, 8) and wherein the retention mechanism (10) passes through an opening defined in a side wall of the housing and adjacent the proximal end of the housing (opening around 10 close to top end of 2, Col. 3, lines 53-60).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the housing of Zinnanti to include an opening so that the opening is defined in a side wall of the housing and adjacent the proximal end of the housing as taught by Oosterhof for the purpose of locking the plunger with the housing as preferable retention mean (Oosterhof, Co. 3, lines 14-22).
Re claim 6, Zinnanti fails to disclose wherein the retention mechanism is a pin having a head and a shaft extending outwardly therefrom, the shaft configured to be received through the opening defined in the housing and to engage with the plunger.
However, Oosterhof discloses an aspiration syringe (Fig, 1-2) and a syringe housing (2, 3) and a plunger (18, 6, 8) and the retention mechanism (10) is a pin (10) having a head (top of 10) and a shaft (Fig. 1) extending outwardly therefrom, the shaft configured to be received through the opening defined in the housing and to engage with the plunger (opening around 10 close to top end of 2, Col. 3, lines 53-60).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the housing of Zinnanti to include an opening so that the retention mechanism is a pin having a head and a shaft extending outwardly therefrom, the shaft configured to be received through the opening defined in the housing and to engage with the plunger as taught by Oosterhof for the purpose of locking the plunger with the housing as preferable retention mean (Oosterhof , Col. 3, lines 14-22).
Re claim 9, Zinnanti fails to disclose wherein the distal end of the housing includes a luer connector.
However, Oosterhof discloses an aspiration syringe (Fig, 1-2) and a syringe housing (2, 3) and a plunger (18, 6, 8) and the distal end of the housing includes a luer connector (needle hub or the distal end of the housing that connected to the luer lock, Col. 4, lines 22-27).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the housing of Zinnanti so that the distal end of the housing includes a luer connector as taught by Oosterhof for the purpose of locking the needle to the syringe (Oosterhof , Col. 4, lines 22-27).
Re claim 10, Zinnanti fails to disclose wherein the plunger includes a retention tab projecting radially outward therefrom, the retention tab configured to engage with the retention mechanism so as to retain the plunger in position relative to the housing with the compression spring in the at least partially compressed state.
However, Oosterhof discloses an aspiration syringe (Fig, 1-2) and a syringe housing (2, 3) and a plunger (18, 6, 8) and the retention mechanism (10) is a pin (10) and the plunger includes a retention tab (18) projecting radially outward therefrom (Fig. 1-2), the retention tab configured to engage with the retention mechanism (as 9 is connected with 10, Fig. 2) so as to retain the plunger in position relative to the housing with the compression spring in the at least partially compressed state (Fig. 2 Col. 3, lines 53-60).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the housing of Zinnanti to include retention tab so that the plunger includes a retention tab projecting radially outward therefrom, the retention tab configured to engage with the retention mechanism so as to retain the plunger in position relative to the housing with the compression spring in the at least partially compressed state as taught by Oosterhof for the purpose of locking the plunger with the housing as preferable retention mean (Oosterhof , Col. 3, lines 14-22).
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinnanti in view of Schreuder et al. (“Optimizing Exchange Transfusion for Severe Unconjugated Hyperbilirubinemia: Studies in the Gunn Rat”, 2013) (“Schreuder”).
Re claim 16, Zinnanti discloses a method of determining a required amount of replacement blood for a mammalian patient using the aspiration syringe device of claim 1 (see the rejection of claim 1), the method comprising: removing the retention mechanism from fixed engagement with the plunger (Fig. 1 to Fig. 2, ¶0025), thereby causing the compression spring to transition to an uncompressed state (Fig. 1) and urge the distal end of the plunger away from the proximal end of the housing (Fig. 2); continuously removing blood contained within the mammalian patient (blood is tissue sample 140, ¶0026) as the compression spring transitions to the uncompressed state (Fig. 2), but it fails to discloses determining an amount of blood removed from the mammalian patient by referencing an amount of blood contained within the housing after the compression spring has transitioned to the uncompressed state ; and calculating a required amount of replacement blood as corresponding to the amount of removed blood contained within the housing.
However, Schreuder discloses an aspiration syringe (pg. 2, see method section under the exchange transfusion) and the method discloses determining an amount of blood removed from the mammalian patient by referencing an amount of blood contained within the housing after the compression spring has transitioned to the uncompressed state (pg. 2, see method section under the exchange transfusion); and calculating a required amount of replacement blood as corresponding to the amount of removed blood contained within the housing (pg. 2, see method section under the exchange transfusion).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Zinnanti to include step of determining an amount of blood removed from the mammalian patient by referencing an amount of blood contained within the housing after the compression spring has transitioned to the uncompressed state ; and calculating a required amount of replacement blood as corresponding to the amount of removed blood contained within the housing as taught by Schreuder for the purpose of optimizing treatment by analyzing the blood (Schreuder, abstract, and introduction see pg. 2, left col).
Re claim 17, Zinnanti discloses that the blood removed from the mammalian patient, but it fails to disclose further comprising: replacing the blood removed from the mammalian patient with the calculated required amount of replacement blood.
However, Schreuder discloses an aspiration syringe (pg. 2, see method section under the exchange transfusion) and the method discloses replacing the blood removed from the mammalian patient with the calculated required amount of replacement blood (pg. 2, see method section under the exchange transfusion).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Zinnanti to include step of replacing the blood removed from the mammalian patient with the calculated required amount of replacement blood as taught by Schreuder for the purpose of optimizing treatment by analyzing the blood (Schreuder, abstract, and introduction see pg. 2, left col).
Re claim 18, Zinnanti discloses a method of measuring a volume of fluid loss during aspiration using the aspiration syringe device of claim 1 (see the rejection of claim 1), the method comprising: removing the retention mechanism from fixed engagement with the plunger (Fig. 1 to Fig. 2, ¶0025), thereby causing the compression spring to transition to an uncompressed state (Fig. 2) and urge the distal end of the plunger away from the proximal end of the housing (blood is tissue sample 140, ¶0026, Fig. 1, Fig. 2); continuously removing fluid contained within the mammalian patient as the compression spring transitions to the uncompressed state (blood is tissue sample 140, ¶0026), but it fails to discloses determining an amount of fluid removed from the mammalian patient by referencing an amount of removed fluid contained within the housing after the compression spring has transitioned to the uncompressed state; and calculating a required amount of replacement fluid as corresponding to the amount of removed fluid contained within the housing.
However, Schreuder discloses an aspiration syringe (pg. 2, see method section under the exchange transfusion) and the method discloses determining an amount of blood removed from the mammalian patient by referencing an amount of blood contained within the housing after the compression spring has transitioned to the uncompressed state (pg. 2, see method section under the exchange transfusion); and calculating a required amount of replacement fluid as corresponding to the amount of removed fluid contained within the housing (pg. 2, see method section under the exchange transfusion).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Zinnanti to include step of determining an amount of fluid removed from the mammalian patient by referencing an amount of removed fluid contained within the housing after the compression spring has transitioned to the uncompressed state; and calculating a required amount of replacement fluid as corresponding to the amount of removed fluid contained within the housing as taught by Schreuder for the purpose of optimizing treatment by analyzing the blood (Schreuder, abstract, and introduction see pg. 2, left col).
Re claim 19, Zinnanti discloses that the blood removed from the mammalian patient, but it fails to disclose, but it fails to disclose replacing the fluid removed from the mammalian patient with the calculated required amount of replacement fluid.
However, Schreuder discloses an aspiration syringe (pg. 2, see method section under the exchange transfusion) and the method discloses replacing the blood removed from the mammalian patient with the calculated required amount of replacement blood (pg. 2, see method section under the exchange transfusion).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Zinnanti to include step of replacing the fluid removed from the mammalian patient with the calculated required amount of replacement fluid as taught by Schreuder for the purpose of optimizing treatment by analyzing the blood (Schreuder, abstract, and introduction see pg. 2, left col).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nentwick in view of (US 20110245665 A1)
Re claim 21, Zinnanti discloses the aspiration syringe device of claim 1, but it fails to disclose a rapid deployment chest port, comprising: a frame comprising a lumen and a plunger port; a removable plunger defining a bodily fluid inlet at the distal end, wherein the removable plunger is within the lumen of the frame; a stabilizing component configured to stabilize the frame inside and outside a chest cavity of a patient; and the aspiration syringe device fluidly connected to the plunger port.
However, Nentwick discloses a rapid deployment chest port (Fig. 1-16), comprising: a frame (3, Fig. 11-13,¶0060) comprising a lumen (lumen of 3) and a plunger port (17 or 63 , Fig. 13); a removable plunger defining a bodily fluid inlet at the distal end (19 capable to be removed from 17), wherein the removable plunger is within the lumen of the frame; a stabilizing component (6) configured to stabilize the frame inside and outside a chest cavity of a patient (¶0060. Fig. 12-13); that a aspiration syringe fluidly connected to the plunger port (the syringe is capable to be connected to 17, ¶0090).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Zinnanti a rapid deployment chest port, comprising: a frame comprising a lumen and a plunger port; a removable plunger defining a bodily fluid inlet at the distal end, wherein the removable plunger is within the lumen of the frame; a stabilizing component configured to stabilize the frame inside and outside a chest cavity of a patient; and the aspiration syringe device fluidly connected to the plunger port as taught by Nentwick for the purpose of accessing the lung for treating desired target location within the lung (Nentwick,, abstract, ¶0090).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783