DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1-14 in the reply filed on 1 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 3-5, 12 and 13 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 3 recites “…the support member causing the…chamber assembly to be spaced from the transfer tray at a first height”. If the support member is part of the transfer tray, it is unclear how the support member could be spaced from the transfer tray. Perhaps the claim should recite a particular part of the transfer tray from which the chamber assembly is spaced from.
Claim 12 recites that the first and second pressure sensors, which are part of the transfer tray, as recited in claim 11, are toward and away from the transfer tray. If the first and second pressure sensors are part of the transfer tray, it is unclear how the first and second pressure sensors could be moved toward and away from the transfer tray. Perhaps the claim should recite a particular part of the transfer tray from which the first and second pressure sensors are movable.
Claim 13 at line 2 recites the limitation "the vertical axis". There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites that the first and second pressure sensors, which are part of the transfer tray, as recited in claim 11, are configured to be disposed in a first plane spaced from the transfer tray. If the first and second pressure sensors are part of the transfer tray, it is unclear how the first and second pressure sensors could be disposed in a first plane spaced from the transfer tray. Perhaps the claim should recite a particular part of the transfer tray from which the first and second pressure sensors are spaced from.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites a priming cart and an incubator, which do not limit the transfer tray, which claim 1 is directed to. Therefore, claim 2 does not further limit the subject matter of claim 1, from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-10 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fassihi et al. (U.S. Pub. No. 2017/0128322). Regarding claim 1, Fassihi et al. (hereinafter Fassihi) teaches a transfer tray for receiving a neonate thereon, the transfer tray (“bath incubator”/ “bath portion”) (Figs. 1 and 11B) comprising:
a body 12 having a first portion (see reproduction below of Fig. 4) configured to receive a neonatal chamber assembly thereon [0095]), the neonatal chamber assembly configured to receive the neonate therein (the neonatal chamber not being required by the claim),
and a second portion (“cover”/“liner”) (see reproduction below and Fig. 1 and [0095]) configured to receive a blood circuit thereon (Fig. 1, [0111] and [0125]-[0127]), the blood circuit comprising an oxygenator, a first conduit for transfer of blood from the neonate to the oxygenator, and a second conduit for transfer of blood from the oxygenator to the neonate, the first conduit having an arterial end portion configured to be placed in liquid communication with an artery of an umbilical cord of the neonate, and the second conduit having a venous end portion configured to be placed in liquid communication with a vein of the umbilical cord (it is noted that the blood circuit is not required by the claim; however Fassihi discloses conduits/circuits for transfer of oxygen, medicine, nutrients and blood to/from the neonate through the umbilical cord [0126]-[0127]); and
a movable support assembly (“bridges/mounts”) affixed to the body of the tray and configured to receive the blood circuit thereon (Fig. 1 and [0125]-[0129]),
wherein, when the neonate is disposed on the first portion and is in liquid communication with the blood circuit, the transfer tray is movable from a first position, in which the transfer tray is disposed on a first surface, to a second position, in which the transfer tray is disposed on a second surface different from the first surface (the transfer tray (“bath incubator”/ “bath portion”) is removable from the rest of the cart as shown in Figs. 10 and 11 and [0130]).
[AltContent: textbox ([img-media_image1.png])]
[AltContent: arrow][AltContent: textbox (“second portion”
“first portion”)]
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Regarding claim 2, the transfer tray (“bath incubator”/ “bath portion”) is configured to move between a first surface of a priming cart, and a second surface of an incubator (“bath incubator”/ “bath portion” is removable from the rest of the cart and configured to move between surfaces as shown in Figs. 10 and 11 and [0130]).
Regarding claims 3 and 4, the transfer tray further comprises a support member with attachment 3E (as shown in 11B) configured to receive the neonatal chamber assembly thereon, the support member causing the neonatal chamber assembly to be spaced from the transfer tray at a first height, wherein the support member is adjustable between having a first height and a second height different from the first height, the first and second heights being measured between the transfer tray and the neonatal chamber assembly (Fassihi discloses the use of multiple bridges/mounts attached to motors/actuators for increasing/decreasing the height(s) of the bridge(s)/mounts(s) [0125]-[0129], therefore a neonatal chamber lying thereon could be spaced from the tray at different heights).
Regarding claim 5, the transfer tray comprises a plurality of support members ([0127]: “the amniotic bath incubator system comprises three or more bridges or mounts”).
Regarding claim 6, the body defines a receptacle defined thereon configured to receive and retain a first volume of liquid 13C/94 (Figs. 1-2 and [0088]-[0090]).
Regarding claim 7, the support assembly comprises a support body attached thereto, the support body configured to receive at least one sensor out of the group of oxygen sensor, flow meter, temperature sensor, pressure sensor, and bubble sensor ([0112] and [0113]: the one or bridges comprise an anchoring mechanism configured to anchor a first end of one or more of a feeding tube, an oxygen tube, cardiac lead wiring, pulse oximeter wiring..”).
Regarding claim 8, the support body is movable relative to the support assembly (via swiveling [0013]).
Regarding claim 9, the support assembly comprises an oxygenator retainer (“anchoring mechanism”) configured to releasably receive the oxygenator thereon ([0013], [0200]).
Regarding claim 10, the oxygenator retainer is movable relative to the support assembly (via swiveling [0013]).
Regarding claim 14, the transfer tray further comprises a retention member 44 on the body of the transfer tray, the retention member configured to perform at least one of: aligning the transfer tray with at least one of the first surface and the second surface; and precluding slidable movement of the transfer tray relative to at least one of the first surface and the second surface (Figs. 3-4 and [0092]-[0093]; raised rim 44 aligns the tray with at least one of the first surface and the second surface).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-13 rejected under 35 U.S.C. 103 as being unpatentable over Fassihi et al. (U.S. Pub. No. 2017/0128322) in view of Falk et al. (U.S. Pub. No. 2017/0347917). Regarding claim 11, Fassihi teaches first and second conduits disposed on the support assembly (Fig. 1 and [0126]), however Fassihi fails to disclose that the first and second conduits comprise first and second pressure sensors, respectively, the first pressure sensor being configured to measure pressure within the first conduit and the second pressure sensor being configured to measure pressure within the second conduit (expired gases). Falk et al. (hereinafter Falk) teaches a newborn respiration monitoring system incorporated into a mobile, newborn transport system (Fig. 1, [0018] and Abstract), as likewise disclosed by Fassihi, wherein the conduits are part of a breathing circuit (conduit for inspired gases; conduit for expired gases), and one or more sensors, such as a CO2 sensor, flow sensor and pressure sensors ([0018] and [0023]) are incorporated into the breathing circuit to measure values within the breathing circuit ([0018] and [0023]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a pressure sensor into conduits of a breathing circuit as taught by Falk, into a support assembly supporting conduits which transport fluids such as oxygen, medicine and nutrients back and forth to an infant as suggested by Fassihi, as Fassihi recognizes the transport of oxygen to/from a newborn ([0126]-[0127]) and maintaining the flow of adequate oxygenation with monitoring via a pulse oximeter ([0012], [0167], [0200]), and Falk teaches the incorporation of a pressure sensor into the oxygen expiration/inspiration conduits provides measurements as to such oxygen levels in the patient ([0018] and [0023]).
Regarding claim 12, and in view of its indefinite nature, Fassihi teaches that sensors, and conduits, anchored to the bridge of the support assembly [0200], are movable along a vertical axis relative to the body of the bath incubator due to height adjustment of the bridge [0126], however Fassihi fails to disclose explicitly that first and second pressure sensors are movable therewith. Falk teaches a newborn respiration monitoring system incorporated into a mobile, newborn transport system (Fig. 1, [0018] and Abstract), as likewise disclosed by Fassihi, wherein the conduits are part of a breathing circuit (conduit for inspired gases; conduit for expired gases), and one or more sensors, such as a CO2 sensor, flow sensor and pressure sensors ([0018] and [0023]) are incorporated into the breathing circuit to measure values within the breathing circuit ([0018] and [0023]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a pressure sensor into conduits of a breathing circuit as taught by Falk, into a support assembly supporting conduits which transport fluids such as oxygen, medicine and nutrients back and forth to an infant as suggested by Fassihi, as Fassihi recognizes the transport of oxygen to/from a newborn ([0126]-[0127]) and maintaining the flow of adequate oxygenation with monitoring via a pulse oximeter ([0012], [0167], [0200]), and Falk teaches the incorporation of a pressure sensor into the oxygen expiration/inspiration conduits provides measurements as to such oxygen levels in the patient ([0018] and [0023]).
Regarding claim 13, Fassihi teaches wherein the neonate is configured to be disposed in a first plane spaced from the transfer tray along the vertical axis (Fassihi discloses the use of multiple bridges/mounts attached to motors/actuators for increasing/decreasing the height(s) of the bridge(s)/mounts(s) [0125]-[0129], therefore a neonatal chamber lying thereon could be spaced from the tray at different heights along a vertical axis), however Fassihi fails to disclose explicitly that first and second pressure sensors are configured to be moved into the first plane.
Falk teaches a newborn respiration monitoring system incorporated into a mobile, newborn transport system (Fig. 1, [0018] and Abstract), as likewise disclosed by Fassihi, wherein the conduits are part of a breathing circuit (conduit for inspired gases; conduit for expired gases), and one or more sensors, such as a CO2 sensor, flow sensor and pressure sensors ([0018] and [0023]) are incorporated into the breathing circuit to measure values within the breathing circuit ([0018] and [0023]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a pressure sensor into conduits of a breathing circuit as taught by Falk, into a support assembly supporting conduits which transport fluids such as oxygen, medicine and nutrients back and forth to an infant as suggested by Fassihi, as Fassihi recognizes the transport of oxygen to/from a newborn ([0126]-[0127]) and maintaining the flow of adequate oxygenation with monitoring via a pulse oximeter ([0012], [0167], [0200]), and Falk teaches the incorporation of a pressure sensor into the oxygen expiration/inspiration conduits provides measurements as to such oxygen levels in the patient ([0018] and [0023]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. Patent No. 3,646,319.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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