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 claims 2-11 in the reply filed on 13 January 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)). Accordingly, claims 12-21 are withdrawn from consideration.
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 Objections
Claim 8 is objected to because of the following informalities: at line 4, “includes first side” should apparently read --includes a first side--. Appropriate correction is required.
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 is 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.
At line 6 of claim 6, it is unclear if “the volume” is the same as or different than “maximum volume” recited at lines 2 and 3.
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 2-5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper (U.S. Patent No. 5,218,958) in view of Fassihi et al. (U.S. Pub. No. 2017/0128322). Regarding claim 2, Cooper teaches a chamber 10 configured to enclose a neonate 11 within an interior space of the chamber (see Figure and col. 1, lines 23-32), the chamber comprising:
an outer wall (30/32 or 20) that defines an outer boundary of the interior space (Figure and col. 2, lines 24-34); and
an inner wall 18 that partially defines both a first portion of the interior space (below dome 18 as shown in Figure) and a second portion of the interior space (above dome 18 as shown in Figure) such that the inner wall separates the first portion from the second portion, the first portion configured to enclose the neonate 11 (see Figure and col. 2, lines 24-54).
While Cooper teaches an opening in the inner wall for passing the umbilical cord therethrough and into the second portion (see claim 1), Cooper fails to disclose that the umbilical cord is clamped within the second portion, the clamp configured to clamp at least one of an umbilical cord and a cannula connected to the umbilical cord. Fassihi et al. (hereinafter Fassihi) teaches a simulated fluid environment, similar to that of a mother’s womb (see Abstract), wherein a neonate is enclosed within a chamber, positioned within a first portion of the chamber comprising a simulated fluid, as shown in Fig. 1, wherein a second portion of the chamber, above the neonate, comprises a bridging/mounting unit with an anchoring mechanism, wherein the anchoring mechanism is fastened to an umbilical cord/catheter line for holding it in place ([0013], [0126], [0129] and [0200]) (the combination of which is construed as the recited “clamp” as Fassihi discloses the anchor being fastened to the umbilical cord/catheter line for holding the umbilical cord/catheter line in place in the cited paragraphs). 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 clamp positioned within a second portion of a neonate chamber as taught by Fassihi, in a neonatal chamber/enclosure which provides access between the neonate and the upper chamber due to presence of an umbilical cord as Cooper teaches an opening for passing the umbilical cord between the upper and lower portion (see claim 1), and Fassihi teaches that a clamping/anchoring mount enables access between the neonatal portion and the upper portion of the enclosure (as discussed above) while additionally preventing kinking and contamination of the umbilicus and its tubing [0200].
Regarding claim 3, the combination further discloses an actuator (“swiveling mechanism”) operably coupled to the clamp such that movement of the actuator moves the clamp ([0013] of Fassihi).
Regarding claim 4, Cooper further discloses wherein the interior space defines a maximum volume (construed as the “maximum volume” of the physiological fluid 24 in the chamber 14 as shown in the Figure), the chamber further comprising a volume adjustment assembly (inlet 21 and outlet 23), wherein the volume adjustment assembly is configured to reduce the maximum volume (outlet 23 removes physiological fluid from chamber 14 – col. 2, lines 43-52).
Regarding claim 5, Cooper further discloses wherein the chamber includes a first shell having the outer wall (30/32) and the inner wall 18 (the Figure and col. 2, lines 24-34), and the chamber further includes a second shell (hinged to the first shell via hinge 26) that cooperates with the first shell to at least partially define the interior space, the chamber configured such that the second shell is movable with respect to the first shell from a first position to a second position (via hinge 26), such that in the first position the chamber is in an open configuration, and in the second position the chamber is in a closed configuration (via hinge 26 and as described at col. 2, lines 29-42).
While Cooper teaches an opening in the inner wall for passing the umbilical cord therethrough and into the second portion (see claim 1), Cooper fails to disclose that a clamp is included in the first shell. Fassihi et al. (hereinafter Fassihi) teaches a simulated fluid environment, similar to that of a mother’s womb (see Abstract), wherein a neonate is enclosed within a chamber, positioned within a first portion of the chamber comprising a simulated fluid, as shown in Fig. 1, wherein a second portion of the chamber, above the neonate (comprising a first shell), comprises a bridging/mounting unit with an anchoring mechanism, wherein the anchoring mechanism is fastened to an umbilical cord/catheter line for holding it in place ([0013], [0126], [0129] and [0200]) (the combination of which is construed as the recited “clamp” as Fassihi discloses the anchor being fastened to the umbilical cord/catheter line for holding the umbilical cord/catheter line in place in the cited paragraphs). 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 clamp positioned within a first shell/second portion of a neonate chamber as taught by Fassihi, in a neonatal chamber/enclosure which provides access between the neonate and the upper chamber/first shell due to presence of an umbilical cord as Cooper teaches an opening for passing the umbilical cord between the upper portion (“first shell”) and the lower portion (see claim 1), and Fassihi teaches that a clamping/anchoring mount enables access between the neonatal portion and the upper portion/first shell of the enclosure (as discussed above) while additionally preventing kinking and contamination of the umbilicus and its tubing [0200].
Regarding claim 7, the chamber of Cooper is configured such that when the chamber is in the open configuration the first shell and the second shell cooperatively define an opening into the interior space, the opening defines a first distance measured from a portion of the first shell to a portion of the second shell (in the open configuration, the hinge 26 enables such opening to place the neonate therein, for instance), and when the chamber is in the closed configuration the opening defines a second distance measured from the portion of the first shell to the portion of the second shell, and the second distance is less than the first distance (as shown in the Figure, the closed configuration would have a second distance measured from the portion of the first shell to the portion of the second shell, however it is would much less than in the open configuration simply by virtue of the hinge being closed).
Regarding claim 8, Cooper teaches that the inner wall 18 includes a first end and a second end spaced from the first end (see reproduction below) along a central axis (shown by solid, double-ended arrow), the first end coupled to the outer wall (20) (see reproduction below and col. 2, lines 31-34), and wherein the inner wall 18 includes a first side and a second side spaced from the first side along a lateral axis (short, dashed, double-ended arrow shown below) perpendicular to a longitudinal axis (see solid black line in reproduction below), the first side facing the first portion (lower chamber 14 where neonate resides) and the second side facing the second portion (upper chamber 16, which is above inner wall 18 as shown in reproduction below).
[AltContent: connector][AltContent: textbox ([img-media_image1.png])]
[AltContent: arrow]
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (“second end”)][AltContent: textbox (“first end”)]
Regarding claim 9, the first portion defines a first maximum dimension measured from a first point on the outer wall (see reproduction below) to a second point on the outer wall (see reproduction below), the second portion defines a second maximum dimension measured from the first point on the outer wall to a first point on the inner wall (see reproduction below), and the first maximum dimension is greater than the second maximum dimension (as shown by distances between points below).
[AltContent: textbox ([img-media_image2.png])]
[AltContent: arrow][AltContent: textbox (“first point on inner wall” 18)]
[AltContent: textbox (“first point”)]
[AltContent: arrow][AltContent: textbox (“second point”)][AltContent: arrow]
Allowable Subject Matter
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claims 10 and 11, while the prior art teaches a chamber configured to enclose a neonate within an interior space of the chamber, the chamber comprising: an outer wall that defines an outer boundary of the interior space; an inner wall that partially defines both a first portion of the interior space and a second portion of the interior space such that the inner wall separates the first portion from the second portion, the first portion configured to enclose the neonate; and a clamp positioned within the second portion, the clamp configured to clamp at least one of an umbilical cord and a cannula connected to the umbilical cord, wherein the first portion defines a first maximum dimension measured from a first point on the outer wall to a second point on the outer wall, the second portion defines a second maximum dimension measured from the first point on the outer wall to a first point on the inner wall, and the first maximum dimension is greater than the second maximum dimension, the prior art of record does not teach or fairly suggest a chamber configured to enclose a neonate within an interior space of the chamber as claimed by Applicant, wherein the first maximum dimension is measured in a first direction, the chamber further comprising a seal positioned within a recess at least partially defined by the outer wall, the seal including a first surface that faces toward the outer wall, a second surface that is opposite the first surface with respect to a second direction that is perpendicular to the first direction such that the second surface faces away from the outer wall, and a slot that extends from the second surface of the seal toward the first surface of the seal along the second direction such that the slot terminates prior to reaching the first surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. Pub. No. 2014/0255253.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791