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 .
This Office Action is responsive to the Amendment filed 21 November 2025. Claims 16-31 are currently under consideration. The Office acknowledges the amendments to claims 16, 17, 19-21, and 23-29.
Claim Objections
Claim 16 is objected to because of the following informalities: in line 12, “an at least one outlet port” should apparently read --[[an]] at least one outlet port-- and in line 13, “an at least one port” should apparently read --[[an]] at least one port--. In other words, each instance of “an” should apparently be deleted. 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.
Claims 16-31 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 16 recites the limitation "the disposable housing" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 also recites the limitation “an at least one port of the disposable housing” in lines 13-14. It is not clear if this is intended to refer to the “at least one inlet port” of the disposable housing previously recited in line 9 or to separate port(s).
Claim 23 recites the limitation “wherein the disposable housing further comprises at least one outlet port in the floor” in lines 1-2. It is not clear if this is intended to refer to the at least one port of the disposable housing previously recited in claim 16 or to a separate port.
Claim 23 also recites the limitation “the at least one outlet port of the disposable housing” in line 2. It is not clear if this is intended to refer to the at least one port of the disposable housing previously recited in claim 16 or the at least one outlet port in the floor recited previously in claim 23.
Claim 23 also recites the limitation “at least one inlet port in the floor” in line 3. It is not clear if this is intended to refer to the at least one inlet port of the disposable housing previously recited in claim 16 or to a separate port.
Claim 23 also recites the limitation “the at least one inlet port of the disposable housing” in lines 3-4. It is not clear if this is intended to refer to the at least one inlet port of the disposable housing previously recited in claim 16 or the at least one inlet port in the floor recited previously in claim 23.
Claim 30 recites that it depends upon claim 1. However, claim 1 has been canceled, so the scope of this claim is not clear. For sake of compact prosecution, this claim will be taken to depend upon independent claim 16.
Claim 30 recites the limitation "the frame" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 is rejected by virtue of its dependence upon claim 30.
Claims 17-31 are rejected by virtue of their dependence upon claim 16.
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.
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.
Claims 16-20, 23, 24, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Breegi et al. (WO 2014/189874 A1; cited in the previous Office action; hereinafter known as “Breegi”), in view of Gustafson et al. (U.S. No. 7,481,234 B1; cited in the previous Office action; hereinafter known as “Gustafson”).
Regarding claim 16, Breegi discloses a controlled environment neonatal infant incubator (Abstract; Figs. 4 and 17-19) comprising: a control module base 70, having a housing for comprising at least one or more air circulation systems or air sterilization systems selected from the group consisting of: an air pump, an air filter, an ultraviolet light, an air sterilizer, a vacuum, an ozonizer, a humidifier and an air heater (p. 8, third paragraph; p. 9, second full paragraph), a frame 23/24/25, the frame configured to be in a collapsed configuration or expanded configuration (p. 6-7; expandable and collapsible frame comprising ribs/arm), and when in the expanded configuration, is detachably connected to the disposable housing 36/73, the disposable housing comprising a plurality of sidewalls and a floor (p. 7, first full paragraph; canopy material; can include complete floor portion base which can be connected to the sidewalls of the canopy), and at least one inlet port with a valve 54 and a tube 51 (p. 8, third paragraph), and wherein the disposable housing forms a contained space configured for an infant when detachably connected to the frame in the expanded configuration (p. 3, first paragraph; p. 11, first paragraph); wherein the control module base comprises an at least one outlet port that is in air communication with the contained space via an at least one port of the disposable housing (p. 8, third paragraph; p. 9, second full paragraph). Breegi fails to expressly disclose that the disposable housing is connected to an inside of the frame, as well as that the control module base is connected to a power supply comprising a battery or voltage converter, or both. Gustafson discloses a similar controlled environment apparatus (Abstract; Fig. 4) comprising a housing 110 comprising a plurality of sidewalls and a floor, wherein the housing is detachably connected to an inside of a frame 10/15 in order to allow a single person to quickly and easily create the assembled configuration from a collapsed configuration (col. 1, lines 10-12; col. 2, lines 33-35; col. 3, lines 35-37; col. 4, lines 59-67), as well as a control module base 200/600 that is connected to a power supply comprising a battery or voltage converter in order to provide power to the control module base (col. 5, lines 32-39; col. 8, lines 21-33). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Breegi so that the disposable housing is connected to an inside of the frame and with such a control module base that is connected to a battery, as taught by Gustafson, in order to allow a single person to quickly and easily create the assembled configuration from a collapsed configuration and to provide power to the control module base.
Regarding claim 17, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, and Breegi further discloses that the frame when in the collapsed configuration is not attached to the control module base (Fig. 1).
Regarding claim 18, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, and Breegi further discloses that the control module base regulates at least one of humidity and air flow in the contained space (p. 8, third paragraph; p. 9, second full paragraph).
Regarding claim 19, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, and Breegi further discloses that the disposable housing further comprises at least one hand port 29 in at least one of the plurality of sidewalls (p. 8, first paragraph).
Regarding claim 20, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, and Breegi further discloses that the disposable housing further comprises at least one air-locked sleeve 45 in at least one of the plurality of sidewalls (p. 8, second paragraph).
Regarding claim 23, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, and Breegi further discloses that the disposable housing further comprises at least one outlet port in the floor, the at least one outlet port of the disposable housing having an outlet port valve and a tube coupling system, or at least one inlet port in the floor, the at least one inlet port of the disposable housing having an inlet port valve and a tube coupling system (p. 8, last paragraph).
Regarding claim 24, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, and Breegi further discloses that the control module base further comprises at least one of: an outlet port of the control module base and a tube coupling system configured for air communication with an inlet port on the controlled environment neonatal infant incubator, or an inlet port of the control module base and a tube coupling system configured for air communication with an outlet port on the controlled environment neonatal infant incubator (p. 8, third paragraph).
Regarding claim 26, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, and Breegi further discloses that the frame or the plurality of sidewalls in the disposable housing are transparent, or both (p. 4, second full paragraph; p. 7, first full paragraph; transparent polymeric material).
Regarding claim 27, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, and Gustafson further discloses that the control module base comprises a HEPA filter (col. 5, lines 41-50; col. 8, lines 39-41).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Breegi and Gustafson as applied to claim 16 above, and further in view of Hingley et al. (U.S. Pub. No. 2012/0152243 A1; hereinafter known as “Hingley”). The combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, but fails to disclose that the disposable housing further comprises at least one air-locked infant access door; Breegi does teach the use of air locks (see rejection of claim 20). Hingley discloses a similar apparatus (Abstract; Fig. 1) comprising an air-locked access door in order to prevent air from entering or exiting the enclosure when the patient enters or exits the enclosure ([0007]; [0014]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breegi and Gustafson with an air-locked infant access door, as taught by Hingley, in order to prevent air from entering or exiting the contained space when the infant enters or exits the contained space.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Breegi and Gustafson as applied to claim 16 above. The combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, but fails to expressly disclose the battery is a 12V battery or a rechargeable 12V battery. However, Gustafson elsewhere teaches the use of a 12V battery (col. 7, lines 36-57). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Breegi and Gustafson with a 12V battery, as taught by Gustafson, as this is a known effective battery type for powering air circulation systems.
Claims 25, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Breegi and Gustafson as applied to claim 16 above, and further in view of Kolarovic (U.S. Pub. No. 2002/0147381 A1).
Regarding claim 25, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, but fails to disclose that the control module base further comprises: a microprocessor connected to the power supply, the microprocessor comprising software for executing a program for controlling one or more of a plurality of functions: maintaining temperature within a pre-determined temperature range, maintaining humidity within a pre-determined humidity range, maintaining light at within a pre-defined wavelength range, maintaining a gas composition within a pre-determined range, and maintaining sterility of an air in the contained space, and an interface with one or more switches for controlling power to the microprocessor, and for controlling any one or more functions (i) to (v). Kolarovic discloses a similar apparatus (Abstract; Fig. 1) comprising a control system 46 including a microprocessor 48, which comprises software for executing a program for controlling one or more of a plurality of functions: maintaining temperature within a pre-determined temperature range, maintaining humidity within a pre-determined humidity range, maintaining light at within a pre-defined wavelength range, maintaining a gas composition within a pre-determined range, and maintaining sterility of an air in the contained space, and an interface with one or more switches for controlling power to the microprocessor and for controlling any one or more of functions (i) to (v), in order to monitor and control the environment within the contained space ([0026]-[0027]; [0031]-[0036]; [0044]-[0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breegi and Gustafson with such a microprocessor and interface, along with such sensors, as taught by Kolarovic, in order to monitor and control the environment within the contained space.
Regarding claim 28, the combination of Breegi, Gustafson, and Kolarovic discloses the invention as claimed, see rejection supra, and Kolarovic further discloses that the control module base is operatively connected to at least one sensor in the contained space, the at least one sensor configured to monitor any one of: temperature, humidity or gas composition of the air in the contained space ([0027]).
Regarding claim 29, the combination of Breegi, Gustafson, and Kolarovic discloses the invention as claimed, see rejection supra, and further discloses that the control module base is configured to control a microenvironment of the contained space, the control module base regulating temperature and gas composition in the contained space (Kolarovic: [0026]-[0027], [0031]-[0036], [0044]-[0046]), the control module base including at least one tube that is in air communication with the contained space via the at least one inlet port of the disposable housing (Breegi: p. 8, third paragraph); and providing and controlling air flow into the contained space with the one or more air circulation systems or air sterilization systems (Breegi: p. 8: third paragraph, p. 9: second full paragraph; Kolarovic: [0026], [0032], [0035]-[0036], [0048]-[0049]).
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Breegi and Gustafson as applied to claim 16 above, and further in view of Jacques, II et al. (U.S. No. 6,487,735 B1; hereinafter known as “Jacques”).
Regarding claim 30, the combination of Breegi and Gustafson discloses the invention as claimed, see rejection supra, but fails to disclose a camera detachably connected to the frame, the camera monitoring at least one of visible or non-visible spectrum. Jacques discloses a similar apparatus (Abstract) comprising a camera 496 detachably connected to a frame 432, the camera monitoring at least one of visible or non-visible spectrum, in order to monitor the patient (col. 15, lines 32-45). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Breegi and Gustafson with such a camera, as taught by Jacques, in order to monitor the patient.
Regarding claim 31, the combination of Breegi, Gustafson, and Jacques discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the camera is operatively connected to the controller system module. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Breegi, Gustafson, and Jacques in the recited manner in order to provide power to the camera.
Response to Arguments
Applicant’s arguments with respect to the objections to the specification and to claims 16 and 25, as well as the rejections under 35 U.S.C. 112(a) and (b), have been fully considered and are persuasive in light of the amendments. The objections and rejections have been withdrawn. However, new grounds of rejection under 35 U.S.C. 103 are made, as detailed supra. The claims, as amended to obviate the rejections under 35 U.S.C. 112(a), now fail to recite subject matter that is allowable over the prior art of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791