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 .
Response to Amendment
This office action is in response to the preliminary amendment filed 7/11/2024. As directed by the amendment, claim 1 has been cancelled, and claims 2-21 have been added. As such, claims 2-21 are pending in the instant application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/679,301, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application does not disclose the structural details/configurations of the instant claims. Therefore, the priority date afforded to the instant application is the filing date of the parent application, that is, 5/31/2019.
Claim Objections
Claims 10, 14 and 17 are objected to because of the following informalities:
Claim 10, line 6 should read “a gas source side” for clearer antecedent basis
Claim 14, line 3 should read “a conical periphery of the deformable seal” for clarity
Claim 17, lines 1 and 2 contain typos: they should read “ports” (two instances), in view of the antecedent basis for the term ‘ports’ in claim 16
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-7, 9-15 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,628,269 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are narrower, where patented claim 7 fully anticipates instant claims 2, 7 and 9, patented claims 8-15 fully anticipate instant claims 3-6 and 10-13, respectively, patented claim 15 also anticipates instant claim 14, and patented claim 12 also anticipates instant claims 15 and 21.
Claims 8 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 12 of U.S. Patent No. 11,628,269 B2 in view of Bowden (US 6,792,947 B1; hereinafter “Bowden”). Patented claim 7 is silent regarding the flow path comprising a tube as instantly claimed, and patented claim 12 is silent regarding the manifold comprising (male) connector ports for connecting the bag/gas source and a tube to the patient. However, Bowden teaches that it was known in the BVM art before the effective filing date of the claimed invention for a flow reduction valve manifold (the housing of valve 7) to comprise (male) connector port(s) (at inlet 9 and outlet 10) for connecting the bag/gas source (bag 3) and flow path comprising a tube to the patient’s mouth and/or nose (tube 26 and/or tube 34) (Figs. 1-4; col. 6, lines 45-46), such that including the absent limitations in the patented claims would have been obvious to an artisan before the effective filing date of the claimed invention in order to provide a known connection arrangement for attaching the patented manifold to the BVM bag and for delivering gas to the patient.
Claims 2-7, 9-15 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,017,008. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are narrower, where patented claim 1 fully anticipates instant claims 2, 7 and 9, patented claims 2-9 fully anticipate instant claims 3-6 and 10-13, respectively, patented claim 9 also anticipates instant claim 14, and patented claim 6 also anticipates instant claims 15 and 21.
Claims 8 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,017,008 in view of Bowden. Patented claim 1 is silent regarding the flow path comprising a tube as instantly claimed, and patented claim 6 is silent regarding the manifold comprising (male) connector ports for connecting the bag/gas source and a tube to the patient. However, Bowden teaches that it was known in the BVM art before the effective filing date of the claimed invention for a flow reduction valve manifold (the housing of valve 7) to comprise (male) connector port(s) (at inlet 9 and outlet 10) for connecting the bag/gas source (bag 3) and flow path comprising a tube to the patient’s mouth and/or nose (tube 26 and/or tube 34) (Figs. 1-4; col. 6, lines 45-46), such that including the absent limitations in the patented claims would have been obvious to an artisan before the effective filing date of the claimed invention in order to provide a known connection arrangement for attaching the patented manifold to the BVM bag and for delivering gas to the patient.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 10-21 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Regarding claim 10 (and thus its dependent claims 11-21), the valve located “between the gas source and a mouth or nose of the patient” positively recites the patient. To address this rejection, Applicant could amend claim 10 to read “configured to be between the gas source and a mouth or nose of the patient.”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification as originally filed does not support the flow path (see instant Fig. 1B and the arrows 48 in instant Fig. 3A) comprising “a tube from the gas source port to the patient’s mouth or nose." At best, fitting 74 of the mask in instant Fig. 1B can be considered a tube comprised by the flow path, but it does not extend from the gas source port 14; rather, it extends from mask fitting 44. To address this rejection (and in conjunction with the clarity issues below), Applicant could amend claim 8 to read “wherein the flow path from the gas source port to the patient’s mouth or nose comprises a tube
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 2-21 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 2 (and thus its dependent claims 3-9) recites the limitation "the BVM" in line 7. There is insufficient antecedent basis for this limitation in the claim. As best understood, for purposes of examination, claim 1 will be considered to read “the gas source assembly”.
Regarding claims 7 and 15, the claims recite “a gas source valve mask (BVM)”. Since ‘gas source’ does not start with the letter B, it is unclear whether the claim is intended to read, in light of the specification, “a bag valve mask (BVM)” or “a gas source valve mask and mask” if it is the intended interpretation. For purposes of examination, a gas source valve and mask will be considered required, but Applicant must make it clear in their response if a bag/BVM is required by claims 7 and 15.
Regarding claim 8, it is unclear in the claim whether “a flow path” in line 1 or “a patient’s mouth or nose” in line 2 are different from that of claim 2 or intended to be the same. As best understood, for purposes of examination, they are the same, such that Applicant could address this rejection by amending claim 8 to read “wherein the flow path from the gas source port to the patient’s mouth or nose”.
Regarding claim 10 (and thus its dependent claims 11-21), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite, see MPEP 2173.05(p).II. Applicant could address this rejection by amending claim 10 to read “a manifold, wherein the manifold is configured to deliver breathing gas to a patient
Further regarding claim 10 (and thus its dependent claims 11-21), line 3 recites “a breathing gas” wherein it is unclear in the claim whether this is the same or different from the breathing gas of line 2. As best understood, for purposes of examination, they are the same, such that Applicant could address this rejection by amending claim 10, line 3, to read “the breathing gas”.
Claim 14 recites the limitation "the flow openings" in line 2. There is insufficient antecedent basis for this limitation in the claim. To address this rejection, Applicant could amend claim 14 to depend from claim 13, which provides the requisite antecedent basis.
Further regarding claim 18, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite, see MPEP 2173.05(p).II, and it is unclear whether the breathing gas of claim 18 is the same as claim 12 or different. As best understood, for purposes of examination, Applicant could address this rejection by amending claim 18 to read “device of claim 16, further comprising a tube attached to the manifold, wherein the tube is configured to deliver the breathing gas from the manifold to the patient
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 7-10 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Figley et al. (US 2004/0163647 A1; hereinafter “Figley”) in view of Smallpeice (US 3,216,451; hereinafter “Smallpeice”).
Regarding claim 2, Figley discloses a method for modifying a breathing-assist device (Figs. 1 and 15) including a gas source assembly (comprising cylinder 204) having a gas source connector (cylinder valve 202) (Fig. 15), said method comprising:
providing a pressure safety device (PSD) (valve 200) (Figs. 16-17) having a gas source port (comprising channel 220) and a flow path from the gas source port to a patient's mouth or nose (Figs. 1, 14A-D and 15); and
connecting the gas source port of the PSD to the gas source connector of the breathing-assist device (Fig. 15);
wherein the PSD is configured to impede breathing gas flow from the BVM to the patient's mouth or nose when a pressure or flow rate of the breathing gas entering the gas source port of the PSD exceeds a maximum threshold value (paras [0232-234]);
wherein the PSD comprises a valve member (comprising plunger 206) having an open position (Fig. 16) and a closed position (similar to Fig. 17, but with plunger 206 pushed all the way against set screw 212), wherein the valve member is configured to move to fully block the flow path in response to the pressure or flow rate exceeding the maximum threshold value ([a]t very high flow rates, the plunger will seat against the set screw [212] and flow will be checked, para [0234]).
Figley is silent regarding where the valve member is or comprises a deformable seal that is configured to deform to fully block the flow path in response to the pressure or flow rate exceeding the maximum threshold value. However, Figley further teaches the use of a deformable seal (O-ring 216) (Fig. 16; para [0232]), and Smallpeice teaches that it was known in the flow control valve art before the effective filing date of the claimed invention to utilize a valve member that is a deformable seal (resilient rubber sealing ring 17) (Fig. 1/4) that is configured to deform to fully block the flow path in response to the pressure or flow rate exceeding the maximum threshold value (e.g. Fig. 3) (the ring 17 will continue to move axially as the pressure difference across it increases until its periphery eventually engages the outer wall and flow is stopped completely, col. 2, lines 42-45; col. 3, lines 69-72). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the flow controlling/shut-off valve arrangement of Figley to either include a deformable o-ring at either end of plunger 213 of Figley for sealing against the adjacent valve seats OR to include the flow controlling/shut-off valve arrangement of Smallpeice, thus arriving at deformable seal as claimed, in order to provide the predictable result of utilizing a known flow controlling/shut-off valve member (rubber/o-ring) to tightly/sealingly achieve the flow control/shut-off functionality disclosed by Figley.
Regarding claim 7, Figley in view of Smallpeice teaches the method of claim 2, wherein Figley further discloses wherein the breathing-assist device comprises a gas source valve (cylinder valve 202) (Fig. 15) and mask (e.g. Fig. 14D).
Regarding claim 8, Figley in view of Smallpeice teaches the method of claim 2, wherein Figley further discloses, as best understood, wherein a flow path from the gas source port to a patient's mouth or nose comprises a tube (Figley Figs. 1, 14A-D).
Regarding claim 9, Figley in view of Smallpeice teaches the method of claim 2, wherein Figley further discloses wherein the gas source connector comprises a bag connector (cylinder valve 202) (Fig. 15) configured to be coupled to a compression bag (there is nothing that would preclude valve 202 from being coupled to a compression bag, such that it comprehends a bag connector as claimed).
Regarding claim 10, Figley discloses a breathing-assist device (Figs. 1 and 15) comprising:
a manifold (body 206), wherein a patient receives breathing gas from the manifold (Figs. 1 and 15; paras [0226-0243]);
a gas source (cylinder 204) attached to deliver a breathing gas to the manifold (Figs. 1 and 15; paras [0229-234]); and
an automatic flow reduction valve (comprising plunger 213) located on a flow path in the manifold between the gas source and a mouth or nose of the patient (Figs. 1, 14A-D, 15), said automatic flow reduction valve being configured to impede flow when a flow rate or a pressure on the gas source side of the automatic flow reduction valve exceeds a maximum threshold value (paras [0232-234]);
wherein the automatic flow reduction valve comprises a valve member (comprising plunger 206) having an open position (Fig. 16) and a closed position (similar to Fig. 17, but with plunger 206 pushed all the way against set screw 212), wherein the valve member is configured to move to fully block the flow path in response to the pressure or flow rate exceeding the maximum threshold value ([a]t very high flow rates, the plunger will seat against the set screw [212] and flow will be checked, para [0234]).
Figley is silent regarding where the valve member is or comprises a deformable seal that is configured to deform to fully block the flow path in response to the pressure or flow rate exceeding the maximum threshold value. However, Figley further teaches the use of a deformable seal (O-ring 216) (Fig. 16; para [0232]), and Smallpeice teaches that it was known in the flow control valve art before the effective filing date of the claimed invention to utilize a valve member that is a deformable seal (resilient rubber sealing ring 17) (Fig. 1/4) that is configured to deform to fully block the flow path in response to the pressure or flow rate exceeding the maximum threshold value (e.g. Fig. 3) (the ring 17 will continue to move axially as the pressure difference across it increases until its periphery eventually engages the outer wall and flow is stopped completely, col. 2, lines 42-45; col. 3, lines 69-72). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the flow controlling/shut-off valve arrangement of Figley to either include a deformable o-ring at either end of plunger 213 of Figley for sealing against the adjacent valve seats OR to include the flow controlling/shut-off valve arrangement of Smallpeice, thus arriving at deformable seal as claimed, in order to provide the predictable result of utilizing a known flow controlling/shut-off valve member (rubber/o-ring) to tightly/sealingly achieve the flow control/shut-off functionality disclosed by Figley.
Regarding claim 15, Figley in view of Smallpeice teaches the breathing-assist device of claim 10, wherein Figley further discloses wherein the breathing-assist device comprises a gas source valve (cylinder valve 202) (Fig. 15) and mask (e.g. Fig. 14D).
Regarding claim 16, Figley in view of Smallpeice teaches the breathing-assist device of claim 10, wherein Figley further discloses wherein the manifold comprises one or more connector ports (surrounding channel 220 and screw 212) (Fig. 16).
Regarding claim 17, Figley in view of Smallpeice teaches the breathing-assist device of claim 16, wherein Figley further discloses wherein the connector ports comprise male connector ports (Figs. 15-16).
Regarding claim 18, Figley in view of Smallpeice teaches the breathing-assist device of claim 16, wherein Figley further discloses wherein the patient receives breathing gas from the manifold via a tube (Figs. 1, 14A-B, 15).
Regarding claim 19, Figley in view of Smallpeice teaches the breathing-assist device of claim 18, wherein Figley further discloses wherein the tube is detachably connected to one of the one or more connector ports (Figs. 1, 14A-B, 15 and 16).
Regarding claim 20, Figley in view of Smallpeice teaches the breathing-assist device of claim 16, wherein Figley further discloses wherein the gas source is detachably connected to one of the one or more connector ports (Figs. 15-16).
Claim(s) 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Figley in view of Smallpeice as applied to claims 1 and 10 above, and further in view of Lecroy (S.C.A. Review of Neonatal & Infant Ventilation Methods. Journal of Emergency Medical Services March 3, 2014, hereinafter “Lecroy”) [copy provided in parent application 16/428,736].
Regarding claims 3 and 11, Figley in view of Smallpeice teaches the method of claim 2 and the breathing-assist device of claim 10, but modified Figley is silent regarding wherein the maximum threshold value is a pressure in a range from 9 mmHg to 20 mmHg. However, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Lecroy demonstrates that that it was well known in the respiratory therapy art before the effective filing date of the claimed invention that the highest level of pressure to applied to neonatal lungs should be 20 cmH2O [14.7 mmHg], see the second paragraph under “Available Tools”. Therefore, it would have been obvious to an artisan through routine experimentation to modify the threshold of Figley through routine experimentation and in view of Lecroy to arrive at the maximum threshold value being a pressure in a range from 5 mmHg to 20 mmHg as taught by Lecroy, in order to provide the predictable result of ensuring that the device is configured to operate at a pressure that is not damaging for neonatal lungs, to allow the device to be used with neonates (Lecroy second paragraph under “Available Tools”).
Claim(s) 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Figley in view of Smallpeice as applied to claims 1 and 10 above, and further in view of Bowden (US 6,792,947 B1; hereinafter “Bowden”).
Regarding claims 4 and 12, Figley in view of Smallpeice teaches the method of claim 2 and the breathing-assist device of claim 10, but modified Figley is silent regarding wherein the maximum threshold value comprises a peak flow rate in a range from 30 L/min to 70 L/min. However, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, and Bowden demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention that an ideal flow rate is 40 l/min (Fig. 1; col. 3, lines 19-20). Therefore, it would have been obvious to an artisan through routine experimentation to modify the threshold of Figley through routine experimentation and in view of Bowden to arrive at the maximum threshold value being a peak flow rate in a range from 30 l/min to 70 l/min, e.g. 40 l/min as taught by Bowden, in order to provide the predictable result of ensuring that the device is configured to operate at common respiratory flow rates (Bowden col. 3, lines 19-20).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional reference teaching a flow control/shut-off valve for use with oxygen cylinders: Mustafa (US 9,494,241 B1). Additional references regarding known flow control/shut-off valve arrangements, including with deformable seals: Lenn (US 8,640,733 B1); Dominguez et al. (US 9,486,884 B2); Dulin (US 6,408,870 B1); Eichler (US 7,258,131 B2); Oh (US 9,133,947 B2); Adams (US 2009/0254049 A1); Chen (US 9,777,857 B2); Masloff (US 5,293,898); Patterson (US 3,468,338); Sanders (US 6,019,115); Schuler et al. (US 2005/0016533 A1; Figs. 43 and 50). Additional references teaching the use of flow control/shut-off valve arrangements in respiratory systems: Kӧhnke (US 4,167,184 and 4,071,025); Han (KR 10-1856869); Spears et al. (US 3,043,302).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, Tu-Th 8a-2p, F 7:30-11:30a ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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