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 responsive to an amendment filed on 9/29/2025. As directed by the amendment, claims 1-2, 9 and 15 were amended, claims 7-8, 10-11, and 21-27 were cancelled and new claims 28-31 were added. Thus, claims 1-6, 9, 12-20 and 28-31 are presently pending in this application.
Claim Objections
Claims 15, 18-19 and 31 are objected to because of the following informalities:
In claim 15, line 10, the term “a user” is suggested to be changed to --the user-- in order to clarify the claim because claim 15, line 8 claims “a user”.
In claim 18, line 3, the term “a user” is suggested to be changed to --the user-- in order to clarify the claim because claim 15, line 8 claims “a user”.
In claim 19, line 2, the term “a user” is suggested to be changed to --the user-- in order to clarify the claim because claim 15, line 8 claims “a user”.
In claim 31, lines 10 and 20, the term “a patient” is suggested to be changed to --the patient-- in order to clarify the claim because claim 31, line 5 claims “a patient”.
In claim 31, line 10, the term “a user” is suggested to be changed to --the user-- in order to clarify the claim because claim 31, line 3 claims “a user”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the limitations “an outtake assembly attached to the chamber and configured to permit a selected flow rate of gas out of the chamber” (claim 1, lines 8-9, the term “assembly” is the generic placeholder and the function is “configured to permit a selected flow rate of gas out of the chamber”), “one or more adjustment mechanisms configured to allow a user to selectively adjust the flow rate of gas permitted out of the chamber” (claim 5, lines 2-4, the term “mechanisms” is a generic placeholder and the function is “configured to allow a user to selectively adjust the flow rate of gas permitted out of the chamber”), “one or more adjustment mechanisms configured to allow a user to selectively adjust the flow rate of gas permitted into the chamber” (claim 6, lines 2-4, the term “mechanisms” is a generic placeholder and the function “configured to allow a user to selectively adjust the flow rate of gas permitted into the chamber”), “an outtake assembly attached to the chamber and configured to permit a selected flow rate of gas out of the chamber” (claim 15, lines 6-7, where the term “assembly” is the generic placeholder and the function is “configured to permit a selected flow rate of gas out of the chamber”), “an intake assembly attached to the chamber and configured to permit air flow into the chamber at a pre-set in-flow rate” (claim 31, lines 7-8, the term “assembly” is a generic placeholder and the function is “configured to permit air flow into the chamber at a pre-set in-flow rate”) and “an outtake assembly attached to the chamber and configured to deliver the pre-set repeatable volume of air to a patient when a user manually grips the grip placement indicator” (claim 31, lines 9-11, the term “assembly” is a generic placeholder and the function is “configured to deliver the pre-set repeatable volume of air to a patient when a user manually grips the grip placement indicator”).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 31 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 limitation “the grip placement indicator being configured to deliver a pre-set repeatable volume of air to a patient by manually compressing the grip placement indicator to a point where opposing portions of the flexible wall come into contact…an outtake assembly attached to the chamber and configured to deliver the pre-set repeatable volume of air to a patient when a user manually grips the grip placement indicator and compresses the compressible chamber to the point where opposing portions of the flexible wall come into contact, the contact generating a finger sensed release signal, and wherein the intake assembly and the compressible chamber are configured to generate a finger-sensed compression signal when the compressible chamber has completely refilled, indicating to the user that it is time to compress the compressible chamber again, wherein the pre-set volume of air delivered through use of the grip placement indicator, and a pace of repeatable compressions achieved through use of a series of alternating finger-sensed compression signals and finger sensed release signals results in a desired volume of air delivery to a patient in eight to twelve compressions per minute” (claim 31, lines 4-6 and 9-21) is not supported by the original disclosure and is new matter. The original disclosure fails to disclose that the grip placement indicator being configured to deliver a pre-set repeatable volume of air to a patient by manually compressing the grip placement indicator to a point where opposing portions of the flexible wall come into contact and an outtake assembly attached to the chamber and configured to deliver the pre-set repeatable volume of air to a patient when a user manually grips the grip placement indicator and compresses the compressible chamber to the point where opposing portions of the flexible wall come into contact, the contact generating a finger sensed release signal, and wherein the intake assembly and the compressible chamber are configured to generate a finger-sensed compression signal when the compressible chamber has completely refilled, indicating to the user that it is time to compress the compressible chamber again, wherein the pre-set volume of air delivered through use of the grip placement indicator, and a pace of repeatable compressions achieved through use of a series of alternating finger-sensed compression signals and finger sensed release signals results in a desired volume of air delivery to a patient in eight to twelve compressions per minute.
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 and 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 pre-AIA the applicant regards as the invention.
Regarding claim 2, the limitation “plural grip placement indicators” (line 2) is unclear if the plural grip placement indicators are in addition to the grip placement indicator in claim 1, line 2 or if the grip placement indicator are part of the plural grip placement indicators.
Regarding claim 31, the limitation “a series of alternating finger-sensed compression signals and finger sensed release signals” (lines 18-19) is unclear if the series of alternating-finger sensed compression signals and finger sensed release signals are the same as or different from “a finger sensed released signal” (lines 12-13) and “a finger-sensed compression signal” (line 15).
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.
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.
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.
Claims 1-6 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Lea (3,046,978) or, in the alternative, under 35 U.S.C. 103 as obvious over Lea (3,046,978) in view of Myklebust (2008/0314386).
Regarding claim 1, Lea discloses a manual resuscitator regulating system (system shown in figs. 1-4), comprising a gas containing compressible chamber (chamber formed by 16 and 18, fig. 1, Col 2, lines 7-18) having a grip placement indicator configured to guide a user where to compress the chamber to expel a selected volume of gas from the chamber (see fig. 1, as shown, grip placement indicator having indicia to indicate where to press for different age groups, see ridge 74, 76, 80, Col 3, lines 3-36), an intake assembly (30 and 31, fig. 1, Col 2, lines 23-39) attached to the chamber, including a valve housing (valve housing is 32, see fig. 3, col 2, lines 19-39) enclosing a regulator disc having an aperture sized to permit a selected flow rate of gas into the chamber (Col 3, lines 54-61, Lea discloses that the intake assembly allows air to enter the chamber 16, the valve 30/31 is designed at a particular size by the designer, therefore, the air/gas that is being allowed to enter the chamber is a selected flow rate of gas, alternatively, Lea discloses that the pin 44 is pushed into valve body 32 manually against the bias of spring 45 to lift core 34 off of the shoulder of the counter bore 42, and when the pin is released, spring 45 expands to close the valve 31, which would allow the intake to be selectively controlled to allow a selected volume to come in, the disc is the wide cylinder 36 having apertures extending from apertures 39, see fig. 5, col 2, lines 19-43), an outtake assembly (50, 54, 57, 62, 64, 68, figs. 1 and 3) attached to the chamber and configured to permit a selected flow rate of gas out of the chamber (col 2, lines 60 to col 3, line 10, Col 3, lines 37-53, the outtake assembly are designed to allow a selected flow rate to move from the chamber to the patient), wherein the chamber provides a tactile feedback to the user signaling when to compress the chamber (see col 2, line 44 to col 3, line 53 and full disclosure, Lea discloses that the bulb/chamber 16 is elastic, and that the user compress the bulb to expel air therefrom, and that the ball further limit manual compression of the bulb/chamber, therefore, when the user completely compress the chamber 16 to the maximum compression point, releasing of the elastic bulb would expand since valve 31 permit ambient air to enter, therefore the chamber would visually and tactilely signals a user to compress the chamber when the bulb is fully expanded, fully compressed or compressed/inflated at different levels in between the full expanded stated and the fully compressed state). If there is any doubt that Lea discloses valve housing enclosing a regulator disc having an aperture.
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Myklebust teaches an intake assembly, the intake assembly has a valve housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) including a first regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) including an aperture (any aperture on 61, fig. 2B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the intake assembly of Lea to have the intake assembly as taught by Myklebust for the purpose of allowing the intake to be adjusted to accommodate different patient needs, thereby, providing comfort and safety to the patient (see paragraph 0024 of Myklebust).
Regarding claim 2, Lea or the modified Lea discloses that the compressible chamber (16 and 18, fig. 1 of Lea) has plural grip placement indicators for directing a user to deliver an appropriate gas volume to a patient (see fig. 1, as shown, grip having indicia to indicate where to press for different age groups, see ridge 74, 76, 80, Col 3, lines 3-36 of Lea) and balls (48 and 50 of Lea).
Regarding claim 3, Lea or the modified Lea discloses that the outtake assembly (50, 54, 57, 62, 64, 68, figs. 1 and 3 of Lea) is configured to permit a selected volume of gas out of the chamber over a predetermined amount of time (col 2, lines 60 to col 3, line 10, Col 3, lines 37-53 of Lea, the outtake assembly are designed to allow a selected flow rate to move from the chamber to the patient, the time it takes to go from fully inflated to fully compressed would be over a predetermined amount of time, which would be over a predetermined amount of time due to the size of the outtake assembly and the size of the bulb/chamber).
Regarding claim 4, Lea or the modified Lea discloses that the intake assembly (30 and 31, fig. 1, Col 2, lines 23-39 of Lea, alternatively see intake assembly of Myklebust as modified above) is configured to permit a selected volume of gas into the chamber over a predetermined amount of time (Col 3, lines 54-61 of Lea, Lea discloses that the intake assembly allows air to enter the chamber 16, the valve 30/31 is designed at a particular size by the designer, therefore, the air/gas that is being allowed to enter the chamber is a selected flow rate of gas, alternatively, Lea discloses that the pin 44 is pushed into valve body 32 manually against the bias of spring 45 to lift core 34 off of the shoulder of the counter bore 42, and when the pin is released, spring 45 expands to close the valve 31, which would allow the intake to be selectively controlled to allow a selected volume to come in, which would be over a predetermined amount of time due to the size of the intake assembly and the size of the bulb/chamber, alternatively, see paragraph 0024 of Myklebust).
Regarding claim 5, Lea or the modified Lea discloses that the outtake assembly (50, 54, 57, 62, 64, 68, figs. 1 and 3 of Lea) includes one or more adjustment mechanisms (valve 62 of Lea) configured to allow a user to selectively adjust flow rate of gas permitted out of the chamber (see col 3, lines 16-53 of Lea, Lea discloses that the valve element 62 moves under air pressure in tube 60 to compress spring 49 and close hoes 55, 57, the pressure of air forces open the triangular flaps in walls 64 permitting the air to pass through passage 68 in element 62, therefore the valve 62 is an adjustment mechanism that is configured to allow a user to selectively adjust flow rate of gas permitted out of the chamber).
Regarding claim 6, Lea or the modified Lea discloses that the intake assembly (30 and 31, fig. 1, Col 2, lines 23-39 of Lea, alternatively see intake assembly of Myklebust as modified above) includes one or more adjustment mechanism (valve 31 of Lea) configured to allow a user to selectively adjust flow rate of gas permitted into the chamber (see col 3, lines 16-61 of Lea, the valve 31 is an adjustment mechanism that allows a user to selectively adjust flow rate of gas permitted into the chamber, since the valve closes when the bulb is being compressed and expands due to its natural resilience to permit air to enter under suction through valve 31, and pin 44 is pushed into valve body 32 manually against the bias of spring 45 to lift core 34 off of the shoulder of the counterbore 42 and provide a passage for air through bores 33 and 42 into the bulb, when the pin is released, spring 45 expands to close the valve 31, alternatively, see 61 or 62 in paragraph 0024 of Myklebust).
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Regarding claim 13, Lea or the modified Lea discloses that the intake assembly (30 and 31, fig. 1, Col 2, lines 23-39 of Lea, alternatively see intake assembly of Myklebust as modified above) and the outtake assembly (50, 54, 57, 62, 64, 68, figs. 1 and 3 of Lea) are attached to opposite sides of the chamber (see the annotated-Lea fig. 3 for claim 13 above, as shown, the chamber be divided into a first side and a second side, and as shown, the intake and outtake assemblies are on opposite sides relative to the dividing axis (double arrows dashed line)).
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Regarding claim 14, Lea or the modified Lea discloses that the intake assembly (30 and 31, fig. 1, Col 2, lines 23-39 of Lea, alternatively see intake assembly of Myklebust as modified above) and the outtake assembly (50, 54, 57, 62, 64, 68, figs. 1 and 3 of Lea) are attached on the same side of the chamber (see the annotated-Lea fig. 3 for claim 14 above, as shown, the chamber be divided into a first side and a second side, and as shown, the intake and outtake assemblies are on the same side relative to the dividing axis (double arrows dashed line)).
Regarding claim 15, Lea discloses a manual resuscitator regulating system (system shown in figs. 1-4), comprising a gas containing compressible chamber (chamber formed by 16 and 18, fig. 1, Col 2, lines 7-18), an intake assembly (30 and 31, fig. 1, Col 2, lines 23-39) attached to the chamber, including a valve housing (valve housing is 32, see fig. 3, col 2, lines 19-39) enclosing a regulator disc having an aperture sized to permit a selected flow rate of gas into the chamber (Col 3, lines 54-61, Lea discloses that the intake assembly allows air to enter the chamber 16, the valve 30/31 is designed at a particular size by the designer, therefore, the air/gas that is being allowed to enter the chamber is a selected flow rate of gas, alternatively, Lea discloses that the pin 44 is pushed into valve body 32 manually against the bias of spring 45 to lift core 34 off of the shoulder of the counter bore 42, and when the pin is released, spring 45 expands to close the valve 31, which would allow the intake to be selectively controlled to allow a selected volume to come in, the disc is the wide cylinder 36 having apertures extending from apertures 39, see fig. 5, col 2, lines 19-43), an outtake assembly (50, 54, 57, 62, 64, 68, figs. 1 and 3) attached to the chamber and configured to permit a selected flow rate of gas out of the chamber (col 2, lines 60 to col 3, line 10, Col 3, lines 37-53, the outtake assembly are designed to allow a selected flow rate to move from the chamber to the patient), a first placement indicate configured to guide a user where to compress the chamber to expel a selected volume of gas from the chamber (see indicia 80, see Col 3, lines 24-36), wherein the chamber signals a user to compress the chamber after a predetermined amount of time, and prevents the full selected volume of gas from leaving the chamber if the chamber is compressed before the predetermined amount of time has elapsed (see col 2, line 44 to col 3, line 53 and full disclosure, Lea discloses that the bulb/chamber 16 is elastic, and that the user compress the bulb to expel air therefrom, and that the ball further limit manual compression of the bulb/chamber, therefore, when the user completely compress the chamber 16 to the maximum compression point, releasing of the elastic bulb would expand since valve 31 permit ambient air to enter, therefore the chamber would visually and tactilely signals a user to compress the chamber after a predetermined amount of time, since when the bulb is fully expanded would signal to the user to compress the chamber again, furthermore, before the time (predetermined amount of time) it takes to fully expanded, if the user was to try to compress the bulb midway (between fully compressed and fully expanded), a full selected volume of gas would be prevented from leaving the chamber, since a full selected volume of gas would be leaving the chamber when the user fully compress the bulb after the bulb has been fully expanded).
If there is any doubt that Lea discloses a valve housing enclosing a regulator disc having an aperture.
Myklebust teaches an intake assembly, the intake assembly has a valve housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) including a first regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) including an aperture (any aperture on 61, fig. 2B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the intake assembly of Lea to have the intake assembly as taught by Myklebust for the purpose of allowing the intake to be adjusted to accommodate different patient needs, thereby, providing comfort and safety to the patient (see paragraph 0024 of Myklebust).
Regarding claim 16, Lea or the modified Lea discloses that manual resuscitator regulating system includes a second placement indicator (78, see Col 3, lines 24-36 of Lea).
Regarding claim 17, Lea or the modified Lea discloses that the first placement indicator and the second placement indicator are configured to coordinate with each other to guide the user where to compress the chamber to expel the selected volume of gas from the chamber (see Col 3, lines 24-36 of Lea, Lea discloses that for an infant the user press the device as advised by instruction 80, the larger ball will limit the compression for the bulb to pass only a small amount of air versus the instruction 78, since the indicators are part of the same device and inflatable bladder, they are coordinated with each other to permit volume of gas out of the chamber).
Regarding claim 18, Lea or the modified Lea discloses that the first placement indicator and the second placement indicator includes a tactile target configured to provide a tactile signal to a user when a selected volume of gas has flowed out of the chamber (see fig. 1 of Lea, the instruction 80 and 78 of Lea comprise ridges, therefore, the ridge would provide a tactile target that would provide tactile signal to a user when a selected volume of gas flows out of the chamber, alternatively, Lea discloses ball 50 and 48, and that when the rescuer press against 80, the user would feel the ball stopping the pressing action, therefore, the balls 50 and 48 would provide a tactile signal, see Col 3, lines 24-36).
Regarding claim 19, Lea or the modified Lea discloses that the first placement indicator (80 and surrounding area of Lea) is configured to allow a user to selectively move finger or hand placement to select a volume of gas (see Col 3, lines 23-36 of Lea, Lea discloses the volume between pressure against at 80 and 78 are different, and the indicator 80 is a ridge that extends around 16, therefore, it allows the user to selectively move finger or hand placement to a different area to provide a selected volume of gas, alternatively, the user can move hand around 80 but closer to 78 to provide a different volume of gas).
Regarding claim 20, Lea or the modified Lea discloses that the first placement indicator (80 of Lea) is oriented circumferentially around the chamber (16, figs. 1-4 of Lea, if there is any doubt that 80 goes circumferentially around the chamber, 79 can be interpreted as first placement indicator, which as shown in fig. 2, goes around the chamber).
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.
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.
Claims 1-6, 9, 13-20 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Myklebust (2008/0314386) in view of Lea (3,046,978).
Regarding claim 1, Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber, including a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit selectable flow rate of gas into the chamber), an outtake assembly (assembly at the end of 11 holding V1 and V2, figs. 1-2A, paragraphs 0019-0025) attached to the chamber and configured to permit a selected flow rate of gas out of the chamber (paragraphs 0021 and 0033-0034, Myklebust discloses that V2 is for letting air from the bag 11 into the outlet 13 to the patient’s airway, the valve would have an opening that would permit a selected flow rate of gas out of the chamber), wherein the chamber provides tactile feedback to the user signaling when to compress the chamber (see paragraphs 0023-0026 and 0033, Myklebust disclose that the on/off valve may comprise a set function, where the user can set the maximum allowable rate to self inflation, for example between 6 and 16 ventilations per minute or some other value, the self-inflation of the chamber would provide a tactile feedback to the user, to signal to the user when to compress the chamber), but fails to disclose a grip placement indicator configured to guide a user where to compress the chamber to expel a selected volume of gas from the chamber.
However, Lea teaches a compressible chamber (16, fig. 1) has plural grip placement indicators for directing a user to deliver appropriate selectable gas volumes to a particular patient (see fig. 1, as shown, grip having indicia to indicate where to press for different age groups, see ridge 74, 76, 80, Col 3, lines 3-36) and balls (48 and 50).
Therefore, 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 chamber of Myklebust to have the plural grip placement indicators and balls for directing a user to deliver appropriate selectable gas volumes to a particular patient as taught by Lea for the purpose of providing safety to the patient by providing additional volume control for different size patient and to additionally guiding the rescuer as to where to press to provide proper volume of air based on the patient’s age (see Col 3, lines 3-36 of Lea).
Regarding claim 2, the modified Myklebust discloses a plural grip placement indicators for directing a user to deliver an appropriate volume to a patient (see the modification with Lea above and the plurality of grip indicators of Lea).
Regarding claim 3, the modified Myklebust discloses that the outtake assembly is configured to permit a selectable volume of gas out of the chamber over a predetermined amount of time (see paragraphs 0019, 0025, 0031 and 0033-0034 of Myklebust, Myklebust discloses that that valve V2 is an on/off valve that could be controlled by a controller, therefore, the volume of air is selectable over a predetermined amount of time by the controller, Myklebust discloses that the valve V2 can be an on off valve that is adjustable, between 6 and 16 ventilations per minute, the on-off valve comprises a selector to set the desired maximum number of self-inflations per minute, changing the self-inflations per minute would require to change the volume, see V4 and the design of V4 for reference, paragraphs 0023-0024 of Myklebust).
Regarding claim 4, the modified Myklebust discloses that the intake assembly (V4 comprising 51 of Myklebust) is configured to permit a selected volume of gas into the chamber over a predetermined amount of time (see paragraphs 0023-0024 of Myklebust, Myklebust discloses adjusting the opening of the intake to allow self-inflation rate to be adjusted, the self-inflation rate would affect the volume of air entering the chamber over a predetermined amount of time).
Regarding claim 5, the modified Myklebust discloses that the outtake assembly (V2 of Myklebust) includes adjustment mechanism configured to allow a user to selectively adjust the flow rate of gas permitted out of the chamber (see paragraphs 0033-0034 of Myklebust, Myklebust discloses that the valve V2 can have a selector that allows the desired maximum number of self-inflations per minute to be set, and as disclosed in paragraphs 0023-0024 of Myklebust, to adjust the self-inflation per minute would need to change the volume over time, alternatively, even if the valve V2 is just an on/off valve, an on/off valve would have an adjustment mechanism that would allow a user to selectively adjust the flow rate of gas permitted out of the chamber, when the valve is closed, there is no flow rate, and when the valve is opened, there is a selective amount of flow rate of gas permitted, wherein the adjustment mechanism would be the portion of the valve that allows the valve to be on and off).
Regarding claim 6, the modified Myklebust discloses that the intake assembly (V4 comprising 51 of Myklebust) includes an adjustment mechanism configured to allow a user to selectively adjust the flow rate of gas permitted into the chamber (see figs. 2A-2C and paragraphs 0023-0024 of Myklebust, Myklebust discloses that the valve V4 comprises a selector/dial 51 (adjustment mechanism) that allows self-inflation per minute to be adjusted by changing the orifice size of the inlet, this would change the flow rate of gas permitted into the chamber, since different sized opening would permit different flow rate).
Regarding claim 9, the modified Myklebust discloses that the adjustment mechanism (selector/dial 51 of Myklebust, see fig. 2A of Myklebust and rejection to claim 6 above) for the intake assembly having coordinated indicia to facilitate selection of relative gas flow between the intake and the outtake assembly (see fig. 2A and paragraphs 0023-0024 of Myklebust, Myklebust discloses indicia to indicate self-inflation rate, since the self-inflation rate is related to flow, due to the size of the orifice changing as shown in figs. 2B-2C of Myklebust, the indicia is coordinated with the adjustment mechanism of the intake assembly to facilitate desired relative gas flow between the intake and the outtake assembly).
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Regarding claim 13, the modified Myklebust discloses that the intake assembly (end assembly comprising V4 and 51 of Myklebust) and the outtake assembly (end assembly comprising V2 of Myklebust) are attached on opposite sides of the chamber (see the annotated-Myklebust fig. 1 above, relative to line 1, the first intake assembly and the outtake assembly are attached on opposite sides of the chamber).
Regarding claim 14, the modified Myklebust discloses that the intake assembly and the outtake assembly are attached on the same side of the chamber (see the annotated-Myklebust fig. 1 above, relative to line 2, the first intake assembly and the outtake assembly are attached on the same sides of the chamber).
Regarding claim 15, Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber, including a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit selectable flow rate of gas into the chamber), an outtake assembly (assembly at the end of 11 holding V1 and V2, figs. 1-2A, paragraphs 0019-0025) attached to the chamber and configured to permit a selected flow rate of gas out of the chamber (paragraphs 0021 and 0033-0034, Myklebust discloses that V2 is for letting air from the bag 11 into the outlet 13 to the patient’s airway, the valve would have an opening that would permit a selected flow rate of gas out of the chamber), wherein the chamber signals a user to compress the chamber after a predetermined amount of time, and prevents the full selected volume of gas from leaving the chamber if the chamber is compressed before the predetermined amount of time has elapsed (see paragraphs 0023-0026 and 0033, Myklebust disclose that the on/off valve may comprise a set function, where the user can set the maximum allowable rate to self inflation, for example between 6 and 16 ventilations per minute or some other value, the self-inflation of the chamber would signal to a user to compress the chamber after a predetermined amount of time, and prevents the full selected volume of gas from leaving the chamber if the chamber is compressed before the predetermined amount of time has elapsed, it is noted, that self-inflation would have multiple levels of inflation, therefore, if the user decided to compressed the bag midway (between maximum inflation and maximum deflation), the position of the bag/chamber at midway would prevent the full selected volume of gas from leaving the chamber if the chamber is compressed before the predetermined amount of time has elapsed (time it takes to be fully inflated), and the full inflation would signal to the user to compress the chamber, since when a bag is full, the full chamber would visually or tactically signal to the user that the bag is full, which takes place after a predetermined amount of time), but fails to disclose a first placement indicator configured to guide a user where to press the chamber to expel a selected volume of gas from the chamber.
However, Lea teaches a manual resuscitator regulating system (system shown in figs. 1-4), comprising a gas containing compressible chamber (16 and 18, fig. 1, Col 2, lines 7-18), an intake assembly (30 and 31, fig. 1, Col 2, lines 23-39) attached to the chamber and configured to permit a selected volume of gas in the chamber (Col 3, lines 54-61, Lea discloses that the intake assembly allows air to enter the chamber 16/18, the valve 30/31 is design at a particular size by the designer, therefore, the air that is being allowed to enter the chamber is a selected volume of gas, alternatively, Lea discloses that the pin 44 is pushed into valve body 32 manually against the bias of spring 45 to lift core 34 off of the shoulder of the counter bore 42, and when the pin is released, spring 45 expands to close the valve 31, which would allow the intake to be selectively controlled to allow a selected volume to come in), an outtake assembly (50, 54, 57, fig. 1) attached to the chamber and configured to expel a gas from the chamber (Col 3, lines 37-53), a plurality of placement indicator (78, 79, 80, figs. 1-4) comprising a first placement indicate configured to guide a user where to compress the chamber to permit a selected volume of gas out of the chamber (see indicia 80, see Col 3, lines 24-36) and balls (48 and 50).
Therefore, 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 chamber of Myklebust to have the plurality of placement indicators and balls as taught by Lea for the purpose of providing safety to the patient by providing additional volume control for different size patient and to additionally guiding the rescuer as to where to press to provide proper volume of air based on the patient’s age (see Col 3, lines 3-36 of Lea).
Regarding claim 16, the modified Myklebust discloses that manual resuscitator regulating system includes a second placement indicator (78, see Col 3, lines 24-36 of Lea).
Regarding claim 17, the modified Myklebust discloses that the first placement indicator and the second placement indicator are configured to coordinate with each other to guide the user where to compress the chamber to expel the selected volume of gas from the chamber (see Col 3, lines 24-36 of Lea, Lea discloses that for an infant the user press the device as advised by instruction 80, the larger ball will limit the compression for the bulb to pass only a small amount of air versus the instruction 78, therefore, after the modification with Myklebust the first placement indicator and the second placement indicator are configured to coordinate with each other to guide the user where to compress the chamber to expel the selected volume of gas from the chamber).
Regarding claim 18, the modified Myklebust discloses that the first placement indicator and the second placement indicator includes a tactile target configured to provide a tactile signal to a user when a selected volume of gas has flowed out of the chamber (see fig. 1 of Lea, the instruction 80 and 78 comprise ridges, therefore, the ridge would provide a tactile target that would provide tactile signal to a user when a selected volume of gas flows out of the chamber, alternatively, Lea discloses ball 50 and 48, and that when the rescuer press against 80, the user would feel the ball stopping the pressing action, therefore, the balls 50 and 48 would provide a tactile signal, see Col 3, lines 24-36).
Regarding claim 19, the modified Myklebust discloses that the first placement indicator (80 and surrounding area of Lea) is configured to allow a user to move finger or hand placement to select a volume of gas (see Col 3, lines 23-36 of Lea, Lea discloses the volume between pressure against at 80 and 78 are different, and the indicator 80 is a ridge that extends around 16, therefore, it allows the user to selectively move finger or hand placement to a different area to provide a selected volume of gas, alternatively, the user can move hand around 80 but closer to 78 to provide a different volume of gas).
Regarding claim 20, the modified Myklebust discloses that the first placement indicator (80 of Lea) is oriented circumferentially around the chamber (16 of Lea, figs. 1-4, if there is any doubt that 80 goes circumferentially around the chamber, 79 can be interpreted as first placement indicator, which as shown in fig. 2, goes around the chamber).
Regarding claim 28, the modified Myklebust discloses that the outtake assembly (assembly at the end of 11 holding V1 and V2, figs. 1-2A, paragraphs 0019-0025) includes a selector (see paragraphs 0033-0034 and 0040 of Myklebust, Myklebust discloses that V2 may be an on and off valve and can be manually operated), but fails to disclose a valve housing enclosing a regulator disc having an aperture sized to permit a selected flow rate of gas out of the chamber.
However, Myklebust teaches a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which can have an off and on setting).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify V2 of the outtake assembly of the modified Myklebust to have the valve housing and disc as taught by Myklebust for the purpose of providing a valve structure that is capable of turning on and off an outtake flow (see paragraphs 0023-0024 of Myklebust).
Regarding claim 29, the modified Myklebust fails to specifically disclose that the aperture of the regulator disc of the outtake assembly is larger than the aperture of the regulator disc of the intake assembly. However, 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 aperture of the regulator disc of the outtake assembly to be larger than the aperture of the regulator disc of the intake assembly for the purpose of allowing the different apertures of the intake assembly of Myklebust to function as intended (see paragraph 0024 and 0033-0034 and 0040 of Myklebust), and since it has been held that discovering an optimum range or workable range of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 30, the modified Myklebust discloses that the intake assembly and outtake assembly are configured to coordinate to deliver a selected tidal volume at a selected pressure (see paragraphs 0019-0040 of Myklebust, both the intake assembly and outtake assembly are designed to provide a flow at a flow rate and a pressure to the patient, therefore, are configured to coordinate to deliver a selected tidal volume at a selected pressure).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Myklebust (2008/0314386) in view of Lea (3,046,978) as applied to claim 9 above, and further in view of Bauman (5,140,982).
Regarding claim 12, the modified Myklebust discloses coordinated indicia (indicia shown in fig. 2A of V4 of Myklebust), but fails to disclose that the coordinated indicia is color coordinated.
However, Bauman teaches an indicia that is color coded (Col 6, lines 22-29).
Therefore, 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 coordinated indicia of the modified Myklebust to be color coded indicia as taught by Bauman for the purpose of providing a visual indication that is easily recognizable (see col 6, lines 22-29 of Bauman).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lea (3,046,978) alternatively in view of Myklebust (2008/0314386) as applied to claim 6 above, and further in view of Myklebust (2008/0314386).
Regarding claim 9, Lea or the modified Lea discloses that the one or more adjustment mechanisms, but fails to disclose that the one or more adjustment mechanisms have coordinated indicia to facilitate selection of relative gas flow between the intake and the outtake assemblies.
However, Myklebust teaches an intake assembly (V4 comprising 51) includes an adjustment mechanism configured to allow a user to selectively adjust the flow rate of gas permitted into the chamber (see figs. 2A-2C and paragraphs 0023-0024, Myklebust discloses that the valve V4 comprises a selector/dial 51 (adjustment mechanism) that allows self-inflation per minute to be adjusted by changing the orifice size of the inlet, this would change the flow rate of gas permitted into the chamber, since different sized opening would permit different flow rate), the adjustment mechanism (selector/dial 51, see fig. 2A) for the intake assembly having coordinated indicia to facilitate selection of relative gas flow between the intake and the outtake assembly (see fig. 2A and paragraphs 0023-0024, Myklebust discloses indicia to indicate self-inflation rate, since the self-inflation rate is related to flow, due to the size of the orifice changing as shown in figs. 2B-2C, the indicia is coordinated with the adjustment mechanism of the intake assembly to facilitate desired relative gas flow between the intake and the outtake assemblies).
Therefore, 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 intake assembly and the adjustment mechanism of Lea or the modified Lea to be the adjustment mechanism as taught by Myklebust for the purpose of providing an alternative adjustment mechanism for an intake assembly that would allow the user to clearly see the settings on the adjustment mechanism (see paragraphs 0023-0024 and fig. 2A of Myklebust).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lea (3,046,978) in view of Myklebust (2008/0314386) as applied to claim 9 above and further in view of Bauman (5,140,982).
Regarding claim 12, the modified Lea discloses coordinated indicia (indicia shown in fig. 2A of V4 of Myklebust), but fails to disclose that the coordinated indicia is color coordinated.
However, Bauman teaches an indicia that is color coded (Col 6, lines 22-29).
Therefore, 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 coordinated indicia of the modified Lea to be color coded indicia as taught by Bauman for the purpose of providing a visual indication that is easily recognizable (see col 6, lines 22-29 of Bauman).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Myklebust (2008/0314386) in view of Kim (2013/0180527).
Regarding claim 31, Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber having a flexible wall (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber and configured to permit air flow into the chamber at a pre-set in-flow rate (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit a pre-set in-flow rate of gas into the chamber), an outtake assembly (assembly at the end of 11 holding V1 and V2, figs. 1-2A, paragraphs 0019-0025) attached to the chamber and configured to deliver the pre-set repeatable volume of air to a patient when a user manually grips the flexible wall and compresses the compressible chamber (paragraphs 0021 and 0033-0034, Myklebust discloses that V2 is for letting air from the bag 11 into the outlet 13 to the patient’s airway, the valve would have an opening that would permit a selected flow rate of gas out of the chamber, furthermore, see paragraphs 0023-0026 and 0033, Myklebust disclose that the on/off valve may comprise a set function, where the user can set the maximum allowable rate to self inflation, for example between 6 and 16 ventilations per minute or some other value, the self-inflation of the chamber would provide a tactile feedback to the user, to signal to the user when to compress the chamber), wherein the intake assembly and the compressible chamber are configured to generate a finger-sensed compression signal when the compressible chamber has completely refill, indicating to the user that it is time to compress the compressible chamber again, wherein the pre-set volume of air delivered through use of the flexible wall, and a pace of repeatable compressions achieved through used of a series of alternating finger-sensed compression signals and finger sensed release signals results in a desired volume of air delivery to a patient in eight to twelve compressions per minute (Myklebust discloses that 11 is compressible and is compressed to provide a volume of air to the patient, and further discloses that there is an intake assembly allowing air to enter, therefore, when the chamber 11 is compressed, the intake assembly would allow intake of the pre-set volume over a time period, furthermore, see paragraphs 0023-0024 of Myklebust, Myklebust discloses that the setting for V4 is self-inflation per minute and discloses that the chamber 11 is compressible, therefore, when the chamber expands, that would be a signal to the user to recompress the chamber, furthermore, the finger sensed compression signals and finger sensed release signals of Myklebust can be done based on tactile feeling alone due to the compressibility and refillable nature of the chamber, furthermore, see paragraphs 0024 and 0033 of Myklebust, Myklebust discloses that the user can operate a dial 51 to set 8, 12, or 20 self-inflations per minute), but fails to disclose that the flexible wall of the chamber having a grip placement indicator configured to guide a user where to grip the chamber by hand, the grip placement indicator being configured to deliver a pre-set repeatable volume of air to a patient by manually compressing the grip placement indicator to a point where opposing portions of the flexible wall come into contact.
However, Kim teaches a manual resuscitator (resuscitator shown in figs. 1 and 7-8, paragraphs 0003 and 0040-0049) comprising a flexible wall (wall forming 20, figs. 1 and 7-8) having a grip placement indicators (see 60 comprising 81 and 83, see figs. 7-8 and paragraphs 0064-0067) configured to guide a user where to compress a chamber (20, figs. 1 and 7-8) to permit a pre-set volume of gas to flow out of the chamber (see paragraphs 0043 and 0046, there is a one way valve, the air is allowed to go through the one way valve would be preset by the designer/manufacturer), wherein outtake assembly (40 having a valve, see figs. 1 and 7-8 and paragraph 0046) attached to the chamber and configured to permit a pre-set volume of air to flow out of the chamber when the chamber is properly gripped on the grip placement indicators, and manually compressed to a point where portions of the flexible wall associated with the first and second grip placement indicators are in contact (see figs. 7 and 8 and paragraphs 0042-0072).
Therefore, 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 chamber and flexible wall of Myklebust to have the flexible wall have the placement indicator as taught by Kim for the purpose of providing efficient resuscitation by providing indicators to signal to the user on where to correctly place the fingers, thereby providing accurate, constant and appropriate ventilation amount of air to the patient (see paragraphs 0009-0013 and 0029 of Kim).
After the modification with Kim, the flexible wall of the chamber having a grip placement indicator configured to guide a user where to grip the chamber by hand, the grip placement indicator being configured to deliver a pre-set repeatable volume of air to a patient by manually compressing the grip placement indicator to a point where opposing portions of the flexible wall come into contact and the outtake assembly attached to the chamber and configured to deliver the pre-set repeatable volume of air to a patient when a user manually grips the grip placement indicator and compresses the compressible chamber to the point where opposing portions of the flexible wall come into contact, the contact generating a finger sensed release signal as explained above.
Claims 1-6, 9, 13-20 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Myklebust (2008/0314386) in view of Kim (2013/0180527).
Regarding claim 1, Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber, including a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit selectable flow rate of gas into the chamber), an outtake assembly (assembly at the end of 11 holding V1 and V2, figs. 1-2A, paragraphs 0019-0025) attached to the chamber and configured to permit a selected flow rate of gas out of the chamber (paragraphs 0021 and 0033-0034, Myklebust discloses that V2 is for letting air from the bag 11 into the outlet 13 to the patient’s airway, the valve would have an opening that would permit a selected flow rate of gas out of the chamber), wherein the chamber provides tactile feedback to the user signaling when to compress the chamber (see paragraphs 0023-0026 and 0033, Myklebust disclose that the on/off valve may comprise a set function, where the user can set the maximum allowable rate to self inflation, for example between 6 and 16 ventilations per minute or some other value, the self-inflation of the chamber would provide a tactile feedback to the user, to signal to the user when to compress the chamber), but fails to disclose a grip placement indicator configured to guide a user where to compress the chamber to expel a selected volume of gas from the chamber.
However, Kim teaches a manual resuscitator (resuscitator shown in figs. 1 and 7-8, paragraphs 0003 and 0040-0049) comprising a flexible wall (wall forming 20, figs. 1 and 7-8) having a grip placement indicators (see 60 comprising 81 and 83, see figs. 7-8 and paragraphs 0064-0067) configured to guide a user where to compress a chamber (20, figs. 1 and 7-8) to permit a pre-set volume of gas to flow out of the chamber (see paragraphs 0043 and 0046, there is a one way valve, the air is allowed to go through the one way valve would be preset by the designer/manufacturer), wherein outtake assembly (40 having a valve, see figs. 1 and 7-8 and paragraph 0046) attached to the chamber and configured to permit a pre-set volume of air to flow out of the chamber when the chamber is properly gripped on the grip placement indicators, and manually compressed to a point where portions of the flexible wall associated with the first and second grip placement indicators are in contact (see figs. 7 and 8 and paragraphs 0042-0072).
Therefore, 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 chamber of Myklebust to have the flexible wall have the placement indicator as taught by Kim for the purpose of providing efficient resuscitation by providing indicators to signal to the user on where to correctly place the fingers, thereby providing accurate, constant and appropriate ventilation amount of air to the patient (see paragraphs 0009-0013 and 0029 of Kim).
Regarding claim 2, the modified Myklebust discloses a plural grip placement indicators for directing a user to deliver an appropriate volume to a patient (see the modification with Kim above and the plurality of grip indicators of Kim).
Regarding claim 3, the modified Myklebust discloses that the outtake assembly is configured to permit a selectable volume of gas out of the chamber over a predetermined amount of time (see paragraphs 0019, 0025, 0031 and 0033-0034 of Myklebust, Myklebust discloses that that valve V2 is an on/off valve that could be controlled by a controller, therefore, the volume of air is selectable over a predetermined amount of time by the controller, Myklebust discloses that the valve V2 can be an on off valve that is adjustable, between 6 and 16 ventilations per minute, the on-off valve comprises a selector to set the desired maximum number of self-inflations per minute, changing the self-inflations per minute would require to change the volume, see V4 and the design of V4 for reference, paragraphs 0023-0024 of Myklebust).
Regarding claim 4, the modified Myklebust discloses that the intake assembly (V4 comprising 51 of Myklebust) is configured to permit a selected volume of gas into the chamber over a predetermined amount of time (see paragraphs 0023-0024 of Myklebust, Myklebust discloses adjusting the opening of the intake to allow self-inflation rate to be adjusted, the self-inflation rate would affect the volume of air entering the chamber over a predetermined amount of time).
Regarding claim 5, the modified Myklebust discloses that the outtake assembly (V2 of Myklebust) includes adjustment mechanism configured to allow a user to selectively adjust the flow rate of gas permitted out of the chamber (see paragraphs 0033-0034 of Myklebust, Myklebust discloses that the valve V2 can have a selector that allows the desired maximum number of self-inflations per minute to be set, and as disclosed in paragraphs 0023-0024 of Myklebust, to adjust the self-inflation per minute would need to change the volume over time, alternatively, even if the valve V2 is just an on/off valve, an on/off valve would have an adjustment mechanism that would allow a user to selectively adjust the flow rate of gas permitted out of the chamber, when the valve is closed, there is no flow rate, and when the valve is opened, there is a selective amount of flow rate of gas permitted, wherein the adjustment mechanism would be the portion of the valve that allows the valve to be on and off).
Regarding claim 6, the modified Myklebust discloses that the intake assembly (V4 comprising 51 of Myklebust) includes an adjustment mechanism configured to allow a user to selectively adjust the flow rate of gas permitted into the chamber (see figs. 2A-2C and paragraphs 0023-0024 of Myklebust, Myklebust discloses that the valve V4 comprises a selector/dial 51 (adjustment mechanism) that allows self-inflation per minute to be adjusted by changing the orifice size of the inlet, this would change the flow rate of gas permitted into the chamber, since different sized opening would permit different flow rate).
Regarding claim 9, the modified Myklebust discloses that the adjustment mechanism (selector/dial 51 of Myklebust, see fig. 2A of Myklebust and rejection to claim 6 above) for the intake assembly having coordinated indicia to facilitate selection of relative gas flow between the intake and the outtake assembly (see fig. 2A and paragraphs 0023-0024 of Myklebust, Myklebust discloses indicia to indicate self-inflation rate, since the self-inflation rate is related to flow, due to the size of the orifice changing as shown in figs. 2B-2C of Myklebust, the indicia is coordinated with the adjustment mechanism of the intake assembly to facilitate desired relative gas flow between the intake and the outtake assembly).
Regarding claim 13, the modified Myklebust discloses that the intake assembly (end assembly comprising V4 and 51 of Myklebust) and the outtake assembly (end assembly comprising V2 of Myklebust) are attached on opposite sides of the chamber (see the annotated-Myklebust fig. 1 above, relative to line 1, the first intake assembly and the outtake assembly are attached on opposite sides of the chamber).
Regarding claim 14, the modified Myklebust discloses that the intake assembly and the outtake assembly are attached on the same side of the chamber (see the annotated-Myklebust fig. 1 above, relative to line 2, the first intake assembly and the outtake assembly are attached on the same sides of the chamber).
Regarding claim 15, Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber, including a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit selectable flow rate of gas into the chamber), an outtake assembly (assembly at the end of 11 holding V1 and V2, figs. 1-2A, paragraphs 0019-0025) attached to the chamber and configured to permit a selected flow rate of gas out of the chamber (paragraphs 0021 and 0033-0034, Myklebust discloses that V2 is for letting air from the bag 11 into the outlet 13 to the patient’s airway, the valve would have an opening that would permit a selected flow rate of gas out of the chamber), wherein the chamber signals a user to compress the chamber after a predetermined amount of time, and prevents the full selected volume of gas from leaving the chamber if the chamber is compressed before the predetermined amount of time has elapsed (see paragraphs 0023-0026 and 0033, Myklebust disclose that the on/off valve may comprise a set function, where the user can set the maximum allowable rate to self inflation, for example between 6 and 16 ventilations per minute or some other value, the self-inflation of the chamber would signal to a user to compress the chamber after a predetermined amount of time, and prevents the full selected volume of gas from leaving the chamber if the chamber is compressed before the predetermined amount of time has elapsed, it is noted, that self-inflation would have multiple levels of inflation, therefore, if the user decided to compressed the bag midway (between maximum inflation and maximum deflation), the position of the bag/chamber at midway would prevent the full selected volume of gas from leaving the chamber if the chamber is compressed before the predetermined amount of time has elapsed (time it takes to be fully inflated), and the full inflation would signal to the user to compress the chamber, since when a bag is full, the full chamber would visually or tactically signal to the user that the bag is full, which takes place after a predetermined amount of time), but fails to disclose a first placement indicator configured to guide a user where to press the chamber to expel a selected volume of gas from the chamber.
However, Kim teaches a manual resuscitator (resuscitator shown in figs. 1 and 7-8, paragraphs 0003 and 0040-0049) comprising a flexible wall (wall forming 20, figs. 1 and 7-8) having a grip placement indicators (see 60 comprising 81 and 83, see figs. 7-8 and paragraphs 0064-0067) configured to guide a user where to compress a chamber (20, figs. 1 and 7-8) to permit a pre-set volume of gas to flow out of the chamber (see paragraphs 0043 and 0046, there is a one way valve, the air is allowed to go through the one way valve would be preset by the designer/manufacturer), wherein outtake assembly (40 having a valve, see figs. 1 and 7-8 and paragraph 0046) attached to the chamber and configured to permit a pre-set volume of air to flow out of the chamber when the chamber is properly gripped on the grip placement indicators, the grip placement indicator being configured to deliver a pre-set repeatable volume of air to a patient by manually compressing the grip placement indicator to a point where opposing portions of the flexible wall come into contact (the first grip placement indicator can be 60 comprising 83, E, C D and B and the second indicator can be 81 or the first placement indicator can be the circumferential portion of the flexible wall that comprises 81 and 83, while the second indicator can be E, D, B, see figs. 7 and 8 and paragraphs 0042-0072).
Therefore, 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 chamber of Myklebust to have the flexible wall have the placement indicator as taught by Kim for the purpose of providing efficient resuscitation by providing indicators to signal to the user on where to correctly place the fingers, thereby providing accurate, constant and appropriate ventilation amount of air to the patient (see paragraphs 0009-0013 and 0029 of Kim).
Regarding claim 16, the modified Myklebust discloses that manual resuscitator regulating system includes a second placement indicator (81 or E, D and B of 60 in figs. 7-8 and paragraphs 0064-0065 of Kim).
Regarding claim 17, the modified Myklebust discloses that the first placement indicator and the second placement indicator (the first grip placement indicator can be 60 comprising 83, E, C D and B and the second indicator can be 81 or the first placement indicator can be the circumferential portion of the flexible wall that comprises 81 and 83, while the second indicator can be E, D, B, see figs. 7 and 8 and paragraphs 0042-0072) are configured to coordinate with each other to guide the user where to compress the chamber to expel the selected volume of gas from the chamber (figs. 7-8 and paragraphs 0064-0065 of Kim).
Regarding claim 18, the modified Myklebust discloses that the first placement indicator and the second placement indicator (the first grip placement indicator can be 60 comprising 83, E, C D and B and the second indicator can be 81 or the first placement indicator can be the circumferential portion of the flexible wall that comprises 81 and 83, while the second indicator can be E, D, B, see figs. 7 and 8 and paragraphs 0042-0072) includes a tactile target configured to provide a tactile signal to a user when a selected volume of gas has flowed out of the chamber (see 81 and see 60 comprising 83 in figs. 7-8 and paragraphs 0064-0065 of Kim, Kim discloses boundary lines printed onto the chamber, therefore, when the chamber is fully compressed, the first and second placement indicators would provide a tactile target that would provide a tactile signal to a user when a selected volume of gas has flowed out of the chamber).
Regarding claim 19, the modified Myklebust discloses that the first placement indicator (60 having 83, E, D, C and B or the circumferential portion of the flexible wall comprising 81 and 83 of Kim) is configured to allow a user to move finger or hand placement to select a volume of gas (see figs. 7-8 and paragraphs 0064-0065 of Kim).
Regarding claim 20, the modified Myklebust discloses that the first placement indicator is oriented circumferentially around the chamber (the first placement indicator can be defined as the circumferential portion of the chamber that comprises 81 and 83, see figs. 7-8 and paragraphs 0064-0065 of Kim).
Regarding claim 28, the modified Myklebust discloses that the outtake assembly (assembly at the end of 11 holding V1 and V2, figs. 1-2A, paragraphs 0019-0025) includes a selector (see paragraphs 0033-0034 and 0040 of Myklebust, Myklebust discloses that V2 may be an on and off valve and can be manually operated), but fails to disclose a valve housing enclosing a regulator disc having an aperture sized to permit a selected flow rate of gas out of the chamber.
However, Myklebust teaches a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which can have an off and on setting).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify V2 of the outtake assembly of the modified Myklebust to have the valve housing and disc as taught by Myklebust for the purpose of providing a valve structure that is capable of turning on and off an outtake flow (see paragraphs 0023-0024 of Myklebust).
Regarding claim 29, the modified Myklebust fails to specifically disclose that the aperture of the regulator disc of the outtake assembly is larger than the aperture of the regulator disc of the intake assembly. However, 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 aperture of the regulator disc of the outtake assembly to be larger than the aperture of the regulator disc of the intake assembly for the purpose of allowing the different apertures of the intake assembly of Myklebust to function as intended (see paragraph 0024 and 0033-0034 and 0040 of Myklebust), and since it has been held that discovering an optimum range or workable range of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 30, the modified Myklebust discloses that the intake assembly and outtake assembly are configured to coordinate to deliver a selected tidal volume at a selected pressure (see paragraphs 0019-0040 of Myklebust, both the intake assembly and outtake assembly are designed to provide a flow at a flow rate and a pressure to the patient, therefore, are configured to coordinate to deliver a selected tidal volume at a selected pressure).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Myklebust (2008/0314386) in view of Kim (2013/0180527) as applied to claim 9 above, and further in view of Bauman (5,140,982).
Regarding claim 12, the modified Myklebust discloses coordinated indicia (indicia shown in fig. 2A of V4), but fails to disclose that the coordinated indicia is color coordinated.
However, Bauman teaches an indicia that is color coded (Col 6, lines 22-29).
Therefore, 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 coordinated indicia of the modified Myklebust to be color coded indicia as taught by Bauman for the purpose of providing a visual indication that is easily recognizable (see col 6, lines 22-29 of Bauman).
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 9, 13-20 and 30 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent No. 11,247,020 in view of Myklebust (2008/0314386).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the patented claims are minor and obvious from each other. For example, the instant claims 1-6, 9, 13-20 and 30 are a broader version of the patented claims 1-20 (i.e., the instant claims 1-6, 9, 13-20 and 30 do not include the first pre-set in-flow rate being greater than the second pre-set in flow rate as in the patented claims 1-20). In the instant claims 1-6, 9, 13-20 and 30, the device included in the patented claims 1-20. Any infringement over the patented claims would also infringe over the instant claims. Therefore, the instant claims 1-6, 9, 13-20 and 30 do not differ in scope from the patented claims 1-20. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
With respect to the additional features recited in claims 1-6, 9, 13-20 and 30, the patented claims 1-20 fail to recite the inclusion of the intake assembly including a valve housing enclosing a regulator disc having an aperture.
Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber, including a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit selectable flow rate of gas into the chamber).
Therefore, 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 intake assembly of the patented claims 1-20 to have the regulator disc as taught by Myklebust for the purpose of providing an alternative intake assembly that would provide the predictable result of allowing the flow rate to be adjusted (see paragraph 0024 of Myklebust).
Instant claim 1 corresponds to the modified patented claims 1-20.
Instant claim 2 corresponds to the modified patented claims 1-20.
Instant claim 3 corresponds to the modified patented claims 1-20.
Instant claim 4 corresponds to the modified patented claims 1-20.
Instant claim 5 corresponds to the modified patented claim 5.
Instant claim 6 corresponds to the modified patented claims 1-20.
Instant claim 9 corresponds to the modified patented claims 1-20.
Instant claim 13 corresponds to the modified patented claim 13.
Instant claim 14 corresponds to the modified patented claim 14.
Instant claim 15 corresponds to the modified patented claims 1-20.
Instant claim 16 corresponds to the modified patented claims 1-20.
Instant claim 17 corresponds to the modified patented claims 1-20.
Instant claim 18 corresponds to the modified patented claim 18.
Instant claim 19 corresponds to the modified patented claim 19.
Instant claim 20 corresponds to the modified patented claim 20.
Instant claim 30 corresponds to the modified patented claims 1-20.
Claim 12 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent No. 11,247,020 in view of Bauman (5,140,982) and Myklebust (2008/0314386).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claim and the patented claims are minor and obvious from each other. For example, the instant claim 12 is a broader version of the patented claims 1-20 (i.e., the instant claim 12 does not include the first pre-set in-flow rate being greater than the second pre-set in flow rate as in the patented claims 1-20). In the instant claim 12, the device included in the patented claims 1-20. Any infringement over the patented claims would also infringe over the instant claims. Therefore, the instant claim 12 does not differ in scope from the patented claims 1-20. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
With respect to the additional features recited in claim 12, the patented claims 1-20 recited that the adjustment mechanism including coordinated indicia that includes a first indicia (first index) and second indicia (second index) (see patented claim 1), but fail to recite the inclusion of the coordinated indicia are color coordinated.
However, Bauman teaches an indicia that is color coded (Col 6, lines 22-29).
Therefore, 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 coordinated indicia of patented claims 1-20 to be color coded indicia as taught by Bauman for the purpose of providing a visual indication that is easily recognizable (see col 6, lines 22-29 of Bauman).
With respect to the additional features recited in claim 12, the patented claims 1-20 fail to recite the inclusion of the intake assembly including a valve housing enclosing a regulator disc having an aperture.
Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber, including a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit selectable flow rate of gas into the chamber).
Therefore, 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 intake assembly of the modified patented claims 1-20 to have the regulator disc as taught by Myklebust for the purpose of providing an alternative intake assembly that would provide the predictable result of allowing the flow rate to be adjusted (see paragraph 0024 of Myklebust).
Claim 28 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent No. 11,247,020 in view of Myklebust (2008/0314386).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the patented claims are minor and obvious from each other. For example, the instant claim 28 is a broader version of the patented claims 1-20 (i.e., the instant claim 28 does not include the first pre-set in-flow rate being greater than the second pre-set in flow rate as in the patented claims 1-20). In the instant claim 28, the device included in the patented claims 1-20. Any infringement over the patented claims would also infringe over the instant claims. Therefore, the instant claim 28 does not differ in scope from the patented claims 1-20. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
With respect to the additional features recited in claim 28, the patented claims 1-20 fail to recite the inclusion of the intake assembly including a valve housing enclosing a regulator disc having an aperture.
Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber, including a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit selectable flow rate of gas into the chamber).
Therefore, 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 intake assembly of the patented claims 1-20 to have the regulator disc as taught by Myklebust for the purpose of providing an alternative intake assembly that would provide the predictable result of allowing the flow rate to be adjusted (see paragraph 0024 of Myklebust).
With respect to the additional features recited in claim 28, the modified patented claims 1-20 fail to recite the inclusion of the outtake assembly including a valve housing enclosing a regulator disc having an aperture.
However, Myklebust teaches a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which can have an off and on setting).
Therefore, 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 outtake assembly of the modified patented claims 1-20 to have the valve housing and disc as taught by Myklebust for the purpose of providing a valve structure that is capable of turning on and off an outtake flow in order to permit a selected flow rate of gas out of the chamber (see paragraphs 0023-0024 of Myklebust).
Claim 29 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent No. 11,247,020 in view of Myklebust (2008/0314386).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the patented claims are minor and obvious from each other. For example, the instant claim 29 is a broader version of the patented claims 1-20 (i.e., the instant claim 29 does not include the first pre-set in-flow rate being greater than the second pre-set in flow rate as in the patented claims 1-20). In the instant claim 29, the device included in the patented claims 1-20. Any infringement over the patented claims would also infringe over the instant claims. Therefore, the instant claim 29 does not differ in scope from the patented claims 1-20. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
With respect to the additional features recited in claim 29, the patented claims 1-20 fail to recite the inclusion of the intake assembly including a valve housing enclosing a regulator disc having an aperture.
Myklebust discloses a manual resuscitator regulating system (10 shown in fig. 2A and fig. 1, wherein V3 is omitted, see paragraphs 0021 and 0024) comprising: a gas containing compressible chamber (11, figs. 1-2A, paragraphs 0019 and 0009, Myklebust discloses that the self-inflating bag 11 is compressed to produce outgoing flow); an intake assembly (assembly at the end of 11 holding V4 comprising 51, fig. 2A, paragraph 0024) attached to the chamber, including a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which is an adjustable restriction, therefore, would permit selectable flow rate of gas into the chamber).
Therefore, 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 intake assembly of the patented claims 1-20 to have the regulator disc as taught by Myklebust for the purpose of providing an alternative intake assembly that would provide the predictable result of allowing the flow rate to be adjusted (see paragraph 0024 of Myklebust).
With respect to the additional features recited in claim 29, the modified patented claims 1-20 fail to recite the inclusion of the outtake assembly including a valve housing enclosing a regulator disc having an aperture.
However, Myklebust teaches a valve housing enclosing a regulator disc (see regulator disc 61 in fig. 2B being housed within a housing (51 and portion housing 61, see the annotated-Myklebust fig. 2C above) in figs. 2A and 2C, paragraph 0024) having an aperture sized to permit selectable flow rate of gas into the chamber (figs. 2A-2C, paragraphs 0023-0024, the intake assembly comprises V4 which can have an off and on setting).
Therefore, 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 outtake assembly of the modified patented claims 1-20 to have the valve housing and disc as taught by Myklebust for the purpose of providing a valve structure that is capable of turning on and off an outtake flow in order to permit a selected flow rate of gas out of the chamber (see paragraphs 0023-0024 of Myklebust).
With respect to the additional features recited in claim 29, the modified patented claims 1-20 fail to recite the inclusion of the aperture of the regulator disc of the outtake assembly is larger than the aperture of the regulator disc of the intake assembly.
However, 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 aperture of the regulator disc of the outtake assembly of the modified patented claims 1-20 to be larger than the aperture of the regulator disc of the intake assembly for the purpose of allowing the different apertures of the intake assembly of the modified patented claims 1-20 to function as intended, and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. MPEP 2144.05(II)
Response to Arguments
Applicant's arguments filed 9/29/2025 have been fully considered but they are not persuasive.
The applicant on pages 11-16 of the remarks and the declarations filed on 9/29/2025 argues that the claimed invention satisfies significant long felt need in the medical field. According to the remarks, the long felt need is for a manual resuscitator that ensures both proper rate and volume of respiration and further stated that the long felt need is for improved BVMs. A first group of the references teach some means of guidance for timing of bag compressions, to achieve appropriate respiratory rate. However, the devices disclosed in these references do not ensure delivery of an appropriate volume. Included in this first group are Myklebust (2008/0314386), Kroupa (2008/0053445), Lee (2012/0222677), Gray, and Al-Ali (2015/0238722), Kim (2013/0180527) and Lea (3,046,978). A second group of references teach some means of guidance for grip or extent of bag compression, to deliver appropriate volume. However, the devices disclosed in these references do not ensure an appropriate respiratory rate. Included in this second group are Lea and Lee. Kim discloses a BVM with identification marks for placement of an operator’s fingers to achieve a constant ventilator amount of air, and teaches an auxiliary electronic alarming unit for timing compressions, however, the device disclosed by Kim does not meet the long felt need, is not available for sale, and has not been implemented by the emergency medical community. The alarm sounds or visual alarming signals produced by the alarming unit are not effective to ensure a proper rate of respiration in the environments where BVMs are used. As documented in the attached declaration documents, BVM operators must perform a variety of tasks in addition to correct compression. For example, the user may need to observe and evaluate efficacy of respiratory interventions via vital signs monitoring and visualization of chest rise when applicable, watch for airway secretions and suction needs, participate in team discussion of patient status and evolving plan or care, and/or participate in medical transport of the patient. These other responsibilities require the use of the operator’s visual and auditory senses, and would impact the operator’s ability to consistently and effectively attend to an alarm sound or visual signal. The BVM disclosed by Kim provides no feedback to a user if compressions are performed out of sync with the signals of the timer, so a distracted operator or one under the influence of adrenaline in an emergency situation might easily perform incorrectly time compressions without being aware of having done so. Therefore, the BVM disclosed by Kim fails to ensure a proper rate of respiration. In contrast, the claimed invention provides tactile feedback to an operator, for both the proper volume and rate of respiration. In addition, an operator who did not wait for the bag to refill, and thereby signal the correct timing of the next compression, would feel a difference in the resulting compression and receive tactile feedback as to their incorrect operation of the BVM. The volume delivered by that incorrectly timed compression would also be reduced. Therefore, the claimed invention meets the need for a manual resuscitator that ensures both proper rate and volume of respiration, while the prior art has failed to do so. Furthermore, in the declarations filed by James DuCanto and Brad Wheeler stated that hyperventilation from misuse or excessive use is common in practice and the current claimed invention solve the above stated issue by providing manual signals to the user including compression until fingers touch through the bag wall, and (b) compression again when the bag stops exerting a refill pressure on the user’s hand.
However, the arguments are not persuasive because in all of the declarations submitted, it is unclear as to what the long felt need is, the declarations fail to specifically point out the long felt need that was recognized, persistent, and not solved by others, and how the prior arts fail to meet that long felt need. Furthermore, the applicant accused that just because documents show that BVMs are consistently misuse, does not equates to the prior art not capable or will not satisfy the long felt need, that is assuming the long felt need is a BVM that prevents misuses, furthermore, the electronic device of Kroupa would prevent misuse, or the device of Lea, Kim and Myklebust would prevent misuse, since the flexible chamber can signal to the user when the chamber is completely refilled in the same manner as the applicant’s chamber, for example, Myklebust discloses in paragraph 0024 that there is an intake assembly V4 that allows the self-inflations per minute to be set to 8, 12, and 20 self-inflations per minute, this would reduce misuse in the same manner as the applicant’s invention in that the self-inflation of the bag is limited to only 8 self-inflations per minute, which would mean that the operator can only fully compress a maximum of 8 squeezes per minute. Furthermore, if the long felt need is for improved BVM as stated in page 4, bullet point 9 of McCollum’s declaration, then it is unclear as to how other device in the prior art does not improve BVM, any manual resuscitator invented in the past, would be considered as an improvement, relatively speaking. If the long felt need is a simple and effective manual resuscitator, then the reference Lea would meet that long felt need. Furthermore, if the long felt need is a manual resuscitator that allows the user to know when the chamber has completely refills, any art having a flexible chamber that can be compressed and is allowed to be expanded such as the chamber of Myklebust, Lea, Kim etc., would have met this long felt need. In response to the applicant’s arguments that the long felt need is a manual resuscitator that ensures both proper rate and volume of respiration. The argument is not persuasive since any of the cited references would satisfy the long felt need of being a manual resuscitator that ensures both proper rate and volume of respiration, since all the devices comprise an elastic bulb and a specific inlet opening, and a specific outlet opening, any amount of air leaving the elastic bulb of the prior art would ensure that a proper rate and volume of respiration is provided. Furthermore, any of the elastic bulb would allow the user to tactically feel when full inflation takes place and when full deflation takes place in the same manner as the applicant’s invention. Regarding the declarations of James DuCanto and Brad Wheeler, it appears that the long felt need is a BVM that provides manual signals to the user including compression until fingers touch through the bag wall, and (b) compression again when the bag stops exerting a refill pressure on the user’s hand, however, this long felt need would be met by Kim, which discloses a flexible chamber that can be felt when the walls contact and be felt when the flexible chamber is inflated (see figs. 6 and 8 and paragraphs 0074-0087). Furthermore, Myklebust also discloses in paragraph 0024 that the bag self inflates at a rate of 8, 12, or 20 compressions per minute, the bulb would provide a tactile sensation when inflated and squeezed. Furthermore, as stated above, it is not clear what the long felt need is, evidence that that long felt need was recognized, persistent and no solved by others. Furthermore, if the long felt need is an improved resuscitator or a resuscitator that prevents hyperventilation or a simple resuscitator that provided tactile feedback, it is noted that each of the long felt needs does not commensurate with the claims, the amended claims 1-6, 9, 12-20 and 28-30 claim an intake assembly comprising a valve housing enclosing a regulator disc having an aperture sized to permit a selected flow rate of gas into the chamber or claim 31 claims a manual resuscitator comprising a pace of repeatable compression achieve through use of a series of alternating finger-sensed compression signals and finger sensed release signals results in a desired volume of air delivery to a patient in eight to twelve compressions per minute. The applicant’s declarations have not clearly established a long felt need that the claimed invention satisfied and which was recognized, persistent, and have not been solved by others. Therefore, the rejection still stands.
The arguments to the newly added claim limitations in claims 1-6, 9, 12-20 and 28-31 has been addressed in the above rejection.
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.
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/TU A VO/Primary Examiner, Art Unit 3785