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 .
Claim Objections
Claim(s) 1-16 is/are objected to because of the following informalities:
Claim 1, Ln. 9-10 recites “a first position to a second position” which should read “the first position to the second position” following after Ln. 7-8
Claim 15, Ln. 15-16 recites “a first position to a second position” which should read “the first position to the second position” following after Ln. 13-14
Claim 15, Ln. 32 recites “a power source” where the indent of the limitation should be moved leftward in order to clearly identify the power source as a separate component of the system and not part of the body
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 15-16 is/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.
Claim 15 recites the limitations “a system” in Ln. 3, “the resuscitation/ventilation system” in Ln. 5, and “the system” in Ln. 5. As an initial matter there is insufficient antecedent basis for the limitation “the resuscitation/ventilation system” in the claim. Additionally, it is unclear whether a single system is being claimed or multiple systems. It appears only a single system is being claimed. Thus, for the purposes of examination the second limitation will be interpreted as reading “the system”.
Claim 15 recites the limitations “a tube” in Ln. 34 which deems the claim indefinite. The claim has earlier recited a respiratory circuit of which the presently claimed tube appears to be an element. However, the claim has not recited the tube as part of the respiratory circuit which makes it appear the tube is in addition to the previously recited respiratory circuit. For the purposes of examination the limitation will be interpreted as reading “a tube of the respiratory circuit”.
Claim Interpretation - 35 USC § 112(f)
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: “engagement mechanism” in claim 6 and “patient airway mechanism” in claim 15.
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.
The corresponding structure for the “engagement mechanism” is best understood from the specification as at least: engagement mechanism 430 as knob 430 (¶¶0058, 0066).
The corresponding structure for the “patient airway mechanism” is best understood from the specification as at least: patient mask 265 (¶0079).
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 § 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 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-5, 8-12, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Younes (U.S. Patent 5044362) in view of Pfeiffer et al. (U.S. Patent 6158430).
Regarding claim 1, Younes discloses a system (Fig. 1; Col. 3, Ln. 41 – Col. 4, Ln. 27) comprising: a first set of components (generally upper half internal components of Fig. 1) configured to be inserted into a body (Fig. 1 #12; Col. 3, Ln. 41 – Col. 4, Ln. 27), the first set of components comprising: a hollow cylindrical chamber (Fig. 1 #24; Col. 3, Ln. 41 – Col. 4, Ln. 27); a piston (Fig. 1 #14; Col. 3, Ln. 41 – Col. 4, Ln. 27) sized and shaped to fit within the hollow cylindrical chamber; an opening (Fig. 1 leading into #32; Col. 3, Ln. 41 – Col. 4, Ln. 27) in the hollow cylindrical chamber through which gas may pass into a respiratory circuit (Fig. 1 #34; Col. 3, Ln. 41 – Col. 4, Ln. 27) for a patient as the piston translates between a first position within the chamber and a second position within the chamber (Col. 3, Ln. 41 – Col. 4, Ln. 27); a motor (Fig. 1 #16; Col. 3, Ln. 41 – Col. 4, Ln. 27) configured to move the piston from the first position to the second position and subsequently move the piston from the second position to the first position within the hollow cylindrical chamber; a first communication/power interface coupling portion (Fig. 1 where #58, 60 connect to #16; Col. 4, Ln. 62 – Col. 5, Ln. 22) configured to couple to a corresponding second communication/power interface coupling portion (Fig. 1 where #58, 60 connect to #22; Col. 4, Ln. 62 – Col. 5, Ln. 22) and establish communicative and electrical coupling between the first set of components and the body; the body, the body comprising: a controller (Fig. 1 #22; Col. 5, Ln. 7-22) configured to control the motor; the second communication/power interface coupling portion configured to couple to the first communication/power interface coupling portion and establish communicative and electrical coupling between the first set of components and the body (Col. 4, Ln. 62 – Col. 5, Ln. 22); and a power source (Fig. 1 #18) configured to provide electrical power to the body and the first set of components. The claim is afforded an effective filing date of 05 Apr 2021 as it does not appear supported by the disclosure of the provisional application to which the instant application claims priority benefit.
Younes fails to disclose the first set of components formed as a canister to be removably inserted into an opening in the body; the body comprising: the opening configured for acceptance of a portion of the canister therein. It is noted that the language “removably inserted into an opening in a body” is understood to imply an accessible hole in the body through which the canister can be readily inserted or removed without causing harm to the body.
Pfeiffer teaches a ventilator system (Figure; Col. 2, Ln. 43 – Col. 4, Ln. 50) comprising a ventilator (one of #2A, 2B; Col. 2, Ln. 43-54) to be removably inserted into an opening (left side recess in #4A, 4B, 4C, 4D) in a docking station (one of #4A, 4B, 4C, 4D; Col. 2, Ln. 43-54); the docking station comprising: the opening configured for acceptance of a portion of the ventilator therein, and the docking station including a controller configured to control the ventilator (Col. 4, Ln. 7-20). The ventilator of Pfeiffer is readable on the canister of the instant claim. Pfeiffer teaches an opening in a docking station which removably receives a ventilator as providing the benefit of supplying a modular and portable ventilator configuration which is particularly helpful when transporting a patient between locations (Col. 1, Ln. 53 – Col. 2, Ln. 6).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Younes the first set of components formed as a canister to be removably inserted into an opening in the body; the body comprising: the opening configured for acceptance of a portion of the canister therein in order to provide the benefit of supplying a modular and portable ventilator configuration which is particularly helpful when transporting a patient between locations in view of Pfeiffer.
Regarding claim 3, Younes teaches the invention as modified above and Pfeiffer as incorporated therein further teaches the canister is configured to be replaceable with another canister (Figure – different #2 can dock to different #4).
Regarding claim 4, Younes teaches the invention as modified above and further teaches the canister further comprises: a shaft (Fig. 1 #44) in mechanical communication with the piston and the motor.
Regarding claim 5, Younes teaches the invention as modified above and further suggests as obvious the motor is configured to move the piston between the first position and the second position via moving the shaft up and down (Fig. 1). The orientation of the piston rod 44 of Younes would obviously be considered by one of ordinary skill in the art as suitable to be made to move up and down instead of side to side as the same functionality would be maintained in either orientation.
Regarding claim 8, Younes teaches the invention as modified above and further suggests as obvious the body further comprises: a motor driver communicatively coupled to the controller and configured to provide instructions to the motor that cause the motor to move the piston between the first position and the second position and between the second position and the first position (Col. 5, Ln. 64 – Col. 28). Younes teaches the functionality required of the claim, of controlling the motor. One of ordinary skill in the art would have considered it prima facie obvious that electronic control functions can be made to be performed by either a single structure, as in Younes, or by a series of structures designed to operate in integrated form. The additional electronic structure in the claim of a motor driver thus fails to patentably distinguish over the various ways one of ordinary skill in the art would expect the functionality of Younes of controlling the motor to be able to be implemented.
Regarding claim 9, Younes teaches the invention as modified above and Pfeiffer as incorporated therein further teaches the canister is configured to reside outside the body (Figure – #2 is not enclosed within #4).
Regarding claim 10, Younes teaches the invention as modified above and Pfeiffer as incorporated therein further teaches the canister is configured to operate when the canister is positioned outside of the body via at least one of
Regarding claim 11, Younes teaches the invention as modified above and Pfeiffer as incorporated therein further teaches the second communication/power interface coupling portion is coupled to a cord (Figure – power mains 24A will be supplied through a cord). The term “coupled” does not imply a direct connection between the claimed elements.
Regarding claim 12, Younes teaches the invention as modified above and Pfeiffer as incorporated therein further suggests as obvious a length of the cord is in a range of 1-10 feet. One of ordinary skill in the art would have considered it prima facie obvious for the power cord from power mains 24A to not need to be more than 10 feet long, based upon commonly available power cords.
Regarding claim 15, Younes discloses an airway circuit (Fig. 1; Col. 3, Ln. 41 – Col. 4, Ln. 27) comprising: an air source (Fig. 1 connecting to #38; Col. 4, Ln. 11-19) configured to draw in a gas; a connector (the gas fed to #38 will obviously be done so through a connector), the connector coupling the air source to a system (Fig. 1) and being configured to allow the gas to flow therethrough; the system, the system comprising: a first set of components (generally upper half internal components of Fig. 1) configured to be resident within a body (Fig. 1 #12; Col. 3, Ln. 41 – Col. 4, Ln. 27), the first set of components comprising: a hollow cylindrical chamber (Fig. 1 #24; Col. 3, Ln. 41 – Col. 4, Ln. 27); a piston (Fig. 1 #14; Col. 3, Ln. 41 – Col. 4, Ln. 27) sized and shaped to fit within the hollow cylindrical chamber; an opening (Fig. 1 leading into #32; Col. 3, Ln. 41 – Col. 4, Ln. 27) in the hollow cylindrical chamber through which gas may pass into a respiratory circuit (Fig. 1 #34; Col. 3, Ln. 41 – Col. 4, Ln. 27) for a patient as the piston translates between a first position within the chamber and a second position within the chamber (Col. 3, Ln. 41 – Col. 4, Ln. 27); a motor (Fig. 1 #16; Col. 3, Ln. 41 – Col. 4, Ln. 27) configured to move the piston from the first position to the second position and subsequently move the piston from the second position to the first position within the hollow cylindrical chamber; a first communication/power interface coupling portion (Fig. 1 where #58, 60 connect to #16; Col. 4, Ln. 62 – Col. 5, Ln. 22) configured to couple to a corresponding second communication/power interface coupling portion (Fig. 1 where #58, 60 connect to #22; Col. 4, Ln. 62 – Col. 5, Ln. 22) and establish communicative and electrical coupling between the first set of components and the body; the body, the body comprising: a controller (Fig. 1 #22; Col. 5, Ln. 7-22) configured to control the motor; the second communication/power interface coupling portion configured to couple to the first communication/power interface coupling portion and establish communicative and electrical coupling between the canister and the body (Col. 4, Ln. 62 – Col. 5, Ln. 22); and a power source (Fig. 1 #18) configured to provide electrical power to the body and the first set of components; and a tube (Fig. 1 #34; Col. 3, Ln. 41 – Col. 4, Ln. 27) of the respiratory circuit coupled to the connector and a patient airway mechanism (patient location in Fig. 1; Col. 3, Ln. 12-21); the tube being configured to deliver the gas from the system to the patient airway mechanism (Fig. 1). The claim is afforded an effective filing date of 05 Apr 2021 as it does not appear supported by the disclosure of the provisional application to which the instant application claims priority benefit.
Younes fails to disclose the first set of components formed as a canister to be removably resident within an opening in the body; the body comprising: the opening configured for acceptance of a portion of the canister therein. It is noted that the language “removably resident within an opening in a body” is understood to imply an accessible hole in the body through which the canister can be readily inserted or removed without causing harm to the body.
Pfeiffer teaches a ventilator system (Figure; Col. 2, Ln. 43 – Col. 4, Ln. 50) comprising a ventilator (one of #2A, 2B; Col. 2, Ln. 43-54) to be removably inserted into an opening (left side recess in #4A, 4B, 4C, 4D) in a docking station (one of #4A, 4B, 4C, 4D; Col. 2, Ln. 43-54); the docking station comprising: the opening configured for acceptance of a portion of the ventilator therein, and the docking station including a controller configured to control the ventilator (Col. 4, Ln. 7-20). The ventilator of Pfeiffer is readable on the canister of the instant claim. Pfeiffer teaches an opening in a docking station which removably receives a ventilator as providing the benefit of supplying a modular and portable ventilator configuration which is particularly helpful when transporting a patient between locations (Col. 1, Ln. 53 – Col. 2, Ln. 6).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Younes the first set of components formed as a canister to be removably resident within an opening in the body; the body comprising: the opening configured for acceptance of a portion of the canister therein in order to provide the benefit of supplying a modular and portable ventilator configuration which is particularly helpful when transporting a patient between locations in view of Pfeiffer.
Regarding claim 16, Younes teaches the invention as modified above and further teaches a positive end-expiratory pressure (PEEP) valve (Fig. 1 #52; Col. 4, Ln. 32-45).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Younes (U.S. Patent 5044362) in view of Pfeiffer et al. (U.S. Patent 6158430) and further in view of Kuypers et al. (U.S. Pub. 2010/0170512).
Regarding claim 2, Younes teaches the invention as modified above but fails to teach the motor is a stepper motor.
Kuypers teaches a resuscitator (Fig. 1; ¶0115) wherein a piston (#10; ¶0120) is driven by a motor (#13; ¶0122) which can be formed as a stepper motor (¶0122). Kuypers teaches a stepper motor as being an obvious design choice alternative to a linear motor for use in the respiratory art which is effective in performing controlled movement of a piston to deliver gas to a patient (¶¶0093, 0122).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Younes the motor is a stepper motor as an obvious design choice alternative to a linear motor for use in the respiratory art which is effective in performing controlled movement of a piston to deliver gas to a patient in view of Kuypers.
Claim(s) 6 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Younes (U.S. Patent 5044362) in view of Pfeiffer et al. (U.S. Patent 6158430) and further in view of Ahmad et al. (U.S. Pub. 2017/0209662).
Regarding claim 6, Younes teaches the invention as modified above but fails to teach the body further comprises: an engagement mechanism configured to enable removal of the canister from the body.
Ahmad teaches a modular ventilation system (Fig. 1) including a locking/unlocking mechanism (Fig. 6 #48; ¶¶0044, 0049) configured to enable removal of a ventilator (Figs. 6 & 9B #12; ¶¶0044, 0049) from a body (Fig. 6 #14). Locking knob 48 is read as a functional equivalent of the disclosed knob 430 as it allows selective locking and unlocking of a gas delivery component. Ahmad teaches a locking/unlocking mechanism as providing the benefit of allowing secured insertion of a ventilator into a docking station (¶¶0044, 0049).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Younes the body further comprises: an engagement mechanism configured to enable removal of the canister from the body in order to provide the benefit of allowing secured insertion of the canister into the body in view of Ahmad.
Regarding claim 13, Younes teaches the invention as modified above and Pfeiffer as incorporated therein further the second communication/power interface coupling portion is configured to communicate wirelessly (Col. 3, Ln. 36-43).
Younes as modified fails to teach the first communication/power interface coupling portion is configured to communicate wirelessly. It is noted the claim does not require the first and second communication/power interface coupling portions to communicate wirelessly with each other.
Ahmad teaches a modular ventilation system (Fig. 1) including a ventilator (Fig. 6 #12; ¶¶0044, 0049) and a body (Fig. 6 #14), the ventilator and the body in wireless communication with each other (¶0075). Ahmad teaches wireless communication as allowing extended range communication of user input controls to enable control whether in a docked or undocked configuration (¶0075).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Younes the first communication/power interface coupling portion is configured to communicate wirelessly in order to provide the benefit of allowing extended range communication of user input controls to enable control whether in a docked or undocked configuration in view of Ahmad.
Regarding claim 14, Younes teaches the invention as modified above but fails to teach the canister further comprises a battery.
Ahmad teaches a modular ventilation system (Fig. 1) including a ventilator (Fig. 6 #12; ¶¶0044, 0049) comprising a battery (Fig. 3 #29; ¶0041). Ahmad teaches a battery as allowing the ventilator to be used remotely from its docking station (¶0044).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Younes the canister further comprises a battery in order to provide the benefit of allowing the canister to be used remotely from the base in view of Ahmad.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Younes (U.S. Patent 5044362) in view of Pfeiffer et al. (U.S. Patent 6158430) and further in view of DeVries et al. (U.S. Pub. 2006/0144396).
Regarding claim 7, Younes teaches the invention as modified above but fails to teach the body further comprises: a control panel, the control panel being configured to accept user inputs for setting at least one of a maximum pressure, an inhale to exhale (l/E) ratio, a number of breaths per minute, and a volume of gas delivered to a patient.
However, Younes teaches an ability to operate in either a pressure control mode or a volume control mode (Col. 5, Ln. 54-63). One of ordinary skill in the art would thus have considered it prima facie obvious for Younes to receive as a user input either of a maximum pressure or a volume of gas delivered to a patient. DeVries teaches a portable ventilator system (Fig. 2A; ¶0010) including a docking station (Fig. 2A #200; ¶0044) including a control panel being configured to accept user inputs (¶0075). Further, DeVries teaches the ventilator as operable for either pressure control or volume control (¶0126), which one of ordinary skill in the art would have obviously expected to be selectable as user input of UI subsystem 400.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Younes the body further comprises: a control panel, the control panel being configured to accept user inputs for setting at least one of a maximum pressure and a volume of gas delivered to a patient in order to provide the benefit of allowing user selection of either pressure control or volume control ventilation in view of DeVries.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785