DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to the filing on 8/7/2026. Since the initial filing, claims 1-37 have been cancelled, claims 38-53 have been added and no claims have been amended. Thus, clams 38-53 are pending in the application.
A Preliminary Amendment was filed on 8/7/2026 to correct a previously misfiled amended claim set filed 1/9/2024.
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 “safety element” in claim 38.
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. In the broadest reasonable reading of the specification, the safety element functions to shut off vacuum in unsafe circumstances. Claim 45 adds additional structural limitations, supported by the disclosure at least on page 4 and 10, describes structural elements without any link to function.
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 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 42, 43 and 51 and 52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 42 recites the limitation "the operator" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “an operator” to overcome this rejection.
Claim 43 recites the limitation "the subject or operator" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “the subject or an operator” to overcome this rejection.
Claim 51 recites the limitation "the operator" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “an operator” to overcome this rejection.
Claim 52 recites the limitation "the subject or operator" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “the subject or an operator” to overcome this rejection.
Claim Rejections - 35 USC § 103
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.
Claim(s) 38-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz (US 2018/0200462) in view of Kim (US 2018/0361089) and Kimm (US 2011/0220107).
In regards to claim 38, Lantz discloses a tracheobronchial-air stimulation device (device 1) intended to be connected to a subject (patient 5, paragraph 52) comprising: (i) a physiological interface able to interface the device with the subject's airways (interface 2); (ii) a vacuum interface (pneumatic base 3 and negative pressure generator 6, Fig 5), said vacuum interface comprising a safety element (deadman remote control, paragraph 69, or safety tube as seen on Annotated Fig 4); (iii) a vent (sound trap 8, paragraph 55); (iv) an electro-valve connected to said physiological interface, said vacuum interface and said vent (solenoid valve 9, Fig 5); and (v) a control module (microcontroller card 10) configured to control said electro-valve for the application of pressure oscillations at a frequency of at least 1 Hz, and set a negative pressure into the physiological interface (paragraph 61).
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Annotated Fig 4
Lantz does not disclose wherein the device is portable and wherein the vacuum interface is able to interface with a wall inlet of a medical vacuum system.
However, Kim teaches wherein such devices may be made portable (Title, paragraph 7).
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 Lantz wherein the device is portable as taught by Kim as this would allow a patient to use the device during activities of daily living.
Further, Kimm teaches wherein a vacuum interface is able to interface with a wall inlet of a medical vacuum system (paragraph 32).
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 Lantz wherein the vacuum interface is able to interface with a wall inlet of a medical vacuum system as taught by Kimm as these are known equivalents which may be obviously substituted (Kimm: paragraph 32; MPEP 2144.06 II).
In regards to claim 39, Lantz in view of Kim and Kimm teaches the device of claim 38 and the combination further teaches which does not comprise a negative pressure generator (Kimm: devices known to be attachable wall vacuum outlet, paragraph 32).
In regards to claim 40, Lantz in view of Kim and Kimm teaches the device of claim 38 and Lantz further discloses wherein the control module is configured to control the electro-valve for the application of an expiration cycle comprising a plurality of successive expirations, each expiration having a frequency and a duty cycle, said expiration cycle comprises a first part of an expiration cycle having a first frequency and a first duty cycle, and a second part of an expiration cycle having a second frequency and a second duty cycle, wherein the first part of the expiration cycle comprises a plurality of expirations having a frequency of the order of 10 to 15 Hz and a duty cycle of 0.2 to 0.7 and the second part of the expiration cycle comprises a plurality of expirations having a frequency of the order of 4 to 7 Hz and a duty cycle of the order of 0.5 to 0.8 (paragraph 32-33 and 61).
In regards to claim 41, Lantz in view of Kim and Kimm teaches the device of claim 40 and Lantz further discloses wherein the first part of the expiration cycle comprises a frequency of 12 Hz and a duty cycle of the order of 0.3 and the second part of the expiration cycle comprises a frequency of 6 Hz and a duty cycle of the order of 0.6 (paragraph 33 and 61).
In regards to claim 42, Lantz in view of Kim and Kimm teaches the device of claim 40 and Lantz further discloses wherein the control module is configured to adapt the expiration cycle previously chosen by the operator or the subject according to one or more results of an evaluated average stimulation duration (paragraph 34).
In regards to claim 43, Lantz in view of Kim and Kimm teaches the device of claim 38 and Lantz further discloses wherein the control module is configured to receive instructions from the subject or operator to adjust an amplitude of one or more departing negative pressures according to their tolerance (paragraph 40-41 and 68).
In regards to claim 44, Lantz in view of Kim and Kimm teaches the device of claim 38 and Lantz further discloses wherein the electro-valve is connected to the physiological interface via a connecting tube and/or the electro-valve is connected to the vacuum interface via a connecting tube (pipe 4 links interface 2 to pneumatic base 3 which holds valve 9, paragraph 57 and 60).
In regards to claim 45, Lantz in view of Kim and Kimm teaches the device of claim 38.
Lantz does not explicitly disclose wherein the safety element is a safety tube having an inner diameter less than 5 mm and a length greater or equal to 1 cm and less or equal to 10 cm.
However, it does show a tube wherein the diameter may be established as within the claimed range (opening diameter of solenoid 9 is less than 6 mm, paragraph 60 line 28-29, encompassing the claimed limitation of less than 5 mm, MPEP 2144.05 I, opening of solenoid in line with “safety tube” with equivalent diameter, see Annotated Fig 4, MPEP 2125) and a length within the claimed range (Fig 4 shows length of “safety tube” being ~3x opening diameter resulting in a length that overlaps the claimed range, see Annotated Fig 4, MPEP 2125, MPEP 2144.05 I).
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 Lantz wherein the safety element is a safety tube having an inner diameter less than 5 mm and a length greater or equal to 1 cm and less or equal to 10 cm as it has been held that in cases where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05 I) and that the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125 II).
In regards to claim 46, Lantz in view of Kim and Kimm teaches the device of claim 38 and Lantz further discloses wherein the pressure oscillations are applied during an expiratory phase of the subject (paragraph 61).
In regards to claim 47, Lantz in view of Kim and Kimm teaches the device of claim 38 and the combination further teaches a method for stimulating tracheobronchial air comprising the steps of: (i) providing a tracheobronchial-air stimulation device according to claim 38 (see above Claim 38 Rejection); (ii) connecting the vacuum interface with a wall inlet of a medical vacuum system (Kimm: paragraph 32); (iii) connecting said tracheobronchial-air stimulation device to a subject via the physiological interface (Lantz: Fig 1); (iv) applying an expiration cycle comprising a plurality of successive expirations to the subject, each expiration having a frequency and a duty cycle, wherein the expiration cycle comprises a first part of an expiration cycle having a first frequency and a first duty cycle, and a second part of an expiration cycle having a second frequency and a second duty cycle (Lantz: paragraph 61).
In regards to claim 48, Lantz in view of Kim and Kimm teaches the method of claim 47 and the combination further teaches wherein the tracheobronchial-air stimulation device does not comprise a negative pressure generator (Kimm: devices known to be attachable to wall vacuum outlet, paragraph 32).
In regards to claim 49, Lantz in view of Kim and Kimm teaches the method of claim 47 and Lantz further discloses wherein the first part of the expiration cycle comprises a plurality of expirations having a frequency of the order of 10 to 15 Hz and a duty cycle of 0.2 to 0.7 and the second part of an expiration cycle comprises a plurality of expirations having a frequency of the order of 4 to 7 Hz and a duty cycle of the order of 0.5 to 0.8 (paragraph 32 and 61).
In regards to claim 50, Lantz in view of Kim and Kimm teaches the method of claim 49 and Lantz further discloses wherein the first part of the expiration cycle comprises a frequency of 12 Hz and a duty cycle of the order of 0.3 and the second part of the expiration cycle comprises a frequency of 6 Hz and a duty cycle of the order of 0.6 (paragraph 33 and 61).
In regards to claim 51, Lantz in view of Kim and Kimm teaches the method of claim 47 and Lantz further discloses wherein the control module is configured to adapt the expiration cycle previously chosen by the operator or the subject according to one or more results of an evaluated average stimulation duration (paragraph 34 and 61).
In regards to claim 52, Lantz in view of Kim and Kimm teaches the method of claim 47 and Lantz further discloses wherein the control module is configured to receive instructions from the subject or operator to adjust an amplitude of one or more departing negative pressures according to their tolerance (paragraph 40-41 and 68).
In regards to claim 53, Lantz in view of Kim and Kimm teaches the method of claim 47 and Lantz further discloses wherein the electro-valve is connected to the physiological interface via a connecting tube and/or the electro-valve is connected to the vacuum interface via a connecting tube (pipe 4 links interface 2 to pneumatic base 3 which holds valve 9, paragraph 57 and 60).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/ Primary Examiner, Art Unit 3785
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