DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the preliminary amendment filed 10/27/2023. As directed by the amendment, the specification, drawings and claim 1 have been amended. Claim 1 is pending in the instant application.
Information Disclosure Statement
The references cited in the PCT international search report by the ISA/CN have been considered, but will not be listed on any patent resulting from this application because they were not provided on a separate list in compliance with 37 CFR 1.98(a)(1). In order to have the references printed on such resulting patent, a separate listing, preferably on a PTO/SB/08 form, must be filed within the set period for reply to this Office action.
Drawings
The drawings are objected to because in Fig. 1, step (3) should read “presetbreathing device” for continuity of language with step (1) as well as with the body of the specification.
The drawings are objected to because Fig. 3 should have a space in the first box to read “Gas delivering module”.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “16” has been used to designate both “second flow control valve” and what is best understood to be intended to be “suction pipeline 34,” given the location of the second label 16 (see Fig. 4 modified, below) and since the label 34 in Fig. 4 is pointing to the patient and not a “suction pipeline” per page 12, line 21, of the substitute specification filed 10/27/20203. To address this objection, Applicant could amend Fig. 4 to move the label 34 off of the patient and to the rightmost element labeled “16,” see below.
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The drawings are objected to because instant drawings do not illustrate one of the exempted types of images described in 37 CFR 1.84(b)(1) and MPEP 608.02.VII.B, such that a grayscale image is not the only practical medium for illustrating the claimed invention and thus the grayscale images within the instant drawings (Figs. 5-10, and the box 1 in Fig. 4 is causing issues with clear resolution of the labels, see e.g. above) should be replaced by line drawings.
The drawings are objected to because the legends of Figs. 5 and 6 are confusing, because they present more colors than are present in the bar charts.
The drawings are objected to because the Y-axes in Figs. 5-10 should be labeled in the Figures for immediate understanding thereof.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The substitute disclosure filed 10/27/2023 is objected to because of the following informalities:
Page 2, line 6 is missing a period at the end
Page 2, lines 14-15 are understood to be intended to read “Avoiding the respiratory alkalosis caused by hyperventilation” because it is specifically hyperventilation that is a well-known physiological cause of alkalosis and in view of similar language within the instant specification at e.g. page 13, lines 10-11, page 17, lines 22-23 and page 23, lines 6-7
Page 2, lines 20-21 are understood to be intended to read “avoiding the alkalosis caused by hyperventilation”, similar to above
Page 6, lines 1-2 should read “until the target alcohol concentration in the subject
Page 12, line 14 should read “first filters 7, check valves 8” because two filters labeled 7 and three valves labeled 8 are depicted in Fig. 4
Page 12, line 15 should read “second filters 13” because three filters labeled 13 are depicted in Fig. 4
Page 12, line 18 should read “s 23” because two outlets are labeled 23 in Fig. 4
Page 12, lines 18-19 should read “the fourth pressure sensor 24, the fifth pressure sensor 25, the sixth pressure sensor
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
Lines 14, 27 and 32 (three instances), should read “the target gas mixture” for clearer antecedent basis with line 4
Appropriate correction is required.
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 1 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. Regarding the amendments to claim 1, the specification as originally filed does not support “body characteristic indexes” (emphasis added). The substitute specification at e.g. page 15, lines 3-4, recites “the current body characteristic index comprises: the subject’s blood pressure, heart rate, etc.,” which is presented as a singular index,” with no other “body characteristic indexes” recited. To address this rejection, Applicant could either amend claim 1 to read “a current body characteristic indexphysiological parameters”.
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 1 is 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.
Regarding claim 1, it is unclear how gas is to be transmitted “based on a preset breathing device” or even what such a device is, and it is unclear how such a device is to work or “stop working.” It is also unclear how an alcohol concentration can “meet a safe range on the basis of” carbon dioxide partial pressure and respiratory rate, as these are three independent variables. Moreover, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite, see MPEP 2173.05(p).II. Furthermore, it is unclear what is meant/what criteria dictates an oxygen and carbon dioxide concentration that a subject “needs,” how multiple dynamic alcohol change concentrations are to be recorded at a single time point, and it is unclear what are the “recorded results” in second-to-last line or what is displayed in the last line. For purposes of examination, as best understood, claim 1 will be interpretated as if it read as follows, where Applicant could adopt the changes below to address the 112a&b rejections as well as the claim objections:
A ventilator for treating alcohol intoxication based on gas mixing ratio, comprising:
a gas transmission module configured to mix oxygen and carbon dioxide to generate a target gas mixture, and transmit the target gas mixture to a subject via a patient interface;
a monitoring module configured to monitor an alcohol concentration in the subject in real time, and meanwhile, monitor a partial pressure of carbon dioxide in the subject and a respiratory rate of the subject;
a control module configured to stop transmission of the target gas mixture via the patient interface when the alcohol concentration in the subject meets a safe range and the partial pressure of the carbon dioxide in the subject and the respiratory rate of the subject are stable;
wherein is configured to perform the mixing the oxygen and the carbon dioxide to generate the target gas mixture by executing the following steps:
collecting a current alcohol concentration of the subject, and at the same time, determining current physiological parameters of the subject;
inputting the current alcohol content concentration of the subject and the current physiological parameters of the subject into an alcohol analysis model for analysis;
based on analysis results in the alcohol analysis model, determining an oxygen concentration and a carbon dioxide concentration that the subject needs in order to treat the alcohol intoxication respectively;
based on the oxygen concentration and the carbon dioxide concentration that the subject needs respectively, determining a mixing ratio of the oxygen and carbon dioxide;
based on the mixing ratio, mixing the oxygen and the carbon dioxide to generate the target gas mixture;
wherein is configured to perform the monitoring the alcohol concentration in the subjectmeanwhile, monitoring the partial pressure of carbon dioxide in the subject and the respiratory rate of the subject by executing the following steps:
when the target gas mixture is transmitted to the subject via the patient interface, starting a first monitoring instruction and a second monitoring instruction;
monitoring a dynamic alcohol concentration in the subject in real time based on the first monitoring instruction;
monitoring the partial pressure of carbon dioxide in the subject and the respiratory rate of the subject in real time based on the second monitoring instruction;
at predetermined intervals, recording dynamic alcohol change concentrations in the subject and the respiratory rate of the subject;
based on the recorded dynamic alcohol change concentrations, generating a monitoring dynamic table and displaying the monitoring dynamic table in real time.
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: “gas transmission module,” “monitoring module” and “control module” in claim 1.
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 light of the specification, a “gas transmission module” is construed as the physical gas-directing structures depicted in instant Fig. 4 and described on page 12, line 17 to page 13, line 3, i.e. gas sources, valves, pathways, and inferred processor(s)/controller(s) in instant Fig. 3 associated with their operation. In light of the specification, a “monitoring module” is construed as the sensors of Fig. 4 and inferred processor(s)/controllers in instant Fig. 3 associated with their operation, e.g., data collection/analysis and display. In light of the specification, a “control module” is construed as one or more processors/controllers (i.e., a memory storing instructions and a processor/controller executing those instructions) in communication with the gas transmission and monitoring modules, as shown in instant Fig. 3, to control operation thereof for the auto-off function (page 28, lines 10-12).
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.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a&b) or 35 U.S.C. 112 (pre-AIA ), 1st and 2nd paragraphs, set forth in this Office action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Known method for treating alcohol intoxication using exhaled/relatively-constant-concentration carbon dioxide: Klostranec et al. Accelerated ethanol elimination via the lungs. Sci Rep 10, 19249 (2020). Alternative gaseous treatment of alcohol intoxication using hyperbaric oxygen: Kuz’mich et al. (RU 2045227 C1). Known oxygen/carbon dioxide mixers: Carter (US 2002/0112722 A1); Downs, III et al. (US 2021/0308396 A1); Klein (US 9,555,209 B2); Oberle et al. (US 8,789,524 B2); L’her et al. (US 2014/0158124 A1); Thomas et al. (US 2004/0144383 A1); Fisher et al. (US 2003/0000525 A1 and US 2002/0185129 A1); Krebs (US 2002/0185126 A1). Known systems for tracking patient gas concentration levels for feedback gas control: Lellouche et al. (US 2018/0280645 A1); Dasse et al. (US 2017/0182088 A1); Slessarev et al. (US 8,459,258 B2); Dixon et al. (US 2010/0224191 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET.
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785