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 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 2-6, 9, 15, and 19-20 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.
In claims 2-4, 9, 15, and 19-20 (in multiple instances) in the limitation “breath type”, the term “type” renders the claim indefinite. The term is unclear if the breath is, for example, volume support or a breath similar to volume support. Similarly for pressure breath and tube compensated.
All remaining claims are rejected based on their dependency of a rejected base claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 6-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,752,287.
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 1:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent Claim 1
Application Claim 1
A ventilator system comprising:
at least one sensor;
a gas-delivery system configured to deliver ventilation gases to a patient;
at least one processor; and
at least one memory comprising computer-executable instructions that when executed by the at least one processor cause the ventilator system to:
receive one or more sensor measurements from the at least one sensor during inhalation of the patient;
based on the one or more sensor measurements, estimate a muscle pressure (PMUS) of the patient during the inhalation of the patient;
determine a PMUS-based metric based on the estimate of PMUS;
in response to determining that the PMUS-based metric meets a cycling threshold, determine a patient intention to cycle from inhalation to exhalation;
evaluate one or more characteristics of the patient intention to cycle from inhalation to exhalation;
when the one or more characteristics of the patient intention to cycle from inhalation to exhalation are not normal, determining a missed cycling effort; and
perform an action in response to the missed cycling effort.
A ventilator system comprising:
at least one sensor;
a gas-delivery system configured to deliver ventilation gases to a patient;
at least one processor; and
at least one memory comprising computer-executable instructions that when executed by the at least one processor cause the ventilator system to:
receive one or more sensor measurements from the at least one sensor during inhalation of the patient;
based on the one or more sensor measurements, estimate a physiological parameter of the patient during the inhalation of the patient;
in response to determining that the physiological parameter meets a cycling threshold, determine a patient intention to cycle from inhalation to exhalation;
evaluate one or more characteristics of the patient intention to cycle from inhalation to exhalation;
when the one or more characteristics of the patient intention to cycle from inhalation to exhalation are abnormal, determine a missed cycling effort; and
perform an action in response to the missed cycling effort.
Thus, it is apparent, for the broadening aspect, that patent claim 1 includes features that are not in application claim 1. 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. Since application claim 1 is anticipated by patent claim 1, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over patent claim 1 with respect to the broadening aspect.
Claim 1 of the instant application is rejected by claims 1-6 of the prior Patent.
Dependent claims 2-4 and 6-9 are rejected by claims 2-6 of the Patent.
Claims 11-13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 9 of U.S. Patent No. 11,752,287.
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 11:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent Claim 1
Application Claim 11
A ventilator system comprising:
at least one sensor;
a gas-delivery system configured to deliver ventilation gases to a patient;
at least one processor; and
at least one memory comprising computer-executable instructions that when executed by the at least one processor cause the ventilator system to:
receive one or more sensor measurements from the at least one sensor during inhalation of the patient;
based on the one or more sensor measurements, estimate a muscle pressure (PMUS) of the patient during the inhalation of the patient;
determine a PMUS-based metric based on the estimate of PMUS;
in response to determining that the PMUS-based metric meets a cycling threshold, determine a patient intention to cycle from inhalation to exhalation;
evaluate one or more characteristics of the patient intention to cycle from inhalation to exhalation;
when the one or more characteristics of the patient intention to cycle from inhalation to exhalation are not normal, determining a missed cycling effort; and
perform an action in response to the missed cycling effort.
A ventilator system comprising:
at least one sensor;
a gas-delivery system configured to deliver ventilation gases to a patient;
at least one processor; and
at least one memory comprising computer-executable instructions that when executed by the at least one processor cause the ventilator system to:
receive one or more sensor measurements from the at least one sensor during inhalation of the patient;
based on the one or more sensor measurements, estimate a muscle pressure (PMUS) of the patient during the inhalation of the patient;
determine a PMUS-based metric based on the estimate of PMUS;
in response to determining that the PMUS-based metric meets a cycling threshold, determine a patient intention to cycle from inhalation to exhalation.
Thus, it is apparent, for the broadening aspect, that patent claim 1 includes features that are not in application claim 11. 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. Since application claim 11 is anticipated by patent claim 1, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 11 is obvious over patent claim 1 with respect to the broadening aspect.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,752,287. Although the claims at issue are not identical, they are not patentably distinct from each other.
Dependent claims 13 and 15 is rejected by claim 9 and 2, respectively, of the Patent.
Claims 16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 and 20 of U.S. Patent No. 11,752,287.
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 16:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Patent Claim 16
Application Claim 16
A method for detecting a patient intention to cycle during spontaneous ventilation of the patient on a ventilator, comprising:
monitoring at least one parameter of the patient receiving spontaneous ventilation based on one or more received non-invasive sensor measurements during inhalation;
estimating a muscle pressure (PMUS) of the patient during the inhalation based on the one or more received non-invasive sensor measurements;
comparing a PMUS-based metric to a cycling threshold;
determining that the PMUS-based metric meets the cycling threshold to identify a patient intention to cycle from inhalation to exhalation;
in response to identifying the patient intention to cycle, evaluating one or more characteristics of the patient intention to cycle;
when the one or more characteristics of the patient intention to cycle are abnormal, determining a missed cycling effort; and
performing an action in response to the missed cycling effort.
A method for detecting a patient intention to cycle during spontaneous ventilation of a patient on a ventilator, comprising:
receiving one or more sensor measurements from at least one sensor during inhalation of the patient;
based on the one or more sensor measurements, estimating a physiological parameter of the patient during the inhalation of the patient;
in response to determining that the physiological parameter meets a cycling threshold, determining a patient intention to cycle from inhalation to exhalation;
evaluating one or more characteristics of the patient intention to cycle from inhalation to exhalation;
when the one or more characteristics of the patient intention to cycle from inhalation to exhalation are abnormal, determining a missed cycling effort; and
perform an action in response to the missed cycling effort.
Thus, it is apparent, for the broadening aspect, that patent claim 16 includes features that are not in application claim 16. 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. Since application claim 16 is anticipated by patent claim 16, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 16 is obvious over patent claim 16 with respect to the broadening aspect.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11,752,287. Although the claims at issue are not identical, they are not patentably distinct from each other.
Dependent claims 19-20 is rejected by claim 20 and 17, respectively, of the Patent.
Allowable Subject Matter
Claims 1-20 are allowed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eichler (WO2013/026902) is cited to show a device for providing breath at the user's intent to cycle.
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785