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 37 is objected to because of the following informalities:
Claim 37 recites “configured to generates”. This should read “configured to generate”.
Appropriate correction is required.
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 25-38 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,532,174 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘174 patent are more narrow than the instant claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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) 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamori et al. (US 5,957,127) in view of Myklebust et al. (GB 2,450,369 A).
Regarding claim 25, Yamamori discloses: An apparatus (figures 1-2) comprising:
an inlet (where 2 and 1a meet) configured to receive exhaled gases from a patient (see figure 4);
an outlet (where 2 and 1b meet) configured to connect with a resuscitation bag (23; connected via adaptor 22);
a housing (2; or alternatively 2+9) comprising a sensor (3, 7) configured to measure one or more respiratory parameters (col. 1, lines 56-65)
and one or more hardware processors (within monitor body 9 col. 2, lines 9-16).
Yamomori does not disclose:
the one or more hardware processors configured to determine manual respiratory intervention parameters based on the measured one or more respiratory parameters; and
a display configured to display instructions for providing respiratory assistance to the patient based on the determined manual respiratory intervention parameters.
Myklebust teaches one or more hardware processors (page 6, lines 37-38; as shown in figure 3 26 is in adapter col. 8, lines 29-30) configured to determine manual respiratory intervention parameters based on the measured one or more respiratory parameters (page 7, lines 29-32); and
a display configured to display instructions for providing respiratory assistance to the patient based on the determined manual respiratory intervention parameters (page 7, lines 29-32).
It would have been obvious to have modified Yamomori to include one or more hardware processors configured to determine manual respiratory intervention parameters based on the measured one or more respiratory parameters; and
a display configured to display instructions for providing respiratory assistance to the patient based on the determined manual respiratory intervention parameters for the benefit of reducing hyperventilation (page 2, lines 9-11).
Regarding claim 26, Yamomori further discloses wherein the one or more hardware processors are integrated with a housing (within housing of 9; see figures 1-2).
Regarding claim 27, Yamomori further discloses wherein the display (13) is integrated with the housing (see figure 1).
Claim(s) 30-33 and 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamori et al. (US 5,957,127) in view of Myklebust et al. (GB 2,450,369 A) in further view of Hickle et al. (EP 1,402,470 B1).
Regarding claim 30, Yamomori further discloses an airway adapter (1; col. 1, lines 21-30) configured to connect with the outlet (where 2 and 1b meet) on a first end and the resuscitation bag (see figure 4) on a second end (1a).
Yamomori does not explicitly disclose the airway adapter on the second end comprising a first information element configured to store adapter data representing information regarding at least one characteristic of the airway adapter.
Hickle teaches it is known to provide first information on a second end of a medical device (62) configured to store medical device data (see figures 5-7) [0043]-[0044].
It would have been obvious to one having ordinary skill in the art to have modified Yamomori to include the airway adapter on the second end comprising a first information element configured to store adapter data representing information regarding at least one characteristic of the airway adapter as taught by Hickle for the benefit of indicating use and storing information about items tubes are connected to [0043].
Regarding claim 31, Yamomori as modified by Hickle further discloses wherein the adapter data includes one or more of a size, type, manufacturer, or usage of the airway adapter (Hickle: use as per [0043]).
Regarding claim 32, Yamomori as modified by Hickle further discloses wherein the one or more hardware processors are further configured to communicate with the first information element to read the adapter data (Hickle: [0043]-[0044] indicate circuitry which corresponds to the circuitry within body 9 of Yamomori).
Regarding claim 33, Yamomori as modified does not explicitly disclose wherein the resuscitation bag comprises a second information element.
Hickle teaches it is known to provide first information on a second end of a medical device (62) configured to store medical device data (see figures 5-7) [0043]-[0044].
It would have been obvious to one having ordinary skill in the art to have modified Yamomori to include the resuscitation bag comprises a second information element as taught by Hickle for the benefit of indicating use and storing information about items in the system [0043].
Regarding claim 35, Yamomori as modified discloses wherein the one or more hardware processors are further configured to communicate with the second information element to read bag data (Hickle: use as per [0043]).
Regarding claim 36, Yamomori as modified discloses wherein the bag data includes one or more of a size, volume, manufacturer, or usage of the resuscitation bag (Hickle: use as per [0043]).
Claim Rejections - 35 USC § 102
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(s) 25, 28 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Myklebust et al. (GB 2,450,369 A).
Regarding claim 25, Myklebust discloses: An apparatus (figure 1) comprising:
an inlet (13) configured to receive exhaled gases from a patient (see figure 1);
an outlet (where 10 connects to 11) configured to connect with a resuscitation bag (11; page 4, lines 3-6);
a housing (housing shown below in annotated figure) comprising a sensor (page 4, lines 27-32) configured to measure one or more respiratory parameters (page 4, lines 27-29);
one or more hardware processors (page 6, lines 37-38; as shown in figure 3 26 is in adapter col. 8, lines 29-30) configured to determine manual respiratory intervention parameters based on the measured one or more respiratory parameters (page 7, lines 29-32); and
a display configured to display instructions for providing respiratory assistance to the patient based on the determined manual respiratory intervention parameters (page 7, lines 29-32).
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Regarding claim 28, Myklebust further discloses a resuscitation bag (11) configured to provide positive pressure ventilation to the patient (page 4, lines 3-8).
Regarding claim 29, Myklebust further discloses wherein the instructions include one or both of a compression rate and a compression depth for compression of the resuscitation bag by a care provider (page 7, lines 28-32).
Allowable Subject Matter
Claims 34 and 37-38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art does not disclose or suggest wherein the one or more hardware processors are further configured to: read the second information element, andwherein the instructions are based at least partly on information provided by the second information element as required by claim 34 nor wherein the one or more hardware processors are configured to generates manual ventilation instructions based at least partly on the adapter data and the bag data as required by claim 37. The examiner notes that claim 38 depends from claim 37.
US 8,707,954 describe keying feature on mask to determine mask size and adjusting ventilation parameters automatically (col. 10, lines 18-24). It would be hindsight reasoning to rely on this teaching to modify Yamomori or Myklebust such that instructions are displayed based on information provided by the second element or on the adapter and bag data.
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785