DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is in response to the preliminary amendment filed 9/3/2024. As directed by the amendment, claims 1-20 have been cancelled, and claims 21-33 have been added. As such, claims 21-33 are pending in the instant application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 61/272,043, 61/272,188, 61/261,527, 61/272,919, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of the provisional documents disclose a control module including an internal accelerometer and configured as claimed. Therefore, the earliest priority date for the instant claims is the PCT filing date, that is, 8/11/2010.
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 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-46 and 53-57 of U.S. Patent No. 9,861,774 in view of Kowk et al. (US 2007/0023045 A1; hereinafter “Kwok), Baeke et al. (US 2005/0235993 A1; hereinafter “Baeke”) and Melker et al. (US 2004/0260161 A1; hereinafter “Melker”). Regarding instant claims 21 and 33, patented claim 46 anticipates a ventilator module and control module per instant claim 21 because patented the ventilator and control unit are separate from each other and thus comprehend modules, also, starting from patented claim 36, Kwok teaches that separate ventilator and control modules were known in the respiratory device art at the time of invention, see Kwok Figs. 1-2, and would have been obvious to an artisan to include in patented claim 36 in order to provide a modular system for control and ventilation for increased versatility of programming/control and/or positioning (Kwok paras [0036-37]), and the limitations of patented claim 46 are identical to those of instant claim 33. Patented claim 46/modified patented claim 36 is silent regarding the control module including an internal accelerometer and configured as recited in instant claim 21 regarding a pulse oximeter/allowing blood oxygen saturation-guided adjustment and/or CO2 monitor/CO2-based control. However, Baeke teaches that it was known in the respiratory device art at the time of invention of the claimed invention to include an accelerometer (accelerometer 21) (Fig. 1) in a patient-adjacent respiratory device, such that it would have been obvious to an artisan at the time of invention of the claimed invention to include an accelerometer in the control module of patented claim 46/modified patented claim 36, in order to provide the predictable result of utilizing a known sensor means to allow the control module to detect that a patient is attempting to use the control module in order to wake up and/or illuminate the control module for (ease of) use (Baeke paras [0014-15], [0026], [0030]), and Melker teaches that it was known in the respiratory device art at the time of invention of the claimed invention for a control device to be connected to a pulse oximeter and to allow oxygen saturation-guided manual adjustment (e.g. Fig. 16A; para [0156]), such that it would have been obvious to an artisan before the effective filing date of the claimed invention to configure the control module of modified patented claim 46/36 to allow connection to a pulse oximeter and to allow a user to adjust oxygen enhancement guided by a sensed blood oxygen saturation (from the pulse oximeter), in order to allow the controller to utilize a common/well-known sensor (pulse oximeter) and operate under manual control to provide the predictable result of user-directed/sufficient oxygenation to the user (Melker para [0156]). Regarding instant claims 22-27, patented claims 43, 44 and 53-57 recite a mucus trap, HME filter and straps as instantly recited, and it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art, see MPEP 2144.04.V.C, such that providing the patented elements as “individually replaceable modules” and thus arriving at the instant claims would have been obvious to an artisan at the time of invention in order to provide a modular construction for easy customization of the patented device. Regarding instant claims 28-32, patented claims 36-42 and 45 recite limitations that are identical to those of instant claims 28-32 and therefore anticipate the limitations of instant claims 28-32.
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 21-33 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 21 (and thus its dependent claims 22-33) recites the limitation "the sensed CO2" and “the sensed blood oxygen saturation” in the last two lines. There is insufficient antecedent basis for this limitation in the claim. Applicant could address this rejection by amending claim 21 read “a CO2 level sensed by the CO2 monitor” and “a blood oxygen saturation sensed by the pulse oximeter.”
Claim 24 recites the limitation "the ventilator" in line 3. There is insufficient antecedent basis for this limitation in the claim. To address this rejection, Applicant could amend the claim to read “the ventilator module”.
Claim 25 recites the limitation "the ventilator" in line 2. There is insufficient antecedent basis for this limitation in the claim. To address this rejection, Applicant could amend the claim to read “the ventilator module”.
Claim Interpretation
Regarding claim 21 (and thus its dependent claims 22-33), it is noted that “guided by the sensed blood oxygen saturation” is an intended-use mental process. If the structure of a prior art device allows a user to know a sensed blood oxygen saturation and allows a user to adjust an oxygen delivery level, the prior art is configured as claimed because it provides for the intended use. It is also noted that no functionality/purpose for the accelerometer of claim 21 is recited in the claims.
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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 21 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Freeman (US 2007/0225623 A1; hereinafter “Freeman”).
Regarding claim 21, Freeman discloses a modular ventilator system (Fig. 1; para [0015]), comprising:
a ventilator module (ventilator 15, optionally comprising laptop 17) (Fig. 1; paras [0015] and [0024]); and
a control module (element 10 comprising microprocessor 14, alternatively optionally comprising laptop 17) configured to remotely control the ventilator module (Fig. 1; paras [0015], [0024-25]),
wherein the control module includes an internal accelerometer (accelerometer-based sternal displacement measurement 3) (Fig. 1; paras [0015], [0024]) and allows a pulse oximeter (Fig. 1; sensors 2…pulse oximetry, para [0024]) configured to sense blood oxygen saturation (SpO2, para [0024) and/or a CO2 monitor (Fig. 1; sensors 2…end-tidal carbon dioxide measurement, para [0024]) configured to sense CO2 (EtCO2, para [0024]) to be connected thereto (Fig. 1; para, and
wherein the control module is configured to regulate the ventilator module based on the sensed CO2 and/or the control module is configured to allow a user to adjust oxygen enhancement guided by the sensed blood oxygen saturation (Figs. 1-2; paras [0024-25]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 21-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lalonde (US 2012/0266873 A2; hereinafter “Lalonde”) in view of Baeke et al. (US 2005/0235993 A1; hereinafter “Baeke”) and Raemer (US 5,365,922; hereinafter “Raemer”).
Regarding claim 21, Lalonde discloses a modular ventilator system (Figs. 3-5A and 10A-B), comprising:
a ventilator module (integrated PAP unit 1122 and/or separable flow generator 912) (Fig. 2/9); and
a control module (remote control 1014) configured to remotely control the ventilator module (Figs. 10A-B),
wherein the control module allows a CO2 monitor configured to sense CO2 to be connected thereto (a sensor used to collect data…include[ing]…CO2…data connection receptacle, which may be used to receive a cable from a remote control 1014, para [0043]; see also paras [0045], [0053-54], [0058]).
Lalonde is silent regarding wherein the control module includes an internal accelerometer. However, Baeke teaches that it was known in the respiratory device art at the time of invention of the claimed invention to include an accelerometer (accelerometer 21) (Fig. 1) in a patient-adjacent respiratory device, such that it would have been obvious to an artisan at the time of invention of the claimed invention to include an accelerometer in the control module of Lalonde, in order to provide the predictable result of utilizing a known sensor means (accelerometer) to allow the control module to detect that a patient is attempting to use the control module in order to wake up and/or illuminate the control module for (ease of) use (Baeke paras [0014-15], [0026], [0030]).
While Lalonde teaches oxygen delivery and oxygen and carbon dioxide sensing (para [0043]), Lalonde is silent regarding wherein the control module allows a pulse oximeter configured to sense blood oxygen saturation to be connected thereto, and wherein the control module is configured to regulate the ventilator module based on the sensed CO2 and/or the control module is configured to allow a user to adjust oxygen enhancement guided by the sensed blood oxygen saturation. However, Raemer teaches that it was known in the respiratory device art at the time of invention for a control module (comprising FIO2 controller 26) (Fig. 1) to allow a pulse oximeter (pulse oximeter 16) configured to sense blood oxygen saturation to be connected thereto (Fig. 1; col. 4, lines 11-16), and wherein the control module is configured to allow a user to adjust oxygen enhancement guided by the sensed blood oxygen saturation (col. 4, line 60-col. 5, line 2). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the control module of Lalonde to include wherein the control module allows a pulse oximeter configured to sense blood oxygen saturation to be connected thereto, and wherein the control module is configured to allow a user to adjust oxygen enhancement guided by the sensed blood oxygen saturation as taught by Raemer, and/or the control module is configured to regulate the ventilator module based on the sensed CO2, in order to provide the predictable result(s) of allowing control of the oxygen and/or ventilation delivery of Lalonde to be directed by well-known physiological parameters/common feedback variables in order to provide sufficient therapy to a user (Lalonde para [0043]; Raemer col. 1, line 10-col. 2, line 20).
Regarding claims 22-24, Lalonde in view of Baeker and Raemer teaches the modular ventilator system according to claim 21, wherein Lalonde discloses one or more of the following individually replaceable modules:
an extension battery module for the control module;
an oxygen enhancement module provided to the ventilator module;
a mucous trap module provided to a distal opening of the ventilator module, wherein the mucous trap module provides a capture plate adapted to capture any particulate matter expired by the patient;
a heat moisture exchange filter module provided to a distal opening of the ventilator module, wherein the heat moisture exchange filter module includes a filter and/or pad to condition air inhaled by the patient and/or protect the ventilator from particulate matter expired by the patient; and/or
a strap module including one or more straps (upper strap 210 and/or strap 212/514) to stabilize the ventilator module and/or the control module (Figs. 2 and 5A; paras [0040-41], [0060]).
Regarding claim 25, Lalonde in view of Baeker and Raemer teaches the modular ventilator system according to claim 22, wherein Lalonde discloses wherein the one or more straps are configured to support the ventilator [module] around a part of a user's body (Figs. 2 and 5A; paras [0040-41], [0060]).
Regarding claim 26, Lalonde in view of Baeker and Raemer teaches the modular ventilator system according to claim 25, wherein Lalonde discloses wherein the one or more straps include a chest band (other locations [for the strap 212/514], such as the…chest, paras [0040-41], [0060]).
Regarding claim 27, Lalonde in view of Baeker and Raemer teaches the modular ventilator system according to claim 25, wherein Lalonde discloses wherein the one or more straps include an arm band (other locations [for the strap 212/514], such as the…arm, paras [0040-41], [0060]).
Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Freeman OR Lalonde in view of Baeke and Raemer as applied to claim 21 above, and further in view of Gilmore et al. (US 5,931,160; hereinafter “Gilmore”).
Regarding claim 33, Freeman discloses OR Lalonde in view of Baeke and Raemer teaches the modular ventilator system according to claim 21, wherein Freeman further discloses wherein the control module is separate from the ventilator module (Fig. 1; para [0015]) and Lalonde further discloses wherein the control module is battery powered and separate from the ventilator module (Lalonde Figs. 10A-B; paras [0074-75]), wherein it would have been obvious to an artisan at the time of invention for the control module of Freeman to be battery powered in order to provide the predictable result of a stand-alone, wire-free control device for ease of use/positioning.
Freeman OR modified Lalonde is silent regarding wherein the ventilator module and the control module both include a micro-controller configured to record patient data and allow transfer of ventilator settings and patient details. However, Gilmore teaches that it was known in the respiratory therapy art at the time of invention to include wherein the ventilator module (comprising embedded controller 14) and the control module (comprising display controller 12) both include a micro-controller (processor 30 and processor 22, respectively) (page 22, lines 11-12; page 16, lines 11-12) configured to record patient data and allow transfer of ventilator settings and patient details (page 13, lines 21-30; page 22, line 11-page 24, line 19). Therefore, it would have been obvious to an artisan at the time of invention to include wherein the ventilator module and the control module both include a micro-controller configured to record patient data and allow transfer of ventilator settings and patient details as taught by Gilmore, in order to provide the predictable result of safe performance/data integrity of the ventilator system by including redundant processors configured as claimed in the different/separate modules (Gilmore page 13, lines 21-30).
Allowable Subject Matter
Claims 28-32 are objected to as being dependent upon a rejected base claim, but they would be allowable if a terminal disclaimer is filed to obviate the double patenting rejections and the claims rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching remote control modules for ventilator systems: Bordewick et al. (US 2007/0277827 A1); Wittenber et al. (US 2013/0118497 A1); Burton et al. (US 6,349,724 B1); Alfieri et al. (US 2011/0259334 A1); Bolam et al. (US 2004/0230113 A1); Hickle (US 2003/0145854 A1); Hartley et al. (US 2005/0065572 A1); Sanchez et al. (US 2011/0259332 A1); Servidio et al. (US 5,598,838); Wedler et al. (DE 102006011151 A1); Wright et al. (WO 02/47747 A1); Yamaura et al. (US 2012/0291884 A1). Additional references teaching the inclusion of accelerometers in respiratory devices: Esposito et al. (US 2010/0168599 A1); Farbarik (US 2008/0110459 A1); Taylor et al. (US 2009/0126736 A1). Additional references teaching the well-known practice of using oximeter data for feedback control of oxygen: Kayyali et al. (US 8,545,416 B1); Knight et al. (US 2010/0031960 A1). References teaching two-way flow through respiratory pressure generators: Ahmad (US 2012/0006326 A1); Bowditch et al. (US 2010/0170513 A1); Brydon et al. (US 6,182,657 B1); Chalvignac et al. (US 2013/0008444 A1); Choromokos (US 5,211,171). References teaching blowers with stators having air-directing grooves: Bader et al. (US 6,659,737 B2); Aue (US 2,609,141); Roberts et al. (US 2008/0178879 A1). Reference teaching an oxygen enhancement module: Hete et al. (US 2007/0044799 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 7:30a-3:30p, Tu-Th 8a-2p, F 7:30-11:30a ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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