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(s) 1-20 is/are objected to because of the following informalities:
Claim 1, Ln. 18 recites “a controller that control” which should read “a controller that controls”
Claim 3, Ln. 3-4 recites “wherein second inspiratory lumen” which should read “wherein the second inspiratory lumen”
Claim 5, Ln. 3-4 recites “the endotracheal tube serves the one or more expiratory lumens” which should read “the endotracheal tube serves as the one or more expiratory lumens”
Claim 14, Ln. 4 recites “the airways” which should read “the airway” for consistency with claim 1
Claim 20, Ln. 4 recites “at least distal tip” which should read “at least a distal tip”
Appropriate correction is required.
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.
Claim(s) 8-10, 16 and 19 is/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 pre-AIA the applicant regards as the invention.
Claim 8 recites the limitations “the first lumen is one of …” and “the second lumen is one of …” which deems the claim indefinite. As currently written the first lumen and the second lumen could both be selected as the same structure, e.g. the first inspiratory lumen, which appears to create a logical impossibility. For the purposes of examination the latter limitation will be interpreted as reading “the second lumen is a different one of ….”
Claim 10 recites the limitations “the first lumen is withdrawn from the second lumen” which deems the claim indefinite. The active language in the limitation raises the question as to whether the claim is attempting to recite a method step. The use of active verbiage is generally not suitable for an apparatus claim since apparatus claims define a structure by what it is. One suggested edit for the claim could be “the first lumen is capable of being withdrawn from the second lumen.”
Claim 16 recites the limitations “the first lumen is one of …” and “the second lumen is one of …” which deems the claim indefinite. As currently written the first lumen and the second lumen could both be selected as the same structure, e.g. the first inspiratory lumen, which appears to create a logical impossibility. For the purposes of examination the latter limitation will be interpreted as reading “the second lumen is a different one of ….”
Claim 19 recites the limitations “the first inspiratory lumen and a first expiratory lumen of the one or more expiratory lumens are withdrawn to above a carina of the airway” which deems the claim indefinite. The active language in the limitation raises the question as to whether the claim is attempting to recite a method step. The use of active verbiage is generally not suitable for an apparatus claim since apparatus claims define a structure by what it is. One suggested edit for the claim could be “the first inspiratory lumen and a first expiratory lumen of the one or more expiratory lumens are capable of being withdrawn to above a carina of the airway.”
Claim Interpretation - 35 USC § 112(f)
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: “inspiratory gas pressure control mechanisms” in claims 1 and 21 and “expiratory gas pressure control mechanisms” in claims 1 and 21.
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.
The corresponding structure for the “inspiratory flow control mechanism(s)” is
found in the instant specification as at least: the inspiratory gas source(s) 160 of FIG. 1, the inspiratory flow control system(s) 150 of FIG. 1, the inspiratory tube(s) 152 of FIG. 1, the inspiratory gas supply system of FIG. 9A, the inspiratory gas supply system(s) of FIG. 9B, the inspiratory gas delivery system of FIG. 9A, the inspiratory gas delivery system(s) of FIG. 9B, the pressurizer(s) 145, the controllers 170, one or more components of one of the previously listed elements, or a combination thereof (¶00269). Note is also made of the discussion in ¶00274.
The corresponding structure for the “expiratory flow control mechanism(s)” is
found in the instant specification as at least: the expiratory gas output(s) 165 of FIG. 1, the expiratory flow control system(s) 155 of FIG. 1, the expiratory tube(s) 157 of FIG. 1, the expiratory gas receipt system of FIG. 9A, the expiratory gas receipt system(s) of FIG. 9B, the expiratory gas removal system of FIG. 9A, the expiratory gas removal system(s) of FIG. 9B, the pressurizer(s) 145, the controllers 170, one or more components of one of the previously listed elements, or a combination thereof (¶00273).
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.
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.
Claim(s) 1-8, 16-17 and 21 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-9, 11 and 17 of U.S. Patent No. 11,285,286. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of instant claim 1 are found within the overall scope of patent claim 1, the instant claim merely being slightly broader in scope. A further mapping of dependent claims is as follows:
Instant claim 2 vs. patent claim 2
Instant claim 3 vs. patent claim 6
Instant claim 4 vs. patent claim 7
Instant claim 5 vs. patent claim 9
Instant claim 6 vs. patent claim 17
Instant claim 7 vs. patent claim 18
Instant claim 8 vs. patent claim 11 – in patent claim 11 the endotracheal tube defines an expiratory lumen with patent claim 9 defining an inspiratory lumen within the endotracheal tube
Instant claim 16 vs. patent claim 11 – in patent claim 11 the endotracheal tube defines an expiratory lumen with patent claim 10 defining an inspiratory lumen within the endotracheal tube
Instant claim 17 as obvious in view of patent claim 11 – one of ordinary skill in the art would obviously recognize that endotracheal tubes are commonly curved to match the natural human anatomical curvature from the mouth into the trachea
Instant claim 21 vs. patent claim 1 in the same manner discussed above in regard to claim 1
Claim(s) 1-2, 5, 8, 10, 16-17 and 21 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 40 and 76 of U.S. Patent No. 12,171,941. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of instant claim 1 are found within the overall scope of any of patent claims 2, 40, and 76, the instant claim merely being slightly broader in scope. A further mapping of dependent claims is as follows:
Instant claim 2 as obvious in view of patent claims 2, 40 and 76 – one of ordinary skill in the art reading the claims as defining inspiratory lumens provided to two different directions of the airway would obviously have expected those opposite directions to be related to separate lungs
Instant claim 5 as obvious in view of patent claims 2, 40 and 76 – one of ordinary skill in the art reading the claims as defining inspiratory lumens provided to two different directions of the airway would obviously have expected the lumens to be part of an endotracheal tube as that is the common structure in the respiratory arts which delivers gas into a patient’s lower airway
Instant claim 8 vs. any of patent claims 4, 42 and 78
Instant claim 10 as obvious in view of patent claims 4, 42 and 78 – one of ordinary skill in the art will obviously expect a lumen which is “threaded through” to also be capable of being withdrawn in a reverse manner
Instant claim 16 vs. any of patent claims 4, 42 and 78 – “threaded through” implies a smaller diameter
Instant claim 17 as obvious in view of patent claims 2, 40 and 76 – one of ordinary skill in the art would obviously recognize that gas delivery lumens being passed into a lower airway are commonly curved to match the natural human anatomical curvature from the mouth into the trachea
Instant claim 21 vs. patent claims 2, 40 and 76 in the same manner discussed above in regard to claim 1
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reissmann (U.S. Pub. 2004/0231673).
Regarding claim 21, Reissmann discloses a method for airflow control (e.g. Fig. 1), the method comprising: setting, by a controller (¶0024 – software-controlled ventilation), a property of a first flow of a plurality of flows based on a property of a second flow of the plurality of flows (¶¶0024, 0026, 0040, 0049 – sensor feedback to ventilator control), wherein the plurality of flows includes one or more expiratory flows and at least one of a plurality of inspiratory flows (e.g. Fig. 1 flows through #11, 12); receiving a first inspiratory gaseous volume into a first inspiratory lumen (Fig. 1 #5; ¶0051); providing the first inspiratory gaseous volume to a first portion of an airway of a patient as a first inspiratory flow through the first inspiratory lumen using one or more inspiratory gas pressure control mechanisms (¶0049) while the first inspiratory lumen is at least partially inserted into the airway (Fig. 1); wherein the controller controls the one or more inspiratory gas pressure control mechanisms (¶0049); and evacuating an expiratory gaseous volume from the first portion of the airway as the one or more expiratory flows through one or more expiratory lumens (Fig. 1 #6; ¶0051) using one or more expiratory gas pressure control mechanisms (¶0049) while the one or more expiratory lumens are at least partially inserted into the airway, wherein the controller controls the one or more expiratory gas pressure control mechanisms (¶0049). It is noted that the disclosed structures for the inspiratory gas pressure control mechanism and expiratory gas pressure control mechanism (see above 35 U.S.C. 112(f) interpretation) cover so many options, including some overlap between those options, that internal structures of ventilator 1 and/or other valves are suitable for reading on the inspiratory gas pressure control mechanism and expiratory gas pressure control mechanism. The instant claim is afforded an effective filing date of not later than 11 Jun 2021.
Reissmann fails to disclose receiving a second inspiratory gaseous volume into a second inspiratory lumen; providing the second inspiratory gaseous volume to a second portion of the airway as a second inspiratory flow through the second inspiratory lumen using the one or more inspiratory gas pressure control mechanisms while the second inspiratory lumen is at least partially inserted into the airway; and evacuating an expiratory gaseous volume from the second portion of the airway as the one or more expiratory flows through one or more expiratory lumens using one or more expiratory gas pressure control mechanisms while the one or more expiratory lumens are at least partially inserted into the airway.
However, it is noted that the claim does not require any of the lumens to be part of a same apparatus, as is required by claim 1. Similarly, the claim places no timing requirements on when the first inspiratory gaseous volume and the second inspiratory gaseous volume are received or when the evacuating of the expiratory gaseous volume is performed. Thus, one of ordinary skill in the art would have considered it prima facie obvious that treatment on a patient could begin in the manner shown in Fig. 1 of Reissmann and address two of the lumens of the claimed invention, as indicated in the above citations. It is a recognized concern in the respiratory arts that when a blocked or otherwise defective endotracheal tube is recognized during treatment the patient may need to be extubated and the endotracheal tube replaced. Such a replacement of the endotracheal tube of Fig. 1 would then introduce two new lumens which would still be expected to have their flow controlled by ventilator 1.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Reissmann a second inspiratory gaseous volume into a second inspiratory lumen; providing the second inspiratory gaseous volume to a second portion of the airway as a second inspiratory flow through the second inspiratory lumen using the one or more inspiratory gas pressure control mechanisms while the second inspiratory lumen is at least partially inserted into the airway; and evacuating an expiratory gaseous volume from the second portion of the airway as the one or more expiratory flows through one or more expiratory lumens using one or more expiratory gas pressure control mechanisms while the one or more expiratory lumens are at least partially inserted into the airway based upon a recognized concern in the respiratory arts that when a blocked or otherwise defective endotracheal tube is recognized during treatment the patient may need to be extubated and the endotracheal tube replaced, with the new endotracheal tube then introducing two new lumens resulting in fulfillment of the overall lumens and flows required by the instant claim. Applicant may wish to consider defining all of the claimed lumens as of the same apparatus and/or to recite all of the lumens as inserted within the airway at the same time.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kinsman (U.S. Patent 5359999).
Regarding claim 21, Kinsman discloses a method for airflow control (e.g. Fig. 2), the method comprising: setting, by a controller (Col. 3, Ln. 35 – Col. , Ln. 3 – electronics of master ventilator; Col. 6, Ln. 34-43 – master ventilator has a controller), a property of a first flow of a plurality of flows based on a property of a second flow of the plurality of flows (Col. 3, Ln. 35 – Col. 5, Ln. 3 – cycling of the ventilator), wherein the plurality of flows includes one or more expiratory flows and at least one of a plurality of inspiratory flows (cycling a ventilator involves inspiratory and expiratory flows); receiving a first inspiratory gaseous volume into a first inspiratory lumen (e.g. Fig. 2 #1 receives from #10); providing the first inspiratory gaseous volume to a first portion of an airway of a patient as a first inspiratory flow through the first inspiratory lumen using one or more inspiratory gas pressure control mechanisms (Fig. 2 operation of #14) while the first inspiratory lumen is at least partially inserted into the airway (Fig. 2); receiving a second inspiratory gaseous volume into a second inspiratory lumen (e.g. Fig. 2 #2 receives from #12); providing the second inspiratory gaseous volume to a second portion of the airway as a second inspiratory flow through the second inspiratory lumen using the one or more inspiratory gas pressure control mechanisms (Fig. 2 operation of #15) while the second inspiratory lumen is at least partially inserted into the airway (Fig. 2), wherein the controller controls the one or more inspiratory gas pressure control mechanisms (Col. 3, Ln. 35 – Col. , Ln. 3; Col. 6, Ln. 34-43 – master and slave configuration), wherein the plurality of inspiratory flows includes the first inspiratory flow and the second inspiratory flow (Fig. 2); and evacuating an expiratory gaseous volume from the first portion of the airway and from the second portion of the airway as the one or more expiratory flows (Fig. 2 through #11, 13) using one or more expiratory gas pressure control mechanisms (Fig. 2 operation of #14, 15), wherein the controller controls the one or more expiratory gas pressure control mechanisms (Col. 3, Ln. 35 – Col. , Ln. 3; Col. 6, Ln. 34-43 – master and slave configuration). Alternately, the left lumen 2 of Kinsman can be read as an expiratory lumen and Kinsman would then fail to disclose a second inspiratory lumen. It is noted that the disclosed structures for the inspiratory gas pressure control mechanism and expiratory gas pressure control mechanism (see above 35 U.S.C. 112(f) interpretation) cover so many options, including some overlap between those options, that internal structures of ventilators 14, 15 are suitable for reading on the inspiratory gas pressure control mechanism and expiratory gas pressure control mechanism. The instant claim is afforded an effective filing date of not later than 11 Jun 2021.
Kinsman fails to disclose both a second inspiratory lumen inserted into the airway and one or more expiratory lumens at least partially inserted into the airway.
However, it is noted that the claim does not require any of the lumens to be part of a same apparatus, as is required by claim 1. Similarly, the claim places no timing requirements on when the first inspiratory gaseous volume and the second inspiratory gaseous volume are received or when the evacuating of the expiratory gaseous volume is performed. Thus, one of ordinary skill in the art would have considered it prima facie obvious that treatment on a patient could begin in the manner shown in Fig. 2 of Kinsman and address two of the lumens of the claimed invention, as indicated in the above citations. It is a recognized concern in the respiratory arts that when a blocked or otherwise defective endotracheal tube is recognized during treatment the patient may need to be extubated and the endotracheal tube replaced. Such a replacement of the endotracheal tube of Fig. 2 would then introduce two new lumens which would still be expected to have their flow controlled by ventilators 14, 15.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Kinsman both a second inspiratory lumen inserted into the airway and one or more expiratory lumens at least partially inserted into the airway based upon a recognized concern in the respiratory arts that when a blocked or otherwise defective endotracheal tube is recognized during treatment the patient may need to be extubated and the endotracheal tube replaced, with the new endotracheal tube then introducing two new lumens resulting in fulfillment of the overall lumens and flows required by the instant claim. Applicant may wish to consider defining all of the claimed lumens as of the same apparatus and/or to recite all of the lumens as inserted within the airway at the same time.
Allowable Subject Matter
Claims 1-20 are allowed over the prior art. Some of these claims are rejected based upon the above 35 U.S.C. 112(b) rejections and nonstatutory double patenting rejections.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the prior art fails to teach or suggest an apparatus including all elements and functionality recited by the instant claim. Specifically, the apparatus is recited as including a first inspiratory lumen communicating to a first portion of the airway, a second inspiratory lumen communicating to a second portion of the airway, and at least one expiratory lumen at least partially inserted into the airway. Thus, the claimed apparatus must include at least three lumens amongst which two lumens communicate inspiratory gas to different portions of the airway of the patient. Additionally, a controller regulates flow through all of the lumens. The instant claim is afforded an effective filing date of not later than 11 Jun 2021.
Closest prior art to the instant claim include: Darowski et al. (U.S. Patent 4598706), Kinsman (U.S. Patent 5359999), and Bell (U.S. Patent 10980954). Darowski (Figure) and Kinsman (Figs. 2-3) each teach a pair of inspiratory limbs delivering gas to a patient. However, neither Darowski nor Kinsman teaches or suggests more than two lumens placed within the patient. There is not found to be a preponderance of the evidence that one of ordinary skill in the art would have modified either of Darowski or Kinsman to have included the requirements minimum of three lumens within the patient without improper hindsight reasoning.
Bell teaches an endotracheal tube which can include multiple inspiratory tubes (Fig. 3B #321 or Fig. 3C #325; Col. 11, Ln. 41-46). However, those multiple inspiratory tubes empty into common a common distal portion of the endotracheal tube (e.g. Fig. 1 #102b; Col. 10, Ln. 35-50). Thus, different inspiratory flows through inspiratory tubes 321, 325 will only provide gas to the same portion of the patient’s airway, at the distal opening of the endotracheal tube, and not to different first and second portions of the patient’s airway.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785