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 .
Prosecution reopened
In view of the Appeal Brief filed on 7/18/2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785
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.
Claim(s) 1-4, 6, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher (2019/0167171) in view of Totz (7,921,847).
Regarding claims 1, 2, and 6, Gallagher discloses an integrated multimodal colorimetric based aspiration detection and intubation placement verification system (10) for an intubation tube comprising: a) a housing (12) with an internal passage ([0041] lines 1-10, [0075] lines 1-10) configured to be coupled to the intubation tube whereby patient exhalation can flow through an internal passage of the housing ([0041] lines 1-10, [0075] lines 1-10); b) Colorimetric based sensors ([0031] lines 1-5, [0032] lines 1-5) within the housing (12) and configured to come into contact with the patient exhalation ([0035] lines 1-10, [0041] lines 1-10), the sensors including a chemical sensor array (54, 56) including a CO2 sensor [0035] lines 1-3 disclose detecting carbon dioxide) and a sensor for a first gastric acid ([0027] lines 1-3 disclose testing for HCl), ii) a sensor for a second gastric acid different from the first gastric acid ([0031] lines 1-5, [0070] lines 1-10 disclose butyric acid), and iii) a PH sensor([0021] lines 1-10, [0070] lines 1-10 disclose detecting pH).
Gallagher discloses detecting correct placement of an intubation tube as intubation placement verification system ([0001] lines 1-5 and detecting whether the tube is within the esophagus or lung ([0075] lines 1-12) but does not specifically disclose being coupled to an endotracheal tube. However, Totz discloses coupling an endotracheal tube (100) and an enteral tube (280, 270) such that the tester of Gallagher can be coupled to the endotracheal tube via the enteral tube. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the colorimetric tester of Gallagher to the combination endotracheal/ enteral tube as taught by Totz to provide the advantage of enhanced ability to ascertain placement of the enteral tube and/or intubation device.
Regarding claims 3, Gallagher discloses the one colorimetric sensor senses butyric acid ([0070] lines 1-12).
Regarding claim 4, Gallagher discloses one colorimetric sensor senses hydrochloric acid ([0027] lines 1-5).
Regarding claim 16 and 18, Gallagher discloses a method of aspiration detection and intubation placement verification for an intubation tube comprising the steps of: a) Attempting to intubate the patient with an intubation tube ([0007] lines 1-10); b) providing an integrated multimodal colorimetric based aspiration detection and intubation placement verification system (10) for an intubation tube having a housing (12) and colorimetric based sensors within the housing, and wherein the colorimetric sensors includes a CO2 sensor [0035] lines 1-3 disclose detecting carbon dioxide) and a sensor for a first gastric acid ([0027] lines 1-3 disclose testing for HCl), ii) a sensor for a second gastric acid different from the first gastric acid ([0031] lines 1-5, [0070] lines 1-10 disclose butyric acid), and iii) a PH sensor([0021] lines 1-10, [0070] lines 1-10 disclose detecting pH), Coupling the housing to the intubation tube whereby patient exhalation can flow through an internal passage of the housing ([0024] lines 1-15) wherein the colorimetric based sensors within the housing come into contact with the patient exhalation ([0024] lines 1-15, [0075] lies 1-10); and d) utilizing the sensor output for detecting aspiration and to verify intubation placement ([0069] lines 1-15).
Gallagher discloses detecting correct placement of an intubation tube [0001] lines 1-5 and detecting whether the tube is within the esophagus or lung ([0075] lines 1-12) but does not specifically disclose coupling to an endotracheal tube. However, Totz discloses coupling an endotracheal tube (100) and an enteral tube (280, 270) such that the tester of Gallagher can be coupled to the endotracheal tube via the enteral tube. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the colorimetric tester of Gallagher to the combination endotracheal/ enteral tube as taught by Totz to provide the advantage of enhanced ability to ascertain placement of the enteral tube and/or intubation device.
Regarding claim 17, Gallagher discloses detection of patient aspiration includes the detection of butyric acid in the patient exhalation([0063] lines 1-5, [0070] lines 1-15).
Claim(s) 7, 8, 10-15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher (2019/0167171) in view of Totz (7,921,847), as applied to claims 1 and 16 above, and further in view of Elia (2019/0240115).
Regarding claim 7, The modified Gallagher discloses a chemical sensor array but does not specifically disclose (electronic based sensors. However, Elia discloses the sensors are electronic based ([0052} discloses that the sensors are electronically connected for display as electronically based). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the colorimetric sensor of Gallagher to be electronic based as taught by Elia to provide the advantage of enhanced digital display for enhanced viewing and data storage.
Regarding claims 8, 11, 12, 14, and 15, Gallagher discloses an integrated multimodal colorimetric based aspiration detection and intubation placement verification system (10) for an intubation tube comprising: a) a housing (12)with an internal passage configured to be coupled to the intubation tube whereby patient exhalation can flow through the internal passage of the housing ([0041] lines 1-10, [0075] lines 1-10); b) Colorimetric based sensors ([0031] lines 1-5, [0032] lines 1-5) within the housing (12) and configured to come into contact with the patient exhalation ([0035] lines 1-10, [0041] lines 1-10), the sensors including a chemical sensor array (54, 56) including a CO2 sensor [0035] lines 1-3 disclose detecting carbon dioxide) and a sensor for a first gastric acid ([0027] lines 1-3 disclose texting for HCl), ii) a sensor for a second gastric acid different from the first gastric acid ([0031] lines 1-5, [0070] lines 1-10 disclose butyric acid), and iii) a PH sensor([0021] lines 1-10, [0070] lines 1-10 disclose detecting pH).
Gallagher discloses detecting correct placement of an intubation tube as intubation placement verification system ([0001] lines 1-5 and detecting whether the tube is within the esophagus or lung ([0075] lines 1-12) but does not specifically disclose being coupled to n endotracheal tube. However, Totz discloses coupling an endotracheal tube (100) and an enteral tube (280, 270) such that the tester of Gallagher can be coupled to the endotracheal tube via the enteral tube. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the colorimetric tester of Gallagher to the combination endotracheal/ enteral tube as taught by Totz to provide the advantage of enhanced ability to ascertain placement of the enteral tube and/or intubation device.
The modified Gallagher discloses a chemical sensor array but does not specifically disclose bioelectric based sensors. However, Elia discloses the sensors are bioelectric based sensors ([0052], [192] lines 1-3 discloses that the sensors are electronically connected for display as electronically based and include optical sensors for an esophageal sphincter as bioelectric sensors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the colorimetric sensor of Gallagher to be bioelectronic based as taught by Elia to provide the advantage of enhanced digital display for enhanced viewing and data storage.
Regarding claim 10, Gallagher discloses detection of patient aspiration includes the detection of butyric acid in the patient exhalation([0063] lines 1-5, [0070] lines 1-15).
Regarding claim 13, Gallagher discloses able to be connected to a face mask ([0018] lines 1-10 disclose connectors enabling at least fluid connection to a face mask).
Regarding claim 20, The modified Gallagher discloses a chemical sensor array but does not specifically disclose optical sensors. However, Elia discloses the sensors are optical based sensors ([0052], [192] lines 1-3 discloses that the sensors are electronically connected for display as electronically based and include optical sensors foe n esophageal sphincter as bioelectric sensors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the colorimetric sensor of Gallagher to be bioelectronic based as taught by Elia to provide the advantage of enhanced digital display for enhanced viewing and data storage.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher) in view of Totz and Elia, as applied to claims 8 and 18 above, and further in view of Haick (2018/0282155).
Regarding claim 9, the modified Gallagher discloses an electric chemical sensor array ([0052], [0192] lines 1-3 of Elia discloses that the sensors are electronically connected for display as electronically based and include optical sensors for an esophageal sphincter as bioelectric sensors) but does not specifically disclose detecting odor of less than 10ppb in gas and 10ppm in liquid. However Haick discloses detecting highly sensitive electronic nose sensors able to detect particles less than 10ppm and 10 ppb in vapor ([0015], [0043], for ventilation/air intake monitoring and medical applications [0092]). While Haick does not specifically disclose detecting odor of less than 10ppb in gas and 10ppm in liquid, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the sensors of the modified Gallagher to be able to detect particles of less than 10ppm and 10 ppb in vapor as taught by Haick to provide the advantage of effective and sensitive detection of odorants such as HCl and butyric acid for enhanced responsiveness. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the sensors of the modified Gallagher to be able to detect particles in the claimed range as such would be well within an artisan’s skill and would to provide the advantage of enhanced sensitivity for liquid and gases phases within vapor. In addition, it has been held that where the general conditions of a claim are known, it is not inventive to determine optimum or workable ranges by routine experimentation.
Regarding claim 19, the modified Gallagher discloses a chemical sensor array but does not specifically disclose the array includes bioelectric based sensors. However, Elia discloses the sensors are bioelectric based sensors ([0052], [192] lines 1-3 discloses that the sensors are electronically connected for display as electronically based and include optical sensors for an esophageal sphincter as bioelectric sensors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the colorimetric sensor of Gallagher to be bioelectronic based as taught by Elia to provide the advantage of enhanced digital display for enhanced viewing and data storage.
The modified Gallagher discloses an electric chemical sensor array but does not specifically disclose detecting odor of less that 10ppb in gas and 10ppm in liquid. However Haick discloses detecting highly sensitive electronic nose sensors able to detect particles less than 10ppm and 10 ppb in vapor ([0015], [0043], for ventilation/air intake monitoring and medical applications [0092]). While Haick does not specifically disclose detecting odor of less than 10ppb in gas and 10ppm in liquid, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the sensors of the modified Gallagher to be able to detect particles of less than 10ppm and 10 ppb in vapor as taught by Haick to provide the advantage of effective and sensitive detection of odorants such as HCl and butyric acid for enhanced responsiveness. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the sensors of the modified Gallagher to be able to detect particles in the claimed range as such would be well within an artisan’s skill and would to provide the advantage of enhanced sensitivity for liquid and gases phases within vapor. In addition, it has been held that where the general conditions of a claim are known, it is not inventive to determine optimum or workable ranges by routine experimentation.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,336,967. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are a broader version of the patented claims. For example, the patented claims include a plastic cylindrical housing. All elements in the instant claim can be found in the patented claim. Thus the instant claims do not differ in scope from the patented claims.
Application 17/195,591
Patent 17,317,108
1. An integrated multimodal aspiration detection system for an endotracheal tube comprising: a)
A housing with an internal passage configured to be coupled to the endotracheal tube, whereby patient exhalation can flow through the internal passage of the housing;
b) sensors within the housing and configured to come into contact with the patient exhalation, the sensors including a chemical sensor array including at least one of
i) a sensor for a first gastric acid, and
ii) a sensor for a second gastric acid different from the first gastric acid.
2. The integrated multimodal aspiration detection system according to claim 1, wherein the chemical sensor array is a colorimetric chemical sensor array.
3. The integrated multimodal aspiration detection system according to claim 1, wherein one sensor senses butyric acid.
4. The integrated multimodal aspiration detection system according to claim 3, wherein one colorimetric sensor senses hydrochloric acid.
6. The integrated multimodal aspiration detection system according to claim 1, wherein the system is configured intubation placement verification system.
1. A butyric and hydrochloric acid detection based platform for verifying placement of a patient airway device or a gastric tube comprising:
i) a transparent plastic cylindrical housing having an internal passage there through and couplings on each end of the housing;
ii) sensor supports coupled to the housing and extending into the internal passage;
iii) a colorimetric based butyric acid sensor that visibly changes color via a chemical reaction in the presence of butyric acid, wherein the butyric acid sensor is mounted on the sensor supports;
iv) a colorimetric based hydrochloric acid sensor that visibly changes color via a chemical reaction in the presence of hydrochloric acid, wherein the hydrochloric acid sensor is mounted on the sensor supports stacked with the butyric acid sensor, whereby the sensors are in the same axial position along the internal passage of the housing; and wherein the housing is configured to be coupled to the patient airway device or a gastric tube via the couplings whereby flow from the coupled patient airway device or a gastric tube can flow through the internal passage of the housing and around the stacked colorimetric based hydrochloric acid sensor and colorimetric based butyric acid sensor and contacting both the colorimetric based hydrochloric acid sensor and colorimetric based butyric acid sensor; and wherein the stacked colorimetric based hydrochloric acid and colorimetric based butyric acid sensors within the housing and which are configured to come into contact with the flow from the coupled patient airway device or a gastric tube form a chemical sensor array.
2. The butyric and hydrochloric acid detection based platform according to claim 1, wherein the platform is configured for coupling to an endotracheal tube.
3. The butyric and hydrochloric acid detection based platform according to claim 2, wherein the platform is configured as an intubation placement verification system.
Response to Arguments
Applicant's arguments filed 6/4/2025 have been fully considered but they are not persuasive.
Applicant argues on page 14 2nd paragraph that the references fail to disclose aspiration detection. Examiner respectfully disagrees. Gallagher discloses using sensors to detect aspiration into a chamber and the content thereof ([0016]). Thus Gallagher discloses aspiration detection as claimed.
Applicant argues on page 15 1st full paragraph that the prior art does not teach an endotracheal coupled to housing for exhalation flow. Examiner respectfully disagrees as it is the combination of references that teach this limitation as claimed. Gallagher discloses detecting correct placement of an intubation tube as intubation placement verification system ([0001] lines 1-5 and detecting whether the tube is within the esophagus or lung ([0075] lines 1-12); a housing (12) with an internal passage configured to be coupled to the intubation tube whereby patient exhalation can flow through the internal passage of the housing ([0041] lines 1-10, [0075] lines 1-10); b) Colorimetric based sensors within the housing (12) configured to come into contact with the patient exhalation ([0035] lines 1-10, [0041] lines 1-10), the sensors including a CO2 sensor ([0035] lines 1-3 disclose detecting carbon dioxide). Totz discloses coupling an endotracheal tube (100) and an enteral tube (280, 270) such that the tester of Gallagher can be coupled to the endotracheal tube via the enteral tube. Thus the combination of Gallagher and Totz teach these limitations as claimed.
Applicant argues on page 17 1st paragraph that the verification device would be on the enteral tube. However, Examiner notes that the claim language recites “coupled” and Tots teaches the enteral tube is coupled to the endotracheal tube. Thus Totz teaches this limitation as claimed.
Applicant argues on page 17 2nd paragraph that the prior art does not disclose dual usage of the system. However Examiner notes that “dual usage” is not found in the language of claim 6. Thus the combination of references teaches the limitations that are claimed.
Applicant argues on page 4 2nd paragraph that Gallagher does not disclose the limitations of claim 19. Examiner respectfully disagrees as the modified Gallagher discloses an electric chemical sensor array. Gallagher discloses detecting carbon dioxide in patient’s exhalation ([0035] lines 1-10, [0041] lines 1-10) thereby able to detect particles of less than 10ppm in gas and liquid since it can detect CO2 but does not specifically disclose the method step of detecting less than 10ppm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the sensors of the modified Gallagher to be able to detect particles less than 10ppm in gas and liquid to provide the advantage of effective detection carbon dioxide and gastric sensors. Thus the combination of references teaches this limitation as claimed.
Applicant argues on page 20 1st through last paragraph that the NG tube technology is unrelated to the intubation technology and Elia does not teach an electric sensor array. Examiner respectfully disagrees and notes that an NG tube is a type of intubation tube often coupled with an endotracheal tube (see abstract of Totz). Gallagher teaches a chemical sensor array (54, 56). Elia is relied on for teaching bioelectric based sensors ([0052], [192] lines 1-3 discloses that the sensors are electronically connected for display as electronically based and include optical sensors for an esophageal sphincter as bioelectric sensors). One of ordinary skill in the art would recognize that configuring the colorimetric sensor array of Gallagher to be bioelectronic based as taught by Elia would provide the advantage of enhanced digital display for enhanced viewing and data storage. Thus the combination of references teach these limitations as claimed.
Applicant’s arguments with respect to claim(s) 7 and 19 on page 18 have been considered but are moot in view of the new ground(s) or rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/Primary Examiner, Art Unit 3785