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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/24/24, 7/25/25, 8/19/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The specification does not have proper antecedent support for the subject matter of claim 6: “wherein the controller is configured to control the rate of the feed or formula introduced such that the GRV is maintained below a predetermined upper limit”; claim 7: “wherein the controller is configured to control the rate of the feed or formula introduced such that the GRV is maintained above a predetermined lower limit”; claim 19: “wherein controlling the rate comprises controlling the rate of the feed or formula introduced such that the GRV is maintained below a predetermined upper limit”; and claim 20: “wherein controlling the rate comprises controlling the rate of the feed or formula introduced such that the GRV is maintained above a predetermined lower limit.”
Here, e.g., ¶198 (all citations to the PGPUB US 2024/0245583) states: “In some embodiments, GRV (or gastric emptying) is monitored over time, and feeding is stopped, started, increased or decreased as a result of changes in GRV over time, or GRV thresholds. For example, if GRV is decreasing, this may be an indicator that the patient can tolerate more food, and feeding rate and/or volume may be increased or initiated. If GRV is increasing, this may be an indication that the patient is not tolerating the feed rate and feeding rate and/or volume may be decreased or stopped. Feeding rate and/or volume may be increased, decreased, stopped or initiated based on GRV trends and/or GRV thresholds.”
However, ¶198 does not provide proper antecedent basis support for a controller configured to control the rate introduced so that the GRV is maintained above a lower limit and below and upper limit. ¶106 states the feed rate may be automatically, semi-automatically, or manually controlled, so the change to the feed rate discussed in ¶198 may be manually achieved.
The specification does not have proper antecedent support for the subject matter of claim 15: “wherein the controller is further configured to pause or stop the feed from being introduced into the stomach when the temperature sensor measures the core body temperature of the subject.” (emphasis added).
The specification does not have proper antecedent support for the subject matter of claim 20: “further comprising pausing or stopping the feed from being introduced into the stomach while the one or more temperature sensors measure a core body temperature of the subject.” (emphasis added).
Here, ¶212 (all citations to the PGPUB US 2024/0245583) states that the controller may control the pump to pause feeding. But fails to properly support that the controller is configured to pause when or while the temperature sensors measure the core body temperature. A controller programmed to pause feeding for a period of time that allows core body temperature to be measured is different than pausing when or while core body temperature is being measured.
Applicant is strongly advised to carefully review the claims in view of the specification and ensure proper antecedent basis is present and/or alternatively cancel the claim(s). Appropriate correction is required.
Claim Objections
Claims 7 and 20 are objected to because of the following informalities:
In regards to claim 7, the term “the controller is configured to control” in line 1 should be changed to “the controller is further configured to control” (emphasis added). Here, the parent claim already recites that the controller is configured to control the rate, so the dependent claim should state that the controller is further configured to control the rate based on the additional condition recited.
In regards to claim 20, the term “the controller is configured to control” in line 1 should be changed to “the controller is further configured to control” (emphasis added). Here, the parent claim already recites that the controller is configured to control the rate, so the dependent claim should state that the controller is further configured to control the rate based on the additional condition recited.
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.
Claims 1-27 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.
The term “at a steady level” (emphasis added) in claims 1 and 16 is a relative term which renders the claim indefinite. The term “steady level” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Here, the specification states in ¶200: “The feed rate target may be the feed rate at which GRV stays relatively steady, not increasing or decreasing appreciably over time.”
¶201 states: “An estimate of feed rate to achieve steady or constant GRV over time may be achieved by measuring the impedance of an empty stomach, as well as knowing or measuring the impedance of formula.”
Thus, the broadest reasonable interpretation of “steady” in view of the specification is something other than “constant” that is “not increasing or decreasing appreciably over time”. Webster’s Dictionary defines “steady” as “showing little variation or fluctuation”.
However, the specification does not provide a standard for ascertaining the requisite degree of what a person of ordinary skill in the art would recognize as an appreciable increase or decrease over time and/or what would be a little variation or fluctuation. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention because there is no standard for determining what would be an appreciable increase or decrease of GRV versus what would be a non-appreciable increase or decrease of GRV over time. Two different people of ordinary skill in the art can come to two different conclusions and thus the limitation is indefinite as being a subjective relative term.
Claims 2-15 and 17-27 are rejected by virtue of depending on a rejected base claim.
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) 1-11, 13, 16-24, 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sutaria et al (2018/0078195).
Sutaria et al discloses a feeding system (e.g. Fig 11), comprising: a gastric access device (102) having a length (e.g. Fig 11); one or more sensors (e.g. 1101-1108; ¶185) positioned along the length (e.g. Fig 11); a controller (e.g. ¶21; monitor 110 – also called a controller see ¶126) in communication with the one or more sensors (e.g. ¶329, ¶361, wherein the controller is configured to receive a signal from the one or more sensors relating to a parameter of a fluid within a stomach of a subject (e.g. Fig 12; ¶329, ¶361), wherein the controller is further configured to determine a gastric residual volume (GRV) based upon the signal and control a rate of a feed or formula introduced into the stomach such that the GRV is maintained at a steady level (e.g. ¶20, ¶329, ¶347, ¶351, ¶180, ¶181, ¶300; see also 112 discussion above readying the scope of “steady”; where e.g., ¶20 disclosed the use of a measured signal to determine GRV and the determined GRV can be used to control patients feeding rate to avoid complications; see also ¶180-¶181 disclosing that when there is abnormal motility, the feed rate can be reduced controlled to reduce risks or increased if the patient is tolerating; ¶347 discloses the level of feed delivery controlled so the GRV is at or below certain preset levels. Here, “maintained at a steady level” is being interpreted as maintained within certain preset levels to not be abnormal and result in complications).
Regarding claim 2, Sutaria et al discloses wherein the one or more sensors comprise impedance or conductivity sensors (¶185: impedance sensors 1101-1108; Fig 11).
Regarding claim 3, Sutaria et al discloses wherein the parameter of the fluid within the stomach is alterable via introduction of an additive into the stomach (¶366, ¶367, e.g. additive liquid).
Regarding claim 4, Sutaria et al discloses wherein the additive comprises a volume of feed or formula (¶366, ¶367, e.g. additive liquid).
Regarding claim 5, Sutaria et al discloses wherein the parameter comprises an impedance or conductivity of the fluid within the stomach (e.g., ¶185-¶186).
Regarding claim 6, Sutaria et al discloses wherein the controller is configured to control the rate of the feed or formula introduced (e.g. ¶20, ¶329) such that the GRV is maintained below a predetermined upper limit (e.g. ¶347 discloses the level of feed delivery controlled so the GRV is at or below certain preset levels; ¶361, target volumes over time of feed can be set and maximum volumes may be programmed).
Regarding claim 7, Sutaria et al discloses wherein the controller is further configured to control the rate of the feed or formula introduced (¶20, ¶329) such that the GRV is maintained above a predetermined lower limit (e.g. ¶347 discloses the level of feed delivery controlled so the GRV is at or below certain preset levels; ¶361, target volumes over time of feed can be set and maximum volumes may be programmed; see also ¶180-¶181 disclosing that when there is abnormal motility, the feed rate can be reduced controlled to reduce risks or increased if the patient is tolerating).
Regarding claim 8, Sutaria et al discloses wherein the one or more sensors are configured to measure a reflux of the fluid (¶180, ¶184-¶186).
Regarding claim 9, Sutaria et al discloses further comprising one or more additional sensors (¶185, impedance sensors 1101-1108; Fig 11) positioned along the length (e.g. Fig 11; 1101-1108 along feeding tube) and which are configured to measure a reflux of the fluid (¶180, ¶184-¶186, e.g. impedance sensors 1101-1108 comprise a conductive electrode in order to measure the impedance between two different sensors. When reflux material spans two sensors, the electrical impedance between the two sensors is reduced and is measured).
Regarding claim 10, Sutaria et al discloses wherein the controller is further configured to reduce the rate (e.g. ¶181, ¶329) when reflux of the fluid is detected (¶181, the impedance sensor data in the stomach can also be combined with sensor data in the esophagus, so the combination of motility data and reflux data, can then automatically reduce the feeding level).
Regarding claim 11, Sutaria et al discloses further comprising one or more temperature sensors positioned along the length (e.g. ¶170, ¶351).
Regarding claim 13, Sutaria et al discloses wherein the controller is further configured to start or stop the rate of the feed or formula introduced based upon a temperature received from the one or more temperature sensors (¶170, ¶351).
Regarding claim 16, Sutaria et al discloses a method of managing delivery of feed or formula into a stomach of a subject (e.g. ¶20, ¶185), comprising: contacting a fluid within a stomach of a subject via one or more sensors positioned along a length of a gastric access device (¶20, ¶185; e.g. Fig 11; sensors 1101-1108 on 102); receiving a signal from the one or more sensors into a controller in communication with the one or more sensors (e.g. ¶21; monitor 110 – also called a controller see ¶126), wherein the signal relates to a parameter of the fluid (e.g. Fig 12; ¶329, ¶361); determining a gastric residual volume (GRV) based upon the signal (e.g. ¶20 disclosed the use of a measured signal to determine GRV); and controlling a rate of a feed or formula introduced into the stomach such that the GRV is maintained at a steady level (e.g. ¶20, ¶329, ¶347, ¶351, ¶180, ¶181, ¶300; see also 112 discussion above readying the scope of “steady”; where e.g., ¶20 disclosed the use of a measured signal to determine GRV and the determined GRV can be used to control patients feeding rate to avoid complications; see also ¶180-¶181 disclosing that when there is abnormal motility, the feed rate can be reduced controlled to reduce risks or increased if the patient is tolerating; ¶347 discloses the level of feed delivery controlled so the GRV is at or below certain preset levels. Here, “maintained at a steady level” is being interpreted as maintained within certain preset levels to not be abnormal and result in complications).
Regarding claim 17, Sutaria et al discloses wherein contacting the fluid comprises contacting the fluid with one or more impedance or conductivity sensors (¶185: impedance sensors 1101-1108; Fig 11).
Regarding claim 18, Sutaria et al discloses wherein receiving the signal comprises receiving an impedance or conductivity signal into the controller (e.g. ¶20-¶21, ¶185, ¶361).
Regarding claim 19, Sutaria et al discloses wherein controlling the rate comprises controlling the rate of the feed or formula introduced such that the GRV is maintained below a predetermined upper limit (e.g. ¶20, ¶329, ¶347 discloses the level of feed delivery controlled so the GRV is at or below certain preset levels; ¶361, target volumes over time of feed can be set and maximum volumes may be programmed).
Regarding claim 20, Sutaria et al discloses wherein controlling the rate further comprises controlling the rate of the feed or formula introduced such that the GRV is maintained above a predetermined lower limit (e.g. ¶20, ¶329, ¶347 discloses the level of feed delivery controlled so the GRV is at or below certain preset levels; ¶361, target volumes over time of feed can be set and maximum volumes may be programmed; see also ¶180-¶181 disclosing that when there is abnormal motility, the feed rate can be reduced controlled to reduce risks or increased if the patient is tolerating).
Regarding claim 21, Sutaria et al discloses further comprising measuring a reflux of the fluid via the one or more sensors (¶180, ¶184-¶186).
Regarding claim 22, Sutaria et al discloses further comprising measuring a reflux of the fluid via one or more additional sensors positioned along the length (¶185, impedance sensors 1101-1108; Fig 11).
Regarding claim 23, Sutaria et al discloses wherein the controller is further configured to reduce the rate when reflux of the fluid is detected (¶181, the impedance sensor data in the stomach can also be combined with sensor data in the esophagus, so the combination of motility data and reflux data, can then automatically reduce the feeding level).
Regarding claim 24, Sutaria et al discloses wherein receiving the signal further comprises receiving a temperature from one or more temperature sensors positioned along the length (e.g. ¶170, ¶351).
Regarding claim 26, Sutaria et al discloses further comprising starting or stopping the rate of the feed or formula introduced based upon a temperature received from the one or more temperature sensors (¶170, ¶351).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12, 14-15, 25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutaria et al, as applied to claims 1, 11, and 24, in view of Boone, III et al (20170020396). Regarding claim 12, 14-15, 25, and 27, Sutaria et al discloses the invention substantially as claimed except for disclosing wherein the one or more temperature sensors are positionable along the length to sense a core body temperature of the subject and are in communication with the controller, wherein the controller is further configured to pause or stop the feed from being introduced into the stomach when the temperature sensor measures the core body temperature of the subject, and wherein the method involve receiving a core body temperature of the subject and pausing or stopping the feed from being introduced into the stomach while the one or more temperature sensors measure a core body temperature of the subject. However, Sutaria et al does disclose the controller pausing/stopping feed based on feedback from the temperature sensor (¶170, ¶351).
Boone, III et al teaches that it is known to have one or more temperature sensors are positionable along the length (e.g. Fig 2b; tube 20; sensor 42) to sense a core body temperature of the subject and are in communication with the controller (¶28) for the purpose of providing accurate data regarding a patient’s internal core temperature that is not influenced by the feed temperature (¶28). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method as taught by Sutaria et al with the temperature sensor for monitoring core body temperature as taught by Boone III et al and pausing/stopping feed delivery during measurement for the purpose of providing accurate data regarding a patient’s internal core temperature that is not influenced by the feed temperature (¶28).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew M. Gilbert whose telephone number is (571)272-7216. The examiner can normally be reached 9:00 am - 5:30 pm (EST), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW M GILBERT/Primary Examiner, Art Unit 3700
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