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(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Election/Restrictions
Claims 22 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 08/19/2026 (hereinafter “Reply”).
The traversal is on the grounds that it would not be a serious burden to search for the two groups of claims (see Reply, pg. 1).
A serious search burden may be shown by a different field of search as defined in MPEP 808.02 (see MPEP 803). In this case, different search queries would be required because one non-elected invention (claim 22) recites that the feeding pump itself requires one or more memories and one or more processors, which would have required queries related to pumps that, themselves, contain one (or possibly multiple) memories and processors. Similarly, the other non-elected invention (claim 24) recites that the feeding set itself is configured for occlusion detection, which would have required a different search query than the elected invention (which at best makes no mention that the feeding set itself performs the occlusion detection, and appears to imply that method be carried out in a controller that is separate from the feeding set).
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed.
Claims 15-17, and all claims depending therefrom, are rejected under 35 U.S.C. 112(d).
Claims 15-17 define the conditions of an occluded or non-occluded feeding formula conduit, but do not actually impose any additional structure or steps to the method of claim 1. For this reason, claims 15-17 do not further limit the invention of claim 1.
For the purpose of examination, claims 15-17, and all claims depending therefrom, will be interpreted as reciting a step of determining that the feeding formula conduit is not occluded/is occluded based on the occluded/non-occluded conditions set forth in the claims (see Claim Rejections – 35 U.S.C §§ 102 and 103, below).
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 15-17 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.
Claims 15-17 define the conditions of an occluded or non-occluded feeding formula conduit in terms of differences between the first, second and third pressure readings of “X”, X2” and “X3”, which do not contain any specific numerical information. The claims amount to reciting that the difference between the pressure readings is another pressure reading, which would be an inherent feature of a mathematical difference (subtracting one value from another value equals a value). For this reason, it is not clear what, if any, additional limitations are imposed by the language of claims 15-17.
Claim 17 also recites “a plurality of previous second pressure sensor readings” but claim 1 does not specify that more than one second pressure readings were taken. Moreover, it is unclear what is meant by “previous second pressure reading” since claim 1 only recites, inter alia, “acquiring a second pressure reading”.
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.
Claims 1, 2, 12, 15-17, 21 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dumas (U.S. Pat. 5,720,721, hereinafter “Dumas”)
Regarding claim 1, Dumas discloses a method of occlusion detection of a feeding pump, the method comprising:
determining when a feeding set including a liquid is engaged in the feeding pump (see col. 4, lines 30-32 and col. 5, lines 30-32), wherein the liquid is a feeding formula (see col. 1, line 12, disclosing an enteral feeding system);
advancing a first amount of the feeding formula through the feeding pump via a feeding formula conduit, wherein the first amount is a first volume of the liquid (see col. 4, lines 9-18, disclosing rotating the rotor 30 to cause solution to be pushed out of the enteral feeding pump and through an output tube; each rotation will move about 1/3 mL of solution);
acquiring a first pressure sensor reading of the feeding formula conduit (see col. 11, lines 11-15, disclosing a first pressure reading from a sensor 50A indicating “strain stopped” condition after a first amount of fluid has been fed through the conduit);
advancing a second amount of the feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid (see col. 11, lines 15-16, disclosing starting a feed interval by rotating the motor unit);
acquiring a second pressure sensor reading of the feeding formula conduit (see col. 11, lines 16-17, disclosing that after the motor has started, pressure sensor 50A takes another reading, indicating a “strain running” condition);
acquiring a third pressure sensor reading of the feeding formula conduit (see col. 11, lines 27-35, disclosing that the sensor 50A can take another reading during the “strain running” condition to indicate that the solution is now of a higher viscosity);
detecting when an occlusion is present in the feeding formula conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading and the third pressure sensor reading (see col. 6, lines 7-8, disclosing that decreases in pressure on the sensor 50A indicates an occlusion or a decrease in fluid viscosity; see also col. 5, lines 49-56, disclosing the determination of viscosity or occlusion conditions based on the strain stopped and strain running conditions discussed above).
Regarding claim 2, it is noted that Dumas does not appear to explicitly disclose the method of claim 1, wherein the feeding formula rated as level 0-4 on the International Dysphagia Diet Standardization Initiative (IDDSI) framework.
However, Dumas discloses that the enteral feeding system is for liquid feeding (see col. 4, line 5). A skilled artisan familiar with the IDDSI would have known (or would have been able to readily determine) that levels 0-2 of the IDDSI framework correspond to liquids, levels 3-4 correspond to either thick liquids or liquidized solids, while levels 5-7 correspond to solid foods1. Therefore, since Dumas explicitly discloses liquid feeding, a skilled artisan would have concluded that Dumas implicitly discloses a product rated at a level of from 0-4 on the IDDSI framework.
Regarding claim 12, Dumas discloses the method of claim 1, wherein the feeding formula conduit is a tube that is compressibly engaged with a rotor of a feeding set (see intake tube 10 and output tube 14 in Figs. 1-2 connecting a section of compressible tubing compressed by rollers 34; and see rotor 30 in Fig. 1 that comprises the rollers 34 that engage the tubing).
Regarding claim 15, Dumas discloses the method of claim 1, further comprising determining that the feeding formula conduit is not occluded when a difference between the third pressure sensor reading and the second pressure sensor reading is less than or equal to X pounds per square inch (PSI) (since the three pressure sensor readings are disclosed in Dumas, subtracting the second sensor reading from the third sensor reading would inherently equal another value in PSI).
Regarding claim 16, Dumas discloses the method of claim 1, further comprising when a difference between the third pressure sensor reading and the second pressure sensor reading is greater than X pounds per square inch, and when a difference between the third pressure sensor reading and the first pressure sensor reading is less than or equal to X2 pounds per square inch, the feeding formula conduit is occluded (since the three pressure sensor readings are disclosed in Dumas, subtracting the first sensor reading from the third sensor reading would inherently equal another value in PSI).
Regarding claims 17 and 21, Dumas discloses the method of claim 1, further comprising when a difference between the third pressure sensor reading and the second pressure sensor reading is greater than X PSI, and when a difference between the third pressure sensor reading and the first pressure sensor reading is greater than X2 PSI, and when an average of a plurality of previous second pressure sensor readings is greater than or equal to X3, the feeding formula conduit is occluded (since the three pressure sensor readings are disclosed in Dumas, subtracting the first sensor reading from the third sensor reading would inherently equal another value in PSI, and averaging the second sensor readings would also inherently equal another value in PSI).
Regarding claim 23, Dumas discloses a computer-readable medium comprising stored instructions for occlusion detection, wherein the instructions are executable by one or more processors, individually or in combination (processors 104, 108, 120, which monitor readings from the pressure sensors 50A/50B and control processor 120 determines whether an occlusion exists based on those readings; see col. 6, line 56 to col. 7, line 20), to:
determine when a feeding set including a liquid is engaged in the feeding pump (see col. 4, lines 30-32 and col. 5, lines 30-32), wherein the liquid is a feeding formula (see col. 1, line 12, disclosing an enteral feeding system);
advance a first amount of the feeding formula through the feeding pump via a feeding formula conduit, wherein the first amount is a first volume of the liquid (see col. 4, lines 9-18, disclosing rotating the rotor 30 to cause solution to be pushed out of the enteral feeding pump and through an output tube; each rotation will move about 1/3 mL of solution);
acquire a first pressure sensor reading of the feeding formula conduit (see col. 11, lines 11-15, disclosing a first pressure reading from a sensor 50A indicating “strain stopped” condition after a first amount of fluid has been fed through the conduit);
advance a second amount of the feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid (see col. 11, lines 15-16, disclosing starting a feed interval by rotating the motor unit);
acquire a second pressure sensor reading of the feeding formula conduit (see col. 11, lines 16-17, disclosing that after the motor has started, pressure sensor 50A takes another reading, indicating a “strain running” condition);
acquire a third pressure sensor reading of the feeding formula conduit (see col. 11, lines 27-35, disclosing that the sensor 50A can take another reading during the “strain running” condition to indicate that the solution is now of a higher viscosity);
detect when an occlusion is present in the feeding formula conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading and the third pressure sensor reading (see col. 6, lines 7-8, disclosing that decreases in pressure on the sensor 50A indicates an occlusion or a decrease in fluid viscosity; see also col. 50, lines 49-56, disclosing the determination of viscosity or occlusion conditions based on the strain stopped and strain running conditions discussed above).
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.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dumas in view of Boulanger et al (U.S. Pub. 2016/0022545 A1, hereinafter “Boulanger"), as evidenced by Bookbinder et al (U.S. Pub. 2019/0271625 A1, hereinafter “Bookbinder”).
Regarding claim 3, it is noted that Dumas does not appear to explicitly disclose the method of claim 1, wherein a feeding formula rated as level 2-4 on the IDDSI framework.
Boulanger discloses a method of operating a flow control apparatus to deliver liquid to a subject using a peristaltic pumping device of the flow control apparatus (1 and abstract), the method comprising recognizing (see para [0013]) a pump set 5 (see Fig. 4) mounted to the flow control apparatus (see Fig. 2), the pump set including a tube 11 in fluid communication with the liquid container and configured to be pinched when acted on by the peristaltic pumping device (see para [0038]). Boulanger teaches that its device is useful as an enteral feeding device for liquids with viscosities above 75 cP (see para [0048]), which, as evidenced by Bookbinder, correspond to a rating of at least 2 on the IDDSI framework (see Bookbinder at pg. 3, table 1).
A skilled artisan, therefore, would have found it obvious at the time of the invention to use a fluid rated 2-4, inclusive, on the IDDSI framework, as fluids of this viscosity were well-known for use in enteral feeding systems to be delivered to a patient by peristaltic action (the same action disclosed in Dumas). Moreover, since Dumas already discloses that its device can compensate for liquids of a variety of viscosities (see col. 6, lines 22-25 discussed above), a skilled artisan could have chosen liquids of higher viscosities in the range of 2-4 on the IDDSI framework, with a reasonable expectation of success that the apparatus of Dumas would have been able to compensate its pumping action to deliver the proper amount of fluid, or if not, would have been able to properly alert personnel that the liquid cannot be pumped (see col. 6, lines 25-28).
Regarding claim 13, it is noted that Dumas does not appear to disclose the method of claim 1, wherein the first volume of the liquid and the second volume of the liquid are one aliquot.
Boulanger teaches that its method of operating a flow control apparatus to deliver liquid to a subject using a peristaltic pumping device of the flow control apparatus delivers one aliquot of fluid to a patient for each fraction of a rotation of its rotor (see para [0047]).
A skilled artisan would have found it obvious at the time of the invention to deliver one aliquot of fluid to a patient for each fraction of a rotation of its rotor, thereby maintaining a constant desired flow rate of fluid (see Boulanger at para [0047]), with a reasonable expectation of success.
Claims 4-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dumas in view of Hudson (U.S. Pub. 2016/0022546 A1, hereinafter “Hudson”).
Regarding claims 4-5, it is noted that Dumas discloses pausing the feeding pump after advancing the first formula (the “strain stopped” condition discussed above), but does not appear to disclose that the stopping is for a predetermined period of time after advancing the first amount of the feeding formula, and before performing the acquiring of the first pressure sensor reading, and
(per claim 5) the predetermined period of time being 1-3 seconds.
Hudson discloses a flow control apparatus and method for accurate detection of occlusion conditions in a feeding set, comprising a step of pausing a feeding pump, after a first feeding formula volume is advanced, for a predetermined period of time before performing an acquiring of a first pressure reading (see para [0003]), the period of time being 1-3 seconds (see para [0033], disclosing “about 100 milliseconds to about one second”, which includes values within the claimed range of 1-3 seconds).
A skilled artisan would have found it obvious at the time of the invention to modify the method of Dumas, to pause the feeding pump after advancing a first formula for a predetermined period of time before performing an acquiring of a first pressure reading, the period of time being 1-3 seconds, as such a delay was well-known in the art for stabilizing the pressure to better indicate an occlusion without releasing pressure from the tube (as taught in Hudson), and would have led to a reasonable expectation of success since delaying the movement of the rotor for the claimed period would not have led to a deleterious effect.
Regarding claims 6-8, it is noted that Dumas does not appear to disclose pausing the feeding pump for a second predetermined period of time after advancing the second amount of the feeding formula and before performing the acquiring of the third pressure sensor reading; and
(per claim 7) the pausing of the feeding pump for the second predetermined period of time is after performing the acquiring of the second pressure sensor reading; and
(per claim 8), the second predetermined period of time being 2-7 seconds.
Hudson discloses a flow control apparatus and method for accurate detection of occlusion conditions in a feeding set, comprising a step of pausing the feeding pump for a second predetermined period of time after advancing a second amount of the feeding formula and before performing the acquiring of a pressure sensor reading (see para [0032]), the second predetermined period of time being 2-7 seconds (see para [0032], disclosing a delay of 5 to about 60 seconds).
A skilled artisan would have found it obvious at the time of the invention to modify the method of Dumas, to pause the feeding pump for a second predetermined period of time after advancing the second amount of the feeding formula and before performing the acquiring of the third pressure sensor reading, the pausing of the feeding pump for the second predetermined period of time is after performing the acquiring of the second pressure sensor reading, the second predetermined period of time being 2-7 seconds, since such a delay was well-known in the art for satisfying a proper indication of occlusion (as taught in Hudson at para [0032]), and would have led to a reasonable expectation of success since such a delay period would not have led to a deleterious effect.
Regarding claim 9-11, it is noted that Dumas disclose does not appear to disclose pausing the feeding pump for a predetermined period of time after advancing the second amount of the feeding formula and before performing the acquiring of the third pressure sensor reading; and
(per claim 10) the pausing of the feeding pump for the second predetermined period of time is after performing the acquiring of the second pressure sensor reading; and
(per claim 11) the second predetermined period of time being 2-7 seconds.
Hudson discloses a flow control apparatus and method for accurate detection of occlusion conditions in a feeding set, comprising a step of pausing the feeding pump for a second predetermined period of time after advancing a second amount of the feeding formula and before performing the acquiring of a pressure sensor reading (see para [0032]), the second predetermined period of time being 2-7 seconds (see para [0032], disclosing a delay of 5 to about 60 seconds).
A skilled artisan would have found it obvious at the time of the invention to modify the method of Dumas, to pause the feeding pump for a second predetermined period of time after advancing the second amount of the feeding formula and before performing the acquiring of the third pressure sensor reading, the pausing of the feeding pump for the second predetermined period of time is after performing the acquiring of the second pressure sensor reading, the second predetermined period of time being 2-7 seconds.as such a delay was well-known in the art for satisfying a proper indication of occlusion (as taught in Hudson at para [0032]), and would have led to a reasonable expectation of success since such a delay period would not have led to a deleterious effect.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dumas in view of Piper et al (U.S. Pub. 2022/0087904 A1, hereinafter “Piper”).
Regarding claim 14, it is noted that Dumas does not appear to disclose the method of claim 1, wherein advancing the first amount is priming the feeding set.
Piper discloses an enteral nutrition system with a feeding set, comprising a step of automatically priming the feeding set in advance of use, and therefore, in advance of a pump occlusion detection (see para [0054], referencing the device as a self-priming device).
A skilled artisan would have found it obvious at the time of the invention to modify the method of Dumas so that the advancing the first amount is priming the feeding set, in order to prime the device automatically (as the first step is conducted automatically in Dumas), thereby eliminating the step of manual priming, thereby reducing the burden of effort required to initiate each feeding session (see Piper at para [0033]) with a reasonable expectation of success.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dumas in view of Hudson, further in view of Pham (U.S. Pat. 11,846,279 B2, hereinafter “Pham”).
Regarding claim 18, it is noted that Dumas does not appear to disclose the method of claim 17, wherein X is between -10 and 2 PSI, X2 is between 0 and 10 PSI, and X3 is between -6 and 8 PSI; and
as per claim 19, X is between -6 and -2 PSI, X2 is between 4 and 8 PSI, and X3 is between -2 and 5 PSI, and
and as per claim 20, X is -4 PSI, X2 is 5 PSI, and X3 is 3 PSI.
Dumas discloses that the first, second and third pressure readings can be subtracted from one another in order to determine a high viscosity solution and thereby increase the motor rotations with each running period/feeding interval (see col. 11, lines 13-35). Dumas also discloses subtracting the pressure values to determine when a partial occlusion is present (see col. 11, lines 35-52). Higher strain values cause the pump to increase its running period/feeding interval to account for the partial occlusion (see col. 11, lines 40-44). Determining the relationship between the three values enables the pump to achieve a desired infusion volume accounting for occlusion, viscosity or back pressure changes during the infusion period (see col. 11, lines 51-53).
Moreover, Hudson discloses that a microprocessor can compare various pressure signals (such as a baseline sensor signal “A” to a dissipation sensor signal “C”, and another peak sensor signal “B” with the dissipation sensor signal “C”) to provide an indication of an occlusion in a feeding set (see paras [0035]-[0036]). Hudson discloses that values that exceed a particular deviation from the baseline can indicate an abnormal flow condition or an occlusion (see paras [0035]-[0036]).
Therefore, both Dumas and Hudson teach comparing multiple sensor signals to one another to arrive at values that indicate the presence of occlusions, but merely lack the disclosure of the specific numerical values themselves.
Further, Pham discloses a flow control apparatus, and discloses that flow signal values can experience variability and noise, and that a processor can average flow signal values to determine an accurate flow rate from a noisy signal (see col. 7, lines 50-60). Therefore, Pham also teaches averaging multiple sensor signals, but merely lacks the disclosure of the specific numerical value itself.
But choosing the claimed values to indicate an occlusion would have been obvious as a matter of routine optimization. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In this case, the magnitude of the difference between the strain stopped (first pressure signals) and strain running (second and third pressure values) are result-effective variables (the greater the difference between the pressure values, the greater the viscosity or indication of occlusion). As a result, choosing certain values that indicate an occlusion would have been a matter of routine experimentation, based not only on the level of occlusion to be indicated but also on variables such as the tube characteristics, motor characteristics, etc. Based on the teachings of the prior art, a skilled artisan would have known that various differences indicate the presence or absence of an occlusion and/or high viscosity solution, and that experimenting with various thresholds would have met a design need. Moreover, Applicant has not shown that the ranges recited in claims 18-20 are critical.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 09/16/2026
1 See https://www.iddsi.org/standards/framework
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