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 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 1-19 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 1 and 9 recite the limitation "the nutrient pump" respectively. There is insufficient antecedent basis for this limitation in the claims.
Claim 4 mentions “the plurality of feeding sub-phases” which lacks antecedent basis. For the purposes of examination this limitation will be interpreted as “the plurality of feeding phases” to match the terminology in parent claim 1.
Claim 10 recites the limitation "the nutrient pump" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the nutrient pump" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the nutrient pump" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-8 and 12-18 are also rejected as they depend on a rejected 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) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elia et al. (herein Elia) (US 2020/0281819). Regarding Claim 1:In the specification and Figures, Elia discloses a nutrient infusion control method (see abstract), comprising: obtaining a feeding scheme (volume to be delivered VTBD, see abstract) for a target object (patient, see abstract) in response to a feeding instruction of the target object (target nutritional goal, see abstract), wherein the feeding scheme comprises a plurality of feeding phases (for instance feeding phases 1674 and 1672 and 1676 in Figure 15C), and at least one feeding parameter (for instance basal rate, see Figure 15C) is different in different feeding phases (as seen in Figure 15C, the basal rate varies from 40 ml/hr in 1674 to 80 ml/hr in 1672); and controlling the nutrient pump (controller 204 implemented as a positive displacement pump, see paragraph [0166]) to output nutrients according to the feeding scheme (for instance as mentioned in paragraph [0141] the stroke frequency of the pump is altered to alter the feeding/basal rate).Regarding Claim 2:In the specification and Figures, Elia discloses the nutrient infusion control method wherein the plurality of feeding phases (1674 and 1672 and 1676 in Figure 15C) comprise at least one first feeding phase, and at least one feeding parameter of the first feeding phase is changed gradually (as mentioned in paragraphs [0368] and [0386] feeding may start gradually and this can be applied to any of the starting feeding phases and isn’t limited to the feeding phases shown in Figure 15C).Regarding Claim 3:In the specification and Figures, Elia discloses the nutrient infusion control method, wherein the plurality of feeding phases comprise at least one second feeding phase (1672, 1676 in Figure 15C); the second feeding phase comprises a plurality of feeding sub-phases (1672, 1676), and at least a part of the feeding sub-phases has the same or different feeding parameters (1672 has a feed rate of 80ml/hr compared to the feeding rate of 40 ml/hr in 1674).Regarding Claim 4:In the specification and Figures, Elia discloses the nutrient infusion control method, wherein the plurality of feeding sub-phases (for instance feeding phases 1674 and 1672 and 1676 in Figure 15C) comprise at least one target feeding sub-phase (1674), and at least one feeding parameter (feed rate of 40 ml/hr) of the target feeding sub-phase is changed gradually (gradual change of the feed rate is defined in paragraphs [0389] and can be applied to any feeding phase as desired).Regarding Claim 5:In the specification and Figures, Elia discloses the nutrient infusion control method, wherein feeding parameters of different feeding phases within a feeding cycle are changed gradually, and the feeding cycle comprises at least two of the plurality of feeding phases (as mentioned in paragraphs [0388]-[0389]: “[0388] Rate ranges e.g. 15-100 mL/hour, and kCal/day 700-2500 kCal/day [0389] Define gradual increase in percentage of target nutritional goal defined per time interval (e.g., per day), for example, define 4 day percentage escalation and fixed percentage thereafter—e.g. 30% on day 1, 50% on day 2, 70% on day 3, 100% on day 4, and thereafter 100%.”).Regarding Claim 6:In the specification and Figures, Elia discloses the nutrient infusion control method, wherein the feeding parameter comprises at least one of the following: a feeding rate, a feeding volume, a feeding time, a feeding concentration, a feeding interval, and a duration of the feeding interval (various parameters such as feeding rate, feeding volume, feeding duration and feeding concentration are mentioned in paragraphs [0388]-[0389] as quoted above in the rejection of claim 5).Regarding Claim 7:In the specification and Figures, Elia discloses the nutrient infusion control method, wherein the step of obtaining the feeding scheme for the target object comprises: displaying a setting page of feeding parameters of the feeding phase; and obtaining the feeding scheme for the target object in response to a setting operation of at least one feeding parameter of the feeding phase by a user (as mentioned in paragraphs [0165], [0307] and [0360], the user interface 216 can include a display for a user to input data such as baseline feeding profile for the target object i.e., patient).Regarding Claim 8:In the specification and Figures, Elia discloses the nutrient infusion control method, wherein the setting page (GUI display, see paragraph [0178]) comprises a calculation strategy for calculating the feeding parameters of the feeding phase (as mentioned in paragraph [0178]: “The food calculator assists in selecting the optimal feeding material based on the REE calculation, hidden calories (optional to insert this information by the user), protein calculation and other optional filters (e.g., low fiber). Based on the food calculator's parameters and the selected nutrition, the volume to be delivered (VTBD) and nutrition basal rate are determined, and may be edited by the user.”); the step of obtaining the feeding scheme for the target object in response to the setting operation of at least one feeding parameter of the feeding phase by the user comprises: obtaining a feeding parameter corresponding to the calculation strategy in response to a setting operation of the user for the calculation strategy (VTBD and basal feed rate parameters are in response to REE calculation and user sets max rates, see paragraph [0178]); and obtaining the feeding scheme for the target object according to the feeding parameter corresponding to the computing strategy (see paragraph [0178]).Regarding Claim 9:In the specification and Figures, Elia discloses the nutrient infusion control method, further comprising: modifying a feeding parameter of a corresponding feeding phase to obtain a modified feeding scheme in response to a modification instruction directed to the feeding parameter of the feeding phase (see paragraph [0178]: “The food calculator assists in selecting the optimal feeding material based on the REE calculation, hidden calories (optional to insert this information by the user), protein calculation and other optional filters (e.g., low fiber). Based on the food calculator's parameters and the selected nutrition, the volume to be delivered (VTBD) and nutrition basal rate are determined, and may be edited by the user.”); and controlling the nutrient pump to output nutrients according to the modified feeding scheme (for instance as mentioned in paragraph [0141] the stroke frequency of the pump is altered to alter the feeding/basal rate).Regarding Claim 10:In the specification and Figures, Elia discloses a nutrient infusion control device (200, see Figure 2), comprising: an obtaining module (208) configured to obtain a feeding scheme (baseline feeding profile) for a target object (patient) in response to a feeding instruction of the target object (see paragraphs [0166] and [0173]), wherein the feeding scheme (for instance scheme depicted in Figure 15C) comprises a plurality of feeding phases (for instance feeding phases 1674 and 1672 and 1676 in Figure 15C), and at least one feeding parameter of different feeding phases are different (as seen in Figure 15C, the basal rate varies from 40 ml/hr in 1674 to 80 ml/hr in 1672); and a control module (204, see paragraph [0166]) configured to control the nutrient pump to output nutrients according to the feeding scheme (for instance as mentioned in paragraph [0141] the stroke frequency of the pump is altered to alter the feeding/basal rate).Regarding Claim 11:In the specification and Figures, Elia discloses an electronic device (200, see Figure 2), comprising: a processor (computing device 208 with processor 206), a communication interface (user interface 216, see paragraph [0165]), and a memory (210); wherein the processor (206) is configured to be communicatively connected to the communication interface (see paragraph [0165]) and the memory (see paragraph [0156]); the memory (210) is configured to store computer-executable instructions (see paragraph [0163]); the communication interface (216) is configured to communicate and interact with an external device (see paragraph [0165]); and the processor (208) is configured to execute the computer-executable instructions stored in the memory to: obtain a feeding scheme (baseline feeding profile) for a target object (patient) in response to a feeding instruction of the target object (see paragraphs [0166] and [0173]), wherein the feeding scheme (for instance scheme depicted in Figure 15C) comprises a plurality of feeding phases (for instance feeding phases 1674 and 1672 and 1676 in Figure 15C), and at least one feeding parameter of different feeding phases are different (as seen in Figure 15C, the basal rate varies from 40 ml/hr in 1674 to 80 ml/hr in 1672); and a control module (204, see paragraph [0166]) configured to control the nutrient pump to output nutrients according to the feeding scheme (for instance as mentioned in paragraph [0141] the stroke frequency of the pump is altered to alter the feeding/basal rate).Regarding Claim 12:In the specification and Figures, Elia discloses the electronic device (200), wherein the plurality of feeding phases (1674 and 1672 and 1676 in Figure 15C) comprise at least one first feeding phase, and at least one feeding parameter of the first feeding phase is changed gradually (as mentioned in paragraphs [0368] and [0386] feeding may start gradually and this can be applied to any of the starting feeding phases and isn’t limited to the feeding phases shown in Figure 15C).Regarding Claim 13:In the specification and Figures, Elia discloses the electronic device (200), wherein the plurality of feeding phases comprise at least one second feeding phase (1672, 1676 in Figure 15C); the second feeding phase comprises a plurality of feeding sub-phases (1672, 1676), and at least a part of the feeding sub-phases has the same or different feeding parameters (1672 has a feed rate of 80ml/hr compared to the feeding rate of 40 ml/hr in 1674).Regarding Claim 14:In the specification and Figures, Elia discloses the electronic device (200), wherein the plurality of feeding sub-phases (for instance feeding phases 1674 and 1672 and 1676 in Figure 15C) comprise at least one target feeding sub-phase (1674), and at least one feeding parameter (feed rate of 40 ml/hr) of the target feeding sub-phase is changed gradually (gradual change of the feed rate is defined in paragraphs [0389] and can be applied to any feeding phase as desired).Regarding Claim 15:In the specification and Figures, Elia discloses the electronic device (200), wherein feeding parameters of different feeding phases within a feeding cycle are changed gradually, and the feeding cycle comprises at least two of the plurality of feeding phases (as mentioned in paragraphs [0388]-[0389]: “[0388] Rate ranges e.g. 15-100 mL/hour, and kCal/day 700-2500 kCal/day [0389] Define gradual increase in percentage of target nutritional goal defined per time interval (e.g., per day), for example, define 4 day percentage escalation and fixed percentage thereafter—e.g. 30% on day 1, 50% on day 2, 70% on day 3, 100% on day 4, and thereafter 100%.”).Regarding Claim 16:In the specification and Figures, Elia discloses the nutrient infusion control method, wherein the feeding parameter comprises at least one of the following: a feeding rate, a feeding volume, a feeding time, a feeding concentration, a feeding interval, and a duration of the feeding interval (various parameters such as feeding rate, feeding volume, feeding duration and feeding concentration are mentioned in paragraphs [0388]-[0389] as quoted above in the rejection of claim 15).Regarding Claim 17:In the specification and Figures, Elia discloses the electronic device (200), wherein the processor obtains the feeding scheme for the target object by: displaying a setting page of feeding parameters of the feeding phase; and obtaining the feeding scheme for the target object in response to a setting operation of at least one feeding parameter of the feeding phase by a user (as mentioned in paragraphs [0165], [0307] and [0360], the user interface 216 can include a display for a user to input data such as baseline feeding profile for the target object i.e., patient).Regarding Claim 18:In the specification and Figures, Elia discloses the electronic device (200), wherein the setting page (GUI display, see paragraph [0178]) comprises a calculation strategy for calculating the feeding parameters of the feeding phase (as mentioned in paragraph [0178]: “The food calculator assists in selecting the optimal feeding material based on the REE calculation, hidden calories (optional to insert this information by the user), protein calculation and other optional filters (e.g., low fiber). Based on the food calculator's parameters and the selected nutrition, the volume to be delivered (VTBD) and nutrition basal rate are determined, and may be edited by the user.”); the processor obtains the feeding scheme for the target object in response to the setting operation of at least one feeding parameter of the feeding phase by the user by: obtaining a feeding parameter corresponding to the calculation strategy in response to a setting operation of the user for the calculation strategy (VTBD and basal feed rate parameters are in response to REE calculation and user sets max rates, see paragraph [0178]); and obtaining the feeding scheme for the target object according to the feeding parameter corresponding to the computing strategy (see paragraph [0178]).Regarding Claim 19:In the specification and Figures, Elia discloses the electronic device (200), wherein the processor is further configured to: modify a feeding parameter of a corresponding feeding phase to obtain a modified feeding scheme in response to a modification instruction directed to the feeding parameter of the feeding phase (see paragraph [0178]: “The food calculator assists in selecting the optimal feeding material based on the REE calculation, hidden calories (optional to insert this information by the user), protein calculation and other optional filters (e.g., low fiber). Based on the food calculator's parameters and the selected nutrition, the volume to be delivered (VTBD) and nutrition basal rate are determined, and may be edited by the user.”); and control the nutrient pump to output nutrients according to the modified feeding scheme (for instance as mentioned in paragraph [0141] the stroke frequency of the pump is altered to alter the feeding/basal rate).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20160235630 – Enteral feeding system.US 20150088058 – Feeding system and pump.
US 20230191023 – Wearable fluid delivery system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINICK L PLAKKOOTTAM whose telephone number is (571)270-7571. The examiner can normally be reached Monday - Friday 12 pm -8 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Essama Omgba can be reached at 469-295-9278. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINICK L PLAKKOOTTAM/Primary Examiner, Art Unit 3746
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