DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 01/11/2024. Claims 1-2, 4-10, 14-17, 20-21, 24-26, 28-32, 34-35, 50, 65-73 are pending and examined below.
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 4, 7, 10, 14, 28, and 35, and claims dependent thereof, is 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.
Regarding claim 4, the claim recites the limitation “wherein the array of energy detectors, the energy generator(s), or both are attached to the attaching structure”. However, claim 1, the claim that claim 4 depends upon does not recite “an array of energy detectors” or multiple generators. As such there is an antecedent basis issues. As such the claim is indefinite.
Claims 7 and 10 have similar antecedent issues with respect to “the array of energy detectors”
For the purpose of this examination the claim is interpreted as including at least one energy detectors and at least one generator.
Regarding claims 14 and 35, the claim recites “A method of reducing the risk of pulmonary aspiration in an individual”, but the body of the claim does not actually recite any steps of reducing the risk of pulmonary aspiration. As such the claim is indefinite.
Regarding claim 28, the claim recites the term “wherein the ordered or desired pattern is a straight line, a triangle, a square, a circle, a diamond, a pentagon, a trapezoid, or a hexagon”. However, the underlined term lacks antecedent basis and it is unclear as to what is being claimed.
For the purposes of this examination the claim as interpreted as a configuration of detectors.
Claim Rejections - 35 USC § 102
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 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) 1-2, 4-10, 14-17, 24-26, 29-32, 34-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170169725 A1 (hereinafter referred to as “Cahan”).
Regarding claim 1, Cahan teaches a system for detecting gastric volume (abstract), comprising an energy generator (108; paragraph [0043]; Figure 1) and at least one energy detector (108; paragraph [0043]; Figure 1), said system configured for detecting gastric volume for an individual (“A processor (e.g., the microprocessor 104 or the remote device microprocessor 111) may be configured to process the received reflected ultrasound signals to determine level of stomach fullness and output fullness data indicative of the determined level of stomach fullness”; paragraph [0043]).
Regarding claim 2, Cahan teaches wherein the energy generator produces mechanical waves, electromagnetic waves, or matter waves, or wherein multiple energy generators produce a combination of mechanical waves, electromagnetic waves, and matter waves (paragraph [0043]) and wherein the energy detectors detect waves produced by the energy generator (paragraph [0043]).
Regarding claim 4, Cahan teaches further comprising at least one attaching structure, wherein the array of energy detectors, the energy generator(s), or both are attached to the attaching structure (101; paragraph [0040]; Figure 1).
Regarding claim 5, Cahan teaches wherein the attaching structure comprises a means for securing the attaching structure to an individual (paragraph [0040]; Figure 1).
Regarding claim 6, Cahan teaches wherein the attaching structure comprises a means for securing the attaching structure to the skin of the individual (paragraph [0040]; Figure 1).
Regarding claim 7, Cahan teaches wherein the array of energy detectors comprises 2, 3, 4, 5, or more energy detectors (paragraph [0046]).
Regarding claim 8, Cahan teaches wherein the energy detectors are physically separate from one another (paragraph [0046]).
Regarding claim 9, Cahan teaches further comprising a computing device capable of processing data detected by the energy detectors and generating a gastric dimension (104; paragraph [0043]; Figure 1).
Regarding claim 10, Cahan teaches wherein the array of energy detectors is a one-dimensional array or a two-dimensional array, and wherein the one- or two-dimensional array of energy detectors is configured in a random, ordered, or desired pattern (paragraph [0046]).
Regarding claim 14, Cahan teaches a method of reducing the risk of pulmonary aspiration in an individual (abstract) comprising
a. placing the system of claim 1 on an abdomen of an individual (paragraphs [0040], [0043]; Figure 1);
b. producing energy into the abdomen of the individual with the energy generator (paragraphs [0040]-[0043]; Figure 1); and
c. detecting the energy from the energy generator with the array of energy detectors, wherein the detecting generates direct, reflect, and refraction data (paragraphs [0040]-[0043]; Figure 1).
Regarding claim 15, Cahan teaches further comprising processing the direct, reflected, and refraction data to determine a gastric dimension of the individual (paragraphs [0040]-[0043]; Figure 1).
Regarding claim 16, Cahan teaches further comprising administering prophylactic and/or therapeutic interventions to the individual when the gastric dimension reaches or exceeds a threshold value indicative of the risk of pulmonary aspiration (paragraphs [0057]-[0059]).
Regarding claim 17, Cahan teaches he method of claim 16, further comprising administering prophylactic and/or therapeutic interventions to the individual when the gastric dimension comprises a gastric silhouette value of more than 5 cm or 10 cm, a gastric volume of more than 200 cm3, 250 cm3, or 500 cm3, or when the gastric dimension increases 100% from a baseline measurement in the individual (paragraphs [0057]-[0059]).
Regarding claim 24, Cahan teaches further comprising the step of placing the energy detectors on an abdominal surface of the individual, wherein the detectors are placed in a random, ordered, or desired pattern on the abdominal surface of the individual (paragraphs [0040], [0046]; Figure 1).
Regarding claim 25, Cahan teaches wherein the abdominal surface comprises the skin of the individual or clothing of the individual (paragraphs [0040], [0046]; Figure 1).
Regarding claim 26, Cahan teaches wherein the abdominal surface is on a posterior or anterior side of the individual (paragraphs [0040], [0046]; Figure 1).
Regarding claim 29, Cahan teaches wherein the individual's fasting state and/or gastric contents are unknown (paragraphs [0058], [0075], [0077]).
Regarding claim 30, Cahan teaches wherein the individual has, or is suspected of having, delayed gastric emptying (paragraph [0058]).
Regarding claim 31, Cahan teaches wherein the delayed gastric emptying is caused by diabetic gastroparesis, advanced liver dysfunction, advanced renal dysfunction, medications, sepsis, inflammation, peritonitis, electrolyte abnormalities, and/or narcotics (paragraph [0058]).
Regarding claim 32, Cahan teaches wherein the individual is critically ill, has unreliable or unclear medical history, or has been non-compliant (paragraph [0058]).
Regarding claim 34, Cahan teaches wherein steps b and c are continuous (paragraph [0047]).
Regarding claim 35, Cahan teaches A method of reducing the risk of pulmonary aspiration in an individual, comprising generating at least one source wave in the individual and detecting direct, reflected, and refracted waves from the source wave at one or more defined locations on the individual, wherein the detecting generates direct, reflected, and refraction data (paragraphs [0040]-[0043]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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) 66-69, 71-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cahan, in view of further rationale.
Regarding claim 66, Cahan teaches A wearable system for detecting gastric distention, comprising one or more energy generators and multiple energy detectors, said system configured for detecting a gastric dimension or gastric silhouette for an individual (paragraphs [0040]-[0043], [0046]; Figure 1); but does not explicitly teach the system comprising 10 energy detectors.
However, it would have been obvious to one having ordinary skill in the art at the time the invention effectively filed to have the system comprising 10 energy detectors, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 67, Cahan teaches wherein the energy generators produce ultrasonic waves (paragraphs [0040]-[0043], [0046]; Figure 1).
Regarding claim 68, Cahan teaches further comprising an attaching structure for holding the energy generators and the detectors (101; paragraphs [0040]-[0043], [0046]; Figure 1).
Regarding claim 69, Cahan teaches wherein the attaching structure comprises an adhesive for securing the attaching structure to the skin of the individual (paragraph [0040], [0047]).
Regarding claim 71, Cahan teaches wherein the energy detectors detect direct, reflected, and refracted waves (paragraphs [0040]-[0043], [0046]; Figure 1).
Regarding claim 72, Cahan teaches wherein the energy detectors measure the time for waves to travel back to the system to generate tissue interface data (paragraphs [0040]-[0043], [0046]; Figure 1).
Regarding claim 73, Cahan teaches wherein the gastric dimension comprises any size, length, width, diameter, radius, circumference, area, volume, capacity, proportion, or measurement of an individual's stomach, and the gastric silhouette comprises the average length, diameter, radius, or circumference of the abdomen of an individual (paragraphs [0040]-[0043], [0046]; Figure 1).
Claim(s) 20, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cahan as applied to claim 14, and further in view of US 20120010228 A1 (hereinafter referred to as “Luehr”).
Regarding claims 20-21, Cahan does not explicitly teach wherein the prophylactic and/or therapeutic intervention comprises withdrawal of sedation, revised positioning of the individual, nasogastric tube placement, a histamine agonist, a proton pump inhibitor, a prokinetic, or a combination thereof; and wherein the histamine agonist comprises cimetidine, famotidine, nizatidine, ranitidine, or a combination thereof, the proton pump inhibitor comprises dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, or a combination thereof, or the prokinetic comprises domperidone, metoclopramide, erythromycin, renzapride, or a combination thereof.
However, Luehr teaches wherein the prophylactic and/or therapeutic intervention comprises withdrawal of sedation, revised positioning of the individual, nasogastric tube placement, a histamine agonist, a proton pump inhibitor, a prokinetic, or a combination thereof; and wherein the histamine agonist comprises cimetidine, famotidine, nizatidine, ranitidine, or a combination thereof, the proton pump inhibitor comprises dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, or a combination thereof, or the prokinetic comprises domperidone, metoclopramide, erythromycin, renzapride, or a combination thereof (paragraphs [0072], [0075], [0078]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Cahan, to take an antihistamine, as taught by Luehr, because doing so provides a solution stomach fullness.
Claim(s) 28 and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cahan as applied to claims 14 and 66 above, and further in view of further rationale.
Regarding claim 28, Cahan teaches having multiple detectors, but does not teach the pattern/shape of the detectors.
However, it would have been an obvious matter of design choice to have wherein the ordered or desired pattern is a straight line, a triangle, a square, a circle, a diamond, a pentagon, a trapezoid, or a hexagon, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 70, Cahan teaches having multiple detectors, but does not teach the pattern/shape of the detectors.
However, it would have been an obvious matter of design choice to have wherein the energy detectors and energy generators are arranged in an ordered pattern comprising a straight line, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art.
Claim(s) 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cahan as applied to claim 15 above, and further in view of US 20190350816 A1 (hereinafter referred to as “Shannon”).
Regarding claim 65, Cahan does not explicitly teach wherein the data is processed by an artificial intelligence or neural network system.
However, Shannon teaches using artificial intelligence (paragraph [0105]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Cahan, to use artificial intelligence, as taught by Shannon, because doing so allows for better more accurate diagnosis.
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791