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 .
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11, drawn to a system for identifying a remediating neonatal withdrawal symptoms, classified in A61B 5/279.
II. Claims 12-18, drawn to an open loop drug delivery system, classified in A61B 5/0036.
III. Claim 19, drawn to a closed loop drug delivery system, classified in A61B 5/4836.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related systems. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention I is directed toward a system for identifying and outputting a determination of neonatal withdrawal symptoms. While Invention II is an open loop drug delivery system with a pump and health care provider approval. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions I and III are directed to related systems. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention I is directed toward a system for identifying and outputting a determination of neonatal withdrawal symptoms. While Invention III is a closed loop drug delivery system with a pump and health care provider approval. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions II and III are directed to related systems. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are mutually exclusive. Invention II is an open loop drug delivery system with a pump and health care provider approval. While Invention III is a closed loop drug delivery system with a pump and health care provider approval. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Dennis Majewski on 6/10/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-11. Affirmation of this election must be made by applicant in replying to this Office action. Claims 12-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11 includes the typographical error; ”Neonatal Abstience Syndrome (NAS)” wherein it should state “Neonatal Abstinence Syndrome (NAS)”. Appropriate correction is required.
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) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luderer et al. (U.S. Pub. 2020/0187777 hereinafter “Luderer”).
Regarding claim 1, Luderer discloses a system for identifying and remediating neonatal withdrawal symptoms (e.g. Abstract) comprising: a wearable device associated with a patient (e.g. ¶33); a data capture device (e.g. 202) associated with said wearable device wherein said data capture device is configured to obtain biometric and behavioral data from said patient over progressive periods of time (e.g. ¶42); a patient evaluation module (e.g. 204) configured to evaluate said biometric and behavioral data to make a probabilistic determination about the likelihood patient is experiencing withdrawal symptoms (e.g. ¶43); and a mobile computing device (e.g. 102) configured to provide a result of said probabilistic determination and output a treatment recommendation (e.g. ¶45).
Regarding claim 2, Luderer further discloses wherein said patient evaluation module applies training inputs to a classification of said biometric and behavioral data (e.g. ¶¶ 8, 12, 16, 43).
Regarding claim 3, Luderer further discloses wherein said probabilistic determination of said biometric and behavioral data comprises determining a weighted score based on said biometric and behavioral data (e.g. ¶¶ 8, 12, 16, 43).
Regarding claim 4, Luderer further discloses wherein said treatment recommendation is based on a severity level dictated by said weighted score (e.g. ¶¶ 8, 43, 58).
Regarding claim 5, Luderer further discloses a drug delivery platform associated with said patient wherein said drug delivery platform is configured to administer a treatment drug based on said probabilistic determination (e.g. ¶¶ 8, 43, 58).
Regarding claim 6, Luderer further discloses wherein said drug delivery platform is a closed-loop system without physician approval (e.g. ¶¶ 8, 43, 58).
Regarding claim 7, Luderer further discloses where said drug delivery platform is an open-loop system requiring physician approval (e.g. ¶ 45).
Regarding claim 8, Luderer further discloses wherein said data capture device comprises at least one of the following: a blood oxygen monitor, pulse sensor, camera with an associated image processing module, temperature sensor, respiratory monitor, acoustic monitor, electromyography device, accelerometer (e.g. ¶¶ 10, 33).
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.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luderer as applied to claims 1-8 above, and further in view of Bloch-Salisbury et al. (U.S. Pub. 2017/0172411 hereinafter “Bloch”).
Luderer discloses the monitoring of withdrawal symptoms of the claimed invention except for the wearable device being used to monitor Neonatal Abstinence Syndrome while being attached to the wrist or the chest of patient. However, Bloch teaches a similar withdrawal monitoring and remediation system that it is known to use wrist and chest mounted sensors for monitoring neonatal abstinence syndrome as set forth in Paragraphs 4 and 47 to provide accurate recording of physiological signals at different stages of drug withdrawal to determine the presence of Neonatal Abstinence Syndrome. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Luderer, with analysis of wrist and chest worn sensors as taught by Bloch, since such a modification would provide the predictable results of providing accurate recording of physiological signals at different stages of drug withdrawal to determine the presence of Neonatal Abstinence Syndrome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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