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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/034474, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claims 1-11 are replete with subject matter that is not only not supported by the instant specification (see Specification Objection below), but also not supported by any means in the prior application.
In claim 1 alone, the subject matter regarding “a mode selected from the group consisting of adherence, attachment, insertion, and combinations thereof,” the Markush grouping of sensors, as well “processing of the physiological data, to identify an item selected from the group consisting of a disease signature and a therapeutic signature and combinations thereof, is achieved by a computing facility selected from the group consisting of the set of microprocessors, the server, and combinations thereof,” is not supported by the prior application. Accordingly, claims 1-11 are not entitled to the benefit of the prior application and are provided with the priority date of 07/24/2023.
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: Claims 1-11 are not supported; see example relative to claim 1 above.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 10/25/2023, has been 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 examiner notes the originally filed claim set (07/24/2023) does not have support within the instant specification for the majority of the claimed subject matter. Specifically, relative to claim 1 alone, the specification lacks proper antecedent basis for “controlled release drug delivery system disposed in the case and configured to receive by a mode selected from the group consisting of adherence, attachment, insertion, and combinations thereof, a drug, and to deliver the drug to the patient” (limitation “b”), the following sensors: inertial motion sensor, ambient temperature sensor, ambient light sensor, skin temperature sensor, skin conductance sensor, skin hydration sensor, blood pressure sensor, blood gas sensor, metabolic marker sensor, or drug sensor (limitation “e”), or “ wherein processing of the physiological data, to identify an item selected from the group consisting of a disease signature and a therapeutic signature and combinations thereof, is achieved by a computing facility selected from the group consisting of the set of microprocessors, the server, and combinations thereof” (limitation “g”).
Additionally, the entirety of claims 2-11 do not have proper antecedent basis within the instant specification.
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 1-11 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.
[Claim 1] The claim recites the limitation of “a controlled release drug delivery system disposed in the case and configured to receive by a mode selected from the group consisting of adherence, attachment, insertion, and combinations thereof, a drug, and to deliver the drug to the patient” in the 3rd-6th lines of the claim. The examiner is unable to determine the metes and bounds of the claim, as it is unclear how to interpret the phrase “configured to receive by a mode selected from the group consisting of adherence, attachment, insertion, and combinations thereof.” First, it is unclear if applicant intended to insert a comma between the words “receive” and “by” in the 4th line of the claim. Furthermore, lacking any explanation within the instant specification or further limitations within the claim, the examiner is unable to interpret the Markush grouping of “a mode selected from the group consisting of adherence, attachment, insertion, and combinations thereof” and how said grouping relates to the delivery of a drug from the controlled release drug delivery system. As such, the limitation (among others) precludes a reasonable search of the prior art and prevents the claim from further examination on the merits at this time.
[Claim 1] The claim recites the limitation of “the drug delivery platform” in the 15th line of the claim. There is a lack of antecedent basis for this limitation within the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this refers to the previously recited “controlled release drug delivery system,” or if a new structure is being introduced into the claim language.
[Claim 1] The claim recites the limitation of “wherein processing of the physiological data, to identify an item selected from the group consisting of a disease signature and a therapeutic signature and combinations thereof, is achieved by a computing facility selected from the group consisting of the set of microprocessors, the server, and combinations thereof” in the last 5 lines of the claim. The examiner is unable to determine the metes and bounds of the claim. Again, lacking any explanation within the instant specification or further limitations within the claim, the examiner is unable to interpret the Markush grouping of “an item selected from the group consisting of a disease signature and a therapeutic signature and combinations thereof” and how identification of said grouping relates processing of physiological data. As such, the limitation (among others) precludes a reasonable search of the prior art and prevents the claim from further examination on the merits at this time.
[Claim 11] The claim contains the limitation of “The bioelectric device of claim 1, wherein the communication module is configured to connect to a cloud network.” in the last 2 lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if Applicant intended to somehow further limit claim 11, or if the limitation was intended to be an additional claim which was not numbered.
[Claims 2-11] The claims are rejected based upon their dependency from independent claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 01/10/2026