DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The claim set and remarks filed on 12/3/2025 are acknowledged.
Claims 1, 3, 13, 16, 17, 19, 24-26, and 30 are amended.
Claims 32-35 are newly added.
Claims 15 and 27-29 are cancelled.
Claims 1-14, 16-26, and 30-35 are pending.
Response to Arguments/Amendments
The claims and remarks filed 12/3/2025 have been fully considered; however, Examiner relies on the teachings from Gross (WO 2010/128495A) and Whitehead et al. (US 20130274352 A1) in a new rejection under 35 USC 103.
A new 35 USC 112(b) rejection is made which is a new ground of rejection, therefore this action is made NON-FINAL.
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.
Claim 26 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 pre-AIA the applicant regards as the invention.
Claim 26 contains the trademark/trade name Bluetooth. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a short range wireless technology and, accordingly, the identification/description is indefinite.
Appropriate correction is required.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-14, 16-26, and 30-35 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (WO 2010/128495 A1) in view of Whitehead et al. (US20130274352A1) hereinafter Whitehead and Gross et al. (US20080063703A1) hereinafter Gross2.
Regarding claims 1-14, 16-26, and 30-35, Gross discloses a duodenal unit that is configured to dispense a drug. The duodenal unit comprises a conventional drug pill comprising the drug. The pill may comprise, for example, a capsule (pg. 7, ln 14-16).
Gross discloses the sheet is initially held in the rolled position by one or more dissolvable elements, such as one or more dissolvable rings placed around the rolled sheet, additionally, the sheet is initially held in the rolled position by a dissolvable capsule or coating, (pg. 18, ln 30- pg. 19, ln 8).
Gross discloses
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Gross discloses the duodenal unit is configured to dispense a drug, such as a drug for treating diabetes and/or obesity (pg. 20, ln 9-10).
Gross does not explicitly disclose wherein the drug is a GLP-1 receptor agonist or a wireless communication device.
However, Whitehead discloses a flexible device device that is sufficiently flexible to be rolled inside a capsule
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[0030]. Whitehead discloses the multicompartmental device is sufficiently flexible to be rolled and placed within a capsule for oral drug delivery. An example of this device is illustrated in FIGS. 12A and B. Rolling makes it possible to put an otherwise large device (410) (as illustrated in FIG. 12B) into a manageable size capsule (420) for oral drug delivery. After the patient swallows the capsule and as the capsule travels through the gastrointestinal tract, the capsule will degrade allowing for the release of the multicompartmental device. Upon exiting the capsule, the device unrolls and adheres to the mucosal membrane (440). The flexible device offers several advantages. Owing to its large size, it offers higher degree of adhesion and decreased interference from other obstacles compared to smaller devices. Further, the flexibility of the device allows it to conform to the surface undulations of the mucosal membrane [0094]. Whitehead discloses wherein the drug is exenatide, a GLP-1 receptor agonist [0069].
However, Gross2 is drawn to an Apparatus (30) for drug administration is provided, including an ingestible capsule (32), which includes a drug (36), stored by the capsule (32), and an environmentally-sensitive mechanism (18), adapted to change a state thereof responsively to a disposition of the capsule (32) within a gastrointestinal (GI) tract (50) of a subject (abstract).
Gross2 discloses an ingestible capsule, which includes: a wireless receiver, adapted to receive the indication; first and second electrodes; and a control component, adapted to facilitate passage of the drug through an epithelial layer of a gastrointestinal (GI) tract of the subject [0160].
Gross2 discloses the ingestible capsule includes a capsule wireless transmitter, the sensor unit includes a sensor unit wireless receiver, and the ingestible capsule is adapted to wirelessly notify the sensor unit of a property of the capsule, via the capsule wireless transmitter and the sensor unit wireless receiver. For some applications, the property is selected from the list consisting of: a location of the capsule, a status of the control component, a pH level of the GI tract, and a temperature of the GI tract, and the capsule is adapted to wirelessly notify the sensor of the selected property [0171].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings as previously disclosed by Gross, wherein the drug is a GLP-1 receptor agonist, as previously disclosed by Whitehead, wherein an ingestible capsule has a wireless transmitter, as previously disclosed by Gross2, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Gross, Whitehead, and Gross2 are in the field of capsule dosage forms, and Whitehead discloses the device is sufficiently flexible to be rolled and placed within a capsule for oral drug delivery. After the patient swallows the capsule and as the capsule travels through the gastrointestinal tract, the capsule will degrade allowing for the release of the device. Upon exiting the capsule, the device unrolls and adheres to the mucosal membrane (440). The flexible device offers several advantages. Further, the flexibility of the device allows it to conform to the surface undulations of the mucosal membrane [0094]. Whitehead discloses wherein the drug is exenatide, a GLP-1 receptor agonist [0069], Gross2 discloses “the ingestible capsule includes a capsule wireless transmitter, the sensor unit includes a sensor unit wireless receiver, and the ingestible capsule is adapted to wirelessly notify the sensor unit of a property of the capsule, via the capsule wireless transmitter and the sensor unit wireless receiver. For some applications, the property is selected from the list consisting of: a location of the capsule, a status of the control component, a pH level of the GI tract, and a temperature of the GI tract, and the capsule is adapted to wirelessly notify the sensor of the selected property” [0171], thus combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615