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 § 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) 15-20 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trovato et al. (US 2009/0306633 A1).
With regard to claims 15, 17, and 18, Trovato et al. teach an ingestible medical device to treat a patient with a medical condition comprising: an ingestible capsule (Fig. 9A member 900); a non-refillable drug dispenser contained within the capsule and comprising a therapeutic agent (Fig. 9A member 960, [0111]); a real-time clock (Fig. 9A 906 includes timing circuitry, [0102], [0063]); and a controller operatively connected to the non-refillable drug dispenser and comprising a memory module and a processor operable to execute a software application stored on the memory module to control the operation of the non-refillable drug dispenser to administer the therapeutic agent according to a real-time schedule measured via the real-time clock ([0102], memory, software, and microprocessor to control preset timing during the day, [0009], [0050]).
With regard to claim 16, see Fig. 9A member 908.
With regard to claim 19, see Fig. 9A antenna 502, RF circuitry 504.
With regard to claim 20, see [0097]-[0099].
With regard to claim 24, as the device passes through the gastrointestinal tract (see at least [0009]) it would necessarily be in the stomach for a period of time.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trovato et al. (US 2009/0306633 A1) as applied to claim 15 above, and further in view of Amoako-Tuffour et al. (US 2015/0011874 A1).
With regard to claim 21, Trovato et al. teach the control circuitry which would necessarily include a substrate ([0102]) but do not specifically disclose a flexible printed circuit board. However, Amoako-Tuffour et al. teach an ingestible device and equivalently using a rigid or flexible circuit board and that flexible circuit boards may reduce the number of components required to operated such a device ([0066]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a flexible circuit board in Trovato et al. as Amoako-Tuffour et al. teach such to be an art effective equivalent and beneficial for reducing components and would yield the same predictable result.
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trovato et al. (US 2009/0306633 A1) as applied to claim 15 above, and further in view of Jones et al. (US 2019/0343425 A1).
With regard to claim 22, Trovato et al. teach signals to the timing are generated ([0087]) but do not explicitly disclose this is stored in the memory. However, Jones et al. teach storing timestamp data ([0388]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to store timestamp data in Trovato et al. as Jones et al. teach this is beneficial for recording use data and would be beneficial in ensuring correct use.
With regard to claim 23, Trovato et al. teach a device substantially as claimed but do not disclose an anchor. Jones et al. teach an ingestible device and that an anchoring system may be used which is trigger to hold the device in a particular location in the gastrointestinal tract for delivery of the substance ([0120], [0493]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an anchor in Trovato et al. as Jones et al. teach such is effective for delivery to the correct location in the gastrointestinal tract.
Claim(s) 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trovato et al. (US 2009/0306633 A1) in view of Belsky et al. (US 2008/0188837 A1).
With regard to claim 25, Trovato et al. teach an ingestible medical device comprising: an ingestible capsule (Fig. 9A member 900); a non-refillable drug dispenser contained within the ingestible capsule and comprising a therapeutic agent (Fig. 9A member 960, [0111]); a power source (Fig. 9A member 908); and a controller operatively connected to the power source ([0102], memory, software, and microprocessor to control preset timing during the day, [0009], [0050]). Trovato et al. do not disclose an iontophoresis circuit. However, Belsky et al. teach an ingestible device which uses iontophoresis comprising an anode and a cathode (Figs. 4 and 5 anodes 16B cathodes 16A, [0120], [0334], [0344]) and that iontophoresis is beneficial for providing an effective and rapid method of delivering medication ([0012]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use iontophoresis in Trovato et al. as Belsky et al. teach it is beneficial for providing an effective and rapid method of delivering medication.
With regard to claim 26, see Fig. 9A 906 includes timing circuitry, [0102], [0063].
With regard to claim 27, see [0102], memory, software, and microprocessor to control preset timing during the day, [0009], [0050].
With regard to claims 28 and 29, see [0155], [0156], pH sensors are used to deliver medicament to a particular location in the alimentary tract.
With regard to claim 30, the embodiment of Fig. 9A does not disclose a plurality if dispensers. However, Fig. 13 discloses multiple dispensers may be used. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a plurality of reservoirs since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. Further, this is beneficial to allow different substances to be delivered to different locations.
Response to Arguments
Applicant's arguments filed November 23, 2025 have been fully considered but they are not persuasive. Applicant has argued that Trovato does not have a non-refillable drug dispenser. The Examiner finds this limitation to be functional and the dispenser of Trovato is capable of not being refilled. There is no structure claimed which prevents re-filling. Applicant has argued one of ordinary skill would not combined Trovato with Belsky as this would provide a more complicated design. The Examiner maintains that both Trovato and Belsky are both ingested devices for delivery of a substance in the intestinal tract. Differing methods of delivery have different pros and cons. Belsky provides explicit teachings to the benefit of using iontophoretic delivery as providing effective and rapid delivery. As such the Examiner maintains that one of ordinary skill would look the such a delivery mechanism. There is no explicit teaching away in the references. The amendments to the drawings and claims have overcome the previous objections and rejections under 35 U.S.C. 112.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783