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 .
Election/Restrictions
Applicant’s election without traverse of Group XVI in the reply filed on 08/08/2025 is acknowledged. Applicant has amended claim 1 pursuant to the elected species and canceled claims 2-26.
Examiner notes that Group XVI is drawn to the embodiment including, inter alia, two magnets and a non-magnetic bridging member spanning therebetween with parallel magnetic vectors which correspond to the embodiment shown in Fig. 15A-B.
At least claims 27-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Claims 27 and 28 are drawn to the non-elected embodiment of Group XVIII, claim 29 is drawn to the non-elected embodiment Group XVIX, claim 30 is drawn to the non-elected embodiment of Group XX, claim 31 is drawn to the non-elected embodiment of Group XXI, and claims 32 and 33 are drawn to the non-elected embodiment of Group XXII.
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.
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 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over WO 01/78836 to Durschinger alone and/or alternatively in view of U.S. Patent Publication No. 2014/0378760 to Ito.
Regarding claim 1, Durschinger teaches a miniature device (Fig. 3) for use in a system configured to deliver a therapeutic component to a treatment site in a patient, the miniature device comprising at least one steering portion (left portion of 1) comprising a magnetic material (3) and at least one carrier portion (right portion of 1) affixed to the steering portion and comprising the therapeutic component (5), the carrier portion being configured to at least partially dissipate under one or more predetermined conditions at the treatment site (wall 6 is dissolvable), thereby releasing the therapeutic component, wherein the steering portion comprises at least one magnet (3) constituting the magnetic material and being spaced along a longitudinal axis of the miniature device (Fig. 3), the magnet being oriented such that the vectors of their magnetic moments are parallel to the longitudinal axis of the miniature device (Fig. 3), but does not explicitly show an embodiment having two magnets and the medicament cavity and a non-magnetic bridging member, although Durschinger does generically disclose the alternative use of a single and dual magnet configuration (Figs. 1 & 2).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 3 of Durschinger with the dual magnet embodiment of Fig. 2 of Durschinger, for the purpose of ensuring that a strong inhomogeneous magnetic field builds up between the two magnets, such that the magnetic field widely penetrates the surroundings of the capsule (last paragraph of page 2 of machine translation of Durschinger).
Once combined, the modified Durschinger device would show the steering portion further comprising a bridging member (portion generally designated by 2 in Fig. 2) spanning therebetween, and wherein both magnets of the modified Durschinger device would be oriented such that the vectors of their magnetic moments are parallel to the longitudinal axis of the miniature device (Figs. 2-3).
Durschinger does not appear to explicitly mention that the bridging material is non-magnetic, however Durschinger’s disclosure of a housing material, which is the same material used for the bridging member, being made of a material resistant to digestive secretions (page 2, paragraph 8 of machine translation of Durschinger) in a device that houses magnets and used inside the body would inherently be non-magnetic in order to prevent any adverse effects upon the magnets contained therein.
Alternatively or in addition, Ito teaches the use of plastic as a capsule body material ([0063]) in a similar type of device incorporating magnets and used in gastrointestinal contexts. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used plastic for the housing material of Durschinger as taught by Ito to obtain the predictable result of protecting an inside of an ingestible capsule device and not obscuring magnetic properties therewithin. Once modified, the bridging member of the device of Durschinger and Ito would be non-magnetic (plastic).
Regarding claim 35, Durschinger and teach a system configured to deliver a therapeutic component to a treatment site in a patient, the system comprising at least one miniature device according to claim 1 as shown above, Durschinger further teaching the system comprising a magnetic inducing apparatus configured to be operated to generate a varying magnetic field, thereby remotely controlling motion of the miniature device (page 2, paragraph 4, lines 6-13 of the machine translation of Durschinger, an external magnet is used to hold the capsule in place, the magnetic field will vary according to the distance the external magnet is held and when it is removed).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Durschinger and Ito.
as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2015/0343144 to Altschul et al. (“Altschul”).
Regarding claim 34, the miniature device according to claim 1, but does not teach the carrier portion comprising one or more materials configured to effervesce.
Altschul teaches comprising one or more materials ([0265], excipients) configured to effervesce during the dissipation ([0266], effervescent agents). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the material of Altschul into the carrier portion of Altschul in order to obtain the predictable result of controlling a release of a therapeutic component to a patient as such physiologically acceptable carriers are common in the art ([0265]-[0266]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783