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 .
Information Disclosure Statement
The IDS form(s) submitted on 1/10/2024, and 6/10/2022 is/are in compliance with the requirements of the provisions of 37 CFR 1.97. Accordingly, the information disclosure(s) are being considered by the examiner.
Response to Amendment
This office action is responsive to the claim amendments filed on 11/26/2025. As directed by the amendment: claims 4, 7, 9, 12, 13, 17-20, 22, and 24-27 have been amended; and no claims have been added. Thus, claims 1-27 are presently pending in this application.
Examiner notes claim 9 is labeled as amended however no changes appear to have been made.
Election/Restrictions
Applicant’s election without traverse of the Species I, (Fig. 2) in the reply filed on 11/26/2025 is acknowledged. Applicant has asserted claims 1-11 and 19-24 are encompassed by claims 1-11 and 19-24. Examiner notes claim 9-11 and 19-24 do not read upon Species I. Species I Figs. 2 is described in Applicant’s specification pg. 6 28-32 “The miniature device 100 further comprises a magnetic arrangement 114, configured to interact with externally applied magnetic fields, i.e., with a rotating magnetic field to effect propulsion of the miniature device, and with a magnetic field gradient to facilitate releasing the payload.”. Claim 9 requires propulsion due to a gradient magnetic field and the release function due to a rotating magnetic field, in line with non-elected Species II Figs. 3A-3B (See Specification pg. 9 lines 6-15). Therefore, dependent claims 9-11 and 19-24 are withdrawn from consideration as being directed to a non-elected species.
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.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0181788 A1 to Yokoi et al. in view of US 2016/0114142 A1 to Ziaie et al.
In regard to claim 1:
Yokoi teaches, a miniature device (Fig. 3A element 1) configured to be maneuvered within a patient under manipulation by an external magnetic field (Fig. 1) and to selectively perform a predefined function (Fig. 5A element 73 function considered delivery of medication), the miniature device comprising a shell (Fig. 3A element 41) defining therewithin an internal cavity (Fig. 3a interior cavity of element 41), and a magnetic arrangement disposed within the cavity (Fig. 3a element 36), said miniature device being configured such that the magnetic arrangement, within a rotating magnetic field, effects one of performance of the function and propulsion of the miniature device within the patient (Para. 65, controls propulsion via rotating magnetic field).
Yokoi does not appear to explicitly teach performance of the function in a magnetic field gradient. Ziaie teaches, within a magnetic field gradient (Fig. 3 element 150, static magnet considered magnetic field gradient), effects the other of performance of the function and propulsion of the miniature device within the patient (magnetic field gradient closes magnet switch element 112 effecting the performance of the function to deliver drug payload. Paras. 26 and 32).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the performance of the function of Yokoi to include the drug payload delivery magnet system of Ziaie, to include subcomponents thereof. This would have been motivated by being able to deliver a large localized drug payload. Examiner notes dependent claims 2-4 and 7 recites said subcomponents considered part of this modification. See each respective dependent claims for specific claim limitation mapping to each respective subcomponent.
In regard to claim 2:
The miniature device according to claim 1, taught by Yokoi in view of Ziaie.
Yokoi does not appear to explicitly disclose performance of the function comprising delivery of the payload as claimed. Ziaie teaches, further comprising a payload (Para. 32), wherein the performance of the function comprises release of said payload (Paras. 26 and 32).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, modify the performance of the function of Yokoi to include delivery of the payload as taught by Ziaie. This would have been motivated by being able to deliver a large localized drug payload.
In regard to claim 3:
The miniature device according to claim 2, taught by Yokoi in view of Ziaie.
Yokoi does not appear to teach performance of the function to include a tool as claimed. Ziaie teaches, further comprising a tool (Fig. 2 element 115), wherein the performance of the function comprises activating the tool (Paras. 25-26).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify performance of the function of Yokoi to include the tool as taught by Ziaie. This would have been motivated by being able to deliver a large localized drug payload.
In regard to claim 4:
The miniature device according to claim 2, taught by Yokoi in view of Ziaie.
Yokoi, being configured such that the magnetic arrangement (Fig. 3a element 36), within a rotating magnetic field, effects the propulsion of the miniature device within the patient (Para. 65, controls propulsion via rotating magnetic field).
Yokoi does not appear to teach the magnetic field gradient effecting performance of the function as claimed. Ziaie teaches, within a magnetic field gradient (Fig. 3 element 150, static magnet considered magnetic field gradient), effects the performance of the function (magnetic field gradient closes magnet switch element 112 effecting the performance of the function to deliver drug payload. Paras. 26 and 32).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the performance of the function of Yokoi to be effected by a magnetic field gradient as taught by Ziaie. This would have been motivated by being able to deliver a large localized drug payload.
In regard to claim 5:
The miniature device according to claim 4, taught by Yokoi in view of Ziaie.
Yokoi teaches, said shell being formed as an elongated member (Fig. 3a element 41) extending along a drive axis (Fig. 3a element 38) and comprising a drive thread (Fig. 3a element 37) formed on an exterior surface thereof helically about the drive axis (Fig. 3a element 37), said magnetic arrangement comprising a propulsion magnet rigidly connected to an interior surface thereof (Fig. 3a element 36) and disposed such that the vector of its magnetic moment is disposed transverse to the drive axis (Fig. 3a element 36)
In regard to claim 6:
The miniature device according to claim 5, taught by Yokoi in view of Ziaie.
Yokoi teaches, said drive thread comprising a tapered portion on a front end of the miniature device (see annotated Fig. 3A below).
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Annotated Fig. 3A
In regard to claim 7:
The miniature device according to claim 4, taught by Yokoi in view of Ziaie.
Yokoi does not appear to teach the ejection magnet as claimed. Ziaie teaches, the magnetic arrangement further comprising an ejection magnet (Fig. 1 element 112) slidably disposable within the internal cavity and an outlet (See annotated Fig. 4 below), said payload being disposed between the ejection magnet and the outlet (See annotated Fig. 4 below)
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Annotated Fig. 3A
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the performance of the function of Yokoi to include the ejection magnet as taught by Ziaie. This would have been motivated by being able to deliver a large localized drug payload.
In regard to claim 8:
The miniature device according to claim 7, taught by Yokoi in view of Ziaie.
Yokoi teaches, further comprising a spacer (Fig. 23 element 210) disposed between the drive magnet (Fig. 23 element left element 36) and the ejection magnet (Fig. 23 right element 36).
Ejection magnet taught by Ziaie as described in claim 7 rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm EST.
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/M.A.I./Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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