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 .
Drawings
2. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “resilient part” must be shown or the feature canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1 and 17-31 are rejected under 35 U.S.C. 103 as being unpatentable over Song (CN Patent No. 111657830), hereinafter, Song, in view of Imran (US Publication No. 2020/0276426), hereinafter, Imran.
Regarding claim 1, Song discloses a drug delivery device (magnetic driving intestinal administration capsule robot with anchoring function which includes a camera module 1, and anchoring module 2, a magnetic drive decoupling module 3, and a medicine applying module 4 in figs.1-3) comprising:
a central axis extending from a first longitudinal end of the drug delivery device to a second longitudinal end of the drug delivery device (central longitudinal axis extending from a first end comprising medicine applying module 4 to a second end comprising camera module 1 in fig. 3);
a first body part (first anchor leg assembly 205 in figs. 4b-5);
a second body part (second anchor leg assembly 206 in figs. 4b-5); and
an actuator mechanism configured to rotate one of the first body part or the second body part (magnetic drive decoupling module 3 with elastic pawl wheels and ratchet that rotates to extend/retract anchoring legs 205 and 206 in figs. 3, 7-9), wherein the actuator mechanism is located more towards the first longitudinal end than the second longitudinal end along the central axis (magnetic drive decoupling module 3 is biased toward medicine applying module 4 in figs. 1-3).
Song does not, however, disclose an attachment part connected to the first body part.
Imran teaches an attachment part (Imran: multiple tissue-penetrating members 40 can be formed to have a shaft and a needle tip or other pointed tip non-parallel to central longitudinal axis so as to readily penetrate tissue of the antrum or other intestinal wall, as shown for example in figs. 3, 8D-1, and 8D-2)
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 drug delivery device of Song to include attachment parts, as taught by Imran, in order to enable controlled rotational deployment and pinching/anchoring of the attachment parts to the intestinal wall for improved stability and targeted drug delivery.
As shown in annotated figure 3 of Song, the dividing line between first body part (medicine applying/drive side with actuator) and the second body part (camera side) is drawn between the anchoring leg assemblies, placing the actuator mechanism more toward the first longitudinal end while maintaining one attachment part on each side.
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Regarding claim 17, modified Song discloses the drug delivery device of claim 1, wherein the actuator mechanism is located fully within the first body part (magnetic drive decoupling module 3 located primarily in first portion biased toward medicine applying module 4 in figs. 1-3, 7-8).
Regarding claim 18, modified Song discloses the drug delivery device of claim 1, wherein the actuator mechanism is located partially within the first body part and partially within the second body part (magnetic drive decoupling module 3 spans and connects to anchoring module 2 in fig. 3; module 2 extend into second body part).
Regarding claim 19, modified Song discloses the drug delivery device of claim 1, wherein the actuator mechanism is located more towards the first longitudinal end (magnetic drive decoupling module 3 located primarily in first portion biased toward medicine applying module 4 and more toward first longitudinal end in fig. 3).
Regarding claim 20, modified Song discloses the drug delivery device of claim 1, wherein the actuator mechanism is centered on the central axis (central longitudinal axis extending from a first end comprising medicine applying module 4 to a second end comprising camera module 1 in fig. 3).
Regarding claim 21, modified Song discloses the drug delivery device of claim 1, further comprising a second attachment part connected to the second body (Imran: second tissue-penetrating member 40 in fig. 3).
Regarding claim 22, modified Song discloses the drug delivery device of claim 21, but fails to explicitly disclose that the second attachment part and the attachment part are within 10mm of each other along the central axis.
Imran suggests that the second attachment part and the attachment part are within 10mm of each other along the central axis (Imran: capsule length is in range of 0.5 to 2 inches, or 12.7 to 50.8 mm, optimizing space between tissue-penetrating members 40; para [0073]). Distance between attachment parts is a results-effective variable that a person of ordinary skill in the art would optimize to achieve effective pinching/anchoring force while maintaining a compact device size; optimizing this spacing is a predictable variation to balance anchoring strength and device miniaturization.
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 drug delivery device of Song to position the attachment parts such that the such that the second attachment part and the attachment part are within 10 mm of each other along the central axis, as suggested by Imran, in order to achieve effective pinching/anchoring force with a compact device size suitable for GI transit.
Regarding claim 23, the rejection of claim 22 is incorporated herein by reference. It would have been obvious to one of ordinary skill in the art to modify the positioning of the attachment parts so that the second attachment part and the attachment part are within 4.1 mm of each other along the central axis for the same reasons discussed above with respect to claim 22.
Regarding claim 24, the rejection of claim 22 is incorporated herein by reference. It would have been obvious to one of ordinary skill in the art to modify the positioning of the attachment parts so that the second attachment part and the attachment part are within 3.9 mm of each other along the central axis for the same reasons discussed above with respect to claim 22.
Regarding claim 25, modified Song discloses the drug delivery device of claim 1, but fails to explicitly disclose that the drug delivery device is a 000 size capsule.
Imran teaches that the drug delivery device is a 000 size capsule (Imran: contemplates capsule sizes ranging in length from 0.5 - 2 inches, or 12.7 - 50.8 mm, and diameters ranging from 0.01 - 0.05 inches, or 2.54 - 12.7 mm, which encompasses capsule size 000 dimensions; para [0073]).
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 drug delivery device of Song to be in a standard 000 capsule size, as taught by Imran, in order to achieve optimal swallowability, manufacturability, and compatibility with existing pharmaceutical filling equipment while maintaining sufficient internal volume for the actuator and medicine modules.
Regarding claim 26, modified Song discloses the drug delivery device of claim 1, wherein the drug delivery device is a 00 size capsule (Imran: contemplates capsule sizes ranging in length from 0.5 - 2 inches, or 12.7 - 50.8mm, and diameters ranging from 0.01 - 0.05 inches, or 2.54 - 12.7mm, which encompasses capsule size 00 dimensions; para [0073]).
Regarding claim 27, modified Song discloses the drug delivery device of claim 1, wherein the drug delivery device is a 0 size capsule (Imran: contemplates capsule sizes ranging in length from 0.5 - 2 inches, or 12.7 - 50.8mm, and diameters ranging from 0.01 - 0.05 inches, or 2.54 - 12.7mm, which encompasses capsule size 0 dimensions; para [0073]).
Regarding claim 28, modified Song discloses the drug delivery device of claim 1 comprising the attachment part, but fails to disclose that the attachment part is configured to provide an active drug substance.
Imran teaches that the attachment part is configured to provide an active drug substance (Imran: tissue-penetrating members 40 can be formed to have a shaft and a needle tip or other pointed tip so as to readily penetrate tissue of the antrum or other intestinal wall, as shown for example in figs. 3, 8D-1, and 8D-2; can be fabricated from various drugs and other therapeutic agents, para [0078]).
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 drug delivery device of Song to provide an active drug substance, as taught by Imran, in order to deliver a therapeutic agent directly into the intestinal wall at the anchored location for targeted treatment.
Regarding claim 29, modified Song discloses the drug delivery device of claim 1, wherein the actuator mechanism comprises a resilient part (magnetic drive decoupling module 3 with elastic pawl wheels and ratchet that rotates to extend/retract anchoring legs 205 and 206 in figs. 3, 7-9; first elastic pawl wheel 3071 is made of elastic material that can generate elastic deformation and recover original shape; page 5, paragraph 4).
Regarding claim 30, modified Song discloses the drug delivery device of claim 1, wherein the attachment part comprises a spike having a distal tip directed non-parallel to the central axis (Imran: the penetrating member 40 can be formed to have a shaft and a needle tip or other pointed tip non-parallel to central longitudinal axis so as to readily penetrate tissue of the antrum or other intestinal wall, as shown in figs. 3, 8D-1, 8D-2).
Regarding claim 31, modified Song discloses the drug delivery device of claim 1, wherein the first body part forms a portion of the first longitudinal end (modular design with first anchor leg assembly 205 forming a portion of first end comprising medicine applying module 4 in fig. 3) and/or the second body part forms a portion of the second longitudinal end (modular design with second anchor leg assembly 206 forming a portion of second end comprising camera module 1 in fig. 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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