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 Interpretation - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-28 and 30-34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jang et al. (2022/0280182). Jang et al. disclose, in figures 1-4 and 10 and para. [0031]-[0049] and [0059]-[0062]; a microrobot, comprising: an attachment module (combination of a suction unit and 140) for connecting said microrobot to a delivery device (110); and b. a tip module, comprising: i. a bullet (200), comprising an outer shell (combination of 220 and 240) and one or more first magnets (220 or 230), wherein said outer shell has a design capable of being propelled by an external magnetic field when said one or more first magnets interacts with said external magnetic field (according to para. [0044]); ii. a holder (combination of 120 and 130) for holding said bullet comprising a release mechanism for releasing said bullet from said holder; wherein said release mechanism comprises: one or more second magnets (120) in said holder; and a configuration for controlling relative movements between said one or more first magnets and said one or more second magnets so that magnetic repulsive force can be generated between said one or more first magnets and said one or more second magnets to release said bullet from said holder (according to para. [0047]); wherein said delivery device is a catheter; wherein said bullet has a functionalized design consists of a driller-type design; wherein said bullet is propelled by said external magnetic field using a propelling strategy selected from the group consisting of spiral type or flexible-ora type; wherein said outer shell (at 240) is a spiral shell capable of turning rotation into linear motion (according to para. [0059]); wherein said attachment module is a cannula; wherein said one or more first magnets (230) comprises a radially magnetized cylindrical magnet; wherein said configuration comprises: a. a cylindrical bucket (130) in said holder for receiving said bullet; b. a cylindrical portion (at 230) in said bullet for insertion into said cylindrical bucket, wherein said bullet can rotate within said holder when a suitable external magnetic field is applied; and a blocking mechanism (at the proximal portion of 130 and distal portion of 120)) that can be activated to prevent rotation of said one or more second magnets under said suitable external magnetic field (when the bullet is reconnected to 130, according to para. [0050]); wherein said one or more second magnets (120) comprise two axially magnetized cylindrical magnets (a cylindrical N pole portion and a cylindrical S pole portion, according to para. [0054]) with opposite magnetization directions.
Jang et al. also disclose a method of using the microrobot of claim 21 for endovascular intervention in a subject (as shown in fig. 4), comprising the steps of: a. Connecting said microrobot to a delivery device (110) via said attachment module (combination of a suction unit and 140); b. Inserting said microrobot into a vessel (30) of said subject via an insertion point; and c. Positioning said microrobot to a suitable site, wherein forward-backward motion of said microrobot is adjusted by a motorized feeder (via an external rotating magnetic field, according to para. [0044] and [0050]); and steering motion of said microrobot is adjusted by an external magnetic field (according to para. [0044] and [0050]); wherein the method further comprises the step of activating said release mechanism to release said bullet from said holder (according to para. [0044]); wherein the method further comprises controlling movement of said bullet using an external magnetic field (according to para. [0044] and [0050]); and wherein the method further comprises the step of controlling said bullet to reattach to said holder (according to para. [0050)]).
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.
Claims 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (2022/0280182) in view of Laby et al. (11,730,927), and further in view of Lemon et al. (11,027,101). Jang et al. disclose the invention substantially as claimed. Jang et al. disclose a system for endovascular intervention in a subject, comprising: a. the microrobot (200) of claim 21 for placement at a site in said subject; an electromagnet array (a magnetic field generator, according to para. [0044]) for generating said external magnetic field; and a delivery device (110) attached to said microrobot; wherein said bullet (230) is propelled by said external magnetic field using a propelling a strategy consisting of a flexible-ora type.
However, Jang et al. do not explicitly disclose an ultrasound probe for medical imaging-based feedback on position of said microrobot; and a parallel manipulator for driving said ultrasound probe and said electromagnet array to the vicinity of said site. Laby et al. teach, in fig. 1 and 1-1 and col. 34, lines 28-38 and col. 34, line 63 to col. 35, line 3; an ultrasound probe (tool 8, including “ultrasound technologies”) for medical imaging, and a parallel manipulator (another catheter) for driving said ultrasound probe to the vicinity of said site. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Laby et al., to modify the system of Jang et al., so that it includes, as claimed, an ultrasound probe and a parallel manipulator. Such modifications would allow imaging of the endovascular site during deployment and use of the microrobot.
Additionally, Jang et al. do not explicitly disclose a motorized feeder for adjusting forward-backward motion of said delivery device. Laby et al. teach, at least in figure 1 and col. 33, line 36 to col. 34, line 8; disclose a motorized feeder (1) for adjusting forward-backward motion (i.e., 3-D automated movement) of a delivery device (3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Laby et al., to modify the system of Jang et al., so that it includes a motorized feeder as claimed. Such a modification would allow proper positioning and shaping of the delivery device for precise positioning of the microrobot within a blood vessel.
However, Jang et al. in view of Laby et al. do not explicitly disclose that said electromagnet array is driven by said parallel manipulator. Nevertheless, Laby et al. teach that the parallel manipulator may support various tools (according to col. 34, lines 35-38). Lemon et al. teach, in figures 4A and 5 and col. 11, lines 26-29; an electromagnet array that may be driven by a manipulator (112, as shown in fig. 4A). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Lemon et al., to modify the system of Jang et al. in view of Laby et al., so that the parallel manipulator also drives an electromagnet array. Such a modification would allow movement of the electromagnet array to the vicinity of the microrobot in order to position the microrobot within a blood vessel.
Allowable Subject Matter
Claim 29 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jang et al. (2023/0050583) and Wulfman et al. (6,818,001) teach systems for endovascular intervention.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771