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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/4/2026 has been entered.
Response to Amendment
This office action is in response to the amendment filed on 5/4/2026. Currently claims 17, 19-24 and 26-30 are pending.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 4/2/2026, with respect to the previous objection of claims 32 and 33 have been fully considered and are persuasive. The previous objection of claims 32-33 has been withdrawn.
Applicant’s arguments, see pg. 5, filed 4/2/2026, with respect to the previous rejection of claims 32 and 33 under 35 USC 112(b) have been fully considered and are persuasive. The previous rejection of claims 32-33 under 35 USC 112(b) has been withdrawn.
Applicant’s arguments, see pgs. 5-8, filed 4/2/2026, with respect to 4/22/2026 have been fully considered and are persuasive based on the amendments. The previous rejections of:
claim(s) 17, 19-29 and 31 under 35 USC 103 as being unpatentable over Yokoi in view of Alfano
claim(s) 32 as being unpatentable over Yokoi in view of Alfano in view of Tang
claim(s) 33 as being unpatentable over Yokoi in view of Alfano in view of Swain
have been withdrawn.
Applicant’s arguments, see pgs. 8-9, filed 4/2/2026, with respect to the rejection(s) of claim(s) 30 under 35 USC 103 as being unpatentable over Yokoi have been fully considered and are persuasive based on the amendments to the claim(s). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the additional reference of Alfano et al (US 6240312).
While the grounds of rejection have changed, since much of the same prior art is being applied applicant’s arguments should be addressed to help improve clarity of the record. Applicant argues that claim 30 is allowable for the same reasons as claim 17. As applicant argues:
“Claim 30 is novel and non-obvious over the prior art of record for the same reasons
as claim 17. We also believe that the examiner's comments (see Office Action, p.
4) are addressed because claim 30 now recites both the blood vessel and the
direct steering/stopping using the magnet (by attraction rather than driving a
propulsion unit).” [see pg. 8 of applicant’s arguments].
However, claim 17 includes additional limitations that claim 30 does not include. For example, claim 17 recites the following limitations:
“wherein the body part comprises a magnetic part which is usable to steer or stop the medical device by being attracted to the external magnetic field while floating in the blood flow, and wherein the medical device is capable of being positioned by loosening the recapture line or pulling the recapture line, wherein the body part is adapted for opening a passage through a blocked opening, such that the medical device is adapted to remove a thrombosis in the blood vessel.”
These limitations require the medical device have a structure capable to float in blood while being steered or stopped and the body part have structure capable to remove a thrombosis. Both of these features are not required for claim 30 when read under broadest reasonable interpretation.
Additionally, while claim 17 positively recites a magnetic field generator which attracts the magnetic part of the body, claim 30 never positively recites an external magnetic field generator, only that the body has a magnetic part which is usable by being attracted to an external magnetic field. Furthermore, claim 17 requires the body has a magnetic part able to to stop or steer the magnetic device and the device be capable of being positioned by the recapture line. However, claim 30 only requires a step of steering or stopping by the magnetic device or positioning by the recapture line when the claim is read under broadest reasonable interpretation, thereby further reinforcing the interpretation that a magnetic field generator and its attractive force are not required for claim 30 under broadest reasonable interpretation if the prior art has a recapture line that positions the medical device as claimed.
Thus, while applicant’s arguments are persuasive for claim 17 and its dependent claims (which is why the rejection to those claims were withdrawn), claim 30 is much broader and the arguments to claim 17 are not commensurate with that of claim 30. For this reason, while the previous grounds of rejection have been withdrawn the new grounds of rejection to claim 30 applies as outlined below.
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.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yokoi et al (US 20030181788) hereafter known as Yokoi in view of Alfano et al (US 6240312) hereafter known as Alfano.
Regarding claim 30:
Yokoi discloses:
A method for controlling a medical device [see Figs. 1-14B and para 62… “A first embodiment of the present invention will be described with reference to FIGS. 1 through 14B. The primary object of the present embodiment is to provide a device and method wherein a capsule-type medical device which performs medical actions can be rotated by external magnetism and thus be smoothly guided to a target portion or beside a target portion; more specifically, to provide a device and method wherein eccentric motion in rotation is suppressed so as to enable effective or smooth propulsion to beside the target portion.”], comprising the steps of:
- inserting of the medical device into a body at an insertion site [see para 101…
“As shown in FIG. 1, in the event that there is the need to observe a body cavity tract such as the stomach 51 for example, of the patient 2, for long periods of time, the operator has the patient swallow the capsule-type medical device 1, and causes the device to pass through the stomach.”], wherein the medical device includes a body part [see Fig. 14A-14B element 120A and para 147… “the capsule main unit 120A”] and a tail part [see Fig. 14A-14B element 121 and para 147… “the flexible insertion portion 121 is detachably mountable to the capsule main unit 120A.”], wherein the body part comprises a magnetic part which is usable to steer or stop the medical device by being attracted to an external magnetic field generated by a magnetic field generator [see Figs. 3A and 14A element 36 (i.e. magnetic part) and Fig. 1 element 5 (i.e. an external magnetic field) and para 65… “Also, the magnetic guiding device 5 is connected to the control device 3, such that the control device 3 can control the direction of the generated rotating magnetic field.” and para 79… “a permanent magnet (hereafter referred to simply as "magnet") 36 upon which the rotating magnetic field, generated by the magnetic guiding device 5 as described above, acts.” And para 89… “magnetic guiding device 5 acting upon the magnet 36” ], and a recapture line [see Fig. 5 element 75 and para 128…. “capsule main unit 70A having connected thereto a string 75 formed of soft plastic or the like”];
- steering and/or stopping the medical device by means of the external magnetic field generator, and/or positioning the medical device by loosening the recapture line or pulling the recapture line [see para 128… “the capsule-type medical device 70 is configured with the capsule main unit 70A having connected thereto a string 75 formed of soft plastic or the like, having sufficient softness, diameter, and strength, to allow the capsule-type medical device 70 to be extracted from the stomach or small intestine through the mouth, or the large intestine from the anus, following inspection, without damaging the mucous membranes in the body cavity. The string 75 is formed in a soft fashion not to impede the rotational progress of the capsule main unit 70A. The string 75 is used by fixing the base end outside of the body.” The string (i.e. the recapture line) anchors the device (i.e. steering or stopping the device via loosening or pulling)].
- navigating the medical device to a target site without pushing the recapture line [see para 102… “the operator activates (turns on) the magnetic guiding device 5, and magnetically controls the capsule-type medical device 1 with the rotating magnetic field generated by the magnetic guiding device 5 so that the capsule-type medical device 1 reaches the target portion”]
- removing the medical device from the target site, by pulling the recapture line [see para 128… “a string 75 formed of soft plastic or the like, having sufficient softness, diameter, and strength, to allow the capsule-type medical device 70 to be extracted from the stomach or small intestine through the mouth, or the large intestine from the anus, following inspection, without damaging the mucous membranes in the body cavity.”]
However, Yokoi is directed to be used in a body cavity [see abstract]. Therefore, Yokoi fails to disclose inserting the medical device “into a blood vessel”. Additionally, Yokoi only discloses placing the recapture line to the base end of the medical device [see para 128… “The string 75 is used by fixing the base end outside of the body. Also, the center of gravity of the capsule-type medical device 70 generally is upon the center axis 38 in the longitudinal direction of the capsule main unit 70A, as with in FIG. 3A and others”]. Thus, Yokoi fails to fully disclose the recapture line is “attached to the tail part of the medical device” or “wherein the recapture line is attached to the tail part of the medical device”.
Alfano discloses in the analogous art of physiological diagnostics inside the body [see abstract… “Remote-controllable, micro-scale, robotic device for use in diagnosing and/or treating abnormalities inside a human body in vivo.” And Col. 1 lines 10-20… “The present invention relates generally to the detection and treatment of diseased and/or abnormal biological materials, such as cells and/or tissues, and relates more particularly to the detection and treatment of diseased and/or abnormal biological materials using photonics”] a medical device being configured and designed to be employed in both in natural openings and the blood stream for the purpose of diagnosing diseases in the GI track and in blood vessels [see claim 25… “The wireless, remote-controllable, micro-scale device as claimed in claim 24 wherein the device diagnoses diseases in vivo of stomach, GI track, prostate, blood vessels, heart, GYN track, and ducts of breast.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Yokoi by placing the recapture line to the base end of the tail part (i.e. thereby reciting the recapture line is “attached to the tail part of the medical device” and “wherein the recapture line is attached to the tail part of the medical device”) because there are a limited number of base ends on the medical device (the base end of the body part or the base end of the tail part) and the base end of the tail part is one of those limited number of choices.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Yokoi to be configured to be used in both the blood vessels and the natural lumens) and to also place it in the blood vessels similarly to that disclosed by Alfano (i.e. thereby reciting inserting of the medical device into a body at an insertion site into a blood vessel) because such a modification would allow for diagnosis of both the GI tract and blood vessels which would potentially increase the versatility of the number of conditions diagnosed.
Allowable Subject Matter
Claims 17, 19-24, 26-29 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 17 is the broadest independent claim. Claim 17 recites a system for controlling a medical device. The closest prior art is Yokoi in view of Alfano. Yokoi in view of Alfano discloses the invention substantially as claimed as outlined in the previous final rejection mailed on 1/5/2026. However, Yokoi in view of Alfano fails to fully disclose “wherein the body part comprises a magnetic part which is usable to steer or stop the medical device by being attracted to the external magnetic field while floating in the blood flow”. In particular, Yokoi in view of Alfano fails to disclose the device floating in the blood or any capability to floating in the blood such as providing buoyancy. Furthermore, nothing in the prior art when viewed with Yokoi in view of Alfano obviates this deficiency. It is important to note that the allowability is not based on the missing limitation alone, but rather the missing limitation in combination with all the limitations of claim 17. Therefore, the combination of limitations recited by claim 17 is neither anticipated, nor obviated in view of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEBASTIAN X LUKJAN whose telephone number is (571)270-7305. The examiner can normally be reached Monday - Friday 9:30AM-6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights