DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of Group II (claims 109-117) in the reply filed on September 21, 2026 is acknowledged. The traversal is on the ground(s) that:
(a): 1) While Applicant does not necessarily agree with the characterizations presented in the Office Action, the Applicant notes that amended claims 70 and 109 both recite "wherein the electromagnetic field generator is movable." To the extent the Office's position is that the method of claim 109 can be practiced by a materially different apparatus from the system of claim 70 because the electromagnetic field generator of claim 109 is not necessarily "movable," Applicant notes that claim 109 expressly recites that the electromagnetic field generator of claim 109 is movable, rendering this ground for restriction moot or improper. 2) The Office Action also states "the electromagnetic field generator can also provide therapeutic effect to the anatomy of the patient that is different than being moved or being used for tracking." While Applicant does not necessarily agree with this characterization, Applicant notes that even if such therapeutic effect were possible, the Office has not identified any reason or rationale why the system recited in claim 70 and the method recited in claim 109 would not both be capable of such use, rendering this ground for restriction improper.
The Examiner disagrees. The method of claim 109 has active method of “moving the electromagnetic field generator …,” while the apparatus of claim 70 only has an apparatus that is movable but does NOT have to be moved electromagnetic field generator. These are TWO different methods. This shows that the apparatus as claimed can be used to practice another and materially different process.
In response to “Applicant notes that even if such therapeutic effect were possible, the Office has not identified any reason or rationale why the system recited in claim 70 and the method recited in claim 109 would not both be capable of such use,” that is not the requirement of MPEP 806.05(e). Applicant admits that the therapeutic method is possible, and that is enough to show there is another method that can be used by the apparatus.
b): As to the restriction between Groups II and III, the Office Action states that "claim 118 includes a feature of 'an electromagnetic filed generator produces an electromagnetic field that allows for detecting or tracking the electromagnetic localization sensor. "'4 Amended claim 118 no longer recites this identified feature, and the Office Action has not identified any other basis for the position that "the inventions as claimed do not encompass overlapping subject matter," rendering this ground of restriction moot or improper.
The Examiner agrees and joins Group II and III.
Because a claimed invention previously restricted from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between groups II and III as set forth in the Office action mailed on July 20, 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
c): As to the restriction between Groups I and III, the Office Action bases the restriction on substantially the same grounds as the restriction between Groups I and II, and Applicant submits that basis of such restriction is moot or improper for at least similar reasons.
The Examiner disagrees for the same reason as shown for Group I and II as shown above.
d) there would be a serious burden on the examiner if restriction is not required. This is not found persuasive because these inventions are distinct for the reasons given above and have acquired a separate status in the art as shown by their different classification, restrictions for examination purposes as indicated is proper. Furthermore, because the search required for Group I is not required for Group II and Group III, restriction for examination purposes as indicated is proper. Literature search for each method and apparatus is distinct since the structural requirements of each invention are different. While searches would be expected to overlap, there is no reason to expect the searches to be coextensive.
e): The Office Action states that "a movable electromagnetic field generator" is NOT the same as "moving the electromagnetic field generator." However, Applicant respectfully submits that there would be no search burden to search for both a movable electromagnetic field generator and moving an electromagnetic field generator since any proper search of such elements would encompass similar search terms. The words "movable" and "moving" both stem from the same root word. While the Office Action purports to identify other distinctions among the various claims, the Office Action provides no plausible basis for the position that such distinctions would require a search burden.
The Examiner disagrees. The method of claim 109 has active method of “moving the electromagnetic field generator …,” while the apparatus of claim 70 only has an apparatus that is movable but does NOT have to be moved electromagnetic field generator. These are TWO different methods. This shows that the apparatus as claimed can be used to practice another and materially different process.
f): Applicant respectfully submits that the Office has provided no explanation as to why the inventions have been classified separately.
The Examiner disagrees. The Application has been classified before the examination by the Examiner. Applicant has never rejected these classification. Furthermore, a reason for such classification is not required in MPEP 806.05(e)
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 70-72, 74-79, 109-119 are pending, claims 70-72, 74-79 have been withdrawn from consideration, and claims 109-119 are currently under consideration for patentability under 37 CFR 1.104.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 113, it is unclear what the metes and bounds of “wherein a transformation is fixed in space and does not require online computation” are. What transformation is this? How and what is used to define “fixed in space”? What parameter is fixed in space? What is online computation? What defines online and offline? A local computer without external world access can still be ONLINE. A local computer with access to a database to 10 miles away can be ONLINE. But it can also be OFFLINE if online means that general public can assessed material.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 109-112, 114-116, 118, 119 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Hastings et al.(US 2005/0256398, hereinafter Hasting ‘398).
In re claims 109 and 118, Hastings ‘398 teaches a method of operating a system for tracking or localizing a robotically controlled elongate instrument, the method comprising:
obtaining an image of an anatomy of a patient (0032-0036);
obtaining localization data for at least a portion of the elongate instrument from an electromagnetic localization sensor coupled to the elongate instrument (0028, 0038, 0042),
wherein at least one fixed reference sensor is positioned (0055) in a workspace of an electromagnetic field generator (0042, 0052), wherein the electromagnetic field generator is movable relative to the reference sensor thereby expanding the workspace for elongate instrument tracking (0059, 0060; 0065, 0068, when catheter is advanced, it is moved, the field generator on the tip of catheter is also moved, and yet the reference sensor 40 is still stationary fixed to the table; “thereby expanding the workspace” as the result of the same method); and moving the electromagnetic field generator relative to the reference sensor thereby expanding the workspace for elongate instrument tracking (0059, 0060; 0065, 0068, when catheter is advanced, it is moved, the field generator on the tip of catheter is also moved, and yet the reference sensor 40 is still stationary fixed to the table; “thereby expanding the workspace” as the result of the same method).
In re claim 110, Hastings ‘398 teaches wherein the reference sensor provides a reference coordinate system that is independent of a placement of the electromagnetic field generator (0055, 0056, fixed coordinate is an independent coordinate, and the coordinate system of a set of transmitter is required to register to this fixed coordinate).
In re claim 111, Hastings ‘398 teaches wherein the localization data is registered to the image via the reference coordinate system to provide a continuously updated location of at least a portion of the elongate instrument in the image to facilitate robotic navigation of the elongate instrument through the anatomy (0055, 0056, fixed coordinate is an independent coordinate, and the coordinate system of a set of transmitter is required to register to this fixed coordinate, real time is continuous update; 0061, 0064).
In re claim 112, Hastings ‘398 teaches wherein a location of the localization sensor is measurable in the reference coordinate system (0085-0093, 0097), wherein the location of the localization sensor is registered to the image via one or more transformations (0073-0084).
In re claim 114, Hastings ‘398 teaches wherein the reference sensor comprises an anatomy patch, wherein the anatomy patch is positioned on the patient such that the reference sensor appears in the image and a position and/or orientation of the reference sensor can be measured in a coordinate system of the image (0033, 0056, 0061).
In re claim 115, Hastings ‘398 teaches wherein the image is 3D or 2D anatomical model or a 2D or 3D fluoroscopic image (0033, 0036, 0038, 0055, 0098, 0105).
In re claim 116, Hastings ‘398 teaches wherein localization data from the localization sensor is registered to a fluoroscopy coordinate system of a fluoroscopy image (0055).
In re claim 119, Hastings ‘398 teaches wherein the reference sensor provides a reference coordinate system that is independent of a placement of the electromagnetic field generator (0055, 0056, fixed coordinate is an independent coordinate, and the coordinate system of a set of transmitter is required to register to this fixed coordinate), wherein the localization sensor provides localization data for at least a portion of the elongate instrument, wherein the localization data is registered to an anatomical image via the reference coordinate system to provide a continuously updated location of at least a portion of the elongate instrument in the anatomical image (0055, 0056, fixed coordinate is an independent coordinate, and the coordinate system of a set of transmitter is required to register to this fixed coordinate, real time is continuous update; 0061, 0064).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 113, 114 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hastings ‘398.
In re claim 113, Hastings ‘398 teaches wherein a transformation is fixed in space (0056, fixed coordinate system is fixed in space) and does not require online computation (fig. 1, it would have been obvious that a complete system of fig 1 that does the transformation, i.e. registration, locally, can be called offline computation; and furthermore, online or offline is a matter of design choice and that offline might be faster to perform data locally.).
In re claim 114, Hastings ‘398 teaches wherein the reference sensor comprises an anatomy patch, wherein the anatomy patch is positioned on the patient such that the reference sensor appears in the image and a position and/or orientation of the reference sensor can be measured in a coordinate system of the image (0033, 0056, 0061). Note that it is obvious that the when the patch is located or render visible in the image (0033), the position can be measured in the image, and that the image of the marker is readily shown in the image. “Can be” is a capable language.
Claim 117 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hastings ‘398 in view of Gutierrez et al. (A practical global distortion correction method for an image intensifier based x-ray fluoroscopy system, Med Phys. 2008 March; 35(3): 997–1007, hereinafter Gutierrez ‘2008).
In re claim 117, Hastings ‘398 fails to teach wherein in order to register the localization data from the localization sensor to a fluoroscopy image, one or more of the following parameters are ascertained or known: a distance from an X-ray source to an image intensifier, a distance from an X-ray source to a bed, a size of the image intensifier, and an axis of rotation of a c-arm of an fluoroscopy machine.
Gutierrez ‘2008 teaches: A practical global distortion correction method for an image intensifier based x-ray fluoroscopy system that include parameters are ascertained or known: a distance from an x-ray source to the bed, or an axis of rotation of a c-arm of the fluoroscopy coordinate system (abstract; page 3, para 1, para 4, para 6; page 4, II.B., para 1; page 5, last para; conclusion).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Hastings ‘398 to include the features of Gutierrez ‘2008 in order to correct distorted images over a large range of c-arm orientations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/ Primary Examiner, Art Unit 3797
