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 .
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive.
Applicant argues that the claimed platform having spherical cap forming part of an imaginary sphere is not taught by the prior art. The Office respectfully disagrees. In support of this argument, Applicant has provided an expert from the specification explaining that the platform comprises a spherical cap and convexed domed portion that form a substantial portion of a hemisphere. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the platform comprises a spherical cap and convexed domed portion that form a substantial portion of a hemisphere) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Instead the amended claim limitation simply states “said platform comprises a spherical cap portion forming part of an imaginary sphere”. The broadest reasonable interpretation of this limitation would include a platform that forms any part of a sphere. As shown below, the platform 120 of Piferi forms a part of a sphere and thus reads on the amended claim language.
Applicant further argues that the prior art fails to teach “configured to move along a surface of said sphere a radial distance from said center point”. The Office respectfully disagrees. In support of this argument, Applicant has provided an expert from the specification explaining that “ ‘the targeted surgical site 434 can be adjusted, for example, by a radial shifting of a first value in a first direction, by shifting spherical cap portion 404 by the same first value in a second direction, which is opposite to the first direction. This correlation ... occurs due to the fact that both the targeted surgical site 434 and the entrance point of the surgical tool to the stereotactic frame 400 are located on the circumference of imaginary sphere 430.” This geometry is only possible because the movable tool holder aperture always lies on the surface of the same imaginary sphere at a fixed radial distance from the center point 432 as the cap 404 moves”. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the movable tool holder aperture always lies on the surface of the same imaginary sphere at a fixed radial distance from the center point as the cap moves) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Instead, the amended claim limitation simply states “said movable tool holder is configured to move along a surface of said sphere at a radial distance from said center point”. The broadest reasonable interpretation of this limitation would include a movable tool holder that is capable of moving along any surface of a sphere at any radial distance for at least a point in time. As explained below, the moveable tool holder of Piferi performs this function. The Office notes that should applicant wish the interpretation to match what is described in the specification, the claims should be amended to match the structures in the specification (i.e. a sphereical cap and convexed domed portion that form a substantial portion of a hemisphere, wherein the spherical cap moves with the moveable tool holder on the surface of the sphere, etc).
Response to Amendment
This office action is responsive to the amendment filed on 02/10/2026. As directed by the amendment: claims 9 and 32 have been amended and claims 1-8, 10, 13-14, 17, 22-23, 26, and 29 have been cancelled. Thus, claims 9, 11-12, 15-16, 18-21, 24-25, 27-28, 30-32 are presently pending in this application with claim 32 withdrawn.
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 9, 12, 15, 16, 18-21, 27, 28, 30, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi (US 2014/0024927 A1) in view of Gowda et al. (US 2013/0053867 A1), Kao et al. (US 2007/0106305 A1), and Perry (US 4,341,220).
Regarding claims 9 Piferi discloses (fig. 1-12) a stereotactic surgical frame 100 for facilitating insertion of a surgical tool into a target surgical site within a patient skull (see abstract), comprising:
a platform 120 defining a curved path of an imaginary sphere having a circumference that crosses through said skull (see annotated fig. 11 below);
said platform 120 comprises a spherical cap portion forming part of an imaginary sphere having a diameter (D1) and a center point, said spherical cap portion defining said curved path (see annotated fig. 13 below, the spherical cap forms part of the sphere making it a spherical cap);
a movable tool holder 130 comprising an aperture (opening in 204; see [0075]) configured to accommodate a surgical tool (lead, see [0075]), and wherein said movable tool holder 130 is configured to move along said curved path (see [0084] and fig. 10);
one or more screws 17 configured to be imbedded in said skull at known locations (see fig. 6 and [0081]);
wherein said frame 100 is configured to be co-registered with said one or more screws 17 (see [0018]), and wherein said movable tool aperture is configured to be positioned on said imaginary sphere circumference {see fig. 3A; 204 is secured to 132 (see [0075]) and 132 is included in 130 (see [0077])};
both said target surgical site and said movable tool aperture are located on said circumference of said imaginary sphere (see note below);
said platform 120 comprises a patch of said imaginary sphere (the platform forms a portion of the imaginary sphere, therefore it comprises a patch) defining said curved path (see annotated fig. 11 below), and wherein said movable tool holder is configured to move along a surface of said sphere (see fig. 10 and [0084]) at a radial distance from said center point (see annotated fig. 13 below).
Note: the language “both said target surgical site and said movable tool aperture are located on said circumference of said imaginary sphere” constitutes intended use, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Piferi as modified meets the structural limitations of the claim, and both said target surgical site and said movable tool aperture are capable of being located on said circumference of said imaginary sphere. The movable tool holder aperture is directly in line with the target surgical site because it determines the target surgical site. The tool is axially moveable to a depth of the target site which can a depth on the circumference of the imaginary sphere.
Therefore both said target surgical site and said movable tool aperture are capable of being located on said circumference of said imaginary sphere.
PNG
media_image1.png
684
697
media_image1.png
Greyscale
PNG
media_image2.png
732
710
media_image2.png
Greyscale
Piferi is silent regarding one or more fiducials.
However Gowda, in the same filed of endeavor, teaches screws 103 for connecting a platform to a skull, wherein the screws 103 are fiducials (see fig. 1c and [0033]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Piferi to have the screws be fiducials as taught by Gowda, for the purpose of aiding in positioning and/or registering the position and/or orientation of the device by being able to see the screws under imaging (see Gowda [0032]).
Piferi as modified is silent regarding at least one frame pod having an upper end connected to said platform and to one or more screws; said at least one frame pod is operable to adjust a position of said stereotactic surgical frame relative to said skull; said at least one frame pod comprises a locking mechanism comprising a screw connected to a joint: said locking mechanism configured to lock said at least one frame pod relative to said one or more fiducials, thereby keeping a mating between said at least one frame pod and said one or more fiducials in a fixed position.
However Kao, in the same filed of endeavor, teaches (fig. 1 and 6A-6B) at least one frame pod 630 having an upper end 642 connected to a platform 116 (see fig. 1, [0059], [0070] and [0071]) and to one or more screws 690 (see fig. 6A); said at least one frame pod 630 is operable to adjust a position of said stereotactic surgical frame 112 relative to said skull (adjusted by adjusting L1; see [0072]); said at least one frame pod 630 comprises a locking mechanism 655 comprising a screw 655A connected to a joint 652 (see [0071] and [0074]): said locking mechanism 655 configured to lock said at least one frame pod 630 relative to said one or more screws 690, thereby keeping a mating between said at least one frame pod 630 and said one or more screws 690 in a fixed position (see [0074]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify each of the screws of Piferi to have a least one frame pod having an upper end connected to said platform and to one or more screws; said at least one frame pod is operable to adjust a position of said stereotactic surgical frame relative to said skull; said at least one frame pod comprises a locking mechanism comprising a screw connected to a joint: said locking mechanism configured to lock said at least one frame pod relative to said one or more fiducials, thereby keeping a mating between said at least one frame pod and said one or more fiducials in a fixed position as taught by Kao, for the purpose of being able to adjust the location of the platform up as needed for the procedure by adjusting a length of the frame pod (see Kao [0011]-[0012]).
Piferi as modified is silent regarding said platform comprises one or more marking scales of a spherical coordinate system defined by the frame.
However Perry, in the same filed of endeavor, teaches (fig. 6) of a platform comprises one or more marking scales of a spherical coordinate system defined by a frame (see fig. 6 and col. 3 ln. 61 – col. 4 ln. 12).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Piferi as modified to have said platform comprises one or more marking scales of a spherical coordinate system defined by the frame as taught by Perry, for the purpose of the choose these angles to minimize damage when the probe is inserted through other portions of the brain and/or to facilitate access to the desired portion of the brain (see Perry col. 3 ln. 61 – col. 4 ln. 12 and col. 6 ln. 61-68).
Regarding claim 27, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi further discloses (fig. 1-12) said frame is configured to proportionally displace said movable tool holder aperture while holding a surgical tool in a first direction (the movable tool holder aperture is in a guide which proportionally displaces the aperture as it moves with 130; see fig. 10 and [0084]), and said target surgical site in which a tip of said surgical tool is positioned in an opposite second direction (see fig. 11-12) according to a ratio between a distance of said movable tool holder from a center point of said imaginary sphere and a distance of said targeted surgical site from said center point (the tool can be moved up and down in the aperture to be held in a position such that a ratio between a distance of said movable tool holder from a center point of said imaginary sphere and a distance of said targeted surgical site from said center point is proportional).
Regarding claim 12, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 27. Piferi further discloses (fig. 1-12) said platform 120 comprises an arc of said imaginary sphere defining said curved path (see annotated fig. 11 above), and wherein said movable tool holder is configured to move along a surface of said arc (see fig. 10 and [0084]).
Regarding claim 15, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi further discloses (fig. 1-12) a lock (148+124; see [0084]) configured to lock said movable tool holder at a selected position along said curved path (130 only moves when worm gear 148 is made to move, therefore 148+124 is a lock configured to lock said movable tool holder at a selected position along said curved path).
Regarding claim 16, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi further discloses (fig. 1-12) said movable tool holder 130 is configured for adjustment of set up parameters of said surgical tool relative to said frame using spherical coordinates. The language “said movable tool holder is configured for adjustment of set up parameters of said surgical tool relative to said frame using spherical coordinates” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Piferi as modified meets the structural limitations of the claim, and the movable tool holder is capable of adjustment of set up parameters of said surgical tool relative to said frame using spherical coordinates. The moveable tool is moving along a portion of a sphere, therefore it is capable of adjustment of set up parameters of said surgical tool relative to said frame using spherical coordinates.
Regarding claim 18, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 17. Piferi further discloses (fig. 1-12) a distance between said movable tool holder aperture and said target surgical site is proportional to a radius defined by said imaginary sphere (the movable tool holder aperture is directly in line with the target surgical site because it determines the target surgical site; the tool is axially moveable to a depth of the target site which can be a depth on the circumference of the imaginary sphere, therefore a distance between said movable tool holder aperture and said targeted surgical site is proportional to a radius defined by said imaginary sphere).
Regarding claim 19, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi further discloses (fig. 1-12) said movable tool holder 130 is configured to allow axial movement of said surgical tool along an axis (axis of 116) perpendicular to said curved path (see fig. 10 and [0083]).
Regarding claim 20, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi further discloses (fig. 1-12) said surgical tool comprises a deep brain stimulation (DBS) lead (see [0075] and [0006]).
Regarding claim 21, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi as modified further teaches said at least one frame pod comprises at least three frame pods (Piferi is modified to have each screw, 17, have a frame pod and there are at least three screws 17 shown in fig. 6 of Piferi).
Regarding claim 28, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 27. Piferi further discloses (fig. 1-12) said frame is configured to said proportionally displace said movable tool holder aperture holding said surgical tool in said first direction while maintaining passage of said surgical tool through said center point of said imaginary sphere. The language “said frame is configured to said proportionally displace said movable tool holder aperture holding said surgical tool in said first direction while maintaining passage of said surgical tool through said center point of said imaginary sphere” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Piferi as modified meets the structural limitations of the claim, and said frame is capable of proportionally displacing said movable tool holder aperture holding said surgical tool in. Furthermore the tool is axially moveable to a depth of the target site which can be selected such that said surgical tool position is maintained through said center point of said imaginary sphere.
Regarding claim 30, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi further discloses (fig. 1-12) said movable tool holder 130 is configured to move along said circumference of said imaginary sphere that crosses through said skull (see fig. 10 and [0084]), when said platform is coupled to said skull using said at least one frame pod 110 (screws 17 are inserted into 110a on 110; see fig. 16 and [0081]).
Regarding claim 31, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi further discloses (fig. 1-12) said movable tool holder 130 is configured to move along a path that is aligned with said curved path of said imaginary sphere (see annotated fig. 11 above, fig. 10 and [0084]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Gowda, Kao, and Perry as applied to claim 9 above, and further in view of Gielen et al. (US 2008/0123921 A1).
Regarding claim 11, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9.
Piferi as modified is silent regarding one or more sensors coupled to said frame, wherein said sensors are configured to communicate with said one or more fiducials.
However Gielen, in the same filed of endeavor, teaches (fig. 9) of a one or more sensors coupled to a frame (see [0088]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Piferi as modified to have one or more sensors coupled to said frame as taught by Gielen, for the purpose of being able to track the position of the surgical instrument and/or other elements of the device (see Gielen [0091]).
Piferi as modified teaches said sensors are configured to communicate with said one or more fiducials. Applicant defines communicate as “[t]he term ‘communicate’ (and its derivatives e.g., a first component ‘communicates with’ or ‘is in communication with’ a second component) and grammatical variations thereof are used to indicate a structural, functional, mechanical, electrical, or optical relationship, or any combination thereof, between two or more components or elements” (specification [00048]) and Piferi is modified to have a sensor on the frame 100 which is in physical contact with screws 103 that contain the fiducials. Therefore said sensors are configured to communicate with said one or more fiducials.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi in view of Gowda, Kao, and Perry as applied to claim 9 above, and further in view of Barricket et al. (US 2002/0087101 A1) and Hunter et al. (US 6,474,341 B1).
Regarding claims 24 and 25, Piferi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Piferi as modified is silent regarding one or more detectors configured to identify a location of one or more fiducials using a wireless signal; said wireless signal comprises a radiofrequency (RF) signal, an optical signal, an infra-red signal, a magnetic signal and/or an ultrasonic signal.
However Barricket, in the analogous art of positioning systems, teaches that one or more fiducials can comprise a sensor (see ¶0027).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Piferi as modified to have the one or more fiducials can comprise a sensor as taught by Barricket, for the purpose of being able determine the location of the fiducial and use it as a reference for positioning the instrument in the correct location (see Barricket ¶0027).
Piferi as modified is silent regarding one or more detectors configured to identify a location of one or more fiducials using a wireless signal; said wireless signal comprises a radiofrequency (RF) signal, an optical signal, an infra-red signal, a magnetic signal and/or an ultrasonic signal.
However Hunter, in the analogous art of positioning systems, teaches (fig. 1) of one or more detectors 16 configured to identify a location of one or more sensors 12 (see col. 3 ln. 24-38) using a wireless signal (see col. 4 ln. 27-39); said wireless signal comprises a radiofrequency (RF) signal (see col. 4 ln. 27-39).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Piferi as modified to have one or more detectors configured to identify a location of one or more sensors using a wireless signal; said wireless signal comprises a radiofrequency (RF) signal as taught by Hunter, for the purpose of being able to easily and wirelessly determine the location of the sensors within the body (see Hunter col. 3 ln. 6-23 and col. 3 ln. 39-65).
Piferi as modified teaches the one or more detectors configured to identify a location of one or more fiducials. Piferi is modified to have the one or more fiducials comprise a sensor and is further modified to have one or more detectors configured to identify a location of the sensor.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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, Darwin Erezo can be reached at (571) 272-4695. 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.
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771