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 Status: Claims 1-20 are pending.
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 12-20 are 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.
Re Claim 12, “the system comprising” in line 5 of Claim 12 makes the claim indefinite, because the preamble is “a programming device”. It should be corrected “the device comprising”.
Indefiniteness of claim 12 renders its dependent claims indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 12-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Re Claim 12, the limitations “a distal end portion implanted in a patient” and “the distal end portion is not parallel to at least one of a sagittal plane or a coronal plane of the patient” encompasses the human organism because the scope of the claim cannot be determined without determining the spatial relationship of the stimulation lead with the human body. A claim which encompasses, to any degree, the human organism or some portion thereof, is directed to ineligible subject matter.
Claims 12-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim recites a device.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 12 is directed towards a device.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “determining a modified set of stimulation parameters that moves the stimulation in the selected anatomically-defined direction.”
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion).
The above steps can be performed in the mind or by hand. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites additional elements “at least one processor”, which can be interpreted as a generic processor. The processing device and the programmable processor do not integrate the judicial exception into a practical application, because it is merely using a generic processor as a tool to perform an abstract idea (see MPEP 2106.05(f)).
The claim recites additional elements, “receiving a user input to move stimulation in a selected anatomically-defined direction” and “transmitting the modified set of stimulation parameters to the stimulation device”; however, these additional elements do not integrate the judicial exception into a practical application, because receiving data and transmitting data amounts to insignificant extra-solution activity.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “at least one processor,” “receiving a user input to move stimulation in a selected anatomically-defined direction,” and “transmitting the modified set of stimulation parameters to the stimulation device”. The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)).
The courts have recognized receiving or transmitting data over a network, e.g., using the Internet to gather data, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity: Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network). See MPEP 2106.05(d)II.
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 13-19, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blum et al. (US 2009/0287271A1).
Re Claim 1, Blum discloses a method for modifying stimulation by a stimulation system comprising a stimulation device (abstract, a processor that calculates a VOA for each of a plurality of sets of parameter settings of the leadwire) and a stimulation lead coupled to the stimulation device (para. [0146], fig. 3D, a stimulation leadwire 335) and comprising a distal end portion implanted in a patient and a plurality of electrodes, optical emitters, or any combination thereof disposed along the distal end portion (para. [0146], the stimulation leadwire 335 includes one or more electrical contacts or electrodes 336), wherein the distal end portion is not parallel to at least one of a sagittal plane or a coronal plane of the patient (fig. 3C and 3D shows that leadwire 335 is not parallel to at least one of a sagittal plane or a coronal plane), the method comprising:
providing stimulation to the patient by the stimulation device through at least one of the electrodes or optical emitters of the stimulation lead according to an initial set of stimulation parameters (para. [0141], fig. 6, a stimulation is applied and the location of the electrodes relative to the brain structures is confirmed axially and rotationally, e.g., based on one or more medical images or other sensor or observed data; para. [0142], fig. 7, That is, trial stimulations may be performed prior to closing of the patient's head to determine whether any benefits and/or side effects result from the stimulations with the leadwire at its present location; para. [0265], [0278]);
receiving, at a programming device, a user input to move the stimulation in a selected anatomically-defined direction (para. [0144], the clinician programmer system can suggest optimal program parameters, e.g., parameters that are predicted to result in an estimated VOA that closely corresponds to a target VOA manually input as described above or automatically determined, for example, based on a therapeutic goal; para. [0243], user input is up/down, side to side, clockwise/counterclockwise. In response to the user input, an algorithm controls the movement of the stimulation field by changing the amount of current delivered to a set of electrodes to either a different amount of current to some or each electrode or a different combination of electrodes; para. [0247], 26 basic linear directional inputs that can be used to steer a current field for a leadwire; para. [0250]-[0253], a directional input for redistributing current from one set of electrodes to another; para. [0266], [0280]);
determining, by the programming device or the stimulation device, a modified set of stimulation parameters that moves the stimulation in the selected anatomically-defined direction (para. [0144], [0145], the clinician programmer system can suggest optimal program parameters, e.g., parameters that are predicted to result in an estimated VOA that closely corresponds to a target VOA manually input as described above or automatically determined, for example, based on a therapeutic goal; para. [0267], [0281]); and
providing stimulation to the patient by the stimulation device through at least one of the electrodes or optical emitters of the stimulation lead according to the modified set of stimulation parameters (para. [0146], stimulation parameters are adjusted to optimal stimulation field orientation. In an example, the parameters can be adjusted to account for variation between the surgical plan and the actual leadwire or other component placement, direction, or location; para. [0267], [0281]).
Re Claim 2, Blum discloses that the anatomically-defined direction is selected from anterior, posterior, superior, inferior, lateral, medial, or any combination thereof (para. [0247], The stimulation leadwire is in the center of the cube shown in FIG. 22. The first set of inputs is directed toward the vertices (8), another set of inputs is directed perpendicular to each face (6), and additionally another set of inputs is directed toward the midpoint of each side or arête (12).).
Re Claim 3, Blum discloses obtaining a trajectory of the distal end portion of the stimulation lead (para. [0094], a lead insertion site and trajectory are planned; para. [0095], the clinician programmer system is configured to plan a surgical path for implantation of a stimulation leadwire using a head-frame (e.g., Lexcel), a frameless head mount (e.g., Nexframe), or other surgical tool; para. [0101], the microelectrode can be inserted into the brain, such as at a proposed or actual trajectory of a therapy delivery or other device or at another area, and can be configured to receive physiological information indicative of a location, structure, or substructure of the brain at which the microelectrode is located or with which the microelectrode is in contact).
Re Claim 4, Blum discloses that obtaining the trajectory comprises receiving, at the programming device, a user input of the trajectory (para. [0091], once imported, the scans can be analyzed, such as automatically by the clinician programmer system using image processing or other techniques or algorithms or manually by the user, to create a model of the patient's brain anatomy, or to fit a pre-loaded best-fit scan or preloaded model of the patient's brain anatomy, such as a brain atlas; para. [0092], the system may provide for receipt and processing of user input selecting a plurality of points within a 2-D or 3-D model to outline a 2-D or 3-D target location. The system may further provide for clicking and dragging upon one or more points of a displayed target location to change its shape; para. [0093], the target location can be identified or suggested by the clinician programmer system, for example, using clinician input, the patient's information (such as a patient disorder, patient history, etc.) population information (such as learned information from one or more other patients)).
Re Claim 5, Blum discloses that obtaining the trajectory comprises determining an actual or estimated trajectory from imaging (para. [0088], fig. 5, importing pre-surgical patient MR (or MRI) and CT scans, fitting patient scans to a pre-loaded best-fit atlas(es), identifying a target location within a graphical representation of a best-fit scan, and planning the lead insertion site and trajectory).
Re Claim 6, Blum discloses obtaining a rotational orientation of the stimulation lead (para. [0110], the post-operative or other CT data can be correlated, registered, co-registered, or otherwise morphed, changed, or altered, e.g., to the same or similar view, plane, or other orientation as the MRI data, to identify the location or placement of the identified lead or electrode on the pre-operative or other MRI data; para. [0125]-[0128], Different types of markers are disclosed. The angle at which these features are viewed under fluoro, CT, and/or MRI can tell the user the direction in which each electrode set is pointing; fig. 24, 25, and 26, para. [0129]-[0131] shows different rotational positions of the leadwire).
Re Claim 7, Blum discloses that obtaining the rotational orientation comprises observing an orientation marker of the stimulation lead or estimating the rotational orientation from responses to stimulation (para. [0125]-[0128], Different types of markers are disclosed. The angle at which these features are viewed under fluoro, CT, and/or MRI can tell the user the direction in which each electrode set is pointing; fig. 24, 25, and 26, para. [0129]-[0131] shows different rotational positions of the leadwire).
Re Claim 8, Blum discloses that obtaining the rotational orientation comprises determining the rotational orientation from imaging of the stimulation lead (para. [0129], [0130], [0131], [0132], Depending on the image the physician sees in the fluoroscopy image, the physician can tell in which direction the electrodes are pointing due to the asymmetry of the marker band. The physician would select, via the user interface, which pictures most closely relate to the image the physician is viewing in a fluoro machine, CT, or MRI.).
Re Claim 9, Blum discloses that determining the modified set of stimulation parameters comprises transforming the selected anatomically-defined direction into a lead coordinate system or at least one lead direction (para. [0243], user input is up/down, side to side, clockwise/counterclockwise. In response to the user input, an algorithm controls the movement of the stimulation field by changing the amount of current delivered to a set of electrodes to either a different amount of current to some or each electrode or a different combination of electrodes; para. [0247], 26 basic linear directional inputs that can be used to steer a current field for a leadwire; para. [0250]-[0253], a directional input for redistributing current from one set of electrodes to another).
Re Claim 10, Blum discloses that determining the modified set of stimulation parameters comprises determining the modified set of stimulation parameters using a predefined algorithm with the selected anatomically-defined direction being an input to the algorithm (para. [0243], user input is up/down, side to side, clockwise/counterclockwise. In response to the user input, an algorithm controls the movement of the stimulation field by changing the amount of current delivered to a set of electrodes to either a different amount of current to some or each electrode or a different combination of electrodes; para. [0247], 26 basic linear directional inputs that can be used to steer a current field for a leadwire; para. [0250]-[0253], a directional input for redistributing current from one set of electrodes to another). .
Re Claim 11, Blum discloses that the programming device comprises a control for switching between user input controls for moving stimulation along anatomically-defined directions and user input controls for moving stimulation along lead directions (para. [0243], there are several ways the field can be manipulated. Looking in two dimensions, the field can be moved either up or down the leadwire in the Z direction by hitting directional up or down arrow buttons 3013 and 3015 as shown in FIG. 23. The field can be moved side to side in the X direction by hitting directional side to side buttons 3012 and 3014 as shown in FIG. 23; para. [0247], The first set of inputs is directed toward the vertices (8), another set of inputs is directed perpendicular to each face (6), and additionally another set of inputs is directed toward the midpoint of each side or arête (12). In addition, two rotational directional inputs can be used (clockwise and counterclockwise) for rotational movement as shown in FIG. 21.).
Re Claims 12 and 20, Claims 12 and 20 are rejected under substantially the same basis as claim 1.
Re Claim 13, Claim 13 is rejected under substantially the same basis as claim 2.
Re Claim 14, Claim 14 is rejected under substantially the same basis as claim 3.
Re Claim 15, Claim 15 is rejected under substantially the same basis as claim 4.
Re Claim 16, Claim 16 is rejected under substantially the same basis as claim 6.
Re Claim 17, Claim 17 is rejected under substantially the same basis as claim 9.
Re Claim 18, Claim 18 is rejected under substantially the same basis as claim 10.
Re Claim 19, Claim 19 is rejected under substantially the same basis as claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, March 6, 2026Examiner, Art Unit 3792