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 Objections
Claim 1, 3, 4, 7, 8, 12 – 16, 18 and 20 are objected to because of the following informalities:
Claim 1 line 3, limitation “a patient” should read “the patient”.
Claim 1 line 4, limitation “the image” should read ‘the scaled image”.
Claim 1 line 5, limitation “the image” should read ‘the scaled image”.
Claim 1 line 7, limitation “the image” should read ‘the scaled image”.
Claim 1 line 13, limitation “a visual representation the patient” should read “a visual representation of the patient; and”.
Claim 3 line 2, limitation “that receives” should read “that is configured to receive”.
Claim 4 line 1, limitation “a scaled image” should read ‘the scaled image”.
Claim 7 line 1 – 2, limitation “a tip of a patient’s coccyx” should read “a tip of the patient’s coccyx”.
Claim 8 line 4, limitation “a patient” should read “the patient”.
Claim 8 line 4, limitation “said image” should read “the at least one scaled image”.
Claim 8 line 8, limitation “image” should read “image;”.
Claim 8 line 9, limitation “the image” should read “the at least one scaled image”.
Claim 8 line 10, limitation “skin” should read “skin;”.
Claim 8 line 11, limitation “the image” should read “the at least one scaled image”.
Claim 8 line 13, limitation “skin” should read “skin;”.
Claim 12 line 2, limitation “that receives” should read “that is configured to receive”.
Claim 13 line 2, limitation “the image” should read “the at least one scaled image”.
Claim 14 line 1 – 2, limitation “a tip of a patient’s coccyx” should read “a tip of the patient’s coccyx”.
Claim 15 line 5, limitation “a patient” should read “the patient”.
Claim 15 line 6, limitation “the image” should read ‘the scaled image”.
Claim 15 line 8, limitation “the image” should read ‘the scaled image”.
Claim 15 line 10, limitation “skin” should read “skin;”.
Claim 15 line 12, limitation “lines” should read “lines;”
Claim 16 line 2, limitation “the image” should read ‘the scaled image”.
Claim 18 line 2, limitation “that receives” should read “that is configured to receive”.
Claim 20 line 1 – 2, limitation “a tip of a patient’s coccyx” should read “a tip of the patient’s coccyx”.
Appropriate correction is required.
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.
Claim 1 – 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.
Claim 1 recites limitation “calculating measurements corresponding to the location on the patient” in line 10. This is the first time “location on the patient” is introduced in the body of claim. It is unclear how the location is determined or defined. Without knowing the determination or definition of the location on the patient, it is also unclear how to calculating measurements associated with the location.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above location on the patient is interpreted as any reasonable location.
Claim 3 recites limitation “wherein the display is computing device having a display” in line 1. It appears applicant intend to claim the display is part of a computing device, but the language used in the claim describe the display as a computing device. Since display and a computing device are two different concepts with well-defined technology names in the art, it is unclear how a display can be a computing device.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as the claimed display is the display of a computing device.
Claim 8 recites limitation “calculate measurements corresponding to the location on the patient based on the first and second lines” in line 14 – 15, This is the first time “location on the patient” is introduced in the body of claim. It is unclear how the location is determined or defined. Without knowing the determination or definition of the location on the patient, it is also unclear how to calculating measurements associated with the location.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above location on the patient is interpreted as any reasonable location.
Claim 12 recites limitation “wherein the display is computing device having a display” in line 1. It appears applicant intend to claim the display is part of a computing device, but the language used in the claim describe the display as a computing device. Since display and a computing device are two different concepts with well-defined technology names in the art, it is unclear how a display can be a computing device.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as the claimed display is the display of a computing device.
Claim 15 recites limitation “calculating measurements corresponding to the location on the patient based on the first and second lines” in line 11 – 12, This is the first time “location on the patient” is introduced in the body of claim. It is unclear how the location is determined or defined. Without knowing the determination or definition of the location on the patient, it is also unclear how to calculating measurements associated with the location.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above location on the patient is interpreted as any reasonable location.
Claim 18 recites limitation “wherein the display is computing device having a display” in line 1. It appears applicant intend to claim the display is part of a computing device, but the language used in the claim describe the display as a computing device. Since display and a computing device are two different concepts with well-defined technology names in the art, it is unclear how a display can be a computing device.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as the claimed display is the display of a computing device.
Therefore, claim 1, 3, 8, 12, 15, 18 and all corresponding dependent claim 2, 4 – 7, 9 – 11, 13, 14, 16, 17, 19 and 20 are rejected under 35 U.S.C. 112(b) as being indefinite.
Allowable Subject Matter
Claim 1 – 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Crites-Bachert (US 2020/0008762 A1; published on 01/09/2020) (hereinafter “CB2020”) and Crites-Bachert (US 2021/0128926 A1; published on 05/06/2021) (hereinafter “CB2021”) are cited as the most relevant prior arts to the claimed invention.
The claimed invention requires a specific system or process for marking a location on a patient for insertion in a neurostimulation therapy. More specifically, there must be two lines imposed on the acquired image, one line must be from an anatomical landmark to the skin surface, and the other line must be from a target in the sacral foremen and perpendicular to the sacrum. In another word, the spatial requirement of two lines restrained the acquired image to be a cross-section image from the sacrum inside the body to skin surface.
Both prior arts CB2020 and CB2021 teach a system/process for needle positioning in neuromodulation. Fluoroscopic images are utilized for planning the needle insertion position. Although there are sever lines drawn on the image to assist the measurement of needle insertion position, such lines are drawn on the plane of skin surface. There is no line imposed on the cross-section plane to reach the sacral foremen from the skin surface.
Thus, neither cited prior arts nor other search results in combination teach the invention as claimed.
Regarding independent claim 1, CB2020, CB2021 and other search results collectively neither teach nor fairly well suggest a method for marking a location on a patient, includes the steps of: “imposing a first line on the image, wherein the first line extends from the patient's anatomical landmark to a surface of the patient's skin; imposing a second line on the image, wherein the second line extends from a target location located in a sacral foramen in a direction perpendicular to the sacrum on the surface of the patient's skin”, in combination with other limitations as recited in the claim 1.
Claim 2 – 7 are dependent on claim 1, which inherently include the allowable feature as discussed above.
Regarding independent claim 8, CB2020, CB2021 and other search results collectively neither teach nor fairly well suggest a system for marking a location on a patient for guiding placement of a neurostimulation lead, the system comprising a processing unit configured to: “impose a first line on the image, wherein the first line extends from the anatomical landmark to a surface of the patient's skin; impose a second line on the image, wherein the second line extends from a target location located in a sacral foramen in a direction perpendicular to the patient's sacrum to the surface of the patient's skin; calculate measurements corresponding to the location on the patient based on the first and second lines”, in combination with other limitations as recited in the claim 8.
Claim 9 – 14 are dependent on claim 8, which inherently include the allowable feature as discussed above.
Regarding independent claim 15, CB2020, CB2021 and other search results collectively neither teach nor fairly well suggest a computer system for marking a location on a patient for guiding placement of a neurostimulation lead, the system comprising: a computing device executing instructions include: “imposing a first line on the image, wherein the first line extends from an anatomical landmark of the patient to a surface of the patient's skin; imposing a second line on the image, wherein the second line extends from a target location located in a sacral foramen in a direction perpendicular to the patient's sacrum to the surface of the patient's skin; calculating measurements corresponding to the location on the patient based on the first and second lines”, in combination with other limitations as recited in the claim 15.
Claim 16 – 20 are dependent on claim 15, which inherently include the allowable feature as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shiroff et al. (US 2018/0008311 A1; published on 01/11/2018) teach desired trajectories for implantation of electrode leads for neurostimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 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, 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.
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.
/CHAO SHENG/ Primary Examiner, Art Unit 3797
Prosecution Insights