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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 is objected to because “utilizing the registration transform” in step c) should be amended to recite “configured to utilize the registration transform” in order to adequately set forth the structural features of the claimed system, as opposed to narrating function of the system.
Claim 4 is objected to because “reconstruct” in the last line appears to be a typographical error intended to recite “reconstructed”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“image processing module for …” in claim 4 - 5
“transform generation module for …” in claim 4 - 5
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. It is noted that the corresponding structure appears to be a processor, as suggested in [0034] of the published specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1 - 3 and 5 - 8 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 is indefinite because there is unclear antecedent basis for “an intersection point” in step c). It is unclear if this is the point in step b). Examiner suggests amending the claim to refer to “the” point, if this is what is intended.
Claim 5 is indefinite because there is unclear antecedent basis for “a physical reference marker”. It is unclear if this is the marker in claim 4.
Claim 5 is indefinite because it is unclear what is meant by “on one or a subject or a radiographic image detector”. The claim appears to contain a typographical and/or logical error.
Claim 6 is indefinite because there is unclear antecedent basis for “an intersection point” in step c). It is unclear if this is the point in step b). Examiner suggests amending the claim to refer to “the” point, if this is what is intended.
Claims 2 - 3 and 7 - 8 are 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.
Claim 5 is 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).
Claim 5 reads on a human organism because the claim recites a marker on a subject, thereby requiring the subject as part of the claimed system. This rejection can be overcome by reciting that the marker is “configured to be” disposed on the subject.
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.
(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 - 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lavallee et. al (WO 2023/186996, of record).
Regarding claims 1 and 6, Lavallee shows a non-transitory computer-readable medium storing instructions that, when executed by a processor ("… computer system … implement algorithms … ", page 5, lines 25-27), cause a system to perform a method for generating a registration transform for surgical navigation systems ("… registering a 3D medical image obtained by an X-ray imaging system …", abstract), the method comprising::
a) capturing a set of two radiographic images ("set of 2D images acquired by the X-ray imaging system", page 3, lines 24-25) and computing, for each of the respective images, a central ray representing a path from a radiation source to a radiographic image detector ("… conical projection … central point of the X-ray source … X-ray image detector …", Page 7 lines 20-26);
b) identifying an intersection point of the central rays ("… intersection between the respective back-projection rays computed for each 2D X-ray image", page 4, lines 7-8);
c) generating a registration transform (registering, abstract, inter alia) based on the intersection point, and generating a 3D volume reconstruction from the two radiographic images ("… 3D medical image is reconstructed from a set of 2D images …", page 3, lines 27-30; "reconstructed 3D volume is defined as the intersection of all the conical projections corresponding to the set of 2D images", page 8, lines 26-27), and
d) integrating the registration transform with a surgical navigation system to align surgical tools with the reconstructed 3D volume ("… navigation of a surgical tool", page 7, lines 2-4; "… provide three-dimensional information … application of real-time navigation on intraoperatively acquired fluoroscopic images to achieve the above-mentioned goals", page 1, lines 30-35).
Regarding claims 2 and 7, Lavallee discloses the claimed invention substantially as noted above. Lavallee further shows that c) comprises generating the registration transform as part of a process of generating the 3D volume reconstruction from back-projection of the radiographic images (back-projection, page 4, lines 5-8).
Regarding claims 3 and 8, Lavallee discloses the claimed invention substantially as noted above. Lavallee further shows that the registration transform includes positional information (x, y, z) (implicit) and rotational information (yaw, pitch, roll) (implicit) relative to a reference marker on one of a subject (tracker fixed on the patient, page 2, lines 5 - 22 and fig. 1A).
Regarding claim 4, Lavallee shows a system for surgical navigation ("navigate a surgical instrument within the 3D image", page 2, lines 21-22), comprising:
a) an image processing module for reconstructing a 3D volume from at least two radiographic images ("… 3D medical image is reconstructed from a set of 2D images …", page 3, lines 27-30; "reconstructed 3D volume is defined as the intersection of all the conical projections corresponding to the set of 2D images", page 8, lines 26-27), and for identifying an intersection point of computed central rays of each of the radiographic images rays ("… intersection between the respective back-projection rays computed for each 2D X-ray image", page 4, lines 7-8);
b) a transform generation module for creating a registration transform (registering, abstract, inter alia) based on the intersection point and orientation of the central rays ("… intersection of all the conical projections corresponding to the set of 2D images", page 8, lines 26-27), wherein the registration transform defines the positional and rotational relationship of the reconstructed 3D volume relative to a physical reference marker (tracker fixed on the patient, page 2, lines 5 - 22 and fig. 1A); and
c) a navigation interface utilizing the registration transform to visually align surgical instruments with the reconstruct 3D volume ("… navigation of a surgical tool", page 7, lines 2-4; "… provide three-dimensional information … application of real-time navigation on intraoperatively acquired fluoroscopic images to achieve the above-mentioned goals", page 1, lines 30-35).
Regarding claim 5, Lavallee discloses the claimed invention substantially as noted above. Lavallee further shows a physical reference marker on a subject (tracker fixed on the patient, page 2, lines 5 - 22 and fig. 1A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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, Pascal Bui-Pho can be reached at (571)272-2714. 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.
/AMELIE R DAVIS/Primary Examiner, Art Unit 3798