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 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.
Claims 1-20, are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding claim 1:
Claim 1 is directed to idea of itself (abstract idea) without significantly more for the following reason(s):
Step 1: Claim 1 recites A method enabling determination of a planned pose of a medical implant based on medical image data, the method being performed by a surgical planning station and comprising: receiving constraint information from a server, the constraint information indicating at least one constraint to be used by the surgical planning station for determining a planned pose of a medical implant; obtaining medical image data of at least a portion of a patient’s body in which portion the medical implant is to be implanted; and determining a planned pose of the medical implant based on the at least one constraint and the medical image data. Thus, the claim is directed to a method which is one of the statutory categories of the invention.
Step 2A prong 1, the claimed receiving constraint information, obtaining medical image data, and determining a planned pose steps are directed to abstract idea for the reason that these steps are processes found by the courts to be abstract ideas in that related to “mental processes grouping” more specifically, “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where said steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);. That is, nothing in the claim element precludes the steps from practically being performed in the mind. More particularly the receiving, obtaining, and determining steps are capable of being done mentally and/or with a pen and paper. Thus, these steps are an abstract idea in the “mental process” grouping. Accordingly, the claim recites an abstract idea.
Step 2A prong 2, The Judicial exception is not integrated into a practical application. Treating claim 1 as a whole, the claim limitations do not show inventive concept in applying the judicial exception. From the scope of claim, the claim fail to address any improvement because merely receiving, obtaining, and determining is not enough to tie the claim towards the technical improvement and can be performed in human mind or with pen and paper. Thus, claim 1 as a whole is not significantly more than the abstract idea itself and is ineligible.
Step 2B, The claim include additional elements “server”, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Hence, the additional elements do not integrate the exception into a practical application and do not amount to claiming significantly more than the recited judicial exception. Therefore, the claim is not patent eligible.
Regarding claims 2-12.
Claims 2-12, are rejected under 35 U.S.C 101 because the claimed invention is directed to idea of itself (abstract idea) without significantly more, nothing in the claims element precludes the steps from practically being performed in the mind or with pen and paper. The claims does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, said claims are not patent eligible.
Regarding claim 13-14.
Claims 13-14, are rejected under 35 U.S.C 101 because the claimed invention is directed to idea of itself (abstract idea) without significantly more, claims 13, and 14, include additional elements “machine learning model” to carry out process, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Hence, the additional elements do not integrate the exception into a practical application and do not amount to claiming significantly more than the recited judicial exception. Therefore, the claims are not patent eligible.
Regarding claims 15-16.
Claims 15-16, are rejected under 35 U.S.C 101 because the claimed invention is directed to idea of itself (abstract idea) without significantly more, nothing in the claims element precludes the steps from practically being performed in the mind as being explained above with respect to claim 1.
Regarding claims 17-19.
Claims 17-19, are rejected under 35 U.S.C 101 because the claimed invention is directed to idea of itself (abstract idea) without significantly more, nothing in the claims element precludes the steps from practically being performed in the mind. The claims does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, said claims are not patent eligible.
Regarding claim 20.
Claims 20, is rejected under 35 U.S.C 101 because the claimed invention is directed to idea of itself (abstract idea) without significantly more, claim 20, include additional elements “machine learning model” to carry out process, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Hence, the additional elements do not integrate the exception into a practical application and do not amount to claiming significantly more than the recited judicial exception. Therefore, the claim is not patent eligible.
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 9-10 and 17, 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 9, line 1, recites "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10, line 2, recites "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 17, line 1, recites "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-3, 5-6, 8-10, and 15-17, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haddad (US PGPUB 2009/0089081 A1).
As per claim 1, Haddad discloses a method enabling determination of a planned pose of a medical implant based on medical image data (Haddad, Fig. 1:10:12:14), the method being performed by a surgical planning station (Haddad, Fig. 1:14:40) and comprising:
receiving constraint information from a server (Haddad, Fig. 1:18:26, and paragraphs 47, 49-50 and 52), the constraint information indicating at least one constraint to be used by the surgical planning station for determining a planned pose of a medical implant (Haddad, paragraphs 47 and 52, discloses the surgical plan system 40 may be configured to determine relevant aspects of the patient's bone or bony anatomy from the medical images. For example, the surgical plan system 40 may determine one or more mechanical axis of the relevant bones, determine one or more resection planes of the relevant bones, locate particular features of the relevant bones, and/or the like. Based on such determinations, the surgical plan system 40 may select an appropriate orthopaedic implant type and size that also satisfies the implant constraint data of the surgical plan request 18. The surgical plan system 40 may also be configured to determine recommended range of sizes of the orthopaedic implant. For example, in some embodiments, the surgical plan system 40 may be configured to determine an orthopaedic implant within a range of plus or minus two sizes. For example, the surgical plan system 40 may recommend an orthopaedic implant of a size 5+/-2 sizes (i.e., a range of size 3 to size 7));
obtaining medical image data of at least a portion of a patient’s body in which portion the medical implant is to be implanted (Haddad, paragraphs 47, 52-53 and 55); and
determining a planned pose of the medical implant based on the at least one constraint and the medical image data (Haddad, paragraphs 47 and 52, discloses the surgical plan system 40 may be configured to determine relevant aspects of the patient's bone or bony anatomy from the medical images. For example, the surgical plan system 40 may determine one or more mechanical axis of the relevant bones, determine one or more resection planes of the relevant bones, locate particular features of the relevant bones, and/or the like. Based on such determinations, the surgical plan system 40 may select an appropriate orthopaedic implant type and size that also satisfies the implant constraint data of the surgical plan request 18. The surgical plan system 40 may also be configured to determine recommended range of sizes of the orthopaedic implant. For example, in some embodiments, the surgical plan system 40 may be configured to determine an orthopaedic implant within a range of plus or minus two sizes. For example, the surgical plan system 40 may recommend an orthopaedic implant of a size 5+/-2 sizes (i.e., a range of size 3 to size 7)).
As per claim 2, Haddad further discloses the method of claim 1, wherein the at least one constraint defines one or more geometrical properties of the medical implant (Haddad, paragraph 49).
As per claim 3, Haddad further discloses the method of claim 2, wherein the one or more geometrical properties include a size of the medical implant, a shape of the medical implant, a volume of the medical implant, and/or an outline of the medical implant (Haddad, paragraph 49).
As per claim 5, Haddad further discloses the method of claim 1, wherein the at least one constraint defines one or more spatial relationships between the medical implant and an anatomical element of a patient’s body (Haddad, paragraphs 49 and 55, discloses, determine a recommended location and orientation of the orthopaedic implant, as represented by the digital template, with respect to the patient's bone. For example, if implant constraint data provides an estimated amount of resection of the patients' bone, the surgical plan system 40 may be configured to position the digital template in the medical images based on such estimated resection….. determined aspects of the relevant bones may be used to determined the proper positioning of the digital template. In this way, the surgical plan system generates a number of digital templated medical images having indicia of the relevant bone's of the patient and indicia of the recommended orthopedic implant positioned in a location and orientation).
As per claim 6, Haddad further discloses the method of claim 5, wherein the one or more spatial relationships include a predefined distance between at least a portion of the medical implant and the anatomical element, a predefined position of at least a portion of the medical implant relative to the anatomical element, and/or a predefined orientation of at least a portion of the medical implant relative to the anatomical element (Haddad, paragraphs 49, 53 and 55).
As per claim 8, Haddad further discloses the method of claim 1, wherein the surgical planning station is equipped with a surgical planning program, wherein determining the planned pose comprises processing, by the surgical planning program, the at least one constraint and the medical image data (Haddad, Fig. 1:40:46:48, and paragraphs 32-33, 49 and 52).
As per claim 9, Haddad further discloses the method of claim 1, wherein the medical image data and optionally any information derived from the medical image data is hidden from the server, at least until the planned pose has been determined (Haddad, Fig. 1:20, and paragraphs 44 and 49).
As per claim 10, Haddad further discloses the method of claim 1, wherein the at least one constraint is pre-operatively provided from the server to the surgical planning station (Haddad, paragraphs 46, 48 and 49), wherein optionally one or more subsequent steps of the method are performed intraoperatively.
As per claim 15, Haddad discloses a surgical planning station (Haddad, Fig. 1:10:40) that is configured to:
receive constraint information from a server (Haddad, Fig. 1:18:26, and paragraphs 47, 49-50 and 52), the constraint information indicating at least one constraint to be used by the surgical planning station for determining a planned pose of a medical implant (Haddad, paragraphs 47 and 52);
obtain medical image data of at least a portion of a patient’s body in which portion the medical implant is to be implanted (Haddad, paragraphs 47, 52-53 and 55); and
determine a planned pose of the medical implant based on the at least one constraint and the medical image data (Haddad, paragraphs 47 and 52).
As per claim 16, Haddad discloses a method enabling determination of a planned pose of a medical implant based on medical image data (Haddad, Fig. 1:10:40:12), the method being performed by a server (Haddad, Fig. 1:12:26) and comprising:
transmitting constraint information to a surgical planning station (Haddad, Fig. 1:18:40), the constraint information indicating at least one constraint to be used by the surgical planning station for determining a planned pose of a medical implant based on medical image data of at least a portion of a patient’s body in which the medical implant is to be implanted (Haddad, paragraphs 47, 52-53 and 55).
As per claim 17, please see the analysis of claim 9.
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 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.
Claim(s) 4 and 7, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haddad (US PGPUB 2009/0089081 A1) and further in view of Kleyman (US PGPUB 2022/0296388 A1).
As per claim 4, Haddad further discloses the method of claim 3, wherein the Haddad does not explicitly disclose medical implant is a pedicle screw and the at least one constraint defines a diameter and/or a length of the pedicle screw.
Kleyman discloses medical implant is a pedicle screw and the at least one constraint defines a diameter and/or a length of the pedicle screw (Kleyman, paragraph 85).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Haddad teachings by performing a specific implant, as taught by Kleyman.
The motivation would be to provide a system with improved selection of one or more implants (paragraph 49), as taught by Kleyman.
As per claim 7, Haddad further discloses the method of claim 5, wherein the Haddad does not explicitly disclose medical implant is a pedicle screw and the anatomical element is a vertebra, and wherein the at least one constraint defines a pose of a screw insertion trajectory relative to the vertebra.
Kleyman discloses medical implant is a pedicle screw and the anatomical element is a vertebra, and wherein the at least one constraint defines a pose of a screw insertion trajectory relative to the vertebra (Kleyman, paragraphs 85 and 89).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Haddad teachings by performing a specific implant, as taught by Kleyman.
The motivation would be to provide a system with improved selection of one or more implants (paragraph 49), as taught by Kleyman.
Claim(s) 11-13, and 18-20, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haddad (US PGPUB 2009/0089081 A1) and further in view of Mckinnon (US PGPUB 2020/0275976 A1).
As per claim 11, Haddad further discloses the method of claim 1, wherein Haddad does not explicitly disclose feedback information is provided from the surgical planning station to the server, the feedback information indicating at least: (i) one or more previously determined planned poses, (ii) at least one constraint used in determining the one or more previously determined planned poses, (iii) one or more previously determined and user-adjusted planned poses, and/or (iv) at least one constraint used in determining the one or more previously determined and user-adjusted planned poses, and wherein the at least one constraint to be used by the surgical planning station for determining the planned pose of the medical implant is based on the feedback information.
Mckinnon discloses feedback information is provided from the surgical planning station to the server (Mckinnon, Fig. 21:2100, and Fig. 30:2432-2448), the feedback information indicating at least: (i) one or more previously determined planned poses, (ii) at least one constraint used in determining the one or more previously determined planned poses, (iii) one or more previously determined and user-adjusted planned poses, and/or (iv) at least one constraint used in determining the one or more previously determined and user-adjusted planned poses, and wherein the at least one constraint to be used by the surgical planning station for determining the planned pose of the medical implant is based on the feedback information (Mckinnon, Fig. 30:2432-2448).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Haddad teachings by performing a specific implant planning, as taught by Mckinnon.
The motivation would be to provide an improved operative Patient Care System with successful clinical outcome (paragraph 207), as taught by Mckinnon.
As per claim 12, Haddad further discloses the method of claim 1, wherein the Haddad does not explicitly disclose at least one constraint is or was determined by the server.
Mckinnon discloses at least one constraint is or was determined by the server (Mckinnon, Fig. 21:2110, and paragraphs 322 and 326).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Haddad teachings by performing a specific implant planning, as taught by Mckinnon.
The motivation would be to provide an improved operative Patient Care System with successful clinical outcome (paragraph 207), as taught by Mckinnon.
As per claim 13, Haddad further discloses the method of claim 1, wherein Haddad does not explicitly disclose feedback information is provided from the surgical planning station to the server, and wherein the at least one constraint is or was obtained as an output of a machine learning model trained using the feedback information as training data.
Mckinnon discloses feedback information is provided from the surgical planning station to the server (Mckinnon, Fig. 21:2100, and Fig. 30:2432-2448), and wherein the at least one constraint is or was obtained as an output of a machine learning model trained using the feedback information as training data (Mckinnon, paragraphs 7, 319 and 327).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Haddad teachings by performing a specific implant planning, as taught by Mckinnon.
The motivation would be to provide an improved operative Patient Care System with successful clinical outcome (paragraph 207), as taught by Mckinnon.
As per claim 18, please see the analysis of claim 11.
As per claim 19, please see the analysis of claim 12.
As per claim 20, please see the analysis of claim 13.
Claim(s) 14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Haddad (US PGPUB 2009/0089081 A1) and further in view of Mckinnon (US PGPUB 2020/0275976 A1) and further in view of Bendfeldt (US PGPUB 2019/0042981 A1).
As per claim 14, Haddad in view of Mckinnon further discloses the method of claim 13, wherein the Haddad in view of Mckinnon does not explicitly disclose machine learning model is or was trained using federated learning.
Bendfeldt discloses machine learning model is or was trained using federated learning (Bendfeldt, paragraph 61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Haddad in view of Mckinnon teachings by implementing a machine learning technique to the system, as taught by Bendfeldt.
The motivation would be to provide an improved system which learn to predict the output from input data (paragraph 61), as taught by Bendfeldt.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYED Z HAIDER whose telephone number is (571)270-5169. The examiner can normally be reached MONDAY-FRIDAY 9-5:30 EST.
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, SAM K Ahn can be reached at 571-272-3044. 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.
/SYED HAIDER/Primary Examiner, Art Unit 2633
Prosecution Insights