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 .
Priority
Applicant claims the benefit of US Provisional Application No. 63/211,226, filed June 16, 2021. Claims 1-38 have been afforded the benefit of this filing date.
Information Disclosure Statement
The IDS dated 10/13/2022, 1/18/2024, 09/05/2024, 02/10/2025, 08/08/2025, 12/02/2025, and 01/30/2026 have been considered and placed in the application file.
Claim Objections
Claim 15 objected to because of the following informalities: the last limitation of Claim 15 reads “and coupling the first plate and/or the second plate an interbody implant positioned in the patient's spinal column” the Examiner finds that the limitation should read “and coupling the first plate and/or the second plate to an interbody implant positioned in the patient's spinal column”. Appropriate correction is required.
Claim Interpretation
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.
Under MPEP 2143.03, "All words in a claim must be considered in judging the patentability of that claim against the prior art." In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494, 496 (CCPA 1970). As a general matter, the grammar and ordinary meaning of terms as understood by one having ordinary skill in the art used in a claim will dictate whether, and to what extent, the language limits the claim scope. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009).
Claim 12 recite “and/or” then listing “at least one of a first cortical rim of the superior vertebra and/or a second cortical rim of the inferior vertebra”. Since “and/or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 13 recite “and/or” then listing “first lateral surface of the superior vertebra and/or a second lateral surface of the inferior vertebra”. Since “and/or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 15 recite “and/or” then listing “coupling the first plate and/or the second plate an interbody implant positioned in the patient's spinal column”. Since “and/or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 17 recite “and/or” then listing “inferior vertebra and/or the inferior surface of the superior vertebra”. Since “and/or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 25 recite “and/or” then listing “first lateral surface of the superior vertebra and/or a second lateral surface of the inferior vertebra”. Since “and/or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 31 recite “and/or” then listing “wherein the first patient-specific geometry is different from the second, third, and/or fourth patient-specific geometry”. Since “and/or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
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 11, 12, 28 and 29 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 pre-AIA the applicant regards as the invention. The Examiner strongly suggested that appropriate corrections be made to clarify the claim scope.
With respect to Claim 11, the claim recites the following, each of which renders the claim indefinite:
“ a length of between about 1 mm and about 20mm” on line 2 (unclear how this affects the scope of the claim due to the fact that the limitation ‘about’ is an approximation).
With respect to Claim 12, the claim recites the following, each of which renders the claim indefinite:
“ by between about 1mm and about 10mm in a posterior direction” on line 3 (unclear how this affects the scope of the claim due to the fact that the limitation ‘about’ is an approximation).
With respect to Claim 28, the claim recites the following, each of which renders the claim indefinite:
“ a length of between about 1 mm and about 20mm” on line 2 (unclear how this affects the scope of the claim due to the fact that the limitation ‘about’ is an approximation).
With respect to Claim 29, the claim recites the following, each of which renders the claim indefinite:
“ has a length of between about 5mm and about 15mm” on line 2 (unclear how this affects the scope of the claim due to the fact that the limitation ‘about’ is an approximation).
Claim Rejections - 35 USC § 102
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, 4, 7-8, 10, 15, 17-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gillman (US Patent Publication 2018/0008349 A1).
Regarding Claim 1, Gillman teaches a computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) for providing patient-specific medical care (Gillman Abstract, ¶0020, Fig 4D, ¶0038 discloses patient specific systems and methods including surgical and implant methods), the method comprising:
receiving a patient data set for a patient (Gillman Fig 1, 102, ¶0008, ¶0037 discloses obtaining spinal images from image data of the patient), the patient data set including one or more images of at least a portion of the patient's spine (Gillman Fig 1, 102, ¶0008, ¶0037 discloses obtaining spinal images from image data of the patient) including a superior vertebra and an inferior vertebra (Gillman ¶0064, ¶0069, Fig 9, discloses including the superior and inferior vertebrae) , the one or more images showing the patient's native anatomical configuration (Gilman Fig 1 102 discloses the image being of the spinal structure of the patient and Fig 3A-3C discloses the view of the patients spine);
determining, using a computing system (Gillman Fig 1 discloses the computer method to determine the correct position of the spine), a corrected anatomical configuration for the patient (Gillman ¶0003, ¶0007, ¶0009, ¶0059 discloses performing deformity corrections), wherein the corrected anatomical configuration (Gillman ¶0003, ¶0007, ¶0009, ¶0059 discloses performing deformity corrections) is different than the native anatomical configuration (Gillman Fig 1 106-112 disclose the superposition over the original spine to determine the correct position for operation to correct the spine); and
designing, using the computing system (Gillman ¶0036 discloses the computing system designing and constructing the patient specific devices), a patient-specific anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) based on the corrected anatomical configuration (Gillman ¶0003, ¶0007, ¶0009, ¶0059 discloses performing deformity corrections), wherein the patient-specific anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) includes-
a first contact region contoured to mate with an anterior surface of the superior vertebra (Gillman ¶0034, ¶0067-¶0069, Fig 10, and disclose the anterior plate mating with the surface of the superior vertebra), a second contact region contoured to mate with an anterior surface of the inferior vertebra (Gillman ¶0034, ¶0067-¶0069, Fig 9, Fig 10, and discloses a second piece of the anterior plate mating with the surface of the inferior vertebra), and an intermediate projection configured to mate with endplates of the superior and inferior vertebrae (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras) when the first and second contact regions are mated with the respective anterior surfaces (Gillman Figure 9 908, and 906 show the contact regions mated to the spine) of the superior and inferior vertebra (Gillman ¶0067-¶0069, Fig 10, and disclose the anterior plate mating with the surface of the superior or inferior vertebra).
Regarding Claim 4, Gillman teaches the computer-implemented method of claim 1, wherein the patient-specific anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) includes one or more seating features configured to hold (Gillman ¶0006 discloses the plate having tines or notches to help the plate align and ¶0067 disclose alignment members to help with the alignment of the plate implant) the at least one of the patient-specific anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) at a specific location along the patient's spine (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant).
Regarding Claim 7, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) of claim 1, further comprising:
generating a virtual model of the patient's spine in the corrected anatomical configuration (Gillman Fig 1 discloses the method of creating a virtual model using the patients data to obtain correct spine configuration);
modifying the virtual model (Gillman Fig 1 106-110 disclose modifying the image based on positioning) to generate a modified virtual model of the patient's spine (Gillman Fig 1 disclose superimposing the images onto the original image to create a new image with guidelines to control the operation on the spine); and
designing the patient-specific anterior plate (Gillman ¶0006, ¶0034, 0036 and Fig 10 discloses the patient implant being comprising plates including an anterior plate and designing the patient specific device) based on the modified virtual model (Gillman Fig 1 106-110 disclose modifying the image based on positioning).
Regarding Claim 8, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) of claim 1, further comprising identifying one or more target positions along the patient's spine (Gillman Fig 8 804 and 816 disclose multiple surgical positions for the resection of the bone and implants), wherein the patient-specific anterior plate (Gillman ¶0006, ¶0034, 0036 and Fig 10 discloses the patient implant being comprising plates including an anterior plate and designing the patient specific device) is designed to correspond with one or more anatomical structures at a corresponding target position (Gillman Fig 8 804 and 816 disclose multiple surgical positions for the resection of the bone and implants).
Regarding Claim 10, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer)of claim 1 wherein designing the patient-specific anterior plate (Gillman ¶0006, ¶0034, 0036 and Fig 10 discloses the patient implant being comprising plates including an anterior plate and designing the patient specific device) includes designing the intermediate portion to contact an intervertebral disc (Gillman Fig 6D 616 discloses an intermediate portion that contacts the replacement disc) in an intervertebral space between the inferior vertebra and the superior vertebra (Gillman Fig 6C discloses the patient specific device being place so that the intermediate portion is in between the vertebrae).
Regarding Claim 15, Gillman teaches a method for implanting a patient-specific implant (Gillman ¶0021 and ¶0037 discloses a method for installing an implant), comprising:
delivering a first plate to a first location proximate a first target position (Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The first plate being attached to the vertebrae above the disc) at the patient's spinal column (Gillman ¶0006 discloses the discs being located between the two vertebrae's), wherein the first plate is designed to mate with a first anatomical structure (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) the first target position (Gillman ¶0006 The first plate being attached to the vertebrae above the disc);
delivering a second plate to a second location proximate a second target position(Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The second plate being attached to the vertebrae below the disc) at the patient's spinal column (Gillman ¶0006 discloses the discs being located between the two vertebrae's), wherein the second plate is designed to mate with a second anatomical structure (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) at the second target position (Gillman ¶0006 The second plate being attached to the vertebrae below the disc); and
coupling the first plate and/or the second plate an interbody implant (Gillman ¶0006 discloses the plates being connected via a disc) positioned in the patient's spinal column (Gillman ¶0006 discloses the discs being located between the two vertebrae's).
Regarding Claim 17, Gillman teaches the method of claim 15 wherein:
the first anatomical structure includes an inferior surface of a superior vertebra and/or a superior surface of an inferior vertebra (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant); and
the second anatomical structure includes the superior surface of the inferior vertebra and/or the inferior surface of the superior vertebra (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant).
Regarding Claim 18, Gillman teaches the method of claim 15 wherein:
positioning the first plate at the first target position (Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The first plate being attached to the vertebrae above the disc) such that the first plate mates with the first anatomical structure (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) comprises forming a generally gapless interface (Gillman ¶0051 discloses the personalized device being flush with the vertebrae after implanting) between the first plate and the first anatomical structure(Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) ; and
positioning the second plate at the second target position (Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The second plate being attached to the vertebrae below the disc) such that the second plate mates with the second anatomical structure (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) comprises forming a generally gapless interface (Gillman ¶0051 discloses the personalized device being flush with the vertebrae after implanting) between the second plate and the second anatomical structure(Gillman ¶0006 The second plate being attached to the vertebrae below the disc).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5, 9, 13-14, 16, 19-27, 30-38 are rejected under 35 U.S.C. 103 as unpatentable over Gillman (US Patent Publication 2018/0008349 A1 hereafter referred to as Gillman) in view of MacLennan et al (US Patent Pub US 2021/0209757 A1 hereafter referred to as MacLennan).
Regarding Claim 5, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) of claim 1, further comprising:
identifying registration features along the patient's spine (Gillman ¶0006-¶0008 discloses features that will allow for installation of the prothesis on the patients spine including removing necessary regions) for engaging (Gillman ¶0006 discloses attaching the plates to the vertebrae) the patient- specific anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate); and
designing regions (Gillman ¶0006 and ¶0067 discloses the plate being designed to abut the aligning device) of the patient-specific anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) to contact (Gillman ¶0011 discloses the plate contacting at least one surface) the identified registration features (Gillman ¶0006 discloses features that will allow for installation of the prothesis on the patients spine).
Gillman does not explicitly disclose for inhibiting movement of a spinal segment of the patient's spine.
MacLennan is in the same field of personalized medical device implantation. Further, MacLennan teaches for inhibiting movement of a spinal segment of the patient's spine (MacLennan ¶0038, ¶0096, ¶0142 discloses limiting lateral movement of the patients spine and limiting the movement of the pad between the vertebras).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including an variety of different implants including different geometries and multiple locations of implant installation for patients that address multiple issues including the inhibition of lateral movement as taught by MacLennan, to make an invention that can adapt to many different patients and specific issues; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for a variety of devices that are intended to maintain spinal mobility within the normal range of spinal movement and to reduce the incidence of degeneration of discs at adjacent segments of the spine. (MacLennan ¶0005).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 9, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) of claim 8, wherein the patient-specific anterior plate is a first patient-specific anterior plate (Gillman ¶0006, ¶0034, 0036 and Fig 10 discloses the patient implant being comprising plates including an anterior plate and designing the patient specific device), and wherein the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) further includes:
designing a second patient-specific anterior plate (Gillman ¶0006 discloses two plates) than the first patient-specific anterior plate (Gillman ¶0006, ¶0034, 0036 and Fig 10 discloses the patient implant being comprising plates including an anterior plate and designing the patient specific device).
Gillman does not explicitly disclose configured to be implanted at a different target location wherein the first patient-specific anterior plate has a different geometry than the second patient-specific anterior plate.
MacLennan is in the same field of personalized medical device implantation. Further, MacLennan teaches configured to be implanted at a different target location (MacLennan Figure 75 and Figure 76 211 discloses plates implanted at different target locations)
wherein the first patient-specific anterior plate has a different geometry than the second patient-specific anterior plate (MacLennan Figure 75 and Figure 76 211 discloses plates implanted at different target locations and the plates differing in the geometry where one is curved ).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including an variety of different implants including different geometries and multiple locations of implant installation for patients that address multiple issues including the inhibition of lateral movement as taught by MacLennan, to make an invention that can adapt to many different patients and specific issues; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for a variety of devices that are intended to maintain spinal mobility within the normal range of spinal movement and to reduce the incidence of degeneration of discs at adjacent segments of the spine. (MacLennan ¶0005).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 13, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer)of claim 1, further comprising designing, using the computing system (Gillman ¶0036 discloses a system for designing and constructing patient specific devices), based on the corrected anatomical configuration (Gillman Fig 1 106-112 disclose the superposition over the original spine to determine the correct position for operation to correct the spine).
Gillman does not explicitly disclose a patient-specific lateral plate wherein the patient-specific lateral plate is configured to mate with at least one of a first lateral surface of the superior vertebra and/or a second lateral surface of the inferior vertebra.
MacLennan is in the same field of personalized medical device implantation. Further, MacLennan teaches a patient-specific lateral plate (MacLennan ¶0126, Fig 67, 187 discloses a lateral extension plate),
wherein the patient-specific lateral plate (MacLennan ¶0126, Fig 67, 187 discloses a lateral extension plate) is configured to mate with at least one of a first lateral surface of the superior vertebra (MacLennan Fig 31 and 33 disclose the lateral projections being attached the superior vertebra) and/or a second lateral surface of the inferior vertebra(MacLennan Fig 31 and 33 disclose the lateral projections being attached the inferior vertebra).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including an variety of different implants including different geometries and multiple locations of implant installation for patients that address multiple issues including the inhibition of lateral movement as taught by MacLennan, to make an invention that can adapt to many different patients and specific issues; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for a variety of devices that are intended to maintain spinal mobility within the normal range of spinal movement and to reduce the incidence of degeneration of discs at adjacent segments of the spine. (MacLennan ¶0005).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 14, Gillman in view of MacLennan teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer)of claim 13 wherein designing the patient- specific lateral plate(MacLennan ¶0126, Fig 67, 187 discloses a lateral extension plate) includes designing one or more connectors configured to couple (MacLennan Fig 67 disclose the lateral extension being connected to the anterior plate via a screw) the patient-specific lateral plate (MacLennan ¶0126, Fig 67, 187 discloses a lateral extension plate) to the patient-specific anterior plate (Gillman ¶0006, ¶0034, 0036 and Fig 10 discloses the patient implant being comprising plates including an anterior plate and designing the patient specific device). See rationale for Claim 13 its parent claim.
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Regarding Claim 16, Gillman teaches the method of claim 15 wherein:
the first anatomical structure (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) includes-
a first anterior surface of a superior vertebra, and a second anterior surface of an inferior vertebra (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant);
the second anatomical structure (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) includes
the interbody implant (Gillman ¶0006 discloses the plates being connected via a disc) is positioned in an intervertebral space (Gillman ¶0006 discloses the discs being located between the two vertebrae's) between the superior vertebra and the inferior vertebra (Gillman Fig 5C shows the disc located between the two vertebra).
Gillman does not explicitly disclose a first lateral surface of the superior vertebra and a second lateral surface of the inferior vertebra.
MacLennan is in the same field of personalized medical device implantation. Further, MacLennan teaches a first lateral surface of the superior vertebra (MacLennan Fig 31 and 33 disclose the lateral projections being attached the superior vertebra), and a second lateral surface of the inferior vertebra (MacLennan Fig 31 and 33 disclose the lateral projections being attached the inferior vertebra).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including an variety of different implants including different geometries and multiple locations of implant installation for patients that address multiple issues including the inhibition of lateral movement as taught by MacLennan, to make an invention that can adapt to many different patients and specific issues; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for a variety of devices that are intended to maintain spinal mobility within the normal range of spinal movement and to reduce the incidence of degeneration of discs at adjacent segments of the spine. (MacLennan ¶0005).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 19, Gillman teaches a plate configured to be implanted (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) at a target position along a patient's spine (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant) so as to mate with a superior vertebra and an inferior vertebra (Gillman ¶0034, ¶0067-¶0069, Fig 10, and disclose the anterior plate mating with the surface of the superior vertebra), wherein the plate includes:
a first contact region contoured to mate with an anterior surface of the superior vertebra (Gillman ¶0034, ¶0067-¶0069, Fig 10, and disclose the anterior plate mating with the surface of the superior vertebra), a second contact region contoured to mate with an anterior surface of the inferior vertebra (Gillman ¶0034, ¶0067-¶0069, Fig 9, Fig 10, and discloses a second piece of the anterior plate mating with the surface of the inferior vertebra), and an intermediate projection configured to mate with endplates of the superior and inferior vertebrae (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras) when the first and second contact regions are mated with the respective anterior surfaces (Gillman Figure 9 908, and 906 show the contact regions mated to the spine) of the superior and inferior vertebra (Gillman ¶0067-¶0069, Fig 10, and disclose the anterior plate mating with the surface of the superior or inferior vertebra).
Gillman does not explicitly disclose a patient-specific implant.
MacLennan is in the same field of personalized medical device implantation. Further, MacLennan teaches a patient-specific implant (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including an variety of different implants including different geometries and multiple locations of implant installation for patients that address multiple issues including the inhibition of lateral movement as taught by MacLennan, to make an invention that can adapt to many different patients and specific issues; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for a variety of devices that are intended to maintain spinal mobility within the normal range of spinal movement and to reduce the incidence of degeneration of discs at adjacent segments of the spine. (MacLennan ¶0005).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 20, Gillman in view of MacLennan teaches the patient-specific implant of claim 19, further comprising an intervertebral device (MacLennan ¶0016, ¶0022, discloses an artificial intervertebral disc that is implanted in at least one disc space that is respectively located between at least two adjacent vertebrae in the spinal column) positioned in an intervertebral space between the superior and inferior vertebrae (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras), wherein the intermediate projection (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras) is further configured to extend into the intervertebral space to contact the intervertebral device (Gillman ¶0064 discloses an anatomic alignment member that extends between the inferior and superior vertebrae to assist with the alignment of the implant). See rationale for Claim 19 its parent claim.
Regarding Claim 21, Gillman in view of MacLennan teaches the patient-specific implant of claim 20 wherein, when implanted at the target position (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant), the plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) is further configured to inhibit anterior movement (Gillman ¶0005, ¶0053, discloses screws being used to secure the implant to the vertebrae) of the intervertebral device (MacLennan ¶0016, ¶0022, discloses an artificial intervertebral disc that is implanted in at least one disc space that is respectively located between at least two adjacent vertebrae in the spinal column). See rationale for Claim 19 its parent claim.
Regarding Claim 22, Gillman in view of MacLennan teaches the patient-specific implant of claim 20 wherein the intervertebral device (MacLennan ¶0016, ¶0022, discloses an artificial intervertebral disc that is implanted in at least one disc space that is respectively located between at least two adjacent vertebrae in the spinal column) is configured to be coupled to the intermediate projection (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras) when the intervertebral device is positioned in the intervertebral space (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras), and the plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) is implanted at the target position (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant). . See rationale for Claim 19 its parent claim.
Regarding Claim 23, Gillman in view of MacLennan teaches the patient-specific implant of claim 20 wherein the intervertebral device (MacLennan ¶0016, ¶0022, discloses an artificial intervertebral disc that is implanted in at least one disc space that is respectively located between at least two adjacent vertebrae in the spinal column) is configured to receive at least a portion of a load (Gillman ¶0006, ¶0009 discloses the disk implant carrying load) applied by the superior vertebra or the inferior vertebra (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras) to the patient-specific implant (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) when the intervertebral device (MacLennan ¶0016, ¶0022, discloses an artificial intervertebral disc that is implanted in at least one disc space that is respectively located between at least two adjacent vertebrae in the spinal column) is positioned in the intervertebral space (MacLennan Figure 4 discloses the device being placed between the two vertebrae). See rationale for Claim 19 its parent claim.
Regarding Claim 24, Gillman in view of MacLennan teaches the patient-specific implant of claim 23 wherein the portion of the load (Gillman ¶0006, ¶0009 discloses the disk implant carrying load) is a first portion of the load (Gillman ¶0006, ¶0009 discloses the disk implant carrying load), and wherein the intermediate projection (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras) is configured to receive at least a second portion of the load (MacLennan ¶0249 Fig 75 and 76 shows that there is an option for support along the vertebrae) when the plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) is implanted at the target position (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant), the second portion of the load (MacLennan ¶0249 Fig 75 and 76 shows that there is an option for support along the vertebrae) being at least 10% of the total load (MacLennan Fig 75 and 76 shows that there is an option for support along the vertebrae while there also still being disk support which splits the load distribution evenly). See rationale for Claim 19 its parent claim.
Regarding Claim 25, Gillman in view of MacLennan teaches the patient-specific implant of claim 19 wherein the plate is an anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate), further comprising a lateral plate (MacLennan ¶0126, Fig 67, 187 discloses a lateral extension plate) configured to mate with at least one of a first lateral surface of the superior vertebra (MacLennan Fig 31 and 33 disclose the lateral projections being attached the superior vertebra) and/or a second lateral surface of the inferior vertebra (MacLennan Fig 31 and 33 disclose the lateral projections being attached the inferior vertebra). See rationale for Claim 19 its parent claim.
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Regarding Claim 26, Gillman in view of MacLennan teaches the patient-specific implant of claim 25, further comprising a connector configured to couple the lateral plate to the anterior plate (MacLennan Fig 67 disclose the lateral extension being connected to the anterior plate via a screw) at least when the anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) is implanted at the target position (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant). See rationale for Claim 19 its parent claim.
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Regarding Claim 27, Gillman in view of MacLennan teaches the patient-specific implant of claim 19 wherein the intermediate projection (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras) includes a posterior terminus configured to contact an intervertebral disc (MacLennan Figure 67 185 discloses a connection between the disc and the plate) positioned within an intervertebral space between the superior vertebra and the inferior vertebra (Gillman Fig 6C discloses the patient specific device being place so that the intermediate portion is in between the vertebrae) when the plate is implanted at the target position (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) is implanted at the target position (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant). See rationale for Claim 19 its parent claim.
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Regarding Claim 30, Gillman in view of MacLennan teaches the patient-specific implant of claim 19 wherein the intermediate projection (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras) is configured to occupy at least 50% of the void space (Gillman Fig 9 discloses that the intermediate projection occupies more than 50% of the space) in an intervertebral space between the superior vertebra and the inferior vertebra (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras). See rationale for Claim 19, its parent claim.
Regarding Claim 31, Gillman teaches a plate (Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The first plate being attached to the vertebrae above the disc) configured to mate with a superior vertebra and an inferior vertebra (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) at a target position along a patient's spine (Gillman ¶0006 discloses an implant being deprived of two plates with a compressible disc in the middle. The first plate being attached to the vertebrae above the disc), wherein the plate includes.
Gillman does not explicitly disclose a patient-specific implant comprising:
a first projection including a first vertebral contact surface having a first patient- specific geometry contoured to mate with an anterior surface of the superior vertebra.
a second projection including a second vertebral contact surface having a second patient-specific geometry contoured to mate with an anterior surface of the inferior vertebra; and
an intermediate projection including-
a first intermediate contact surface having a third patient-specific geometry contoured to mate with at least a portion of an inferior surface of the superior vertebra, and a second intermediate contact surface having a fourth patient-specific geometry contoured to mate with at least a portion of a superior surface of the inferior vertebra;
wherein the first patient-specific geometry is different from the second, third, and/or fourth patient-specific geometry.
MacLennan is in the same field of personalized medical device implantation. Further, MacLennan teaches a patient-specific implant (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient), comprising:
a first projection including a first vertebral contact surface (MacLennan Figure 17 34 discloses a projection that goes along the spine vertebrae) having a first patient- specific geometry contoured (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient) to mate with an anterior surface of the superior vertebra (MacLennan Figure 17 34 discloses a plate that goes along the vertebrae up the spine and down the spine),
a second projection including a second vertebral contact surface (MacLennan Figure 17 34 discloses a projection that goes along the spine vertebrae in both directions) having a second patient-specific geometry contoured (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient) to mate with an anterior surface of the inferior vertebra (MacLennan Figure 17 34 discloses a plate that goes along the vertebrae up the spine and down the spine); and
an intermediate projection (MacLennan Fig 17 38 discloses intermediate projections) including-
a first intermediate contact surface having a third patient-specific geometry (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient Fig 17 discloses 38 and 34 which are different geometries) contoured to mate with at least a portion of an inferior surface of the superior vertebra (MacLennan Fig 17 38 and ¶0114 discloses a pad that is inserted in between the vertebrae), and a second intermediate contact surface having a fourth patient-specific geometry (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient Fig 17 discloses 38 and 34 which are different geometries) contoured to mate with at least a portion of a superior surface of the inferior vertebra (MacLennan Fig 17 38 and ¶0114 discloses a pad that is inserted in between the vertebrae);
wherein the first patient-specific geometry is different from the second, third, and/or fourth patient-specific geometry (MacLennan Fig 17 discloses the first geometry as 34 and the second geometry as 38 which differ in shape).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including an variety of different implants including different geometries and multiple locations of implant installation for patients that address multiple issues including the inhibition of lateral movement as taught by MacLennan, to make an invention that can adapt to many different patients and specific issues; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for a variety of devices that are intended to maintain spinal mobility within the normal range of spinal movement and to reduce the incidence of degeneration of discs at adjacent segments of the spine. (MacLennan ¶0005).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 32, Gillman in view of MacLennan teaches the patient-specific implant of claim 31 wherein, when the plate is implanted at the target position (Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The first plate being attached to the vertebrae above the disc), the plate forms a generally gapless interface (Gillman ¶0051 discloses the personalized device being flush with the vertebrae after implanting) with the anterior surface of the superior vertebra and the anterior surface of the inferior vertebra (Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant). See rationale for Claim 30 its parent claim.
Regarding Claim 33, Gillman in view of MacLennan teaches the patient-specific implant of claim 31 wherein the first projection (MacLennan Figure 17 34 discloses a projection that goes along the spine vertebrae) includes an uppermost portion having a third contact surface (MacLennan Figure 80 220 discloses an uppermost portion of an implant), wherein the third contact surface (MacLennan Figure 80 220 discloses an uppermost portion of an implant) has a fifth patient-specific geometry contoured to mate with a surface adjacent the anterior surface of the superior vertebra (MacLennan Figure 80 220 discloses the implant having an L shape that attaches to the vertebrae). See rationale for Claim 30 its parent claim.
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Regarding Claim 34, Gillman in view of MacLennan teaches the patient-specific implant of claim 33 wherein the surface adjacent the anterior surface of the superior vertebra (MacLennan Figure 80 220 discloses the implant having an L shape that attaches to the vertebrae) is a superior surface of the superior vertebra (MacLennan Figure 80 220 discloses the implant having an L shape that attaches to the vertebrae where the L goes up the superior surface of the vertebrae). See rationale for Claim 30 its parent claim.
Regarding Claim 35, Gillman in view of MacLennan teaches the patient-specific implant of claim 31 wherein the second projection (MacLennan Figure 17 34 discloses a projection that goes along the spine vertebrae in both directions) includes a lowermost portion having a third contact surface (MacLennan Figure 80 221 discloses an lower portion of an implant), wherein the third contact surface (MacLennan Figure 80 221 discloses an lower portion of an implant)has a fifth patient-specific geometry contoured to mate with a surface adjacent the anterior surface of the inferior vertebra (MacLennan Figure 80 221 discloses the implant having an L shape that attaches to the vertebrae). See rationale for Claim 30 its parent claim.
Regarding Claim 36, Gillman in view of MacLennan teaches the patient-specific implant of claim 35 wherein the surface adjacent the anterior surface of the inferior (MacLennan Figure 80 221 discloses the implant having an L shape that attaches to the vertebrae) vertebra is an inferior surface of the inferior vertebra(MacLennan Figure 80 221 discloses the implant having an L shape that attaches to the vertebrae where the L goes down the surface of the vertebrae). See rationale for Claim 30 its parent claim.
Regarding Claim 37, Gillman in view of MacLennan teaches the patient-specific implant of claim 31 wherein the plate is a first plate and the target position is a first target position (Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The first plate being attached to the vertebrae above the disc), further comprising a second plate(Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The second plate being attached to the vertebrae below the disc) configured to mate with the superior vertebra and the inferior vertebra at a target position(Gillman ¶0064 discloses that alignment member may have first and second alignment surfaces shaped to mate with respective surfaces of the inferior and superior vertebrae for correct alignment of the implant) , wherein the second plate (Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The second plate being attached to the vertebrae below the disc) includes:
a third projection including a fifth contact surface (MacLennan Figure 17 34 discloses a projection that goes along the spine vertebrae), the fifth contact surface having a fifth patient-specific geometry contoured (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient) to mate with a lateral surface of the superior vertebra(MacLennan Fig 31 and 33 disclose the lateral projections being attached the superior vertebra), and
a fourth projection having a sixth contact surface (MacLennan Figure 17 34 discloses a projection that goes along the spine vertebrae), the sixth contact surface having a sixth patient-specific geometry contoured (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient) to mate with a lateral surface of the inferior vertebra (MacLennan Fig 31 and 33 disclose the lateral projections being attached the inferior vertebra),
wherein the first plate is coupled to the second plate by one or more connectors (MacLennan ¶0038, ¶0088, discloses an interconnecting shank or brackets that connects and spans vertebrae's). See rationale for Claim 30 its parent claim.
Regarding Claim 38, Gillman in view of MacLennan teaches the patient-specific implant of claim 37 wherein the second plate (Gillman ¶0006 discloses an implant being derived of two plates with a compressible disc in the middle. The second plate being attached to the vertebrae below the disc) further includes a second intermediate projection positioned between the third projection and the fourth projection (MacLennan ¶0263 discloses that multiple plates can be repeated to immobilize multiple vertebrae), the second intermediate projection (MacLennan Fig 17 38 discloses intermediate projections) including-
a third intermediate contact surface having a seventh patient-specific geometry (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient Fig 17 discloses 38 and 34 which are different geometries) contoured to mate with at least a portion of the inferior surface of the superior vertebra (MacLennan Fig 17 38 and ¶0114 discloses a pad that is inserted in between the vertebrae), and
a fourth intermediate contact surface having an eighth patient-specific geometry contoured (MacLennan ¶0016, ¶0024, ¶0043 discloses the implant device custom made specifically for the patient Fig 17 discloses 38 and 34 which are different geometries) to mate with at least a portion of the superior surface of the inferior vertebra (MacLennan Fig 17 38 and ¶0114 discloses a pad that is inserted in between the vertebrae). See rationale for Claim 30 its parent claim.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as unpatentable over Gillman (US Patent Publication 2018/0008349 A1 hereafter referred to as Gillman) in view of Greenwald et al US 2020/0138523 A1 (US Patent Pub US 2020/0138523 A1 hereafter referred to as Greenwald).
Regarding Claim 2, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) of claim 1, further comprising:
determining a target implant location along a virtual model of the patient's spine (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant) in the corrected anatomical configuration (Gillman Fig 1 106-112 disclose the superposition over the original spine to determine the correct position for operation to correct the spine); and
of at least one of the patient-specific anterior plates (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) to seat against the target implant location (Gillman ¶0008, ¶0010, ¶0039 discloses using 3D models for proper alignment and positioning of the implant).
Gillman does not explicitly disclose constructing a virtual model.
Greenwald is in the same field of personalized medical device implantation. Further, Greenwald teaches constructing a virtual model (Greenwald ¶0011-¶0012, ¶0041, ¶0058 disclose a model of a virtual object including the plate or implant).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including virtual models of the implant as taught by Greenwald, to make an invention that can model and adjust implants before implantations based on the specific patient; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for the specification of the desired cavity that corresponds to the shape and size of the particular spinal plate to be used. (Greenwald ¶0011).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 6, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) of claim 1, further comprising:
generating a virtual model of the patient's spine in the corrected anatomical configuration (Gillman Fig 1 discloses the method of creating a virtual model using the patients data to obtain correct spine configuration);
of the patient-specific anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) of another spinal implant (Gillman ¶0006 discloses two plates).
Gillman does not explicitly disclose and in response to modifying the virtual model, dynamically adjusting a first virtual model and a second virtual model.
Greenwald is in the same field of personalized medical device implantation. Further, Greenwald teaches and in response to modifying the virtual model, dynamically adjusting a first virtual model (Greenwald ¶0011-¶0012, ¶0041, ¶0058 disclose a model of a virtual object including the plate or implant) and a second virtual model (Greenwald ¶0011-¶0012, ¶0041, ¶0058 disclose a model of a virtual object including the plate or implant).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including virtual models of the implant as taught by Greenwald, to make an invention that can model and adjust implants before implantations based on the specific patient; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for the specification of the desired cavity that corresponds to the shape and size of the particular spinal plate to be used. (Greenwald ¶0011).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Claim 3 is rejected under 35 U.S.C. 103 as unpatentable over Gillman (US Patent Publication 2018/0008349 A1 hereafter referred to as Gillman) in view of Greenwald et al US 2020/0138523 A1 (US Patent Pub US 2020/0138523 A1 hereafter referred to as Greenwald) in further view of MacLennan et al (US Patent Pub US 2021/0209757 A1 hereafter referred to as MacLennan).
Regarding Claim 3, Gillman teaches the computer-implemented method (Gillman ¶0008, ¶0042 discloses a method performed by a computer) of claim 1, further comprising:
between a first vertebra and a second vertebra (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras); and
designing the patient-specific anterior plate (Gillman ¶0006, ¶0034, and Fig 10 discloses the patient implant being comprising plates including an anterior plate) to couple to the first and second vertebrae (Gillman ¶0067-¶0069, Fig 10, and disclose the anterior plate mating with the surface of the superior or inferior vertebra) to obstruct movement of the intervertebral implant (Gillman ¶0005, ¶0053, discloses screws being used to secure the implant to the vertebrae) when the intervertebral implant is located between the first and second vertebrae (Gillman Fig 9 990 discloses an intermediate projection that mates with the endplates in between the two vertebras).
Gillman does not explicitly disclose designing a virtual model.
Greenwald is in the same field of personalized medical device implantation. Further, Greenwald teaches designing a virtual model (Greenwald ¶0011-¶0012, ¶0041, ¶0058 disclose a model of a virtual object including the plate or implant).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman by including virtual models of the implant as taught by Greenwald, to make an invention that can model and adjust implants before implantations based on the specific patient; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for the specification of the desired cavity that corresponds to the shape and size of the particular spinal plate to be used. (Greenwald ¶0011).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Gillman and Greenwald in combination do not specifically disclose of an intervertebral implant for implantation.
MacLennan is in the same field of personalized medical device implantation. Further, MacLennan teaches of an intervertebral implant for implantation (MacLennan ¶0016, ¶0022, discloses an artificial intervertebral disc that is implanted in at least one disc space that is respectively located between at least two adjacent vertebrae in the spinal column).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Gillman in view of Gillman by including an variety of different implants including different geometries and multiple locations of implant installation for patients that address multiple issues including the inhibition of lateral movement as taught by MacLennan, to make an invention that can adapt to many different patients and specific issues; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need for a variety of devices that are intended to maintain spinal mobility within the normal range of spinal movement and to reduce the incidence of degeneration of discs at adjacent segments of the spine. (MacLennan ¶0005).
Allowable Subject Matter
Claims 11-12 and 28-29 are objected to as being dependent upon a rejected base claim, but would be allowable if current 112(b) rejections are overcome and the claims are rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reference Cited
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US Patent Pub US-20200046511-A1 to Singh et al. discloses a system and method for correcting spinal deformities using pads and implants.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL LYNN ROBERTS whose telephone number is (571)272-6413. The examiner can normally be reached Monday- Friday 7:30am- 5:00pm.
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/RACHEL L ROBERTS/Examiner, Art Unit 2674
/ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674