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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 5, 2025 has been entered.
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP19305487.1, filed on April 15, 2019.
Response to Amendment
In the amendment filed on May 5, 2025, the following has occurred: claim(s) 1-2, 4, 6-7, 9, 12-13 have been amended, claim(s) 20-25 have been added, and claim(s) 11, 16-19 have been cancelled. Now, claim(s) 1-10, 12-15, 20-25 are pending.
Notice to Applicant
The Examiner has not applied 35 U.S.C. 101 rejection(s) to claims 1-10,12-15, 20-25 as the claimed limitations are primarily directed to generating and manipulating 3D images, which does not fall into one of the categories of the abstract idea.
Claim Objections
Claim 7 objected to because of the following informalities: “…3D base virtual object or homothetically adjusting adjust the size of the represented 3D virtual object” in p. 3, ll. 20. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “…3D base virtual object or homothetically adjust the size of the represented 3D virtual object”.
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 1-4, 6-10, 12-15, 20, 22-23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Forstein et al. (U.S. Patent Pre-Grant Publication No. 2020/0121391) in view of Glor et al. (U.S. Patent Pre-Grant Publication No. 2009/0162813).
As per independent claim 1, Forstein discloses a computer-based method for dynamically assisting a practitioner in preparing a dental bone grafting operation, the method comprising the steps of:
providing at least one image representing a three-dimensional (3D) volume of at least a portion of a jaw member where bone grafting is to be carried out (See Fig. 2, 4A and Paragraphs [0042]-[0047]: Bone models are obtained by generating a three-dimensional (3D) bone model from an image data set of the subject's anatomy, and the targeted region may be a mandible, which the Examiner is interpreting the 3D bone model to encompass one image representing a three-dimensional (3D) volume);
adding to the at least one image a representation of a 3D virtual object representing dental bone graft material (See Fig. 4A-4B and Paragraphs [0042]-[0047], [0049]: A graphical user interface (GUI) can be used to allow a user to manually, semi-automatically, or automatically design a custom graft, and identify a location at the harvest region to create a custom graft, which the Examiner is interpreting a custom graft to encompass a representation of a three-dimensional (3D) virtual object representing dental bone graft material);
estimating a value of at least one geometric characteristic relating to the bone graft material to be used, as a function of geometric characteristics of the represented three-dimensional (3D) virtual object (See Paragraphs [0046]-[0051]: The planning system may semi-automatically identify an optimal harvest location and based on the geometry of the custom graft designed by the user, the planning system may first identify harvest locations where there is 100% overlap between the graft geometry and the harvesting region, and the system may evaluate the bone quality at harvest locations to identify optimal harvest locations, which the Examiner is interpreting evaluate the bone quality at the harvest location to encompass estimating a value of at least one geometric characteristic relating to the bone graft material to be used), and selecting a standardized three-dimensional (3D) virtual object representing a standardized shape, standardized size, or standardized volume of exogenous bone graft material, from among a plurality of standardized 3D virtual objects representing different shapes, different sizes, or different volumes or packaging of exogenous bone graft material, as a function of a size and a shape of the represented 3D virtual object (See Paragraphs [0046]-[0047]: The initial custom graft refers to a graft design that replaces a region of bone requiring removal or to restore the function of a subject's joint or bone for the surgical procedure, the GUI includes tools such as splines, lines, and generic shapes with or without modifiable meshed surfaces to design the graft, a library of modifiable shapes resembling typical structures of a particular bone (e.g., a generic modifiable shape of a mandible, a generic modifiable shape of a vertebral body) may also be provided in the GUI, which the Examiner is interpreting a library of modifiable shapes resembling typical structures of a particular bone to encompass a standardized three-dimensional (3D) virtual object representing a standardized shape, standardized size, or standardized volume of exogenous bone graft material, from among a plurality of standardized 3D virtual objects representing different shapes, different sizes, or different volumes or packaging of exogenous bone graft material, as a function of a size and a shape of the represented 3D virtual object as the identification of a particular bone would relate to a function of a size and a shape of the represented 3D virtual object);
enabling a user to modify the representation of the three-dimensional (3D) virtual object (See Paragraphs [0046]-[0051], [0064]: The GUI includes tools such as splines, lines, and generic shapes with or without modifiable meshed surfaces to design the graft, a library of modifiable shapes resembling typical structures of a particular bone may also be provided in the GUI, which the Examiner is interpreting GUI includes tools such as splines, lines, and generic shapes with or without modifiable meshed surfaces to design the graft enabling a user to modify the representation of the 3D virtual object) upon modification of the representation of the three-dimensional (3D) virtual object, updating the estimated value of the at least one geometric characteristic, according to the modification of the representation of the three-dimensional (3D) virtual object, and repeating the selecting of the standardized 3D virtual object from among the plurality of standardized 3D virtual objects as a function of a size and shape of the modified represented 3D virtual object (See Paragraphs [0046]-[0051], [0064]: A duplicate of the model/outline of the custom graft is generated, a first model of the graft remains at the target region, while a second model of the graft is manipulated by the user to identify a harvesting location, the user may select on the GUI different potential harvesting locations and an indicator can alert the user of the percentage of overlap, and the planning system may semi-automatically identify an optimal harvest location and based on the geometry of the custom graft designed by the user, the planning system may first identify harvest locations where there is 100% overlap between the graft geometry and the harvesting region, and the system may evaluate the bone quality at harvest locations to identify optimal harvest locations, the Examiner is interpreting the duplicate (second model) to encompass upon modification of the representation of the three-dimensional (3D) virtual object and a method of Forstein allows for the user to determine how the graft will interact with a target region and the method is repeated until the user creates a mock graft that achieves a desired goal to encompass repeating the selecting of the standardized 3D virtual object from among the plurality of standardized 3D virtual objects as a function of a size and shape of the modified represented 3D virtual object ([0049]).)
While Forstein teaches the method as described above, Forstein may not explicitly teach providing at least one image representing a three-dimensional (3D) volume of at least a portion of a jaw member where bone grafting is to be carried out.
Glor teaches a method for providing at least one image representing a three-dimensional (3D) volume of at least a portion of a jaw member where bone grafting is to be carried out (See Paragraphs Fig. 7-8 and [0017], [0080]: The means of generating 3D models of parts of the jaw may be characterized in that image objects corresponding to natural or artificial teeth in the jaw are detected.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Forstein to include providing at least one image representing a three-dimensional (3D) volume of at least a portion of a jaw member where bone grafting is to be carried out as taught by Glor, Forstein discloses utilizing 3D models and that the target region may be a mandible, however Glor identifies the jaw as the focus of the 3D model. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forstein with Glor with the motivation of improve surgical planning (See Technical Background of Glor in Paragraph [0004]).
Claim(s) 14-15 mirrors claim 1 only within different statutory category/categories, and is rejected for the same reason as claim 1. Claim 14 recites the additional limitations of "a computer program product for a programmable apparatus, the computer program product comprising instructions for carrying out each step" which is encompassed by Forstein in Paragraphs [0045] and [0068] that discloses a pre-operative planning software program having a GUI, which the Examiner is interpreting the pre-operative planning software program to encompass a computer program product for a programmable apparatus. Claim 15 recites the additional limitations of "the device comprising a microprocessor configured for carrying out each of the steps" which is encompassed by Forstein in Paragraphs [0068]-[0070] that discloses a planning computer including a processor, a device computer including a processor, a tracking computer including a processor, and peripheral devices.
As per claim 2, Forstein/Glor discloses the method of claim 1 as described above. Forstein further teaches wherein the method further comprises a step of enabling a user to select a type of grafting from amongst a plurality of types of grafting (See Paragraphs [0025], [0045]-[0047]: The system and method is especially advantageous for complex cases requiring the replacement of missing bones, filling gaps in a bone, or bridging of two or more bone fragments together, the user designs the initial custom graft by determining at least one of a size, type, geometry and position for the graft, which the Examiner is interpreting the determination of a type for the graft to encompass selecting a type of grafting from amongst a plurality of types of grafting as the grafting may be for the replacement of missing bones, filling gaps in a bone, or bridging of two or more bone fragments together, and the GUI includes widgets and other tools which allow a user to manually, semi-automatically, or automatically design a custom graft, which the Examiner is interpreting the GUI includes widgets and other tools which allow a user to manually, semi-automatically, or automatically design a custom graft to encompass a step of enabling a user), and determining the at least one geometric characteristic, the at least one geometric characteristic being determined as a function of the selected type of grafting (See Paragraphs [0046], [0051]: The planning system can semi-automatically identify an optimal harvest location, based on the geometry of the custom graft designed by the user, the planning system may first identify harvest locations where there is a 100% overlap between the graft geometry and the harvesting region, which the Examiner is interpreting the graft geometry to encompass the geometric characteristic and the harvesting region to encompass a type of grafting.)
As per claim 3, Forstein/Glor discloses the method of claims 1-2 as described above. Forstein further teaches wherein the value of the at least one geometric characteristic is further estimated as a function of the selected type of grafting (See Paragraphs [0046], [0051]: The planning system can semi-automatically identify an optimal harvest location, based on the geometry of the custom graft designed by the user, the planning system may first identify harvest locations where there is a 100% overlap between the graft geometry and the harvesting region, which the Examiner is interpreting the degree of overlap to encompass the value of the at least one geometric characteristic is further estimated.)
As per claim 4, Forstein/Glor discloses the method of claim 1 as described above. Forstein further teaches wherein the method further comprises a step of selecting at least one three-dimensional (3D) base virtual object among a plurality of 3D base virtual objects, the plurality of 3D base virtual objects comprising 3D base virtual objects of different sizes and/or of different shapes, with the represented 3D virtual object comprising the at least one selected 3D base virtual object (See Paragraphs [0046] [0051]: The GUI includes tools such as splines, lines, and generic shapes with or without modifiable meshed surfaces to design the graft, a library of modifiable shapes resembling typical structures of a particular bone may also be provided in the GUI, which the Examiner is interpreting a library of modifiable shapes resembling typical structures of a particular bone may also be provided in the GUI to encompass a plurality of 3D base virtual objects.)
Claim(s) 20 and 23 mirror claim 4 only within different statutory categories, and is rejected for the same reason as claim 4.
As per claim 6, Forstein/Glor discloses the method of claims 1 and 4 as described above. Forstein further teaches wherein the method further comprises a step of selecting multiple 3D base virtual objects to form a set of 3D base virtual objects, the represented 3D virtual object resulting from the combination of the multiple 3D base virtual objects of the set of 3D base virtual objects (See Paragraphs [0045]-[0047]: The user designs the initial custom graft by determining at least one of a size, type, geometry, and position for the graft, and the GUI includes tools such as splines, lines, and generic shapes, and boundary tools, which include planes, spheres, prisms, or other shapes having control points to adjust their shapes to define the boundaries, which the Examiner is interpreting that the presence of multiple generic shapes that can be selected to design the custom graft to encompass multiple 3D base virtual objects to form a set of 3D base virtual objects as the custom graft is made from the generic shapes.)
Claim(s) 22 and 25 mirror claim 6 only within different statutory categories, and is rejected for the same reason as claim 6.
As per claim 7, Forstein/Glor discloses the method of claims 1 and 4 as described above. Forstein further teaches wherein the method further comprises a step of enabling a user to homothetically adjust the size of at least one of the at least one selected 3D base virtual object or homothetically adjust the size of the represented 3D virtual object (See Paragraphs [0045]-[0047]: The user designs the initial custom graft by determining at least one of a size, type, geometry, and position for the graft, and the GUI includes tools such as splines, lines, and generic shapes, and boundary tools, which include planes, spheres, prisms, or other shapes having control points to adjust their shapes to define the boundaries, which the Examiner is interpreting boundary tools, which include planes, spheres, prisms, or other shapes having control points to adjust their shapes to define the boundaries to encompass homothetically adjust the size of the represented 3D virtual object.)
As per claim 8, Forstein/Glor discloses the method of claim 1 as described above.
Forstein further teaches wherein the geometric characteristics of the represented 3D virtual object comprise at least one of a shape, a volume, and a size (See Paragraphs [0045]-[0047]: The user designs the initial custom graft by determining at least one of a size, type, geometry, and position for the graft, and the GUI includes tools such as splines, lines, and generic shapes, and boundary tools, which include planes, spheres, prisms, or other shapes having control points to adjust their shapes to define the boundaries.)
As per claim 9, Forstein/Glor discloses the method of claim 1 as described above. Forstein further teaches wherein the representation of the 3D virtual object comprises a plurality of points located on an external surface of the represented 3D virtual object, and wherein the method further comprises a step of enabling a user to modify the representation of the 3D virtual object by selecting one point of the plurality of points and moving the selected point, deformation of the represented 3D virtual object accordingly (See Paragraphs [0045]-[0047]: The user designs the initial custom graft by determining at least one of a size, type, geometry, and position for the graft, and the GUI includes tools such as splines, lines, and generic shapes, and boundary tools, which include planes, spheres, prisms, or other shapes having control points to adjust their shapes to define the boundaries, which the Examiner is interpreting the control points to adjust their shapes to encompass modify the representation of the 3D virtual object by selecting one point of the plurality of points and moving the selected point, deformation of the represented 3D virtual object accordingly.)
As per claim 10, Forstein/Glor discloses the method of claims 1 and 10 as described above. Forstein may not explicitly teach wherein the selected point is selected in a two dimensional (2D) image representing a cross section of the 3D volume.
Glor teaches a method wherein the selected point is selected in a two dimensional (2D) image representing a cross section of the 3D volume (See Paragraphs [0081]-[0085]: The 3D model of the jaw can be sliced into a number of 2D slice images, which the Examiner is interpreting to encompass the claimed portion when combined with Forstein's disclosure of control points to adjust the shapes.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Forstein to include the selected point is selected in a two-dimensional (2D) image representing a cross section of the 3D volume as taught by Glor. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forstein with Glor with the motivation of improve surgical planning (See Technical Background of Glor in Paragraph [0004]).
As per claim 12, Forstein/Glor discloses the method of claim 1 as described above. Forstein further teaches wherein the method further comprises a step of receiving a standardized shape, standardized size, or standardized volume of exogeneous bone graft material corresponding to the selected standardized 3D virtual object and milling the provided bone graft material according to the represented 3D virtual object (See Paragraphs [0046], [0065]-[0075]: The target region and/or harvest region is registered, the robot then either mills the custom graft from the harvest region at the identified optimal location, or prepares the target region to receive the custom graft, which the Examiner is interpreting the custom graft to encompass a standardized shape, standardized size, or standardized volume of exogeneous bone graft material as the custom graft is based on a library of modifiable shapes resembling typical structures of a particular bone (a library of modifiable shapes resembling typical structures of a particular bone (e.g., a generic modifiable shape of a mandible, a generic modifiable shape of a vertebral body) may also be provided in the GUI in [0046]).)
As per claim 13, Forstein/Glor discloses the method of claim 1 as described above. Forstein further teaches wherein the method further comprises a step of generating a three-dimensional (3D) model of the represented 3D virtual object (See Paragraph [0069]: The planning computer contains hardware, software, data, and utilities that are dedicated to the design of the custom graft and planning of a surgical procedure either pre-operatively or intra-operatively, this may include reading medical imaging data, segmenting imaging data, constructing three-dimensional (3D) virtual models), the generated 3D model making it possible three-dimensional (3D) printing of a corresponding standardized volume of exogeneous bone graft material or to perform milling of a standardized shape or standardized size of exogenous bone graft material according to the represented 3D virtual object (See Paragraphs [0069] and [0075]: The target region and/or harvest region is registered, the robot then either mills the custom graft from the harvest region at the identified optimal location, or prepares the target region to receive the custom graft, which the Examiner is interpreting to encompass the generated 3D model making it possible three-dimensional (3D) printing of a corresponding standardized volume of exogeneous bone graft material or to perform milling of a standardized shape or standardized size of exogenous bone graft material according to the represented 3D virtual object.)
Claim 5, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Forstein et al. (U.S. Patent Pre-Grant Publication No. 2020/0121391) in view of Glor et al. (U.S. Patent Pre-Grant Publication No. 2009/0162813) in further view of Bhattacharyya et al. (U.S. Patent Pre-Grant Publication No. 2018/0303616).
As per claim 5, Forstein/Glor discloses the method of claim 1 as described above.
Forstein/Glor may not explicitly teach wherein the at least one selected three-dimensional (3D) base virtual object has a shape of an olive, a parallelepiped, a cone, or a combination thereof.
Bhattacharyya teaches a method wherein the at least one selected three-dimensional (3D) base virtual object has a shape of an olive, a parallelepiped, a cone, or a combination thereof (See Paragraphs [0051], [0170], [0265]: A variety of 3D models of the bone graft can be generated that will fit within the bone defect, the computer will generate a virtual 3D model of the bone graft including a virtual depth, thickness and volume of the bone graft that can fit within the bone defect, and the computer will create a variety of shapes and sizes of the bone graft that will fit within the bone defect and the user can select the desired shape, which the Examiner is interpreting create a variety of shapes and sizes of the bone graft that will fit within the bone defect to encompass a shape of an olive, a parallelepiped, a cone, or a combination thereof, and a 3-D digital model to encompass the at least one selected three-dimensional (3D) base virtual object.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Forstein/Glor to include the at least one selected three-dimensional (3D) base virtual object has a shape of an olive, a parallelepiped, a cone, or a combination thereof as taught by Bhattacharyya. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forstein/Glor with Bhattacharyya with the motivation of producing custom-made bone grafts (See Background of Bhattacharyya in Paragraph [0009]).
Claim(s) 21 and 24 mirrors claim 5 only within different statutory categories, and are rejected for the same reason as claim 5.
Response to Arguments
In the Remarks filed on May 5, 2025, the Applicant argues that the newly amended and/or added claims overcome the 35 U.S.C. 103 rejection(s). The Examiner does not acknowledge that the newly added and/or amended claims overcome the 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) the Office purports to be "interpreting modifiable shapes resembling typical structures of a particular bone to encompass a plurality of standardized 3D virtual objects as a function of a size and a shape of the 3D virtual object," the cited support discloses only "modifiable shapes resembling typical structures of a particular bone (e.g., a generic modifiable shape of a mandible, a generic modifiable shape of a vertebral body)," such that Forstein provides no disclosure or suggestion of, e.g., plural generic shapes resembling the structure of a particular bone, nor that selection amongst such plural shapes is based upon the size and shape of the [represented] 3D virtual object or a portion thereof. Rather, Forstein only expressly discloses that a single shape such as "a generic modifiable shape of a mandible" is pre selected and subsequently modified in a broad manner (e.g., "the GUI may include boundary tools to simply define boundaries 307 on the model 302... ," Forstein '391, para. 0046) to design the initial custom graft 306. That is not enough, and the Office may not use the guise of "interpretation" to supply missing the elements. When considering the disclosures of the prior art, the Office cannot resort to speculation and chance: "[t]he inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness," In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995), and "[t]he fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic." MPEP § 2112(IV) (citing In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993)). Moreover, in making a rejection under§ 103, the Office is required to provide specific reasoning explaining "why every limitation in [the rejected claim] would have been obvious to a person of ordinary skill in the art." See Ex parte Wada and Murphy, Appeal No. 2007-3733, slip op. at p. 8 (BPAI, January 14, 2008) (citing In re Lowry, 32 F.3d 1579, 1582 (Fed. Cir. 1994)), where "[o]bviousness requires a suggestion of all limitations in a claim," CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (emphasis added). The Office has not shown such any such express or inherent disclosure and suggestion here. The Office does not identify any express or inherent teaching that selection of one of Forstein's "library of modifiable shapes" is based upon an extant "initial custom graft" object or other represented 3D virtual object, rather than being selected to "design the graft" ab initio as expressly stated in the cited material, so as to be within the recited claim limitation. Furthermore, the Office does not identify any express or inherent disclosure that, after modification of one of Forstein's "library of modifiable shapes," the Forstein or Forstein-Glor system(s) would repeat the "selecting of a standardized three-dimensional virtual object... upon modification of the representation of the three-dimensional (3D) virtual object," nor any appropriate rationale for the Forstein system to do so. If the Office's assertion is to be taken literally, a selection of a standardized three-dimensional (3D) virtual object (such as a generic mandible that) is followed by modification for the design the initial custom graft 306 would result in repeated selection of another standardized three-dimensional (3D) virtual object (such as another generic mandible), undoing the modification of and design of that initial custom graft 306. The Office's finding is facially illogical, or at best incomplete and unexplained. Again, that is not enough, and the Office must explain why suck a repeated selection would be made. Still furthermore, the Office response that "[t]he process as disclosed in Forstein for designing a custom graft begins with determining at least one of a size, type, geometry, and position for the graft..." where "[t]he modifiable shapes of Forstein relies on the identification of the target region's size, type, geometry, or position." Office Action at pp. 20-21. This argument admits that, contrary to the Office's findings, the selection of a standardized 3D virtual object is not based upon an extant "initial custom graft" object or other represented 3D virtual object, but rather a different, inchoate user requirement or different, provided element of the at least one image, not the "added... representation of a three-dimensional (3D) virtual objected representing dental bone graft material" recited and required by the claim. The Forstein disclosure does not provide such functionality or even suggest such composite construction, and instead attempts to identify and select harvest locations based upon a 100% match to the overall 3D object size and shape of graft geometry. Office Action at pp. 56 and 7-8, citing Forstein para. 0051. Additionally, the Glor disclosure does not appear to remedy this deficiency. Accordingly, the claim is not anticipated by or obvious over the asserted art. To advance prosecution, claim 1 has been further amended consistent with the above cited disclosure. Specifically, claim 1 has been amended to (1) incorporate the limitations of claim 11, (2) recite that the standardized three-dimensional (3D) virtual object represents a standardized shape, standardized size, or standardized volume of exogenous bone graft material, (3) clarify that the first-recited selection is as a function of a size and a shape of the represented 3D virtual object added in the adding step, and (4) clarify that the second-recited selection is as a function of a size and a shape of the modified represented 3D virtual object. Forstein, being directed to the creation of a custom graft 306 harvested from a single region with 100% overlap between the graft geometry and harvesting region, see Forstein '391, para. 0051, does not explicitly or inherently disclose, nor plausibly suggest, the recited features. Accordingly, claim 1 is not anticipated by or obvious over the asserted art;
(2) claim 2 has been amended to specify that the computer-based method includes "enabling a user to select a type of grafting." Support for the amendment may be found in paragraph 0057 of the specification as filed. Claims 4 and 6 have been amended to reference "the represented 3D virtual object comprising" and to improve clarity. Claims 7 and 9 has been amended to specify that the computer-based method includes "enabling a user to homothetically adjust the size" of a 3D base virtual object and modify the representation of the 3D virtual object QY. selecting and moving a point to deform it, respectively. Support for the amendments may be found in paragraphs 0073-74 of the specification as filed. respect to claim 12, the Office alleges that "Forstein further teaches wherein the method further comprises a step of providing bone graft material corresponding to the selected standardized three-dimensional (3D) virtual object and milling the provided bone graft material according to the three-dimensional (3D) virtual object (See Paragraphs [0069] and [0075]... )." Office Action at p. 12. The rejection is respectfully traversed. In addition to the reasons provide above with respect to amended claim 1, the cited support discloses only a harvest of "the [custom] graft (306, 306')," Forstein '391 para. 0069, and even more specifically, as quoted in the rejection, "the robot then either mills the custom graft [(306, 306')] from the harvest region [... ] at the identified optimal location, or prepares the target region [304] to receive the custom graft [(306, 306')]... " Office Action at p. 12, paraphrasing Forstein '391 para. 0075. Such a custom 3D virtual object does not correspond to any of the "generic shapes" or "modifiable shapes resembling typical structures" cited in the Office's rejections, Office Action at p. 11, and is admitted by the reference itself to be "custom," not "standardized." The Office does not substantively respond, arguing only that "the combination of Forstein/Glor encompasses dependent claim 12." Claim 12 has been amended to recite "receiving a standardized shape, standardized size, or standardized volume of exogenous bone graft material corresponding to the selected standardized 3D virtual object and milling the provided bone graft material according to the represented 3D virtual object. Claim 13 has likewise been amended to recite "three dimensional (3D) printing of a corresponding standardized volume of exogenous bone graft material or to perform milling of a standardized shape or standardized size of exogenous bone graft mate. Support for the amendment may be found in paragraphs 0032-33 and 0070 of the specification as filed. Again, the Forstein disclosure does not even suggest such composite construction, and the Glor disclosure does not appear to remedy this deficiency. Accordingly, the claims are not anticipated by or obvious over the asserted art;
(3) claims 2-4 and 6-10 depend, directly or indirectly, from base claim 1. "If an independent claim is nonobvious under 35 U.S.C. 103, then any claim depending therefrom is nonobvious." MPEP § 2143.03 (citing In re Fine, 837 F.2d 1071 (Fed. Cir. 1988)). Thus, in view of the arguments presented above, the rejections of those dependent claims should be withdrawn. Claims 14 and 15 are hybrid independent claims which depend from claim 1. Thus, for the reasons presented in connection with claim 1 and pursuant to In re Fine, the rejections of those claims should be withdrawn;
(4) the rejection with respect to claim 5 is respectfully traversed. The cited material is utterly silent as to whether "a variety of 3-D models of the bone graft" creating "a variety of shapes of the bone graft" will include any particular shape, much less the creation of the shape of "an olive, a parallelepiped, a cone, or a combination thereof' as recited in the claim. See Bhattacharyya '616, para. 0265. Moreover, such models and 3-D printed shapes are not "the [user-]selected 3D base virtual object" as required by pending claim 5, and the Office simply uses the mention of "a variety of shapes" to perform a hindsight reconstruction of a feature that it has implicitly admitted is absent in Forstein/Glor combination and distinct from the custom graft design process cited in its rejections of the parent claims. Otherwise, and again, when considering the disclosures of the prior art, the Office may not resort to speculation and chance: "[t]he inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness," In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995), and "[t]he fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic." MPEP § 2112(1V) (citing In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993)). Moreover, in making a rejection under§ 103, the Office is required to provide specific reasoning explaining "why every limitation in [the rejected claim] would have been obvious to a person of ordinary skill in the art." See Ex parte Wada and Murphy, Appeal No. 2007-3733, slip op. at p. 8 (BPAI, January 14, 2008) (citing In re Lowry, 32 F.3d 1579, 1582 (Fed. Cir. 1994)), where "[o]bviousness requires a suggestion of all limitations in a claim," CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (emphasis added). The Office has not shown then requisite express or inherent disclosure and suggestion here. The Bhattacharyya reference in no way discloses, and the person of ordinary art would not believe, that Bhattacharyya expressly, implicitly, or otherwise discloses the required geometric shapes and suggests their use in creating a representation of a three-dimensional (3) virtual object such as a dental graft. Accordingly, the rejection is deficient and should be withdrawn; and
(5) dependent claims 20-22 and 23-25 replicate dependent claims 5-7 under claims 14 and 15, respectively. Support for claims 20-22 and 23-35 may be found in paragraphs 0025-27, 0072, 0074 of the specification as filed.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Forstein’s disclosure in Paragraph [0046] that the initial custom graft refers to a graft design that replaces a region of bone requiring removal or to restore the function of a subject's joint or bone for the surgical procedure, the GUI includes tools such as splines, lines, and generic shapes with or without modifiable meshed surfaces to design the graft, a library of modifiable shapes resembling typical structures of a particular bone (e.g., a generic modifiable shape of a mandible, a generic modifiable shape of a vertebral body) may also be provided in the GUI, which the Examiner is interpreting a library of modifiable shapes resembling typical structures of a particular bone to encompass a standardized three-dimensional (3D) virtual object representing a standardized shape, standardized size, or standardized volume of exogenous bone graft material, from among a plurality of standardized 3D virtual objects representing different shapes, different sizes, or different volumes or packaging of exogenous bone graft material, as a function of a size and a shape of the represented 3D virtual object as the identification of a particular bone would relate to a function of a size and a shape of the represented 3D virtual object. The Examiner maintains that Forstein’s disclosure in Paragraph [0046] of “In another embodiment, geometric data about the bone model 306 may be extracted to aid in the initial graft design. The topology of the bone model may be extracted to define the natural contours and curvature of the native bone. The contours and curvatures may define at least a portion of the graft shape to match the actual bone topology. The extracted topology data may also originate from the lateral side of the subject and mirrored to create a graft resembling the natural structure of the native bone. In a further embodiment, the GUI may include boundary tools to simply define boundaries 307 on the model 302 to create design the custom graft 306. The boundary tools may include planes, spheres, prisms, or other shapes having control points to adjust their shapes to define the boundaries 307. In one embodiment, the boundary tool may be used to virtually cut out a custom graft 306, where all the voxels inside the boundaries are removed from the surrounding voxels. It should be appreciated that the tools for defining a desired shape (i.e., splines, lines and shapes), the generic models, the geometry extraction tools, and boundary tools may all be available to the user in the GUI.” and in Paragraph [0047]: “In a particular inventive embodiment, as depicted in FIG. 4A, the initial graft 306 may include a body 308 having one or more sides 310 with no joint features. The sides 310 of the body 308 are non-planar and have a curved profile to better match the native anatomy. A graft having this curved profile is nearly impossible to create using conventional planar shaped tools without any post-processing techniques common to allograft manufacture, which would otherwise increase the operating room time when autograft harvesting.” The Examiner maintains that Forstein’s disclosure of an “initial graft” to encompass “initial custom graft”. The Examiner maintains that Forstein’s disclosure in Paragraphs [0046]-[0051], [0064] that a duplicate of the model/outline of the custom graft is generated, a first model of the graft remains at the target region, while a second model of the graft is manipulated by the user to identify a harvesting location, the user may select on the GUI different potential harvesting locations and an indicator can alert the user of the percentage of overlap, and the planning system may semi-automatically identify an optimal harvest location and based on the geometry of the custom graft designed by the user, the planning system may first identify harvest locations where there is 100% overlap between the graft geometry and the harvesting region, and the system may evaluate the bone quality at harvest locations to identify optimal harvest locations, the Examiner is interpreting the duplicate (second model) to encompass upon modification of the representation of the three-dimensional (3D) virtual object and a method of Forstein allows for the user to determine how the graft will interact with a target region and the method is repeated until the user creates a mock graft that achieves a desired goal to encompass repeating the selecting of the standardized 3D virtual object from among the plurality of standardized 3D virtual objects as a function of a size and shape of the modified represented 3D virtual object. Further, the Examiner maintains that the disclosure in Paragraph [0064] of “For complex surgical procedures, such as Dega or Salter osteotomies for pelvic correction, the physical models are used to practice, tune, and/or design mock custom grafts. The mock custom grafts may be physically manipulated by the user to determine how the graft will interact with a target region. The method is repeated until the user creates a mock graft that achieves a desired goal (e.g., structural integrity, limb alignment, or the complete replacement of a region). In a particular inventive embodiment, the user creates the mock grafts by manipulating a cutting instrument attached to a robotic arm.” and “For clarity, the initial custom graft 306 refers to a graft design that replaces a region of bone requiring removal or to restore the function of a subject's joint or bone for the surgical procedure. In a particular inventive embodiment, the GUI includes tools such as splines, lines, and generic shapes with or without modifiable meshed surfaces to design the graft 306. A library of modifiable shapes resembling typical structures of a particular bone (e.g., a generic modifiable shape of a mandible, a generic modifiable shape of a vertebral body) may also be provided in the GUI.” which the Examiner is interpreting the generic shapes to encompass a standardized three-dimensional virtual object. The Examiner maintains that the repeating of the method (Paragraph [0064]) would manipulate the mock graft until the mock graft achieves the desired goal, the desired goals being, for example, structural integrity, limb alignment, or the complete replacement of a region, which the Examiner is interpreting the repeating of the mock graft to encompass selecting a standardized virtual object based upon an “initial custom graft”. The Examiner maintains that the combination of Forstein/Glor encompasses the newly amended claimed portions as described above. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the newly amended claims 2, 4, 6-7, 9, 12 are encompassed by the combination of Forstein/Glor. The Examiner maintains that the custom graft to encompass a standardized shape, standardized size, or standardized volume of exogeneous bone graft material as the custom graft is based on a library of modifiable shapes resembling typical structures of a particular bone (a library of modifiable shapes resembling typical structures of a particular bone (e.g., a generic modifiable shape of a mandible, a generic modifiable shape of a vertebral body) may also be provided in the GUI in [0046].) The Examiner maintains that the combination of Flor/Gorstein encompasses the newly amended claim 13 as Forstein teaches in Paragraphs [0069] and [0075]: The target region and/or harvest region is registered, the robot then either mills the custom graft from the harvest region at the identified optimal location, or prepares the target region to receive the custom graft, which the Examiner is interpreting to encompass the generated 3D model making it possible three-dimensional (3D) printing of a corresponding standardized volume of exogeneous bone graft material or to perform milling of a standardized shape or standardized size of exogenous bone graft material according to the represented 3D virtual object. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner has rejected claims 2-4 and 6-10 individually and due to the dependent claims dependency on independent claim 1. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (4), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Bhattacharyya to encompass claim 5 as the “Osteoimplant is used herein in its broadest sense and is not intended to be limited to any particular shapes, sizes, configurations, compositions, or applications.” ([0051]), which the Examiner maintains that the recitation of the osteoimplant is not limited to any particular shape or size to encompass “an olive, a parallelepiped, a cone, or a combination thereof”. Further, Bhattacharyya discloses that a user is able to generate a 3-D digital model to be created with the 3-D printing machine, which the Examiner is interpreting a 3-D digital model to encompass “the [user-]selected 3D base virtual object”. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (5), the Examiner does not find the Applicant’s argument(s) persuasive. Dependent claims 20-22 and 23-25 have been rejected as described above in the 35 U.S.C. 103 rejection(s). The 35 U.S.C. 103 rejection(s) stand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Salah et al. (U.S. Patent Pre-Grant Publication No. 2021/0366119), describes a method of enrichment of a reference model to be enriched representing a dental arch of a patient.
Sachdeva et al. (U.S. Patent Pre-Grant Publication No. 2014/0329194), describes planning orthodontic treatment for a patient, including surgery, using biological constraints such as those arising from bone, soft tissue, and roots of patient's teeth.
Tappa ("Three-Dimensional Printing and Nanotechnology for Enhanced Implantable Materials"), describes the use of customized biopolymer filaments and 3D printing technology to treat bone diseases such as osteomyelitis, osteosarcoma, and osteoporosis, the study showed that 3D printing technology can be used to fabricate bioactive biopolymers for personalized medicine and localized drug delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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