DETAILED ACTION
Notice of 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
This application discloses and claims only subject matter disclosed in prior Application No. 16/925,700, filed 7/10/2020 and prior Application No. 15/474,684, filed 03/30/2017, and names the inventor or at least one joint inventor named in the prior applications. Accordingly, this application may constitute a continuation or divisional. Should applicant desire to claim the benefit of the filing date of the prior applications, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Information Disclosure Statement
The five information disclosure statements (IDS) submitted on 8/18/2023 have been considered by the examiner.
Abstract
Abstract is objected to because of the following informality:
On Page 1, Line 9, the term “surface The contour lines establish peripheral” should be changed to “surface. The contour lines establish peripheral”, insert period to conclude sentence, in order to correct typographical/grammar issues.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 12 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3 and 7-8 of Patent No. US 10846925 B2.
Although the claims of this Application No. 18/234,649 and the claims at issue of Patent No. US 10846925 B2 are not identical, they are not patentably distinct from each other because the instant application and the conflicting Patent No. US 10846925 B2 are claiming common subject matter, as follows:
This Application No. 18/234,649
Patent No. US 10846925 B2
Claim 1: A method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising:
generating a three-dimensional head data file for said shape;
processing said modified head shape data file to generate a device data file for said custom cranial remodeling orthosis, said device data file defining a cranial remodeling orthosis having an interior surface and an outer surface;
identifying predetermined reference points on said head shape represented by data in said three-dimensional head data file in said standardized orientation;
processing said three-dimensional head data file in said standardized orientation to generate a modified head shape data file;
orienting said three-dimensional head data file into a standardized orientation;
and utilizing said predetermined reference points to establish inner and outer surface peripheral edges on said cranial remodeling orthosis.
(Lines 1-13)
Claim 1: A method for fabricating a custom cranial remodeling device (wherein the cranial remodeling device is the cranial remodeling orthosis.) for correction of cranial deformities in a subject's head, said method comprising:
generating a three-dimensional head data file for a shape of said head;
utilizing (wherein utilizing is processing/operating) said modified head shape data file to generate a device shape for a said custom cranial remodeling device (wherein the cranial remodeling device is the cranial remodeling orthosis.), said device shape having an interior surface to contact said head and an outer surface;
identifying predetermined reference points on said head shape represented by data in said three-dimensional head data file;
automatically generating a modified head shape data file for said head;
(Col. 16, Lines 58-67)- (Col. 17, Lines 1-20)
Claim 1/6: comprising:
modifying said three-dimensional data file by automatically orienting said three-dimensional head data file to a predetermined plane by first automatically identifying two predetermined physical points on said head shape as represented by data in said three-dimensional head data file and utilizing said two predetermined points to form a horizontal plane to which said head shape is rotated to produce a standardized oriented head data file.
(Col. 17, Lines 36-45)
Claim 1/8: comprising: generating a three-dimensional device data file comprising said custom cranial remodeling device (wherein the cranial remodeling device is the cranial remodeling orthosis.) shape with said corresponding inner and outer surface peripheral edges.
(Col. 17, Lines 51-55)
Claim 1/7: comprising:
determining predetermined reference points on said head shape data in said three-dimensional head data file;
and automatically utilizing said predetermined reference points to calculate said contour lines.
(Col. 17, Lines 46-50)
The further limitations of the dependent claims are similar as indicated below:
This Application No. 18/234,649
Patent No. US 10846925 B2
Claim 6: comprising:
juxtaposing said device shape data file with said three-dimensional head data file.
(Lines 27-28)
Claim 7: comprising:
utilizing said predetermined reference points to determine contour lines on said head in said three-dimensional head data file;
juxtaposing said device shape data file with said three-dimensional head data file in standardized orientation;
and utilizing said contour lines to determine said peripheral edges on said cranial remodeling orthosis in said device data file.
(Lines 29-35)
Claim 8: comprising:
projecting said contour lines to said outer surface of said cranial remodeling orthosis to determine said peripheral edges in said device data file.
(Lines 36-38)
Claim 9: wherein:
said device data file comprises peripheral edges for said inner and outer surfaces.
(Lines 39-40).
Claim 10: comprising:
providing said device data file to an additive manufacturing device to manufacture said cranial remodeling orthosis.
(Lines 41-43)
Claim 1: said method comprising:
juxtaposing said modified head shape represented by said modified head shape data file with said head represented by said three-dimensional head data file having said one or more contour lines thereon;
(Col. 16, Lines 58-67)- (Col. 17, Lines 1-20)
Claim 1: said method comprising:
processing said predetermined reference points to automatically calculate one or more contour lines on said head shape represented by said three-dimensional head data file, said contour lines defining peripheral edges of said custom cranial remodeling device;
automatically generating a modified head shape data file for said head;
juxtaposing said modified head shape represented by said modified head shape data file with said head represented by said three-dimensional head data file having said one or more contour lines thereon; (Col. 16, Lines 58-67)- (Col. 17, Lines 1-20)
Claim 1: said method comprising:
projecting lines outward from said one or more contour lines;
and utilizing said projected lines to establish corresponding inner and outer surface peripheral edges on said device shape for said custom cranial remodeling device to provide customized inner and outer surfaces for said custom cranial remodeling device.
(Col. 16, Lines 58-67)- (Col. 17, Lines 1-20)
Claim 2: comprising:
generating a three-dimensional device data file comprising said device shape of said custom cranial modeling device comprising said inner and outer surface peripheral edges.
(Col. 17, Lines 21-25)
Claim 3: comprising:
providing said three-dimensional device data file to an additive manufacturing device.
(Col. 17, Lines 26-28)
Claims 6-10 contain the same limitations as Patent No. US 10846925 B2 claims 1-3 respectively. Therefore, given that claims 6-10 depend from claim 1, respectively and claims 2-3 of Patent No. US 10846925 B2 depend from claim 1, respectively. Claims 6-10 are rejected for the same reasons set forth in the rejection of the independent claim 1 above.
Claim 4, is rejected on the ground of non-statutory double patenting as being unpatentable over claim 1, of Patent No. US 10846925 B2 in view of POMATTO et al. (US 6340353 B1).
Regarding claim 4, Patent No. US 10846925 B2 claim 1 teaches the custom cranial remodeling device of claim 1, Patent No. US 10846925 B2 claim 1 fails to explicitly teach wherein said predetermined reference points comprise anthropometric points.
However, POMATTO explicitly teaches wherein said predetermined reference points comprise anthropometric points (Figs. 1-4C, Col. 4, Lines [23-37]-POMATTO discloses prior to scanning the patient's head, patient specific data is entered into the computer. The patient specific data includes identification information and also includes anthropomorphic information specific relative to the patient. For example, the patient's age, weight, height, sex, race and other characterizing features are entered and stored in the patient's data file. Computer 130 also contains a data base stored in memory 132 which contains anthropomorphic data such as age, sex, race, height, weight and similar information which is of significance in determining an appropriate desired head shape. The computer also includes expert system software which will utilize the anthropomorphic data in conjunction with the patient specific data and the scan data to design an appropriate orthosis device.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of the Patent No. US 10846925 B2 claim 1 of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape; orienting said three-dimensional head data file into a standardized orientation; processing said three-dimensional head data file in said standardized orientation to generate a modified head shape data file, with the teachings of POMATTO of having wherein said predetermined reference points comprise anthropometric points.
Wherein having Patent No. US 10846925 B2 claim 1 having a custom cranial remodeling device, wherein said predetermined reference points comprise anthropometric points.
The motivation behind the modification would have been to obtain a custom cranial remodeling device system that is accurately manufactured and easily manufactured.
Claims 2-3, 5, and 12, are rejected on the ground of non-statutory double patenting as being unpatentable over claim 1, of Patent No. US 10846925 B2 in view of PIETRZAK et al. (US 20140201889 A1).
Regarding claims 2 and 12, Patent No. US 10846925 B2 claim 1 teaches the custom cranial remodeling device of claim 1, Patent No. US 10846925 B2 claim 1 fails to explicitly teach wherein operating on said three-dimensional head data file to remove extraneous information from said three-dimensional head data file.
However, PIETRZAK explicitly teaches wherein operating on said three-dimensional head data file to remove extraneous information from said three-dimensional head data file (Figs. 4A-7C, Paragraph [0078]-PIETRZAK discloses customization of base unit 86 for the formation of custom-fitted helmet 81 can be by an additive or subtractive process. In fact, helmet base unit helmet 86 may, in particular customizable embodiments, be initially formed as a block of protective material that is entirely trimmed down to form the customized helmet shape and design that conforms to customer head 30 according to 3D headform 66. Thus, helmet base unit 86 can be initially formed as a non-descript block base unit or as a helmet-shaped base unit that includes material inside and outside of the final customized helmet, which will be customized through removing excess material from the helmet base unit. Please also read Paragraphs [0054] and [0097].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of the Patent No. US 10846925 B2 claim 1 of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape; orienting said three-dimensional head data file into a standardized orientation; processing said three-dimensional head data file in said standardized orientation to generate a modified head shape data file, with the teachings of PIETRZAK of having wherein operating on said three-dimensional head data file to remove extraneous information from said three-dimensional head data file.
Wherein having Patent No. US 10846925 B2 claim 1 having a custom cranial remodeling device, wherein operating on said three-dimensional head data file to remove extraneous information from said three-dimensional head data file.
The motivation behind the modification would have been to obtain a custom cranial remodeling device system that is accurately manufactured and easily manufactured.
Regarding claim 3, Patent No. US 10846925 B2 claim 1 teaches the custom cranial remodeling device of claim 1, Patent No. US 10846925 B2 claim 1 fails to explicitly teach wherein operating on said three-dimensional head data file to remove information from said three-dimensional head date file, said information comprising one or more of extraneous information and said subject's body.
However, PIETRZAK explicitly teaches wherein operating on said three-dimensional head data file to remove information from said three-dimensional head date file (Figs. 4A-7C, Paragraph [0078]-PIETRZAK discloses customization of base unit 86 for the formation of custom-fitted helmet 81 can be by an additive or subtractive process. In fact, helmet base unit helmet 86 may, in particular customizable embodiments, be initially formed as a block of protective material that is entirely trimmed down to form the customized helmet shape and design that conforms to customer head 30 according to 3D headform 66. Thus, helmet base unit 86 can be initially formed as a non-descript block base unit or as a helmet-shaped base unit that includes material inside and outside of the final customized helmet, which will be customized through removing excess material from the helmet base unit. Please also read Paragraphs [0054] and [0097].), said information comprising one or more of extraneous information and said subject's body (Figs. 4A-7C and 10A-10B, Paragraph [0097]-PIETRZAK discloses FIGS. 10A and 10B show additional exemplary embodiments of custom-fitted helmets 81, in which portions of the helmets other than just a top inner portion near a crown of user head 30 is customized. For example, by gathering data relating to placement and shape of one or more of a brow, nose, ears, eyes, mouth, cheek, chin, or neck of customer 20, and by knowing how the particular helmet will be used, other customizations may be made. For example, other helmet components that may contact the face or head 30 of customer 20 can be adjusted to comprise a surface or topography that matches a shape, size, or contour, of any feature of customer 20. Please also read Paragraphs [0054] and [0097].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of the Patent No. US 10846925 B2 claim 1 of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape; orienting said three-dimensional head data file into a standardized orientation; processing said three-dimensional head data file in said standardized orientation to generate a modified head shape data file, with the teachings of PIETRZAK of having wherein operating on said three-dimensional head data file to remove information from said three-dimensional head date file, said information comprising one or more of extraneous information and said subject's body.
Wherein having Patent No. US 10846925 B2 claim 1 having a custom cranial remodeling device, wherein operating on said three-dimensional head data file to remove information from said three-dimensional head date file, said information comprising one or more of extraneous information and said subject's body.
The motivation behind the modification would have been to obtain a custom cranial remodeling device system that is accurately manufactured and easily manufactured.
Regarding claim 5, Patent No. US 10846925 B2 claim 1 teaches the custom cranial remodeling device of claim 1, Patent No. US 10846925 B2 claim 1 fails to explicitly teach wherein generating one or more curvature maps of said subject's head; utilizing said curvature maps to determine a position of one or more contour lines for determining said peripheral edges.
However, PIETRZAK explicitly teaches generating one or more curvature maps of said subject's head (Figs. 2A-2C, Paragraph [0037]-PIETRZAK discloses therefore, reference lines 36, 38, and 40 form an exemplary reference pattern 28 that can show a shape, contour, or topography of customer head 30, and can be used in collecting data for the customer head, including length, width, and at least one contour of the customer head.); utilizing said curvature maps to determine a position of one or more contour lines for determining said peripheral edges (Figs. 2A-2C, Paragraph [0037]-PIETRZAK discloses for example, vertical line 40 a can follow and delineate a contour of customer head 30 along a peak or ridge of the customer head along its length. Similarly, vertical reference line 40 b can follow and delineate a contour of customer head 30 along a peak or ridge of the customer head along its width. Additionally, a plurality of other contour lines can also be captured by any number of different reference patterns 20.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of the Patent No. US 10846925 B2 claim 1 of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape; orienting said three-dimensional head data file into a standardized orientation; processing said three-dimensional head data file in said standardized orientation to generate a modified head shape data file, with the teachings of PIETRZAK of having generating one or more curvature maps of said subject's head; utilizing said curvature maps to determine a position of one or more contour lines for determining said peripheral edges.
Wherein having Patent No. US 10846925 B2 claim 1 having a custom cranial remodeling device, wherein generating one or more curvature maps of said subject's head; utilizing said curvature maps to determine a position of one or more contour lines for determining said peripheral edges.
The motivation behind the modification would have been to obtain a custom cranial remodeling device system that is accurately manufactured and easily manufactured.
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 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 of this title, 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.
Claims 1-3, 5, and 9-12, are rejected under 35 U.S.C. 103 as being unpatentable over MOTTRAM et al. (US 20190015238 A1), hereinafter referenced as MOTTRAM in view of PIETRZAK et al. (US 20140201889 A1).
Regarding claim 1, MOTTRAM teaches a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head (Figs. 1A-4 and 13, Paragraph [0026]-MOTTRAM discloses according to a second aspect of the invention there is provided a method of manufacturing an orthosis for correcting head deformities comprising forming a mesh layer, wherein regions of varying stiffness in the mesh layer are adapted to apply varying pressure to a wearer's head, so as to restrict undesirable growth and allow desired growth to correct the deformities.), said method comprising:
generating a three-dimensional head data file for said shape (Figs. 1A-4 and 13, Paragraph [0027]-MOTTRAM discloses preferably, the method comprises forming the mesh layer based on a virtual 3D model. Preferably, the virtual 3D model is based on measurements of the wearer's head, preferably established by means of a 3D scan. Further in Paragraph [0102]-MOTTRAM discloses firstly, in step S1, the head of the wearer is measured to establish a virtual 3D model of the head. In one example, a 3D scan is taken of the infant's head, and a 3D point cloud is established that represents the shape of the wearer's head in 3D space. Please also read Paragraph [0005].);
orienting said three-dimensional head data file into a standardized orientation (Figs. 1A-4 and 13, Paragraph [0102]-MOTTRAM discloses the scanning process may be aided by attaching reference point location markers to the head. In one example, a sock is placed over the head, with stick-on location markers affixed thereto. Further in Paragraph [0104]-MOTTRAM discloses in some examples, the model is modified by the application of predefined routines or protocols that provide a commonly required modification to the model. In some examples, the user compares the model to a library of suitable shapes—i.e. standard shapes for correcting particular deformities, and modifies the model with reference to a suitable library shape. In some examples, the user makes freehand modifications to the model, based on their assessment of the shape of the deformities and the required shape of the orthosis.);
processing said three-dimensional head data file in said standardized orientation to generate a modified head shape data file (Figs. 1A-4 and 13, Paragraph [0104]-MOTTRAM discloses Secondly, in step S2, the 3D model of the head is modified to so that the shape includes regions where growth is allowed or growth is restricted. This is typically done in suitable computer-aided design software, by a suitably trained user with the knowledge to assess what shape will correct the deformity. In some examples, the model is modified by the application of predefined routines or protocols that provide a commonly required modification to the model. In some examples, the user compares the model to a library of suitable shapes—i.e. standard shapes for correcting particular deformities, and modifies the model with reference to a suitable library shape. In some examples, the user makes freehand modifications to the model, based on their assessment of the shape of the deformities and the required shape of the orthosis);
processing said modified head shape data file to generate a device data file for said custom cranial remodeling orthosis (Figs. 1A-4 and 13, Paragraph [0104]-MOTTRAM discloses Secondly, in step S2, the 3D model of the head is modified to so that the shape includes regions where growth is allowed or growth is restricted. This is typically done in suitable computer-aided design software, by a suitably trained user with the knowledge to assess what shape will correct the deformity. In some examples, the model is modified by the application of predefined routines or protocols that provide a commonly required modification to the model. In some examples, the user compares the model to a library of suitable shapes—i.e. standard shapes for correcting particular deformities, and modifies the model with reference to a suitable library shape. In some examples, the user makes freehand modifications to the model, based on their assessment of the shape of the deformities and the required shape of the orthosis. Further in Paragraph [0105]-MOTTRAM discloses thirdly, in step S3, the mesh layer 30 of the orthosis 10 is formed based on the model, using a 3D printer or other suitable additive manufacturing means. In one example, the 3D printer makes use of a material that is suitable for prolonged contact with the skin of the wearer without irritation. Accordingly, a mesh layer 30 suitable for the particular needs of an individual wearer can be easily manufactured.), said device data file defining a cranial remodeling orthosis having an interior surface and an outer surface (Figs. 1A-4, 7 and 13, Paragraph [0104]-MOTTRAM discloses secondly, in step S2, the 3D model of the head is modified to so that the shape includes regions where growth is allowed or growth is restricted. This is typically done in suitable computer-aided design software, by a suitably trained user with the knowledge to assess what shape will correct the deformity. In some examples, the model is modified by the application of predefined routines or protocols that provide a commonly required modification to the model. In some examples, the user compares the model to a library of suitable shapes—i.e. standard shapes for correcting particular deformities, and modifies the model with reference to a suitable library shape. In some examples, the user makes freehand modifications to the model, based on their assessment of the shape of the deformities and the required shape of the orthosis. Further in Paragraph [0106]-MOTTRAM discloses in one example, the outer layer 20 is formed separately, and the mesh layer 30 is then subsequently affixed within the outer layer 20. In one example, the outer layer 20 is also formed using a 3D printer or other suitable additive manufacturing means. This allows the dimensions of the outer layer 20 to be easily customised based on the head shape of the user. In a further example, the outer layer 20 is formed using injection moulding or plastic thermoforming. This allows for cost-effective production of the outer layer 20 in one or more standard sizes, with only the mesh layer 30 being specifically adapted for the wearer's head. (wherein the outer layer is the outer surface and the mesh layer is the inner surface). Please also read Paragraph [0105].);
identifying predetermined reference points on said head shape represented by data in said three-dimensional head data file in said standardized orientation (Figs. 1A-4 and 13, Paragraph [0102]-MOTTRAM discloses the scanning process may be aided by attaching reference point location markers to the head. In one example, a sock is placed over the head, with stick-on location markers affixed thereto. Further in Paragraph [0103]-MOTTRAM discloses in other examples, an MRI scan, a CT scan, a plurality of 2D or 3D images, or manual measurements can be used to establish the 3D model. Further in Paragraph [0104]-MOTTRAM discloses secondly, in step S2, the 3D model of the head is modified to so that the shape includes regions where growth is allowed or growth is restricted.);
MOTTRAM fails to explicitly teach and utilizing said predetermined reference points to establish inner and outer surface peripheral edges on said cranial remodeling orthosis.
However, PIETRZAK explicitly teaches and utilizing said predetermined reference points to establish inner and outer surface peripheral edges on said cranial remodeling orthosis (Figs. 1-4C, Paragraph [0041]-PIETRZAK discloses as shown in FIG. 3A, a width (W) of customer head 30 can be measured by taking a distance from opposing outer edges of customer head 30 in the coronal plane. As shown in FIG. 3B, a length (L) of customer head 30 can be measured by taking a distance from opposing outer edges of customer head 30 in the sagittal plane. Thus, a length L and width W of customer head 30, as well as a general shape of customer head 30, can be obtained by imaging customer head 30. Additionally, contours of customer head 30 can also be obtained. Exemplary contours can include a first contour 54 that includes a crest or ridgeline along a peripheral edge of customer head 30 as seen in FIG. 3A or a second contour 56 that includes a crest or ridgeline along a peripheral edge of customer head 30 as seen in FIG. 3B. Further in Paragraph [0052]-PIETRZAK discloses as shown in FIG. 5A, 3D headform 66 of customer 20 can be automatically or graphically compared to helmet safety standard 71, including minimum dimensions DM, to determine suitable sizing and dimensions for custom-fitted helmet 81. Based on 3D headform 66 and minimum dimensions DM, custom-fitted helmet 81 can be formed comprising a custom inner surface 82 b comprising a topography that conforms to the length, width, and at least one contour of customer head 30. Please also read Paragraphs [0038]-[0039] and [0054].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of MOTTRAM of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape;
orienting said three-dimensional head data file into a standardized orientation, with the teachings of PIETRZAK of having and utilizing said predetermined reference points to establish inner and outer surface peripheral edges on said cranial remodeling orthosis.
Wherein having MOTTRAM’s cranial remodeling system of and utilizing said predetermined reference points to establish inner and outer surface peripheral edges on said cranial remodeling orthosis.
The motivation behind the modification would have been to obtain a cranial remodeling system that provides a cost effective, efficacious and hygienic orthosis for correcting head deformities, and an efficient and cost effective method of manufacturing the same, since both MOTTRAM and PIETRZAK are systems that relate to custom cranial fabrication. Wherein MOTTRAM’s custom cranial fabrication system effectively provides resistance in regions where growth is to be restrained and flexibility in regions where growth is to be permitted, while PIETRZAK’s system provides improvements in fit, airflow, and comfort also achieved without reducing safety for particular customers and customer head shapes. Please see MOTTRAM (US 20190015238 A1), Paragraphs [0007, 0020, 0087, and 0127] and PIETRZAK et al. (US 20140201889 A1), Paragraph [0003].
Regarding claim 2, MOTTRAM in view of PIETRZAK teaches the method of claim 1, MOTTRAM fails to explicitly teach comprising: operating on said three-dimensional head data file to remove extraneous information from said three-dimensional head data file.
However, PIETRZAK explicitly teaches comprising: operating on said three-dimensional head data file to remove extraneous information from said three-dimensional head data file (Figs. 4A-7C, Paragraph [0078]-PIETRZAK discloses customization of base unit 86 for the formation of custom-fitted helmet 81 can be by an additive or subtractive process. In fact, helmet base unit helmet 86 may, in particular customizable embodiments, be initially formed as a block of protective material that is entirely trimmed down to form the customized helmet shape and design that conforms to customer head 30 according to 3D headform 66. Thus, helmet base unit 86 can be initially formed as a non-descript block base unit or as a helmet-shaped base unit that includes material inside and outside of the final customized helmet, which will be customized through removing excess material from the helmet base unit. Please also read Paragraphs [0054] and [0097].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of MOTTRAM in view of PIETRZAK of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape; orienting said three-dimensional head data file into a standardized orientation, with the teachings of PIETRZAK of having comprising: operating on said three-dimensional head data file to remove extraneous information from said three-dimensional head data file.
Wherein having MOTTRAM’s cranial remodeling system of comprising: operating on said three-dimensional head data file to remove extraneous information from said three-dimensional head data file.
The motivation behind the modification would have been to obtain a cranial remodeling system that provides a cost effective, efficacious and hygienic orthosis for correcting head deformities, and an efficient and cost effective method of manufacturing the same, since both MOTTRAM and PIETRZAK are systems that relate to custom cranial fabrication. Wherein MOTTRAM’s custom cranial fabrication system effectively provides resistance in regions where growth is to be restrained and flexibility in regions where growth is to be permitted, while PIETRZAK’s system provides improvements in fit, airflow, and comfort also achieved without reducing safety for particular customers and customer head shapes. Please see MOTTRAM (US 20190015238 A1), Paragraphs [0007, 0020, 0087, and 0127] and PIETRZAK et al. (US 20140201889 A1), Paragraph [0003].
Regarding claim 3, MOTTRAM in view of PIETRZAK teaches the method of claim 1, MOTTRAM fails to explicitly teach comprising: operating on said three-dimensional head data file to remove information from said three-dimensional head date file, said information comprising one or more of extraneous information and said subject's body.
However, PIETRZAK explicitly teaches comprising: operating on said three-dimensional head data file to remove information from said three-dimensional head date file (Figs. 4A-7C, Paragraph [0078]-PIETRZAK discloses customization of base unit 86 for the formation of custom-fitted helmet 81 can be by an additive or subtractive process. In fact, helmet base unit helmet 86 may, in particular customizable embodiments, be initially formed as a block of protective material that is entirely trimmed down to form the customized helmet shape and design that conforms to customer head 30 according to 3D headform 66. Thus, helmet base unit 86 can be initially formed as a non-descript block base unit or as a helmet-shaped base unit that includes material inside and outside of the final customized helmet, which will be customized through removing excess material from the helmet base unit. Please also read Paragraphs [0054] and [0097].), said information comprising one or more of extraneous information and said subject's body (Figs. 4A-7C and 10A-10B, Paragraph [0097]-PIETRZAK discloses FIGS. 10A and 10B show additional exemplary embodiments of custom-fitted helmets 81, in which portions of the helmets other than just a top inner portion near a crown of user head 30 is customized. For example, by gathering data relating to placement and shape of one or more of a brow, nose, ears, eyes, mouth, cheek, chin, or neck of customer 20, and by knowing how the particular helmet will be used, other customizations may be made. For example, other helmet components that may contact the face or head 30 of customer 20 can be adjusted to comprise a surface or topography that matches a shape, size, or contour, of any feature of customer 20. Please also read Paragraphs [0054] and [0097].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of MOTTRAM in view of PIETRZAK of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape; orienting said three-dimensional head data file into a standardized orientation, with the teachings of PIETRZAK of having comprising: operating on said three-dimensional head data file to remove information from said three-dimensional head date file, said information comprising one or more of extraneous information and said subject's body.
Wherein having MOTTRAM’s cranial remodeling system of comprising: operating on said three-dimensional head data file to remove information from said three-dimensional head date file, said information comprising one or more of extraneous information and said subject's body.
The motivation behind the modification would have been to obtain a cranial remodeling system that provides a cost effective, efficacious and hygienic orthosis for correcting head deformities, and an efficient and cost effective method of manufacturing the same, since both MOTTRAM and PIETRZAK are systems that relate to custom cranial fabrication. Wherein MOTTRAM’s custom cranial fabrication system effectively provides resistance in regions where growth is to be restrained and flexibility in regions where growth is to be permitted, while PIETRZAK’s system provides improvements in fit, airflow, and comfort also achieved without reducing safety for particular customers and customer head shapes. Please see MOTTRAM (US 20190015238 A1), Paragraphs [0007, 0020, 0087, and 0127] and PIETRZAK et al. (US 20140201889 A1), Paragraph [0003].
Regarding claim 5, MOTTRAM in view of PIETRZAK teaches the method of claim 1, MOTTRAM fails to explicitly teach comprising: generating one or more curvature maps of said subject's head; utilizing said curvature maps to determine a position of one or more contour lines for determining said peripheral edges.
However, PIETRZAK explicitly teaches comprising: generating one or more curvature maps of said subject's head (Figs. 2A-2C, Paragraph [0037]-PIETRZAK discloses therefore, reference lines 36, 38, and 40 form an exemplary reference pattern 28 that can show a shape, contour, or topography of customer head 30, and can be used in collecting data for the customer head, including length, width, and at least one contour of the customer head.); utilizing said curvature maps to determine a position of one or more contour lines for determining said peripheral edges (Figs. 2A-2C, Paragraph [0037]-PIETRZAK discloses for example, vertical line 40 a can follow and delineate a contour of customer head 30 along a peak or ridge of the customer head along its length. Similarly, vertical reference line 40 b can follow and delineate a contour of customer head 30 along a peak or ridge of the customer head along its width. Additionally, a plurality of other contour lines can also be captured by any number of different reference patterns 20.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of MOTTRAM in view of PIETRZAK of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape; orienting said three-dimensional head data file into a standardized orientation, with the teachings of PIETRZAK of having comprising: generating one or more curvature maps of said subject's head; utilizing said curvature maps to determine a position of one or more contour lines for determining said peripheral edges.
Wherein having MOTTRAM’s cranial remodeling system of comprising: generating one or more curvature maps of said subject's head; utilizing said curvature maps to determine a position of one or more contour lines for determining said peripheral edges.
The motivation behind the modification would have been to obtain a cranial remodeling system that provides a cost effective, efficacious and hygienic orthosis for correcting head deformities, and an efficient and cost effective method of manufacturing the same, since both MOTTRAM and PIETRZAK are systems that relate to custom cranial fabrication. Wherein MOTTRAM’s custom cranial fabrication system effectively provides resistance in regions where growth is to be restrained and flexibility in regions where growth is to be permitted, while PIETRZAK’s system provides improvements in fit, airflow, and comfort also achieved without reducing safety for particular customers and customer head shapes. Please see MOTTRAM (US 20190015238 A1), Paragraphs [0007, 0020, 0087, and 0127] and PIETRZAK et al. (US 20140201889 A1), Paragraph [0003].
Regarding claim 9, MOTTRAM in view of PIETRZAK teaches the method of claim 1, MOTTRAM fails to explicitly teach wherein: said device data file comprises peripheral edges for said inner and outer surfaces.
However, PIETRZAK explicitly teaches wherein: said device data file comprises peripheral edges for said inner and outer surfaces (Figs. 1-4C, Paragraph [0041]-PIETRZAK discloses as shown in FIG. 3A, a width (W) of customer head 30 can be measured by taking a distance from opposing outer edges of customer head 30 in the coronal plane. As shown in FIG. 3B, a length (L) of customer head 30 can be measured by taking a distance from opposing outer edges of customer head 30 in the sagittal plane. Thus, a length L and width W of customer head 30, as well as a general shape of customer head 30, can be obtained by imaging customer head 30. Additionally, contours of customer head 30 can also be obtained. Exemplary contours can include a first contour 54 that includes a crest or ridgeline along a peripheral edge of customer head 30 as seen in FIG. 3A or a second contour 56 that includes a crest or ridgeline along a peripheral edge of customer head 30 as seen in FIG. 3B. Please also read Paragraph [0054].).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings of MOTTRAM in view of PIETRZAK of having a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities of the shape of a subject's head, said method comprising: generating a three-dimensional head data file for said shape; orienting said three-dimensional head data file into a standardized orientation, with the teachings of PIETRZAK of having wherein: said device data file comprises peripheral edges for said inner and outer surfaces.
Wherein having MOTTRAM’s cranial remodeling system of wherein: said device data file comprises peripheral edges for said inner and outer surfaces.
The motivation behind the modification would have been to obtain a cranial remodeling system that provides a cost effective, efficacious and hygienic orthosis for correcting head deformities, and an efficient and cost effective method of manufacturing the same, since both MOTTRAM and PIETRZAK are systems that relate to custom cranial fabrication. Wherein MOTTRAM’s custom cranial fabrication system effectively provides resistance in regions where growth is to be restrained and flexibility in regions where growth is to be permitted, while PIETRZAK’s system provides improvements in fit, airflow, and comfort also achieved without reducing safety for particular customers and customer head shapes. Please see MOTTRAM (US 20190015238 A1), Paragraphs [0007, 0020, 0087, and 0127] and PIETRZAK et al. (US 20140201889 A1), Paragraph [0003].
Regarding claim 10, MOTTRAM in view of PIETRZAK teaches the method of claim 1, MOTTRAM further teaches comprising: providing said device data file to an additive manufacturing device to manufacture said cranial remodeling orthosis (Figs. 1A-4 and 13, Paragraph [0028]-MOTTRAM discloses preferably, the mesh layer is formed using an additive manufacturing means, preferably a 3D printer. Preferably, the mesh layer is formed using a material that is suitable for prolonged contact with the skin of the wearer without irritation. Accordingly, a mesh layer suitable for the particular needs of an individual wearer can be easily manufactured. Further in Paragraph [0029]-MOTTRAM discloses Preferably, the method comprises inserting the mesh layer into an outer layer. Preferably, the outer layer is formed using the additive manufacturing means, preferably the 3D printer. This allows the dimensions of the outer layer to be easily customised based on the head shape of the wearer. Alternatively, the outer layer is formed by injection moulding or plastic thermoforming. Preferably, the mesh layer and the outer layer are secured together by one or more of hook and loop fastener material, click lock attachments or pin and hole type fastenings. This enables cost-effective production of the outer layer in one or more standard sizes, with only the mesh layer being specifically adapted for the wearer's head. Alternatively, the method comprises forming the outer layer and the mesh layer concurrently, preferably in a nested arrangement, preferably using the additive manufacturing means.).
Regarding claim 11, MOTTRAM teaches a method for fabricating a custom cranial remodeling orthosis for correction of cranial deformities in the shape of a subject's head (Figs. 1A-4 and 13, Paragraph [0026]-MOTTRAM discloses according to a second aspect of the invention there is provided a method of manufacturing an orthosis for correcting head deformities comprising forming a mesh layer, wherein regions of varying stiffness in the mesh layer are adapted to apply varying pressure to a wearer's head, so as to restrict undesirable growth and allow desired growth to correct the deformities.), said method comprising:
generating a three-dimensional head data file for said subject's head shape (Figs. 1A-4 and 13, Paragraph [0027]-MOTTRAM discloses preferably, the method comprises forming the mesh layer based on a virtual 3D model. Preferably, the virtual 3D model is based on measurements o