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 .
Claims 1-14 and 21-26 are pending.
Claims 15-20 are cancelled.
Claim Objections
Claim 24 is objected to because of the following informalities: Claim 24 recites “configured to abut the patient's”, it does not have any meaning. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14 and 21-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mottram et al. USPGPUB 2019/0015238 (hereinafter “Mottram”).
As to claim 1, Mottram teaches a method comprising: obtaining scan data of a patient's head (paragraph 0102 “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. The scanning process may be aided by attaching reference point location markers to the head” and paragraph 0028, FIG. 13); using computer assisted design to generate a print file of a cranial remodeling orthosis (CRO) based on the scan data (paragraph 0104 “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 paragraph 0034-0035, FIG. 13); and performing additive manufacturing by a 3D printer to produce the CRO using the print file of the CRO (paragraph 0105-0106 “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” and FIG. 13).
As to claim 2, Mottram teaches wherein the CRO comprises an outer shell configured to receive a patient interfacing insert (paragraph 0009-0014 and 0107, FIG. 1 and 7), wherein at least one of the outer shell or the patient interfacing insert are manufactured by the 3D printer (paragraph 0105-0108 and FIG. 13).
As to claim 3, Mottram teaches wherein using the computer assisted design further comprises designing a print file of the patient interfacing insert based on the scan data (paragraph 0102-0105 and 0034), and the method further comprises performing additive manufacturing by the 3D printer to produce the patient interfacing insert of the CRO using the print file of the patient interfacing insert (paragraph 0104-0105 and Fig. 13).
As to claim 4, Mottram teaches wherein the patient interfacing insert is offset from the outer shell (paragraph 0080-081 and 0016, FIG. 17).
As to claim 5, Mottram teaches wherein using the computer assisted design to generate the print file comprises modifying a position, thickness, and trim area of the print file such that the CRO produced using the print file is configured to provide therapy to reshape the patient's head over time (paragraph 0027-0029, 0080 and 0104).
As to claim 6, Mottram teaches wherein using the computer assisted design to generate the print file includes drawing lines and shapes onto the scan data of the patient's head and generating the print file based on the lines and shapes (paragraph 0102-0104).
As to claim 7, Mottram teaches wherein the CRO has the form of a helmet configured to be worn on the patient's head (paragraph 0070 and FIG. 1).
As to claim 8, Mottram teaches a method comprising: obtaining scan data of a patient's head from a scan device (paragraph 0102-0103 “an MRI scan, a CT scan, a plurality of 2D or 3D images, or manual measurements can be used to establish the 3D model”); using computer assisted design to generate a print file of a cranial remodeling orthosis (CRO) based on the scan data (paragraph 0104 “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 paragraph 0034-0035, FIG. 13 and 0034-0035); and perform additive manufacturing by a 3D printer to produce the CRO using the print file of the CRO (paragraph 0105-0106 “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” and FIG. 13), wherein the CRO comprises an outer shell configured to receive a patient interfacing insert, wherein at least one of the outer shell or the patient interfacing insert are manufactured by the 3D printer (paragraph 0105-0108 “mesh layer 30 of the orthosis 10 is formed based on the model, using a 3D printer or other suitable additive manufacturing means” and FIG. 13).
As to claim 9, Mottram teaches wherein using the computer assisted design further comprises designing a print file of the patient interfacing insert based on the scan data (paragraph 0102-0105 and 0034), and the method includes performing processing circuitry is further configured to perform additive manufacturing by the 3D printer to produce the patient interfacing insert of the CRO using the print file of the patient interfacing insert (paragraph 0104-0105 and Fig. 13).
As to claim 10, Mottram teaches wherein the patient interfacing insert is offset from the outer shell (paragraph 0080-081 and 0016, FIG. 17).
As to claim 11, Mottram teaches wherein using the computer assisted design to generate the print file comprises modifying a position, thickness, and trim area of the print file such that the CRO produced using the print file is configured to provide therapy to reshape the patient's head over time (paragraph 0027-0029, 0080 and 0104).
As to claim 12, Mottram teaches wherein using the computer assisted design to generate the print file includes drawing lines and shapes onto the scan data of the patient's head and generating the print file based on the lines and shapes (paragraph 0102-0104).
As to claim 13, Mottram teaches wherein the CRO has the form of a helmet configured to be worn on the patient's head (paragraph 0070 and FIG. 1).
As to claim 14, Mottram teaches wherein the patient interfacing insert is configured to abut the patient's head in a plurality of locations (paragraph 0027-0028).
15-20. (Canceled)
As to claim 21, Mottram teaches a method of manufacturing a cranial remodeling orthosis (CRO), the method comprising: scanning geometry of a patient's head by a scan device to generate scan data (paragraph 0102 “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. The scanning process may be aided by attaching reference point location markers to the head” and paragraph 0028, FIG. 13); generating a print file of the CRO based on the scan data (paragraph 0104 “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 paragraph 0034-0035, FIG. 13); additively manufacturing the CRO, by providing a plurality of material layers with a 3D printer, using the print file (paragraph 00730-0074 “outer layer 20 is manufactured from a stable semi rigid plastic material. In the example shown, the outer layer 20 comprises a single layer. However, in further examples, the outer layer 20 may comprise multiple layers, for example two layers”).
As to claim 22, Mottram teaches additively manufacturing the CRO comprises providing the plurality of material layers with the 3D printer in the form of a helmet configured to be worn on the patient's head (paragraph 0070-0072 and FIG. 1).
As to claim 23, Mottram teaches wherein additively manufacturing the CRO comprises additively manufacturing both an outer shell and a patient interfacing insert (paragraph 0105-0108, 0009-0014 and FIG. 1, 7 and 13).
As to claim 24, Mottram teaches wherein the patient interfacing insert is configured to abut the patient's head in a plurality of locations (paragraph 0027-0028).
As to claim 25, Mottram teaches wherein the patient interfacing insert is offset from the outer shell (paragraph 0080-081 and 0016, FIG. 17).
As to claim 26, Mottram teaches comprising drawing lines and shapes onto the scan data of the patient's head and generating the print file based on the lines and shapes (paragraph 0102-0105).
It is noted that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
Conclusion
The prior art made of record and listed on the attached PTO Form 892 but not relied upon is considered pertinent to applicant's disclosure.
Gilmer et al USPGPUB 2016/0287425 teaches a method are presented. Various embodiments of the disclosed apparatus include a plurality of layers configured and oriented to be deployed on a subject in a manner that disperses forces and lowers peak pressures experienced by the subject when resting on a surface, which tends to minimize risks of deformation and local ischemia. An innovative combination of novel construction methods, material selections, and sensors produce an apparatus that possesses an inherent three-dimensional shape despite being built from essentially flat components, while also retaining an ability to effectively distribute forces and reduce pressures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZIAUL KARIM whose telephone number is (571)270-3279. The examiner can normally be reached on Monday-Thursday 8:00-4:00 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mohammad Ali can be reached on 571 272 4105. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZIAUL KARIM/Primary Examiner, Art Unit 2119
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