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 .
Status of Claims and Application
This final action on the merits is in response to the remarks and amendment received by the office on 03 June 2026. Claims 1, 4-20 are pending. Claims 1, 4-20 are amended. No claims are added. Claims 2 and 3 are cancelled.
Priority
Examiner acknowledges the office’s receipt on 03 June 2026 of a corrected Application Data Sheet correcting the priority claim deficiencies noted in the office action mailed 06 April 2026. Applicant has not complied with all of the requirements of 37 CFR 1.78(e). Applicant is required to petition the office in order to make a delayed claim of priority. The petition must include (1) the reference required by 35 USC 120 and 37 CFR 1.78(d)(2) (unless previously submitted), (2) the petition fee set forth 37 CFR 1.17(m), and a statement that the entire delay between the date the benefit claim was due under 37 CFR 1.78(d)(3) and the date the benefit claim was filed was unintentional. The Director may require additional information where there is a question whether the delay was unintentional.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/180,180, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. While supporting the additive manufacture of cranial orthotics from device files generally, the 17/180,180 application does not disclose at least the following:
Concurrent manufacture of custom orthotics for a plurality of subjects.
A partitioned device file the partitions corresponding to portions of the orthotic claimed.
Processing the data files into nested data files
Assembling orthotics from additively manufactured components
Concurrent manufacture of components of a cranial orthotic
Including manufacturing or subject data on the components of the cranial orthotics
Integrally formed connecting portions
Partitioning the device data files into anterior/posterior or superior/inferior portions
Accordingly, the effective filing date of the claimed invention for claims 1-20 will be the filing date of the instant application, 09/29/2024.
Response to Amendment
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.
Claim(s) 1, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 8,305,376 to Ran et al. (‘376 hereafter) in view of, U.S. Patent Application Publication 2016/0279879 to Zheng et al. (‘879 hereafter), and U.S. Patent Application Publication 2018/0286118 to Littlefield et al. (‘118 hereafter).
Regarding claim 1, ‘376 teaches a method of manufacture of custom devices comprising: a method of manufacture of a plurality of devices for a corresponding plurality of subjects, each device customized said method comprising: generating a plurality of digital device data files (Fig. 2 item 108), each digital data file of said plurality of digital data files comprising a shape (Fig. 2 ‘Bracket’) providing a processor to receive each digital device file of said plurality of digital device data files (Fig. 6 item 602, C9L7-C9L25); utilizing said processor to partition each said digital device data file into a corresponding plurality of digital device portion data files, each digital device portion data file corresponding to a device portion of said shape of a device (Fig. 2 items ‘bracket’ and nested subcomponents of same), each said digital device portion data file of said plurality of digital device portion data files selected to facilitate arranging a nested data array of said plurality of digital device portion data files (Fig. 2). ‘376 does not teach processing digital device portion files into a nested data array, additive manufacturing the pieces or assembly of the pieces into custom cranial orthotics.
In the related art of additive manufacturing ‘879 teaches processing each of said plurality of digital device portion data files to select and position said plurality of corresponding device data files into a nested digital data array corresponding to a nested device portions array comprising each said device portion of each said device of said plurality of devices, said nested digital data array configured to be utilizable by additive manufacture apparatus for concurrent manufacture of said nested portions array (Fig. 1 items 101 to 104); providing said nested digital data array to additive manufacture apparatus (Fig 1 item 105); utilizing said additive manufacture apparatus to process said nested digital data array to concurrently manufacture all of said device portions of said nested device portions array (Fig 1 item 105) and assembling said device portions from said manufactured into said plurality of paragraphs 0007-0008 devices for the benefit of maximizing the utilization of a 3D printer with a definite build volume. It would have been obvious to combine the teachings of ‘376 with those of ‘879 for the benefit of efficiently designing and additively manufacturing devices. ‘376 in view of ‘879 does not teach the production of custom cranial orthotics.
In the related art of design and additive manufacturing of custom cranial orthotics, ‘118 teaches that it is known to manufacture custom cranial orthotics from data files specifying them (ABSTRACT) for the benefit of providing individualized medical care to patients with mal-formed craniums. It would have been obvious to the ordinary artisan at the time of effective filing to combine the teachings of ‘376 in view of ‘879 with those of ‘118 for the benefit of providing individualized medical treatment to patients.
Regarding claim 17, ‘376 teaches that component parts may be organized in their relation to each other (Fig 2 items 202, 204, 206 and 208) while ‘118 teaches that the articles made have anterior and posterior components (paragraphs and 131 and 0138). It would have been obvious to one of ordinary skill in the art at the time of effective filing to combine the teachings so that the parts of the customized cranial orthotic device are organized in their spatial relation.
Regarding claim 18, ‘376 teaches that component parts may be organized in their relation to each other (Fig 2 items 202, 204, 206 and 208) while ‘118 teaches that the articles made have anterior and posterior components (paragraphs and 131 and 0138). It would have been obvious to one of ordinary skill in the art at the time of effective filing to combine the teachings so that the parts of the customized cranial orthotic device are organized in their spatial relation.
Regarding claim 19, ‘376 teaches that component parts may be organized in their relation to each other (Fig 2 items 202, 204, 206 and 208) while ‘118 teaches that the articles made have anterior and posterior components (paragraphs and 0129 and 0141). It would have been obvious to one of ordinary skill in the art at the time of effective filing to combine the teachings so that the parts of the customized cranial orthotic device are organized in their spatial relation.
Regarding claim 20, ‘376 teaches that component parts may be organized in their relation to each other (Fig 2 items 202, 204, 206 and 208) while ‘118 teaches that the articles made have anterior and posterior components (paragraphs and 0129 and 0141). It would have been obvious to one of ordinary skill in the art at the time of effective filing to combine the teachings so that the parts of the customized cranial orthotic device are organized in their spatial relation.
Claim(s) 4 - 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘376 in view of ‘879 and ‘118 as applied to claim 1 above, and further in view of U.S. Patent Application Publication 2020/0246119 to Long et al. (‘119 hereafter).
Regarding claim 4, ‘376 in view of ‘879 and ‘118 does not teach individualized data labelling.
In the related art of additively manufactured customized orthotic devices, ‘119 teaches the method comprising: processing said plurality of digital device portion data files for each said custom orthotic device to include subject identification data, all of said digital device portion data files for a corresponding custom orthotic device comprising the same said subject identification data (paragraph 0024) for the benefit of ensuring the proper orthotics reach the intended end user. One possessed of ordinary skill at the time of effective filing would have been motivated to combine the teachings of ‘376 in view of ‘879 and ‘118 with those of ‘119 for the benefit of ensuring proper medical treatment of patients.
Regarding claim 5, ‘376 does not teach concurrent additive manufacture.
In the related art of additive manufacturing, ‘879 teaches the method comprising: utilizing said additive manufacture apparatus to process said nested digital data array to concurrently manufacture all of said device portions of said nested device portions array (Fig 1, items 101-106). For the benefit of increasing additive manufacturing apparatus utilization and manufacturing efficiency.
‘119 teaches the labelling of articles with an individualized tracking mark for the reasons stated above. It would have been obvious to one possessed of ordinary skill in the art at the time of effective filing to combine the teachings of ‘376 in view of ‘118 in view of ‘119 with those of ‘879 for the benefit of manufacturing customized cranial orthotics with increased efficiency.
Regarding claim 6, ‘376 does not teach assembling the additively manufactured components.
In the related art of additive manufacture, ‘879 teaches the method comprising: assembling together each said device portions carrying same said subject identification data (Paragraph 0007) for the benefit of additively manufacturing articles which may be too large to manufacture as monoliths with available additive manufacturing devices. It would have been obvious to one possessed of ordinary skill in the art at the time of invention to combine the teachings of ‘376 in view of ‘118 in view of ‘119 in view of ‘879 with those of ‘257 for the benefit of constructing individualized cranial remodeling orthotic devices which are too large to manufacture as monoliths.
Regarding claim 7, ‘376 in view of ‘879 and ‘118 does not teach individualized data labelling.
In the related art of additively manufactured customized orthotic devices, ‘119 teaches the method comprising: processing said plurality of digital device portion data files for each corresponding custom orthotic device to include part identification data, said part identification data included on each manufactured said device portion of said corresponding orthosis device (paragraph 0024) for the benefit of ensuring the proper orthotics reach the intended end user. One possessed of ordinary skill at the time of effective filing would have been motivated to combine the teachings of ‘376 in view of ‘879 and ‘118 with those of ‘119 for the benefit of ensuring proper medical treatment of patients.
Regarding claim 8, ‘376 in view of ‘879 and ‘118 does not teach individualized data labelling.
In the related art of additively manufactured customized orthotic devices, ‘119 teaches the method comprising: processing said plurality of digital device portion data files for each said custom cranial remodeling device to include one or both of manufacturing trace information and subject identification data, said subject identification data included on each manufactured said device portion, said subject identification data being the same for all manufactured said device portions for said corresponding orthosis device (paragraph 0024) for the benefit of ensuring the proper orthotics reach the intended end user. One possessed of ordinary skill at the time of effective filing would have been motivated to combine the teachings of ‘376 in view of ‘879 and ‘118 with those of ‘119 for the benefit of ensuring proper medical treatment of patients.
Regarding claim 9, ‘376 does not teach concurrent additive manufacture. ‘119 teaches the labelling of articles with an individualized tracking mark for the reasons stated above. ‘118 teaches custom cranial orthotics achieved by additive manufacture for the reasons stated above.
In the related art of additive manufacturing, ‘879 teaches the method comprising: processing said nested digital data array to concurrently manufacture said nested portions array by additive manufacture, each said manufactured device portion carrying corresponding said subject identification data (Fig 1, items 101-106). For the benefit of increasing additive manufacturing apparatus utilization and manufacturing efficiency. It would have been obvious to one possessed of ordinary skill in the art at the time of effective filing to combine the teachings of ‘376 in view of ‘118 in view of ‘119 with those of ‘879 for the benefit of manufacturing customized cranial orthotics with increased efficiency.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘376 in view of ‘879 and 118 as applied to claim 1 above, and further in view of U.S. Patent Application Publication 2009/0085257 to YANG et al. (‘257 hereafter).
Regarding claim 10, ‘376 in view of ‘879 and ‘118 does not teach connecting portions.
In the related art of additive manufacturing, ‘257 teaches the method comprising: processing said plurality of digital device portion data files for each corresponding device to include integral connecting portions to interconnect each manufactured said custom device portion with one or more adjacent manufactured device portions of said corresponding device (Fig 1 item 150) for the benefit of additively manufacturing articles which may be too large to manufacture as monoliths with available additive manufacturing devices. It would have been obvious to one possessed of ordinary skill in the art at the time of invention to combine the teachings of ‘376 in view of ‘879 and ‘118 with those of ‘257 for the benefit of constructing individualized cranial remodeling orthotic devices which are too large to manufacture as monoliths.
Regarding claim 11, ‘376 does not teach concurrent manufacturing.
In the related art of additive manufacturing, ‘879 teaches the method comprising: processing said nested digital data array by additive manufacture apparatus to concurrently manufacture said plurality of device portions of said devices (Fig 1, items 101-106). For the benefit of increasing additive manufacturing apparatus utilization and manufacturing efficiency. It would have been obvious to one possessed of ordinary skill in the art at the time of effective filing to combine the teachings of ‘376 in view of ‘118 in view of ‘257 with those of ‘879 for the benefit of manufacturing customized cranial orthotics with increased efficiency.
Regarding claim 12, ‘257 teaches the method comprising: assembling together said device portions for each corresponding said cranial remodeling orthosis device by utilizing said connecting portions to affix each of said device portions to its adjacent one or more said device portions to form a unitary device (Fig 1 item 170) for the benefit of additively manufacturing articles which may be too large to manufacture as monoliths with available additive manufacturing devices. It would have been obvious to one possessed of ordinary skill in the art at the time of invention to combine the teachings of ‘376 in view of ‘118 in view of ‘879 with those of ‘257 for the benefit of constructing individualized cranial remodeling orthotic devices which are too large to manufacture as monoliths.
Regarding claim 13, ‘376 in view of ’879 and ‘118 does not teach connecting portions.
In the related art of additive manufacturing, ‘257 teaches the method comprising: providing each digital device portion data file of said plurality of device portion data files for a corresponding custom device with data for one or more integrally formed connecting portions to be coupled with one or more corresponding connecting portions carried by one or more adjacent other device portions of said corresponding device when said plurality of portions are manufactured (Fig 1 item 150) for the benefit of additively manufacturing articles which may be too large to manufacture as monoliths with available additive manufacturing devices. It would have been obvious to one possessed of ordinary skill in the art at the time of invention to combine the teachings of ‘376 in view of ‘879 and ‘118 with those of ‘257 for the benefit of constructing individualized cranial remodeling orthotic devices which are too large to manufacture as monoliths.
Regarding claim 14, ‘376 in view of ‘118 in view of ‘257 does not teach concurrent manufacturing.
In the related art of additive manufacturing, ‘879 teaches the method comprising: processing said data array by additive manufacture apparatus to concurrently manufacture said device portions of said cranial remodeling orthosis devices (Fig 1, items 101-106) for the benefit of increasing additive manufacturing apparatus utilization and manufacturing efficiency. It would have been obvious to one possessed of ordinary skill in the art at the time of effective filing to combine the teachings of ‘376 in view of ‘118 in view of ‘257 with those of ‘879 for the benefit of manufacturing customized cranial orthotics with increased efficiency.
Regarding claim 15, ‘257 teaches the method comprising: assembling together said device portions for each corresponding said cranial remodeling orthosis device by utilizing said connecting portions to affix each of said device portions to its adjacent one or more said device portions (Fig 1 item 170) for the benefit of additively manufacturing articles which may be too large to manufacture as monoliths with available additive manufacturing devices. It would have been obvious to one possessed of ordinary skill in the art at the time of invention to combine the teachings of ‘376 in view of ‘118 in view of ‘879 with those of ‘257 for the benefit of constructing individualized cranial remodeling orthotic devices which are too large to manufacture as monoliths.
Regarding claim 16, ‘376 in view of ‘879 and ‘118 does not teach connecting portions.
In the related art of additive manufacturing, ‘257 teaches the method comprising: processing said plurality of digital device portion data files to determine quantities and locations of said connecting portions for each of said device portions in a production chamber of said additive manufacture apparatus (Fig 1 item 150) for the benefit of additively manufacturing articles which may be too large to manufacture as monoliths with available additive manufacturing devices. It would have been obvious to one possessed of ordinary skill in the art at the time of invention to combine the teachings of ‘376 in view of ‘118 with those of ‘257 for the benefit of constructing individualized cranial remodeling orthotic devices which are too large to manufacture as monoliths.
Response to Arguments
In support of the patentability of the instant claims, applicant has advanced several arguments. They are:
‘376 is silent as to the nesting of components of a plurality of devices as claimed.
No applied reference teaches processing of portion data files into a nested array.
‘879 does not teach concurrent manufacture of a plurality of custom devices.
Regarding argument (i), examiner agrees with applicant. That is why the rejection above indicates that feature as being taught by ‘879.
Regarding argument (ii), ‘376 teaches the making of a nested array of parts of a single article and ‘879 teaches the processing of a number of distinct models into a single, concurrently manufacturable model. Therefore, one of ordinary skill at the time of effective filing would find the teaching suggestion and motivation to combine a plurality of individual nested device files as taught by ‘376 into one nested device file for the purpose of improving manufacturability as taught by ‘879.
Regarding argument (iii), ‘879 teaches the concurrent manufacture of disparate articles in at least paragraph 0020, where it is disclosed that a plurality of 3D model files are received and processed.
No arguments are persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JPR/Examiner, Art Unit 1743
/GALEN H HAUTH/Supervisory Patent Examiner, Art Unit 1743
