Prosecution Insights
Last updated: April 19, 2026
Application No. 18/117,747

SYSTEM AND METHOD OF MANUFACTURING A MEDICAL IMPLANT

Final Rejection §103
Filed
Mar 06, 2023
Examiner
BOWMAN, ANDREW J
Art Unit
1717
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Curiteva Inc.
OA Round
4 (Final)
66%
Grant Probability
Favorable
5-6
OA Rounds
3y 6m
To Grant
78%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
576 granted / 879 resolved
+0.5% vs TC avg
Moderate +13% lift
Without
With
+12.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
76 currently pending
Career history
955
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
56.8%
+16.8% vs TC avg
§102
20.4%
-19.6% vs TC avg
§112
18.5%
-21.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 879 resolved cases

Office Action

§103
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 . 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, 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 2-4, 10, 12-14, 18, 21 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Vishnubotta et al. (USPGPub 2018/0263785) in view of Palermo (“Fused Deposition Modeling: Most Common 3D Printing Method” Live Science, 9/2013, pp. 1-12), Naware (USPGPub 2016/0096326), Luo et al. (USPGPub 2018/0085826) and Atwood et al. (USPGPub 2021/0396593). Regarding claims 2-4, 13 and 38-39, Vishnubotta teaches forming a PEEK (a known PAEK) or PE [0051], porous spinal implant (abstract) via “3D printing” or a “layer-by-layer” process [0051]. Vishnubotta is generally non-specific with regards to the specifics of the 3D printing process. However, Palmero teaches that a known 3D printing process common at the time of invention is the FDM method (second paragraph) which involves the use of a filament (second paragraph) that is heated and extruded through a nozzle (see How FMD work) to create objects in a layer-by-layer process (second paragraph) wherein a first layer is deposited on the top surface of a build platform (see How FMD work) wherein the deposition necessary occurs at an X-Y position relative to the plate, wherein the manner of deposition would read on “contiguous deposition” and wherein successive layers thereafter are deposited on the first layer by moving the nozzle relative to the build platform in the Z-direction (see How FMD work) wherein the second starting location must in some manner be relative to the surface of the build plate and have a determined angle and distance in the X-Y plane, especially given that the path followed by the extruder is provided by a CAD drawing (see How FMD work) wherein the final product is continually formed in this successive manner until the final product is formed (second paragraph) wherein the formation of all further layers reasonably requires movement of the nozzle in the Z-direction relative to the build plate in order to build the product taller and taller as described. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to form the 3D printed object of Vishnubotta by the 3D printing method of Palmero as a use of a series of known techniques for forming 3D printed objects to the known 3D printing method of Vishnubotta in order to improve the methods of Vishnubotta and wherein the results would be reasonably predictable. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Further, Vishnubotta teaches that his product has a porosity gradient that may vary widely including implants that have the highest degree of porosity internal from top to bottom (Fig. 2A-B), the lowest degree of porosity internally from top to bottom (Fig 3A-B), those having highest porosity on the bottom (Figs. 4A-B) or the top (Figs. 5A-B), varying porosity across the width of the invention (Figs 6A-9B) and having varying porosity from front to back (Figs. 10A-11B). To form these varied products successively as claimed wherein porosity can be varied widely in any region, Vishnubotta shows a reasonable ability to further layers and regions of varying porosity material one on top of another as desired by the inventor wherein the porosity is varied according to the desire of the inventor to control bone ongrowth and ingrowth on the implant [0004]. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to form the object of Vishnubotta in view of Palmero with any particular pattern of porosity desired as a matter of choice that is shown to be within the skill of the art of Vishnubotta in view of Palmero and wherein the known reason for doing so would be to vary bone ingrowth and ongrowth as desired. Further, states that the nozzle moves over the platform “horizontally and vertically” (see How FMD work). Further it is noted that Palermo teaches wherein “the nozzle melts” the material being deposited, thereby implying the use of a heated nozzle. The teachings of Vishnubotta in view of Palermo are as shown above. Vishnubotta in view of Palermo fails to teach maintaining the temperature of the print material on the build plate during the 3D printing process. However, Naware teaches that it is known to control the temperature of the build plate of a 3D printing process in order to control the temperature of the article being created to control warping and curling of the object (abstract and background of the invention). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to control the build plate temperature of the invention of Vishnubotta in view Palermo as guided by Naware in order to control the temperature of the product produced and the warping and curling thereof. Further it is noted that the heated build plate of Naware further comprises an insulting layer that would function as a heat reflective plate, redirecting heat upwards to the build plate surface as is the intention of the part, wherein the insulting layer is heated in the same manner as the build plate. The teachings of Vishnubotta in view of Palermo and Naware are as shown above. Vishnubotta in view of Palermo and Naware fails to teach wherein the process further involves the use of a reflector that reflects heat back towards the part being formed on the build plate. However, Luo teaches that it is known to incorporate heated reflectors surrounding and slightly above a dispensing nozzle housed by a print head of an additive manufacturing device wherein the reflector both generates heat and reflects it downward towards the area on which material is deposited wherein the heat applied using the reflector allows for “even heat distribution to the build or printing area…” [0035-0040]. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the reflective heating element of Luo into the invention of Vishnubotta in view Palermo as guided by Naware in order to evenly distribute heat in the build and print areas of the invention of Vishnubotta in view Palermo as guided by Naware. Further, the reflector of Vishnubotta in view of Palermo, Naware and Luo is controlled by its placement and the temperature of the build plate is controlled as described above and the heated nozzle has a controlled heat level wherein all deposited layers are necessarily maintained at some elevated temperature, although it is not required by the claims that all temperatures be the same and no particular temperature is claimed. The teachings of Vishnubotta in view Palermo, Naware and Luo are as shown above. Vishnubotta in view Palermo, Naware and Luo fail to teach wherein the temperature of the object being printed is maintained at a temperature based upon the sensed temperature of layers that were previously deposited. However, Atwood teaches that it is known in the 3D printing field to maintain the temperature of layers of a 3D printed objected at a given temperature based upon a sensed temperature of previously deposited layers [0048] in order to provide proper bonding between layers and desired properties [0002]. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to control the temperature of the layers of the invention of Vishnubotta in view Palermo, Naware and Luo as guided by Atwood in order to control the bonding between layers and desired properties of the invention of Vishnubotta in view Palermo, Naware and Luo as guided by Atwood. Regarding claim 10, the current claims limitations read upon the use of the build heat to maintain the temperature of the article at a predetermined temperature. Regarding claim 12, Naware further teaches that the build plate may be employed to heat or cool (abstract). Regarding claim 14, Naware further teaches wherein the build plate may be moved [0029] wherein necessarily movement is based on an extrusion rate and target thickness. Otherwise thicknesses and parts collectively would vary in an uncontrolled manner, which is implicitly undesirable. Regarding claims 18 and 21, based on the description of Palermo is appears as though the printing of rows follows as claimed in the current claims. However, further, the shape and alignment of the rows deposited constitutes a shape of the material deposited, wherein the Court has long held that in the absence of a new and unexpected result arising from a new shape provided by the current application, the current application shape is considered to be a mere change in shape or the prior art deposited material and obviousness in view thereof. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Regarding claim 37, the heating element of Luo as cited above would reasonably heat all structures underneath the heating element including those reading on the claimed elements to be heated. Regarding claim 40, although Luo does not teach a step of cooling using his reflective heat element, Luo does explicitly teach that the gas provided by the heating device may be provided at 0 Celsius. Given a melting temperature of the additive manufacturing material being above 0, this would reasonably read upon an element capable of providing cooling as part of the reflector. Claims 5-6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Vishnubotta et al. (USPGPub 2018/0263785) in view of Palermo (“Fused Deposition Modeling: Most Common 3D Printing Method” Live Science, 9/2013, pp. 1-12) and Naware (USPGPub 2016/0096326), Luo et al. (USPGPub 2018/0085826) and Atwood et al. (USPGPub 2021/0396593) as applied to claims 2-4, 10, 12-14, 18, 21 and 37-40 above and further in view of Yi et al. (“Slow and fast crystallizing poly aryl ether ketones (PAEKs) in 3D printing: Crystallisation kinetics, morphology, and mechanical properties” Additive Manufacturing, 03/2021, No. 39, pp. 1-13). Regarding claims 5-6 and 11, the teachings of Vishnubotta in view of Palermo, Naware, Luo and Atwood are as shown above. Naware explicitly teaches controlling the temperature of the build plate to control warping of the substrates formed but Vishnubotta in view of Palermo, Naware, Luo and Atwood fails to provide any understanding of the mechanism of how this is accomplished other than through heat regulation. However, the general disclosure of Yi explicitly shows that the crystallization of PAEK materials is directly affected by the heating and cooling temperatures of these material and the rate at which is occurs affects the properties of the material formed by additive manufacturing including warping (see sections 2.2.2 and 3.3). Therefore in the absence of criticality of the specific temperature range of the current claims, based on the disclosure of Yi, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to control the cooling/heating rate and temperature range of the deposited PAEK of Vishnubotta in view of Palermo, Naware, Luo and Atwood as guided by Yi in order to control warping in materials formed by Vishnubotta in view of Palermo, Naware, Luo and Atwood. Claims 7-9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Vishnubotta et al. (USPGPub 2018/0263785) in view of Palermo (“Fused Deposition Modeling: Most Common 3D Printing Method” Live Science, 9/2013, pp. 1-12), Naware (USPGPub 2016/0096326), Luo et al. (USPGPub 2018/0085826) and Atwood et al. (USPGPub 2021/0396593) as applied to claims 2-4, 10, 12-14, 18, 21 and 37-40 above and further in view of Rupel et al. (USPGPub 2018/0169971). Regarding claim 7, the teachings of Vishnubotta in view of Palermo, Naware, Luo and Atwood are as shown above. Vishnubotta in view of Palermo, Naware, Luo and Atwood and Luo fails to teach the use of a heated feed tube upstream of the nozzle for heating the filament material. However, Rupel teaches that it is known to heat filaments to be provided in FFF (abstract) in heated feed tubes. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the heated feed tubes of Rupel in the FFF deposition device of Vishnubotta in view of Palermo, Naware, Luo and Atwood as a use of a known filament heating method applied to a known FFF device in the same way. Regarding claim 8, Rupel teaches that the heater in controlled by a controller [0044]. Regrading claim 9, although Rupel does not explicitly state that the heater is explicitly controlled based on a sensed condition, it is noted that Rupel provides sensors to detect the temperature of the heater and the media provided [0046] and that the controller controls the temperature of the media. It is unclear what the sensed data is used for by Rupel but based on the manner in which Rupel describes these systems it seems reasonably implicit that the system of Rupel is designed to intake temperature information and control heaters based on this. If this is not implicit, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine these abilities provided by Rupel to operate the machinery of Rupel in the manner defined so as to give control of the heaters of Rupel based on real-time information rather than preset conditions. Regarding claim 15, Rupel further teaches wherein input may be taken from the user for controlling components of the operation [0045] or software (implicit of algorithms) may be employed [0051]. Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Vishnubotta et al. (USPGPub 2018/0263785) in view of Palermo (“Fused Deposition Modeling: Most Common 3D Printing Method” Live Science, 9/2013, pp. 1-12), Naware (USPGPub 2016/0096326), Luo et al. (USPGPub 2018/0085826) and Atwood et al. (USPGPub 2021/0396593) as applied to claims 2-4, 10, 12-14, 18, 21 and 37-40 above and further in view of Chandar et al. (USPGPub 2019/0054700). Regarding claim 17, the teachings of Vishnubotta in view of Palermo, Naware, Luo and Atwood are as shown above. Vishnubotta in view of Palermo, Naware, Luo and Atwood fails to teach wherein the control system of the FFF machine employs machine learning. However, Chandar teaches that it is known to incorporate machine learning solutions into the operations of FFF [0004][0061] in order to improve the products produced. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the machine learning solution of Chandar in the FFF deposition method of Vishnubotta in view of Palermo, Naware, Luo and Atwood in order to improve those deposition methods in the same manner. Claims 19-20 is rejected under 35 U.S.C. 103 as being unpatentable over Vishnubotta et al. (USPGPub 2018/0263785) in view of Palermo (“Fused Deposition Modeling: Most Common 3D Printing Method” Live Science, 9/2013, pp. 1-12), Naware (USPGPub 2016/0096326), Luo et al. (USPGPub 2018/0085826) and Atwood et al. (USPGPub 2021/0396593) as applied to claims 2-4, 10, 12-14, 18, 21 and 37-40 above and further in view of Koci (“Everything you need to know about infills” Prusa Printers, 01/2021, pp. 1-30). Regarding claims 19-20, the teachings of Vishnubotta in view of Palermo, Naware, Luo and Atwood are as shown above. Vishnubotta in view of Palermo, Naware, Luo and Atwood fails to teach wherein the pattern is rotated between the deposition of layers. However, Koci teaches that the infill process for providing interior density to 3D printed objects was known at the time of invention and allows one to control print time, reliability and material usage. Infill is performed by choosing a basic internal filling pattern for the object to be created and rotating the object at a certain angle between depositions to create and interior shape (see for example Grid, wherein the pattern is rotated 90 degrees between layers for two directional printing or Triangles wherein the pattern is rotated 60 degrees presumably based on three direction printing or Line wherein it would appear that multiple varying angles of rotation would be used). Koci shows that ability to rotate patterns at different angles and the angles of rotation determine the pattern of the infill. Therefore, in the absence of criticality of the specific angle of rotation claimed, it would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to optimize the angle of rotation between the deposition of layers in order to control the infill pattern of the invention of Vishnubotta in view of Palermo, Naware, Luo and Atwood as guided by Koci in order to control the print time, print reliability, material usage and mechanical properties of the 3D printed object of Vishnubotta in view of Palermo, Naware, Luo and Atwood. Claims 22 is rejected under 35 U.S.C. 103 as being unpatentable over Vishnubotta et al. (USPGPub 2018/0263785) in view of Palermo (“Fused Deposition Modeling: Most Common 3D Printing Method” Live Science, 9/2013, pp. 1-12), Naware (USPGPub 2016/0096326), Luo et al. (USPGPub 2018/0085826) and Atwood et al. (USPGPub 2021/0396593) as applied to claims 2-4, 10, 12-14, 18, 21 and 37-40 above and further in view of Barnes et al. (USPGPub 2020/0324458). Regarding claim 22, the teachings of Vishnubotta in view of Palermo, Naware, Luo and Atwood are as shown above. Vishnubotta in view of Palermo, Naware, Luo and Atwood fails to teach the specific gap width and manner in which successive rows of material are deposited. However, Barnes teaches that it is known to deposit filaments in the dimensions claimed in order to allow for the manufacture of certain products by FFF printing [0024-0026], wherein said products have dimensions and row widths meeting the claim limitations. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to use the deposition dimensions of Barnes in the invention of Vishnubotta in view of Palermo, Naware, Luo and Atwood in order to allow for the manufacture of the products of Barnes having the particular dimensions claimed. Response to Arguments The applicants’ arguments largely revolve around newly added claim limitations that were not previously addressed by the prior art and are therefore largely moot. However, the examiner has provided new art herein that addresses the new limitations in questions. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dah-Wei Yuan can be reached at 571-272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANDREW J BOWMAN/Examiner, Art Unit 1717 /Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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Prosecution Timeline

Mar 06, 2023
Application Filed
Jun 29, 2024
Non-Final Rejection — §103
Oct 17, 2024
Applicant Interview (Telephonic)
Oct 18, 2024
Examiner Interview Summary
Oct 31, 2024
Response Filed
Feb 03, 2025
Final Rejection — §103
Jun 02, 2025
Applicant Interview (Telephonic)
Jun 05, 2025
Examiner Interview Summary
Jul 02, 2025
Applicant Interview (Telephonic)
Jul 10, 2025
Request for Continued Examination
Jul 11, 2025
Examiner Interview Summary
Jul 14, 2025
Response after Non-Final Action
Aug 09, 2025
Non-Final Rejection — §103
Oct 30, 2025
Response Filed
Feb 06, 2026
Final Rejection — §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
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Grant Probability
78%
With Interview (+12.6%)
3y 6m
Median Time to Grant
High
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