Office Action Predictor
Application No. 17/698,316

SYSTEMS AND METHODS FOR MANUFACTURING PERSONALIZED ORAL CARE DEVICES

Final Rejection §102§103
Filed
Mar 18, 2022
Examiner
LUCCHESI, NICHOLAS D
Art Unit
3772
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Fresh Health INC.
OA Round
2 (Final)
79%
Grant Probability
Favorable
3-4
OA Rounds
2y 9m
To Grant
83%
With Interview

Examiner Intelligence

79%
Career Allow Rate
619 granted / 787 resolved
Without
With
+4.4%
Interview Lift
avg trend
2y 9m
Avg Prosecution
59 pending
846
Total Applications
career history

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
32.8%
-7.2% vs TC avg
§102
28.4%
-11.6% vs TC avg
§112
31.1%
-8.9% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§102 §103
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 . Claim Rejections - 35 USC § 102 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 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. Claims 42-44,46,47,49-52,54-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanuschik et al 20190000599. With regard to claim 42, Hanuschik et al discloses an oral insert (fig. 1E), comprising: a fluid inlet port 124; one or more manifolds (see fig. 7A); a plurality of fluid nozzles 174 coupled to the fluid inlet port via the one or more manifolds; and a tray 120 configured to retain teeth, wherein the tray 120 includes the plurality of fluid nozzles 174, wherein a first manifold of the one or more manifolds includes a plurality of portions 700/702, one of the plurality of portions 702 is a tapered portion, and one or more physical characteristics associated with the tapered portion 702 is based on a fluid pressure associated with at least one of the plurality of fluid nozzles. See paragraphs 6 and 70. With regard to the newly presented limitation in claim 41, note that the first manifold 702 is configured to permit a relatively constant fluid pressure along the length, by decreasing a diameter of the first manifold along a length thereof. See annotated figure below. Furthermore, note that Hanuschik et al disclose that the geometry of the manifolds may be based upon the arrangement (placement) of the nozzles. See paragraph 12. PNG media_image1.png 363 607 media_image1.png Greyscale With regard to claims 43 and 44, note that a first manifold of the one or more manifolds includes one or more pressure ports, wherein a pressure port of the one or more pressure ports is configured to release pressure as fluid flows through the first manifold. See paragraph 70 which describes how some of the nozzles may be configured to act as pressure ports (“release nozzles”). With regard to claim 46, note that a number, shape, size, and/or location of a first pressure port of the one or more pressure ports is configured to provide a predetermined range of pressures through at least a portion of the first manifold. See paragraph 70 which describes how the release nozzles irrigate once a particular pressure occurs in a manifold, and does so based on the size of the release nozzle. With regard to claim 47, note that a number of the one or more pressure ports is based on a number of the plurality of fluid nozzles coupled to the first manifold. This is inherent in the final arrangement of fluid nozzles/release nozzles connected to a particular manifold. With regard to claims 49 and 50, note that the oral insert may further comprise one or more alignment features, the one or more alignment features include protrusions, slots, or recesses that receive and/or articulate with a user’s teeth, gums, hard palate, soft palate, other oral structures, and/or have contours that correspond to one or more teeth. See paragraph 45. With regard to claim 51 and 52, note that the recesses disclosed, which receive a user’s teeth, are considered to be “keying features” which are configured to facilitate correct and consistent placement and alignment of the oral insert within a mouth of a user. With regard to claim 54, note that the oral insert includes a fluid outlet port. See paragraph 65 which describes “outlet surfaces” to allow for drainage. With regard to claim 55, note that the oral insert is releasably attached to a handle 104. See fig. 1D. With regard to claim 56, note that the handle includes 104 may include a manifold switch configured to output fluid to each manifold at a predetermined rate. See paragraph 12. With regard to claim 57, note that the handle includes a manifold switch (paragraph 12) configured to sequentially output fluid to each manifold at a predetermined rate. See paragraph75 which discloses how the manifold switch may be programmed to “cycle through” the manifolds. With regard to claim 58, note that the one or more manifolds include a plurality of manifolds, wherein a first subset of the plurality of manifolds are associated with upper teeth of a user and a second subset of the plurality of manifolds are associated with lower teeth of the user. See paragraph 13, which discloses how an insert may comprise separate upper and lower portions that can be attached simultaneously to the handle. Thus, the at least one manifold in each of the upper and lower portions is considered to be a “first” and “second” subset of the plurality of manifolds. With regard to claim 59, note that a number of the one or more manifolds is greater than or equal to one manifold and less than or equal to 16 manifolds. See manifolds 808 in figure 8A. With regard to claim 60, note that a number of the plurality of fluid nozzles is greater than or equal to one fluid nozzle and less than or equal to 64 fluid nozzles. See nozzles 812 in figure 8A. With regard to claims 61 and 62, note that the tray may be a single tray configured to fit over maxillary teeth associated with a user or mandibular teeth associated with the user, or may further comprise a second tray, wherein the tray is configured for maxillary teeth associated with a user and the second tray is configured for mandibular teeth associated with the user. See paragraph 13. 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. Claims 45 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Hanuschik et al 20190000599. With regard to claim 45, note that while Hanuschik et al disclose a second manifold, Hanuschik et al do not disclose wherein a first number of fluid nozzles of the plurality of fluid nozzles associated with the first manifold is different thana second number of fluid nozzles of the plurality of fluid nozzles associated with the second manifold. However, it is noted that Hanuschik et al disclose that the number and arrangement of the nozzles may be adjusted in order to accommodate specific tooth locations. See paragraphs 51,53,54,55,56. It would have been obvious to one skilled in the art to include a first number of fluid nozzles associated with a first manifold to be different than a second number of fluid nozzles associated with a second manifold in the oral insert disclosed by Hanuschik et al, as a matter of routine optimization, in view of the teaching of Hanuschik et al that the number and arrangement of nozzles in an oral insert may be adjusted to accommodate different areas of the oral cavity. With regard to claim 48, Hanuschik et al do not disclose wherein a radius of the one or more pressure ports is based on a number of the plurality of fluid nozzles coupled to the first manifold. However, Hanuschik et al do disclose that the size of the pressure ports may be made larger than the irrigating nozzles, in order to relieve pressure in a manifold. See paragraph 70 which discloses how the “release nozzles” operate. Therefore, it would have been obvious to one skilled in the art to base the radius of the pressure ports (“release nozzles”) on the number of fluid nozzles coupled to the first manifold, of the oral insert of Hanuschik et alas a matter of routine optimization, in view of the teaching that the size of the release nozzles may be larger than the fluid nozzles in order to be able to relieve pressure within the manifold. Response to Arguments Applicant's arguments filed 7/7/25 have been fully considered but they are not persuasive. Applicant argues that Hanuschik is silent regarding a manifold having a radius/diameter decreasing along the length of the manifold (page 6, response). This is not found persuasive. As shown in the annotated figure above, the diameter of the manifold decreases at the point that it narrows. Thus, the diameter decreases “along a length” of the manifold (from section 700 to the end of section 702). Conclusion THIS ACTION IS MADE FINAL. 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 NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430. 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, Eric Rosen can be reached at 571-270-7855. 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. /NICHOLAS D LUCCHESI/Primary Examiner, Art Unit 3772
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Prosecution Timeline

Mar 18, 2022
Application Filed
Nov 23, 2022
Response after Non-Final Action
Mar 04, 2025
Non-Final Rejection — §102, §103
Jul 07, 2025
Response Filed
Oct 02, 2025
Final Rejection — §102, §103
Apr 10, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
79%
Grant Probability
83%
With Interview (+4.4%)
2y 9m
Median Time to Grant
Moderate
PTA Risk
Based on 787 resolved cases by this examiner