Prosecution Insights
Last updated: April 19, 2026
Application No. 18/290,054

METHOD AND DEVICE FOR ANALYSING A DEVICE FOR SPRAYING A PHARMACEUTICAL FLUID PRODUCT

Final Rejection §112
Filed
Nov 09, 2023
Examiner
FRANK, RODNEY T
Art Unit
2855
Tech Center
2800 — Semiconductors & Electrical Systems
Assignee
Aptar France SAS
OA Round
2 (Final)
73%
Grant Probability
Favorable
3-4
OA Rounds
3y 3m
To Grant
76%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
663 granted / 913 resolved
+4.6% vs TC avg
Minimal +4% lift
Without
With
+3.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
23 currently pending
Career history
936
Total Applications
across all art units

Statute-Specific Performance

§101
3.8%
-36.2% vs TC avg
§103
43.9%
+3.9% vs TC avg
§102
21.2%
-18.8% vs TC avg
§112
25.6%
-14.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 913 resolved cases

Office Action

§112
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 . Election/Restrictions Newly submitted claims 37-40 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The new claims require a determination of a spatial distribution of a flow of compressed gas and an analysis of said spatial distribution compared to a visualization and an analysis of a visualization. These do not appear to be the same thing. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 37-40 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “30” has been used to designate both a filter and sensors. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. The disclosure is objected to because of the following informalities: Item 30 is referred to as both sensors and filters. Which one is it? Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 20-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claims 20 and 26 are the independent claims in the present application. Both claims require visualizing an impact zone on a receiving surface based on a detection of the flow of compressed gas by sensors. This limitation is not described in the specification in such a way to allow one of ordinary skill in the art to actually perform this limitation. It’s not even disclosed what visualizing is. Is it done by a machine such as a camera or is it done by a person? Further, the limitation requires the visualization by detection of flow by sensors. It is not disclosed how sensors visualize anything. Flow sensors are well known, but flow sensors measure the flow of something. How is flow related to a “visualization”. The specification notes that :“ The means for analysis may comprise means for measuring the geometry of the impact zone of the flow of compressed gas F on the reception zone 10. As an example, the centre of mass of the impact zone is determined, and the maximum and minimum distances of this centre of mass from the edge of the impact zone are measured. Comparing these distances with predetermined values then makes it possible to evaluate the compliance of the tested device. Thus, the compliance evaluation takes not only the surface of the impact zone into account, but also its geometry, in particular its symmetry. This makes it possible to establish that a spray leaving a compliant spray head will have an acceptable conical shape, both from the point of view of the angle of the spray and as regards its symmetry. “ IS this what is meant by visualization? A determination of the geometry of the impact zone? If so, how is geometry related to the flow of the compressed gas? Also, while this section states that this is an analysis, thus while this could correspond to the analysis of the visualization, it still would not explain what a visualization is and how flow is related to or determines a visualization. Flow gives a flow rate. Nothing is seen or visualized from that. With respect to visualization, the specification states: ”The particular shape of the receiving surface 10, with a plurality of sensors 30 close to one another , thus forming a regular and dense array on said receiving surface, means that a local contact can be made by the flow of compressed gas F on the sensors 20, without dispersions and without perturbations to the flow, which makes the impact zone visible with great reliability.” While it states that the impact zone is visible, it is not clear what a visible impact zone actually is or means. While it is assumed that the sensors use collected flow rate data in order to perform the “visualization”, it’s not disclosed how the data obtained (flow rate) results in a visualization. There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). With respect to the case of the present invention, there is not enough direction provided as to how the visualization would be accomplished (Wands Factor F), there is no comparison to some working examples to compare the present invention to (Wands Factor G), and the amount of experimentation required to perform processes that are considered to be visualization would be great (Wands Factor H). For at least these reasons, claims 20 and 26 are deemed to lack enablement. Since claims 20 and 26 lack enablement, then claims 21-25 and 27-36, which depend from either claim 20 or 26, lack enablement as well. Response to Arguments Applicant's arguments filed 13 February 2026 have been fully considered but they are not persuasive. The Applicant argues: “In rejecting the claims, the Examiner refers to the feature of visualizing the impact zone on the receiving surface with sensors. This feature is described, for example, in Applicant's published specification US2024255330 at paragraph [0059]: The particular shape of the receiving surface 10, with a plurality of sensors 30 close to one another, thus forming a regular and dense array on said receiving surface, means that a local contact can be made by the flow of compressed gas F on the sensors 20, without dispersions and without perturbations to the flow, which makes the impact zone visible with great reliability. The dense array of sensors allows local contact by the flow of gas with the sensors, thus making the impact zone visible. With respect to Fig. 2, Applicant's specification at paragraph [0067] further describes: FIG. 2 illustrates a schematic representation obtained with the method and the device of the invention, from which it is possible to evaluate in particular the planar extent and the geometry, in particular the symmetry, of the impact zone. Thus, in this example which shows a compliant result, it is found that the measurements of the different sensors are homogeneous in the spatial distribution, and with acceptable differences between the different concentric zones the array, which of demonstrates a good geometric distribution The Examiner is correct that the sensors are not visualizing, the sensors are detecting the flow of gas, and the dense array of sensors provides the visualization of the impact zone. Applicant has amended claim 1 to clarify this aspect.” How does this explain what a visualization is? If the spray is visible, does that mean you can see it? If that’s the case, what does “seeing”, by the eye or a camera image, have to do with a flow sensor? Do you note the flow rate at which the spray becomes visible? Figure 1 shows a spray S hitting a receiving surface 10 which has openings 11 that receive the spray and the spray travels through tubes 12 to sensors 30, and eventually sensors 20. The data obtained from these sensors is sent to an analysis device 40. Sensors 20 are disclosed to be mass flow sensors. There is no disclosure of what type of sensors “sensors 30” are, and 30 is also disclosed to be filters, which would make more sense based upon the structure shown in Figure 1, so we will assume that flow sensors 20 data is used. Flow sensors produce flow rate data or mass flow rate data. How is that the same as or equivalent to a visualization? Once the spray travels to the sensor 20, a flow rate of the spray into to flow sensors would be obtained. How is this considered a visualization? Figure 2 is a display or results obtained from the flow sensor data. There is no “visualization” result shown and no disclosure of what the visualization is or how a flow rate is related to a visualization. The results display in Figure 2 shows a wide range of results that appear to be obtained from the analysis based on the sensors data obtained, but what exactly all that information depicted is, isn’t quite disclosed or known. Even in the sections cited by the Applicant, there is no disclosure of what a visualization is or how a flow sensor would determine a visualization. Thus, the arguments do not address or answer the questions originally posed by the Examiner and the rejection is thus being maintained. 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 RODNEY T FRANK whose telephone number is (571)272-2193. The examiner can normally be reached M-F 9am-5:30pm. 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, Peter Macchiarolo can be reached at (571) 272-2375. 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. RODNEY T. FRANK Examiner Art Unit 2855 /PETER J MACCHIAROLO/Supervisory Patent Examiner, Art Unit 2855 March 11, 2026
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Prosecution Timeline

Nov 09, 2023
Application Filed
Nov 05, 2025
Non-Final Rejection — §112
Feb 13, 2026
Response Filed
Mar 09, 2026
Final Rejection — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
73%
Grant Probability
76%
With Interview (+3.6%)
3y 3m
Median Time to Grant
Moderate
PTA Risk
Based on 913 resolved cases by this examiner. Grant probability derived from career allow rate.

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