Prosecution Insights
Last updated: August 16, 2026
Application No. 18/945,863

SYSTEMS AND METHODS FOR PRODUCING SMALL-SCALE MIXERS FOR DRUG MANUFACTURING

Non-Final OA §103
Filed
Nov 13, 2024
Priority
Nov 13, 2023 — provisional 63/548,260
Examiner
PATEL, VISHAL I
Art Unit
1746
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Regeneron Pharmaceuticals Inc.
OA Round
1 (Non-Final)
79%
Grant Probability
Favorable
1-2
OA Rounds
10m
Est. Remaining
89%
With Interview

Examiner Intelligence

Grants 79% — above average
79%
Career Allowance Rate
643 granted / 816 resolved
+13.8% vs TC avg
Moderate +10% lift
Without
With
+10.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
34 currently pending
Career history
838
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
57.3%
+17.3% vs TC avg
§102
17.1%
-22.9% vs TC avg
§112
21.3%
-18.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 816 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 . Election/Restrictions Applicant's election with traverse of species (a) in the reply filed on 05/19/2026 is acknowledged. The traversal is on the ground(s) that searching the species together would not be a serious on the Examiner, as any search for species (a) will generate results relevant to species (b) and (c). This is not found persuasive because: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. The requirement is still deemed proper and is therefore made FINAL. 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, 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dawson et al. (US Pub. No.: 2015/0165675 A1) (hereinafter Dawson) and further in view of Myrick (US Pub. No.: 2023/0271248 A1) (hereinafter Myrick). Regarding claims 1 and 7 Dawson discloses a 3D printing system, comprising: at least one three-dimensional (3D) printer (Fig. 3) which is capable of producing a first and second set of predetermined components with a respective first attribute and second attribute of the small-scale mixer that replicate operation of corresponding components of the second mixer; at least one follower assembly (310) (corresponding to smoothing apparatus) configured to smooth a surface of the components of the small-scale mixer produced by the at least one 3D printer (Fig. 3; ¶0060-¶0061). Dawson is silent about a fusing apparatus configured to fuse the smoothed components of the small-scale mixer to produce the small-scale mixer. Myrick also discloses a three-dimensional printer for manufacturing composition. The system discloses the use of fusing or sintering apparatus such as UV heating, microwave or curing lamp to fuse the green body produced by 3D printer. The additive-formed and/or 3D-formed product or object with reactive polymer or oligomer components may be cured or fused by subsequent heat treatment, such as in an oven, light energy application or microwave heating (¶0010, ¶0024). Thus, the use of fusing device is well known within the art. Give the wealth of knowledge, it would have been obvious to a person of ordinary skill in the art to utilize fusing apparatus as taught by Myrick within the system of producing a 3D printer object. The benefit of doing so would have been to cure and fuse the final product. Regarding claim 9, Dawson discloses the use of laser assembly (515) (corresponding to heat gun) which causes a local heating effect and induces melting (¶0064-¶0067). Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dawson and Myrick as applied to claims 1, 7 and 9 above, and further in view of Peter et al. (US Pub. No.: 2018/0370147 A1) (hereinafter Peter). Regarding claim 2, the limitations of claim 1 are taught by the combined teaching of Dawson and Myrick. They are both silent about limitation of claim 2. Peter discloses a 3D printing device. The printing device has printhead (22) with two discharge devices (24) (Fig. 2). A discharge device (24) is executed as a jetting nozzle (28). The jetting nozzle (28) places the print materials (42) in the form of individual droplets or voxels (44). The other discharge device (24) is configured as a dispenser (26) and places the print materials (42) in the form of strands (46) (Fig. 2; ¶0115). The benefit of doing so would have been to utilize two different forms depending on final design. Given the wealth of knowledge, it would have been obvious to a person of ordinary skill in the art to utilize discharge device with two different form such as droplets and strands as taught by Peter within the 3D system as taught by the combined teaching of Dawson and Myrick. The benefit of doing so would have been to used the ability to print droplets or strands during 3D printing. Claim(s) 3-6, 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dawson and Myrick as applied to claim 1, 7 and 9 above, and further in view of Vo et al. (US Pub. No.: 2022/0040926 A1) (hereinafter Vo). Regarding claims 3-6, 8 and 10, the limitations of claim 1 are taught by the combined teaching of Dawson and Myrick as cited above. They are both silent about limitations of claims 3-6 and 10. Vo discloses a systems for producing a small-scale mixer. Vo discloses generating the small-scale mixer using the first dimensions and the second dimensions using a three-dimensional printer. The system includes a three-dimensional printer configured to produce the small-scale mixer having first dimensions based on a respective dimension of an at-scale mixer and based on second dimensions independent of the dimensions of the at-scale mixer. The system also includes a smoothing apparatus that smooths a surface of the small-scale mixer (¶0004). Vo further disclose the dimensions attribute are size and scale (¶0029) and the mixer has a fill volume of about 2 liter (¶0029) (corresponding to 50 L or less). Vo further discloses a first computer system coupled to the at least one 3D printer, the first computer system configured to store at least one 3D model of the components of the small-scale mixer and to communicate the at least one 3D model to the at least one 3D printer; and a second computer system coupled to the first computer system, the second computer system configured to generate the at least one 3D model, wherein generating the at least one 3D model uses a scaling factor relating a plurality of dimensions of the at least one 3D model to a plurality of dimensions of a second mixer, wherein plurality of dimensions comprise one or more of tank and an impeller (¶0029 and ¶0032). Vo additionally discloses a smoothing apparatus can be solvent bath or mechanical smoothing device such friction heads configured to deburr, sand, and polish the 3D shapes. The benefit of doing so would have been to produce small-scale mixer which can be used for manufacturing pharmaceutical products. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to VISHAL I PATEL whose telephone number is (571)270-7660. The examiner can normally be reached M-F: 9-5. 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, Michael Orlando can be reached at (571) 270-5038. 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. /VISHAL I PATEL/Primary Examiner, Art Unit 1746
Read full office action

Prosecution Timeline

Nov 13, 2024
Application Filed
Aug 03, 2026
Non-Final Rejection mailed — §103 (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

1-2
Expected OA Rounds
79%
Grant Probability
89%
With Interview (+10.3%)
2y 7m (~10m remaining)
Median Time to Grant
Low
PTA Risk
Based on 816 resolved cases by this examiner. Grant probability derived from career allowance rate.

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