Prosecution Insights
Last updated: April 19, 2026
Application No. 18/289,298

CODED HOUSING COMPONENTS FOR AN INJECTION DEVICE

Non-Final OA §102§103§DP
Filed
Nov 02, 2023
Examiner
SCHMIDT, EMILY LOUISE
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Sanofi
OA Round
1 (Non-Final)
59%
Grant Probability
Moderate
1-2
OA Rounds
3y 5m
To Grant
95%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allow Rate
581 granted / 992 resolved
-11.4% vs TC avg
Strong +36% interview lift
Without
With
+36.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
77 currently pending
Career history
1069
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
48.9%
+8.9% vs TC avg
§102
25.8%
-14.2% vs TC avg
§112
18.7%
-21.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 992 resolved cases

Office Action

§102 §103 §DP
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. Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 45. 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. Claim Objections Claim 34 is objected to because of the following informalities: claim 34 recites “the outer lateral extent, the outer cross-sectional geometry, or outer shape” there is insufficient antecedent basis for these limitations in the claim, claim 32 recites a lateral extent, cross-sectional geometry, or cross-sectional shape. Appropriate correction is required. Claim Rejections - 35 USC § 102 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. Claim(s) 16 -31 is/are rej ected under 35 U.S.C. 102 (a)(1) as being anticipated by Rekaya et al. (US 2019/0269855 A1) . With regard to claim s 16 -18 , 20-24, Rekaya et al. teach a housing of a drug delivery device, the housing comprising: - a first housing component (Fig. 1 member 20) configured to accommodate a cartridge filled with a medicament, the first housing component comprising a first connecting end (Fig. 4 end 23) , - a second housing component (Fig. 3 member 30) configured to accommodate a drive mechanism of the drug delivery device, the second housing component comprising a second connecting end (Fig. 3 end 33) , - an insert (Fig. 4 member 21) provided on one of the first connecting end or the second connecting end, - a receptacle (Fig. 3 member 31) provided on the other one of the first connecting end or the second connecting end, wherein the insert is insertable into the receptacle along a longitudinal direction for mutually fastening the first housing component and the second housing component, - a fastening element provided on the insert (Fig. 4 member 24) , - a counter fastening element having a complementary shape to the fastening element, the counter fastening element provided in the receptacle (Fig. 3 member 34) , - a mechanical coding provided on the insert and comprising a coding feature, wherein the mechanical coding comprises one of a lateral extent of the coding feature or a cross-sectional geometry or shape of the coding feature in a plane transverse to the longitudinal direction (Fig. 4 one of projection s 120 defined by an outer diameter, cross-section, or shape of the insert ) , - a mechanical counter coding provided in the receptacle and comprising a counter coding feature, wherein the mechanical counter coding comprises one of a lateral extent of the counter coding feature or a cross-sectional geometry or shape of the counter coding feature in the plane transverse to the longitudinal direction (Fig. 3 one of groove s 130 defined by an inner diameter, cross-section, or shape of the receptacle ) , - wherein the mechanical coding and the mechanical counter coding are operable to prevent an engagement of the fastening element with the counter fastening element when the mechanical coding does not match the mechanical counter coding (if the groove and projection do not match the components are not able to mate and fasten the fastening elements , this would occur if the outer diameter, cross-section, or shape of the insert was too larger ) . With regard to claim 19, insert portion 21 has a different extent, geometry, and shape than the sidewall of portion 122 (Fig. 4). With regard to claim s 25-27, see Fig. 6 snap engagement of 24 and 34, if the insert is too small the components would not attach . With regard to claim 28, a second of members 120 and 130 (Figs. 3-5). With regard to claim s 2 9 and 30 , insert portion 21 has a different extent, geometry, and shape than the sidewall of portion 122 (Fig. 4) , the diameter of the insert includes the flange between 21 and 122 making a diameter of the insert larger than a diameter of 122 . With regard to claim 31, Rekaya et al. teach a n injection device for injecting a dose of a medicament and comprising the housing of claim 16, the injection device comprising: - the housing (see the rejection of claim 16 above) ,- the cartridge (Fig. 1 member 50) arranged inside the housing, the cartridge comprising a barrel filled with the medicament and sealed in a proximal longitudinal direction by a movable bung (Fig. 2 bung 52) , and - the drive mechanism (Fig. 1 member 5) arranged inside the housing, the drive mechanism comprising a piston rod (Fig. 1 member 110) operable to exert a distally directed dispensing force onto the bung of the cartridge. Claim Rejections - 35 USC § 103 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. C laim(s) 32 -34 is/are reje cted under 35 U.S.C. 103 as being unpatentable over Rekaya et al. (US 2019/0269855 A1) in view of Sanofi (EP 3 597 236 A1). With regard to claim 32 , Rekaya et al. teach a kit of parts comprising: a first housing o comprising: - a first housing component (Fig. 1 member 20) configured to accommodate a cartridge filled with a medicament, the first housing component comprising a first connecting end (Fig. 4 end 23) , - a second housing component (Fig. 3 member 30) configured to accommodate a drive mechanism of the drug delivery device, the second housing component comprising a second connecting end (Fig. 3 end 33) , - an insert (Fig. 4 member 21) provided on one of the first connecting end or the second connecting end, - a receptacle (Fig. 3 member 31) provided on the other one of the first connecting end or the second connecting end, wherein the insert is insertable into the receptacle along a longitudinal direction for mutually fastening the first housing component and the second housing component, - a fastening element provided on the insert (Fig. 4 member 24) , - a counter fastening element having a complementary shape to the fastening element, the counter fastening element provided in the receptacle (Fig. 3 member 34) , - a mechanical coding provided on the insert and comprising a coding feature, wherein the mechanical coding comprises one of a lateral extent of the coding feature or a cross-sectional geometry or shape of the coding feature in a plane transverse to the longitudinal direction (Fig. 4 one of projections 120 defined by an outer diameter, cross-section, or shape of the insert) , - a mechanical counter coding provided in the receptacle and comprising a counter coding feature, wherein the mechanical counter coding comprises one of a lateral extent of the counter coding feature or a cross-sectional geometry or shape of the counter coding feature in the plane transverse to the longitudinal direction (Fig. 3 one of grooves 130 defined by an inner diameter, cross-section, or shape of the receptacle) , - wherein the mechanical coding and the mechanical counter coding are operable to prevent an engagement of the fastening element with the counter fastening element when the mechanical coding does not match the mechanical counter coding (if the groove and projection do not match the components are not able to mate and fasten the fastening elements, this would occur if the outer diameter, cross-section, or shape of the insert was too larger) . Rekaya et al. do not explicitly disclose a second housing as recited. However, Sanofi teaches a coded cartridge assembly and that a plurality of assemblies may be provided which differ in configuration of the interface features such that if the features match assembly is allowed and if not, the connection is denied. Cartridge assemblies may be different and the fixing may be different to distinguish the members ([0069]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention To use a kit with a second housing as recited having components as in the first housing except for coding features which are distinguished from each other in Rekaya et al. as Sanofi teaches this is beneficial to provide a plurality of assemblies for delivery and ensures only assemblies with matching features are connected for delivery . This may allow a patient to have additional does and medications depending on treatment. With regard to claim 3 3 , insert portion 21 has a diameter which includes the flange between 21 and 122 making a diameter of the insert larger than an inner geometry of the receptacle, additionally a lateral extent of the insert can be considered which is larger than an inner lateral extent of the receptacle . With regard to claim 3 4 , as the insert fits into the receptacle it has an outer feature which is smaller than an inner feature less a radial extent of a protrusion of 24 (Fig. 6). Double Patenting Claims 16, 25, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of copending Application No. 18/289,008 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application are more specific and teach the limitations of the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 16 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 24 of copending Application No. 18/288,4 50 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application are more specific and teach the limitations of the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Van Bulow et al. (US 2009/0254043 A1) and Einwachter (US 2015/0073350 A1) disclosing coded cartridge housings. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT EMILY L SCHMIDT whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3648 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday through Thursday 7:00 AM to 4:30 PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kevin Sirmons can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-4965 . 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. /EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Nov 02, 2023
Application Filed
Feb 20, 2026
Non-Final Rejection — §102, §103, §DP (current)

Precedent Cases

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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
59%
Grant Probability
95%
With Interview (+36.0%)
3y 5m
Median Time to Grant
Low
PTA Risk
Based on 992 resolved cases by this examiner. Grant probability derived from career allow rate.

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