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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/16/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 09/16/2026. As directed by the amendment: claims 7 and 15 have been amended. Claims 3 and 8 are cancelled.
Thus, claims 1, 2, 4-7 & 9-15 are pending in this application.
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 1, 2, 4, 6 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rossitto et al (US 20170065763 A1).
Regarding claim 1, Rossitto et al disclose a cartridge adapter (312 in fig 6A) for a drug delivery device (310), the cartridge adapter comprising: a body (346) having a first end (see annotated figure below) and a second end (see annotated figure below) positioned opposite the first end, the body comprising a first clamp member (see annotated figure below), a second clamp member (see annotated figure below) spaced from the first clamp member, and a connection interface (352) configured to be received by a recess (322) inside a housing (318) of a drug delivery device (para 0072), wherein the first and second clamp members are moveable relative to each other (para 0086) and configured to receive and engage a plurality of different sized cartridges for a drug delivery device (para 0085-86), wherein the first and second clamp members are configured to exhibit a biasing force against each cartridge of the plurality of different sized cartridges after engagement therewith (para 0088-89), and wherein the body and the first and second clamp members are integrally co-formed with each other (figs 11A-B).
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Regarding claim 2, Rossitto et al disclose the cartridge adapter of claim 1, wherein the first clamp member extends from the first end of the body to the second end of the body, and wherein the second clamp member extends from the first end of the body to the second end of the body (see annotated figure above).
Regarding claim 4, Rossitto et al disclose the cartridge adapter of claim 1, wherein the connection interface (352) comprises a dovetail (see fig 8A).
Regarding claim 6, Rossitto et al disclose the cartridge adapter of claim 1, wherein the body, the first and second clamp members, and the connection interface are integrally formed with each other (see figs 11A-B and annotated figure above).
Regarding claim 14, Rossitto et al disclose the cartridge adapter of claim 1, wherein the connection interface (352) of the body is configured to extend substantially fully within the recess inside the housing of a drug delivery device (para 0075, fig 6A-B).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rossitto et al (US 20170065763 A1) in view of Nemoto et al (US 20040249276 A1).
Regarding claim 5, Rossitto et al disclose the limitations of claim 1 but fail to teach wherein the first and second clamp members are arcuate.
However, Nemoto discloses an adapter (400) comprising a first clamp and a second clamp (401) wherein the first and second clamp members are arcuate (figs 2a-b).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the clamps of Rossitto et al to be arcuate as taught by Nemoto. This would provide the benefit of having a suitable shape that correspond to the shape of the cartridge (figs 2a-b, para 0010).
Claims 9-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Burren et al (EP 3656418 A1) in view of Rossitto et al (US 20170065763 A1).
Regarding claim 7, Burren et al disclose a drug delivery device (1 in fig 1) comprising: a housing (2) including a first connection interface (25) comprising a recess inside the housing (fig 4); a first cartridge (7) to receive a medicament (abstract), the cartridge having a first diameter (fig 1); a second cartridge configured to receive a medicament, the second cartridge having a second diameter, the second diameter is larger than the first diameter (para 0017, page 4, lines 8-9: the volume adapter can be used with a plurality of cartridges having different outer dimensions without the need for a separate cartridge holder that can accommodate each specific cartridge, thus said device can comprise a second cartridge having a larger diameter than cartridge 7); a drive assembly (17) received within the housing (fig 2) and configured to engage the cartridge and dispense medicament from the cartridge (claim 1); a needle actuator assembly (para 0034, The needle insertion mechanism) comprising a patient needle, each of the needle actuator assembly and the patient needle received within the housing, wherein the patient needle is configured to pierce a patient's skin in an extended position at least partially outside of the housing (para 0013 and 0034-35); and a cartridge adapter (41) comprising a body (fig 7) having a first end (42) and a second end (43) positioned opposite the first end (fig 7), the body comprising a first clamp member (fig 7), a second clamp member spaced from the first clamp member (fig 7), and a second connection interface (lower surface of 41) configured to be received by the recess inside the housing of the drug delivery device (para 0044, fig 8), wherein the first and second clamp engaging at least one of the first cartridge and the second cartridge (para 0017, page 4, lines 8-9: the volume adapter can be used with a plurality of cartridges having different outer dimensions without the need for a separate cartridge holder that can accommodate each specific cartridge), and wherein the first and second clamp members are configured to exhibit a biasing force against the first cartridge after engagement therewith (fig 8, said adapter 41 exhibit a force against cartridge 7).
Burren et al fail to teach wherein the first and second clamp members are moveable relative to each other, and wherein the first and second clamp members are configured to exhibit a biasing force against the second cartridge after engagement therewith.
However, Rossitto et al disclose a cartridge adapter (312 in fig 6A) for a drug delivery device (310), the cartridge adapter comprising: a body (346) having a first end (see annotated figure above) and a second end (see annotated figure above) positioned opposite the first end, the body comprising a first clamp member (see annotated figure above), a second clamp member (see annotated figure above) spaced from the first clamp member, wherein the first and second clamp members are moveable relative to each other (para 0086) and configured to receive and engage a plurality of different sized cartridges for a drug delivery device (para 0085-86), wherein the first and second clamp members are configured to exhibit a biasing force against each cartridge of the plurality of different sized cartridges after engagement therewith (para 0088-89).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the first and second clamp members of Burren et al moveable relative to each other, the first and second clamp members receiving, and wherein the first and second clamp members are configured to exhibit a biasing force against the second cartridge after engagement therewith as taught by Rossitto et al. This would provide the benefit of having a universal adapter configured to hold cartridges having different diameters by making said clamps movable relative to each other to exert pressure on the cartridge and to maintain said second cartridge in the desired alignment (para 0085).
Regarding claim 9, Burren et al in view of Rossitto et al disclose the drug delivery device of claim 7,
Burren et al further disclose wherein the first clamp member extends from the first end of the body to the second end of the body, and wherein the second clamp member extends from the first end of the body to the second end of the body (fig 7).
Regarding claim 10, Burren et al in view of Rossitto et al disclose the drug delivery device of claim 7,
Burren et al further disclose wherein the body and the first and second clamp members are integrally formed with each other (fig 7).
Regarding claim 11, Burren et al in view of Rossitto et al disclose the limitations of claim 7 but fail to teach wherein the second connection interface comprises a dovetail.
Rossitto et al disclose an adapter (312) comprising a connection interface (352) wherein the connection interface comprises a dovetail (fig 7B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the second connection interface comprises a dovetail as taught by Rossitto et al. This would provide the benefit of having a structure to engage with said housing that is intended to provide structural support for the adapter to counteract forces imparted on the adapter by the injector piston (para 0075-76).
Regarding claim 12, Burren et al in view of Rossitto et al disclose the drug delivery device of claim 7,
Burren et al further disclose wherein the first and second clamp members are arcuate (fig 7).
Regarding claim 13, Burren et al in view of Rossitto et al disclose the drug delivery device of claim 7,
Burren et al further disclose wherein the body, the first and second clamp members, and the second connection interface are integrally formed with each other (fig 7).
Regarding claim 15, Burren et al in view of Rossitto et al disclose the drug delivery device of claim 7,
Burren et al further disclose wherein the second connection interface of the body is configured to extend substantially fully within the recess inside the housing of the drug delivery device (figs 7-8).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 09/16/2026, with respect to the rejection(s) of claim(s) 1, 2, 4-7 & 9-15 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Burren et al (EP 3656418 A1) in view of Rossitto et al (US 20170065763 A1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/29/2026
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