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
Applicant’s election without traverse of Species I (Figure 3) in the reply filed on November 13, 2025, is acknowledged.
Claims 22-31 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Species II-IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 13, 2025,
Currently, claims 16-21 and 32-34 are under examination as readable upon elected Species I (Figure 3).
Information Disclosure Statement
The information disclosure statement filed November 25, 2024, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
The entire RU 2016111378 document, including Drawings, has not been provided
The entire RU 2017134127 document, including Drawings, has not been provided
Specification
The abstract of the disclosure is objected to because:
In line 1, “device comprising” should be changed to “device, the system comprising”
In line 7, “it” should be changed to “the at least one compliant spring member”
In line 7, “the first” should be changed to “the first stage”
In line 8, “the housing coding element” should be changed to “a housing coding element”
In line 8, “the holder coding element” should be changed to “a holder coding element”
In lines 8-9, “the compliant spring member” should be changed to “the at least one compliant spring member”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 16, 20-21, 32, and 34 are objected to because of the following informalities:
In regards to claim 16, line 1, “device comprising:” should be changed to “device, the system comprising:”.
In regards to claim 16, lines 6-7, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 16, line 7, “the holder coding element” should be changed to “the at least one holder coding element”.
In regards to claim 16, line 9, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 16, lines 9-10, “the holder coding element” should be changed to “the at least one holder coding element”.
In regards to claim 16, line 10, “a cartridge holder” should be changed to “the cartridge holder”.
In regards to claim 16, line 17, “it” should be changed to “the at least one compliant spring member”.
In regards to claim 16, lines 18-19, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 16, line 19, “the holder coding element” should be changed to “the at least one holder coding element”.
In regards to claim 16, line 20, “the compliant spring member” should be changed to “the at least one compliant spring member”.
In regards to claim 16, lines 21-22, “the compliant spring member” should be changed to “the at least one compliant spring member”.
In regards to claim 20, line 3, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 20, line 4, “the holder coding element” should be changed to “the at least one holder coding element”.
In regards to claim 21, lines 2-3, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 21, line 3, “the holder coding element” should be changed to “the at least one holder coding element”.
In regards to claim 32, lines 7-8, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 32, line 8, “the holder coding element” should be changed to “the at least one holder coding element”.
In regards to claim 32, line 10, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 32, lines 10-11, “the holder coding element” should be changed to “the at least one holder coding element”.
In regards to claim 32, line 11, “a cartridge holder” should be changed to “the cartridge holder”.
In regards to claim 32, line 18, “it” should be changed to “the at least one compliant spring member”.
In regards to claim 32, lines 19-20, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 32, line 20, “the holder coding element” should be changed to “the at least one holder coding element”.
In regards to claim 32, line 21, “the compliant spring member” should be changed to “the at least one compliant spring member”.
In regards to claim 32, lines 22-23, “the spring member” should be changed to “the at least one compliant spring member”.
In regards to claim 34, line 3, “the housing coding element” should be changed to “the at least one housing coding element”.
In regards to claim 34, line 4, “the holder coding element” should be changed to “the at least one holder coding element”.
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.
Claims 16-19 and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plumptre et al (US 9,835,279).
In regards to claim 16, Plumptre et al teaches a system (Figures 2-5) for a drug delivery device comprising:
a housing (100) comprising at least one housing coding element (210) selected from a group of at least two different housing coding elements (210, 214, 218)
a cartridge holder (200) comprising at least one holder coding element (204) selected from a group of at least two different holder coding elements (204, 212, 216)
wherein the cartridge holder is releasably attachable to the housing when the housing coding element of the housing matches with the holder coding element of the cartridge holder (Figure 4), whereas a full attachment of the cartridge holder to the housing is prevented when the housing coding element of the housing does not match with the holder coding element of a cartridge holder (Figure 5)
wherein the cartridge holder is releasably attachable to the housing by at least one bayonet type attachment interface (202, 204, 210) through an attachment movement comprising a first stage (Figures 2-3) and a second stage (Figures 3-4), wherein the first stage comprises at least an axial movement component of the cartridge holder relative to the housing (Figures 2-3), and the second stage comprises at least a rotational movement component of the cartridge holder relative to the housing (Figures 3-4)
at least one compliant spring member (206, 208) arranged and designed such that it is strained during the first stage and/or the second stage of the attachment movement at least when the housing coding element does not match the holder coding element (Figure 5)
wherein the compliant spring member is arranged and designed to move the cartridge holder relative to the housing in a direction contrary to the attachment movement when the compliant spring member is relaxing (Figure 2)
In regards to claim 17, Plumptre et al teaches wherein the at least one compliant spring member is a spring washer (206).
In regards to claim 18, Plumptre et al teaches wherein when a cartridge (120) is retained in the cartridge holder:
the spring washer is arranged in the housing so as to exert a force on the cartridge (Figure 4)
the cartridge holder is fully attached to the housing to secure the cartridge against an axial movement with respect to the cartridge holder (Figure 4)
In regards to claim 19, Plumptre et al teaches wherein the spring washer comprises fixing elements (210, 208) extending in an axial direction for fixing the spring washer within the housing (Figure 4).
In regards to claim 32, Plumptre et al teaches a drug delivery device (Figures 2-5) comprising:
a cartridge (120) containing a medicament (125)
a housing (100) comprising at least one housing coding element (210) selected from a group of at least two different housing coding elements (210, 214, 218)
a cartridge holder (200) holding the cartridge and comprising at least one holder coding element (204) selected from a group of at least two different holder coding elements (204, 212, 216)
wherein the cartridge holder is releasably attachable to the housing when the housing coding element of the housing matches with the holder coding element of the cartridge holder (Figure 4), whereas a full attachment of the cartridge holder to the housing is prevented when the housing coding element of the housing does not match with the holder coding element of a cartridge holder (Figure 5)
wherein the cartridge holder is releasably attachable to the housing by at least one bayonet type attachment interface (202, 204, 210) through an attachment movement comprising a first stage (Figures 2-3) and a second stage (Figures 3-4), wherein the first stage comprises at least an axial movement component of the cartridge holder relative to the housing (Figures 2-3), and the second stage comprises at least a rotational movement component of the cartridge holder relative to the housing (Figures 3-4)
at least one compliant spring member (206, 208) arranged and designed such that it is strained during the first stage and/or the second stage of the attachment movement at least when the housing coding element does not match the holder coding element (Figure 5)
wherein the compliant spring member is arranged and designed to move the cartridge holder relative to the housing in a direction contrary to the attachment movement when the spring member is relaxing (Figure 2)
In regards to claim 33, Plumptre et al teaches wherein the at least one compliant spring member is a spring washer (206),
wherein the spring washer is arranged in the housing so as to exert a force on the cartridge (Figure 4)
wherein the cartridge holder is fully attached to the housing to secure the cartridge against an axial movement with respect to the cartridge holder (Figure 4)
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.
Claims 20-21 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre et al, as applied to claims 17 and 33 above, and further in view of Cerman et al (US 2013/0253427).
In regards to claim 20, Plumptre et al does not teach wherein at least one rib is formed on an inner wall of the cartridge holder, wherein the at least one rib is located so that, when the housing coding element does not match the holder coding element, at least at an end of the first stage of the attachment movement, an end surface of the at least one rib engages and compresses the spring washer. Cerman et al teaches a system (Figures 5-7) for a drug delivery device, wherein at least one rib (222) is formed on an inner wall of a cartridge holder (220), wherein the at least one rib is located so that, when a housing coding element (214) does not match a holder coding element (222), at least at an end of a first stage of an attachment movement, an end surface of the at least one rib engages and compresses a spring washer (216, 218) (paragraph [0063]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system, of Plumptre et al, with at least one rib formed on an inner wall of the cartridge holder, wherein the at least one rib is located so that, when the housing coding element does not match the holder coding element, at least at an end of the first stage of the attachment movement, an end surface of the at least one rib engages and compresses the spring washer, as taught by Cerman et al, as such will interact with a key validation part of the housing when an upper part of the cartridge holder is brought together with a lower part of the housing (paragraph [0055), wherein if the at least one rib of the cartridge holder is not matched to the key validation part of the housing, the cartridge holder will be prevented from screwing into the housing (paragraph [0063]) in order to support the use of matching components (Abstract).
In regards to claim 21, in the modified system of Plumptre et al and Cerman et al, Plumptre et al does not teach wherein the at least one rib is located in the cartridge holder such that the at least one rib does not compress the spring washer when the housing coding element of the housing matches with the holder coding element of the cartridge holder. Cerman et al teaches wherein the at least one rib is located in the cartridge holder such that the at least one rib does not compress the spring washer when the housing coding element of the housing matches with the holder coding element of the cartridge holder (Figure 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system, of Plumptre et al and Cerman et al, with wherein the at least one rib is located in the cartridge holder such that the at least one rib does not compress the spring washer when the housing coding element of the housing matches with the holder coding element of the cartridge holder, as taught by Cerman et al, as such will interact with a key validation part of the housing when an upper part of the cartridge holder is brought together with a lower part of the housing (paragraph [0055), wherein if the at least one rib of the cartridge holder is matched to the key validation part of the housing, a user is able to screw the cartridge holder into the housing (paragraph [0061]) in order to support the use of matching components (Abstract).
In regards to claim 34, Plumptre et al does not teach wherein at least one rib is formed on an inner wall of the cartridge holder, wherein the at least one rib is located so that, when the housing coding element does not match the holder coding element, at least at an end of the first stage of the attachment movement, an end surface of the at least one rib engages and compresses the spring washer. Cerman et al teaches a drug delivery device (Figures 5-7), wherein at least one rib (222) is formed on an inner wall of a cartridge holder (220), wherein the at least one rib is located so that, when a housing coding element (214) does not match a holder coding element (222), at least at an end of a first stage of an attachment movement, an end surface of the at least one rib engages and compresses a spring washer (216, 218) (paragraph [0063]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of Plumptre et al, with at least one rib formed on an inner wall of the cartridge holder, wherein the at least one rib is located so that, when the housing coding element does not match the holder coding element, at least at an end of the first stage of the attachment movement, an end surface of the at least one rib engages and compresses the spring washer, as taught by Cerman et al, as such will interact with a key validation part of the housing when an upper part of the cartridge holder is brought together with a lower part of the housing (paragraph [0055), wherein if the at least one rib of the cartridge holder is not matched to the key validation part of the housing, the cartridge holder will be prevented from screwing into the housing (paragraph [0063]) in order to support the use of matching components (Abstract).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783