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 .
Acknowledgments
In the reply, filed on April 6, 2026, Applicant amended claims 16, 20-22, 29, 31-32, and 34-35.
In the non-final rejection of January 9, 2026, Examiner noted that the information disclosure statement filed November 25, 2024, fails to comply with 37 CFR 1.98(a)(2). Applicant did not address the concern in the reply. Concern is maintained.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 16, 20-21, 32, and 34. Applicant amended claims 16, 20-21, 32, and 34; however, Applicant did not address all of the objections. Objection is maintained.
Currently, claims 16-21 and 32-34 are under examination.
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
Claim Objections
Claim 32 is objected to because of the following informalities:
In regards to claim 32, line 31, “the at least one spring member” should be changed to “the at least one compliant spring member”.
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 Schneider et al (US 2014/0052075).
In regards to claim 16, Schneider et al teaches a system (Figures 1-9) for a drug delivery device, the system comprising:
a housing (3/14) comprising at least one bayonet feature (65) and at least one ramp shaped housing coding element (52) selected from a group of at least two different ramp shaped housing coding elements (it is noted that claim 16 is drawn to a system comprising a housing comprising at least one ramp shaped housing coding element; however, “a group of at least two different ramp shaped housing coding elements” is not a positively recited structure of the claimed system. Schneider et al teaches the claimed system comprising a housing comprising at least one ramp shaped housing coding element which has the ability to be selected from a group of at least two different ramp shaped housing coding elements, as claimed)
a cartridge holder (2) comprising at least one counter bayonet feature (64) mating with the at least one bayonet feature of the housing and at least one ramp shaped holder coding element (63) selected from a group of at least two different ramp shaped holder coding elements (it is noted that claim 16 is drawn to a system comprising a cartridge holder comprising at least one ramp shaped holder coding element; however, “a group of at least two different ramp shaped holder coding elements” is not a positively recited structure of the claimed system. Schneider et al teaches the claimed system comprising a cartridge holder comprising at least one ramp shaped holder coding element which has the ability to be selected from a group of at least two different ramp shaped holder coding elements, as claimed)
wherein the cartridge holder is releasably attachable to the housing when the at least one ramp shaped housing coding element of the housing matches with the at least one ramp shaped holder coding element of the cartridge holder (paragraph [0117]), whereas a full attachment of the cartridge holder to the housing is prevented when the at least one ramp shaped housing coding element of the housing does not match with the at least one ramp shaped holder coding element of the cartridge holder (it is understood that if the at least one ramp shaped housing coding element 52 did not match with the at least one ramp shaped holder coding element 63, the cartridge holder 2 would not fully attach to the housing 3/14)
wherein the cartridge holder is releasably attachable to the housing by at least one bayonet type attachment interface (65/64) through an attachment movement comprising a first stage and a second stage, wherein the at least one bayonet type attachment interface comprises the at least one bayonet feature of the housing and the at least one counter bayonet feature of the cartridge holder, wherein the first stage comprises at least an axial movement component of the cartridge holder relative to the housing, and the second stage comprises at least a rotational movement component of the cartridge holder relative to the housing (paragraphs [0128]-[0134])
at least one compliant spring member (10) located between the cartridge holder and the housing, wherein the at least one compliant spring member is arranged and designed such that the at least one compliant spring member is strained during the first stage and/or the second stage of the attachment movement at least when the at least one ramp shaped housing coding element does not match the at least one ramp shaped holder coding element (it is understood that if the at least one ramp shaped housing coding element 52 did not match with the at least one ramp shaped holder coding element 63, the at least one compliant spring member 10 is capable of being strained by improperly fitting structures of the cartridge holder 2 within the housing 3/14)
wherein the at least one 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 at least one compliant spring member is relaxing (paragraph [0141])
In regards to claim 17, Schneider et al teaches wherein the at least one compliant spring member is a spring washer (10).
In regards to claim 18, Schneider et al teaches wherein when a cartridge is retained in the cartridge holder:
the spring washer is arranged in the housing so as to exert a force on the cartridge
the cartridge holder is fully attached to the housing to secure the cartridge against an axial movement with respect to the cartridge holder (paragraphs [0137][0138])
In regards to claim 19, Schneider et al teaches wherein the spring washer comprises fixing elements (9) extending in an axial direction for fixing the spring washer within the housing (Figure 6).
In regards to claim 32, Schneider et al teaches a drug delivery device (Figures 1-9) comprising:
a cartridge (6) containing a medicament (paragraph [0091]: drug)
a housing (3/14) comprising at least one bayonet feature (65) and at least one ramp shaped housing coding element (52) selected from a group of at least two different ramp shaped housing coding elements (it is noted that claim 32 is drawn to a drug delivery device comprising a housing comprising at least one ramp shaped housing coding element; however, “a group of at least two different ramp shaped housing coding elements” is not a positively recited structure of the claimed drug delivery device. Schneider et al teaches the claimed drug delivery device comprising a housing comprising at least one ramp shaped housing coding element which has the ability to be selected from a group of at least two different ramp shaped housing coding elements, as claimed)
a cartridge holder (2) holding the cartridge and comprising at least one counter bayonet feature (64) mating with the at least one bayonet feature of the housing and at least one ramp shaped holder coding element (63) selected from a group of at least two different ramp shaped holder coding elements (it is noted that claim 32 is drawn to a drug delivery device comprising a cartridge holder comprising at least one ramp shaped holder coding element; however, “a group of at least two different ramp shaped holder coding elements” is not a positively recited structure of the claimed drug delivery device. Schneider et al teaches the claimed drug delivery device comprising a cartridge holder comprising at least one ramp shaped holder coding element which has the ability to be selected from a group of at least two different ramp shaped holder coding elements, as claimed)
wherein the cartridge holder is releasably attachable to the housing when the at least one ramp shaped housing coding element of the housing matches with the at least one ramp shaped holder coding element of the cartridge holder (paragraph [0117]), whereas a full attachment of the cartridge holder to the housing is prevented when the at least one ramp shaped housing coding element of the housing does not match with the at least one ramp shaped holder coding element of the cartridge holder (it is understood that if the at least one ramp shaped housing coding element 52 did not match with the at least one ramp shaped holder coding element 63, the cartridge holder 2 would not fully attach to the housing 3/14)
wherein the cartridge holder is releasably attachable to the housing by at least one bayonet type attachment interface (65/64) through an attachment movement comprising a first stage and a second stage, wherein the at least one bayonet type attachment interface comprises the at least one bayonet feature of the housing and the at least one counter bayonet feature of the cartridge holder, wherein the first stage comprises at least an axial movement component of the cartridge holder relative to the housing, and the second stage comprises at least a rotational movement component of the cartridge holder relative to the housing (paragraphs [0128]-[0134])
at least one compliant spring member (10) located between the cartridge holder and the housing, wherein the at least one compliant spring member is arranged and designed such that the at least one compliant spring member is strained during the first stage and/or the second stage of the attachment movement at least when the at least one ramp shaped housing coding element does not match the at least one ramp shaped holder coding element (it is understood that if the at least one ramp shaped housing coding element 52 did not match with the at least one ramp shaped holder coding element 63, the at least one compliant spring member 10 is capable of being strained by improperly fitting structures of the cartridge holder 2 within the housing 3/14)
wherein the at least one 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 at least one spring member is relaxing (paragraph [0141])
In regards to claim 33, Schneider et al teaches wherein the at least one compliant spring member is a spring washer (10)
wherein the spring washer is arranged in the housing so as to exert a force on the cartridge
wherein the cartridge holder is fully attached to the housing to secure the cartridge against an axial movement with respect to the cartridge holder (paragraphs [0137][0138])
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 Schneider 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, Schneider 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 at least one ramp shaped housing coding element does not match the at least one ramp shaped 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 at least one housing coding element (214) does not match at least one 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 Schneider 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 at least one housing coding element does not match the at least one 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 the combination of Schneider et al and Cerman et al, the at least one housing coding element and the at least one holder coding element are at least one ramp shaped housing coding element and at least one ramp shaped holder coding element, as taught by Schneider et al.
In regards to claim 21, in the modified system of Schneider et al and Cerman et al, Schneider 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 at least one ramp shaped housing coding element of the housing matches with the at least one ramp shaped 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 at least one housing coding element of the housing matches with the at least one 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 Schneider 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 at least one housing coding element of the housing matches with the at least one 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 the combination of Schneider et al and Cerman et al, the at least one housing coding element and the at least one holder coding element are at least one ramp shaped housing coding element and at least one ramp shaped holder coding element, as taught by Schneider et al.
In regards to claim 34, Schneider 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 at least one ramp shaped housing coding element does not match the at least one ramp shaped 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 at least one housing coding element (214) does not match at least one 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 Schneider 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 at least one housing coding element does not match the at least one 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 the combination of Schneider et al and Cerman et al, the at least one housing coding element and the at least one holder coding element are at least one ramp shaped housing coding element and at least one ramp shaped holder coding element, as taught by Schneider et al.
Response to Arguments
Applicant’s arguments with respect to claims 16-21 and 32-34 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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