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 January 16, 2024, Applicant amended claims 16, 18-19, 21, and 28-32.
In the non-final rejection of March 25, 2026, Examiner noted that the information disclosure statement filed December 19, 2023, fails to comply with 37 CFR 1.98(a)(2): Upon review, Applicants note that the IDS 2023 contains the typo in the publication number of reference #7. The correct publication number is W02022/233757 published in English (Remarks, page 12). Concern is withdrawn.
Examiner objected to claims 18-19, 21, and 28-32. Applicant amended claims 18-19, 21, and 28-32. Objection is withdrawn.
Examiner rejected claim 32 under 35 U.S.C. 112(b). Applicant argued: Claim 32 has been amended to clarify the recitations and to address the Examiner's concern. In particular, claim 32 now consistently refers to the first injection device and the second injection device. Accordingly, Applicants respectfully submit that claim 32 now particularly points out and distinctly claims the subject matter regarded as the invention, and withdrawal of the rejection under 35 U.S.C. § 112(b) is respectfully requested (Remarks, page 13). Examiner disagrees. Claim 32, lines 1-2 was not amended. It is still unclear whether “injection devices” of claim 32, line 1 and “a first injection device and a second injection device” of claim 32, lines 1-2 refer to the same components or to different components. Rejection is maintained.
Claim Objections
Claim 32 is objected to because of the following informalities:
In regards to claim 32, line 55, “a further medicament container” should be changed to “a further barrel”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 32 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 32, lines 1-2 recite “a first injection device and a second injection device”. Claim 32, line 1 previously recites “injection devices”. It is unclear whether the two recitations refer to the same components or to different components.
In regards to claim 32, line 59 recites “the further barrel”. There is insufficient antecedent basis for this limitation in the claim.
Examiner notes that originally “a further barrel” in claim 32, line 55, provided antecedent basis for “the further barrel” in claim 32, line 59; however amending “a further barrel” of claim 32, line 55, to “a further medicament container” eliminated said antecedent basis.
Examiner suggests changing “a further medicament container” of claim 32, line 55, back to “a further barrel” in order to provide antecedent basis for “the further barrel” in claim 32, line 59.
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 16-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osman et al (US 9,731,085).
In regards to claim 16, Osman et al teaches a housing (Figures 2, 5a-8b) of a drug delivery device, the housing comprising:
a first housing component (200) comprising a first connecting end provided with a fastening element (210/212), the first housing component being shaped and configured to accommodate a medicament container (column 12, lines 26-27), the medicament container comprising a mechanical coding and an alignment element (Figure 2)
a second housing component (202) configured to accommodate a drive mechanism of the drug delivery device (column 14, lines 27-28) and comprising a second connecting end provided with a counter fastening element (236) complementary shaped to the fastening element, the second connecting end being connectable to the first connecting end (Figures 5a-8b)
a counter alignment element (216) complementary shaped to the alignment element and provided in or on the first housing component (Figure 2)
a mechanical counter coding (232) provided in or on the second housing component
wherein when the medicament container is arranged in the first housing component and when the mechanical coding does not match the mechanical counter coding, the mechanical coding and the mechanical counter coding are operable to prevent an engagement of the fastening element with the counter fastening element (column 11, lines 51-54)
wherein the mechanical counter coding is one of longitudinally or tangentially offset from the counter fastening element (Figure 5a)
In regards to claim 17, Osman et al teaches wherein the first connecting end comprises a first sidewall (204) and wherein the second connecting end comprises a second sidewall (202), and wherein one of the first connecting end and the second connecting end comprises an insert (proximal portion of 204 having 216), and wherein the other one of the first connecting end and the second connecting end comprises a receptacle (inner space of 202) complementary shaped to the insert, and wherein the insert is insertable into the receptacle along a longitudinal direction for mutually fastening the first housing component and the second housing component (Figure 5a).
In regards to claim 18, Osman et al teaches wherein the mechanical counter coding comprises at least one counter coding feature (232) and wherein the mechanical counter coding is defined by at least one of: a number of counter coding features on the second sidewall (Figures 5a-8b), a circumferential position of the counter coding features relative to the counter fastening element (Figures 5a-8b), a circumferential extent of the counter coding features (Figures 5a-8b), a radial extent of the counter coding features on the second sidewall (Figures 5a-8b), and a cross-sectional geometry or shape of the counter coding features in a plane transverse to the longitudinal direction (Figures 5a-8b).
In regards to claim 19, Osman et al teaches wherein the insert comprises a through recess (216) in one of the first sidewall or the second sidewall, the through recess being sized and shaped to receive at least one of the mechanical coding or the mechanical counter coding radially therethrough (Figure 2).
In regards to claim 20, Osman et al teaches wherein the through recess provides or forms a secondary mechanical counter coding (216) complementary shaped to the mechanical coding of the medicament container or complementary shaped to the mechanical counter coding of the second housing component (Figure 2).
In regards to claim 21, Osman et al teaches wherein when the secondary mechanical counter coding does not match the mechanical coding or the mechanical counter coding, the mechanical coding and the secondary mechanical counter coding are operable to prevent at least one of a complete insertion of the medicament container into the first housing component or a complete insertion of the insert into the receptacle (column 13, lines 19-24)(column 11, lines 51-54).
In regards to claim 22, Osman et al teaches wherein one of the fastening element and the counter fastening element comprises a fastening projection (210/212), and wherein the other one of the fastening element and the counter fastening element comprises a fastening recess (236).
In regards to claim 23, Osman et al teaches wherein the fastening projection comprises a snap element (210/212), and wherein the fastening recess comprises a counter snap element (236) complementary shaped to the snap element.
In regards to claim 24, Osman et al teaches wherein the fastening recess comprises a fastening groove comprising a first groove portion (236) and a second groove portion (234), wherein the first groove portion extends along a longitudinal direction and wherein the second groove portion extends along a circumferential direction and merges into the first groove portion (Figures 5a-8b).
In regards to claim 25, Osman et al teaches wherein one of the mechanical coding and the mechanical counter coding comprises a radial coding projection (212), and wherein the other one of the mechanical coding and the mechanical counter coding comprises a coding recess (232) complementary shaped to the radial coding projection.
In regards to claim 26, Osman et al teaches wherein the coding recess comprises a coding groove comprising a first groove portion (232) and a second groove portion (234), wherein the first groove portion extends along a longitudinal direction and wherein the second groove portion extends along a circumferential direction and merges into the first groove portion (Figures 5a-8b).
In regards to claim 27, Osman et al teaches wherein one of the alignment element and the counter alignment element comprises an alignment projection (214), and wherein the other one of the alignment element and the counter alignment element comprises an alignment recess (216) complementary shaped to the alignment projection.
In regards to claim 28, Osman et al teaches a medicament container (Figures 2, 5a-8b, cartridge 206) comprising:
a barrel (206) sized and configured for insertion into a first housing component of a housing of a drug delivery device (Figure 2), wherein the housing comprises:
the first housing component comprising a first connecting end provided with a fastening element, the first housing component being shaped and configured to accommodate the medicament container (Figure 2), the medicament container comprising a mechanical coding (212) and an alignment element (214)
a second housing component configured to accommodate a drive mechanism of the drug delivery device and comprising a second connecting end provided with a counter fastening element complementary shaped to the fastening element, the second connecting end being connectable to the first connecting end (Figure 2)
a counter alignment element complementary shaped to the alignment element and provided in or on the first housing component (Figure 2)
a mechanical counter coding provided in or on the second housing component, wherein when the medicament container is arranged in the first housing component and when the mechanical coding does not match the mechanical counter coding, the mechanical coding and the mechanical counter coding are operable to prevent an engagement of the fastening element with the counter fastening element (column 11, lines 51-54), wherein the mechanical counter coding is at least one of longitudinally or tangentially offset from the counter fastening element (Figure 5a)
the alignment element on the medicament container sized and shaped to engage with the counter alignment element of the first housing component when the barrel is inserted in a longitudinal direction into the first housing component (Figure 2)
the mechanical coding on the medicament container sized and shaped to engage with the mechanical counter coding of the second housing component when the first housing component with the barrel arranged inside is connected to the second housing component (Figures 5a-8b)
In regards to claim 29, Osman et al teaches wherein the mechanical coding comprises at least one coding feature (212) and wherein the mechanical coding is defined by: a number of the at least one coding feature on the medicament container (Figure 2), a circumferential position of the at least one coding feature relative to the alignment element on the medicament container (Figure 2), a circumferential extent of the at least one coding feature (Figure 2), a radial extent of the at least one coding feature on the medicament container (Figure 2), and a cross-sectional geometry or shape of the at least one coding feature in a plane transverse to the longitudinal direction (Figure 2).
In regards to claim 30, Osman et al teaches an injection device (Figures 2, 5a-8b) comprising:
a housing (Figures 2, 5a-8b) of a drug delivery device, the housing comprising:
a first housing component (200) comprising a first connecting end provided with a fastening element (210/212), the first housing component being shaped and configured to accommodate a medicament container (column 12, lines 26-27), the medicament container comprising a mechanical coding (212) and an alignment element (214)
a second housing component (202) configured to accommodate a drive mechanism of the drug delivery device (column 14, lines 27-28) and comprising a second connecting end provided with a counter fastening element (236) complementary shaped to the fastening element, the second connecting end being connectable to the first connecting end (Figures 5a-8b)
a counter alignment element (216) complementary shaped to the alignment element and provided in or on the first housing component
a mechanical counter coding (232) provided in or on the second housing component, wherein when the medicament container is arranged in the first housing component and when the mechanical coding does not match the mechanical counter coding, the mechanical coding and the mechanical counter coding are operable to prevent an engagement of the fastening element with the counter fastening element (column 11, lines 51-54), wherein the mechanical counter coding is at least one of longitudinally or tangentially offset from the counter fastening element (Figure 5a)
the medicament container (206) comprising:
a barrel (206) sized and configured for insertion into the first housing component of the housing (Figure 2)
the alignment element on the medicament container sized and shaped to engage with the counter alignment element of the first housing component when the barrel is inserted in a longitudinal direction into the first housing component (Figure 2)
the mechanical coding on the medicament container sized and shaped to engage with the mechanical counter coding of the second housing component when the first housing component with the medicament container arranged inside is connected to the second housing component, wherein the medicament container is arranged inside the first housing component (Figures 5a-8b)
the drive mechanism arranged inside the second housing component (column 14, lines 27-28)
In regards to claim 31, Osman et al teaches wherein the mechanical coding comprises at least one coding feature (212) and wherein the mechanical coding is defined by: a number of the at least one coding feature on the medicament container (Figure 2), a circumferential position of the at least one coding feature relative to the alignment element on the medicament container (Figure 2), a circumferential extent of the at least one coding feature (Figure 2), a radial extent of the at least one coding feature on the medicament container (Figure 2), and a cross-sectional geometry or shape of the at least one coding feature in a plane transverse to the longitudinal direction (Figure 2).
In regards to claim 32, Osman et al teaches a kit of injection devices (Figures 2, 5a-8b)(column 18, lines 23-25: drug delivery devices… coded cartridge assemblies), the kit comprising a first injection device (Figures 2, 5a-8b) and a second injection device (column 18, lines 23-25 states “drug delivery devices… coded cartridge assemblies”, thus teaching a first injection device having a first drug delivery device and a first coded cartridge assembly and a second injection device having a second drug delivery device and a second coded cartridge assembly),
wherein the first injection device comprises:
a housing (Figures 2, 5a-8b) of the first injection device, the housing comprising:
a first housing component (200) comprising a first connecting end provided with a fastening element (210/212), the first housing component being shaped and configured to accommodate a medicament container (column 12, lines 26-27), the medicament container comprising a mechanical coding (212) and an alignment element (214)
a second housing component (202) configured to accommodate a drive mechanism of the first injection device (column 14, lines 27-28) and comprising a second connecting end provided with a counter fastening element (236) complementary shaped to the fastening element, the second connecting end being connectable to the first connecting end (Figures 5a-8b)
a counter alignment element (216) complementary shaped to the alignment element and provided in or on the first housing component
a mechanical counter coding (232) provided in or on the second housing component, wherein when the medicament container is arranged in the first housing component and when the mechanical coding does not match the mechanical counter coding, the mechanical coding and the mechanical counter coding are operable to prevent an engagement of the fastening element with the counter fastening element (column 11, lines 51-54), wherein the mechanical counter coding is at least one of longitudinally or tangentially offset from the counter fastening element (Figure 5a)
the medicament container (206) comprising:
a barrel (206) sized and configured for insertion into the first housing component of the housing (Figure 2)
the alignment element on the medicament container sized and shaped to engage with the counter alignment element of the first housing component when the barrel is inserted in a longitudinal direction into the first housing component (Figure 2)
the mechanical coding on the medicament container sized and shaped to engage with the mechanical counter coding of the second housing component when the first housing component with the medicament container arranged inside is connected to the second housing component, wherein the medicament container is arranged inside the first housing component (Figures 5a-8b)
the drive mechanism arranged inside the second housing component (column 14, lines 27-28)
wherein the second injection device comprises:
a further housing (column 18, lines 23-25 states “drug delivery devices… coded cartridge assemblies”, thus teaching a second injection device having a further housing) of the second injection device, the further housing comprising:
a further first housing component comprising a further first connecting end provided with a further fastening element, the further first housing component being shaped and configured to accommodate a further medicament container, the further medicament container comprising a further mechanical coding and a further alignment element (it is understood that the further housing of the second injection device would have a further first housing component, a further first connecting end, and a further fastening element similar to the housing of the first injection device of Figures 2, 5a-8b)
a further second housing component configured to accommodate a further drive mechanism of the second injection device and comprising a further second connecting end provided with a further counter fastening element complementary shaped to the further fastening element, the further second connecting end being connectable to the further first connecting end (it is understood that the further housing of the second injection device would have a further second housing component, a further second connecting end, and a further counter fastening element similar to the housing of the first injection device of Figures 2, 5a-8b)
a further counter alignment element complementary shaped to the further alignment element and provided in or on the further first housing component (it is understood that the further housing of the second injection device would have a further counter alignment element similar to the housing of the first injection device of Figures 2, 5a-8b)
a further mechanical counter coding provided in or on the further second housing component, wherein when the further medicament container is arranged in the further first housing component and when the further mechanical coding does not match the further mechanical counter coding, the further mechanical coding and the further mechanical counter coding are operable to prevent an engagement of the further fastening element with the further counter fastening element, wherein the further mechanical counter coding is at least one of longitudinally or tangentially offset from the further counter fastening element (it is understood that the further housing of the second injection device would have a further mechanical counter coding similar to the housing of the first injection device of Figures 2, 5a-8b)
the further medicament container (it is understood that the second injection device would have a further medicament container similar to the first injection device of Figures 2, 5a-8b) comprising:
a further medicament container sized and configured for insertion into the further first housing component of the further housing (it is understood that the further medicament container of the second injection device would have a further medicament container similar to the medicament container of the first injection device of Figures 2, 5a-8b)
the further alignment element on the further medicament container sized and shaped to engage with the further counter alignment element of the further first housing component when the further barrel is inserted in a further longitudinal direction into the further first housing component (it is understood that the further alignment element would engage with the further counter alignment element similar to the first injection device of Figures 2, 5a-8b)
the further mechanical coding on the further medicament container sized and shaped to engage with the further mechanical counter coding of the further second housing component when the further first housing component with the further medicament container arranged inside is connected to the further second housing component, wherein the further medicament container is arranged inside the further first housing component (it is understood that the further mechanical coding would engage with the further mechanical counter coding similar to the first injection device of Figures 2, 5a-8b)
the further drive mechanism arranged inside the further second housing component (it is understood that the second injection device would have a further drive mechanism similar to the first injection device of Figures 2, 5a-8b)
wherein one of the mechanical coding and the mechanical counter coding of the first injection device distinguishes from the further mechanical coding or the further mechanical counter coding of the second injection device with regard to at least one of:
a number of coding features or counter coding features (column 13, lines 53-55)
a circumferential position of the coding features relative to the alignment element on the medicament container (column 13, lines 53-55)
a circumferential position of the counter coding features relative to the counter fastening element (Figures 5a-8b, 9a-12c)
a circumferential extent of the coding features or the counter coding features (column 13, lines 53-55)
a radial extent of the coding features or the counter coding features (column 13, lines 53-55)
a cross-sectional geometry or shape of the coding features or the counter coding features in a plane transverse to the longitudinal direction (column 13, lines 53-55)
Response to Arguments
Applicant's arguments filed June 24, 2026, have been fully considered but they are not persuasive:
In regards to claims 16, 28, 30, and 32, Applicant argued: Independent claims 16, 28, 30, and 32, as amended, recite that the mechanical counter coding is at least one of longitudinally or tangentially offset from the counter fastening element. This limitation requires the claimed mechanical counter coding of the second housing component to be spatially separate from the counter fastening element in at least one of the longitudinal or tangential directions. The Office Action maps the groove 230 of the drug delivery device 202 according to Osman to represent both a counter fastening element and a mechanical counter coding. That mapping does not establish anticipation of the amended claims (Remarks, page 14). Examiner disagrees. First, the claims do not require the claimed mechanical counter coding of the second housing component to be “spatially separate from” the counter fastening element in at least one of the longitudinal or tangential directions, as argued by Applicant. Second, Osman et al teaches wherein the mechanical counter coding (232) is one of longitudinally or tangentially offset from the counter fastening element (236) (Figure 5a).
In regards to claims 16, 28, 30, and 32, Applicant argued: Accordingly, in Osman, the proximal housing of drug delivery device 202 is only provided with groove 230, which acts as a counter fastening element. In this respect, Osman fails to disclose a mechanical counter coding of drug delivery device 202 that is at least one of longitudinally or tangentially offset from the counter fastening element, as presently claimed. By spatially separating the mechanical counter coding from the counter fastening element, a comparatively large variety of differently configured first and second housing components can be provided with one and the same fastening structure, which provides a well-defined, intuitive, and robust mutual fastening and connection between the first and second housing components. In this way, the principles of mechanically encoding and mechanically fastening the first and second housing components can be strictly separated, which is beneficial to provide the same and unaltered type of mechanical fastening between the first and second housing components (Remarks, page 15). Examiner disagrees. First, Osman et al teaches wherein the mechanical counter coding (232) is one of longitudinally or tangentially offset from the counter fastening element (236) (Figure 5a). Second, the claims do not require “spatially separating” the mechanical counter coding from the counter fastening element, as argued by Applicant
In regards to claims 16, 28, 30, and 32, Applicant argued: Osman does not disclose, propose, or suggest such a separated arrangement. Rather, in Osman, the coding and fastening features are inextricably linked. The rejection relies on the same groove 230 as both the counter fastening element and the mechanical counter coding, but groove 230 cannot also disclose a mechanical counter coding that is longitudinally or tangentially offset from the counter fastening element (Remarks, page 15). Examiner disagrees. First, the claims do not require “a separated arrangement”, as argued by Applicant. Second, Osman et al teaches wherein the mechanical counter coding (232) is one of longitudinally or tangentially offset from the counter fastening element (236) (Figure 5a).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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