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 October 31, 2023, Applicant cancelled claims 1-15.
Applicant added new claims 16-35.
Currently, claims 16-35 are under examination.
Specification
The abstract of the disclosure is objected to because:
In line 4, “first and second housing components” should be changed to “a first housing component and a second housing component”
In line 4, “first and second connecting ends” should be changed to “a first connecting end and a second connecting end”
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, 18, 27-28, 31, 33, and 35 are objected to because of the following informalities:
In regards to claim 16, line 18, “and” should be changed to “or”.
In regards to claim 18, line 3, “the first and second connecting ends” should be changed to “the first connecting end and the second connecting end”.
In regards to claim 27, line 2, “and the mechanical counter coding” should be changed to “or the mechanical counter coding”.
In regards to claim 27, line 4, “the longitudinal position” should be changed to “a longitudinal position”.
In regards to claim 27, lines 4-5, “the longitudinal position” should be changed to “a longitudinal position”.
In regards to claim 27, lines 6-7, “the first and second connecting ends” should be changed to “the first connecting end and the second connecting end”.
In regards to claim 27, line 7, “the longitudinal extent” should be changed to “a longitudinal extent”.
In regards to claim 27, line 7, “transverse extent” should be changed to “a transverse extent”.
In regards to claim 27, line 9, “the first and second connecting end” should be changed to “the first connecting end and the second connecting end”.
In regards to claim 27, lines 9-10, “the longitudinal extent” should be changed to “a longitudinal extent”.
In regards to claim 27, line 10, “transverse extent” should be changed to “a transverse extent”.
In regards to claim 28, line 2, “and” should be changed to “or”.
In regards to claim 28, line 3, “and the counter fastening element” should be changed to “or the counter fastening element”.
In regards to claim 28, line 4, “the groove” should be changed to “the first groove”.
In regards to claim 28, lines 7-8, “the first groove portion” should be changed to “the first groove portion of the second groove”.
In regards to claim 31, lines 4-5, “a medicament” should be changed to “the medicament”.
In regards to claim 31, line 7, “the drug delivery device” should be changed to “the injection device”.
In regards to claim 31, line 23, “and” should be changed to “or”.
In regards to claim 31, line 30, “a cartridge” should be changed to “the cartridge”.
In regards to claim 31, line 32, “a drive mechanism” should be changed to “the drive mechanism”.
In regards to claim 33, line 3, “the first and second connecting ends” should be changed to “the first connecting end and the second connecting end”.
In regards to claim 35, line 2, “A first housing” should be changed to “a first housing”.
In regards to claim 35, line 23, “and” should be changed to “or”.
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.
Claims 22 and 35 are 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 22, lines 1-2 recite “a first mechanical coding”. Claim 22 depends upon claim 16. Claim 16, line 14 recites “a mechanical coding”. It is unclear whether the two recitations are the same component or different components.
In regards to claim 35, line 7 recites “the drug delivery device”. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-18, 20-22, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 and 24-26 of copending Application No. 18/289,267 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications at least claim A housing of a drug delivery device, a first housing component, a second housing component, an insert, a receptacle, a fastening element, a counter fastening element, a mechanical coding, a mechanical counter coding, a groove (a coded groove), a first groove portion, and a second groove portion,
The table below shows application claims 16-18, 20-22, and 26 corresponding to claims 16-17 and 24-26 of copending Application No. 18/289,267:
Application claims
Application No. 18/289,267 claims
16
16, 17, 24, 25
17
25
18
25
20
17
21
17
22
26
26
17
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 16-29 and 31-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Avery et al (US 9,180,254).
In regards to claim 16, Avery et al teaches a housing (Figures 3A-3C) of a drug delivery device, the housing comprising:
a first housing component (300) configured to accommodate a cartridge filled with a medicament (column 11, lines 58-61), the first housing component comprising a first connecting end (310)
a second housing component (302) configured to accommodate a drive mechanism of the drug delivery device (column 11, lines 39-49), the second housing component comprising a second connecting end (308)
an insert (309) provided on one of the first connecting end and the second connecting end
a receptacle (inner space of 302) provided on the other one of the first connecting end and 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 (Figures 3A-3B)
a fastening element (314) provided on the insert and comprising a snap element (314)
a counter fastening element (328) complementary shaped to the fastening element, wherein the counter fastening element is provided in the receptacle (Figure 3A) and comprises a counter snap element (328) configured to engage with the snap element (Figure 3B)
a mechanical coding (314) provided on the insert and comprising a coding feature (314)
a mechanical counter coding (328) provided in the receptacle and comprising a counter coding feature (328)
wherein at least one of the fastening element, the counter fastening element, the mechanical coding, and the mechanical counter coding comprises a groove (314) with a first groove portion (labeled in Figure 3A below) and a second groove portion (labeled in Figure 3A below), wherein the first groove portion extends along the longitudinal direction and wherein the second groove portion extends along a circumferential direction and merges into the first groove portion (Figure 3A)
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 (column 13, lines 17-20)
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In regards to claim 17, Avery et al teaches wherein the first groove portion adjoins a longitudinal end face of one of the first connecting end and the second connecting end (Figure 3A).
In regards to claim 18, Avery et al teaches wherein the second groove portion merges into the first groove portion at a longitudinal distance from the longitudinal end face of the one of the first and second connecting ends (Figure 3A).
In regards to claim 19, Avery et al teaches wherein one of the snap element and the counter snap element is arranged in the second groove portion or at a circumferential offset from the first groove portion (Figure 3B).
In regards to claim 20, Avery et al teaches wherein one of the snap element and the counter snap element comprises a radial projection (328) on one of the insert and the receptacle (Figure 3A).
In regards to claim 21, Avery et al teaches wherein the other one of the snap element and the counter snap element comprises a radial recess (314) on the other one of the insert and the receptacle configured to receive the radial projection (Figure 3B).
In regards to claim 22, Avery et al teaches wherein the coding feature of a first mechanical coding distinguishes from a coding feature of another mechanical coding with regard to at least one of: a number of coding features (column 5, lines 49-50), a longitudinal position (column 5, lines 51-53), a longitudinal extent (column 5, lines 64-65), a circumferential position (column 5, lines 51-53), a circumferential extent (column 5, lines 64-65), or a cross-sectional geometry or shape in a plane transverse to the longitudinal direction (column 6, lines 1-2).
In regards to claim 23, Avery et al teaches wherein the mechanical coding is integrated into the snap element and wherein the mechanical counter coding is integrated into the counter snap element (Figure 3A).
In regards to claim 24, Avery et al teaches wherein the coding feature is defined by a longitudinal position and a longitudinal extent of the snap element on the insert (Figure 3A).
In regards to claim 25, Avery et al teaches wherein the counter coding feature is defined by a longitudinal position and a longitudinal extent of the counter snap element in the receptacle (Figure 3A).
In regards to claim 26, Avery et al teaches wherein the coding feature and the counter coding feature comprise: a radial coding protrusion (328) on one of the insert and the receptacle; and a radial coding recess (314) on the other one of the insert and the receptacle.
In regards to claim 27, Avery et al teaches wherein at least one of the mechanical coding and the mechanical counter coding comprises the groove (314) and wherein the coding feature and the counter coding feature distinguish from coding features and counter coding features of another housing by varying the longitudinal position of the second groove portion and the longitudinal position of the radial coding protrusion correspondingly (column 5, lines 51-53), wherein an increase of a longitudinal distance of the second groove portion from a free end of one of the first and second connecting ends is accompanied by an increase of the longitudinal extent and/or transverse extent of the second groove portion (column 5, lines 64-65)(Figure 10A), by a corresponding decrease of a distance of the radial coding protrusion from the other one of the first and second connecting end (column 5, lines 64-65)(Figure 10A), and by a corresponding increase of the longitudinal extent and/or transverse extent of the radial coding protrusion (column 5, lines 64-65)(Figure 10A).
In regards to claim 28, Avery et al teaches wherein at least one of the mechanical coding and the mechanical counter coding comprises the groove (314), wherein the groove is a first groove (314), and wherein at least one of the fastening element and the counter fastening element comprises a second groove located circumferentially offset from the groove (Figure 11B), wherein the second groove comprises a first groove portion and a second groove portion, wherein the first groove portion of the second groove extends along the longitudinal direction, wherein the second groove portion of the second groove extends along the circumferential direction and merges into the first groove portion (Figure 11B shows a first groove receiving a first pin and a second groove receiving a second pin. It is understood that the second groove would have a first groove portion extending along the longitudinal direction and a second groove portion extending along the circumferential direction and merging into the first groove portion in order to receive the second pin, as it is understood that the second groove is of the same construction as the first groove, shown in Figure 3A, receiving the first pin).
In regards to claim 29, Avery et al teaches wherein one of the coding feature and the counter coding feature is defined by a circumferential distance between the first groove portion of the first groove and the first groove portion of the second groove (Figure 11B).
In regards to claim 31, Avery et al teaches an injection device (Figures 3A-3C) for injecting a dose of a medicament, the injection device comprising:
a housing (Figures 3A-3C) comprising:
a first housing component (300) configured to accommodate a cartridge filled with a medicament (column 11, lines 58-61), the first housing component comprising a first connecting end (310)
a second housing component (302) configured to accommodate a drive mechanism of the drug delivery device (column 11, lines 39-49), the second housing component comprising a second connecting end (308)
an insert (309) provided on one of the first connecting end and the second connecting end
a receptacle (inner space of 302) provided on the other one of the first connecting end and 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 (Figures 3A-3B)
a fastening element (314) provided on the insert and comprising a snap element (314)
a counter fastening element (328) complementary shaped to the fastening element, wherein the counter fastening element is provided in the receptacle (Figure 3A) and comprises a counter snap element (328) configured to engage with the snap element (Figure 3B)
a mechanical coding (314) provided on the insert and comprising a coding feature (314)
a mechanical counter coding (328) provided in the receptacle and comprising a counter coding feature (328)
wherein at least one of the fastening element, the counter fastening element, the mechanical coding, and the mechanical counter coding comprises a groove (314) with a first groove portion (labeled in Figure 3A above) and a second groove portion (labeled in Figure 3A above), wherein the first groove portion extends along the longitudinal direction and wherein the second groove portion extends along a circumferential direction and merges into the first groove portion (Figure 3A)
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 (column 13, lines 17-20)
a cartridge (20) arranged inside the housing (column 11, lines 58-61), the cartridge comprising a barrel (22) filled with the medicament (26) and sealed in a proximal longitudinal direction by a movable bung (28)
a drive mechanism (17) arranged inside the housing (column 11, lines 39-49), the drive mechanism comprising a piston rod (17) operable to exert a distally directed dispensing force onto the bung of the cartridge
In regards to claim 32, Avery et al teaches wherein the first groove portion adjoins a longitudinal end face of one of the first connecting end and the second connecting end (Figure 3A).
In regards to claim 33, Avery et al teaches wherein the second groove portion merges into the first groove portion at a longitudinal distance from the longitudinal end face of the one of the first and second connecting ends (Figure 3A).
In regards to claim 34, Avery et al teaches wherein one of the snap element and the counter snap element is arranged in the second groove portion or at a circumferential offset from the first groove portion (Figure 3B).
In regards to claim 35, Avery et al teaches a kit (Figures 3A-3C)(column 18, lines 16-32: a collection of cartridge assemblies and dose setting members) comprising:
A first housing (Figures 3A-3C) and a second housing (column 18, lines 16-32 states “a collection of cartridge assemblies and dose setting members”, thus teaching a first housing having a first cartridge assembly and a first dose setting member and a second housing having a second cartridge assembly and a second dose setting member), each of the first housing and the second housing comprising:
a first housing component (300) configured to accommodate a cartridge filled with a medicament (column 11, lines 58-61), the first housing component comprising a first connecting end (310)
a second housing component (302) configured to accommodate a drive mechanism of the drug delivery device (column 11, lines 39-49), the second housing component comprising a second connecting end (308)
an insert (309) provided on one of the first connecting end and the second connecting end
a receptacle (inner space of 302) provided on the other one of the first connecting end and 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 (Figures 3A-3B)
a fastening element (314) provided on the insert and comprising a snap element (314)
a counter fastening element (328) complementary shaped to the fastening element, wherein the counter fastening element is provided in the receptacle (Figure 3A) and comprises a counter snap element (328) configured to engage with the snap element (Figure 3B)
a mechanical coding (314) provided on the insert and comprising a coding feature (314)
a mechanical counter coding (328) provided in the receptacle and comprising a counter coding feature (328)
wherein at least one of the fastening element, the counter fastening element, the mechanical coding, and the mechanical counter coding comprises a groove (314) with a first groove portion (labeled in Figure 3A above) and a second groove portion (labeled in Figure 3A above), wherein the first groove portion extends along the longitudinal direction and wherein the second groove portion extends along a circumferential direction and merges into the first groove portion (Figure 3A)
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 (column 13, lines 17-20)
wherein the coding feature the first housing distinguishes from the coding feature of the second housing with regard to at least one of:
a number of coding features (column 5, lines 49-50)
a longitudinal position (column 5, lines 51-53)
a longitudinal extent (column 5, lines 64-65)
a circumferential position (column 5, lines 51-53)
a circumferential extent (column 5, lines 64-65), or
a cross-sectional geometry or shape in a plane transverse to the longitudinal direction (column 6, lines 1-2)
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.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Avery et al, as applied to claim 16 above, and further in view of Cerman et al (US 2013/0345641).
In regards to claim 30, Avery et al is silent about wherein the insert comprises a visible indicator on an outside surface, and wherein the receptacle comprises a through recess in a sidewall through which the indicator is visible when the insert is correctly assembled and fixed inside the receptacle. Cerman et al teaches a drug delivery device (Figures 4A and 4C) wherein a cartridge (120) comprises a visible indicator (350) on an outside surface, and wherein a cartridge holder (304) comprises a through recess (354) in a sidewall through which the indicator is visible when the cartridge is correctly assembled and fixed inside the cartridge holder (Figure 4C). 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 drug delivery device, of Avery et al, with a visible indicator and a through recess, as taught by Cerman et al, as such will confirm that a correct cartridge has been assembled into a correct cartridge holder (paragraph [0163]).
However, Cerman et al does not teach an insert comprising the visible indicator and a receptacle comprising the through recess, as Cerman et al instead teaches a cartridge comprising the visible indicator and a cartridge holder comprising the through recess (Figures 4A and 4C). However, as the insert (309) and the receptacle (inner space of 302) are the interacting components having coding features in Avery et al, 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 insert and the receptacle, of the modified drug delivery device having a housing of Avery et al and Cerman et al, to comprise a visible indicator and a through recess, as taught by Cerman et al, as such will confirm that a correct first housing component has been assembled into a correct second housing component (paragraph [0163]).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783