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 C in the reply filed on 05/21/2026 is acknowledged.
Claims 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/21/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 discloses “the injector device of claim 1, wherein the needle sleeve is adapted to disengage from the needle unit after the needle unit has rotated such that the needle sleeve can move independently of the needle unit” wherein this limitation is recited verbatim in claim 1, lines 10-11. Thus, claim 8 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwarz (U.S Patent No. 3967621).
Regarding claim 1, Schwarz discloses (Claim 1) an injector device (see Fig. 1-2 and 5 and Col.1, lines 7-10, see Col.7, lines 1-18 – the injector device of Fig. 1-2 may be used with the cuff 518 and body 502 in Fig. 5 in replacement with cuff 18 and body 2 in Fig. 1-2) comprising:
a housing (502 in Fig. 5),
a cartridge (6 in Fig. 1-2) having a reservoir for medicament (see Col.5, lines 12-14 – cartridge 6 is a preparation holder having an inner chamber interpreted as the reservoir),
a needle unit (24 in Fig. 1-2) comprising a needle (8 in Fig. 1-2, see Col.5, lines 39-47), the needle unit (24) being movably mounted to the housing (502) and wherein prior to use of the injector device the reservoir is sealed from the needle (8, see Fig. 1 for prior to use position, see Col.5, lines 39-47 – needle hub 24 movably mounted to body 2 and thus body 502 in the embodiment of Fig. 5 prior to use with needle 8 not puncturing closure 10 of cartridge 6 as seen in Fig. 1),
a needle sleeve (28 in Fig. 1-2) configured to move the needle unit (24) into engagement with the cartridge (6) such that the needle (8) is moved into fluid communication with the reservoir (see Fig. 2, see Col.6, lines 5-15 – when sleeve 28 is rotated its threaded connection rotates needle unit 24 into engagement with cartridge 6 and thus into fluid communication with the cartridge’s interior as seen in Fig. 2), and
a thread (22 in Fig. 1) adapted to cause rotation of the needle unit (24) as the needle unit (24) moves into engagement with the cartridge (6, see Col.6, lines 5-15);
wherein the needle sleeve (28) is adapted to disengage from the needle unit (24) after the needle unit (24) has rotated such that the needle sleeve (28) can move independently of the needle unit (24, see Col.6, lines 31-41 - needle sleeve 24 disengages with base body 2 and thus with needle unit 24 such that it can be axially removed after needle unit 24 has been rotated to pierce closure 10).
Regarding claim 2, Schwarz discloses (Claim 2) the injector device of claim 1, wherein the thread (22) is disposed between the needle unit (24) and the cartridge (6, see Fig. 1-2 and 5 – the thread of the body 502 is disposed between the needle unit 24 and cartridge in both embodiments).
Regarding claim 3, Schwarz discloses (Claim 3) the injector device of claim 1, wherein the thread (22) is arranged to couple the needle unit (24) to the cartridge (6) and/or the housing (502) after rotation of the needle unit (24, see Fig. 2 and 5 – thread 22 of the body 2 and thus body 502 in Fig. 5 couples needle unit 24 to both cartridge 6 said body 502 after its rotation and piercing of closure 10).
Regarding claim 4, Schwarz discloses (Claim 4) the injector device of claim 1, wherein the housing (502) comprises a cartridge mounting portion (distal portion of 502) that surrounds at least a part of the cartridge (6, see Fig. 5 – body 502 comprises a distal portion that surrounds at least the distal surface of the cartridge wherein the distal portion of 502 is interpreted as the cartridge mounting portion), and wherein the thread (22) is arranged between the needle unit (24) and the cartridge mounting portion (see Fig. 1-2 and 5 – thread 22 of the body 2 and thus body 502 in Fig. 5 is arranged between needle unit 24 and the distal portion of body 502).
Regarding claim 5, Schwarz discloses (Claim 5) the injector device of claim 4, wherein the cartridge mounting portion comprises the thread (22) and the needle unit (24) comprises a thread engaging member (26 in Fig. 1-2) arranged to engage the thread (22, see Fig. 1-2 and Fig. 5 and Col.6, lines 5-15 – the distal portion of body 502 comprises the thread 22, examiner notes the distal portion of body 502 is analogous to the body 2 in Fig. 1-2, and the needle unit 24 in Fig. 1-2 comprises a complementary thread 26 to said thread 22).
Regarding claim 7, Schwarz discloses (Claim 7) the injector device of claim 1, wherein the needle (8) comprises a needle axis (see Fig. 1 – needle 8 comprises a longitudinal axis extending along its length interpreted as the needle axis), and the needle unit (24) is adapted to rotate about the needle axis (see Fig. 1-2 – needle unit 23 rotates around the needle 8’s longitudinal axis).
Regarding claim 8, Schwarz discloses (Claim 8) the injector device of claim 1, wherein the needle sleeve (28) is adapted to disengage from the needle unit (24) after the needle unit (24) has rotated such that the needle sleeve (28) can move independently of the needle unit (24, see Col.6, lines 31-41 - needle sleeve 24 disengages with base body 2 and thus with needle unit 24 such that it can be axially removed after needle unit 24 has been rotated to pierce closure 10).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6 rejected under 35 U.S.C. 103 as being unpatentable over Schwarz in view of Cowan et al. (U.S Patent Pub. No. 20020147429 A1, “Cowan”).
Regarding claim 6, Schwarz discloses the injector device of claim 5, as discussed above. Schwarz further discloses that the distal portion of body (502 in Fig. 5) interpreted as the cartridge mounting portion comprises the thread (22).
However, Schwarz fails to disclose (Claim 6) wherein the cartridge mounting portion further comprises a groove leading into the thread, the groove being arranged such that during movement of the needle unit the needle unit moves linearly before the thread rotates the needle unit.
Cowan discloses a bayonet-type connector (1650 in Fig. 9C) for use in medical connections (see Abstract), wherein the connector (1650) comprises a male section (1680 in Fig. 9C) having a partial, helical threads (1688 in Fig. 9C) broken up by axial slots (1690a in Fig. 9C, see para. 0154). The connector (1650) further comprises a female section (1660 in Fig. 9C) for connection to male section (1680), wherein the female section (1660) comprises tabs (1664a in Fig. 9C) which during connection are first moved axially through slots (1690a) and then rotated through channels (1688, see para. 0155). Thus, Cowan teaches (Claim 6) a groove (1690a) leading into a thread (1688), the groove (1690a) being arranged such that during movement of the female section (1660) the female section (1660) moves linearly before the thread (1688) rotates the female section (1660, see para. 0155).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the threaded connection taught by Schwarz to incorporate the teachings of Cowan such that the thread (22) of Schwarz comprises a groove (1690a) at its distal end as taught by Cowan and the needle unit (24) of Schwarz comprises a tab (1664a) as the locking member for engaging with said groove and thread as taught by Cowan. Cowan discloses a bayonet-type connector that is suitable for use at low pressure or even pressures above 300 psi while maintaining a sealed connection (see para. 0155). Thus, the needle unit of Schwarz would be provided an improved connection suitable at low or high pressures and maintaining a sealed connection for fluid flow during use of the medical device.
Allowable Subject Matter
Claims 11-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Schwarz (U.S Patent No. 3967621), Ejlersen (U.S Patent No. 4976701), Archilla et al. (U.S Patent Pub. No. 20180117240 A1, “Archilla”), and Helmer et al. (U.S Patent Pub. No. 20170304542, “Helmer”).
Schwarz discloses an injector device (see Fig. 102) comprising a housing (18 in Fig. 1-2), a cartridge (6 in Fig. 1-2) having a reservoir for medicament, a needle unit (24 in Fig. 1-2) comprising a needle (8 in Fig. 1-2), the needle unit (24) being movably mounted to the housing (18) and wherein prior to use of the injector device the reservoir is sealed from the needle (8), a needle sleeve (28 in Fig. 1-2) configured to move the needle unit (24) into engagement with the cartridge (6), and a thread (22 in Fig. 1) adapted to cause rotation of the needle unit (24) as the needle unit (24) moves into engagement with the cartridge (6); wherein the needle sleeve (28) is adapted to disengage from the needle unit (24) after the needle unit (24) has rotated such that the needle sleeve (28) can move independently of the needle unit (24, needle sleeve 24 disengages with base body 2 and thus with needle unit 24 such that it can be axially removed). Therefore, Schwarz discloses claim 1. However, Schwarz fails to disclose claim 11 as the needle sleeve (28) is not slidably mounted to the housing (8) and does not slide into the housing (23) nor does the needle sleeve (28) push the needle unit (24) into engagement with the cartridge (6) when the needle sleeve (28) is pressed against an injection site during use. Rather, Schwarz discloses that the needle sleeve (28) is rotatably mounted to the needle unit (24) and thus is not slidably mounted to the housing (8). Further, Schwarz discloses that the needle sleeve (28) pushes the needle unit (24) when the needle sleeve (28) is being screwed off, and wherein the needle sleeve (28) is removed before use of the device. Thus, Schwarz cannot be modified to disclose the limitations of claim 11 as it would render the device inoperable for its intended operation of having a needle sleeve that is rotatable and removable before use of the device. Regarding claim 12, Schwarz fails to disclose the needle sleeve (28) having a groove for engagement with a protrusion of the needle unit (24). Rather, Schwarz discloses the needle sleeve (28) is engaged with a body (2 in Fig. 1-2) in threaded engagement, and is not directly engaged with the needle unit (24) at all. There is no motivation to modify Schwarz to have the engagement between the needle sleeve and needle unit as claimed in claim 12 as it would render the axial gear tooth system of Schwarz inoperable for its intended use. Regarding claim 14, Schwarz fails to disclose a needle sleeve (28) that is movable into the housing (8) and that when disengaged is able to continue moving into the housing (8). As discussed above, the needle sleeve (28) is rotatably mounted onto the needle unit (24) and does not move into the housing (8). Further, the needle sleeve (28) does not move further proximally when disengaged, but rather is removed distally altogether. Therefore, Schwarz fails to disclose the limitations of claim 14 as it would render the device inoperable for its intended operation of having a needle sleeve that is rotatable and removable before use of the device.
Ejlersen discloses an injector device (see Fig. 1-2) comprising: a housing (23 in Fig. 1), a cartridge (11 in Fig. 1) having a reservoir for medicament (see Col.2, lines 38-44), a needle unit (28 in Fig. 1-2) comprising a needle (27 in Fig. 1-2, ), the needle unit (28) being movably mounted to the housing (23) and wherein prior to use of the injector device the reservoir is sealed from the needle (27, see Fig. 1), a needle sleeve (34 in Fig. 1-2) configured to move the needle unit (28) into engagement with the cartridge (11) such that the needle (27) is moved into fluid communication with the reservoir (see Fig. 2, - needle sleeve 34 is a protective case that when rotated due to rotation of the cap 26 is configured to move the needle unit 28 into engagement with cartridge 11), and a thread (17 in Fig. 1) adapted to cause rotation of the needle unit (28) as the needle unit (28) moves into engagement with the cartridge (11); wherein the needle sleeve (34) is adapted to disengage from the needle unit (28) after the needle unit (28) has rotated such that the needle sleeve (34) can move independently of the needle unit (28, needle sleeve 34 can be axially removed from the needle unit 28 after its rotation such that it moves independently of needle unit 28). Therefore, Ejlersen discloses claim 1. However, Ejlersen fails to disclose claim 11 as the needle sleeve (34) is not slidably mounted to the housing (23) and does not slide into the housing (23) nor does the needle sleeve (34) push the needle unit (28) into engagement with the cartridge (11) when the needle sleeve (34) is pressed against an injection site during use. Rather, Ejlersen discloses that the needle sleeve (34) is rotatably mounted to the needle unit (23) and thus is not slidably mounted to the housing (23). Further, Ejlersen discloses that the needle sleeve (34) pushes the needle unit (28) when the cap (26) is being screwed off, and wherein the needle sleeve (34) is removed before use of the device. Thus, Ejlersen cannot be modified to disclose the limitations of claim 11 as it would render the device inoperable for its intended operation of having a needle sleeve that is rotatable and removable before use of the device. Regarding claim 12, Ejlersen fails to disclose the needle sleeve (34) having a groove for engagement with a protrusion of the needle unit (28). Rather, Ejlersen discloses a friction fit between a rear part (35) of the needle sleeve (34) and fins (32) of the needle unit (28). There is no reference that discloses a needle sleeve and needle unit engagement as claimed in claim 12 where the needle sleeve can be moved to engage the needle unit through a groove and protrusion engagement to rotate a needle unit to engage a cartridge. Regarding claim 14, Ejlersen fails to disclose a needle sleeve (34) that is movable into the housing (23) and that when disengaged is able to continue moving into the housing (23). As discussed above, the needle sleeve (34) is rotatably mounted onto the needle unit (23) and does not move into the housing (23). Further, the needle sleeve (34) does not move further proximally when disengaged, but rather is removed distally altogether. Therefore, Ejlersen fails to disclose the limitations of claim 14 as it would render the device inoperable for its intended operation of having a needle sleeve that is rotatable and removable before use of the device.
Archilla discloses an injector device (101 in Fig. 5-5A) comprising: a housing (102 in Fig. 5), a cartridge (160 in Fig. 5) having a reservoir for medicament (see Fig. 5, see para. 0098 and 0103 – the interior chamber of cartridge 160 being interpreted as the reservoir), a needle unit (140 in Fig. 5A) comprising a needle (130, see para. 0109), the needle unit (140) being movably mounted to the housing (102) and wherein prior to use of the injector device (101) the reservoir is sealed from the needle (130, see Fig. 5-5A, see para. 0102), a needle sleeve (110 in Fig. 5-5A) configured to move the needle unit (140) into engagement with the cartridge (160) such that the needle (130) is moved into fluid communication with the reservoir (see para. 0107-0110), and a thread (181 in Fig. 10) adapted to cause rotation of the needle unit (140) as the needle unit (140) moves into engagement with the cartridge (160, see para. 0110). However, Archilla fails to disclose wherein the needle sleeve (110) is adapted to disengage from the needle unit (140) after the needle unit (140) has rotated such that the needle sleeve (110) can move independently of the needle unit (140) as claimed in claim 1. Instead, Archilla explicitly discloses that the needle sleeve (110) remains engaged with the needle unit (140) after the needle unit (140) is rotated into engagement with cartridge (160) as this ensures the needle (130) is moves distally after injection with the needle sleeve (110) to be placed into the cleaning chamber (120) where the distal tip of needle (130) is maintained between injections (see para. 0137). Therefore, Archilla cannot be modified to have a needle unit that disengages with the needle sleeve as this would render it inoperable for its intended use.
Helmer discloses an injector device (1 in Fig. 1) comprising: a housing (8 in Fig. 1), a cartridge (2 in Fig. 1) having a reservoir for medicament (see para. 0030), a needle unit (5 in Fig. 1) comprising a needle (6 in Fig. 1, see para. 0035), the needle unit (5) being movably mounted to the housing (8) and wherein prior to use of the injector device (1) the reservoir is sealed from the needle (6, see P1 in Fig. 1, see para. 0029-0030), a needle sleeve (7 in Fig. 1) configured to move the needle unit (5) into engagement with the cartridge (2) such that the needle (6) is moved into fluid communication with the reservoir (see para. 0041-0043 – needle sleeve 7 is configured to move proximally which causes proximal movement of needle unit 5 and thus engagement of the needle 6 with the cartridge 2), wherein the needle sleeve (7) is adapted to disengage from the needle unit (5) after the needle unit (5) has engaged with the cartridge (2) such that the needle sleeve (7) can move independently of the needle unit (5, see Fig. 3 and para. 0052 – the engagement between the needle sleeve 7 and needle unit 5 disengages after the needle unit 5 is moved into engagement with the cartridge 2 such that needle sleeve 7 can move relative to needle unit 5). However, Helmer fails to disclose a thread adapted to cause rotation of the needle unit (5) as the needle unit (5) moves into engagement with the cartridge (2) as claimed in claim 1. Rather, Helmer discloses that the needle unit (5) and needle sleeve (7) are engaged through a resilient arm (7.2 in Fig. 1-2) engaged in a recess (5.2 in Fig. 1-2) of the needle unit (5), and that the needle unit (5) further comprises a protrusion (5.1 in Fig. 1-2) that is engaged with a recess (4.1 in Fig. 1-2) of the cartridge holder (4) that acts as an anti-rotation lock to prevent rotation of the needle unit (5, see para. 0033). Thus, Helmer cannot be modified such that the needle unit can rotate as this would render the device inoperable for its intended use.
Therefore, there is no reference that discloses or teaches the slidably mounted needle sleeve (claim 11), groove and protrusion engagement (claim 12), and movement of the needle sleeve into the housing (claim 14).
Claims 18-20 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 18, Schwarz discloses the injector device as discussed above but fails to disclose a slidably mounted needle sleeve. Rather, Schwarz discloses that the needle sleeve (28) is rotatably mounted to the needle unit (24) and thus is not slidably mounted to the housing (28). Further, Schwarz discloses that the needle sleeve (28) pushes the needle unit (24) when the needle sleeve (28) is being screwed off, and wherein the needle sleeve (28) is removed before use of the device. Thus, Schwarz cannot be modified to disclose the limitations of claim 18 as it would render the device inoperable for its intended operation of having a needle sleeve that is rotatable and removable before use of the device.
Regarding claim 18, Ejlersen discloses the injector device as discussed above but fails to disclose a slidably mounted needle sleeve. . Rather, Ejlersen discloses that the needle sleeve (34) is rotatably mounted to the needle unit (23) and thus is not slidably mounted to the housing (23). Further, Ejlersen discloses that the needle sleeve (34) pushes the needle unit (28) when the cap (26) is being screwed off, and wherein the needle sleeve (34) is removed before use of the device. Thus, Ejlersen cannot be modified to disclose the limitations of claim 18 as it would render the device inoperable for its intended operation of having a needle sleeve that is rotatable and removable before use of the device.
Regarding claim 18, as discussed above, Archilla cannot be modified to have a needle unit that disengages with the needle sleeve as this would render it inoperable for its intended use.
Regarding claim 18, as discussed above, Helmer cannot be modified such that the needle unit can rotate as this would render the device inoperable for its intended use.
Therefore, there is no reference that discloses or teaches the slidably mounted needle sleeve (claim 18).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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