DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-6, 10 and 11 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Lesch Jr et al. (PG PUB 2009/0299278).
Re claim 1, Lesch discloses an injection device 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) for administering a substance (Para 6), comprising: a housing 12 with an exterior (facing radially outward in Fig 1) configured to be held by a user (Para 16); a syringe 18 (Para 16) with a needle 24 and a stopper 28 (as seen in Fig 1), the syringe connected to the housing in an axially fixed manner during manual piercing by the needle by pushing the injection device onto or against a surface (Para 16,27); a plunger rod 60 which is movable in the housing (Para 26), the plunger rod formed as a unitary component (Para 37 discloses that portion 101 belongs to ram 60 and Para 23 discloses that recess 58 belongs to ram 60) with a proximal end (facing upward in Fig 1) and a distal end (facing downward in Fig 1), the proximal end forming or fixedly attached to at least one retaining element 58 which holds the plunger rod relative to the housing (Para 23), the distal end configured to be received within the syringe (as seen in Fig 1) and push against and move the stopper for dispensing the substance through the needle (Para 26); an injection spring 62 which is supported at a distal end against the plunger rod (as seen in Fig 1; Para 45) and at a proximal end against the housing or an element connected to the housing (as seen in Fig 1, the proximal end is supported against element 54 that is connected to the housing); and a displaceable lock 64 displaceable within the housing (Para 26, “slid proximately”), wherein in a first position (seen in Fig 1,2), the displaceable lock holds the at least one retaining element in a positive locking relationship in a retaining position relative to the housing against a force of the injection spring in a tensed state (Para 24), and in a second position (not shown, but described in Para 26), releases the at least one retaining element (Para 26).
Re claim 2, Lesch discloses that the displaceable lock comprises a retaining region (“latching portion”, Para 26; the portion of 64 that directly contacts inner housing 54) which holds the at least one retaining element in the first position (as seen in Fig 1,2; Para 24).
Re claim 3, Lesch discloses that the syringe is fixedly mounted in the housing (Para 16).
Re claim 4, Lesch discloses a protective sleeve 66 and a spring 72 configured to urge the protective sleeve in a distal direction (Para 27), wherein when the protective sleeve is pushed against an injection surface, the protective sleeve moves in a proximal direction and into the housing (Para 25) and the needle is caused to be manually inserted into the injection surface in an insertion position of the protective sleeve (Para 25).
Re claim 5, Lesch discloses that when the protective sleeve is in the insertion position, the displaceable lock can be moved to the second position (Para 26).
Re claim 6, Lesch discloses that upon the displaceable lock releasing the at least one retaining element, a dispensing operation is automatically triggered (Para 26,27).
Re claim 10, Lesch discloses that, upon the displaceable lock releasing the at least one retaining element, a dispensing operation is automatically triggered (Para 26).
Re claim 11, Lesch discloses that prior to the displaceable lock reaching the second position, the dispensing operation is prevented (Para 24).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lesch Jr et al. (PG PUB 2009/0299278) in view of Lavi et al. (PG PUB 2005/0027255).
Re claims 7 and 8, Lesch discloses that upon removal of the injection device from the injection surface, the spring pushes the protective sleeve in the distal direction into a front-most position (Para 27), but does not disclose that this result in a locked state where the protective sleeve is blocked from moving. Lavi, however, teaches a substantially similar injection device (as seen in Fig 2) comprising a housing 160 (Fig 2), a protective sleeve 250 (Fig 2,36) and a spring 450 (Fig 36) configured to urge the protective sleeve in a distal direction (Para 122), wherein upon removal of the injection device from an injection surface, the spring pushes the protective sleeve in a distal direction into a front-most position (seen in Fig 36) to a locked state where the protective sleeve is blocked from moving (by means of leaf springs 281 that engage with an inner surface of the housing, Para 118; as seen in Fig 36) for the purpose of preventing accidental injury or contamination by the used needle after use (Para 8). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Lesch to include the sleeve such that it is locked in its front-most position and blocked from moving, as taught by Lavi, for the purpose of preventing accidental injury or contamination by the used needle after use (Para 8).
Re claim 9, Lesch discloses all the claimed features except explicitly disclosing that the protective sleeve is mounted in the housing so that the protective sleeve is prevented from rotating . Lavi, however, teaches a substantially similar injection device (as seen in Fig 2) comprising a housing 160 (Fig 2) and a protective sleeve 250 (Fig 2) that is mounted in the housing so that the protective sleeve is prevented from rotating (due to leaf springs 281 of the sleeve 250 being received in slits 120 of the housing, as seen in Fig 36 and described in Para 104 and 118) for the purpose of ensuring that the protective sleeve can be locked relative to the housing (due to springs 281 being received in openings 122 of slits 120, as seen in Fig 36) in a shielded position after use (Para 8,118). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Lesch to include the sleeve such that it is mounted in the housing in a manner that prevents the sleeve from rotating, as taught by Lavi, for the purpose of ensuring that the sleeve can be locked relative to the housing in a shielded position after use (Para 8,118).
Response to Arguments
Applicant’s arguments filed 3/2/2026 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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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