DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/21/2026 is acknowledged. Accordingly, claim 9 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Acknowledgment is made of applicant’s claim for priority to US Patent Application Nos. 17/576,311 (filed 1/14/2022), 16/896,831 (filed 6/9/2020), 14/862,275 (filed 9/23/2015) and 12/644,304 (filed 12/22/2009), PCT Application No. PCT/CH2008/000288 (filed 6/26/2008), and Foreign Application No. DE10 2007 030 327.2 (filed 6/29/2007).
Specification
The disclosure is objected to because of the following informalities: The first paragraph on Page 1 of the Specification refers to US Application No. 16/896,831; since this application was issued as US Patent No. 12,377,217 or 8/5/2025, the first paragraph on Page 1 should be updated to indicate this.
Appropriate correction is required.
Claim Objections
Claims 2, 3, 5, 6 and 7 are objected to because of the following informalities: Each of claims 2, 3, 5, 6 and 7 are grammatically incorrect due to missing commas; in order to be grammatically correct, a comma should be placed after the term “wherein” on line 6 of claim 2, after the term “element” on lines 3 and 4 of claim 3, after the term “wherein” on line 1 of claim 5, after the term “which” on line 2 of claim 6, and after the term “wherein” on line 1 of claim 7. Appropriate correction is required.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2 and 4-6 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lavi et al. (PG PUB 2003/0105430).
Re claim 2, Lavi discloses an injection device 300 (Fig 38,39,44-47; it is noted that all reference characters cited below refer to Fig 38,39,44-47 unless otherwise noted) comprising: a housing 304 enclosing a product container 30 with an injection needle 32 fastened to the product container and a piston 38 in the product container that can be shifted relative to the housing (as seen in comparison for Fig 38 and Fig 45; Para 188), wherein the product container is held in a product container holder 34 which can be moved together with the product container in an injection direction from an initial position (seen in Fig 38) into an end position (seen in Fig 45), wherein in the end position, the injection needle protrudes distally beyond a distal end of the injection device (as seen in Fig 45, the needle protrudes distally beyond all other elements of the injection device); an activating element 302 shiftable relative to the housing from an initial position (seen in Fig 38) to a proximal position (seen in Fig 9) when activated (Para 188); a restoring spring 50 operably coupled to the activating element such that the activating element can be shifted distally from the proximal position into an end position (seen in Fig 47) by the restoring spring (Para 192); an advancing member 232 shiftable relative to the housing in an advancing direction (as seen in comparison of Fig 38 and Fig 45) and acting on the piston (Para 192); and a triggering element 54 to release, when moved in a distal direction (as seen in comparison of Fig 38 and 39, the triggering element 54 rotates in clockwise direction, resulting in it moving distally from the position of Fig 38 to the position of Fig 39) and in combination with activating the activating element, a latching connection (formed between 56 and 210; Para 187) by which the advancing member is held (Para 187), wherein the restoring spring can be tensed by a first amount when the activating element moves from the initial position to the proximal position (as seen in Fig 38 to Fig 39), and wherein the restoring spring can be tensed by a second amount when the advancing member moves in the advancing direction from an initial position (seen in Fig 38) of the advancing member (as seen in Fig 44).
Re claim 4, Lavi discloses an injection spring 20 for shifting the advancing member in the injection direction (Para 183).
Re claim 5, Lavi discloses that, in the end position of the activating element, the activating element protrudes distally beyond a distal end of the housing (as seen in Fig 47).
Re claim 6, Lavi discloses that the activating element comprises a needle protecting sleeve (“sleeve 306” – Para 184), which in the end position of the activating element, protrudes beyond a distal end of the injection needle (as seen in Fig 47).
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 2-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bitdinger et al. (US Pat 5,478,316) in view of Lavi et al. (PG PUB 2003/0105430).
Re claim 2, Bitdinger discloses an injection device 10 (Fig 1-8; it is noted that all reference characters cited below refer to Fig 1-8 unless otherwise noted) comprising: a housing 12 enclosing a product container 30 with an injection needle 38 fastened to the product container and a piston 32 in the product container that can be shifted relative to the housing (seen in one position relative to the housing in Fig 5, another position relative to the housing in Fig 6 and another position relative to the housing in Fig 7; Col 6, Lines 10-12) wherein the product container can be moved in an injection direction from an initial position (seen in Fig 4) into an end position (seen in Fig 8), wherein in the end position, the injection needle protrudes distally beyond a distal end of the injection device (a seen in Fig 8, the needle protrudes distally beyond the distal end of the housing; since the housing is a component of the injection device, the distal end of the housing is “a distal end of the injection device”); an activating element 28 shiftable relative to the housing from an initial position (seen in Fig 4) to a proximal position (seen in Fig 5) when activated (as described in Col 5, Lines 51-56); a restoring spring 40 operably coupled to the activating element such that the activating element can be shifted distally from the proximal position into an end position (seen in Fig 8) by the restoring spring (Col 6, Lines 22-26); an advancing member 46 shiftable relative to the housing in an advancing direction (as seen in the comparison of Fig 5, Fig 6 and Fig 7) and acting on the piston (Col 6, Lines 10-12); and a triggering element 58 to release, when moved in a distal direction (as seen in the comparison of Fig 5 and Fig 6) and in combination with activating the activating element, a latching connection (formed by pawl 60 and notch 52 – Col 4, Lines 33-35) by which the advancing member is held (Col 5, Lines 28-29), wherein the restoring spring can be tensed by a first amount when the activating element moves from the initial position to the proximal position (Fig the position seen in Fig 4 to the position seen in Fig 5; Col 5, Lines 53-54), and wherein the restoring spring can be tensed by a second amount when the advancing member moves in the advancing direction from an initial position (seen in Fig 5) of the advancing member (as seen in Fig 6; due to the forward movement the container 30 – Col 5, Lines 63-66). Bitdinger is silent as to a product container is held in a product container holder which holds the product container therein and which can be moved together with the product container in the injection direction from the initial position into the end position.
Lavi, however, teaches an injection device (Fig 38; it is noted that all reference characters cited below refer to Fig 38 unless otherwise noted) comprising a housing 304 enclosing a product container 36 with an injection needle 32 fastened to the product container and a piston 38 (labeled in Fig 39) in the product container (as seen in Fig 38) that can be shifted relative to the housing (as seen in comparison of Fig 38 and Fig 45; Para 192), wherein the product container is held in a product container holder 34 (as seen in Fig 38) which can be moved together with the product container in an injection direction (as seen in the movement between the position seen in Fig 38 to the position seen in Fig 45); Lavi discloses that the product container holder 34 attaches the needle to the product container for providing fluid communication there between (Para 122). Since Bitdinger discloses that their needle is “mounted to” the product container but is silent as to how it is “mounted”, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Bitdinger to include a product container holder, as taught by Lavi, for the purpose of mounting the needle to the container in a manner that provides fluid communication therebetween (Para 122).
Re claim 3, Bitdinger discloses a transfer element 66 which abuts a proximal end of the activating element (Col 4, Lines 48-49) and which is moved relative to the housing when the activating element is activated (Col 4, Line 65 – Col 5, Line 4), and which prevents the activating element in the initial position of the activating element from moving in the distal direction (Col 4, Lines 50-52).
Re claim 4, Bitdinger discloses an injection spring 56 for shifting the advancing member in the injection direction (Col 6, Lines 8-10).
Re claim 5, Bitdinger discloses that, in the end position of the activating element, the activating element protrudes distally beyond a distal end of the housing (as seen in Fig 8).
Re claim 6, Bitdinger discloses that the activating element comprises a needle protecting sleeve (as seen in Fig 8; “sleeve 28” – Col 3, Line 26), which, in the end position of the activating element, protrudes beyond a distal end of the injection needle (as seen in Fig 8).
Re claim 7, Bitdinger discloses that, in the end position of the activating element, the needle protection sleeve protrudes distally beyond a distal end of the housing by a greater amount than in the initial position of the activating element (as seen in comparison of Fig 4 and Fig 8; in the initial position, tongue 14A of the housing is proximal to the notch 28B of the activating element and, in the end position, the tongue 14A is within notch 28B).
Re claim 8, Bitdinger discloses that a distal movement of the needle protecting sleeve causes a locking tongue 14A to block the needle protecting sleeve against moving in a proximal direction (Col 6, Lines 22-26).
Conclusion
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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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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