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 .
Response to Amendment
The amendment filed 05/26/26 has been entered. Claims 11-12, 15-16, 18, 28, have been amended. Claims 13-14, 17, 19-27, and 29-30 are in the original/previously presented form. Claims 1-10 are cancelled. Thus, claims 11-30 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection, 112f interpretation, and 112(b) rejection previously set forth in the Non-Final Office Action mailed 02/25/26.
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.
Claims 27-28 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen (U.S. Patent No. 6,605,067).
Regarding claim 27, Larsen discloses a method comprising:
activating a drug delivery device (such as by pressing to injection site and removing a pin blocking the holder 27, see FIG. 7 and col 6 lines 25-54) to cause a proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) of a needle (22) to move relative (see movement from FIG. 7 to FIG. 6 and as described in col 6 lines 25-54) to a distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) of the needle (24, see col 6 lines 7-24: needle 22/26/24 integrally formed as one “needle”) in order to pierce a septum of a medicament cartridge in the drug delivery device (see col 6 lines 6-15); and
dispensing drug from the medicament cartridge in the drug delivery device (see col 1 lines 10-20 & col 2 lines 54-67) through a fluid channel (26, see col 6 lines 15-24: 26 connects needles 22/24) between the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22).
Regarding claim 28, Larsen discloses the method of claim 27, and Larsen further discloses wherein the activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) comprises:
releasing energy (see col 6 lines 25-54: holder 37 forced into housing and held by pin which would force spring 31 into compressed/ biased/ stored energy configuration as shown in FIG.7. Energy is released upon removal of pin out of slot 25 such that the spring drives holder 27 to allow needle to penetrate injection site) stored in a spring (31) arranged between (see FIG. 7) a distal needle holder (27) holding (see col 6 lines 15-24: distal end of needle 24 fixed in 27 and thus 27 must be “holding” the needle) a distal needle end (end of needle 24) and a proximal needle holder (19) holding (see col 6 lines 6-24: end of needle 22 fixed to 19 and thus 19 must be “holding” the needle) a proximal needle end (end of needle 22) such that the spring (31) biases the proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) and the distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) to move away from one another (as seen from FIG. 7 to FIG. 6 and biasing described in col 6 lines 25-54).
Regarding claim 30, Larsen discloses the method of claim 27, and Larsen further discloses wherein the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22) point (see FIG. 7) in opposite directions (as shown in FIG. 7 and described in col 6 lines 6-15: needles penetrate opposite sites), and/or wherein the spring is adapted to act in two directions.
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.
Claims 11-14, 23-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (U.S. Patent No. 6,605,067) in view of Newby (U.S. PGPUB No. 2003/0181872).
Regarding claim 11, Larsen discloses a method comprising:
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Activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) a drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause a proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) of a needle (22, see col 6 lines 6-15) and a distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) of the needle (24, see col 6 lines 7-24: needle 22/26/24 integrally formed as one “needle”) to be moved away from one another by a spring (31, see col 6 lines 25-54 and movement as shown in transition between FIGs. 6&7), wherein the spring (31) is arranged between (see ‘Modified FIG. 7’ above) a distal needle holder (27) holding (see col 6 lines 15-24: distal end of needle 24 fixed in 27 and thus 27 must be “holding” the needle) a distal needle end (end of needle 24) and a proximal needle holder (19) holding (see col 6 lines 6-24: end of needle 22 fixed to 19 and thus 19 must be “holding” the needle) a proximal needle end(end of needle 22); wherein the activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) comprises releasing (see col 6 lines 25-54: removal of pin releases 27 to move in distal direction to pierce injection site) the distal needle holder (27), thereby causing the spring (31) to bias the proximal needle tip (tip of needle 22) and the distal needle tip (tip of needle 24) to move away from one another (such as shown from FIG. 7 to 6 or as described in at least col 6 lines 25-54); and
dispensing drug from a medicament cartridge in the drug delivery device (see col 1 lines 10-20 & col 2 lines 54-67) through a fluid channel (26, see col 6 lines 15-24: 26 connects needles 22/24) between (see ‘Modified FIG. 7’ above) the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22), wherein the proximal needle tip (tip of needle 22) is adapted to pierce a septum of the medicament cartridge (see col 6 lines 6-15).
Larsen is silent to wherein the activating comprises releasing the “proximal” needle holder.
However, Newby teaches a method comprising activating (see [0036]) a drug delivery device, wherein the activating comprises releasing a proximal needle holder (30, see FIG. 2), thereby causing the proximal needle holder (30) to move away (see [0036]: 30/40 move axially away from each other such as from position in FIG. 2 to position in FIG. 3) from a distal needle holder (40).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of activating a drug delivery device disclosed in Larsen to include releasing the proximal needle holder by way of an axially movable proximal needle hub as taught by Newby for the purpose of allowing both the proximal and distal needle holders to move axially between first and second positions (see [0030]) such that the needle can be covered after use (see [0036]), which increases the safety of Larsen’s device that appears to have the distal end of the distal needle exposed even after an injection is completed, thus achieving wherein the activating comprises releasing the “proximal” needle holder.
Alternatively, mere duplication of parts (i.e.: duplicating the longitudinally movable distal holder 27 in Larsen to form a secondary longitudinally movable proximal holder--A person of ordinary skill in the art in view of Larsen would find it obvious to form the proximal holder as a longitudinally movable plug, such as disclosed for distal holder 27, in order to obtain longitudinal movement for the proximal holder. See Larsen col 6 lines 18-25) has no patentable significance unless a new and unexpected result is produced (see MPEP § 2144.04.VI.B).
Regarding claim 12, the modified system of Larsen teaches the method of claim 11, and Larsen further discloses wherein the activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) comprises:
releasing (see col 6 lines 25-54: removal of pin releases 27 to move in distal direction to pierce injection site) the distal needle holder (27), thereby causing the spring (31) to bias the proximal needle tip (tip of needle 22) and the distal needle tip (tip of needle 24) to move away from one another (such as shown from FIG. 7 to 6 or as described in at least col 6 lines 25-54).
Regarding claim 13, the modified system of Larsen teaches the method of claim 11, and Larsen discloses further comprising: causing the distal needle tip (tip of needle 24) to be inserted into an injection site (see col 6 lines 25-54) before dispensing the drug from the medicament cartridge (see col 6 lines 25-54: distal holder 27 is released to pierce injection site “ready for injection”. Thus, injection site MUST BE pierced prior to delivery of drug as described in at least col 1 lines 10-20 & col 2 lines 54-67).
Regarding claim 14, the modified system of Larsen teaches the method of claim 13, and Larsen discloses further comprising preventing (at least by way of the spring force that drives distal needle holder to penetrate the injection site when the device is held against the injection site as described in col 6 lines 25-54) the distal needle holder (27) from retracting (when pin is released, spring force acts completely against the needle holder and would therefore prevent the holder from being retracted by an amount equal to the spring force. See col 6 lines 25-54), when the distal needle tip (tip of needle 24, see FIG.7) is pushed against the injection site (see col 6 lines 25-54).
Regarding claim 23, the modified system of Larsen teaches the method of claim 11, and Larsen further discloses wherein the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22) point (see FIG. 7) in opposite directions (as shown in FIG. 7 and described in col 6 lines 6-15: needles penetrate opposite sites), and/or wherein the spring is adapted to act in two directions.
Regarding claim 24, the modified system of Larsen teaches the method of claim 11, and Larsen further discloses wherein the fluid channel (26, see FIG. 7) is flexible (see FIG. 7 and FIG. 6 showing channel 26 in compressed and expanded configurations, thus, channel MUST BE flexible. See also col 6 lines 25-54: needle has desired elasticity for moving between compressed and expanded configurations and thus such an elasticity is inherently flexible).
Regarding claim 25, the modified system of Larsen teaches the method of claim 24, but in the embodiment of FIG. 7, Larsen is silent to “wherein the spring is formed by the flexible fluid channel”.
However, in another embodiment (see FIGs.4/5), Larsen teaches a method (see FIG. 4 &5) comprising:
Activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) a drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause a proximal needle tip (tip of 22, see FIG. 5) of a needle (22) and a distal needle tip (tip of needle 24) of the needle (24, see col 6 lines 7-24: needle 22/26/24 integrally formed as one “needle”) to be moved away from one another (see movement from FIG. 5 to FIG. 4 and description in col 6 lines 25-54) by a spring (see col 6 lines 49-54: needle 26 inherently acts as spring by providing force via elasticity), wherein the spring (elastic force inherently in needle 26) is arranged between (see portion of needle 26 in housing chamber between the needle holders in FIG. 5) a distal needle holder (27) holding (see col 6 lines 15-24: distal end of needle 24 fixed in 27 and thus 27 must be “holding” the needle) a distal needle end (end of needle 24) and a proximal needle holder (19) holding (see col 6 lines 6-24: end of needle 22 fixed to 19 and thus 19 must be “holding” the needle) the proximal needle end (end of needle 22); and
dispensing drug from a medicament cartridge in the drug delivery device (see col 1 lines 10-20 & col 2 lines 54-67) through a fluid channel (channel of 26, see col 6 lines 15-24: 26 connects needles 22/24) between the distal needle tip (tip of needle 24) and the proximal needle tip (tip of needle 22), wherein the proximal needle tip (tip of needle 22) is adapted to pierce a septum of the medicament cartridge (see col 6 lines 6-15),
wherein the fluid channel (channel of 26, see col 6 lines 15-24: 26 connects needles 22/24) is flexible (see FIG. 5 and FIG. 4 showing channel of 26 in compressed and expanded configurations, thus, channel MUST BE flexible. See also col 6 lines 25-54: needle has desired elasticity for moving between compressed and expanded configurations and thus such an elasticity is inherently “flexible”),
and wherein the spring (see col 6 lines 49-54: needle 26 inherently acts as spring by providing force via elasticity and FIG.5) is formed by the flexible fluid channel (channel of 26, see col 6 lines 15-24: 26 connects needles 22/24).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of activating a drug delivery device that causes a proximal and distal needle holder to move away from each other by a spring disclosed in Larsen (FIGs.7&8) to form the spring from the flexible fluid channel/needle alone as taught by Larsen (FIGs. 4&5) for the purpose of providing the necessary force to insert the needle through skin by the needle itself (see col 6 lines 34-54), thus achieving “wherein the spring is formed by the flexible fluid channel”.
Further, omission of an element and its function is obvious if the function of the element is not desired (see MPEP § 2144.04(II).A. In the instant case, the spring of FIG. 7 is provided to supplement the fluid channel/needle incapable of providing appropriate penetration force—see col 6 lines 49-54. Thus, if the spring of FIG. 7 is eliminated because the function of providing supplemental force is no longer required, omission of the spring element and supplementary force function is obvious. Therefore, a person of ordinary skill in the art would find it obvious to omit the supplementary spring in Larsen FIG. 7 and achieve “wherein the spring is formed by the flexible fluid channel” by selecting a fluid channel/ needle with appropriate elasticity/penetration force for inserting into skin by itself).
Regarding claim 26, the modified system of Larsen teaches the method of claim 24, and Larsen further discloses wherein the flexible fluid channel (26, see FIG. 7) is formed as a helical spring or as an S-shaped spring (see s-shape in FIG. 7 and see col 5 lines 38-60: s-shape described and see col 6 lines 49-54: needle 26 inherently acts as spring by providing force via elasticity).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Newby as applied to claim 11 above, and further in view of Gratwohl et al. (U.S. Patent No. 8,052,653), hereinafter Gratwohl.
Regarding claim 15, the modified system of Larsen teaches the method of claim 11, and Larsen further discloses wherein activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) the drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause the proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) and the distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) to move away from one another (see col 6 lines 25-54 and movement as shown in transition between FIGs. 6&7) comprises:
Biasing (see col 6 lines 25-27: 27 is forced into the housing 23 and would therefore provide a biasing force), by the spring (see col 6 lines 49-54: spring 31 provided as shown in Fig.6/7 and by this location would inherently be biased by the step described in col 6 lines 25-27), the distal needle holder (27) away from (see col 6 lines 25-54) the proximal needle holder (19).
Larsen is silent to the spring biasing the proximal and distal needle holders away from each other “such that a guided surface on the distal needle holder is guided by a corresponding guide surface of the drug delivery device.”
However, Gratwohl teaches a method comprising activating a drug delivery device (see Fig. 2 and col 1 lines 15-28), the drug delivery device comprising a distal needle holder (5), where the distal needle holder (5) is biased by a spring (6, see col 6 lines 26-52) such that a guided surface (see surfaces 5a/5b in Fig.7) on the distal needle holder (5) is guided by (see col. 6 lines 26- col. 7 line 35) a corresponding guide surface (surface of recesses 4a/4b, see Fig. 6D and see col 6 line 61- col. 7 line 11) of the drug delivery device (as in Fig. 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal needle holder and drug delivery device disclosed by the method of Larsen to include a guided feature and a corresponding guide feature, respectively, as taught by Gratwohl for the purpose of guiding the holder along the device until a stop point (see col 6 line 61- col. 7 line 11), which would be advantageous to Larsen because a stop point for the distal needle holder relative the drug delivery device could define/set a depth of needle insertion/injection, or to prevent the distal needle holder from rotating (see col. 7 lines 12-35), thus achieving the spring biasing the proximal and distal needle holders away from each other “such that a guided surface on the distal needle holder is guided by a corresponding guide surface of the drug delivery device.”
Regarding claim 16, the modified system of Larsen teaches the method of claim 11, and Larsen further discloses wherein activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) the drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause the proximal needle tip (tip of needle 22, see ‘Modified FIG. 7’ above) and the distal needle tip (tip of needle 24, see ‘Modified FIG. 7’ above) to move away from one another (see col 6 lines 25-54 and movement as shown in transition between FIGs. 6&7) comprises:
Biasing (see col 6 lines 25-27: 27 is forced into the housing 23 and would therefore provide a biasing force), by the spring (see col 6 lines 49-54: spring 31 provided as shown in Fig.6/7 and by this location would inherently be biased by the step described in col 6 lines 25-27), the proximal needle holder (19) away from (see col 6 lines 25-54) the distal needle holder (27).
Larsen is silent to the spring biasing the proximal and distal needle holders away from each other “such that a guided surface on the proximal needle holder is guided by a corresponding guide surface of the drug delivery device.”
However, Gratwohl teaches a method comprising activating a drug delivery device (see Fig. 2 and col 1 lines 15-28), the drug delivery device comprising a proximal needle holder (2 formed of base 9 and retaining region 10, see col 6 lines 19-20) biased by a spring (see col 8 lines 23-36) such that a guided surface (see surface grooves 11 in base 9 in at least fig. 16) on the proximal needle holder is guided by (see col 7 line 66- col. 10 line 5 and see FIG. 16 for side-by- side interaction shown between proximal needle holder 2, including base 9, and the protrusions 16 of guide feature 7) a corresponding guide surface (7, a surface rib having surface protrusions 16) of the drug delivery device (as seen in FIG. 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal needle holder and drug delivery device disclosed by the method of Larsen to include a guided surface and a corresponding guide surface, respectively, as taught by Gratwohl for the purpose of forming a locking mechanism that allows the device to move to the releasing position only once such that the user is further protected from inadvertent needle sticks (see col 8 line 41- col 9 line 4), thus achieving the spring biasing the proximal and distal needle holders away from each other “such that a guided surface on the proximal needle holder is guided by a corresponding guide surface of the drug delivery device.”
Claims 17-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Newby as applied to claim 11 above, and further in view of Haber et al. (U.S. Patent No. 4,927,019), hereinafter Haber.
Regarding claim 17, the modified system of Larsen teaches the method of claim 11, and Larsen further discloses wherein the fluid channel (26, see col 6 lines 15-24: 26 connects needles 22/24) is arranged within (see Fig.7) the expandable (see compressed configuration in Fig. 7 and expanded configuration in Fig. 6. Thus, the spring body is expandable) spring body (31).
Larsen is silent to wherein the fluid channel is arranged within “an expandable elastomer body”.
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ below) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ below) by an expandable elastomer body (bellows 95),
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wherein the expandable elastomer body (95) is arranged between (as shown in ‘Modified FIG. 21’ above) a distal needle holder (see ‘Modified FIG. 21’ above) holding a distal needle tip (tip of needle 96) and a proximal needle holder (see ‘Modified FIG. 21’ above) holding a proximal needle tip (tip of needle 98); dispensing a drug from a medicament cartridge (106, see FIG. 21) in the drug delivery device (see col. 3 lines 40-51 & col 8 lines 22-41) through a fluid channel (channel formed between proximal needle 98 and distal needle 96 to perform injection, see col 8 lines 37-41); wherein the fluid channel (channel formed between proximal needle 98 and distal needle 96 to perform injection) is arranged within (see “modified FIG. 21’ above with fluid channel radially within bellows) the expandable elastomer body (bellows 95).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body between the proximal and distal needle holders as disclosed in the method of Modified Larsen to include an expandable elastomer body as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), thus achieving wherein the fluid channel is arranged within “an expandable elastomer body”.
Regarding claim 18, the modified method of Larsen teaches the method of claim 17, and Larsen further discloses wherein the expandable (see compressed configuration in Fig. 7 and expanded configuration in Fig. 6. Thus, the spring body is expandable) spring body (31, see FIG. 7) extends between (see FIG. 7) the proximal needle holder (19) and the distal needle holder (27).
Larsen is silent to the expandable body being an expandable elastomer body, “wherein the expandable elastomer body comprises bellows” extending between the proximal needle holder and the distal needle holder”.
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ above) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ above) by an expandable elastomer body (bellows 95), wherein the expandable elastomer body (bellows 95) comprises bellows (see col 8 lines 22-41) extending between a proximal needle holder (see ‘Modified FIG. 21’ above) and a distal needle holder (see ‘Modified FIG. 21’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body between the proximal and distal needle holders as disclosed in the method of Larsen to include an expandable elastomer body comprising bellows as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), thus achieving the expandable body being an expandable elastomer body, “wherein the expandable elastomer body comprises bellows” extending between the proximal needle holder and the distal needle holder”.
Regarding claim 19, the modified method of Larsen teaches the method of claim 17, and Larsen further discloses wherein activating (such as by pressing to injection site and removing a pin blocking the holder 27, see col 6 lines 25-54) the drug delivery device (see col. 4 lines 62-65: threads for connecting onto drug delivery device) to cause the proximal needle tip (tip of needle 22, see FIG. 7) and the distal needle tip (tip of needle 24) to move away from one another (see col 6 lines 25-54 and movement as shown in transition between FIGs. 6&7) comprises: guiding the distal needle holder (27) by the spring body (31, see col 6 lines 25-54).
Larsen is silent to guiding the distal needle holder by the “elastomer” body.
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ above) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ above) comprising guiding (see col 7 line 38- col 8 line 41: base 110 with distal needle holder is guided by bellows during attachment process) a distal needle holder (see ‘Modified FIG. 21’ above) by an elastomer body (bellows 95).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body guiding the distal needle holder as disclosed in the method of Larsen to include an expandable body as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), thus achieving guiding the distal needle holder by the “elastomer” body.
Regarding claim 22, the modified method of Larsen teaches the method of claim 17, but Larsen is silent to “wherein the expandable elastomer body is configured to support the spring.”
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ above) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ above) by an expandable elastomer body (bellows 95), wherein the expandable elastomer body (bellows 95) is configured to support a spring (see col 8 lines 3-6: bellows biased to longitudinally expanded position and must be “forced” to compress. Thus, bellows inherently provide some degree of elasticity in the longitudinal direction and are thus “configured to” support a spring disposed along the same longitudinal direction because the bellows are providing a supplementary elastic force along the same direction).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body between the proximal and distal needle holders as disclosed in the method of Larsen to include an expandable elastomer body configured to support a spring as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), and for providing a supplementary force along the longitudinal direction (see Haber col 8 lines 3-6), thus achieving “wherein the expandable elastomer body is configured to support the spring.”
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Newby and Haber as applied to claim 17 above, and further in view of Gratwohl (U.S. Patent No. 8,052,653).
Regarding claim 20, the modified method of Larsen teaches the method of claim 17, but Modified Larsen is silent to “wherein at least one of the distal needle holder, the proximal needle holder, or the expandable elastomer body has a guiding surface adapted to be guided by corresponding surfaces within the drug delivery device.”
However, Gratwohl teaches a method comprising activating a drug delivery device (see Fig. 2 and col 1 lines 15-28), the drug delivery device comprising a distal needle holder (5), wherein the distal needle holder (5) has a guiding surface (5a/5b, see Fig.7 and col 7 lines 12-15) adapted to be guided by (see col. 6 lines 26- col. 7 line 35) corresponding surfaces (recesses 4a/4b, see Fig. 6D, aligning with 112f interpretation above including “grooves” and see col 6 line 61- col. 7 line 11) within the drug delivery device (as in Fig. 2).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal needle holder and drug delivery device disclosed by the method of Larsen to include a guided surface and a corresponding guiding surface, respectively, as taught by Gratwohl for the purpose of guiding the holder along the device until a stop point (see col 6 line 61- col. 7 line 11), which would be advantageous to Larsen because a stop point for the distal needle holder relative the drug delivery device could define/set a depth of needle insertion/injection, or to prevent the distal needle holder from rotating (see col. 7 lines 12-35), thus achieving “wherein at least one of the distal needle holder, the proximal needle holder, or the expandable elastomer body has a guiding surface adapted to be guided by corresponding surfaces within the drug delivery device.”
Regarding claim 21, the modified method of Larsen teaches the method of claim 20, but Larsen is silent to “wherein the guiding surface is cylindrical”.
However, Gratwohl teaches a method comprising activating a drug delivery device (see Fig. 2 and col 1 lines 15-28), the drug delivery device comprising a distal needle holder (5), wherein the distal needle holder (5) has a guiding surface (5a/5b, see Fig.7 and col 7 lines 12-15), wherein the guiding surface is cylindrical (see FIG. 7 and col 7 lines 12-15: axial groove 5b extends along the outer surface of cylindrical tube and thus is cylindrical in as much as is disclosed by Applicant in FIG. 2 and [0039]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal needle holder and drug delivery device disclosed by the method of Larsen to include a cylindrical guiding surface and a corresponding guiding surface, respectively, as taught by Gratwohl for the purpose of guiding the holder along the device until a stop point (see col 6 line 61- col. 7 line 11), which would be advantageous to Larsen because a stop point for the distal needle holder relative the drug delivery device could define/set a depth of needle insertion/injection, or to prevent the distal needle holder from rotating (see col. 7 lines 12-35), thus achieving “wherein the guiding surface is cylindrical.”
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Larsen as applied to claim 27 above, and further in view of Haber (U.S. Patent No. 4,927,019).
Regarding claim 29, Larsen discloses the method of claim 27, and Larsen further discloses wherein the fluid channel (26, see col 6 lines 15-24: 26 connects needles 22/24) is arranged within (see Fig.7) the expandable (see compressed configuration in Fig. 7 and expanded configuration in Fig. 6. Thus, the spring body is expandable) spring body (31).
Larsen is silent to wherein the fluid channel is arranged within “an expandable elastomer body”.
However, Haber teaches a method comprising activating a drug delivery device (see col. 3 lines 40-51 & col. 8 lines 7-41: assembling the needle portion onto the syringe portion to penetrate skin of patient for drug delivery/ fluid infusion) with a proximal needle tip (proximal tip of needle 98, see ‘Modified FIG. 21’ below) caused to be moved away from (see transition from FIG. 21 to FIG. 20 and see col. 8 lines 22-41: a force must be applied to move bellows to compressed position as shown in FIG. 21. Therefore, the bellows must cause the needle tips to be “moved away” from each other at rest) a distal needle tip (distal tip of needle 96, see ‘Modified FIG. 21’ below) by an expandable elastomer body (bellows 95),
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wherein the expandable elastomer body (95) is arranged between (as shown in ‘Modified FIG. 21’ above) a distal needle holder (see ‘Modified FIG. 21’ above) holding a distal needle tip (tip of needle 96) and a proximal needle holder (see ‘Modified FIG. 21’ above) holding a proximal needle tip (tip of needle 98); dispensing a drug from a medicament cartridge (106, see FIG. 21) in the drug delivery device (see col. 3 lines 40-51 & col 8 lines 22-41) through a fluid channel (channel formed between proximal needle 98 and distal needle 96 to perform injection, see col 8 lines 37-41); wherein the fluid channel (channel formed between proximal needle 98 and distal needle 96 to perform injection) is arranged within (see “modified FIG. 21’ above with fluid channel radially within bellows) the expandable elastomer body (bellows 95).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the expandable spring body between the proximal and distal needle holders as disclosed in the method of Larsen to include an expandable elastomer body as taught by Haber for the purpose of keeping the needle shielded and sterile during packaging and assembly (see Haber col 7 line 38- col. 8 line 41), which would be advantageous to Larsen that has the exposed distal needle tip during assembly such as when forcing the distal needle holder (27) into the housing (see Larsen col 6 lines 25-48), thus achieving wherein the fluid channel is arranged within “an expandable elastomer body”.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11 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.
A new 35 U.S.C. § 103 rejection under Larsen in view of Newby has been used to reject the newly amended claim limitations of claim 11, rendering the arguments against the previously applied 35 U.S.C. § 102 claim rejection under Larsen moot.
Applicant's arguments filed 05/26/26 have been fully considered but they are not persuasive.
On pages 8-9, Applicant argues that Larsen fails to disclose a movement of the proximal needle tip “relative to” a distal needle tip “causes the proximal needle tip to pierce a septum…” and therefore the 35 U.S.C. § 102 claim rejection of claim 27 under Larsen should be withdrawn. The examiner disagrees and has maintained the rejection.
Applicant’s argument seems to suggest that the “relative” movement MUST BE an axial movement (see page 9 where Applicant argues that the disclosed rotational movement of the proximal needle to penetrate the cartridge in Larsen does not disclose the claim limitation). However, the examiner is not persuaded by this argument due to breadth of the currently recited claim language. Claim 27 only requires a proximal needle tip of a needle to move “relative to” a distal needle tip of the needle in order to pierce a septum of a medicament cartridge. Thus, rotating the proximal needle tip meets this claim limitation (Larsen discloses rotation of the proximal needle tip “relative to” the distal needle tip such as rotation of the proximal needle tip about a longitudinal axis extending through the distal needle tip==relative movement). Therefore, because there is nothing in claim 27 to require that the proximal needle tip must move axially relative to the distal needle tip, the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 102 claim rejection of claim 27.
Because so further arguments were presented, the examiner has subsequently maintained the depending claim rejections.
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 KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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