DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Species I, Figs. 3-5, claims 1-4, 8-14, and 16 in the reply filed on 3/6/2026 is acknowledged. Thus, claims 5-7, 15, and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 16 should depend from claim 10, not withdrawn claim 15. Appropriate correction is required.
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 1-2, 10-11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waskonig 5,549,573.
Waskonig discloses, regarding claim 1, a delivery system comprising: a reservoir 10 including a sidewall 26 defining an internal volume therein; and a delivery mechanism comprising: a piston 12 received in the internal volume, the piston 12 including: a body 29, a seal 24 received around a perimeter of the body 29 and extending outward beyond the perimeter and forming a seal between the body 29 and the sidewall 26, and at least one protrusion 16 extending from the body 29 beyond the perimeter and towards the sidewall 26; and a rod 14 connected to the body 29 of the piston, the delivery mechanism configured to cause a friction bias between the seal 24 and the sidewall 26 around the perimeter of the body 29 of the piston during movement of the piston relative to the reservoir 10 (clearly shown in Figs. 1-4); Re claim 2, wherein the friction bias applies a moment to the piston 12 during movement of the piston 12 and the at least one protrusion 16 is positioned to counteract the moment and prevent rotation of the piston 12 while the piston moves in a first direction, movement in the first direction reducing a medicament volume defined by the reservoir 10 and the piston 12 (Substantially broad, piston 12 would clearly perform in this way to an extent. Furthermore, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited, then it meets the claim).
Waskonig discloses, regarding claim 10, a delivery system comprising: a reservoir 10 including a sidewall 26 defining an internal volume therein; and a delivery mechanism comprising: a piston 12 received in the internal volume, the piston 12 including: a body 29 including a connection end and a pressure end, opposite the connection end, a seal 24 received around a perimeter of the body of the piston 12 and extending outward beyond the perimeter and forming a seal between the body 29 of the piston 12 and the sidewall 26, one or more first protrusions 20 extending from a first side of the body 29 of the piston 12 adjacent to the connection end and extending toward the sidewall 26, and one or more second protrusions 16 extending from a second side of the body 29 of the piston 12, opposite the first side, adjacent to the pressure end and extending toward the sidewall 26; and a rod 14 connected to the body 29 of the piston at a connection point on the connection end, the connection point being offset from a center of the body (where the rod connects to 29 is clearly not in the center of the piston in the axial direction) of the piston 12 to the first side of the body of the piston 12; Re claim 11, wherein each of the plurality of protrusions 16, 20 extends from the body of the piston 12 and contacts the sidewall 26 (this could clearly be the case as the piston shifts within 10); Re claim 13, wherein the internal volume (of 10) includes a first cross-sectional shape and the body 29 of the piston includes a second cross-sectional shape substantially similar to the first cross-sectional shape, the second cross-sectional shape is smaller than the first cross-sectional shape (clearly shown in Figs. 1-2); Re claim 14, wherein the one or more second protrusions 16 on the second side are symmetrically positioned relative to an axis of symmetry of the body 29 of the piston 12 and the one or more first protrusions 20 on the first side are symmetrically positioned relative to the axis of symmetry of the body 29 of the piston 12.
Claims 1-3, 8-10, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reid 3,581,956.
Reid discloses, regarding claim 1, a delivery system comprising: a reservoir 10 including a sidewall 16 defining an internal volume therein; and a delivery mechanism comprising: a piston 12/14 received in the internal volume, the piston 12/14 including: a body 14, a seal 52 received around a perimeter of the body 14 and extending outward beyond the perimeter and forming a seal between the body 14 and the sidewall 16, and at least one protrusion 42 extending from the body 14 beyond the perimeter and towards the sidewall 16; and a rod 12 connected to the body 14 of the piston, the delivery mechanism configured to cause a friction bias between the seal 52 and the sidewall 16 around the perimeter of the body 14 of the piston during movement of the piston relative to the reservoir 10 (clearly shown in Figs. 1-2); Re claim 2, wherein the friction bias applies a moment to the piston 12/14 during movement of the piston and the at least one protrusion 42 is positioned to counteract the moment and prevent rotation of the piston 12/14 while the piston moves in a first direction, movement in the first direction reducing a medicament volume defined by the reservoir 10 and the piston 12/14 (Substantially broad, piston 12/14 would clearly perform in this way to an extent. Furthermore, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited, then it meets the claim); Re claim 3, wherein the at least one protrusion 42 extends from the body of the piston 12/14 and contacts the sidewall 16; Re claim 8, wherein a first force caused by friction between the seal 52 and the sidewall 16 along a first side (pressure end of the piston) is smaller than a second force caused by friction between the seal 52 and the sidewall 16 along a second side (the rod end of the piston) resulting in a known moment applied to the piston 12/14 during movement thereof (again, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990))); Re claim 9, wherein the at least one protrusion 42 is configured to slide along the sidewall 16 while preventing rotation of the piston 12/14 (rotation is prevented in the sense that the piston stays straight in the syringe) while the piston 12/14 moves in a first direction, movement in the first direction reducing a medicament volume defined by the reservoir 10 and the piston 12/14.
Waskonig discloses, regarding claim 10, a delivery system comprising: a reservoir 10 including a sidewall 16 defining an internal volume therein; and a delivery mechanism comprising: a piston 12/14 received in the internal volume, the piston 12/14 including: a body 14 including a connection end and a pressure end, opposite the connection end, a seal 52 received around a perimeter of the body of the piston 12/14 and extending outward beyond the perimeter and forming a seal between the body 14 of the piston 12/14 and the sidewall 16, one or more first protrusions 28 extending from a first side of the body 14 of the piston 12/14 adjacent to the connection end and extending toward the sidewall 16, and one or more second protrusions 42 extending from a second side of the body 14 of the piston, opposite the first side, adjacent to the pressure end and extending toward the sidewall 16; and a rod 12 connected to the body 14 of the piston at a connection point on the connection end, the connection point being offset from a center of the body (where the rod connects to 14 is clearly not in the center of the piston 12/14 in the axial direction) of the piston 12/14 to the first side of the body of the piston 12/14; Re claim 12, the plurality of protrusions 42 are configured to slide along the sidewall 16 while preventing rotation of the piston 12/14 (rotation is prevented in the sense that the piston stays straight in the syringe) while the piston moves in a first direction, movement in the first direction reducing a medicament volume defined by the reservoir 10 and the piston 12/14; Re claim 13, wherein the internal volume (of 10) includes a first cross-sectional shape and the body 14 of the piston includes a second cross-sectional shape substantially similar to the first cross-sectional shape, the second cross-sectional shape is smaller than the first cross-sectional shape (clearly shown in Figs. 1-2); Re claim 14, wherein the one or more second protrusions 42 on the second side are symmetrically positioned relative to an axis of symmetry of the body 14 of the piston 12/14 and the one or more first protrusions 28 on the first side are symmetrically positioned relative to the axis of symmetry of the body 14 of the piston 12/14.
Allowable Subject Matter
Claims 4 and 16 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Peter J Bertheaud whose telephone number is (571)272-3476. The examiner can normally be reached 9am - 5pm M-F.
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PJB
/PETER J BERTHEAUD/Primary Examiner, Art Unit 3746
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