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 IX in the reply filed on 09/08/2026 is acknowledged.
Claim Objections
Claims 6-7 & 27 are objected to because of the following informalities.
Claim 6 should read --The system of claim 3, wherein the proximal and distal
Claim 7 should read --The system of claim 3, wherein the proximal and distal
Claim 27 should read --The system of claim 24, wherein the fenestrated separator is configured to transform from the closed configuration to the open configuration with the increased pressure in the proximal drug chamber relative to the distal drug chamber.--; the increased pressure was first defined in Claim 1
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to Claim 1, the limitation “a plunger member configured to be manually manipulated to insert the stopper member relative to the injection system body”, in Lines 8-9, is indefinite. The limitation is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: what the stopper member is being inserted into. For the purpose of examination, the limitation will be interpreted as a plunger member configured to be manually manipulated to insert the stopper member into the injection system body.
As to Claim 17, the term, “the annular portion”, lacks antecedent basis. Additionally, since the term is written in a manner which is commonly used to indicate the term has been previously defined or claimed, it is not clear if Applicant intended for Claim 17 to be dependent on Claim 14, as written, or on Claim 15, which positively claims an annular portion. For the purpose of examination, the limitation will be interpreted as the system of claim 14, wherein an annular portion defines a plurality of ports…
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 1-11 & 13-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeppesen (FR1478062A – see attached translation).
As to Claim 1, Jeppesen teaches an injection system (Figures 1-4), comprising:
an injection system body (10) defining a proximal opening (the left side of 10, as viewed in Figure 1, within which 12 sits) at a proximal end (the left side of 10, as viewed in Figure 1) thereof (10) and a distal needle interface (17, where one of ordinary skill in the art would conclude a needle may be interfaced with 17) at a distal end (the right side of 10, as viewed in Figure 1) thereof (10);
a stopper member (34) and a fenestrated separator (11/25) disposed in (as shown in Figures 1-4) the injection system body (10), forming a proximal drug chamber (14) between (as shown in Figure 1) the stopper member (34) and the fenestrated separator (11/25) and a distal drug chamber (13) between (as shown in Figure 1) the fenestrated separator (11/25) and the distal end (the right side of 10, as viewed in Figure 1) of the injection system body (10); and
a plunger member (36) configured to be manually manipulated to insert (as shown in Figures 1-3) the stopper member (34) relative to (as shown in Figures 1-4) the injection system body (10);
wherein the fenestrated separator (11/25) forms an openable barrier (via openings 24/28; as shown in Figure 2) between (as shown in Figures 1-4) the proximal (14) and distal (13) drug chambers, and
wherein the fenestrated separator (11/25) is configured to allow flow from the proximal drug chamber (14) to the distal drug chamber (13) with increased pressure (the “inwardly directed pressure” described at the bottom of Page 7) in the proximal drug chamber (14) relative to (bottom of Page 7, to of Page 8) the distal drug chamber (13).
As to Claim 2, Jeppesen teaches all the limitations of Claim 1, and continues to teach the fenestrated separator (11/25) is configured to move (as shown in Figures 1-4) longitudinally (left and right, as viewed in Figures 1-4) within (as shown in Figures 1-4) the injection system body (10).
As to Claim 3, Jeppesen teaches all the limitations of Claim 1, and continues to teach the fenestrated separator (11/25) comprising proximal (the left gasket 31, as viewed in Figure 1) and distal (the right gasket 31, as viewed in Figure 1) gaskets (31) disposed adjacent (as shown in Figure 1) respective proximal (the left end of 25, as viewed in Figure 1) and distal (the right end of 25, as viewed in Figure 1) ends thereof (11/25) and extending (as shown in Figure 1) radially (up and down, as viewed in Figure 1) therefrom (11/25).
As to Claim 4, Jeppesen teaches all the limitations of Claims 1 & 3, and continues to teach the fenestrated separator (11/25) is configured to maintain contact between (top of Page 7) an inner surface (the inner wall of 10, described at the top of Page 7) of the injection system body (10) and the proximal gasket (the left gasket 31, as viewed in Figure 1) and between the inner surface (the inner wall of 10, described at the top of Page 7) of the injection system body (10) and the distal gasket (the right gasket 31, as viewed in Figure 1) as the fenestrated separator (11/25) moves (as shown in Figures 1-4) longitudinally (left and right, as viewed in Figures 1-4) within (as shown in Figures 1-4) the injection system body (10).
As to Claim 5, Jeppesen teaches all the limitations of Claims 1 & 3-4, and continues to teach the proximal (the left gasket 31, as viewed in Figure 1) and distal (the right gasket 31, as viewed in Figure 1) gaskets are separated by a minimum longitudinal distance (the distance defined by the axial gap between the two gaskets 31 shown in Figure 1).
As to Claim 6, Jeppesen teaches all the limitations of Claims 1 & 3, and continues to teach the proximal (the left gasket 31, as viewed in Figure 1) and distal (the right gasket 31, as viewed in Figure 1) circumferential (as shown in Figures 1-4) gaskets (31) are configured to form respective first (the seal defined by the proximal gasket 31, as described at the top of Page 7) and second (the seal defined by the distal gasket 31, as described at the top of Page 7) fluid-tight seals with an inner surface (the inner wall of 10, described at the top of Page 7) of the injection system body (10).
As to Claim 7, Jeppesen teaches all the limitations of Claims 1 & 3, and continues to teach the proximal (the left gasket 31, as viewed in Figure 1) and distal (the right gasket 31, as viewed in Figure 1) circumferential (as shown in Figures 1-4) gaskets (31) are made from an elastic material (bottom of Page 6).
As to Claim 8, Jeppesen teaches all the limitations of Claims 1, 3 & 7, and continues to teach the elastic material (bottom of Page 6) is rubber (bottom of Page 6), thermoplastic elastomer, butyl rubber, or polyisoprene elastomer.
As to Claim 9, Jeppesen teaches all the limitations of Claim 1, and continues to teach the fenestrated separator (11/25) comprises a port (24) configured to be opened by (as shown in Figure 2) the increased pressure (the “inwardly directed pressure” described at the bottom of Page 7) in the proximal drug chamber (14) relative to (bottom of Page 7, to of Page 8) the distal drug chamber (13).
As to Claim 10, Jeppesen teaches all the limitations of Claim 1, and continues to teach the fenestrated separator (11/25) comprises a rigid portion (11) and an elastic portion (25).
As to Claim 11, Jeppesen teaches all the limitations of Claims 1 & 10, and continues to teach the elastic portion (25) defines a pocket (formed by 23/26) configured to receive (as shown in Figures 1-4) the rigid portion (11) therein (formed by 23/26).
As to Claim 13, Jeppesen teaches all the limitations of Claims 1 & 10, and continues to teach the elastic portion (25) is made from rubber (bottom of Page 6), thermoplastic elastomer, butyl rubber, or polyisoprene elastomer.
As to Claim 14, Jeppesen teaches all the limitations of Claims 1 & 10, and continues to teach the elastic portion (25) comprises:
an annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) configured to be disposed adjacent (as shown in Figure 1) a distal surface (the surface of 11 in contact with 23, as viewed in Figure 1) of the rigid portion (11);
a ring (26) configured to support (as shown in Figure 1) the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2); and
proximal (the left gasket 31, as viewed in Figure 1) and distal (the right gasket 31, as viewed in Figure 1) circumferential (as shown in Figures 1-4) gaskets (31) extending from (as shown in Figure 1) an outer circumference (the radially outer facing surface of ring 26, as viewed in Figure 1) of the ring (26),
wherein the proximal (the left gasket 31, as viewed in Figure 1) and distal (the right gasket 31, as viewed in Figure 1) circumferential (as shown in Figures 1-4) gaskets (31) are configured to form respective first (the seal defined by the proximal gasket 31, as described at the top of Page 7) and second (the seal defined by the distal gasket 31, as described at the top of Page 7) fluid-tight seals with an inner surface (the inner wall of 10, described at the top of Page 7) of the injection system body (10).
As to Claim 15, Jeppesen teaches all the limitations of Claims 1, 10 & 14, and continues to teach the rigid portion (11) comprises an annular portion (23),
wherein the annular portion (23) defines a port (24) extending therethrough (as shown in Figure 1), and
wherein the port (24) is configured to be removably closed by (as shown in Figures 1-4) the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) of the elastic portion (25).
As to Claim 16, Jeppesen teaches all the limitations of Claims 1, 10 & 14-15, and continues to teach the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) of the elastic portion (25) is configured such that:
the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) is biased to removably close (as shown in Figure 1) the port (24); and
the increased pressure (the “inwardly directed pressure” described at the bottom of Page 7) in the proximal drug chamber (14) relative to (bottom of Page 7, to of Page 8) the distal drug chamber (13) deforms (as shown in Figure 2) the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) away from (as shown in Figure 2) the port (24) defined by the annular portion (23) of the rigid portion (11), thereby opening (as shown in Figure 2) the port (24).
As to Claim 17, Jeppesen teaches all the limitations of Claims 1, 10 & 14, and continues to teach the annular portion (23) defines a plurality of ports (24) extending therethrough (as shown in Figure 1), and
wherein each of the plurality of ports (24) is configured to be removably closed by (as shown in Figures 1-4) the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) of the elastic portion (25).
As to Claim 18, Jeppesen teaches all the limitations of Claims 1, 10, 14 & 17, and continues to teach the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) of the elastic portion (25) is configured such that:
the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) is biased to removably close each (as shown in Figures 1-4) of the plurality of ports (24); and
the increased pressure (the “inwardly directed pressure” described at the bottom of Page 7) in the proximal drug chamber (14) relative to (bottom of Page 7, to of Page 8) the distal drug chamber (13) deforms (as shown in Figure 2) the annular flap (the end wall of 25 with hole 28, as viewed in Figure 2) away from (as shown in Figure 2) each of the plurality of ports (24) defined by the annular portion (23) of the rigid portion (11), thereby opening (as shown in Figure 2) each of the plurality of ports (24).
As to Claim 19, Jeppesen teaches all the limitations of Claims 1 & 10, and continues to teach the rigid portion (11) comprises a distally extending portion (29/30) coupled to (as shown in Figures 1-4) an annular portion (23), and
wherein the elastic portion (25) has a radially inward circumferential surface (the radial circumferential surface of 28, as viewed in Figures 1-4) defining a central port (28).
As to Claim 20, Jeppesen teaches all the limitations of Claims 1, 10 & 19, and continues to teach the radially inward circumferential surface (the radial circumferential surface of 28, as viewed in Figures 1-4) of the elastic portion (25) is configured to form a fluid-tight seal around (bottom of Page 6) the distally extending portion (29/30) of the rigid portion (11), thereby closing (as shown in Figure 1) the central port (28) in the elastic portion (25).
As to Claim 21, Jeppesen teaches all the limitations of Claims 1, 10 & 19-20, and continues to teach the elastic portion (25) is biased to close (as shown in Figure 1) the central port (28) therein (25) with the distally extending portion (29/30) of the rigid portion (11), and
wherein the increased pressure (the “inwardly directed pressure” described at the bottom of Page 7) in the proximal drug chamber (14) relative to (bottom of Page 7, to of Page 8) the distal drug chamber (13) deforms (as shown in Figure 2) the elastic portion (25) away from (as shown in Figure 2) the distally extending portion (29/30) of the rigid portion (11), removing the fluid-tight seal therearound (as shown in Figure 2), and opening (as shown in Figure 2) the central port (28) in the elastic portion (25).
As to Claim 22, Jeppesen teaches all the limitations of Claims 1, 10 & 19, and continues to teach the distally extending portion (29/30) of the rigid portion (11) defines a circumferential groove (the groove between 30 and 23, as shown in Figure 2) configured to receive (as shown in Figure 1) the radially inward circumferential surface (the radial circumferential surface of 28, as viewed in Figures 1-4) of the elastic portion (25).
As to Claim 23, Jeppesen teaches all the limitations of Claims 1 & 10, and continues to teach the rigid portion (11) defines a first port (24), and
wherein the elastic portion (25) defines a second port (28).
As to Claim 24, Jeppesen teaches all the limitations of Claims 1, 10 & 23, and continues to teach the fenestrated separator (11/25) has a closed configuration (Figure 1) and an open configuration (Figure 2),
wherein in the closed configuration (Figure 1), both the first (24) and second (28) ports are closed (as shown in Figure 1), and
wherein in the open configuration (Figure 2), both the first (24) and second (28) ports are open (as shown in Figure 2).
As to Claim 25, Jeppesen teaches all the limitations of Claims 1, 10 & 23-24, and continues to teach in the open configuration (Figure 2) a flow path fluidly couples (bottom of Page 7 to top of Page 8) the proximal (14) and distal drug chambers (13) through the first (24) and second (28) ports.
As to Claim 26, Jeppesen teaches all the limitations of Claims 1, 10 & 23-24, and continues to teach the elastic portion (25) is biased to close (as shown in Figure 1) the first (24) and second (28) ports, thereby placing (as shown in Figure 1) the fenestrated separator (11/25) in the closed configuration (Figure 1).
As to Claim 27, Jeppesen teaches all the limitations of Claims 1, 10 & 23-24, and continues to teach the fenestrated separator (11/25) is configured to transform from the closed configuration (Figure 1) to the open configuration (Figure 2) with increased pressure (the “inwardly directed pressure” described at the bottom of Page 7) in the proximal drug chamber (14) relative to (bottom of Page 7, to of Page 8) the distal drug chamber (13).
Claim Rejections - 35 USC § 103
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jeppesen, in view of Kouyoumjian (U.S. PGPub 2013/0245561).
As to Claim 12, Jeppesen teaches all the limitations of Claims 1 & 10, and continues to teach the rigid portion (11) is made from plastic (top of Page 7).
Jeppesen is silent on the type of plastic, so does not explicitly teach the rigid portion is made from cyclic olefin copolymer.
Kouyoumjian describes an injection system, and teaches the use of cyclic olefin copolymer to make injection system components (Paragraph 0087).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the rigid portion, as taught by Jeppesen, from cyclic olefin copolymer, as taught by Kouyoumjian, to ensure the rigid portion is “compatible with the primary medicament (Paragraph 0087)”.
Additionally, it would have been obvious to one of ordinary skill in the art at the time of filing to make the rigid portion, as taught by Jeppesen, from cyclic olefin copolymer, as taught by Kouyoumjian, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. (1960)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bartlett (2014/0228746 – see Figures 1A/1B/36) and Bartlett (2014/0163465 – see Figures 3/4) teach similar injection systems with similar valve members.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
