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 .
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 limitations: “The injection device of claim 2, wherein the first disengagement element is translationally coupled to the plunger actuation assembly as the spring drives the plunger actuation assembly the second distance.” is not consistent with the specification.
Specification of instant application discloses [0033]: “While the plunger actuation assembly 100 is being driven the second distance D2, the first disengagement element 110 is in a fixed position due to its translational disengagement from the plunger actuation assembly 100”
For examination purposes claim 16 limitation will be interpreted as “The injection device of claim 2, wherein the first disengagement element is translationally coupled to the plunger actuation assembly as the spring drives the plunger actuation assembly the first distance.”
Appropriate correction is required.
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 1-2, 13-18, and 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gillespie et al. (US 7988675 B2).
Regarding claim 1, Gillespie discloses an injection device (10), comprising: a housing (housing 12+16, Fig 2); a cartridge (cartridge 14, Fig 2) defining a chamber (chamber 1000, Annotated Fig 1) configured to hold a medicament (chamber of cartridge 14 comprising liquid medicament (M), Fig 3; Fig 2); a plunger (piston 24, Fig 3) disposed within the chamber (1000, Annotated Fig 1); a plunger actuation assembly (plunger rod 90, Fig 10) configured to drive the plunger (24); a power source (injection spring 86, Fig 10) configured to drive the plunger actuation assembly (90) such that the plunger (24) forces the medicament (M) from the chamber (1000, Annotated Fig 1); a first disengagement element (syringe ring 92, Fig 10) translationally fixed relative to the plunger actuation assembly (90) (Col 12, lines 8-18); and a second disengagement element (coupling 88, Fig 10) coupled to the plunger actuation assembly (90) and to the power source (86), wherein the second disengagement element (88) is translationally fixed relative to the plunger actuation assembly (90) (Col 12, lines 19-30), wherein the first disengagement element (92) is configured to 1) translationally decouple from the plunger actuation assembly (90) when the power source (86) drives the plunger (24) actuation assembly a first distance (predetermined distance, hereinafter D1) (Col 12, lines 19-30; predetermined distance traveled by 92 decouples and is no longer drivingly engaged to plunger rod 90 (FIG. 25)), and 2) translationally decouple the second disengagement element (88) from the plunger actuation assembly (90) when the power source (24) drives the plunger actuation assembly (90) a second distance (distance traveled by 90 after decoupling of 92; (Col 9, lines 8-20; Col 12, lines 19-30) (Decoupling of ring 92 allows further movement of the coupling 88 and plunger rod 90 through the cartridge to inject the medication until it reaches the decoupling surface 110 of mid-housing 94).
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Regarding claim 2, Gillespie discloses the injection device of claim 1, wherein the power source is a spring (spring 86, Fig 10).
Regarding claim 13, Gillespie discloses the injection device of claim 2, wherein the spring (86) ceases to drive the plunger actuation assembly after the second disengagement element (88) is translationally decoupled from the plunger actuation assembly (90) (Col 9, lines 8-20).
Regarding claim 14, Gillespie discloses the injection device of claim 2, further comprising: a needle (hypodermic needle 20, Fig 2) extending from the cartridge (14), wherein the spring (86) is configured to drive the plunger actuation assembly (90) and the cartridge (14) the first distance (D1) to insert the needle into a user (Col 8, lines 56-63), and the spring (86) is configured to drive the plunger actuation assembly (90) and the plunger the second distance (D2) to inject the medicament into the user (Col 9, lines 4-7).
Regarding claim 15, Gillespie discloses the injection device of claim 1, wherein the first disengagement element (92) is longitudinally spaced from the second disengagement element (88) as it moves the first distance (D1) (Fig 10; Col 8, lines 56-63).
Regarding claim 16, Gillespie discloses the injection device of claim 2, wherein the first disengagement element (92) is translationally coupled to the plunger actuation assembly (90) as the spring (88) drives the plunger actuation assembly (90) the first distance (D1) (Fig 10; Col 8, lines 56-63). (See claim objection).
Regarding claim 17, Gillespie discloses a method of disconnecting a power source (injection spring 86, Fig 10) of an injection device (Auto-injector 10, Fig 1) from a plunger actuation assembly (plunger rod 90, Fig ), wherein the plunger actuation assembly (90) is configured to drive a plunger (piston 24, Fig 9) disposed within a chamber (1000, Annotated Fig 1) of a cartridge (cartridge 14, Fig 2), the chamber (1000, Annotated Fig 1) being configured to hold a medicament (liquid medicament not shown; Col 5, lines 24-37), the method comprising: actuating the power source (86) to drive the plunger actuation assembly (90) distally a first distance (predetermined distance, hereinafter D1), wherein a second disengagement element (coupling 88, Fig 10) is configured to couple the plunger actuation assembly (90) to the power source (86) (Col 8, lines 46-62); translationally decoupling a first disengagement element (92) from the plunger actuation assembly (90) (Col 12, lines 19-25); driving the plunger actuation assembly (90) distally a second distance (second distance, hereinafter D2 representative of the distance traveled by actuation assembly inside the cartridge 14 to dispense the liquid medicine; Col 9, lines 4-7); and translationally decoupling, via the first disengagement element (92), the second disengagement element (88) and the power source (86) from the plunger actuation assembly (90) (Col 9, lines 8-20; Col 12, lines 19-30) (Decoupling of ring 92 allows further movement of the coupling 88 and plunger rod 90 through the cartridge to inject the medication until it reaches the decoupling surface 110 of mid-housing 94; therefore coupling 88 is decoupled via further movement of 90 as result of decoupling of 92 as 88 reaches 110).
Regarding claim 18, Gillespie discloses the method of claim 17, wherein the power source is a spring (spring 86, Fig 10).
Regarding claim 20, Gillespie discloses the method of claim 18, wherein decoupling the second disengagement element (88) from the plunger actuation assembly (90) includes engaging the first (92) and second (88) disengagement elements, thus biasing at least one tab (1011, Annotated Fig 5) of the second disengagement element (88) outwards and disengaging a projection (1012, Annotated Fig 55) extending from the at least one tab (1011, Annotated Fig 5) of the second disengagement element (88) from at least one second groove (1009, Annotated Fig 4) of the plunger actuation assembly (90) (Col 9, lines 8-20; Col 12, lines 19-30) (Decoupling of ring 92 allows further movement of the coupling 88 and plunger rod 90 through the cartridge to inject the medication until it reaches the decoupling surface 110 of mid-housing 94; therefore coupling 88 is decoupled via further movement of 90 as result of decoupling of 92 as 88 reaches 110).
Regarding claim 21, Gillespie discloses the method of claim 18, wherein actuating the spring (88) includes driving the cartridge (14) the first distance (D1), and the cartridge (14) is translationally fixed relative to the plunger actuation assembly (90) during the driving step (Col 8, lines 56-62).
Regarding claim 22, Gillespie discloses the method of claim 18, wherein the first disengagement element (92) is translationally fixed relative to the plunger actuation assembly (90) during the driving step (Col 8, lines 56-62).
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.
Claims 3-4, 6-11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gillespie et al. (US 7988675 B2).
Regarding claim 3, Gillespie discloses the injection device of claim 2, wherein the plunger actuation assembly (90) has a body (body of plunger rod 90, Fig 10) defining at least one first external projection (external rim 168, Fig 22), wherein the first disengagement element (92) includes a body (body 1001 of ring 92, Annotated Fig 2) defining a channel (Channel 1002, annotated Fig 2) extending therethrough (Fig 23a-b), the channel (1002, Annotated Fig 2) being configured to receive the plunger actuation assembly (90) (See Annotated Fig 1), at least one tab (1003, Annotated Fig 2) extending longitudinally from the body (1001, Annotated Fig 2), and a groove (internal rim 166, Fig 22 ) extending radially inward from the at least one tab (1003, Annotated Fig 2) and configured to engage the at least one first external projection (168) to translationally couple the first disengagement element (92) to the plunger actuation assembly (90).
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Gillespie is silent wherein actuation assembly has at least one first external groove and the first disengagement element includes a projection configured to engage the at least one first external groove. (Note: Fitment of Gillespie is between projection 168, located on the plunger actuation assembly and groove 166, located on first disengagement element).
However, since the engagement between the plunger actuation assembly and the first disengagement element can only consist of:
Groove on the plunger actuation assembly; projection on the first disengagement element.
Groove on the first disengagement element; projection on the plunger actuation assembly.
It would have been obvious to one of ordinary skill in the art to try and have the groove on the plunger actuation assembly and the projection on the first disengagement element of device of Gillespie because when choosing from a finite number of predictable solutions a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill.
Regarding claim 4, Gillespie discloses the injection device of claim 3, wherein the at least one tab includes a plurality of tabs circumferentially spaced apart (two tabs 1003, Annotated Fig 2; tabs 1003 are circumferentially spaced apart, see Annotated Fig 2).
Gillespie further discloses wherein the at least one first external projection (168) includes a plurality of external projections (two external rims 168 that engages the internal rims 166 of the ring 92; Fig 22-23), wherein a respective groove (166) extends radially from each of the plurality of tabs (1003, Annotated Fig 1).
Gillespie is silent wherein the at least one first external groove includes a plurality of external grooves, wherein a respective projection extends radially from each of the plurality of tabs. (Note: Fitment of Gillespie is between projection 168, located on the plunger actuation assembly and groove 166, located on first disengagement element)
However, since the engagement between the plunger actuation assembly and the first disengagement element can only consist of:
Groove on the plunger actuation assembly; projection on the first disengagement element.
Groove on the first disengagement element; projection on the plunger actuation assembly.
It would have been obvious to one of ordinary skill in the art to try and have the groove on the plunger actuation assembly and the projection on the first disengagement element of device of Gillespie because when choosing from a finite number of predictable solutions a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill.
Regarding claim 6, Gillespie discloses the injection device of claim 3, further comprising: a power pack housing (syringe guide 32, Fig ) disposed within the housing (12+16), the power pack housing (32) having a body defining a first end (1004, Annotated Fig 3), a second end (1005, Annotated Fig 3) opposite the first end (1004, Annotated Fig 3) (Fig 5), and an inner surface (1006, Annotated Fig 3) defining a channel (1007, Annotated Fig 3) extending through the body from the first end (1004, Annotated Fig 3) to the second end (1005, Annotated Fig 3) (Fig 9) and a ledge (1008, Annotated Fig 3) facing the channel (1007, Annotated Fig 3) ( inner portion of Ledge 1008 faces channel 1007, See Annotated Fig 3).
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Regarding claim 7, Gillespie discloses the injection device of claim 6, wherein the ledge (1008, Annotated Fig 3) extends circumferentially about the entirety of the inner surface (Annotated Fig 3 shows the ledge 1008, extending circumferentially about the entirety of the inner surface 1006).
Regarding claim 8, Gillespie discloses the injection device of claim 6, wherein the first disengagement element (92) is configured to engage the ledge (1008, Annotated Fig 9) when the spring (86) drives the plunger actuation assembly (90) the first distance (D1), wherein engagement between the first disengagement element (92) and the ledge (1008, Annotated Fig 3) biases the at least one tab (1003, Annotated Fig 2) outwards such that the groove (166)disengages the at least one first external projection (168) of the plunger actuation assembly (90), thus translationally decoupling the first disengagement element (92) from the plunger actuation assembly (90) (Ring 92 engages with syringe guide 32 through direct contact with medicine compartment 22, and moves a first distance D1, which causes outward disengagement of tabs 1003 at the end of the traveled distance when ring 92 moves from the first bore 162 to the second bore 164)
Gillespie is silent wherein the actuation assembly has at least one first external groove and the first disengagement element includes a projection (Note: Fitment of Gillespie is between projection 168, located on the plunger actuation assembly and groove 166, located on first disengagement element)
However, since the engagement between the plunger actuation assembly and the first disengagement element can only consist of:
Groove on the plunger actuation assembly; projection on the first disengagement element.
Groove on the first disengagement element; projection on the plunger actuation assembly.
It would have been obvious to one of ordinary skill in the art to try and have the groove on the plunger actuation assembly and the projection on the first disengagement element of device of Gillespie because when choosing from a finite number of predictable solutions a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill.
Regarding claim 9, Gillespie discloses the injection device of claim 8, wherein the body of the plunger actuation assembly (90) defines at least one second external groove (1009, Annotated Fig 4) longitudinally spaced from the at least one first external groove (modified first groove 168, see modification of claim 8 and 3), wherein the second disengagement element (88) includes a body (body of 88, Fig 10) defining a channel (1010, Annotated Fig 4) extending therethrough, the channel (1010, Annotated Fig 4) being configured to receive the plunger actuation assembly (90), at least one tab (1011, Annotated Fig 5) extending longitudinally from the body (body of 88), and a projection (projection 1012, Annotated Fig 5) extending radially inward from the at least one tab (1011, Annotated Fig 5) and configured to engage the at least one second external groove (1009, Annotated Fig 4) to translationally couple the second disengagement element (88) to the plunger actuation assembly (90).
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Regarding claim 10, Gillespie discloses the injection device of claim 9, wherein the first disengagement element (92) is configured to engage the second disengagement element (88) when the spring (86) drives the plunger actuation assembly (90) the second distance (D2), wherein engagement between the first and second disengagement elements (indirect engagement between 88 and 92 trough 90) is configured to bias the at least one tab (1011, Annotated Fig 5) of the second disengagement element (88) outwards such that the projection (1012, Annotated Fig 5) disengages the at least one second external groove (1009, Annotated Fig 4) of the plunger actuation assembly, thus translationally decoupling the second disengagement element (88) from the plunger actuation assembly (90)(Col 9, lines 8-20; Col 12, lines 19-30) (Decoupling of ring 92 allows further movement of the coupling 88 and plunger rod 90 through the cartridge to inject the medication until it reaches the decoupling surface 110 of mid-housing 94; therefore coupling 88 is decoupled via further movement of 90 via decoupling of 92 as 88 reaches decoupling surface 110)
Regarding claim 11, Gillespie discloses the injection device of claim 10, wherein the at least one tab (1011, Annotated Fig 5) of the second disengagement element (88) includes radially spaced apart tabs (1011, Annotated Fig 5) (Fig 10 shows tabs radially spaced apart) and the at least one second external groove (1009, Annotated Fig 4) extends substantially continuously circumferentially about the plunger actuation assembly (90).
Regarding claim 19, Gillespie discloses the method of claim 18, wherein decoupling the first disengagement element (92) includes engaging the first disengagement element (92) with a ledge (1008, Annotated Fig 3) defined by a power pack housing (32), thus biasing at least one tab (1003, Annotated Fig 2) of the first disengagement element (92) outwards and disengaging a groove (internal rim 166, Fig 23a-b) extending from the at least one tab (1003, Annotated Fig 2) from at least one first external projection (external rim 168, Fig 25) of the plunger actuation assembly (90).
Gillespie is silent wherein actuation assembly has at least one first external groove and the first disengagement element includes a projection. (Note: Fitment of Gillespie is between projection 168, located on the plunger actuation assembly and groove 166, located on first disengagement element).
However, since the engagement between the plunger actuation assembly and the first disengagement element can only consist of:
Groove on the plunger actuation assembly; projection on the first disengagement element.
Groove on the first disengagement element; projection on the plunger actuation assembly.
It would have been obvious to one of ordinary skill in the art to try and have the groove on the plunger actuation assembly and the projection on the first disengagement element of device of Gillespie because when choosing from a finite number of predictable solutions a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783