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 .
Status of Claims
This office action is responsive to the application filed 20 October 2023.
Claims 1-20 are presently pending in this application.
Claim Objections
Claim 1 and 17 are objected to because of the following informalities:
“chamber under vacuum” – Interpreted as “chamber under vacuum pressure”
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 1-20 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.
Claim 1 and 17 recite the limitation "the vitreous humor" in line 6 of claim 1 and line 6 in claim 17. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the vitreous humor” is interpreted as --a vitreous humor--.
Claim 14 recites the limitation "the vacuum chamber" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the vacuum chamber” is interpreted as --the chamber under vacuum pressure--.
Claim 14 also recites the limitation “a piercing member” in line 8 of the claim. It is unclear if this is the same piercing member as “the piercing member” of claim 1. For the purposes of examination, examiner interprets “a piercing member” to mean –the piercing member--.
Claim 16 recites the limitation “the follower” in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination. For the purposes of examination, “the follower” is interpreted as “a follower”.
Claims 18 and 20 recite the limitation “the method of claim 16” in line 1 of both claims. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claims 18 and 20 are interpreted to be dependent from claim 17.
Claim 19 recites the limitation "the biasing feature" and “the third position” in lines 1 and 3 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claim 19 is interpreted to be dependent from claim 18.
All other claims are rejected as they depend from independent claim 1.
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 1, 12, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ang et al. (US Patent Publication No. 20190159930 A1), hereinafter Ang, in view of Luloh et al. (US Patent Publication No. 20070078359 A1), hereinafter Luloh, in further view of Wang (US Patent No. 4799494 A).
Regarding claim 1, Ang discloses a vitrectomy device (Ang: Fig. 1, device 100) comprising: a body (Fig. 2A, casing 200), extending along an axis from a proximal end (Fig. 2A, side of casing 200 towards plunger 410) to a distal end (Fig. 2A, side of casing towards needle portion 600) and having a central passage (Fig. 2A, syringe 400 resides within a passage of the casing 200); a needle (Fig. 2A, needle portion 600) for insertion into the vitreous humor of an eye (para. 0037) and extending within the central passage (Fig. 2A, portion 600 is shown extending within casing 200) and out of the distal end of the body (Fig. 2A, portion 600 is shown extending out of casing 200); and an assembly (Fig. 2A, comprising module 500 and vacuum syringe 300) including a chamber (Fig. 2A, vacuum syringe 300) under vacuum pressure and a piercing member (Fig. 3A, connecting tube 520) extending away from the chamber (Fig. 3A, tube 520 extends away from syringe 300), wherein the piercing member (520) is fluidly connected to the chamber (Fig. 3A, tube 520 is fluidly connected to syringe 300), and wherein the chamber (300) is movable in a direction from a first position (Fig. 2A) to a second position (Fig. 2B, plunger 410 of the syringe 400 is moved to a second position) for drawing a vitreous sample into the chamber (300) under vacuum pressure (para. 0037).
Ang does not expressly disclose that, in the first position, the chamber is not fluidly connected to the needle, and in the second position the piercing member fluidly connects the chamber to the needle.
Luloh teaches in a first position (Luloh: Fig. 1A), a chamber (Fig. 1A, comprising cavity 16 and plunger 18) is not fluidly connected to a needle (Fig. 1A, cavity 16 is not in fluid connection to the needle 14 due to plug 34; para. 0017), and in a second position (para. 0017) a member (Fig. 1A, orifice 30) fluidly connects a chamber (16) to the needle (when plug 34 is released, the orifice 30 fluidly connects the chamber 16 to the needle 14; para. 0017).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang such that, in the first position, the chamber is not fluidly connected to the needle, and in the second position the piercing member fluidly connects the chamber to the needle as taught by Luloh in order to prevent fluid backflow (Luloh: para. 0017).
Ang in view of Luloh does not expressly disclose that the chamber is movable transverse to the centerline.
Wang teaches that a chamber (Wang: Fig. 1, comprising syringe barrel 1 and handle 2) is movable transverse to a centerline (Fig. 1, handle 2 is withdrawn transverse to the axis of needle 6; col 2, ln 54-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh such that the chamber is movable transverse to the centerline as taught by Wang in order to allow the use of the syringe as a handle during use (Wang: col 2, ln 54-67). Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the chamber is movable transverse to the centerline this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 12, Ang in view of Luloh and Wang discloses the device above, wherein the distal end (Ang: Fig. 6, inner needle 620) of the needle (600) comprises a sharpened tip configured for insertion into or through at least one of the sclera, the pars plana, the anterior segment or the vitreous body of the eye (needle 620 is profiled to allow for cutting and inserting into the vitreous through the pars plana; para. 0046 and 0050).
Regarding claim 13, Ang in view of Luloh and Wang discloses the device above, wherein the body (Ang: 200) comprises a pencil-grip type body (Fig. 1, casing 200 is designed to be gripped, and can be gripped like a pencil; para. 0037).
It would have been an obvious matter of design choice to make the body of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other designs. Absent a teaching as to criticality that body comprises a pencil-grip type body, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 15, Ang in view of Luloh and Wang discloses the device above, wherein the needle (Ang: 600) and the piercing member (520) are formed a single, continuous component (Fig. 3A-B, connecting tube 520 and needle 600 form a continuous connection, fluidly connected through module 500).
Regarding claim 16, Ang in view of Luloh and Wang discloses the device above, wherein the chamber (300) is removably inserted in the follower (Fig. 2A, both module 500 and syringe 300 are removable; para. 0038 and 0041) for separation of the vitreous sample from the vitrectomy device (para. 0043).
Regarding claim 17, Ang discloses a method comprising: inserting a sharpened distal end of a needle (600) of a device (Ang: Fig. 1, device 100) into a globe of an eye (para. 0037), wherein the device (100) comprises: a body (Fig. 2A, casing 200), extending along an axis from a proximal end (Fig. 2A, side of casing 200 towards plunger 410) to a distal end (Fig. 2A, side of casing towards needle portion 600) and having a central passage (Fig. 2A, syringe 400 resides within a passage of the casing 200); a needle (Fig. 2A, needle portion 600) for insertion into the vitreous humor of an eye (para. 0037) and extending within the central passage (Fig. 2A, portion 600 is shown extending within casing 200) and out of the distal end of the body (Fig. 2A, portion 600 is shown extending out of casing 200); and an assembly (Fig. 2A, comprising module 500 and vacuum syringe 300) including a chamber (Fig. 2A, vacuum syringe 300) under vacuum pressure and a piercing member (Fig. 3A, connecting tube 520) extending away from the chamber (Fig. 3A, tube 520 extends away from syringe 300), wherein the piercing member (520) is fluidly connected to the chamber (Fig. 3A, tube 520 is fluidly connected to syringe 300), and wherein the chamber (300) is movable in a direction from a first position (Fig. 2A) to a second position (Fig. 2B, plunger 410 of the syringe 400 is moved to a second position) for drawing a vitreous sample into the chamber (300) under vacuum pressure (para. 0037). When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02
Ang does not expressly disclose that, in the first position, the chamber is not fluidly connected to the needle, and in the second position the piercing member fluidly connects the chamber to the needle.
Luloh teaches in a first position (Luloh: Fig. 1A), a chamber (Fig. 1A, comprising cavity 16 and plunger 18) is not fluidly connected to a needle (Fig. 1A, cavity 16 is not in fluid connection to the needle 14 due to plug 34; para. 0017), and in a second position (para. 0017) a member (Fig. 1A, orifice 30) fluidly connects a chamber (16) to the needle (when plug 34 is released, the orifice 30 fluidly connects the chamber 16 to the needle 14; para. 0017).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang such that, in the first position, the chamber is not fluidly connected to the needle, and in the second position the piercing member fluidly connects the chamber to the needle as taught by Luloh in order to prevent fluid backflow (Luloh: para. 0017).
Ang in view of Luloh does not expressly disclose that the chamber is movable transverse to the centerline.
Wang teaches that a chamber (Wang: Fig. 1, comprising syringe barrel 1 and handle 2) is movable transverse to a centerline (Fig. 1, handle 2 is withdrawn transverse to the axis of needle 6; col 2, ln 54-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh such that the chamber is movable transverse to the centerline as taught by Wang in order to allow the use of the syringe as a handle during use (Wang: col 2, ln 54-67). Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the chamber is movable transverse to the centerline this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Claims 2-5, 8, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ang in view of Luloh and Wang, in further view of Pilkington et al. (US Patent No. 20180280623 A1), hereinafter Pilkington.
Regarding claim 2, Ang in view of Luloh and Wang discloses the device above.
Ang in view of Wang does not expressly disclose the chamber is longitudinally movable with the assembly, the assembly movable to a third position in which the needle is fluidly connected to a drug to be delivered to the eye.
Luloh teaches a chamber (Luloh: 16 and 18) that is movable (Fig. 1A, plunger 18 is movable) with an assembly (Fig. 1A, comprising lever 36, plug 34, and lever 72 are all capable of moving simultaneously with plunger 18), wherein the assembly is movable to a third position (lever 72 is pressed, releasing pressure from tube 62; para. 0015) in which the needle (14) is fluidly connected to a drug to be delivered to the eye (when lever 72 is pressed, tube 62 fluidly connect the needle 14 to the fluid; para. 0015).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Wang such that the chamber is movable with the assembly, the assembly movable to a third position in which the needle is fluidly connected to a drug to be delivered to the eye as taught by Luloh in order to allow for manual release of fluid to the treatment site (Luloh: para. 0015-0016). Furthermore, it would have been an obvious matter of design choice to have the chamber and assembly longitudinally movable together applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other simultaneous moving directions. Absent a teaching as to criticality that the chamber and assembly are longitudinally movable together, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Ang in view of Luloh and Wang does not expressly disclose the chamber is movable to a third position.
Pilkington teaches a chamber (Pilkington: Fig. 21, barrel 202) that is movable to a third position (Fig. 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh and Wang such that the chamber is movable to a third position as taught by Pilkington in order to allow for several, predetermined volumetric capacities (Pilkington: para. 0050) while blocking reversed slidable displacement (para. 0011).
Regarding claim 3, Ang in view of Luloh, Wang, and Pilkington discloses the device above, further comprising a plunger (Ang: Fig. 2A, plunger 410) received in the body (200) and longitudinally displaceable relative to the body (Fig. 5A, plunger 410 is advanced forward to inject fluid; para. 0046) to force the drug into the eye (para. 0046).
Regarding claim 4, Ang in view of Luloh, Wang, and Pilkington discloses the device above.
Ang in view of Wang and Pilkington does not expressly disclose a biasing feature for biasing the plunger towards the distal end of the body.
Luloh teaches a biasing feature (Luloh: Fig. 1, springe-loaded mechanism 82) for biasing a plunger (Fig. 1, plunger 88) plunger towards a distal end of a body (mechanism 82 biases plunger 88 forward when released, pushing the plunger 88 forward; para. 0016).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Wang and Pilkington such that it further comprising a biasing feature for biasing the plunger towards the distal end of the body as taught by Luloh in order to inject an appropriate volume and maintain a fixed pressure (Luloh: para. 0016).
Regarding claim 5, Ang in view of Luloh, Wang, and Pilkington discloses the device above.
Ang in view of Wang and Pilkington does not expressly disclose a cam system that cooperates with the biasing feature for preventing pressurization of the drug until after the chamber reaches the third position.
Luloh teaches a cam system (Fig. 1A, lever 74) that cooperates with a biasing feature (Fig. 1, lever 74 and mechanism 82 work simultaneously to control pressurization; para. 0015-0016) for preventing pressurization of a drug until after a chamber (16 and 18) reaches a third position (para. 0015-0016).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Wang and Pilkington such that it further comprised a cam system that cooperates with the biasing feature for preventing pressurization of the drug until after the chamber reaches the third position in order to maintain a fixed pressure during release and allow for manual release of fluid to a treatment site (para. 0015-0016).
Regarding claim 8, Ang in view of Luloh, Wang, and Pilkington discloses the device above, further comprising a feature (Ang: Fig. 2A, spring 310) for biasing the chamber (Fig. 2A-2B, spring 310 biases the actuator 330 proximally).
Ang in view of Luloh and Wang does not expressly disclose the chamber moving from the second position to the third position.
Pilkington teaches a chamber (Pilkington: 202) moving from a second position (Fig. 22) to a third position (Fig. 23). Examiner interprets that the chamber of Pilkington would be biased towards a third position by the feature of Ang if combined.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh and Wang such that the chamber moves from the second position to the third position as taught by Pilkington in order to allow for several, predetermined volumetric capacities (Pilkington: para. 0050) while blocking reversed slidable displacement (para. 0011).
Regarding claim 18, Ang in view of Luloh and Wang discloses the device above, further comprising a biasing feature (Ang: Fig. 2A, spring 310) for biasing the chamber (Fig. 2A-2B, spring 310 biases the actuator 330 proximally)
Ang in view of Wang and Pilkington does not expressly disclose a biasing feature for biasing the plunger towards the distal end of the body.
Luloh teaches a biasing feature (Luloh: Fig. 1, springe-loaded mechanism 82) for biasing a plunger (Fig. 1, plunger 88) plunger towards a distal end of a body (mechanism 82 biases plunger 88 forward when released, pushing the plunger 88 forward; para. 0016).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Wang and Pilkington such that it further comprising a biasing feature for biasing the plunger towards the distal end of the body as taught by Luloh in order to inject an appropriate volume and maintain a fixed pressure (Luloh: para. 0016).
Ang in view of Luloh and Wang does not expressly disclose the chamber is movable to a third position.
Pilkington teaches a chamber (Pilkington: Fig. 21, barrel 202) that is movable to a third position (Fig. 23). Examiner interprets that the chamber of Pilkington would be biased towards a third position by the feature of Ang if combined.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh and Wang such that the chamber is movable to a third position as taught by Pilkington in order to allow for several, predetermined volumetric capacities (Pilkington: para. 0050) while blocking reversed slidable displacement (para. 0011).
Regarding claim 19, Ang in view of Luloh, Wang, and Pilkington discloses the device above further comprising a plunger (Ang: Fig. 2A, plunger 410) received in the body (200) and longitudinally displaceable relative to the body (Fig. 5A, plunger 410 is advanced forward to inject fluid; para. 0046) to force the drug into the eye (para. 0046).
Ang in view of Wang does not expressly disclose the biasing feature comprises a spring that automatically urges a plunger received in the body and longitudinally displaceable relative to the body to force the drug into the eye once the third position is reached.
Luloh teaches a biasing feature (Luloh: 82) comprises a spring (Fig. 1, mechanism 82 comprises a spring) that automatically urges a plunger (88) to force a drug into an eye once a third position is reached (mechanism 82 biases plunger 88 forward when released, pushing the plunger 88 forward and releasing fluid when the lever 72 is pressed; para. 0016).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Wang such that the biasing feature comprises a spring that automatically urges a plunger received in the body and longitudinally displaceable relative to the body to force the drug into the eye once the third position is reached as taught by Luloh in order to maintain a fixed pressure during release and allow for manual release of fluid to a treatment site (para. 0015-0016).
Ang in view of Luloh and Wang does not expressly disclose the chamber is movable to a third position.
Pilkington teaches a chamber (Pilkington: Fig. 21, barrel 202) that is movable to a third position (Fig. 23). Examiner interprets that the chamber of Pilkington would be biased towards a third position by the feature of Ang if combined.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh and Wang such that the chamber is movable to a third position as taught by Pilkington in order to allow for several, predetermined volumetric capacities (Pilkington: para. 0050) while blocking reversed slidable displacement (para. 0011).
Claims 6, 7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ang in view of Luloh, Wang, and Pilkington, in further view of Alexandersson (US Patent No. 20210106756 A1).
Regarding claim 6, Ang in view of Luloh, Wang, and Pilkington discloses the device above, wherein the plunger (410) is part of a syringe (Fig. 2A, syringe 400).
Ang in view of Luloh and Wang does not expressly disclose the chamber moving from the second position to the third position.
Pilkington teaches a chamber (Pilkington: 202) moving from a second position (Fig. 22) to a third position (Fig. 23). Examiner interprets that the chamber of Pilkington would be biased towards a third position by the feature of Ang if combined.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh and Wang such that the chamber moves from the second position to the third position as taught by Pilkington in order to allow for several, predetermined volumetric capacities (Pilkington: para. 0050) while blocking reversed slidable displacement (para. 0011).
Ang in view of Luloh, Wang, and Pilkington does not expressly disclose a septum that is pierced by the needle.
Alexandersson teaches a septum (Alexandersson: Fig. 5c, elastic sealing member 31d) that is pierced by a needle (Fig. 5c, comprising needle portion 13a and b) to place the needle (13a and b) in fluid communication with the drug (Fig. 5d, needle portion 13b penetrates member 31d to fluidly connect needle portion 13a with the fluid within cartridge 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh, Wang, and Pilkington such that a septum that is pierced by the needle as taught by Alexandersson in order to prevent oxygen from entering the container body (Alexandersson: para. 0028).
Regarding claim 7, Ang in view of Luloh, Wang, Pilkington, and Alexandersson disclose the device above.
Ang in view of Wang and Pilkington does not disclose a second portion for biasing the plunger relative to the syringe towards the distal end of the body.
Luloh teaches a biasing feature (Luloh: Fig. 1, springe-loaded mechanism 82) for biasing a plunger (Fig. 1, plunger 88) relative to a syringe towards a distal end of a body (mechanism 82 biases plunger 88 forward when released, pushing the plunger 88 forward; para. 0016).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Wang and Pilkington such that it further comprised a biasing feature for biasing the plunger relative to a syringe towards the distal end of the body as taught by Luloh in order to inject an appropriate volume and maintain a fixed pressure (Luloh: para. 0016).
Ang in view of Wang does not disclose a biasing feature having a first portion for biasing the syringe towards the distal end of the body.
Alexandersson teaches a biasing feature (Alexandersson: Fig. 3c, resilient member 29) for biasing the syringe (Fig. 4a, medicament container 31) towards the distal end of the body (Fig. 5c-d, member 29 biases the medicament container forward; para. 0060 and 0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh, Wang, and Pilkington such that it comprised a biasing feature having a first portion for biasing the syringe towards the distal end of the body as taught by Alexandersson in order to prevent oxygen from entering the container body (Alexandersson: para. 0028) and automatically penetrate and fluidly communicate the needle with the container (para. 0075).
Regarding claim 11, Ang in view of Luloh, Wang, and Pilkington disclose the device above.
Ang in view of Luloh, Wang, and Pilkington does not expressly disclose a sharpened tip provided on the proximal end of the needle; a compliant member provided in the assembly such that moving the assembly to the third position causes the sharpened tip to pass through the compliant member to stop fluid communication between the piercing member and the proximal end of the needle and establish fluid communication between the needle and the drug.
Alexandersson teaches a sharpened tip (Alexandersson: Fig. 5c, proximal end of needle portion 13b) provided on a proximal end of a needle (Fig. 5c, portion 13b); a compliant member (Fig. 5c, fluid barrier 31e) provided in an assembly (Fig. 3a, administration mechanism 15) such that moving an assembly (15) to a position (when mechanism 15 is moved proximally, the auto-penetration function begins; para. 0075) causes the sharpened tip (proximal 13b) to pass through the compliant member (Fig. 5d, portion 13b penetrates barrier 31e; para. 0075) and establish fluid communication between the needle (13a and b) and the drug (para. 0075). Examiner interprets that if the proximal end of the needle were to pass through the compliant member of Alexandersson, fluid communication between the proximal end of the needle of Alexandersson and the piercing member of Ang would be stopped.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Ang in view of Luloh, Wang, and Pilkington such that a sharpened tip provided on the proximal end of the needle; a compliant member provided in the assembly such that moving the assembly to the third position causes the sharpened tip to pass through the compliant member to stop fluid communication between the piercing member and the proximal end of the needle and establish fluid communication between the needle and the drug as taught by Alexandersson in order to prevent oxygen from entering the container body (Alexandersson: para. 0028) and automatically penetrate and fluidly communicate the needle with the container (para. 0075).
Allowable Subject Matter
Claims 9, 10, 14, and 20 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 9, 10, and 20, Ang in view of Luloh, Wang, and Pilkington disclose the device above, but do not disclose a projection for preventing movement of the chamber to a third position.
Regarding claim 14, Ang in view of Luloh and Wang disclose the device above, but do not disclose an advancement clip including first and second pairs of pockets; a follower connected to the advancement clip including first and second projections.
The prior art does not disclose the features of claims 9, 10, 14, and 20, and, therefore, are indicated to contain allowable subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEI GONZALEZ/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights