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 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.
(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, 3, 6, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Persons (US 20170049972).
Regarding claim 1, Persons discloses a hybrid blunt cannula with puncture needle assembly (Figs. 8, cannula/trocar 130) comprising: a barrel body (Fig. 8A, syringe 133) having an outer surface (Fig. 8A, outer surface of syringe 133), an inner surface opposing the outer surface of the barrel body (Fig. 8A, inner surface of syringe 133), defining and enclosing a barrel channel (Fig. 8A, 8G channel inside of syringe 133 which plunger 134 traverses through), and defining a button translation channel defined therethrough (Fig. 8A, 8E channel inside of syringe 133 and plunger 134 which plunger 132 traverses through); an outer cannula member (Fig. 8A, cannula 140) with a first cannula end (Fig. 8A, proximal end of cannula 140 which couples to syringe 133), a second cannula end (Fig. 8A-B, distal end of cannula 140 with cannula tip 143), a cannula length separating the first and second cannula ends, of a slender configuration (Fig. 8, length of cannula 140 which is of slender configuration), defining an eye disposed proximal to the second cannula end (Fig. 8B, hole 142 near cannula tip 143), with an inner surface defining and enclosing a needle channel fluidly coupled to the barrel channel (Fig. 8B and 8H, inner surface of cannula 140 defines channel for trocar 150 and is in fluid communication with barrel channel which contains substance 91); a hub (Fig. 1 and [0065, 0082], connector 18 of syringe 12/133, examiner notes: [0082] discloses that cannula 140 is connected to syringe 133 in same manner as is seen in Fig. 1, therefore syringe 133 has a connector 18 and cannula 140 has a female connector portion 22 which mates with connector 18) coupled to first cannula end (Fig. 1, connector 18 couples to connector 22 on proximal end of cannula 140), the hub defining and enclosing a hub channel fluidly coupled to the barrel channel and the needle channel (Fig. 1, connector 18 comprises a channel within the connector 18, which is fluidly coupled to the channel within syringe 12/133, which defines the barrel channel and the channel within the cannula 20/140 which defines the needle channel); an inner needle member (Figs. 8, trocar 150) of a substantially rigid material ([0069], trocar is made of a hard metal), having a first inner needle end (Fig. 8A and [0082-0083], proximal end of trocar 150 which is coupled to plunger 132), a second inner needle free end opposite the first inner needle end and of a sharp configuration (Fig. 8A-B and [0083], distal end with trocar tip 152, which is a sharpened tip), and an inner needle member length separating the first inner needle end and the second inner needle free end (8A-D, length of trocar 150); and at least one button (Fig. 8A, plunger 132) coupled to the hub (Fig. 8A, plunger 132 is coupled to the hub 18 (see Fig. 1) via the syringe body 133) and operably configured to translate within the button translation channel to cause the inner needle to translate through the second cannular end (Fig. 8C-F and [0082-0083], plunger 132 travels through button translation channel inside of syringe 133 and plunger 134 in order to translate the trocar tip 152 through the cannula tip 143) with the eye fluidly coupled to the barrel channel l (Fig. 8B and 8H and [0083], hole 142 is in fluid communication with barrel channel which contains substance 91 via the internal channel of cannula 140).
Regarding claim 3, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 1, wherein the button is operably configured to have a button translation path with a static position including the second inner needle free end disposed proximal to the second cannula end and within the needle channel (Fig. 8E-F and [0083], plunger 132 has a translation path with a static position (fig. 8E) wherein the trocar tip 152 is proximal to the cannula tip 143 and within the needle channel) and with an insertion position with the second inner needle free end disposed proximal to second cannula end and outside of the needle channel (Fig. 8A-D and [0083], plunger 132 translation path has an insertion position (fig. 8A, 8C) wherein the trocar tip 152 is proximal to the cannula tip 143 and outside the needle channel).
Regarding claim 6, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 1, wherein the hub is directly coupled to the outer cannular member (Fig. 1, connector 18 couples directly to connector 22 at proximal end of cannula 140).
Regarding claim 9, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 3, further comprising: a stopper member coupled to the second cannula end in a watertight configuration and defining a terminal end of the outer cannula member (Fig. 8F and [0083], cannula tip 143 comprises a flexible memory polymer portion which extends from cannula wall to define the terminal end of the cannula 140), wherein the insertion position of the at least one button includes a portion of the inner needle member length spanning through the stopper member (Fig. 8B, 8D and [0083], in the insertion position, the trocar tip 152 and a portion of the trocar length extend through the flexible memory polymer portion of the cannula tip 143).
Regarding claim 11, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 9, wherein the stopper member is configured to at least partially protrude past the terminal end of the second cannula end (Figs. 8B, 8D, 8F, 8H, and [0083], flexible memory polymer portion defines the distal-most tip 143 of the cannula 140, therefore it protrudes past the terminal end of the cannula 140).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Persons (US 20170049972) in view of Qian (US 20100206834).
Regarding claim 10, Persons discloses the--- hybrid blunt cannula with puncture needle assembly according to claim 9.
Persons fails to disclose wherein the stopper member is of a butyl rubber material. However, Qian discloses wherein the stopper member is of a butyl rubber material (Fig. 15 and [0047], a flexible polymer septum 507, which allows for puncturing and resealing multiple times by needle tip (similar to flexible memory polymer portion of Persons) may be made from butyl rubber).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Persons to incorporate the disclosures of Qian and modify the stopper member to be of butyl rubber material. Doing so would provide a stopper made of a material which allows the punctured hole of the stopper to reseal itself multiple times, thus allowing the stopper to comprise a rest (static) closed state and a punctured (inserted) state (Qian, [0005, 0047]).
Allowable Subject Matter
Claims 12-17 are allowed.
Claims 2, 4-5, and 7-8 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 1.
Persons is silent to wherein the at least one button is directly coupled to the hub and operably configured to cause translation of the hub and the outer cannula member to cause the inner needle to translate through the second cannular end. The best art for these limitations is the embodiment of Figs. 3-6 of Persons (US 20170049972), which discloses a side button (transporter housing 80) which is fixed to a hub (housing connector 84) which is coupled to an outer cannula (cannula 90) and the button is configured to move the hub/cannula relative to a barrel (tube 60) and needle (needle 70/72). However, in this embodiment the needle is external to the cannula, and there is no obvious modification for the needle to be within the cannula without destroying the functionality of the device in embodiment of Figs. 3-6. Therefore, no reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Persons to satisfy these limitations in combination with the limitations of claim 1.
Regarding claim 4, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 3.
Persons is silent to wherein the button translation path is curvilinear. The closest art to these limitations is Mueller (US 20110071476), which discloses two containers having a track/protrusion relationship such that the components move in a curvilinear path relative to each other (see 36/38 interaction in figs. 2, 6-8), however the button itself (flange 44) does not traverse this curvilinear path, but instead is only rotated so that the container 16 which it is connected to is able to move linearly, due to the curvilinear track engagement (see Fig.4-5 and [0022]), therefore Mueller does not fully meet the claimed limitations. Therefore, no reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Persons to satisfy these limitations in combination with the limitations of claim 3.
Regarding claim 5, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 3.
Persons is silent to wherein the button is operably configured to translate the outer cannula member independent of the inner needle to translate the inner needle through the second cannular end. The best art for these limitations is the embodiment of Figs. 3-6 of Persons (US 20170049972), which discloses a side button (transporter housing 80) which is fixed to a hub (housing connector 84) which is coupled to an outer cannula (cannula 90) and the button is configured to move the hub/cannula relative to a barrel (tube 60) and needle (needle 70/72). However, in this embodiment the needle is external to the cannula, and there is no obvious modification for the needle to be within the cannula without destroying the functionality of the device in embodiment of Figs. 3-6. Therefore, no reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Persons to satisfy these limitations in combination with the limitations of claim 3.
Regarding claim 7, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 1.
Persons is silent to wherein the hub is translatably coupled to the barrel body. The best art for these limitations is the embodiment of Figs. 3-6 of Persons (US 20170049972), which discloses a hub (housing connector 84) which is coupled to an outer cannula (cannula 90) and a button is configured to move the hub/cannula relative to a barrel (tube 60) and needle (needle 70/72). However, in this embodiment the needle is external to the cannula, and there is no obvious modification for the needle to be within the cannula without destroying the functionality of the device in embodiment of Figs. 3-6. Therefore, no reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Persons to satisfy these limitations in combination with the limitations of claim 1.
Regarding claim 8, Persons discloses the hybrid blunt cannula with puncture needle assembly according to claim 1.
Persons is silent to wherein the button translation channel is of a curvilinear path. The closest art to these limitations is Mueller (US 20110071476), which discloses two containers having a track/protrusion relationship such that the components move in a curvilinear path relative to each other (see 36/38 interaction in figs. 2, 6-8), however the button itself (flange 44) does not traverse this curvilinear path, but instead is only rotated so that the container 16 which it is connected to is able to move linearly, due to the curvilinear track engagement (see Fig.4-5 and [0022]), therefore Mueller does not fully meet the claimed limitations. Therefore, no reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Persons to satisfy these limitations in combination with the limitations of claim 1.
Regarding independent claim 12, Persons (US 20170049972) discloses a hybrid blunt cannula with puncture needle assembly 800 (Figs. 8, cannula/trocar 130) comprising: a barrel body (Fig. 8A, syringe 133) having a sidewall with an outer surface (Fig. 8A, outer surface of sidewall of syringe 133), and with an inner surface opposing the outer surface (Fig. 8A, inner surface of syringe 133), two opposing ends defining a barrel body length separating the two opposing ends (Fig. 8, length of syringe 133), defining and enclosing a barrel channel (Fig. 8A, 8G channel inside of syringe 133 which plunger 134 traverses through), a hub (Fig. 1 and [0065, 0082], connector 18 of syringe 12/133, examiner notes: [0082] discloses that cannula 140 is connected to syringe 133 in same manner as is seen in Fig. 1, therefore syringe 133 has a connector 18 and cannula 140 has a female connector portion 22 which mates with connector 18) and defining a hub channel fluidly coupled to the barrel channel (Fig. 1, connector 18 comprises a channel within the connector 18, which is fluidly coupled to the channel within syringe 12/133, which defines the barrel channel); an outer cannula member (Fig. 8A, cannula 140) with a first cannula end (Fig. 8A, proximal end of cannula 140 which couples to syringe 133) and coupled to the hub (Fig. 1, connector 18 couples to connector 22 on proximal end of cannula 140), a second cannula end (Fig. 8A-B, distal end of cannula 140 with cannula tip 143), a cannula length separating the first and second cannula ends, of a slender configuration (Fig. 8, length of cannula 140 which is of slender configuration), defining an eye disposed proximal to the second cannula end (Fig. 8B, hole 142 near cannula tip 143), with an inner surface defining and enclosing a needle channel fluidly coupled to the barrel channel and the hub channel (Fig. 8B and 8H, inner surface of cannula 140 defines channel for trocar 150 and is in fluid communication with barrel channel which contains substance 91 via the hub channel, which the needle channel is coupled to (see Fig. 1)); an inner needle member (Figs. 8, trocar 150) of a substantially rigid material ([0069], trocar is made of a hard metal), having a first inner needle end disposed within the barrel channel (Fig. 8A and [0082-0083], proximal end of trocar 150 which is coupled to plunger 132, and is therefore within the barrel channel), a second inner needle free end opposite the first inner needle end, of a sharp configuration (Fig. 8A-B and [0083], distal end with trocar tip 152, which is a sharpened tip), and disposed proximal to second cannular end and within the needle channel (Fig 8F, trocar tip 152 is disposed proximal to the cannula tip 143 and is within needle channel), and an inner needle member length separating the first inner needle end and the second inner needle free end (8A-D, length of trocar 150); and at least one button (Fig. 8A, plunger 132) translatably coupled to the hub (Fig. 8A, plunger 132 is translatable and is coupled to the hub 18 (see Fig. 1) via the syringe body 133).
Persons is silent to defining a button translation channel through the sidewall of the barrel body; the hub translatably disposed within the barrel channel; the first cannula end disposed within the hub channel; and the at least one button disposed within the button translation channel, and operably configured to modulate the hub and outer cannular member independent of the inner needle member to cause the inner needle to translate through the second cannular end. The best art for these limitations is the embodiment of Figs. 3-6 of Persons (US 20170049972), which discloses a button translation channel through the sidewall of the barrel body (opening in sidewall of tube 60), a hub (housing connector 84) translatably disposed within the barrel channel (translatably disposed in channel of tube 60); the first cannula end (proximal end of cannula 90) disposed within the hub channel ( disposed in channel of housing connector 84); and the at least one button (transporter housing 80) disposed within the button translation channel (disposed in opening in sidewall of tube 60), and operably configured to modulate the hub and outer cannular member independent of the inner needle member to cause the inner needle to translate through the second cannular end (moves cannula 90 and housing connector 84 independent of needle 70 to cause needle to extend past cannula distal end, see Figs. 6B vs Fig. 6C). However, in this embodiment the needle is external to the cannula, and there is no obvious modification for the needle to be within the cannula without destroying the functionality of the device in embodiment of Figs. 3-6. Therefore, no reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Persons to satisfy these limitations in combination with the rest of claim 12. Claims 13-17 depend from claim --12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783