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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/24/2026 has been entered.
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 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.
In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 18-21 have been canceled, Claims 5-7 withdrawn, Claims 22 and 23 have been newly added and Claims 1-4, 8-17, 22, and 23 are currently pending and being examined.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 8, 10-15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Himbert (USPN 6,238,371) in view of Clarke (USPAP 2014/0243754).
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In reference to independent claim 1, Himbert discloses a medical injection device (fig 1, 2, & 7), comprising:
a syringe including a barrel that defines a barrel cavity (barrel cavity, see annotated fig 7 above) with a proximal open end (right side of barrel that is receiving the plunger), a barrel tip on a distal end of the barrel (area that holds the base of the needle), a plunger inserted in a proximal open end of the barrel that is translatable in the barrel cavity (see annotated figure), the plunger defining a plunger stopper on a distal end thereof (see annotated figure); a needle hub coupled to the barrel tip (see annotated figure), the needle hub coupled to a needle that defines a needle tip (tip of needle), oriented distal the needle hub (see annotated figure, shows the tip distal to the hub), the needle extending a first axial length relative to the needle hub; the barrel cavity, barrel tip, needle hub and needle in fluid communication with each other (col 3, lines 51-59 discloses “The cannulas will further comprise an attachment to the barrel or housing of the injection device which can be in the form of screw-threads, a conventional luer lock device or a snap-lock device of a conventional type. Moreover, it is provided with a needle holding part, also of a conventional type, to position the needle which typically is a standard needle, having for example a length of 8 or 12 mm, and is arranged to be in liquid communication with the drug in a conventional manner.”); and
a collapsible needle shield (see annotated figure) coupled to the distal end of the syringe barrel (see annotated figure), the needle shield extending distally from the needle hub and circumscribing the needle (see annotated figure), the distal axial end of the collapsible needle shield having a contact surface (bottom of the needle shield in fig 7) on a distal axial end thereof and an aperture (aperture that the needle penetrates in fig 2) formed therein that is coaxial with the needle (seen in fig 2 and fig 7);
wherein, when the needle shield is in a relaxed, non-collapsed state, its contact surface extends axially from the needle hub a second axial length that is longer than the first axial length of the needle, so that the needle tip is oriented proximal to and shielded by the contact surface (shown in fig 1);
wherein, when the needle shield is in a collapsed state, its contact surface extends axially from the needle hub a third axial length that is shorter than the first axial length of the needle, so that the needle tip is exposed and extends distally through the aperture of the contact surface (shown in fig 2) and wherein the third axial length limits the needle insertion depth (compression of the bellows will limit the needle depth) ; and
wherein the collapsible needle shield comprises a corrugated bellows (claim 6 discloses “the collapsible needle cover has a bellows like structure” https://www.dictionary.com/browse/corrugated defines corrugated as “shaped into wavy folds or alternating furrows and ridges” fig 7 clearly shows the bellows is corrugated), however
Himbert does not teach a collapsible shield being transparent, and a distal axial end of the collapsible needle shield coupled to a cup-shaped skirt.
Clarke, a similar injection device, teaches a shield (skirt 43) being transparent (cite below), and a distal axial end of the needle shield (38, fig 3) coupled to a cup-shaped skirt (skirt 43; para 0027 discloses “the placement foot 43 of the exemplary embodiments may be made from an at least partially transparent material such that alignment with the eye, e.g. a periphery of the cornea, may be facilitated. Further, those of skill in the art will understand that an underside of the placement foot 43, for example a surface of the foot 43 which contacts the eye may include a frictional layer or other means for gripping, without injury, the eye”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the structural features of Clarke in the injection device of Himbert to provide “an apparatus for intraocular injection which ensures that a needle remains covered until use and facilitates removal of a needle cover” para 0007, Clarke. To be clear the modification is done by adding the contact surface and the aperture for the needle of Clarke to the end of the bellows of Himbert and making the two unitary as in Clarke and making both the bellows and the cup-shaped skirt out of the transparent material.
In reference to independent claim 14, Himbert discloses a medical injection device (fig 1, 2, & 7), comprising:
a syringe including a barrel that defines a barrel cavity (barrel cavity, see annotated fig above) with a proximal open end (right side of barrel that is receiving the plunger), a barrel tip on a distal end of the barrel (area that holds the base of the needle), a plunger inserted in a proximal open end of the barrel that is translatable in the barrel cavity (see annotated figure), the plunger defining a plunger stopper on a distal end thereof (see annotated figure); a needle hub coupled to the barrel tip (see annotated figure), the needle hub coupled to a needle that defines a needle tip (see annotated figure), oriented distal the needle hub (see annotated figure), the needle extending a first axial length relative to the needle hub (see annotated figure); the barrel cavity, barrel tip, needle hub and needle in fluid communication with each other (col 3, lines 51-59 discloses “The cannulas will further comprise an attachment to the barrel or housing of the injection device which can be in the form of screw-threads, a conventional luer lock device or a snap-lock device of a conventional type. Moreover, it is provided with a needle holding part, also of a conventional type, to position the needle which typically is a standard needle, having for example a length of 8 or 12 mm, and is arranged to be in liquid communication with the drug in a conventional manner.”); and
a flexible bellows tube forming a collapsible needle shield (see annotated figure), the bellows tube defining an internal cannula (inside surface of the tube), a proximal axial end of the bellows tube coupled directly to the needle hub (see annotated figure), the bellows tube extending distally from the needle hub and circumscribing the needle within its internal cannula (see annotated figure), , whose distal axial end defines a contact surface (distal end of the needle shield, see annotated fig), and an aperture formed in the needle shield that is in communication with the internal cannula and that is coaxial with the needle ; wherein, when the flexible bellows is in a relaxed, non-collapsed state (seen in fig 1), the contact surface of the skirt extends axially from the needle hub a second axial length that is longer than the first axial length of the needle (fig 1), so that the needle tip is oriented proximal to and shielded by the contact surface (distal end of the needle shield); and wherein, the flexible bellows is in a collapsed state (seen in fig 2), the contact surface of the skirt extends axially from the needle hub a third axial length that is shorter than the first axial length of the needle, so that the needle tip is exposed and extends distally through the aperture of the ocular contact surface (fig 2), however
Himbert does not teach a distal axial end of the bellows tube coupled to a cup-shaped skirt that forms an ocular contact surface and a transparent tube.
Clarke, a similar injection device, teaches a distal axial end of the tube (38, fig 5) coupled to a cup-shaped skirt (43) made of transparent material (disclosed below) that forms an ocular contact surface (para 0027 discloses “the placement foot 43 of the exemplary embodiments may be made from an at least partially transparent material such that alignment with the eye, e.g. a periphery of the cornea, may be facilitated. Further, those of skill in the art will understand that an underside of the placement foot 43, for example a surface of the foot 43 which contacts the eye may include a frictional layer or other means for gripping, without injury, the eye”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the structural features of Clarke in the injection device of Himbert to provide “an apparatus for intraocular injection which ensures that a needle remains covered until use and facilitates removal of a needle cover” para 0007, Clarke. To be clear the modification is done by adding the contact surface and the needle aperture of Clarke to the end of the bellows of Himbert and making the two unitary as in Clarke and making both the bellows and the cup-shaped skirt out of the transparent material.
In reference to dependent claim 2, Himbert in view of Clarke discloses the injection device of claim 1, Himbert further discloses a device wherein the collapsible needle shield (see annotated figure) comprising a flexible bellows tube (see annotated figure) having a proximal axial end coupled to the needle hub (see annotated figure), the distal axial end defining the contact surface (bottom of the needle shield) and its aperture (hole that is pierced by the needle fig 2), and an internal cannula circumscribing the needle (internal cannula formed by needle shield).201744
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In reference to dependent claim 3, Himbert in view of Clarke discloses the injection device of claim 2, Himbert discloses a device further comprising the flexible bellows tube (see annotated figs above) and formed as a polymer unistructure (col 3, lines 7-11 discloses “the collapsible needle cover comprises a resilient, cylindrical or vaguely conical sleeve made of a foamed polymer and is provided with an axial through hole forming an aperture for the needle” the contact surface and the bellows are one unitary structure), however
Himbert does not teach the flexible bellows tube and a cup-shaped, formed as a polymer unistructure.
Clarke, a similar injection device, teaches a tube (38, fig 5) and a cup-shaped (see fig 5), flexible contact surface (43) formed as a polymer unistructure (fig 5 clearly shows the tube 38 and the contact surface 43 being a unitary flexible structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the structural features of Clarke in the injection device of Himbert in view of Clarke to provide “an apparatus for intraocular injection which ensures that a needle remains covered until use and facilitates removal of a needle cover” para 0007, Clarke. To be clear the modification is done by adding the contact surface and needle aperture of Clarke to the end of the bellows of Himbert and making the two unitary as in Clarke.
In reference to dependent claim 4, Himbert in view of Clarke discloses the injection device of claim 1, Clarke further discloses the device cup-shaped skirt (43) being flexible (Clarke is silent to “flexible”, however Himbert combined above, col 3, lines 7-11 discloses “the collapsible needle cover comprises a resilient, cylindrical or vaguely conical sleeve made of a foamed polymer and is provided with an axial through hole forming an aperture for the needle” as a result the needle shield and cup are resilient ) and transparent (para 0027 discloses “the placement foot 43 of the exemplary embodiments may be made from an at least partially transparent material such that alignment with the eye, e.g. a periphery of the cornea, may be facilitated. Further, those of skill in the art will understand that an underside of the placement foot 43, for example a surface of the foot 43 which contacts the eye may include a frictional layer or other means for gripping, without injury, the eye”).
In reference to dependent claim 8, Himbert in view of Clarke discloses the injection device of claim 1, Himbert discloses a device further comprising the collapsible needle shield coupled to the needle hub (see annotated figure wherein the shield is coupled to the hub).
In reference to dependent claim 10, Himbert in view of Clarke discloses the injection device of claim 1, Clarke discloses the contact surface is an ocular contact surface (43, fig 5) having a surface profile for abutment against a sclera (white portion of the eye) of a patient's eye (para 0007 discloses that the injector device is “an apparatus for intraocular injection which ensures that a needle remains covered until use and facilitates removal of a needle cover” examiner takes the position “ocular” would include the sclera).
In reference to dependent claim 11, Himbert in view of Clarke discloses the injection device of claim 10, Clarke further discloses an injection device further comprising a flexible ocular contact surface (43) that conforms to surface profile of a sclera (white part of the eye) of a patient's eye when abutted against the sclera (para 0027 discloses “the placement foot 43 of the exemplary embodiments may be made from an at least partially transparent material such that alignment with the eye, e.g. a periphery of the cornea, may be facilitated. Further, those of skill in the art will understand that an underside of the placement foot 43, for example a surface of the foot 43 which contacts the eye may include a frictional layer or other means for gripping, without injury, the eye” examiner takes the position “ocular” would include the sclera).
In reference to dependent claim 12, Himbert in view of Clarke discloses the injection device of claim 11, Clarke further discloses an injection device further comprising the flexible ocular contact surface (43) comprising a cup-shaped skirt (43 fig 5 is clearly cup-shaped).
In reference to dependent claim 13, Himbert in view of Clarke discloses an injection device capable of the method for injecting a patient's eye with the injection device of claim 10, Clarke discloses the injection device comprising:
contacting a desired site on a sclera (white part of the eye) of a patient's eye with the ocular contact surface of the injection device (para 0027 discloses “the placement foot 43 of the exemplary embodiments may be made from an at least partially transparent material such that alignment with the eye, e.g. a periphery of the cornea, may be facilitated. Further, those of skill in the art will understand that an underside of the placement foot 43, for example a surface of the foot 43 which contacts the eye may include a frictional layer or other means for gripping, without injury, the eye” examiner takes the position “ocular” would include the sclera); advancing the syringe barrel to depress the sclera with the ocular contact surface, thereby stabilizing the ocular contact surface and its aperture relative to the sclera; pivoting the syringe barrel after stabilizing the aperture, thereby orienting a central axis of the needle in a desired angular position relative to the sclera; further advancing the syringe barrel (para 0028 discloses “When the apparatus has been properly placed on the eye, the physician may depress a plunger or similar depressible element coupled to the body and/or the syringe 32 which advances the syringe 32 distally within the body towards the injection site. Then a medicament may be delivered to the predetermined region of the eye.”), thereby collapsing the needle shield (the bellows needle shield disclosed in Himbert, see annotated fig above, see Himbert fig 2 in the collapsed state) and piercing the sclera with the needle tip to a desired depth within the eye (the “predetermined region” within the eye); injecting the intra ocular region of the patient's eye with fluid contained in the syringe barrel's cavity by advancing the plunger (the “medicament in para 0028”); and with drawing the syringe from the patient's eye, thereby causing the needle shield to relax from its collapsed state and again shield the needle tip (the bellows needle shield disclosed in Himbert, see annotated fig above, see fig 1 in the non-collapsed state).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the structural features of Clarke in the injection device of Himbert to provide “an apparatus for intraocular injection which ensures that a needle remains covered until use and facilitates removal of a needle cover” para 0007, Clarke. To be clear the modification is done by adding the contact surface of Clarke to the end of the bellows of Himbert and making the two unitary as in Clarke.
In reference to dependent claim 15, Himbert in view of Clarke discloses the ocular injection device of claim 14, Clarke further discloses the injection device wherein the distal face of the cup- shaped skirt (43) capable of adhering and/or suction anchoring to a patient's eye sclera and stabilizing the syringe (para 0027 discloses “the placement foot 43 of the exemplary embodiments may be made from an at least partially transparent material such that alignment with the eye, e.g. a periphery of the cornea, may be facilitated. Further, those of skill in the art will understand that an underside of the placement foot 43, for example a surface of the foot 43 which contacts the eye may include a frictional layer or other means for gripping, without injury, the eye”; examiner takes the position “ocular” would include the sclera). Ezekiel
In reference to dependent claim 22, Himbert in view of Clarke discloses the injection device of claim 2, Clarke further comprising the aperture (aperture in 43) of the bellows (Clarke does not disclose a bellows, however Himbert, combined above, explicitly discloses bellows) disposed on the cup-shaped skirt in communication with the internal cannula and coaxial with the needle (seen in fig 6 of Clarke).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Himbert (USPN 6,238,371) in view of Clarke (USPAP 2014/0243754) in reference to claim 1 above, and further in view of Ke (USPAP 2024/0315871).
In reference to independent claim 9, Himbert in view of Clarke discloses a method for injecting a patient with the injection device of claim 1, Himbert further discloses a device comprising: contacting a desired site on a patient's body with the contact surface of the injection device (distal end of the bellows, fig 1, 2, and 7); advancing the syringe barrel to depress the body site with the contact surface (shown in fig 2), thereby stabilizing the aperture of the contact surface relative to the body site;; further advancing the syringe barrel, thereby collapsing the needle shield and piercing the body site with the needle tip to a desired depth within the body (collapse of the needle shield is shown in fig 2); injecting the patient with fluid contained in the syringe barrel's cavity by advancing the plunger (col 3, lines 43-46 disclose “The injection device may in its simplest form be a conventional syringe operated with a plunger and is prefilled with a liquid drug in the barrel or in an ampoule therein”); and with drawing the syringe from the patient's body thereby causing the needle shield to relax from its collapsed state and again shield the needle tip (col 2 lines 65-col 3 line 3 discloses “the needle is forced into the injection site and is compressible against the injection site to such an extent that substantially the entire length of the needle is used for the injection. The needle cover will thereafter immediately reexpand”), however
Himbert and Clarke are silent to pivoting the syringe barrel after stabilizing the contact surface and its aperture, thereby orienting a central axis of the needle in a desired angular position relative to the body site (normal functional language capable of being done by the syringe in fig 1, 2, and 7)
Ke, a similar ophthalmic injection system, teaches pivoting the syringe barrel after stabilizing the contact surface and its aperture, thereby orienting a central axis of the needle in a desired angular position relative to the body site (para 0157-158 discloses “applying a force to a side of clamping port 31 of the sleeve 3 via the syringe 1 to form a pivot point on the conjunctival surface with the side of clamping port 31;
[0158] A third step of pivoting the clamping port 31 around the pivot point toward the other side of clamping port 31 so that the distal end of needle 2 pierces the conjunctival tissue at the injection site”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Ke in the injection device of Himbert in view of Clarke “so that the effective dose of the drug is accurately delivered to the target tissue via the needle” para 0071, Ke.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Himbert (USPN 6,238,371) in view of Clarke (USPAP 2014/0243754) in reference to claim 14 above, and further in view of Ke (USPAP 0224/0315871).
In reference to dependent claim 16, Himbert in view of Clarke discloses the injection device capable of the method for injecting a patient with the injection device of claim 14, Clarke discloses the injection device comprising:
contacting a desired site on a patient's body with the contact surface of the injection device; advancing the syringe barrel to depress the body site with the contact surface, thereby stabilizing the aperture of the contact surface relative to the body site (para 0027 discloses “the placement foot 43 of the exemplary embodiments may be made from an at least partially transparent material such that alignment with the eye, e.g. a periphery of the cornea, may be facilitated. Further, those of skill in the art will understand that an underside of the placement foot 43, for example a surface of the foot 43 which contacts the eye may include a frictional layer or other means for gripping, without injury, the eye”); further advancing the syringe barrel (para 0028 discloses “When the apparatus has been properly placed on the eye, the physician may depress a plunger or similar depressible element coupled to the body and/or the syringe 32 which advances the syringe 32 distally within the body towards the injection site. Then a medicament may be delivered to the predetermined region of the eye.”), thereby collapsing the needle shield (the bellows needle shield disclosed in Himbert, see annotated fig above, see Himbert fig 2 in the collapsed state) and piercing the body site with the needle tip to a desired depth within the body (the “predetermined region” within the eye); injecting the patient with fluid contained in the syringe barrel's cavity by advancing the plunger (the “medicament in para 0028”); and withdrawing the syringe from the patient's body thereby causing the needle shield to relax from its collapsed state and again shield the needle tip (the bellows needle shield disclosed in Himbert, see annotated fig above, see fig 1 in the non-collapsed state), however
Himbert and Clarke are silent to pivoting the syringe barrel after stabilizing the contact surface and its aperture, thereby orienting a central axis of the needle in a desired angular position relative to the body site (natural part of positioning the needle before insertion).
Ke, a similar ophthalmic injection system, teaches pivoting the syringe barrel after stabilizing the contact surface and its aperture, thereby orienting a central axis of the needle in a desired angular position relative to the body site (para 0157-158 discloses “applying a force to a side of clamping port 31 of the sleeve 3 via the syringe 1 to form a pivot point on the conjunctival surface with the side of clamping port 31;
[0158] A third step of pivoting the clamping port 31 around the pivot point toward the other side of clamping port 31 so that the distal end of needle 2 pierces the conjunctival tissue at the injection site”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Ke in the injection device of Himbert in view of Clarke “so that the effective dose of the drug is accurately delivered to the target tissue via the needle” para 0071, Ke.
In reference to dependent claim 17, Himbert in view of Clarke and Ke discloses the injection device capable of the method for injecting a patient's eye with the medical injection device of claim 16,
Clarke further discloses the injection device comprising: contacting a desired site on a sclera (white part of the eye) of a patient's eye with the distal face of cup-shaped skirt (43), contact surface of the injection device (para 0027 discloses “the placement foot 43 of the exemplary embodiments may be made from an at least partially transparent material such that alignment with the eye, e.g. a periphery of the cornea, may be facilitated. Further, those of skill in the art will understand that an underside of the placement foot 43, for example a surface of the foot 43 which contacts the eye may include a frictional layer or other means for gripping, without injury, the eye”; examiner takes the position “ocular” would include the sclera); advancing the syringe barrel to depress the sclera with the contact surface, thereby stabilizing the aperture of the contact surface relative to the sclera; pivoting the syringe barrel after stabilizing the aperture, thereby orienting a central axis of the needle in a desired angular position relative to the sclera (Himbert and Clarke are silent to pivoting, however Ke, combined above discloses in para 0157-158 “applying a force to a side of clamping port 31 of the sleeve 3 via the syringe 1 to form a pivot point on the conjunctival surface with the side of clamping port 31;
[0158] A third step of pivoting the clamping port 31 around the pivot point toward the other side of clamping port 31 so that the distal end of needle 2 pierces the conjunctival tissue at the injection site”);
further advancing the syringe barrel (para 0028 discloses “When the apparatus has been properly placed on the eye, the physician may depress a plunger or similar depressible element coupled to the body and/or the syringe 32 which advances the syringe 32 distally within the body towards the injection site. Then a medicament may be delivered to the predetermined region of the eye.”), thereby collapsing the needle shield (the bellows needle shield disclosed in Himbert, see annotated fig above, see Himbert fig 2 in the collapsed state) and piercing the sclera with the needle tip to a desired depth within the eye (the “predetermined region” within the eye); injecting the intra ocular region of the patient's eye with fluid contained in the syringe barrel's cavity by advancing the plunger (the “medicament in para 0028”); and with drawing the syringe from the patient's eye, thereby causing the needle shield to relax from its collapsed state and again shield the needle tip (the bellows needle shield disclosed in Himbert, see annotated fig above, see fig 1 in the non-collapsed state).
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Himbert (USPN 6,238,371) in view of Clarke (USPAP 2014/0243754) in reference to claim 3 above, and further in view of Leahy (USPAP 2016/0338947).
In reference to dependent claim 23, Himbert in view of Clarke discloses the injection device of claim 3, however
Himbert and Clarke do not teach the polymer unistructure comprises a silicon hydrogel.
Leahy, a similar drug delivery device that touches the eye, teaches a polymer unistructure (contact lens can be considered a unistructure) comprises a silicon hydrogel (para 0086 discloses “Another approach to addressing the problem of delivering dopaminergic drugs, is by soaking a contact lens in a drug solution prior to insertion. A conventional commercially available contact lens product, made of a hydrogel material such as etafilcon A or a silicon hydrogel such as narafilcon A or B, galyfilcon A or senofilcon A”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the material of Leahy in the injection device of Himbert in view of Clarke “for the comfort and safety of the patient” para 0028; Leahy.
Response to Arguments
In response to applicant’s argument that “Himbert only describes an aperture that's formed after the cannula is compressed; there is no collapsible needle shield with an aperture pre-use”, examiner agrees. However Clarke clearly defines an aperture for the needle that aperture is also incorporated into Himbert, see rejection above.
In response to applicant’s argument that “According to Himbert, "[i]t is an important feature of the present invention that the collapsible needle cover can be compressed as much as possible when pressing its front part against the injection site at the skin surface...so substantially the entire length of the needle will be used for injection. Otherwise an unnecessarily long needle must be used which will give rise to an inconvenient flow resistance during injection" (Himbert at col, 3, lines 59-67, emphasis added). In other words, the injection mechanism in Himbert does not have a maximum collapsible length where needle insertion depth is limited; Himbert is teaching away from collapsible needle covers that don't inject the entire length of a needle” examiner respectfully disagrees. Himbert specifically states that “the collapsible needle cover can be compressed as much as possible” and “substantially the entire length of the needle will be used for injection” both terms “as much as possible” and “substantially” mean the bellows is compressed very small, but not gone. As a result Himbert still meets applicant’s broad claim language. Furthermore, fig 2 above shows the bellows collapsed, and as the figure shows the bellows still has length. Finally, simply that there are differences between two references is insufficient to establish that such references “teach away” from any combination thereof. In re Beattie, 974 F. 2d 1309, 1312-13, 24 USPQ2d 1040, 1042 (Fed Cir. 1992).
In response to applicant’s argument that “the cannulas attach to the syringe barrel; there is no separate needle hub that the cannulas and the barrel attach to. Thus, Himbert does not disclose a needle hub. Therefore, Himbert does not disclose, teach, or suggest a corrugated collapsible needle shield having an aperture on the distal axial end, limiting a needle insertion depth, or a needle hub” examiner respectfully disagrees, applicant’s recitation of a “hub” is broad and unspecific, examiner has interpreted the feature of Himbert, in the annotated fig 7 above, as a “hub”
In response to applicant’s argument that “Clarke does not speak to the flexibility of the cup-shaped skirt” examiner agrees. However, Himbert the primary reference does disclose using a polymer for the needle cover and in col 3, lines 7-11 discloses “the collapsible needle cover comprises a resilient, cylindrical or vaguely conical sleeve made of a foamed polymer” once combined the cup-shaped skirt is made of the same material and is therefore resilient and flexible.
In response to applicant’s argument that “Ke relates to ocular injection assemblies. (Ke at [0001]). Ke, however, does not disclose, teach, or suggest a corrugated collapsible needle shield having an aperture on the distal axial end, limiting a needle insertion depth, or a needle hub. Moreover, Ke does not disclose, teach, or suggest a flexible cup-shaped skirt, or a transparent corrugated needle shield. Thus, Ke does not remedy the deficiencies of either Himbert or Clarke. Accordingly, the claimed invention is patentable over the combination of Himbert, Clarke, and Ke”. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783
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