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 § 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 10 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “substantially” in claim 10 line 2 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “the lumen is substantially non-siliconized” is rendered indefinite. Applicant is advised to remove the term “substantially” from the claim in order to overcome this rejection. For examination purposes, Examiner is consider this limitation to read “the lumen is non-siliconized”.
The term “substantially” in claim 27 line 13 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “the lumen is substantially non-siliconized” is rendered indefinite. Applicant is advised to remove the term “substantially” from the claim in order to overcome this rejection. For examination purposes, Examiner is consider this limitation to read “the lumen is non-siliconized”.
Claim Rejections - 35 USC § 103
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 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(s) 1, 7, 8, 10 – 20, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spada (U.S. 2015/0080845).
Regarding claim 1, Spada teaches a system for treating an eye of a patient in need (paragraph [0015]), the system comprising:
a delivery device (syringe 100, Figure 1) comprising:
a housing (housing 120) sized to be held by an operator and comprising an actuator (plunger 130) and a distal nose cone (the end of syringe 100 where proximal end 112 of the needle 110 is attached to as shown in Figure 1) as discussed in paragraph [0026] and shown in Figure 1;
a needle (needle 110) coupled to and extending distal from the nose cone (as shown in Figure 1), the needle having a lumen (hollow needle 110 as discussed in paragraph [0026]) and a beveled distal end defining a distal opening having a sharpened tip and heel proximal the distal opening (Figures 2A and 2B, sharp distal tip 16, and aperture 113, heel as shown in the annotated Figure 2B below) as discussed in paragraph [0026];
and a retention plug (polymer retainer 120, Figure 2A, paragraph [0030] – [0032]) positioned within and spanning the lumen of the needle proximal to the heel (since the needle is dipped into the polymer retainer as discussed in paragraph [0031] and the retainer polymer covers pass the heel as shown in the annotated Figure 2A below),
the retention plug formed from a flowable retainer solution of hydroxypropyl methylcellulose (HPMC) in water (see disclosure of the polymer retainer comprises HPMC in water in paragraphs [0016] and [0022]) and
and an intraocular implant positioned within the lumen of the needle proximal to the retention plug (implant within the needle before applying the retainer at the distal end as discussed in paragraph [0036]).
Spada further discloses that excipients can be added to the polymer retainers (one or more excipient can be present in the range of 0.2% to 10% total weight of the solution) in order to modify the viscosity of the solution or gel so that they can be easily applied to the implant administration device (paragraph [0022]). Therefore, the concentration of the polymer retainer is a result effective variable since changing the concentration of the polymer retainer by adding or removing excipients will result in a change in the viscosity of the polymer retainer.
However, Spada does not specify that the retention plug has a concentration of HPMC that is greater than 2.5% w:w and less than about 4% w:w.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the retention plug has a concentration of HPMC that is greater than 2.5% w:w and less than about 4% w:w for the purpose of having a desire viscosity and easier to apply to an implant administration device since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
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Regarding claim 7, Spada teaches that the retention plug prevents inadvertent release of the implant from the lumen prior to actuation of the device (effectively retain the implant prior the handling of the device, paragraph [0015])
Regarding claim 8, Spada teaches that the retention plug slows an ejection speed of the implant from the lumen upon deployment using the actuator (since the retainer does not immediately allow the implant to be ejected while still minimize the actuation force necessary to expel the implant from the needle, paragraphs [0034]).
Regarding claim 10, Spada teaches that the needle has a siliconized external surface and the lumen is substantially non-siliconized (since the needle has a polymer retainer covering the external surface at the tip but does not cover the majority of the length of the needle as shown in Figures 2A and 2B and discussed in paragraph [0031]).
Regarding claim 11, Spada teaches claim 1 as seen above.
Spada further discloses that excipients can be add to the polymer retainers (one or more excipient can be present in the range of 0.2% to 10% total weight of the solution) in order to modify the viscosity of the solution or gel so that they can be easily applied to the implant administration device (paragraph [0022]). Therefore, the concentration of the polymer retainer is a result effective variable since changing the concentration of the polymer retainer by adding or removing excipients will result in a change in the viscosity of the polymer retainer.
However, Spada does not specify that the flowable retainer solution of HPMC in water has a HPMC concentration of 3% w:w.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the flowable retainer solution of HPMC in water has a HPMC concentration of 3% w:w for the purpose of having a desire viscosity and easier to apply to an implant administration device since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 12, Spada teaches claim 1 as seen above.
Spada further discloses that excipients can be add to the polymer retainers (one or more excipient can be present in the range of 0.2% to 10% total weight of the solution) in order to modify the viscosity of the solution or gel so that they can be easily applied to the implant administration device (paragraph [0022]). Therefore, the concentration of the polymer retainer is a result effective variable since changing the concentration of the polymer retainer by adding or removing excipients will result in a change in the viscosity of the polymer retainer.
However, Spada does not specify that the HPMC is F4M grade having about 27.0%-30.0% methoxyl substitution and about 4.0% - 7.5% hydroxypropoxyl substitution.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the HPMC is F4M grade having about 27.0%-30.0% methoxyl substitution and about 4.0% - 7.5% hydroxypropoxyl substitution for the purpose of having a desire viscosity and easier to apply to an implant administration device since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 13, Spada teaches claim 1 as seen above.
Spada further discloses that the polymer has suitable viscosity for any intended purposes such as ease of application to the needle tip (paragraph [0022]). Therefore, the viscosity of the polymer is a result effective variable since Spada discloses that the viscosity can be modified as needed (paragraph [0022]).
However, Spada does not specify that the retainer solution has a viscosity between 6,780 cP and 12,780 cP.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the retainer solution has a viscosity between 6,780 cP and 12,780 cP for the purpose of having a desire viscosity and easier to apply to an implant administration device since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 14, Spada teaches that wherein the needle is sized between 22 gauge and 30 gauge (paragraph [0027]).
Regarding claim 15, Spada teaches that the needle is 22 gauge (paragraph [0027]).
Spada further discloses that a suitable amount of polymer retainer may be used to effectively plug the aperture to contain the implant within the needle, but still beneficially minimize the amount of actuation force necessary to expel the implant from the needle (paragraph [0034]). Therefore, the amount of the polymer retainer is a result effective variable since Spada discloses that the amount of the polymer retainer affect the ability of to contain the implant within the needle and the amount of actuation force necessary to expel the implant.
However, Spada does not specify that the retainer solution is dispensed within the lumen of the needle as a dispensed mass greater than 300 go and less than 1000 go.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the retainer solution is dispensed within the lumen of the needle as a dispensed mass greater than 300 go and less than 1000 go for the purpose of effectively plug the aperture to contain the implant within the needle, but still beneficially minimize the amount of actuation force necessary to expel the implant from the needle since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 16, Spada teaches that the needle is 28 gauge (paragraph [0027]).
Spada further discloses that a suitable amount of polymer retainer may be used to effectively plug the aperture to contain the implant within the needle, but still beneficially minimize the amount of actuation force necessary to expel the implant from the needle (paragraph [0034]). Therefore, the amount of the polymer retainer is a result effective variable since Spada discloses that the amount of the polymer retainer affect the ability of to contain the implant within the needle and the amount of actuation force necessary to expel the implant.
However, Spada does not specify that the retainer solution is dispensed within the lumen of the needle as a dispensed mass greater than 100 go and less than 300 go.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the retainer solution is dispensed within the lumen of the needle as a dispensed mass greater than 100 go and less than 300 go for the purpose of effectively plug the aperture to contain the implant within the needle, but still beneficially minimize the amount of actuation force necessary to expel the implant from the needle since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 17, Spada teaches that the delivery device further comprises a cylindrical, distal extension (as shown in the annotated Figure 1 below) projecting distal from the nose cone and covering at least a proximal end region of the needle, the distal extension defining an exposed working length of the needle (as shown in the annotated Figure 1 below).
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Regarding claim 18, Spada teaches that the distal extension has an outer diameter that is greater than a maximum outer diameter of the exposed length of the needle (as shown in the annotated Figure 1 above)
Regarding claim 19, Spada teaches that the outer diameter of the distal extension is sized to remain outside the eye and provide a depth stop for the exposed length of the needle sized to be inserted within an eye (since Spada disclosed that the needle is sized appropriately for ocular injection, paragraph [0027]).
Regarding claim 20, Spada teaches claim 17 as seen above.
Spada further discloses that the syringe and needle are appropriately sized to effectively deliver an implant to an eye of a human or animal (paragraph [0027]). Therefore, the length and size of the syringe and needle are result effective variable since the length and the size of the syringe and needle can appropriately selected effectively used to inject an implant into the organ.
However, Spada does not specify that the distal extension has a length that is 8 mm to 15 mm and the exposed working length of the needle is 5.5 mm to 6.5 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the distal extension has a length that is 8 mm to 15 mm and the exposed working length of the needle is 5.5 mm to 6.5 mm for the purpose of effectively deliver an implant to a specific organ, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 23, Spada teaches that the intraocular implant comprises a therapeutic and a biodegradable polymer matrix comprising at least one biodegradable polymer (active pharmaceutical ingredient associated with a biodegradable polymer matrix, paragraph [0028]).
Claim(s) 2, 3, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spada (U.S. 2015/0080845) in view of Highley (U.S. 2009/0281520).
Regarding claim 2, Spada teaches claim 1 as seen above.
However, Spada does not specify that the delivery device further comprises a push rod operatively coupled to the actuator via a linkage to move the push rod through the lumen and push the implant out from the needle.
Highley teaches a device similar to Spada and the current application, further including a push rod (rod 226, Figure 24D) operatively coupled to the actuator (plunger 208, Figure 24D) via a linkage (open end 224 of plunger 228 for receiving the rod 226, paragraph [0061]) to move the push rod through the lumen and push the implant out from the needle (rod 226 eject implants 242 from the lumen of needle 234 as discussed in paragraph [0064] and shown in Figures 24A – 24D.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Highley with the device of Spada in order to deliver the implant at the desired location of the eye (Highley, paragraph [0009]).
Regarding claim 3, Spada and Highley teach claim 2 as seen above.
However, Spada does not specify that the push rod has a length relative to a length of the needle sufficient for a distal end of the push rod to advance past the sharpened tip of the needle upon deployment of the implant using the actuator
Highley further teaches that the push rod has a length relative to a length of the needle sufficient for a distal end of the push rod to advance past the sharpened tip of the needle upon deployment of the implant using the actuator (see rod 226 extending pass the distal tip of needle 234 as shown in Figure 24D).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Highley with the device of Spada in order to deliver the implant at the desired location of the eye (Highley, paragraph [0009]).
Regarding claim 9, Spada teaches claim 8 as seen above.
However, Spada does not tech that the ejection speed is no greater than about 25 mm/second at an ejection distance of about 20 mm away from the lumen.
Highley teaches a device similar to Spada and the current application, and further discloses that that in an ocular implantation device embodiment wherein an implant is delivered by being forced out of a needle by a rod, the implant delivery location may be affected by the force with which the rod presses the implant or by the distance from the needle that the rod extends to eject the implant (paragraph [0069]).
Therefore, the ejection speed and ejection distant (resulting from the force with which the rod presses the implant and by the distance from the needle that the rod extends to eject the implant) are result effective variables since a change in the ejection speed and ejection distance would effect the ability to deliver an implant at a specific location.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the ejection speed is no greater than about 25 mm/second at an ejection distance of about 20 mm away from the lumen for the purpose of effectively deliver an implant to a specific organ, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Claim(s) 2, 4 – 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spada (U.S. 2015/0080845) in view of Weber (U.S. 2004/0054374).
Regarding claim 2, Spada teaches claim 1 as seen above.
However, Spada does not specify that the delivery device further comprises a push rod operatively coupled to the actuator via a linkage to move the push rod through the lumen and push the implant out from the needle.
Weber teaches a device similar to Spada and the current application, further including a push rod (rod 48 and linkage 60, Figures 9A and 9B) operatively coupled to the actuator (actuator 50) via a linkage (via the physical interaction between actuator 50 and linkage 60 as Figures 9A and 9B) to move the push rod through the lumen and push the implant out from the needle (paragraph [0045])
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Weber with the device of Spada in order to provide a smooth and controlled delivery of the implant (Weber, paragraph [0017]).
Regarding claim 4, Spada and Weber teach claim 2 as seen above.
However, Spada does not specify that the push rod has a shortened length relative to a length of the needle to avoid a distal end of the push rod advancing past the sharpened tip of the needle upon deployment of the implant using the actuator
Weber further teaches that the push rod has a shortened length relative to a length of the needle to avoid a distal end of the push rod advancing past the sharpened tip of the needle upon deployment of the implant using the actuator (rod 48 does not extend pass the distal tip of the needle as shown in Figure 9B).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Weber with the device of Spada in order to provide a smooth and controlled delivery of the implant (Weber, paragraph [0017]).
Regarding claim 5, Spada and Weber teach claim 4 as seen above.
Examiner notes that the limitation “the shortened length of the push rod slows an ejection speed of the implant from the lumen upon deployment using the actuator” does not specify or require what degree the shortened length of the push rod slows an ejection speed or how the shortened length of the push rod perform the function of slowing an ejection speed of the implant. Therefore, the length of the push rod as disclosed by Weber and the ejection speed of the implant in the combined system of Spada and Weber reads this limitation.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Weber with the device of Spada in order to provide a smooth and controlled delivery of the implant (Weber, paragraph [0017]).
Regarding claim 6, Spada teaches that the retention plug further slows the ejection speed of the implant (since the retention plug does not increase the ejection force of the implant as discussed in paragraph [0037]). Examiner notes that the limitation “the retention plug further slows an ejection speed of the implant” does not specify or require what degree the shortened length of the push rod slows an ejection speed or how the shortened length of the push rod perform the function of slowing an ejection speed of the implant. Therefore, the retention plug as disclosed by Spada and the ejection speed of the implant in the combined system of Spada and Weber reads this limitation.
Claim(s) 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spada (U.S. 2015/0080845) in view of Tenhuisen (U.S. 2003/0004491).
Regarding claim 21, Spada teaches claim 17 as seen above,
However, Spada does not specify that the distal extension and the nose cone comprises a plastic material and the needle comprises a metal material.
Tenhuisen teaches a device similar to Spada and the current application, further including that the distal extension and the nose cone comprises a plastic material and the needle comprises a metal material (barre 20 and hub 24 can be made of plastic while needle 22 can be made of metal as discussed in paragraph [0016]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Tenhuisen with the device of Spada in order to provide a simple medicinal implant loading and injecting mechanism that maximally preserves the medicament from degradation during the processing/formation of the implant (Tenhuisen, paragraph [0003]).
Regarding claim 22, Spada and Tenhuisen teaches claim 21 as seen above.
Spada does not specify that the plastic material is acrylonitrile-butadiene styrene and the metal comprises stainless steel.
Tenhuisen teaches a device similar to Spada, and the current application, further teaches that the metal comprises stainless steel (noncorrodible material as discussed in paragraph [0016]) and that the device can be made of suitable plastic material (paragraph [0016]). Therefore, the type of material of the device can be select to for reuse and sterilization (paragraph [0016]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Tenhuisen with the combined device of Spada and Tenhuisen in order to provide a simple medicinal implant loading and injecting mechanism that maximally preserves the medicament from degradation during the processing/formation of the implant (Tenhuisen, paragraph [0003]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to select the plastic material to be acrylonitrile-butadiene styrene for the purpose of provide a simple medicinal implant loading and injecting mechanism that maximally preserves the medicament from degradation during the processing/formation of the implant (Tenhuisen, paragraph [0003]), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP (2144.06)
Claim(s) 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spada (U.S. 2015/0080845) in view of White (U.S. 2022/0249517).
Regarding claim 24, Spada teaches claim 23 as seen above.
However, Spada does not specify that the therapeutic comprises dexamethasone or Bigatures.
White teaches a device similar to Spada and the current application, further including that the therapeutic comprises dexamethasone (paragraph [0184]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of White with the device of Spada in order to treats, prevents and/or ameliorates diabetic macular edema (White, paragraph [0184]).
Regarding claim 25, Spada and White teach claim 24 as seen above.
However, Spada does not specify that the therapeutic ocular implant is OZURDEX®.
White teaches a device similar to Spada and the current application, further including that the therapeutic ocular implant is OZURDEX® (paragraph [0184]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of White with the device of Spada in order to treats, prevents and/or ameliorates diabetic macular edema (White, paragraph [0184]).
Claim(s) 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spada (U.S. 2015/0080845) in view of Blizzard (U.S. 2021/0251893).
Regarding claim 24, Spada teaches claim 23 as seen above.
However, Spada does not specify that the therapeutic comprises dexamethasone or Bigatures.
Blizzard teaches a device similar to Spada and the current application, further including that the therapeutic comprises Bigatures (paragraph [0010]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Blizzard with the device of Spada in order to reduce of intraocular pressure in patients with open angle glaucoma or ocular hypertension (Blizzard, paragraph [0010]).
Regarding claim 26, Spada and Blizzard teach claim 24 as seen above.
However, Spada does not specify that the therapeutic ocular implant is DURYSTA®
Blizzard teaches a device similar to Spada and the current application, further including that the therapeutic ocular implant is DURYSTA ® (paragraph [0010]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Blizzard with the device of Spada in order to reduce of intraocular pressure in patients with open angle glaucoma or ocular hypertension (Blizzard, paragraph [0010]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spada (U.S. 2015/0080845) in view of Weber (U.S. 2004/0054374), and in view of Highley (U.S. 2009/0281520).
Regarding claim 27, Spada teaches a method of retaining an implant in an implant administration device (paragraph [0015]), the method comprising:
formulating a flowable retainer solution of hydroxypropyl methylcellulose (HPMC) (see disclosure of the polymer retainer comprises HPMC in water in paragraphs [0016] and [0022])
dispensing a dispensed mass of the retainer solution into a lumen of a needle (hollow needle 110 having a lumen, paragraph [0026]) to form a retention plug that is contained within and spanning the lumen of the needle proximal to a distal opening from the needle (polymer retainer is directly applied to the tip of the needle or the needle is dipped in the retainer solution, paragraph [0030])
positioning an intraocular implant within the lumen of the needle proximal to the retention plug (implant within the needle before applying the retainer at the distal end as discussed in paragraph [0036]);
wherein the retention plug prevents inadvertent release of the implant from the lumen prior to actuation of the implant administration device (effectively retain the implant prior the handling of the device, paragraph [0015]);
wherein the needle is 22 Gauge or smaller (paragraph [0027]);
and the lumen is substantially non-siliconized, wherein the needle has a siliconized external surface (since the needle has a polymer retainer covering the external surface at the tip but does not cover the majority of the length of the needle as shown in Figures 2A and 2B and discussed in paragraph [0031]).
However, Spada does not specify that positioning a shortened push rod proximal to the implant, the push rod operatively coupled to an actuator of the implant administration device, the retention plug works in conjunction with the shortened push rod to slow the ejection speed of the implant from the lumen upon deployment in the eye using the actuator; wherein the ejection speed is no greater than about 25 mm/second at an ejection distance of about 20 mm away from the lumen; and wherein the retainer solution has a concentration that is greater than 2.5% w:w and less than about 4% w:w.
Examiner notes that Spada further discloses that excipients can be add to the polymer retainers (one or more excipient can be present in the range of 0.2% to 10% total weight of the solution) in order to modify the viscosity of the solution or gel so that they can be easily applied to the implant administration device (paragraph [0022]). Therefore, the concentration of the polymer retainer is a result effective variable since changing the concentration of the polymer retainer by adding or removing excipients will result in a change in the viscosity of the polymer retainer.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the retention plug has a concentration of HPMC that is greater than 2.5% w:w and less than about 4% w:w for the purpose of having a desire viscosity and easier to apply to an implant administration device since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Weber teaches a device similar to Spada and the current application, further including positioning a shortened push rod(rod 48 and linkage 60, Figures 9A and 9B) proximal to the implant, the push rod operatively coupled to an actuator (actuator 50) of the implant administration device (paragraph [0045]); the retention plug works in conjunction with the shortened push rod to slow the ejection speed of the implant from the lumen upon deployment in the eye using the actuator; Examiner notes that the limitation “the shortened length of the push rod slows an ejection speed of the implant from the lumen upon deployment using the actuator” does not specify or require what degree the shortened length of the push rod slows an ejection speed or how the shortened length of the push rod perform the function of slowing an ejection speed of the implant. Therefore, the length of the push rod as disclosed by Weber and the ejection speed of the implant in the combined system of Spada and Weber reads this limitation.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Weber with the device of Spada in order to provide a smooth and controlled delivery of the implant (Weber, paragraph [0017]).
Highley teaches a method similar to Spada, Weber, and the current application, and further discloses that that in an ocular implantation device embodiment wherein an implant is delivered by being forced out of a needle by a rod, the implant delivery location may be affected by the force with which the rod presses the implant or by the distance from the needle that the rod extends to eject the implant (paragraph [0069]).
Therefore, the ejection speed and ejection distant (resulting from the force with which the rod presses the implant and by the distance from the needle that the rod extends to eject the implant) are result effective variables since a change in the ejection speed and ejection distance would affect the ability to deliver an implant at a specific location.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Highley with the device of Spada in order to deliver the implant at the desired location of the eye (Highley, paragraph [0009]).
Further, It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the ejection speed is no greater than about 25 mm/second at an ejection distance of about 20 mm away from the lumen for the purpose of effectively deliver an implant to a specific organ, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH T BUI whose telephone number is (571)270-1028. The examiner can normally be reached M - F 8 - 5.
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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.
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ANH T. BUI
Examiner
Art Unit 3783
/Anh Bui/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783