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 .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 6/16/26. The claims 1-6, 10-13, and 21 are pending.
Response to Arguments
Applicant’s arguments, filed 6/16/26 with respect to the rejections of claims 1-4, 10, 13, and 21 under 103 as obvious over Badawi (US2013/0253438) in view of Hammack (WO2012/051575) and Akahoshi (US2010/0010419) have been fully considered but the arguments are not persuasive.
Applicant argues, the combination of Badawi with Hammack, and states Hammack teaches away from modifying a distance between a first end of a collar and a distal cannula end to at most 350 micrometers. Applicant further argues, this modification would make Hammack’s device inoperable for its intended purpose, since Hammack is directed to access to suprachoroidal and sub-retinal spaces, rather than advancement through the anterior chamber to anterior structures such as the trabecular meshwork and reducing the exposed shaft length to at most 350 micrometers would mean the device cannot penetrate at a depth needed.
Examiner disagrees, the rejection does not propose modifying Hammack’s device to penetrate the suprachoroidal or sub-retinal space with an exposed shaft of at most 350 micrometers. The rejection proposes modifying Badawi’s cannula which enters the trabecular meshwork to incorporate Hammack’s collar, wherein Hammack’s collar is disposed around the outside of the cannula with a first end and a second end, and then modifying the spacing between the collars first end and the distal cannula end to be at most 350 micrometers, based on the anatomical requirements of the trabecular meshwork with Badawi’s cannula. It appears Applicant argues the modification is for Hammack’s device. For clarification, the primary reference is Badawi and Hammock is only relied upon for teaching the collar. Examiner makes notice, the rejection finds one having ordinary skill in the art would have found it obvious to modify Badawi’s cannula with a collar and then selecting a spacing of at most 350 micrometers appropriate for the trabecular meshwork penetration depth. The result effective variable is for Badawi’s cannula that enters the trabecular meshwork; and not for Hammack’s cannula that enters suprachoroidal or sub-retinal procedure.
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(s) 1-4, 10, 13, and 21 are rejected under 35 U.S.C. 103 as obvious over Badawi (US2013/0253438) in view of Hammack (WO2012/051575) and further in view of Akahoshi (US2010/0010419).
Regarding claim 1, Badawi discloses an instrument to perforate ocular tissue (cannula is inserted into the eye tissue, Paragraph [0017, 0060]), the instrument comprising:
a handle (202) configured to be grasped by a user (Paragraph [0080]), the handle including a proximal handle end (portion near grip 204) and a distal handle end (portion near housing 208) (see Fig. 2); and
a dissection cannula (212) configured to core intraocular tissue (conduit may be used to remove tissue and would therefore be capable of coring intraocular tissue, Paragraph [0053]), the dissection cannula including:
a proximal shaft end (where cannula 212 is coupled to housing, see Fig. 2) configured to interface with the handle (proximal end of cannula is coupled and extends from housing distal end, Paragraph [0053], see Fig. 2);
a distal cannula end (distal curved portion 304) including an opening into a cannula bore (opening at the distal tip 306, see Fig. 3; where the cannula has a lumen that extends to the distal tip, Paragraph [0014]; Note Fig 3 shows the cannula of an exemplary delivery system, and Figure 2 depends an exemplary delivery system Paragraph [0080, 0081]); and
an indicator (indicators may be used any portion of the system to identify the location of the distal end of the cannula, Paragraph [0053]; Note Fig 3 shows the cannula of an exemplary delivery system, and Figure 2 depends an exemplary delivery system Paragraph [0080, 0081]), wherein the dissection cannula is fixed with respect to the handle (fixed longitudinally with respect to the handle by being threaded to the distal end of the cannula, Paragraph [0057], see threads shown in Fig. 10B).
Badawi is silent regarding a collar disposed around at least a portion of the outside of the dissection cannula, the collar comprising a first end and a second end, wherein the first end is spaced from the distal cannula end by at most 350 micrometers, such that the distal cannula end is configured to be advanced into at least trabecular meshwork, accessed via an anterior chamber, at a penetration depth limited by the first end of the collar. However, Badawi teaches the cannula within the eye (Paragraph [0060]); and teaches indicators being on any portion of the system to identify the distal end of the cannula (Paragraph [0053]).
Hammack teaches devices to access suprachoroidal space (anterior portion of the eye, see background of invention). The device having a seal 55 (collar) disposed about the outside of the needle (see Fig. 15). The seal 55 having a first end and a second end (see annotated Fig. 15), the first end spaced from the distal cannula end by some distance (see Fig. 15). Where the seal 55 has a tissue contacting surface to stop the main shaft from extending too far a length into the tissue, where the preferred lengths of the main shaft are from the distal edge 53 of the lumen to the seal 55 (Page 15, lines 5-15).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have substituted the collar comprising a first end and a second end, around the cannula that indicates a spacing (penetration depth) from the distal end of the cannula, as taught by Hammack, for the indicator spaced from the distal end of the cannula of the Badawi device, since the substitution would have the same predictable result of determining an penetration depth of the cannula and the collar of Hammack. The modified Badawi device would be capable of being advanced into at least trabecular meshwork accessed via an anterior chamber. The modified invention of Badawi/Hammack is intended to be advanced into ocular tissue, and has the capability of accessing the anterior chamber and advancing into trabecular meshwork as disclosed by Badawi ([0004]), at a penetration depth indicated by the spacing as defined by the seal 55 (Page 15, line 15). The distal cannula end and the collar have the capability to be inserted into the anterior chamber of the eye when the penetration depth of achieved.
Hammack further teaches the length of the shaft being between 2.75mm to 3mm (2750 to 3000 micrometers) (Page 10, lines 10-12). Hammack teaches this length is a result effective variable, dependent on the anatomical dimensions and mechanical characteristics of the tissues to be penetrated (Page 10, lines 15-18). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the shaft to be less than 350 micrometers, since the length of the shaft is a result effective variable that can be modified dependent on the tissue to be penetrated and anatomical dimensions of the patient. 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. In re Aller, 105 USPQ 233.
Badawi is silent regarding the distal cannula end includes a cross-section at a distal most end, the cross-section defining a plane that is perpendicular to a major cannula axis, and wherein the cross-section of the distal cannula end comprises a geometrical shape. Badawi according to other embodiment teaches the cannula is formed to have a cross-sectional profile that is circular ([0059]) and different designs for the beveled distal end ([0063]). Akahoshi teaches a needle for accessing the eye ([0056]), where the needle tip 112 terminates in a cutting edge 116 formed by beveling a first portion 118 of the outer surface 108 and a second portion 120 of the inner surface 110 a sharpened and continuous tip edge 116 ([0069], see Fig. 14). Akahoshi further teaches a bevel 58 with a leading edge 56, similar to the bevel of Badawi is an obvious alternative as shown in Figs. 3 & 4. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have substituted the needle tip of Akahoshi for the needle tip of Badawi, since the substitution would have yielded the same predictable result of providing a needle tip for accessing eye tissue by piercing, and provide the added benefit of creating cutting surfaces in both the torsional and longitudinal directions (see Abstract of Akahoshi).
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Regarding claim 2, Badawi/Hammack/Akahoshi makes obvious the instrument of claim 1, Akahoshi further teaches wherein the distal cannula end includes a beveled edge (bevel of first portion 118).
Regarding claim 3, Badawi/Hammack/Akahoshi makes obvious the instrument of claim 2; yet, is silent regarding the beveled edge includes at least one of a single bevel. Akahoshi further teaches wherein the beveled edge includes at least one of a single bevel (see single bevel 96 of Fig. 9; Akahoshi). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the bevel edge to include a single bevel since Akahoshi teaches the embodiments are obvious variants.
Regarding claim 4, Badawi/Hammack/Akahoshi makes obvious the instrument of claim 3, Akahoshi further teaches wherein the beveled edge is sloped toward an interior surface of the cannula (see Fig. 14, [0069] of Akahoski).
Regarding claim 10, Badawi/Hammack/Akahoshi makes obvious the instrument of claim 1, Badawi further discloses comprising a pressure source (mechanism as described in Paragraph [0016]) in communication with the cannula bore to adjust pressure in the cannula bore - lumen of cannula may be pressurized, see Paragraphs [0016], [0029], [0119]).
Regarding claim 13, Badawi/Hammack/Akahoshi makes obvious the instrument of claim 1, the modified invention further discloses wherein the handle is integral with the dissection cannula (Examiner interprets the handle being integral with the cannula by being of being connected in construction of the device, see Fig. 2, Paragraph [0080] of Badawi).
Regarding claim 21, Badawi/Hammack/Akahoshi makes obvious the instrument of claim 1, the modified invention further discloses wherein the ocular tissue is trabecular meshwork (the ocular tissue is capable of being trabecular meshwork, Badawi discloses the ocular tissue accessed is near the trabecular meshwork, [0004]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as obvious over Badawi (US2013/0253438) in view of Hammack (WO2012/051575) and Akahoshi (US2010/0010419), as applied to claim 1 above, and further in view of Lee (US5423330).
Badawi/Hammack/Akahoshi is silent regarding a serrated edge extending about at least a portion of the distal end as recited in claim 5, or extending about the entire distal cannula end as recited in claim 6. Lee teaches a device for making an incision in the eye and insertion of instruments (C1:L38-40). The incision is performed by a cannula having a serrated edge that extends about the entire distal cannula end (the edge at the opening of the cutting member 24 may be serrated and adapted to make a hole, C4:L60-64, see Figs. 1-3 & 13). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal cannula end to have the entire edge be serrated, as taught by Lee, in order to facilitate holding, piercing and penetrating of tissue (C5:L62-65).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as obvious over Badawi (US2013/0253438) in view of Hammack (WO2012/051575) and Akahoshi (US2010/0010419), as applied to claim 10 above, and further in view of Smedley (US2002/0133168).
Regarding claims 11 and 12, Badawi/Hammack/Akahoshi makes obvious the instrument of claim 10 as discussed above; yet, is silent regarding the pressure source is configured to generate enough negative pressure in the cannula bore to draw ocular tissue into the bore and cut the ocular tissue against the distal cannula end. Badawi teaches cutting and removing the trabecular meshwork and using a conduit to pull excised tissue back into the cannula during retraction (paragraph [0029]). Smedley teaches a device for placing a fluid shunt 10 in the eye for treatment of glaucoma (see Abstract). The device including a punch 42 having an inner tube 6 (cannula) within an outer tube 4. The inner tube ends in a circular blade 56 (paragraph [0066]), wherein the shunt 10 is held in place by negative pressure prior to delivery (paragraph [0083]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the invention of Badawi/Hammack/Akahoshi to have the pressure source generate negative pressure, as taught by Smedley, in order to hold or release a structure within the cannula (paragraph [0083] of Smedley, paragraph [0029] of Badawi).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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