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 .
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Note also that the drawings include improper shading.
Applicant made an assertion that replacement drawings were submitted however no replacement sheets were present in the Response.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanlon et al. (US 2013/0102966 A1).
Regarding claim 1, Hanlon discloses an ophthalmic insertion tool 100 comprising: a housing 120 having a distal end and a proximal end (Fig. 1); a cannula 110 attached to the distal end of the housing (Figs. 1-2), the cannula including a distal tip with at least one port in communication with a lumen extending through the cannula (Figs. 1-2); a retractable sheath 130 coupled with the distal end of the housing (Figs. 1-3), the retractable sheath configured to move between a first position covering the distal tip of the cannula (para. [0038]) and a second position exposing the distal tip of the cannula (paras. [0038]-[0042]); and at least one scleral marker 1146 integral with the housing (Figs. 1-3), the at least one scleral marker located adjacent the distal end of the housing, the proximal end of the housing (i.e., Figs. 1-3 para. [0027]), or both the distal end and the proximal end.
Regarding claim 3, Hanlon discloses the ophthalmic insertion tool of claim 1. Hanlon also discloses the at least one scleral marker is located adjacent the proximal end of the housing (para. [0027]; Figs. 1-3).
Regarding claim 5, Hanlon discloses the ophthalmic insertion tool of claim 1. Hanlon also discloses the distal end (of the cannula) includes a sharp tip 112 configured to puncture a posterior of an eye of a patient (Fig. 3).
Claims 1, 6-10, 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2012/123355.
Regarding claim 1, ‘355 discloses an ophthalmic insertion tool (Fig. 11) comprising: a housing 401 having a distal end and a proximal end (Fig. 11); a cannula 407 attached to the distal end of the housing (Figs. 11), the cannula including a distal tip with at least one port in communication with a lumen extending through the cannula (Figs. 11); a retractable sheath 402 coupled with the distal end of the housing (Figs. 11), the retractable sheath configured to move between a first position covering the distal tip of the cannula and a second position exposing the distal tip of the cannula (pg. 12 lines 4-10); and at least one scleral marker 405 integral with the housing (Figs. 11), the at least one scleral marker located adjacent the distal end of the housing (Fig. 11), the proximal end of the housing, or both the distal end and the proximal end.
Regarding claim 6, ‘355 discloses the ophthalmic insertion tool of claim 1. ‘355 also discloses the retractable sheath is configured to move longitudinally along an outer surface of the housing between the first position and the second position (pg. 12 lines 4-9).
Regarding claim 7, ‘355 discloses the ophthalmic insertion tool of claim 6. ‘355 also discloses the retractable sheath is configured to retract from the first position to the second position in response to the distal end of the housing pressing against a sclera of an eye of a patient (pg. 12 lines 4-9).
Regarding claim 8, ‘355 discloses the ophthalmic insertion tool of claim 7. ‘355 also discloses wherein the housing includes a first locking point configured to maintain the retractable sheath in the second position to expose the distal tip of the cannula to facilitate puncturing the sclera with the distal tip (pg. 12 line 27- pg. 13 line 2).
Regarding claim 9, ‘355 discloses the ophthalmic insertion tool of claim 8. ‘355 also discloses wherein the housing includes a second locking point configured to maintain the retractable sheath in the first position to protect the distal tip of the cannula from damage (pg. 13 lines 17-24).
Regarding claim 10, ‘355 discloses the ophthalmic insertion tool of claim 9. ‘355 also discloses wherein the second locking point is configured to apply a retention force to the retractable sheath to facilitate marking the sclera according to the at least one scleral marker (Fig. 11 i.e., at least by viewing placement), while the retractable sheath is maintained in the first position (Fig. 11; see also pg. 5 lines 15-29 although another embodiment, foot 105 is the same as foot 405 such that there is a pressure applied to 405 during placement such that 405 engages with the scelera).
Regarding claim 13, Bley discloses the ophthalmic insertion tool of claim 1. ‘355 also discloses wherein the at least one scleral marker includes at least one of a protruding tip of an end of the retractable sheath (Fig. 11).
Regarding claim 14, ‘355 discloses the ophthalmic insertion tool of claim 13. The device of ‘355 is fully capable of having the protruding tip of the at least one scleral marker is configured to make an indentation when pressed against the sclera of an eye of a patient without incising the sclera if one desired to do so - note that the limitations of claim 14 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 15, ‘355 discloses the ophthalmic insertion tool of claim 13. ‘355 also discloses wherein the at least one scleral marker includes multiple scleral markers spaced apart from one another at the end of the retractable sheath (i.e., each of foot 405 as shown in Fig. 11).
Claims 1, 2, 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bley et al. (US 2020/0261266 A1).
Regarding claim 1, Bley discloses an ophthalmic insertion tool comprising: a housing 1 having a distal end and a proximal end (Fig. 1); a cannula 8 attached to the distal end of the housing (Figs. 1-2), the cannula including a distal tip with at least one port in communication with a lumen extending through the cannula (Figs. 1-2); a retractable sheath 5 coupled with the distal end of the housing (para. [0080]-[0081]), the retractable sheath configured to move between a first position covering the distal tip of the cannula and a second position exposing the distal tip of the cannula (paras. [0080]-[0081]); and at least one scleral marker integral with the housing (i.e., as disclosed in para. [0072] wherein the marker can be a visual marker regarding depth), the at least one scleral marker located adjacent the distal end of the housing (para. [0072]), the proximal end of the housing (i.e., on the plunger as disclosed by para. [0072]), or both the distal end and the proximal end (para. [0072]).
Regarding claim 2, Bley discloses the ophthalmic insertion tool of claim 1. Bley also discloses wherein the at least one scleral marker is located adjacent the distal end of the housing (para. [0072]).
Regarding claim 4, Bley discloses the ophthalmic insertion tool of claim 1. Bley also discloses the at least one scleral marker includes a first scleral marker located adjacent the proximal end of the housing, and a second scleral marker adjacent the distal end of the housing (i.e., at least by having index or measurement markings in the body and the plunger having markings as disclosed by para. [0072]).
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.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over ‘355.
Regarding claim 16, ‘355 discloses the ophthalmic insertion tool of claim 15.
‘355 also discloses in Fig. 11 and pg. 12 lines 4-9; see also pg. 5 lines 15-29 that the distance between the two markers needs to be optimized to aid in placement of the feet on the sclera (see Fig. 11) As seen in Fig. 11, the distance between each of the feet 405 is disclosed to be a result effective variable in that distance between the feet would change both the ability for the needle to penetrate through, but also stabilizing the device on the curvature of the eye. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of ‘355 by making two of the multiple scleral markers are spaced apart from one another by three millimeters or four millimeters as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17, ‘355 discloses at least one ophthalmic insertion tool (Fig. 11) inside the container package, the ophthalmic insertion tool including, a housing 401 having a distal end and a proximal end (Fig. 11), a retractable sheath 402 coupled with the distal end of the housing (Figs. 11), the retractable sheath configured to move between a first position covering the distal end of the housing and a second position exposing the distal end of the housing (pg. 12 lines 4-10); and at least one scleral marker 405 integral with the housing (Figs. 11), the at least one scleral marker located adjacent the distal end of the housing (Fig. 11), the proximal end of the housing, or both the distal end and the proximal end; and at least one cannula 407 inside the container package, the cannula including a distal tip with at least one port in communication with a lumen extending through the cannula (Fig. 11).
‘355 doesn’t directly disclose a container package, or the device being inside the container package, however since the device is used clinically and includes sterile components (see for example page 12 lines 11-15) such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of ‘355 to have a sterile container for surgical use.
Regarding claim 18, ‘355 discloses the ophthalmic insertion tool package of claim 17. ‘355 also discloses wherein the at least one cannula is attached to the distal end of the housing of the at least one ophthalmic insertion tool (Fig. 11).
Regarding claim 19, ‘355 discloses the ophthalmic insertion tool package of claim 17. ‘355 also discloses wherein the at least on cannula is configured to be loaded into the housing of the at least one ophthalmic insertion tool (i.e., at least during manufacturing and assembly of the device).
Regarding claim 20, ‘355 discloses the ophthalmic insertion tool package of claim 17. ‘355 also discloses wherein the at least one ophthalmic insertion tool includes at least three ophthalmic insertion tools inside the container package (i.e., at least by way of having 402, 402, 417, 407 each in the package (i.e., either assembled or disassembled).
Allowable Subject Matter
Claims 11-12 are allowed.
Regarding claim 11, ‘355 doesn’t directly disclose wherein the housing is configured to release the cannula to maintain the cannula in the sclera as the housing is moved away from the eye of the patient.
Specifically, there is no teaching, suggestion, or motivation to cause the device of ‘355 to “break apart” such that 407 would remain inside the sclera while the housing is removed. 407 in ‘355 acts as a port to deliver fluid and is connected to syringe 406 such that the housing is necessarily connected to 407 for the delivery of fluid. Separating 407 from the syringe and housing 406 would destroy the device of ‘355.
Response to Arguments
Applicant's arguments filed 8/13/26 have been fully considered but they are not persuasive.
Hanlon
Applicant argues that Hanlon separately discloses cannulas 130 from trocar 110a and doesn’t disclose the trocar as a cannula. Examiner disagrees. Examiner notes that the broadest reasonable interpretation of a cannula is defined by Merriam-Webster as being a “small tube.” As such, a trocar absolutely is a cannula.
Applicant also argues that Hanlon doesn’t disclose a “retractable sheath coupled with a distal end of the housing.” Examiner notes that Applicant never explicitly disclosed whether the retractable sheath is directly or indirectly coupled with a distal end of the housing and just because the sheath is removable does not prevent it from being coupled to the housing. Also, para. [0048] discloses that the sheath covers the distal tip of the cannula at least during placement and removal of the cannula.
Smith
Applicant argues that Smith does not disclose a retractable sheath. Examiner disagrees and notes that Applicant conceded that the application discloses that Smith’s device moves between a retracted position and an extended position “when the apparatus is being positioned for an injection.” Smith page 2, lines 4-14. As such, the sheath is capable of moving such that under the broadest reasonable interpretation it can be described as being a “retractable sheath.” Further, when the sheath is retractable is not limited by Applicant’s claim.
Regarding Applicant’s argument that the foot 405 cannot be used as a “sclera marker,” Examiner disagrees. Examiner notes that under the broadest reasonable interpretation, the sclera marker must indicate a position but does not require physical marking. Further, because the sclera marker is a functional limitation and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Bley
Applicant argues that Bley does not disclose a retractable sheath. Applicant argues that since the flexible cannula 5 extends from within the needle 8, it cannot be coupled to the distal end of the housing. Examiner disagrees. Examiner notes that coupling can occur directly or indirectly. In this case, there is no language that requires a fixed connection to the distal end of the housing. Because the cannula 5 distally para. [0080] with regard to plunger compression spring, cannula 5 can therefore be a retractable sheath.
Further, with regard to the above scleral marker limitation, Examiner also notes that the label or indicator as disclosed by para. [0072] is a scleral marker used to indicate position. Also, Examiner notes that scleral marker is a functional limitation.
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 RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
