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
The Amendment filed 12/11/25 has been entered. Claims 1-3, 6, 8-12, 14, and 16 have been amended, and claims 4-5, 7, and 18-20 have been cancelled. Claims 1-3, 6, and 8-17 are addressed in the following office action.
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 1-3, 6, and 8-17 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.
Claim 1 recites the limitation "the distal end" in line 7. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be interpreted as “a distal end of the distal part”. Claims 2-3, 6, and 8-17 are rejected for the same reasons as claim 1 by virtue of dependency on claim 1.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “a movement mechanism configured to advance said device along the axis X” in claim 15, and “a movement mechanism configured to rotate said soft-tissue cutting tool” in claim 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-3, 6, 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Schaaf et al. (US 2001/0053873) in view of Rusnak (US 2010/0280408) and De Juan, JR. et al. (US 2007/0191863). Note, Schaaf and De Juan were cited in the previous office action.
Regarding claim 1, an invention relating to ophthalmologic devices, Schaaf discloses (Figs. 1-3, 4H, 5) a method for removing a portion of soft tissue from a target tissue layer of the eye to enable drainage of excessive fluid from inside the eye (Abstract), the method comprising: providing a device comprising a soft-tissue cutting tool (35.6) extending along an axis X (X.3), the cutting tool comprising an elongated proximal part [i.e. a proximal portion including the proximal end] attached to a proximal handle (28) for gripping the device (Fig. 6A), a distal part (81) having an open distal end [i.e. the opening at the circular cutting edge] and a distal cutting edge (81.1) at the distal end configured to attach to and cut the soft tissue portion (Par. 0065), and a cavity (see annotated figure below) extending inside the cutting tool from said open distal end to receive the cut soft tissue portion (Par. 0065-0066); positioning the device at a first point with respect to the eye (Par. 0045); advancing the device along the axis X until contacting said target tissue layer (Par. 0049); distally progressing at least the distal part of the cutting tool into the target tissue layer to thereby cut and remove the soft tissue portion, extending between two side walls of the target tissue layer, by said distal part of the cutting tool, thereby creating a channel of a predetermined geometry across the target tissue layer (Par. 0065-0066 & 0068-0069); retracting at least the distal part proximally out of the target tissue layer [i.e. retraction will be required to open a passageway at two or more locations] (Par. 0071); and withdrawing the device out of the eye substantially along the axis X [i.e. withdrawing the device from the trabecular meshwork (9)], thereby leaving the created channel allowing the drainage of the excessive fluid therethrough (Par. 0065-0066 & 0071-0072); wherein: the elongated proximal part has a uniform outer diameter (see annotated figure below), the distal cutting edge is a round cutting edge (81.1), the round cutting edge having a first diameter [i.e. diameter at the open distal end (81.1)] smaller than said uniform outer diameter, the distal part has a continuously decreasing outer diameter [i.e. taper] from said uniform outer diameter to said first diameter of the cutting edge (see annotated figure below & Par. 0065-0066), the cavity has a cavity diameter that decreases from said first diameter of the cutting edge at a distal side of the cavity [i.e. the cavity diameter is less than the cutting edge diameter which is an outer diameter that includes the wall thickness of the cutting edge]. However, Schaaf fails to disclose the target tissue layer is located inside the eye at the superonasal or inferonasal quadrants of the eye.
PNG
media_image1.png
276
271
media_image1.png
Greyscale
PNG
media_image2.png
170
249
media_image2.png
Greyscale
In the alternative and in the analogous art of surgical tools, Rusnak teaches (Fig. 5) a cavity has a cavity diameter that decreases from a first diameter of a cutting edge (134) at a distal side of the cavity (see annotated figure below).
PNG
media_image3.png
151
276
media_image3.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaaf to have wherein the cavity has a cavity diameter that decreases from said first diameter of the cutting edge at a distal side of the cavity. Doing so would provide a mouth that more efficiently receives tissue into the needle lumen by aspiration (Par. 0014), as taught by Rusnak.
In the analogous art of glaucoma treatment device, De Juan teaches wherein the target tissue layer is located inside the eye at the superonasal or inferonasal quadrants of the eye (Par. 0204).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Schaaf with the method steps: the target tissue layer is located inside the eye at the superonasal or inferonasal quadrants of the eye, as taught by De Juan. Schaaf discloses inserting a device at the limbus across the anterior chamber to the target tissue to open a passageway for drainage of the aqueous humor is desired (Par. 0143 & 0204), thus Schaaf’s method steps would have provided Schaaf with an approach to the target tissue where the passageway would be opened.
Regarding claim 2, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses the method according to claim 1. Schaaf further discloses comprising repeating said positioning, progressing, and retracting steps for a plurality of times to create a respective plurality of channels at respective plurality of locations at said target tissue layer (Par. 0068-0069, 0071-0072).
Regarding claim 3, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses wherein said target tissue layer is the sclera located at the superonasal quadrant of the eye [i.e. see De Juan paragraph 0204], said channel having a length of 1- 1.5mm substantially and being created between the anterior chamber of the eye and a sub- conjunctival space of the eye [Note, the length of the channel in the trabecular meshwork would be 1-1.5mm because it is created in the claimed location between the anterior chamber of the eye and the sub-conjunctival space] (Par. 0045 & 0071). However, Schaaf fails to further disclose said positioning step comprises introducing said device into the anterior chamber of the eye through the temporal half of the eye, said advancing step comprises advancing the device through the anterior chamber until contacting the target tissue layer from inside the eye.
In the analogous art of glaucoma treatment device, De Juan teaches wherein said positioning step comprises introducing said device into the anterior chamber of the eye through the temporal half of the eye, said advancing step comprises advancing the device through the anterior chamber until contacting the target tissue layer from inside the eye (Par. 0204).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Schaaf, in view of Rusnak and De Juan, with said positioning step comprises introducing said device into the anterior chamber of the eye through the temporal half of the eye, said advancing step comprises advancing the device through the anterior chamber until contacting the target tissue layer from inside the eye, as taught by De Juan. Schaaf discloses inserting a device at the limbus across the anterior chamber to the target tissue to open a passageway for drainage of the aqueous humor is desired (Par. 0143 & 0204), thus Schaaf’s method steps would have provided Schaaf with an approach to the target tissue where the passageway would be opened.
Regarding claim 6, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses the method according to claim 1. Schaaf further discloses wherein said target tissue layer is the trabecular meshwork, said channel having a length of 0.5mm substantially and being created between the anterior chamber of the eye and the Schlemm's canal of the eye [Note, the length of the channel in the trabecular meshwork would be 0.5mm because it is created in the claimed location between the anterior chamber of the eye and the Schlemm’s canal] (Par. 0045 & 0071). However, Schaaf fails to disclose said positioning step comprises introducing said device into the anterior chamber of the eye through the temporal half of the eye, said advancing step comprises advancing the device through the anterior chamber until contacting the target tissue layer from inside the eye.
In the analogous art of glaucoma treatment device, De Juan teaches wherein said positioning step comprises introducing said device into the anterior chamber of the eye through the temporal half of the eye, said advancing step comprises advancing the device through the anterior chamber until contacting the target tissue layer from inside the eye (Par. 0204).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Schaaf, in view of Rusnak and De Juan, with said positioning step comprises introducing said device into the anterior chamber of the eye through the temporal half of the eye, said advancing step comprises advancing the device through the anterior chamber until contacting the target tissue layer from inside the eye, as taught by De Juan. Schaaf discloses inserting a device at the limbus across the anterior chamber to the target tissue to open a passageway for drainage of the aqueous humor is desired (Par. 0143 & 0204), thus Schaaf’s method steps would have provided Schaaf with an approach to the target tissue where the passageway would be opened.
Regarding claim 10, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses the method according to claim 1. Schaaf further discloses wherein said cavity diameter is constant in the proximal direction after said distal side of the cavity (Fig. 4H).
Regarding claim 11, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses the method according to claim 1. Schaaf further discloses (Fig. 3A) wherein said device further comprises an elongated outer member (33) coaxially surrounding the soft-tissue cutting tool (Par. 0048); said outer member comprises an open distal side [i.e. the opening elements 34 and 81 extend through (Fig. 4H)] configured for sticking to said target tissue layer when the device is brought to contact the target tissue layer during said advancing step; said soft-tissue cutting tool being configured to project distally through said open distal side of the outer member in order to cut the soft tissue portion from the target tissue layer (Par. 0068 & 0071-0072).
Regarding claim 12, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses the method according to claim 1. Schaaf discloses further comprising rotating the distal part of the soft-tissue cutting tool to thereby cut and remove the soft tissue portion (Par. 0068-0069 & 0071-0072).
Regarding claim 13, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses the method according to claim 11. Schaaf further discloses wherein said soft-tissue cutting tool is fixedly [i.e. rotatably fixed such that it shares the same longitudinal axis] attached to and housed within said outer member during said advancing of said outer member to contact the target tissue layer (Par. 0049).
Regarding claim 14, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses the method according to claim 11. Schaaf further discloses wherein said outer member is manually moved along the axis X during said advancing step until its said sticking to the target tissue layer (Par. 0049).
Regarding claim 15, Schaaf discloses the method according to claim 1. Schaaf further discloses (Fig. 6A) wherein said handle comprises a movement mechanism (60) configured to advance said device along the axis X (Par. 0030, 0042, 0068-0069, 0078).
Regarding claim 16, Schaaf discloses the method according to claim 12. Schaaf further discloses (Fig. 6A) wherein said handle comprises a movement mechanism (60) configured to rotate said soft-tissue cutting tool (Par. 0030, 0042, 0068-0069, 0078).
Regarding claim 17, Schaaf discloses the method according to claim 16. Schaaf further discloses wherein said movement mechanism is configured to rotate said soft-tissue cutting tool in reciprocal movement (Par. 0030, 0042, 0068-0069, 0078).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schaaf et al. (US 2001/0053873) in view of Rusnak (US 2010/0280408) and De Juan, JR. et al. (US 2007/0191863) as applied to claim 1 above, and further in view of Shmukler et al. (US 2015/0127037), cited in previous office action.
Regarding claim 8, Schaaf, as modified by Rusnak in the alternative and De Juan, discloses the method according to claim 1. Schaaf further discloses wherein said cavity has dimensions matching shape of said soft tissue portion, and wherein said shape of the soft tissue portion has a length of 0.5-1.5mm [Note, page 12, paragraph 4 of applicant's original disclosure filed 06/28/22 divulges the target tissue layer is the sclera located at the sclera- corneal junction, said channel having a length of 0.5-1.5mm substantially and being created between the anterior chamber of the eye and a sub-conjunctival space of the eye. Hence, the soft tissue portion is cylindrical and has a length of 0.5-1.5 mm because the device is inserted into the same location, the limbus (Par. 0039)]. However, Schaaf fails to disclose wherein the soft tissue portion has a diameter of between 0.1mm and 0.2mm substantially.
In the analogous art of glaucoma treatment, Shmukler teaches that a diameter of a channel greater than about 200 µm after tissue recoil, e.g. 1,000 µm, would cause collapse of the eye (probably due to excessive leakage of the fluids from the anterior chamber of the eye) (Par. 0096).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaaf to have wherein the soft tissue portion has a diameter of between 0.1mm and 0.2mm substantially. Doing so would prevent collapse of the eye (Par. 0096), as taught by Shmukler.
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Concerning claim 9, cited prior art reference Schaaf et al. (US 2001/0053873) discloses the method according to claim 7. Schaaf further discloses wherein said cavity has a length of at least the length of the removed soft tissue portion (Fig. 4H). However, Schaaf fails to disclose a cavity diameter smaller than said first diameter at a distal end of the cavity, the cavity diameter increases continuously towards a proximal end of the cavity.
Prior art reference Sullivan et al. (US 2013/0046316) teaches a cavity diameter [i.e. the diameter of the lumen of element 395] increases continuously towards a proximal end of the cavity (Par. 0102). However, Sullivan fails to disclose a cavity diameter smaller than said first diameter at a distal end of the cavity.
Prior art reference Ouchi (US 6,514,215) teaches a cavity diameter [i.e. the diameter of the lumen of element 210] smaller than said first diameter at a distal end (211) of the cavity (Fig. 14). However, modifying the prior art to include the missing limitations wouldn’t have been obvious because modification would only be motivated by hindsight.
Response to Arguments
Applicant’s arguments, see page 6, filed 12/11/25, with respect to claim objections have been fully considered and are persuasive. The objection of claims has been withdrawn.
Applicant’s arguments, see page 7, filed 12/11/25, with respect to claim rejections in view of previously cited prior art reference Shmukler have been fully considered and are persuasive. The rejection of claims in view of Shumkler have been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive. Applicant argues that a person of ordinary skilled in the art would not be motivated to modify Schaaf in view of De Juan because De Juan is directed towards a different application which is the implanting of a shunt in the eye, De Juan is interested in a different tissue within the eye which is the Scleral Spur (different from both the sclera and the trabecular meshwork), and De Juan continues and states that it is possible to implant the shunt at any quadrant, without indicating any advantage to any of the quadrants, unlike what the method of currently amended claim 1 entails. Examiner respectfully disagrees.
Both prior art reference Schaaf and De Juan are from the analogous art of glaucoma treatment device, see paragraph 0005 of Schaaf and paragraph 0009 of De Juan. Both prior art reference Schaaf and De Juan are interested in the same target tissue, see the abstract of Schaaf and see paragraphs 0150 and 0174 of De Juan. Lastly, applicant does not state any advantage of the quadrants. Applicant claims the target tissue layer is located in the supernasal or inferonasal quadrants of the eye, and De Juan teaches different approach pathways to target locations in the various quadrants which obviates applicants claim limitation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 February 6, 2026