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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 28th 2026 has been entered.
Claim Rejections - 35 USC § 102
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 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hickingbotham et al. (US 2013/0178822).
Regarding claim 1, Hickingbotham et al. disclose an ophthalmic surgical instrument (Abstract), comprising: a handpiece (4); an actuator (3) mounted on the handpiece; an outer tube (2) having a proximal end mounted to the handpiece; a dissection spatula (1; Figure 11a) extendable outwardly relative to a distal end of the outer tube responsive to movement of the actuator (¶[0130]; noting that in view of claim 2 and Applicant’s pgpub ¶[0016], movement of tube 2 to uncover the spatula is readable by “extendable outwardly relative to a distal end of the outer tube”; however, Hickingbotham et al. also disclose the actuator distally extending the spatula relative to the outer tube - ¶[0130], Figure 7), the dissection spatula defining a channel (within each member 31; ¶[0212]) connected to an opening at a distal edge of the dissection spatula (Figure 11a) and configured to delaminate a portion of a retinal membrane (Applicant has not disclosed any particular fluid pressure required for the delamination; it is asserted that a syringe could apply sufficient fluid pressure - ¶[0229]; furthermore the preceding limitation does not appear to be referring to a sharpness of the distal edge as evident from its grammatical structure and in view of ¶[0027] and [0028] of the published application); and a dispensing system in fluid communication with the channel (¶[0212], [0238]).
Regarding claim 2, the actuator is configured to move the outer tube relative to the handpiece (¶[0130]).
Regarding claim 3, the dissection spatula is wider than an inner diameter of the outer tube (evident from Figure 5b).
Regarding claim 5, a hollow rod (30; ¶[0212]) connects the dissection spatula to the handpiece, the hollow rod being in fluid communication with the channel and the dispensing system (¶[0212]).
Regarding claim 6, the dispensing system includes one of a button (Table 1) mounted to the handpiece and a footswitch configured to cause fluid to flow through the channel.
Regarding claim 7, the dispensing system includes a reservoir (27) within the handpiece (Figure 4).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hickingbotham et al. (US 2013/0178822) in view of Nishida et al. (US 2017/0079838).
Regarding claims 8 and 9, Hickingbotham et al. disclose that the outer tube defines a longitudinal direction that is collinear with an axis of symmetry of the outer tube (Figure 4) but fail to disclose that the spatula is at least 2 times wider than a thickness as claimed.
Nishida et al. discloses a similar spatula (50) also for delivering substances and/or objects to an eye (¶[0002]-[0006]) having a width at least 2 times wider than a thickness (¶[0105]). Tools for delivering substances and/or implants to an eye would be reasonably pertinent to one solving the problem addressed by Applicant.
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 the spatula of Hickingbotham et al. with the width to thickness ratio as taught by Nishida et al. as a suitable width to thickness ratio disclosed for a very similar spatula with a reasonable expectation of success when applied to Hickingbotham et al.
Regarding claim 9, the dissection spatula is curved in a plane parallel to the longitudinal direction and a vertical direction that is perpendicular to the longitudinal direction and the transverse direction (Figure 9).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hickingbotham et al. (US 2013/0178822) in view of Pollack et al. (US 2022/0346876).
Regarding claim 4, Hickingbotham et al. fail to disclose that the dissection spatula comprises nitinol.
Pollack et al. teach that nitinol is a suitable material for constructing a similar spatula (2106; ¶[0309]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Pollack et al. to have made the spatula of Hickingbotham et al. from nitinol 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. In re Leshin, 125 USPQ 416.
Claims 1, 3 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Van Heugten et al. (US 6,551,326) in view of Dishler et al. (US 2012/0046680).
Regarding claim 1, Van Heugten et al. disclose an ophthalmic surgical instrument comprising: a handpiece (11); an actuator (16) mounted on the handpiece; an outer tube (12) having a proximal end mounted to the handpiece; a dissection spatula (20/14; Figure 2C; it has a flat upper surface capable of supporting an object in the manner of a spatula) extendable outwardly relative to a distal end of the outer tube responsive to movement of the actuator (evident from Figures 3A-3E; col. 5, lines 58-60).
Van Heugten et al. fail to disclose that the dissection spatula defines a channel connected to an opening at a distal edge of the dissection spatula and configured to delaminate a portion of a retinal membrane; and a dispensing system in fluid communication with the channel.
Dishler et al. disclose an ophthalmic cutting instrument (ophthalmic cutting instruments of the above references being reasonably pertinent to Applicant’s problem of removing eye tissue) having a channel (166) extending to a an opening (168) at a distal edge (Figure 12) and a dispensing system in fluid communication with the channel (¶[0071]) in order to lubricate an incision during insertion into an eye to prevent unwanted damage to the eye (¶[0071]).
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 the channel of Dishler et al. leading to an opening at a distal edge of the Van Heugten et al. spatula and in communication with a dispensing system as claimed in order to lubricate the incision as it is being inserted into an eye to prevent unwanted damage to the eye. The above dispensing system would be capable of delaminating a retinal membrane as claimed since Applicant has not disclosed any particular fluid pressure required for the delamination. It is asserted that a syringe could apply sufficient fluid pressure - ¶[0071] of Dishler et al.)
Regarding claim 3, the dissection spatula is wider than an inner diameter of the outer tube (evident from Figure 2C of Van Heugten et al.).
Regarding claim 16, Van Heugten et al. fail to disclose that the dissection spatula is formed monolithically. However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the spatula monolithically since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893). Furthermore, Applicant has not disclose any advantage for or particular reason why the spatula should be monolithic such that it appears to be a matter of routine design choice to for it as so.
Regarding claim 17, the dissection spatula tapers distally (at “20” in figure 2C of Van Heugten et al.) towards the distal edge.
Regarding claim 18, the channel extends along a central portion of the dissection spatula (it must extend to the distal edge of 14 of Van Heugten et al. and therefore would need to extend along a central portion as claimed).
Regarding claim 19, the dissection spatula comprises one or more teeth (14 of Van Heugten et al.) formed on the distal edge of the dissection spatula (the distal edge of 20 being the claimed distal edge in this interpretation and the opening in which 14 resides being the claimed opening), the one or more teeth configured to form an opening in the retinal membrane (the tooth is capable of cutting eye tissue - col. 4, lines 52-57 of Van Heugten et al., and would be capable of creating an opening as claimed).
Regarding claim 20, the one or more teeth extend from an upper surface of the dissection spatula (part of 14 extends above the upper surface of 20 - Figure 2C of Van Heugten et al.) and are angled such that outward-facing surfaces of the one or more teeth define an angle (see angled edges in Figure 4 of Van Heugten et al.) with respect to the upper surface of the dissection spatula. Van Heugten et al. and are angled such that outward-facing surfaces of the one or more teeth define an angle of between 20 degrees and 40 degrees with respect to the upper surface of the dissection spatula. However, Van Heugten et al. disclose that the above angled edges are formed so that the tooth can engage eye tissue at an angle rather than parallel (col. 5, lines 14-20). Thus, these angles are considered to be a result-effective variable, in that adjusting these angles will allow a user to select the appropriate non-parallel cutting angle. Therefore, it would have been obvious to one having ordinary skill in
the art before the effective filing date of the claimed invention to modify one or more of the above angles to be within the claimed range 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, 1t 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).
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are not persuasive. Applicant has argued that the current amendment presents limitations similar to what was agreed to as overcoming Hickingbotham et al. However, the current amendment does not appear to convey that the distal edge causes the delamination, but rather the channel connected to the opening does. The new limitations in claim 1 do not appear to be referring to a sharpness of the distal edge as evident from their grammatical structure and in view of ¶[0027] and [0028] of the published application. Since Hickingbotham et al. disclose that the above channel conveys fluid from a syringe, and Applicant has not disclosed any specific fluid pressure required for the delamination, it is respectfully asserted that at least claim 1 still remains anticipated by Hickingbotham et al. For the purpose of encouraging additional amendments to advance prosecution, an additional grounds of rejection has been presented above which definitely discloses a distal edge sharp enough to perform some amount of delamination as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
Prosecution Insights