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 examiner acknowledges the reply filed on 05/26/2026 in which claims 1-10 were amended. Currently, claims 1-10 are pending for examination in this application.
Response to Arguments
Applicant's arguments, filed 05/26/2026, have been fully considered but they are not persuasive. Applicant’s representative asserts that the prior art of record does not disclose the invention as claimed.
The examiner has fully considered the applicant’s arguments but they are not persuasive. It is the examiner’s position that given a careful reading, the claims do not distinguish over the prior art of record.
With regards to the standing 35 U.S.C. 112(b) rejection of claim 5, applicant’s representative asserts the claimed terms “substantially” and “normal” do not render the claim indefinite. The examiner respectfully disagrees. Although applicant’s representative presents excerpts from the instant specification, the examiner disagrees that these excerpts provide any definitive “boundaries” for the limitations in the claim. Specifically, “substantially” does not define to what degree the elongated sleeve may or may not be “collapsed” while still meeting the limitations of the claim. Additionally, the term “normal” (a term only used once within the instant specification) simply does not define the boundaries of surgical use. Furthermore, applicant’s representative’s provided definition within the submitted Remarks are not a substitute for said boundaries. As such, the examiner finds applicant’s representative’s arguments unconvincing.
With regards to the standing 35 U.S.C. 103 art rejection under Strukel, in view of Hee, applicant’s representative asserts the prior art fails to meet the claimed limitations. The examiner respectfully disagrees. As an initial matter, the examiner would note that the basis for applicant’s representative’s argument (i.e. the material functionality of the “polyether block amide resin”) is not found within the independent claim language; it is merely stated as a material for the claimed “elongated sleeve” and “hub.” Additionally, applicant’s representative’s arguments relative to Strukel requiring “a built-in reinforcing member” are irrelevant to the standing rejection. This structural component taught by Strukel in no way “teaches away” from the use of the claimed “polyether block amide resin.” In fact, the examiner finds this “reinforcing member” as motivation as to why one of ordinary skill in the art would look to alternative materials to achieve the same result. It should be noted that the currently recited claim limitations do not prevent the “elongated sleeve” and “hub” from being formed from multiple materials. Strukel states “the sleeve could be reinforced with any number of different devices so long as the reinforcing member has a higher durometer (i.e., is harder) than the silicone” (column 5, lines 59-62). As such, the reinforcing materials taught by Strukel (Teflon, fiber glass, Kevlar, etc.) could simply be substituted with the claimed “polyether block amide resin.” Given this, the examiner finds applicant’s representative’s arguments unconvincing.
Additionally, applicant’s representative’s allegation that the prior art to Hee is “non-analogous art” is simply not true. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). As Hee is directed to an apparatus and method for ocular treatment, Hee and Strukel are clearly within the same field of endeavor. Finally, applicant’s representative appears to make the argument that the use of the material taught by Hee would render the device of Strukel “unsuitable for the vibrational and sealing demands of phacoemulsification surgery.” As Strukel and the instant application are both directed to phacoemulsification surgery, the examiner fails to understand the logic in this assertion. Again, the examiner finds applicant’s representative’s arguments unconvincing.
In light of the remarks and standing rejection above, the examiner asserts the prior art of record teaches all elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
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.
Claim 5 is 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 5] The claim recites the limitation of “wherein the elongated sleeve is not substantially collapsed by the eye incision during normal surgical use.” The terms “substantially” and “normal” are relative terms which renders the claim indefinite. The terms “substantially” and “normal” are 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. As such, the degree of “collapse,” as well as the type of acceptable “use,” are rendered indefinite.
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.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 9, and 10, are rejected under 35 U.S.C. 103 as being unpatentable over Strukel et al. (USPN 5,741,226), in view of Hee et al. (PGPub 2010/0173866).
[Claims 1-3 and 6] Strukel teaches an ophthalmic surgical irrigation assembly (figure 3c) for attachment to an ophthalmic surgical instrument (figure 4, item 11) (the examiner notes the “ophthalmic surgical instrument” is only functionally recited) (column 5, lines 45-48), the ophthalmic surgical irrigation assembly comprising:
an elongated sleeve (figure 3c, item 10) having a hollow interior space through which fluid is passed (figure 1a) and for surrounding a majority length of a cannula (figure 28, item 16) (the examiner notes the “cannula” is only functionally recited) attached to the ophthalmic surgical instrument (figure 4, item 11) (figure 28);
at least one fluid port (figure 3c, item 17) formed adjacent a distal end of the elongated sleeve (figure 3c, item 10) for allowing the fluid to exit the interior space (figures 3a-3f);
a distal opening (as shown in figure 28) formed in the elongated sleeve (figure 3c, item 10) for allowing a distal end portion of the cannula (figure 28, item 16) to extend beyond the distal opening (figure 28); and
a hub (proximal end of item 10; as best shown in figure 3c) integrally formed (molded as a single unit) with a proximal end of the elongated sleeve (figure 3c, item 10) and adapted for attachment to at least a portion of the ophthalmic surgical instrument (figure 4, item 11) (column 1, lines 25-26) for allowing fluid to flow from the ophthalmic surgical instrument (figure 4, item 11) through the interior space and exit out of the fluid port (figure 28).
Although disclosing the use of a soft, compressible material, such as silicone, Strukel does not specifically disclose that the elongated sleeve and the hub are each formed of a polyether block amide resin.
However, Hee teaches a sleeve (figure 1, item 1) and hub (figure 1, item 2) for use during an ocular treatment wherein the sleeve and hub are each formed of a polyether block amide resin (PEBAX) (paragraphs [0031], [0032]) having a durometer of 90 Shore A or less (paragraph [0048]).
It would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have modified the structure taught by Strukel, by utilizing a similar material such as a polyether block amide resin, as taught by Hee, 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 4 and 5] Strukel and Hee teach the limitations of claim 1, upon which claims 4 and 5 depend. In addition, Strukel discloses the elongated sleeve (figure 3c, item 10) is compressible by an eye incision (figure 2a, item 14) after insertion through the eye incision (figure 2a, item 14) for forming a fluid seal between the elongated sleeve (figure 3c, item 10) and the eye incision (figure 2a, item 14) to reduce fluid leakage at the eye incision (figure 2a, item 14) (figure 2a; column 5, lines 65-67; column 6, lines 1-2); wherein the elongated sleeve (figure 3c, item 10) is not substantially collapsed by the eye incision (figure 2a, item 14) during normal surgical use (figure 2a), thus allowing a continuous flow of fluid out of the fluid port (figure 2a; column 6, lines 2-9).
[Claims 9 and 10] Strukel and Hee teach the limitations of claim 1, upon which claims 9 and 10 depend. As noted above, the “ophthalmic surgical instrument” is only functionally recited and thus is not a positively recited claim limitation. As such, the irrigation assembly taught by Strukel is functionally capable of being utilized with a phacoemulsification instrument or an irrigation/aspiration instrument (figures 4 and 28; column 7, lines 57-59).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Strukel et al. (USPN 5,741,226), in view of Hee et al. (PGPub 2010/0173866), in further view of Ramanathan et al. (PGPub 2023/0201531).
[Claims 7 and 8] Strukel and Hee teach the limitations of claim 1, upon which claims 7 and 8 depend. Strukel and Hee do not specifically disclose the polyether block amide resin is PEBAX® 4033 SA 01 Med and that the sleeve has a flexural modulus of at least about 10,000 pounds per square inch.
However, Ramanathan teaches a tubular access member (figure 2a, item 213) (sleeve) which is formed from PEBAX® 4033 SA 01 Med (“Available grades of PEBAX range from soft to stiff, PEBAX 2533 to 7433”) having a flexural modulus of at least about 10,000 pounds per square inch (figure 2a; paragraphs [0086], [0087]).
It would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have modified the structure taught by Strukel and Hee, by utilizing a similar material such as PEBAX® 4033 SA 01 Med with the claimed flexural modulus, as taught by Ramanathan, 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.
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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 07/31/2026
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