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 .
EXAMINER’S COMMENT
The examiner notes that the claim set filed 10/04/2023 contains two claims numbered as claim 8. For the purpose of this Office action, the second claim 8 will be henceforth be referred to as claim “8a.” Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the connection of the hub resulting in a “fluid tight attachment to at least a portion of the surgical instrument” (as recited in claim 1) must be shown or the feature(s) canceled from the claim(s). (The examiner notes the proximal end of the cannula in figure 2 appears to show a threaded engagement; however, this structure is not the “hub” as claimed.) No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-8, 8a (see comment above), and 9, 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] The claim recites the limitation of “the surgical instrument” in the 11th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “ophthalmic surgical instrument,” or if an additional structure is being introduced into the claim limitations. For the purposes of examination, it is interpreted that “the surgical instrument” refers to the previously recited “ophthalmic surgical instrument.”
[Claim 4] The claim recites the limitation of “wherein the elongated sleeve is compressible by an eye incision after insertion through the eye incision for forming a fluid seal to reduce fluid leakage at the eye incision.” The examiner is unable to determine the metes and bounds of the claim limitations, as the wording is unclear as to what defines an “eye incision.” Further, it is unclear if the limitation is intending to indicate that eye tissue is compressing the elongated sleeve to form “a fluid seal” between eye tissue and the sleeve, or if the “fluid seal” is meant to occur through an alternative structure/location. For purposes of examination, it is interpreted that any “compressible” elongate sleeve meets the functional requirements of the claim.
[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.
[Claims 8 and 8a] As indicated above, the claim set filed 10/04/2023 contains two claims numbered as claim 8. The examiner is unable to determine the metes and bounds of the claims, since it unclear if both claims were intended to be included in the claim set. For purposes of examination, both claims will be examined on the merits, wherein the second claim reciting “wherein the ophthalmic surgical instrument is a phacoemulsification instrument” will be referred to as claim “8a.”
[Claims 2-8, 8a, and 9] The claims are rejected based upon their dependency from independent claim 1.
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, 8a, and 9, 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) 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 fluid tight attachment to at least a portion of the surgical instrument (figure 4, item 11) (column 1, lines 25-26) for allowing fluid to flow from the 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 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 8a and 9] Strukel and Hee teach the limitations of claim 1, upon which claims 8a and 9 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
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 02/22/2026