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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/13/2026 has been entered.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 4/13/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant's arguments, see pages 1-3, alleging that the embodiment of Fig. 3 of Sobel generally operates in an up-and-down motion have been fully considered but they are not persuasive. First, the embodiment of Fig. 3 was not used in the pending rejections, therefore Applicant’s arguments regarding that embodiment are moot and off-point. Second, Applicant admits (see page 2) that in the embodiments of Sobel “the saw strip may be rotated” thereby reading on the claim language at issue. Claim 11 only requires “said single tip being configured to act in the direction of rotation” and, as both admitted by Applicant and expressly disclosed in Sobel ([0024]; [0045]), the single distal tip is fully capable of being rotated and/or advanced to cut tissue into tissue at the single sharp distal tip (see annotated Fig. 4 below). For at least these reasons, Applicant’s arguments are not persuasive.
PNG
media_image1.png
347
481
media_image1.png
Greyscale
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitation(s) is/are: “gripper” in claims 1 and 8.
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 § 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 14-16 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 14 recites the limitations "said pair of forceps" and “said hook” in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 15 recites the limitations "said pair of forceps" and “said hook” in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 16 recites the limitations "said pair of forceps" and “said hook” in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claim(s) 11, 14 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sobel (US 2009/0048619).
Sobel discloses (see Figs. 4-5) a capsulorhexis instrument comprising the following claim limitations:
(claim 11) An instrument for opening a capsular bag in an eye (see Abstract; Fig. 1; [0010]), the instrument comprising a cannula (5, Fig. 4) configured to be (i.e., capable of) inserted into the eye in an insertion direction of the cannula (5) (as shown in exemplary Fig. 1; [0010]); said cannula (5) having a cannula longitudinal end (i.e., distal end adjacent cutter 11) arranged in said insertion direction (as expressly shown in Fig. 4); said cannula (5) further having a cannula opening (i.e., the cannula lumen shown containing inner cylinder 9 therein in Fig. 4) arranged in a cannula portion extending from said cannula longitudinal end (as expressly shown in Fig. 4); a rotor (9, Fig. 4) defining a rotational axis (i.e., rotational arrows shown at both the proximal and distal ends in Fig. 4) and being arranged within said cannula (5) so as to be rotatable about said rotational axis in a direction of rotation (as shown in Fig. 4; [0024]; [0045]; rotation both expressly depicted and expressly disclosed); said rotor (9) having a rotor longitudinal end (i.e., distal end at cutter 11) arranged in the direction of said rotational axis (as shown in Fig. 4); said rotor (9) defining a deployed state wherein said rotor (9) extends through said cannula opening so as to protrude from said cannula (5) and wherein said rotor longitudinal end is arranged outside of said cannula (5) (as expressly shown in Fig. 4); a gripper (11, Fig. 4) arranged outside of said cannula (5) in said deployed state and being configured to (i.e., capable of) grip a part of the capsular bag; said gripper (11) including a single tip (i.e., a single distal end tip, as expressly shown in annotated Fig. 4 below); said single tip being configured to act in the direction of rotation so as to introduce an initial opening into the capsular bag (as shown in Fig. 4; [0024]; [0045]; the single distal tip is fully capable of being rotated and advanced to cut tissue into tissue at the single sharp distal tip); and, said rotor (9) being configured to (i.e., capable of) wind up part of said capsular bag via rotation of said rotor (9) ([0024]; [0045]; as shown in Fig. 4, cutting projections 11 are fully capable of rotating and gripping/winding part of a capsular bag during rotation);
PNG
media_image1.png
347
481
media_image1.png
Greyscale
(claim 14) wherein said at least one of said single tip, said pair of forceps, and said hook is only said single tip (as expressly shown in annotated Fig. 4 above); and
(claim 18) An instrument for opening a capsular bag in an eye (see Abstract; Fig. 1; [0010]), the instrument comprising a cannula (5, Fig. 4) configured to be (i.e., capable of) inserted into the eye in an insertion direction of the cannula (5) (as shown in exemplary Fig. 1; [0010]); said cannula (5) having a cannula longitudinal end (i.e., distal end adjacent cutter 11) arranged in said insertion direction (as expressly shown in Fig. 4); said cannula (5) further having a cannula opening (i.e., the cannula lumen shown containing inner cylinder 9 therein in Fig. 4) arranged in a cannula portion extending from said cannula longitudinal end (as expressly shown in Fig. 4); a rotor (9, Fig. 4) defining a rotational axis (i.e., rotational arrows shown at both the proximal and distal ends in Fig. 4) and being arranged within said cannula (5) so as to be rotatable about said rotational axis in a direction of rotation (as shown in Fig. 4; [0024]; [0045]; rotation both expressly depicted and expressly disclosed); said rotor (9) having a rotor longitudinal end (i.e., distal end at cutter 11) arranged in the direction of said rotational axis (as shown in Fig. 4); said rotor (9) defining a deployed state wherein said rotor (9) extends through said cannula opening so as to protrude from said cannula (5) and wherein said rotor longitudinal end is arranged outside of said cannula (5) (as expressly shown in Fig. 4); a gripper (11, Fig. 4) arranged outside of said cannula (5) in said deployed state and being configured to (i.e., capable of) grip a part of the capsular bag; said gripper (11) including a hook (i.e., a hook at the distal end tip, as expressly shown in annotated Fig. 4 below); said hook being configured to act in the direction of rotation so as to introduce an initial opening into the capsular bag (as shown in Fig. 4; [0024]; [0045]; the hook at the distal tip is fully capable of being rotated and advanced to cut into tissue at the single sharp distal tip); and, said rotor (9) being configured to (i.e., capable of) wind up part of said capsular bag via rotation of said rotor (9) ([0024]; [0045]; as shown in Fig. 4, cutting projections 11 are fully capable of rotating and gripping/winding part of a capsular bag during rotation).
PNG
media_image2.png
347
602
media_image2.png
Greyscale
Claim(s) 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banko (US 4,368,734).
Banko discloses (see Figs. 1-2 and 10A-10B) a surgical instrument comprising the following claim limitations:
(claim 17) An instrument (10, Fig. 1) for opening a capsular bag in an eye (see Fig. 1; col. 1, lines 4-33; col. 2, lines 41-42 and 52-59), the instrument (10) comprising a cannula (18, Figs. 1-2 and 10A-10B) configured to be (i.e., capable of) inserted into the eye in an insertion direction of the cannula (18) (as expressly shown in Fig. 1); said cannula (18) having a cannula longitudinal end (i.e., distal end adjacent jaws 130/140 in Figs. 10A-10B) arranged in said insertion direction (as expressly shown in Figs. 1-2 and 10A-10B); said cannula (18) further having a cannula opening (i.e., the cannula lumen shown containing inner membe16 therein in Figs. 1-2 and 10A-10B) arranged in a cannula portion extending from said cannula longitudinal end (as expressly shown in Figs. 1-2 and 10A-10B); a rotor (16, Figs. 1-2 and 10A-10B) defining a rotational axis (col. 4, lines 34-40; col. 5, line 67-col. 6, line 24; rotation of rotor 16 expressly disclosed) and being arranged within said cannula (18) so as to be rotatable about said rotational axis in a direction of rotation (col. 4, lines 34-40; col. 5, line 67-col. 6, line 24; rotation of rotor 16 expressly disclosed); said rotor (16) having a rotor longitudinal end (i.e., distal end at jaws 130/140) arranged in the direction of said rotational axis (as shown in Figs. 10A-10B); said rotor (16) defining a deployed state wherein said rotor (16) extends through said cannula opening so as to protrude from said cannula (18) and wherein said rotor longitudinal end is arranged outside of said cannula (18) (as expressly shown in Figs. 10A-10B; rotor jaw 140 expressly depicted extending outside cannula 18); a gripper (130/140, Figs. 10A-10B) arranged outside of said cannula (8) in said deployed state and being configured to (i.e., capable of) grip a part of the capsular bag (see exemplary Fig. 1 and Figs. 10A-10B; col. 5, line 67-col. 6, line 24); said gripper (130/140) including a pair of forceps (as shown in Figs. 10A-10B; col. 6, lines 14-24; gripper 130/140 may expressly be used for gripping tissue and/or cutting tissue, as so desired); said pair of forceps (130/140) being configured to (i.e., capable of) act in the direction of rotation so as to introduce an initial opening into the capsular bag (as shown in exemplary Fig. 1 and Figs. 10A-10B; col. 5, line 67-col. 6, line 24; gripper 130/140 at the distal tip is fully capable of being rotated and advanced to cut into tissue); and, said rotor (16) being configured to (i.e., capable of) wind up part of said capsular bag via rotation of said rotor (16) (Figs. 10A-10B; col. 5, line 67-col. 6, line 24, rotor 16 fully capable of rotating and gripping/winding part of a capsular bag during rotation).
Claim Rejections - 35 USC § 103
Claim(s) 12-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sobel as applied to claim 11 above, and further in view of Kahook et al. (US 2015/0230981).
Sobel, as applied above, discloses a capsulorhexis instrument comprising all the limitations of the claim except for the gripper including a plurality of hooks (i.e., one or more hooks) arranged on said rotor forming a structured surface for a hook-and-loop fastening arrangement and/or gripper including only a pair of forceps.
However, Kahook teaches a similar eye tissue manipulation tool comprising a gripper including a plurality of hooks (246, Fig. 23H) (i.e., one or more hooks) arranged on said rotor forming a structured surface for a hook-and-loop fastening arrangement (as shown at 246 in Fig. 23H; [0105]-[0108]) and/or a gripper including only a pair of forceps (237, Figs. 23A-23G) ([0099]-[0103]). Accordingly, Kahook teaches that it is known that one or more hooks, a pair of forceps, and/or a single tip are elements that are functional equivalents for providing a surface specifically configured for facilitating the grasping of eye tissue and/or other structures during a surgical eye procedure. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the one or more hooks or a pair of forceps taught by Kahook for the single tip of Sobel because these elements were known equivalents for providing a surface specifically configured for facilitating the grasping of eye tissue and/or other structures during a surgical eye procedure within the ocular surgery arts. The substitution would have resulted in the predictable results of providing a surface specifically configured for facilitating the grasping of eye tissue and/or other structures during a surgical eye procedure to the device of Sobel.
Allowable Subject Matter
Claims 1, 3-7, 9-10 are allowed.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious an instrument for opening a capsular bag in an eye as claimed that includes, in combination with the claim(s) as a whole, including a rotor interior arranged within the rotor and/or the specific control over the position of the rotor. The closest prior art appears to be Sobel (US 2009/0048619) disclosing a similar capsulorhexis cutter, but failing to disclose a capsulorhexis device as claimed having a rotor interior arranged within the rotor and/or the specific control over the position of the rotor.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
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 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.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
Prosecution Insights