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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/7/2025, 6/30/2025 and 4/2/2026 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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: “one or more receiving features” and “one or more protruding features” in claim 6.
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 § 102
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 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.
Claim(s) 1, 8-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kahook et al. (US 2021/0121326).
Kahook discloses (see Figs. 1B-1E) an ocular material extraction system comprising the following claim limitations:
(claim 1) An ophthalmic surgical instrument (100) for peeling a retinal membrane (as shown in Figs. 1B-1E; [0101]-[0104]; two roughened/texturized wires 130/140 can be moved relative to each other to grasp tissue therebetween, as desired), comprising: a handle (see exemplary handle 500 of Figs. 5A-5B); an actuator (530/540, Fig. 5A) mounted to the handle (500) (as shown in Fig. 5A); a first loop (130) extending outwardly from the handle (as shown in Figs. 1B-1E), the first loop (130) comprising: a first plurality of protruding features extending from a surface of the first loop (130) and configured to (i.e., capable of) grip an internal limiting membrane (ILM) flap in an eye ([0101]; both wires 130/140 expressly texturized or including other grasp-enhancing feature); and a second loop (140) extending outwardly from the handle and positioned within the first loop (130) and configured to (i.e., capable of) grasp the ILM flap (as shown in Figs. 1B-1E; [0102]; [0104] as shown in Figs. 1B-1C, second wire loop 140 can be distally actuated to grasp tissue against the first wire loop 130 at point 132; and as shown in Figs. 1D-1E, first and second wire loops 130/140 can be rotated relative to each other to grasp tissue captured/pinched between the rotated wires), wherein the actuator (530/540) is configured to (i.e., capable of) move the second loop (140) to engage the first loop (140) to grasp the ILM flap (as expressly shown in Figs. 1B-1C and in Figs. 1D-1E, as set forth above);
(claim 8) further comprising: a first half rod (532, Fig. 5B) connected to the first loop (130); and a second half rod (542, Fig. 5B) connected to the second loop (140), wherein the second half rod (542) is slidably disposed against the first half rod (532) (as shown in Fig. 5B; [0122]; slidable actuation including extension and retraction of the respective loop interface connections expressly disclosed);
(claim 9) wherein the first plurality of protruding features protrude transversely from a rounded end portion (at 132) of the first loop (130) ([0101]; the outer surface of wires 130/140 expressly may be textured and/or include other features for enhancing the gripping and grasping of desired ocular tissue);
(claim 10) wherein the first loop (130) comprises a pair of sides (i.e., top and bottom sides of loop 130); and a rounded end portion (i.e., rounded side wall at 132 connecting the top and bottom sides of loop 130) connecting the pair of sides, wherein the first plurality of protruding features protrude from a first side of the rounded end portion, and a second plurality of protruding features protrude from a second side of the rounded end portion ([0101]; the outer surface of wires 130/140 expressly may be textured and/or include other features for enhancing the gripping and grasping of desired ocular tissue);
(claim 11) the second loop (140) further comprising: a second plurality of protruding features configured to (i.e., capable of) grip the ILM flap in the eye ([0101]; both wires 130/140 expressly texturized or including other grasp-enhancing feature);
(claim 12) wherein the actuator (530/540) is configured to (i.e., capable of) move the second loop (140) toward the first loop (140) responsive to movement of the actuator (530/540) in a first direction (as shown moving from Fig. 1B to Fig. 1C; [0122]; deployment/distal extension of the second loop 140 via distal movement of actuator 540 expressly disclosed);
(claim 13) wherein the actuator (530/540) is configured to (i.e., capable of) move the second loop (140) away from the first loop (130) responsive to movement of the actuator (530/540) in a second direction opposite the first direction (as shown moving from Fig. 1C to Fig. 1B; [0122]; proximal retraction of the second loop 140 via proximal movement of actuator 540 expressly disclosed); and
(claim 15) An ophthalmic surgical instrument (100) for peeling a retinal membrane, comprising: a handle (see exemplary handle 500 of Figs. 5A-5B); an actuator (530/540, Fig. 5A) mounted to the handle (500) (as shown in Fig. 5A); a first loop (130) extending outwardly from the handle (as shown in Figs. 1B-1E) and configured to (i.e., capable of) create an internal limiting membrane (ILM) flap in an eye (as shown in Figs. 1B-1E; [0101]-[0104]; two roughened/texturized wires 130/140 can be moved relative to each other to grasp tissue therebetween, as desired); and a second loop (140) extending outwardly from the handle and positioned within the first loop (130), the second loop (140) configured to (i.e., capable of) grasp the ILM flap as shown in Figs. 1B-1E; [0102]; [0104] as shown in Figs. 1B-1C, second wire loop 140 can be distally actuated to grasp tissue against the first wire loop 130 at point 132; and as shown in Figs. 1D-1E, first and second wire loops 130/140 can be rotated relative to each other to grasp tissue captured/pinched between the rotated wires, wherein the actuator (530/540) is configured to (i.e., capable of) move the second loop (140) to engage the first loop (130) to grasp the ILM flap (as expressly shown in Figs. 1B-1C and in Figs. 1D-1E, as set forth above); wherein the first loop (130) and the second loop (140) each comprise a rounded end portion (i.e., each wire shown having a rounded distal end at contact point 132 in Figs. 1C-1E) that defines an angle relative to a longitudinal-transverse plane of the handle (as shown between Figs. 1D-1E; [0104]; wires 130/140 expressly can be rotated relative to each other and move out of the longitudinal-transverse plane of the handle forming any desired angles therebetween).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 12-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-8 of co-pending Application No. 18/533,465 in view of Kahook et al. (US 2021/0121326).
This is a provisional nonstatutory double patenting rejection.
Present Invention
U.S. App. No. 18/533,465
1
2-8
12
3
13
3
15
2-8
Co-pending Application No. 18/533,465 claims all the limitations of the above-referenced claims except for the first loop having a first plurality of features extending from a surface of the first loop and configured to grip an internal limiting membrane (ILM) flap in an eye. However, Kahook teaches (see Figs. 1B-1E) a similar ocular tissue gripper (100) comprising a first loop (130) having a first plurality of features ([0101]; both wires 130/140 expressly texturized or including other grasp-enhancing feature) extending from a surface of the first loop (130) and configured to grip an internal limiting membrane (ILM) flap in an eye in order to beneficially allow a lens to be grasped and to grip the lens while it is being moved ([0101]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of co-pending Application No. 18/533,465to to have the first loop include a first plurality of features extending from a surface of the first loop and configured to grip an internal limiting membrane (ILM) flap in an eye in order to beneficially allow a lens to be grasped and to grip the lens while it is being moved, as taught by Kahook.
Allowable Subject Matter
Claim 14 is allowed.
Claims 2-7 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see Ianchulev et al. (US 2016/0346121).
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.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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