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 Arguments
In response to applicant's argument that Shmukler fails to show certain amended features of the invention, (i.e., flexible haptics) the examiner disagrees. See new rejection below.
In response to applicant's argument that Shmukler fails to show certain amended features of the invention, (i.e., connection haptics) the examiner disagrees. See new rejection below.
In response to applicant's argument that Shmukler fails to show certain amended features of the invention, (i.e., a shaped ultrasonic field) the examiner agrees however the combination of prior art teaches the amended feature. See new rejection below.
In response to applicant's argument that Shmukler fails to show certain amended features of the invention, (i.e., a distinct primary ring and secondary device) the examiner disagrees. See rejection below. The annotated figure clearly shows distinct components. It is also noted that the feature upon which the applicant relies upon “distinct” and “two-component” are not recited in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Shmukler fails to show certain features of the invention, (i.e., a conventional lens) the examiner disagrees. See pg. 5, lines 14-17.
Applicant’s arguments with respect to the JP reference are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 45 is objected to because of the following informalities:
Claim 45 recites “said system” but should recite “said intraocular ring system”
Appropriate correction is required.
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:
“Secondary device” in claim 45
Dependent claims are likewise interpreted.
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.
The “Secondary device” is described as comprising flexible material, rigid material or a combination of materials, having a rectangular, oval, circular, elliptical, polygonal or combinational cross-section, and can be a partial ring;
Dependent claims are likewise interpreted.
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 45-55 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 45 recites “said movement of the intraocular lens” without proper antecedent basis.
Claim 46 recites “the group” without proper antecedent basis.
Dependent claims are likewise rejected
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.
Claim(s) 45-49 and 51-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shmukler (WO 2018229766 A1) in view of Goetz (US 20190282399 A1) and Vivien (“Ultrasonic Physics and Techniques”).
Regarding claim 45, Shmukler teaches an intraocular ring system comprising: a conventional intraocular lens comprising an optic (pg. 5, lines 14-17, see annotated fig 3b) and at least two haptics (see 4 haptic structures annotated fig 3b), at least one of the at least two haptics being flexible (pg. 9, lines 21-24, see haptics can be adapted according to patient needs, flexibility of a haptic is a common anatomical need), the at least two haptics configured for holding the optic in position relative to an eye (see annotated fig 3b, entire structure is responsible holding the optic in the correct position of the eye, including the haptics); and a support system for said intraocular lens comprising: a primary intraocular ring mountable to an eye (see annotated fig 3b, PIR structure is capable of being mounted to an eye); and a secondary device configured for connection with said intraocular lens (see annotated fig 3b, SD holds iol), said secondary device configured to be in mechanical communication with said primary intraocular ring and configured for movement relative to at least one of said primary intraocular ring and said intraocular lens (pg. 16, lines 1-3), said movement selected from a group consisting of rotatable, forward-movable, backward-movable, decentralizable, tiltable, angulatable and any combination thereof (pg. 15, lines 16-32); wherein said connection of the secondary device to said intraocular lens is via said at least two haptics (see annotated fig 3b, upper haptics connect the SD to the iol); wherein said intraocular lens has controllable and non-invasive movement relative to said primary intraocular ring while said system is implanted in the eye (pg. 16, lines 1-3), said movement of the intraocular lens selected from a group consisting of rotation, forward- backward movement, decentralization, tilt, angulation and any combination thereof (pg. 15, lines 16-32); and further wherein said movement relative to said primary intraocular ring is effectuated by a shaped ultrasonic field (pg. 6, lines 22-28, see movement is controlled via remote activation).
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Annotated figure 3b
Shmukler does not specifically teach wherein the remote source is an ultrasonic field. Goetz teaches an ophthalmic lens wherein a remote ultrasonic signals cause and actuator within a lens to perform functions within an eye (abstract, fig 2a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Shmukler by applying the teachings of ultrasonic actuators, as taught by Goetz, because it would be obvious to try choosing from a finite number of remote activation devices know in the art so solve a problem of actuator activation to obtain predictable results of controlling an actuator within an eye (MPEP 2143).
Shmukler in view of Goetz does not exactly state wherein the ultrasonic field is shaped however Vivien teaches about the physics of ultrasonic technology and describes that ultrasonic beams are shaped through various components to get desired effects and consequently create shaped fields
(see chapter 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Shmukler in view of Goetz by applying the teachings of ultrasonic shape, as taught by Vivien, in order to get a desired intensity and focus (see chapter 5).
Regarding claim 46, Shmukler further teaches wherein said at least two haptics are selected from the group consisting of a plate haptic, a loop haptic or any combination thereof (see annotated fig 3b).
Regarding claim 47, Shmukler further teaches wherein said PIR is configured to be supported by a member of a group consisting of a zonula of the eye, a capsular bag of the eye and any combination thereof (pg. 15, lines 14-15).
Regarding claim 48, Shmukler further teaches wherein at least one member of a group consisting of said primary intraocular ring and secondary device has a back, said back is selected from a group consisting of a solid back, a non-solid back and a partial back (see annotated fig 3b).
Regarding claim 49, Shmukler further teaches wherein a non-solidity of said back is selected from a group consisting of a perforation, a slot, a hole, a regularly shaped gap, an irregularly shaped gap, a mesh, and any combination thereof (see slot/hole/gap in annotated fig 3b).
Regarding claim 51, Shmukler further teaches wherein said SD has at least one IOL guide configured by means of size and shape to guide said haptic into a correct location (see inner wall of SD in annotated fig 3b).
Regarding claim 52, Shmukler further teaches wherein said secondary device comprises at least one of a mounting groove, a V groove, a U, an indentation and any combination thereof configured by means of size and shape to hold said intraocular lens (see annotated fig 3b, a groove is present and has a u shape).
Regarding claim 53, Shmukler further teaches wherein at least a portion of said at least two haptics is held snugly by said at least one of the mounting groove, V groove, U, indentation and any combination thereof (see annotated fig 3b, a groove is present and has a u shape and holds the top haptics).
Regarding claim 54, Shmukler further teaches wherein said SD is configured to move with respect to said PIR and wherein said movement is by means of a controlled movement of said SD with respect to said PIR (pg. 16, lines 1-3).
Regarding claim 55, Shmukler further teaches wherein said intraocular lens is removably attached to said secondary device (pg. 5, lines 14-14).
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shmukler (WO 2018229766 A1) in view of Goetz (US 20190282399 A1) and Vivien (“Ultrasonic Physics and Techniques”) and in further view of Brady (US 20130297018 A1).
Regarding claim 50, Shmukler is silent to the details of the primary intraocular ring or secondary device having backing (ring wall) transparency. Brady teaches and intraocular lens teaches wherein a ring comprises transparent material ([0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Shmukler in view of Goetz and Vivien by applying the teachings of a transparent ring component, as taught by Brady, because it would be obvious to try choosing from a finite number of backing materials know in the art so solve a problem of material compatibility to obtain predictable results of a patient safe iol device (MPEP 2143).
Claim(s) 52-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shmukler (WO 2018229766 A1) in view of Goetz (US 20190282399 A1) and Vivien (“Ultrasonic Physics and Techniques”) and I further view of Whitesett (US 8728158 B2).
Regarding claim 52, Shmukler teaches a mounting groove but doesn’t specifically state the groove details. Whitesett teaches and iol wherein said secondary device comprises at least one of a mounting groove, a V groove, a U, an indentation and any combination thereof configured by means of size and shape to hold said intraocular lens (fig 1, col 5, lines 37-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Shmukler in view of Goetz and Vivien by applying the detailed teachings of a mounting groove, as taught by Whitesett, in order to optimize seating of and IOL based on specific patient’s needs (col 4 lines 52- col 5 line 3).
Regarding claim 53, Shmukler teaches a mounting groove but doesn’t specifically state the groove details. Whitesett teaches and iol wherein at least a portion of said at least two haptics is held snugly by said at least one of the mounting groove, V groove, U, indentation and any combination thereof (fig 1, col 5, lines 37-38, fig 7b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Shmukler in view of Goetz and Vivien by applying the detailed teachings of a mounting groove, as taught by Whitesett, in order to optimize seating of and IOL based on specific patient’s needs (col 4 lines 52- col 5 line 3).
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 HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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, the examiner’s supervisor, Thomas Barrett can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799