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 .
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.
Response to Amendment
The amendment filed 0 has been entered. Claims 1-4 and 6-8, 11-21 and 23 remain pending. Claims 16-20 remain withdrawn from consideration. Claim 24 has been added.
Response to Arguments
Applicant's arguments filed 0 have been fully considered and are not persuasive.
Regarding the argument that the amended claim 1 is no longer anticipated by US 20210315687 A1 (hereafter –Brodie--), the Examiner respectfully disagrees. Since the entire device of Brodie is made of a flexible material (see paragraph [0027], the fixing arms at the “attachment point” would therefore be capable of making an angle in a posterior direction with the radial plane in which the ring-shaped body resides), the fixing arms would be capable of being offset in a posterior direction relative to a radial plane at the attachment point, just as the fixing arms of the Instant Application can (see paragraph [0048] of The Instant Application for context, as the fixing arms are placing anterior to the body, then displaced at an angle posterior to the body as they are flexible strand-like structures). Additionally the device of the Brodie is capable of forming an angle between each fixing arm and the radial plane in which the ring-shaped body resides, the angle being between 1 and 10 degrees, as paragraph [0027] denotes that the fixing arms are made of flexible material, and therefore are capable of being in a position where the angle is between 1 and 10 degrees. The prior art does not need to disclose this exact position, but only needs to be capable of being manipulated into this position. This similar to Applicant’s disclosure, as the Instant Application discloses the fixing arms are placed anterior to the body, then displaced at an angle posterior to the body (see paragraph [0048] of The Instant Application for context), illustrating that the posterior orientation of the arms is based on flexibility thereof. Applicant’s claim that even though the flexible material can be bent, it does not read on the claim, the Examiner disagrees. The prior art is not required to disclose functional, but merely have the capability of performing the recited function. An angle of 1 to 10 degrees is a small angle in comparison to the radial plane, and a flexible material is capable of bending to and angle of said size.
Regarding the argument that the amended claim 1 is no longer anticipated by US 20040148022 A1 (hereafter –Eggleston--), the Examiner respectfully disagrees. Since the entire device of Eggleston is made of a flexible material (see paragraph [0081], the fixing arms at the “attachment point” would therefore be capable of making an angle in a posterior direction with the radial plane in which the ring-shaped body resides), the fixing arms would be capable of being offset in a posterior direction relative to a radial plane at the attachment point, just as the fixing arms of the Instant Application can (see paragraph [0048] of The Instant Application for context, as the fixing arms are placing anterior to the body, then displaced at an angle posterior to the body as they are flexible strand-like structures). Additionally the device of the Eggleston is capable of forming an angle between each fixing arm and the radial plane in which the ring-shaped body resides, the angle being between 1 and 10 degrees, as paragraph [0081] denotes that the fixing arms are made of flexible material, and therefore are capable of being in a position where the angle is between 1 and 10 degrees. The prior art does not need to disclose this exact position, but only needs to be capable of being manipulated into this position. This similar to Applicant’s disclosure, as the Instant Application discloses the fixing arms are placed anterior to the body, then displaced at an angle posterior to the body (see paragraph [0048] of The Instant Application for context), illustrating that the posterior orientation of the arms is based on flexibility thereof. Applicant’s claim that even though the flexible material can be bent, it does not read on the claim, the Examiner disagrees. The prior art is not required to disclose functional, but merely have the capability of performing the recited function. An angle of 1 to 10 degrees is a small angle in comparison to the radial plane, and a flexible material is capable of bending to and angle of said size.
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 23 and 24 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.
The term “approximately” in claim 23 is a relative term which renders the claim indefinite. The term “approximately” is 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.
The term “substantially” in claim 24 is a relative term which renders the claim indefinite. The term “substantially” is 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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8, 11, 12, 14, 15, and 23-24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20210315687 A1 (hereafter –Brodie--).
Regarding Claim 1, Brodie discloses an intraocular optic capture device for repositioning an implanted intraocular lens in an eye (see annotated intraocular optic capture device in Figure 3 below, see also paragraph [0027] regarding allowing support and stabilization of intraocular lens, see also paragraph [0030] denoting that the device is intended to provide support and centration for the IOL), the device comprising: a ring-shaped body defining an opening configured to receive and hold at least a portion of the intraocular lens (see annotated body and opening in Figure 3 below, see annotated IOL in Figure 3 below in the opening of the body); one or more fixing arms extending outwardly in a direction relative to a center axis of the opening in the ring-shaped body (see annotated fixing arms extending from annotated body in Figure 3 below), wherein each of the fixing arms is flexible, has an elongated, strand-like shape, and is (see paragraph [0027] denoting the entire device is made of a flexible material, and therefore comprising of flexible “strands”) configured to fix into a sclera of the eye (see Abstract, see also paragraph [0027] denoting that the “haptics” or fixing arms of the device ensure a secure position of the IOL for proper placement); wherein at least two of each the one or more fixing arms are structurally discrete from each other (see annotated fixing arms in Figure 3 below); and wherein each of the one or more fixing arms attached to the ring-shaped body at an attachment point (see annotated attachment point in Figure 3 below), and wherein at the attachment point, each fixing arm is offset in a posterior direction relative to a radial plane the ring-shaped body such that, when the intraocular optic capture device is in a position of repose (since the entire device is made of a flexible material (see paragraph [0027], the fixing arms at the “attachment point” would therefore be capable of making an angle in a posterior direction with the radial plane in which the ring-shaped body resides), just as the fixing arms of the Instant Application can (see paragraph [0048] of The Instant Application for context, as the fixing arms are placing anterior to the body, then displaced at an angle posterior to the body as they are flexible strand-like structures), an angle is formed between each fixing arm and the radial plane in which the ring-shaped body resides, the angle being between 1 and 10 degrees (see paragraph [0027] denoting that the fixing arms are made of flexible material, and therefore are capable of being in a position where the angle is between 1 and 10 degrees).
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Regarding Claim 8, Brodie discloses the intraocular optic capture device of claim 1, wherein the one or more fixing arms are symmetrically arranged relative to a center of the opening (see annotated fixing arms in Figure 3 above, the arms symmetrically arranged around the center of the opening).
Regarding Claim 11, Brodie discloses the intraocular optic capture device of claim 1, wherein the one or more fixing arms include one or more strands (see fixing arms in Figure 3 above, in which each fixing arm is a “strand”). The term “strand” is being given its broadest reasonable interpretation, meaning “an elongated body resembling a rope“ (see Merriam Webster online definition 3).
Regarding Claim 12, Brodie discloses the intraocular optic capture device of claim 11, wherein the one or more strands of the fixing arms include curved hooked portions at distal ends of the one or more strands (see annotated hooked portions in Figure 3 above, in which the T-shape part on the end can be a “hook”, the “haptic ends” of the fixing arms being the “distal ends”).
Regarding Claim 14, Brodie discloses intraocular optic capture device of claim 1, wherein the body is made of a flexible material (see paragraph [0027]).
Regarding Claim 15, Brodie discloses the intraocular optic capture device of claim 1, wherein the body is made of acrylic (see paragraph [0027]).
Regarding Claim 23, Brodie discloses the intraocular optic capture device of claim 1, wherein the angle formed between each of the one or more fixing arms and the radial plane in which the ring-shaped body is approximately 5 degrees when the intraocular optic capture device is in the position of repose (see paragraph [0027] denoting that the fixing arms are made of flexible material, and therefore are capable of being in a position where the angle approximately 5 degrees).
Regarding Claim 24, Brodie discloses the intraocular optic capture device of claim 1, wherein each of the one or more fixing arms extends tangentially from the ring-shaped body along a substantially circular are exterior to the ring-shaped body (see annotated ring-shaped body and fixing arms in Figure 3 above, the fixing arms extending from the ring shaped body, which the outer edge of the ring shaped body forms a “circular arc” that the fixing arm extends from).
Claims 1-4, 6, 7, 11, 12, 14, and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20040148022 A1 (hereafter –Eggleston--).
Regarding Claim 1, Eggleston discloses an intraocular optic capture device for repositioning an implanted intraocular lens in an eye (see annotated intraocular optic capture device in Figure 12 below, see also paragraph [0082] regarding allowing capture and stabilization of a lens insert in the posterior or anterior chamber of the eye), the device comprising: a ring-shaped body defining an opening configured to receive and hold at least a portion of the intraocular lens (see annotated body and opening in Figure 12 below, see also paragraph [0082] denoting that the lens portion of IOL 114 is received into opening 108) and one or more fixing arms extending 180 degrees from the ring-shaped body (see annotated fixing arms 104, 106 extending from annotated body in Figure 12 below) wherein each of the one or more fixing arms extending outwardly in a direction relative to a center axis of the opening (see annotated opening and fixing arms in Figure 12 below) in the ring-shaped body, wherein each of the one or more fixing arms is flexible (see paragraph [0081] denoting the implant is made of a flexible material, and therefore comprising of flexible “strands”), has an elongated, strand-like shape (see annotated fixing arms in Figure 12 below), and is configured to fix the body to a sclera of the eye (see paragraph [0082] denoting that the fixing arms 104, 106 secure the positioning of the intraocular lens 114, see also paragraph [0004] denoting that an incision is typically made in the sclera) wherein at least two of the one or more fixing arms are structurally discrete from each other (see annotated fixing arms in Figure 12 below); and wherein each of the one or more fixing arms attached to the ring-shaped body at an attachment point (see annotated attachment point in Figure 12 below), and wherein at the attachment point, each fixing arm is offset in a posterior direction relative to a radial plane the ring-shaped body such that, when the intraocular optic capture device is in a position of repose (since the entire device is made of a flexible material (see paragraph [0081], the fixing arms at the “attachment point” would therefore be capable of making an angle in a posterior direction with the radial plane in which the ring-shaped body resides), just as the fixing arms of the Instant Application can (see paragraph [0048] of The Instant Application for context, as the fixing arms are placing anterior to the body, then displaced at an angle posterior to the body as they are flexible strand-like structures), an angle is formed between each fixing arm and the radial plane in which the ring-shaped body resides, the angle being between 1 and 10 degrees (see paragraph [0081] denoting that the fixing arms are made of flexible material, and therefore are capable of being in a position where the angle is between 1 and 10 degrees).
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Regarding Claim 2, Eggleston discloses the intraocular optic capture device of claim 1, wherein the opening is sized to be identical to a lens portion of the intraocular lens (see Figure 12 above in which the opening of device is identical to the lens portion 114 of an IOL, see also paragraph [0082]).
Regarding Claim 3, Brodie discloses the intraocular optic capture device of claim 1, wherein the opening is sized to be smaller than a size of a lens portion of the intraocular lens (see Figure 12 above in which the opening of device is threaded and tapered, being that some areas of the opening are “smaller” than some “areas” of the lens portion since the lens portion is also tapered, see also paragraph [0082]).
Regarding Claim 4, Eggleston discloses the intraocular optic capture device of claim 3, wherein the opening is configured to interference fit with a lens portion of the intraocular lens (see Figure 12 above in which the opening of device is identical to the lens portion 114 of an IOL, see also paragraph [0082]).
Regarding Claims 6 and 7, Eggleston discloses the intraocular optic capture device of claim 1, wherein each of the one or more fixing arms defines a suture opening configured to receive a suture for fixing the body to the sclera of the eye, the sclera being part of an eye wall (see suture opening 103 in Figure 12 above that would be capable of receiving a suture for fixing the body to the structure of the eye, which may be the sclera, being an “eye wall”). Examiner notes a suture is only recited as part of the intended use of the device and is not positively recited as part of the claimed invention. Therefore, the prior art is not required to explicitly disclose a suture or any particular part of the eye to which it is attached. (see paragraph [0081] denoting the implant can be inserted into the eye through an incision, the incision being made through an “eye wall”, the eye wall being the sclera of the eye).
Regarding Claim 11, Eggleston discloses the intraocular optic capture device of claim 1, wherein the one or more fixing arms include one or more strands (see annotated fixing arms in Figure 12 above, in which each fixing arm is a “strand”). The term “strand” is being given its broadest reasonable interpretation, meaning “an elongated body resembling a rope“ (see Merriam Webster online definition 3).
Regarding Claim 12, Eggleston discloses the intraocular optic capture device of claim 11, wherein the one or more strands of the fixing arms include curved hooked portions at distal ends of the one or more strands (see annotated fixing arms in Figure 12 above, in that since the strand defines a generally hooked shape, it has a “hooked portion”). The Examiner notes that the term “end” is being given it’s broadest reasonable interpretation, in being that the distal end is the start of the curve to the terminal end of the fixing arm that is not attached to the ring body. “End” can be any arbitrary portion of the fixing arm.
Regarding Claim 14, Eggleston discloses intraocular optic capture device of claim 1, wherein the body is made of a flexible material (see paragraph [0081]).
Regarding Claim 23, Eggleston discloses the intraocular optic capture device of claim 1, wherein the angle formed between each of the one or more fixing arms and the radial plane in which the ring-shaped body is approximately 5 degrees when the intraocular optic capture device is in the position of repose (see paragraph [0081] denoting that the fixing arms are made of flexible material, and therefore are capable of being in a position where the angle approximately 5 degrees).
Regarding Claim 24, Eggleston discloses the intraocular optic capture device of claim 1, wherein each of the one or more fixing arms extends tangentially from the ring-shaped body along a substantially circular arc exterior to the ring-shaped body (see annotated ring-shaped body and fixing arms in Figure 12 above, the fixing arms extending from the ring shaped body, which the outer edge of the ring shaped body forms a “circular arc” that the fixing arm extends from).
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.
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over US 20210315687 A1 (hereafter –Brodie--), in view of US 20040148022 A1 (hereafter –Eggleston--).
Regarding Claim 21, Brodie discloses the intraocular optic capture device of claim 1, wherein the intraocular optic capture device is configured to position the intraocular lens in a predetermined axis and prevent rotation of the intraocular lens (see paragraph [0030]).
Brodie fails to disclose the purpose of the IOL that is received into the device, and therefore fails to disclose wherein the intraocular lens is an astigmatic correction lens or a presbyopia correction lens.
Eggleston teaches wherein the intraocular lens is an astigmatic correction lens or a presbyopia correction lens (see paragraph [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted IOL of Brodie’s with the IOL taught by Eggleston with a reasonable expectation for yielding an IOL for the purpose of correcting astigmatisms or presbyopia for implantation into the eye as taught by Eggleston.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 20040148022 A1 (hereafter –Eggleston--), in further view of US 20170348095 A1 (hereafter –Wortz--).
Regarding Claim 13, Eggleston as modified discloses the intraocular optic capture device of claim 12. Eggleston fails to disclose wherein the one or more strands are made of polyvinylidene fluoride (PVDF) monofilament.
Wortz discloses an intraocular optic capture device for repositioning an implanted intraocular lens in an eye (see annotated intraocular optic capture device in Figure 36 below, see also paragraph [0352] denoting that the device 3600 supports the positioning of an IOL), the device comprising: a body defining an opening configured to receive and hold at least a portion of the intraocular lens (see annotated body and opening in Figure 36 below, see annotated IOL in Figure 3 below in the opening of the body, see also paragraph [0352] denoting that device 3600 has an opening can receive in a lens structure); and one or more fixing arms extending from the body (see annotated fixing arm extending from annotated body in Figure 36 below) and configured to fix the body to a structure of the eye (see paragraphs [0352] and [0353] denoting that the fixing arm 3603 in combination with the housing structure 3601 of the device help to position the IOL into the eye for implantation). Wortz teaches wherein the fixing arm (ring structure) is made of polyvinylidene fluoride (PVDF) monofilament (see paragraph [0013]).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the one or more strands of the fixing arm of Eggleston to be made of polyvinylidene fluoride (PVDF) monofilament, as taught by Wortz, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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