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 .
Detailed Action
This is in response to the amendment filed 10/17/2023.
Claim Interpretation - 35 USC § 112(f)
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.
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(s) 1, 3, 5, 6-14, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0180404 (Tran) in view of U.S. Patent Publication Number 2011/0251685 (Chu)
Regarding claims 1, 3, 5, 6 Tran discloses as shown in Figures 2A, 2B an accommodating intraocular lens (AIOL) comprising: a base lens (base lens 16, see paragraph [0023]) having— an accommodating lens (accommodating IOL 10, see paragraph [0027]); an optical axis passing through the accommodating lens; a haptic portion (haptic structure 18, see paragraph [0023]) positioned radially-outward from the accommodating lens with respect to the optical axis; a cavity (one of recesses 39, see paragraph [0025]) formed in the haptic portion and extending radially-outward with respect to the optical axis; and a removable lens (fluidic optical lens 13 and actuator 12, see paragraphs [0024], [0051]) configured to removably couple with the base lens, the removable lens having a lens portion (13); and a tab (33, see paragraph [0025]) extending radially-outward from the lens portion and configured to extend at least partially into the cavity when the removable lens is coupled to the base lens, wherein at least a portion of the tab is positioned posterior to the visual marker and at least partially hidden from view from an anterior-posterior perspective when the removable lens is coupled to the base lens.
Tran fails to disclose a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker.
Chu, from the same field of endeavor teaches a similar AIOL where a visual marker positioned anterior for the purpose of tracking the anterior of a portion of the AIOL, wherein the visual marker is opaque, wherein the visual marker is less transparent than at least a portion of the base lens surrounding the visual marker; wherein the visual marker comprises a darkened and/or colored silicone structure. See paragraphs [0054], [0075], [0090].
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 AIOL by including the visual marker taught Chu such that a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker in order to track the anterior of the cavity, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claims 7-10, the limitations are product by process.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).
In this case, it is the position of the Office that the visual marker is formed in a mold separate from the base lens, the visual marker is partially cured and then co-molded with the base lens during manufacture, the visual marker is adhered to the base lens during manufacture, the visual marker is overmolded to the base lens during manufacture do not imply any structure not already disclosed by Tran.
Regarding claim 11, Tran fails to disclose wherein the tab is coplanar with the lens portion of the removable lens.
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 AIOL disclosed by Tran by rearranging the location of the tab such that it was coplanar with the lens portion of the removable lens because it would only require a rearrangement of parts without changing how to the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Regarding claims 12, 13 Tran discloses as shown in Figures 2A, 2B method of assembling an accommodating intraocular lens (AIOL), the method comprising: providing a base lens (base lens 16, see paragraph [0023]), the base lens having an accommodating lens (accommodating IOL 10, see paragraph [0027]); an optical axis passing through the accommodating lens; a haptic portion (haptic structure 18, see paragraph [0023]) positioned radially-outward from the accommodating lens with respect to the optical axis; a cavity (one of recesses 39, see paragraph [0025]) formed in the haptic portion and extending radially-outward with respect to the optical axis; coupling a removable lens (fluidic optical lens 13 and actuator 12, see paragraphs [0024], [0051]) to the base lens by inserting a tab (33, see paragraph [0025]) of the removable lens into the cavity such that the tab is positioned; and aligning a lens portion of the removable lens with the optical axis, wherein the removable lens is coupled to the base lens after the base lens is implanted in an eye of a patient.
Tran fails to disclose a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker.
Chu, from the same field of endeavor teaches a similar AIOL where a visual marker positioned anterior for the purpose of tracking the anterior of a portion of the AIOL, wherein the visual marker is opaque, wherein the visual marker is less transparent than at least a portion of the base lens surrounding the visual marker; wherein the visual marker comprises a darkened and/or colored silicone structure, wherein the visual marker is less transparent than at least a portion of the base lens surrounding the visual marker, wherein the visual marker is opaque, adhering the visual marker to the base lens. See paragraphs [0054], [0075], [0090].
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 AIOL by including the visual marker taught Chu such that a visual marker positioned anterior to the cavity, wherein at least a portion of the tab is positioned posterior to the visual marker in order to track the anterior of the cavity, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Regarding claim 14, So modified Tran in view of Chu are considered to disclose wherein the visual marker hides a portion of the tab when observed from a position anterior to the visual marker. See Figures 2A, 2B of Tran and Figure 7A of Chu.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0180404 (Tran) in view of U.S. Patent Publication Number 2011/0251685 (Chu) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2019/0076295 (Bashir).
Regarding claim 2, Tran fails to disclose wherein the visual marker is a different color from at least a portion of base lens surrounding the visual marker.
Bashir, from the same field of endeavor teaches a similar AIOL as shown in Figure 3, where the visual marker is a different color from at least a portion of base lens surrounding the visual marker. See paragraph [0044].
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 AIOL disclosed by Tran by substituting the color of the visual marker or at least a portion of the base lens surrounding the visual marker such that they were different colors because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0180404 (Tran) in view of U.S. Patent Publication Number 2011/0251685 (Chu) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2011/0153014 (Zhang et al.)
Regarding claim 4, Tran fails to disclose wherein the visual marker is translucent.
Zhang et al., from the same field of endeavor teaches a similar AIOL as shown in Figure 3, wherein the visual marker is translucent. See paragraph [0042].
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 AIOL disclosed by Tran by substituting the color of the visual marker disclosed by Tran for the translucent color taught by Zhang because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 15, 16, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0180404 (Tran) in view of U.S. Patent Publication Number 2011/0251685 (Chu) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2008/0215008 (Nance al.)
Regarding claims 15, 16, Tran fails to disclose overmolding the visual marker to the base lens, wherein the visual marker is overmolded to the base lens, comprising co-molding the visual marker with the base lens.
Nance et al., from a related field of endeavor teaches a similar method were the method includes the step of attaching maker, where the method includes the step includes overmolding a visual marker. See paragraph [0084].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify method disclosed by Tran by substituting the method of attaching the marker disclosed by Tran for the method taught by Zhang such that it was overmolding the visual marker to the base lens, wherein the visual marker is overmolded to the base lens because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0180404 (Tran) in view of U.S. Patent Publication Number 2011/0251685 (Chu) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2007/0203562 (Malewicz et al.)
Regarding claim 20 Tran fails to disclose co-molding the visual marker with the base lens.
Malewicz et al., from a related field of endeavor teaches a similar method were the method includes the step of co-molding the visual marker with the base. See paragraph [0049].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify method disclosed by Tran by substituting the method of attaching the marker disclosed by Tran for the method taught by Zhang such that it was co-molding the visual marker with the base because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771