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 .
Claim Objections
Claim 13, lines 2-3 recite “the optical subelements within one optical element are in abutting contact (in the lens construction).” It would be clearer if this limitation is amended to read “the optical subelements within one optical element are in abutting contact with each other.”
Claim 16, line 2 “chape function” should be “shape function.”
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: “a mechanical construction configured to move at least two optical elements in the same direction along the optical axis” (emphasis added) in claim 8. Attention is directed to the specification of the present application. At page 3, lines 15-19, applicant discloses “In a preferred embodiment of the present invention the lens construction comprises two independent hinges to allow for the two independent directions of movement of the optical elements.”
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 1-16 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.
Referring to claim 1, lines 6-7 recite “wherein at least one, preferably each, optical element comprises at least two optical subelements” (emphasis added). The limitation of “preferably each” renders the scope of the claim unclear because it is unclear about one of the at least two optical elements (line 2) or each optical element of the at least two optical elements (line 2) comprises at least two optical subelements. For examination purpose the limitation of “wherein at least one, preferably each, optical element comprises at least two optical subelements” has been interpreted as “wherein each optical element comprises at least two optical subelements.”
Claims 2-16, which are dependent on claim 1, are rejected for the same reasons as claim 1 by virtue of dependency on claim 1.
Claim 14, line 3 recites “the lens construction comprises a combination of at least two independent sets of hinges, in particular two independent sets of hinges.” (emphasis added). The limitation of “in particular” is similar to the term “example”, thus it renders the scope of the claim unclear. It is unclear that the narrow limitation “two independent sets of hinges” is part of the claimed invention or not. For examination purpose the limitation of “the lens construction comprises a combination of at least two independent sets of hinges, in particular two independent sets of hinges.” has been interpreted as “the lens construction comprises a combination of at least two independent sets of hinges.”
Claim 16 recites “wherein at least one optical surface is shaped like a cubic chape function, in particular like a Hermitian shape function.” (emphasis added). The limitation of “shape like a cubic [c]hape function” and “in particular like a Hermitian shape function” renders the scope of the claim unclear. It is unclear that the narrow limitation “in particular like a Hermitian shape function” is part of the claimed invention or not. Furthermore “Hermitian shape function” also renders the scope of the claim unclear because the specification fails to define or disclose what is constituted a Hermitian function. For examination purpose claim 16 has been interpreted as “wherein at least one optical surface has a shape defined by a cubic function.”
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) 1-6, 9-14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simonov et al. (US 9,622,852, hereinafter “Simonov”).
Referring to claim 1, Simonov discloses an accommodating intraocular lens construction (Figs. 1-4A, Fig. 3 is reproduced and annotated below) comprising an optical axis with the lens comprising at least two optical elements with each element comprising two optical surfaces (Fig. 3 shows each optical element includes a spherical surface 15 and a cubic surface 17),
wherein the optical elements are mutually elastically coupled by at least one elastic haptic (“The lens and connecting element can also include supporting components such as haptics, for example flanges, hooks or loops, to facilitate positioning of the IOL in the eye, for example in the capsular bag, in the sulcus or in the iris of the eye, which haptic design can differ between different positioning and between different types of IOLs and AIOLs.” (col. 4, ln. 65 to col. 5, ln. 4)), and
wherein at least one, preferably each, optical element comprises at least two optical subelements (the spherical surface 15 constitutes one subelement and the cubic surface 17 constitute one subelement, thus, each optical element includes two subelements) wherein at least one optical subelement comprises an optical surface that is at least partially cubic function shaped or free-formed and wherein at least one other optical subelement comprises at least one optical surface that is at least partially spherical shaped (“FIG. 3, diagram of an AIOL, at rest, at low diopter power, in the capsular bag, (FIG. 3 in combination with FIG. 4; for 1-9 refer to FIG. 1-2), with the capsular bag, 10, the capsulorrhexis, 11, the iris, 12, the ciliary muscle, 13, the zonulae, 14, surfaces for focusing by axial movement, comprising a telescope arrangement including a positive spherical lens, 15, and a negative lens, 16, and surfaces for focusing by lateral movement, an arrangement of cubic surfaces, 17. The combination of the telescope arrangement and arrangement of cubic surfaces provide the combination of foci of the AIOL.” (col. 7, ln. 32-43)), and
wherein the elastic haptic is configured to provide, at compression of the lens construction in a lateral direction, said lateral direction being directed perpendicular to the optical axis, a combination of lateral movements in lateral direction and axial movements in axial direction of the optical elements of the optical elements, wherein the axial movements are directed along the optical axis (col. 7, ln. 31 to col. 8, ln. 4).
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Referring to claim 2, Simonov discloses the lens construction according to claim 1, comprising two optical elements (Fig. 3, which is reproduced and annotated above shows the AIOL includes an anterior optical element and a posterior optical element), wherein the two optical elements are positioned on opposite sides of the lens construction and are divided by an intra-lenticular space 5 between the optical elements (Figs. 3-4 and col. 7, ln. 31 to col. 8, ln. 4).
Referring to claim 3, Simonov discloses the lens construction according to claim 2, wherein the optical elements are configured to shift in lateral and opposite directions such that and both the optical elements move in the axial direction which mutual displacement increases the intra-lenticular space between the optical elements (Figs. 3-4, Fig. 3 is reproduced and annotated above, and col. 7, ln. 31 to col. 8, ln. 4).
Referring to claim 4, Simonov discloses the lens construction according to claim 1 wherein a combination of at least two at least partially cubic function shaped or free-formed shaped surfaces is configured to provide a lens of variable optical power of which the degree of optical power depends on the degree of mutually opposite movements of the optical elements in a lateral direction (Figs. 3-4, Fig. 3 is reproduced and annotated above, and col. 7, ln. 31 to col. 8, ln. 4).
Referring to claim 5, Simonov discloses the lens construction according to claim 1 wherein a combination of at least two at least partially spherical optically shaped surfaces is configured to provide a lens of variable optical power of which the degree of optical power depends on the degree of movements of the elements in an axial direction (Figs. 3-4, Fig. 3 is reproduced and annotated above, and col. 7, ln. 31 to col. 8, ln. 4).
Referring to claim 6, Simonov discloses the lens construction according to claim 4 wherein the axial movements of the optical elements are movements in opposite directions along the optical axis (Fig. 4 show space 5 between two optical elements is larger as compared to Fig. 3, thus, the optical elements are movements in opposite direction).
Referring to claim 9, Simonov discloses the lens construction according to claim 1 wherein at least one optical element comprises a spherical optical shape of a positive optical power (the annotated figure above shows anterior optical element includes a positive power, which is outward-curving or convex) and wherein at least one other optical element comprises a spherical optical shape of a negative optical power (the annotated figure above shows posterior optical element includes a negative power, which is inward-curving or concave), wherein the lens construction is adapted to move both elements in opposite directions along the optical axis (Figs. 3-4. “FIG. 3, diagram of an AIOL…comprising a telescope arrangement including a positive spherical lens, 15, and a negative lens, 16, and surfaces for focusing by lateral movement, an arrangement of cubic surfaces, 17. The combination of the telescope arrangement and arrangement of cubic surfaces provide the combination of foci of the AIOL.” (col. 7, ln. 32-43)).
Referring to claim 10, Simonov discloses the lens construction according to claim 1 wherein the optical elements also comprise at least two additional free-form optical surfaces 17 (Figs. 3-4) configured to provide a variable optical power of at least one additional aberration of which the degree of optical power depends on the degree of mutually opposite movements of the elements in a lateral direction (Fig. 4 shows the optical elements are moved in a direction perpendicular to the optical axis. Each optical element includes cubic optical surface (free-form optical surface)).
Referring to claim 11, Simonov discloses the lens construction according to claim 9 wherein the additional free-form surfaces are configured to provide variable correction of variable astigmatism (“The lens can, but not necessarily has to, include at least one additional surface for fixed correction of fixed aberrations other than fixed focus. Such additional surfaces can correct for, for example, a fixed astigmatism of the cornea of the eye, a standard correction provided by modern IOLs.” (col. 2, ln 24-27). Fig. 4 shows the optical elements are moved in a direction perpendicular to the optical axis. Each optical element includes cubic optical surface (free-form optical surface). At page 5, lines 1-5, applicant discloses the lateral movement of spherical surfaces and cubic surface (free-form surface) can provide variable correction of variable astigmatism and/or coma. The lateral movement of optical elements of Simonov accommodating lens would variable correction of variable astigmatism and/or coma).
Referring to claim 12, Simonov discloses the lens construction according to claim 9 wherein the additional free-form surfaces are configured to provide variable correction of variable coma Fig. 4 shows the optical elements are moved in a direction perpendicular to the optical axis. Each optical element includes cubic optical surface (free-form optical surface). At page 5, lines 1-5, applicant discloses the lateral movement of spherical surfaces and cubic surface (free-form surface) can provide variable correction of variable astigmatism and/or coma. The lateral movement of optical elements of Simonov accommodating lens would variable correction of variable astigmatism and/or coma).
Referring to claim 13, Simonov discloses the lens construction according to claim 1, wherein the optical subelements within one optical element are in abutting contact (in the lens construction) and are configured for providing a combination of lateral and axial movements of the optical elements and/or of the optical subelements (spherical surface 15 constitutes one subelement and cubic surface 17 constitute one subelement, thus, each optical element includes two subelements and subelement 17 of the posterior optical element is in abutting contact with subelement 15 of the posterior optical element).
Referring to claim 14, Simonov discloses the lens construction according to claim 1 wherein the lens construction comprises a combination of at least two independent sets of hinges, in particular two independent sets of hinges (Figs. 1-2 show two independent sets of hinges 3; col. 7, lines 15-26: “FIG. 1, diagram of a first embodiment of an AIOL, at rest, at low diopter power, (FIG. 1 in combination with FIG. 2), with an anterior optical element, 1, with at least one surface for focusing, a posterior optical element, 2, also with at least one surface for focusing, a swivable connecting component, 3, the variable angle of the connecting components versus the plane of the optical elements, 4, the variable distance between the optical elements, 5, the optical axis of the first element, 6, the optical axis of the second element, 7, with the lens at rest in overlap, and the direction of the driving force, 8, in this example, along the optical axis, in axial direction.” (emphasis added); col. 5, ln. 20-40).
Referring to claim 16, Simonov discloses the lens construction according to claim 1, wherein at least one optical surface is shaped like a cubic chape function, in particular like a Hermitian shape function (based on 112(b) rejection above claim 16 has been interpreted as “wherein at least one optical surface has a shape defined by a cubic function.” Figs. 3-4 show each optical element includes a cubic shape 17).
Claim Rejections - 35 USC § 103
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 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) 7-8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simonov in view of Silvestrini et al. (US 2014/0180403, hereinafter “Silvestrini”)
Referring to claims 7-8 and 15, Simonov discloses the lens construction includes at least two optical elements comprise a spherical optical shape of a positive optical power (the annotated figure above shows anterior optical element includes a positive power, which is outward-curving. “FIG. 3, diagram of an AIOL…comprising a telescope arrangement including a positive spherical lens, 15, and a negative lens, 16, and surfaces for focusing by lateral movement, an arrangement of cubic surfaces, 17. The combination of the telescope arrangement and arrangement of cubic surfaces provide the combination of foci of the AIOL.” (col. 7, ln. 32-43)) and hinges to allow the anterior optical element and posterior optical element to move along the optical axis and in lateral direction with respect to the optical axis (Figs. 1-4).
Referring again to 7-8 and 15, Simonov fails to disclose wherein the axial movements of the optical elements are in the same direction along the optical axis (claims 7 and 8) and wherein the at least two independent sets of hinges comprise one set of hinges adapted to provide lateral movement of the optical elements and one set of hinges adapted to provide axial movement of the optical elements (claim 15).
Referring still to 7-8 and 15, however, in the same field of endeavor, which is an accommodating intraocular lenses, Silvestrini discloses (FIG. 8 is reproduced below) the accommodating IOL includes a set of hinges 325 for anterior element 310 and a set of hinges 354 for the posterior element 356 (para. [0073]). Silvestrini discloses the hinges allow the posterior element 356 and anterior element 310 move in the same direction along the optical axis during the accommodation process. In view of Silvestrini’s teaching, it would have been obvious to one of ordinary kill in the art, before the effective filing date of the claimed invention, to have provided more independent set of hinges to the accommodating IOL of Simonov to allow the posterior optical element and anterior element move along the optical axis and lateral direction with respect to the optical axis during the accommodation process.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771