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 .
The amendment filed 07/07/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/KR2021/000445 and of the *foreign* patent application PCT/KR2021/000445 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 01/13/2023, see MPEP 1893.03(b). Therefore, the specification amendment of 07/07/2023 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 1, the limitation “and a plurality of fixing parts extending outward from the frame in a diameter direction of the frame and having tips inserted and fixed into tunnels formed in a sclera of the eyeball”, is directed to a non-statutory subject matter. Specifically, the phrase “tunnels formed in a sclera of the eyeball” implies the sclera is part of the claimed invention. As stated in MPEP 2105(III), claims directed to or encompassing a human organism are excluded from patentability. For the purposes of examination, the limitation will be interpreted to mean "having tips to be configured inserted and fixed into tunnels into a sclera of an eyeball".
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 1-8 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 limitations: 1. “a plurality of support parts disposed to be spaced apart from one another in a circumferential direction of the frame and configured to support the artificial eye lens to prevent the artificial eye lens from separating from the support structure” and 2. “Each of the support parts extends from the frame and is configured to come into contact with a side surface of the artificial eye lens opposite to one side surface of the artificial eye lens“ invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Objections
Claim 3 objected to because of the following informalities/grammatical errors: "and wherein the artificial eye lens is supported as rims of two opposite surfaces of the lens of the artificial eye lens are in contact with the first and second portions of the support part ". Appropriate correction is required. Examiner recommends the following amendment: “and wherein the artificial eye lens is supported by two opposite surfaces of the lens of the artificial eye lens, wherein the artificial eye lens is in contact with the first and second portions of the support part”
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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahook et al. US 20200022840 A1, herein referred to as Kahook, in view of Reich et al. WO 2012106673 A1, herein referred to as Reich.
RE. claim 1, Kahook discloses: A support structure (Figure 40, device 30) for supporting an artificial eye lens (Fig 1, intraocular lens 22 of device 20; [0049]; Kahook discloses combining intraocular devices disclosed intraocular devices as needed for improved support [0005] and [0106] also refer to Figs 17 and 27 for combined configurations) in an eyeball [0004], the artificial eye lens being implanted into the eyeball so as to be substituted for an eye lens [0109], the support structure comprising: a frame (Fig 41, Scaffold 34) extending in an arc shape concentric (Figure 41, stabilizing feature 48) with a lens of the artificial eye lens (Figure 1, 22), having an opening portion (Annotated Figure 41 below, scaffold 34 and the space between stabilizing feature 48) therein, disposed adjacent to a rim (Fig 41, intracapsular scaffold 34) of the lens of the artificial eye lens or disposed to support a rim (Figure 41) of one side surface of the lens (Fig 27); a plurality of support parts (Fig 41, support feature 46, [0104]) disposed to be spaced apart from one another in a circumferential direction of the frame (Fig 41) and configured to support the artificial eye lens to prevent the artificial eye lens from separating from the support structure (Fig 27, [0087]); and a plurality of fixing parts (Fig 42, 28) extending outward from the frame in a diameter direction of the frame and having tips inserted and fixed into tunnels formed in a sclera of the eyeball ([105] lines 5-7 and [0048], support in sclera), wherein the artificial eye lens comprises the lens (Fig 1, intraocular lens 22; [0049]),
But Kahook fails to discloses a plurality of haptic parts extending outward from the lens in a diameter direction of the lens and configured to come into contact with a capsular sac, and wherein the artificial eye lens is disposed on the frame so that the haptic parts each protrude between the support parts.
But Reich discloses a similar intraocular device (Abstract). Reich teaches and a plurality of haptic parts (Reich Fig 4, haptics 115) extending outward from the lens in a diameter direction of the lens (Reich Fig 4, lens 100) and configured to come into contact with a capsular sac (Reich [0033], capable of contacting capsular sac), and wherein the artificial eye lens is disposed on the frame (Kahook Fig 41, Scaffold 34)) so that the haptic parts each protrude between the support parts (Fig 4, force translation element 110).
Therefore, it would have been obvious for one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the ocular device of Kahook to incorporate a plurality of haptic parts extending outward from the lens in a diameter direction of the lens and configured to come into contact with a capsular sac, and wherein the artificial eye lens is disposed on the frame so that the haptic parts each protrude between the support parts as taught and suggested by Reich in order to provide support to the sulcus (Kahook [0104]).
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RE. Claim 2, the combination of Kahook and Reich discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the support parts each comprise: a first portion (Kahook Figure 41, stabilizing feature 48) extending from the frame (Kahook Fig 41, scaffold 34) and being in contact with one side surface of the lens of the artificial eye lens that faces one surface of the frame (Capable of being in contact with lens depending on orientation of modular devices see Kahook Fig 21; ¶0081); and a second portion (Annotated Fig 41, element can be divided into first and second portion as shown in applicant’s drawing, see Kahook Fig 2) extending from a tip of the first portion and being in contact with a side surface of the lens opposite to one side surface of the lens, and wherein the artificial eye lens is supported as rims of two opposite surfaces (Kahook Fig 27, size of lens would allow contact with lens; [0053]) of the lens of the artificial eye lens are in contact with the first and second portions of the support part (Fig 27).
RE. Claim 3, the combination of Kahook and Reich discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the support parts each comprise: a first portion (Kahook Annotated Fig 41 above)extending from the frame and being in contact with one side surface of the lens of the artificial eye lens that faces one surface of the frame (Kahook Fig 41, scaffold 34); and a second portion (Kahook Annotated Fig 41 above)extending from the frame and being in contact with a side surface of the lens opposite to one side surface of the lens (Kahook Capable of being in contact with lens depending on orientation of modular devices see Fig 21; ¶0081), and wherein the artificial eye lens is supported as rims of two opposite surfaces of the lens of the artificial eye lens are in contact with the first and second portions of the support part (Fig 27).
RE. Claim 4, the combination of Kahook and Reich discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein a circumference of one side surface of the artificial eye lens is in contact with one surface of the frame (Kahook Fig 41, scaffold 34), and each of the support parts extends from the frame and is configured (Kahook Figure 41, stabilizing feature 48; this element is being interpreted under 112(f) as “elongate[s]” or “protru[sions]”, see pages 1 and 4 of the instant application, and equivalents thereof) to come into contact with a side surface of the artificial eye lens opposite to one side surface of the artificial eye lens (Capable of being in contact with lens depending on orientation of modular devices see Kahook Fig 21; ¶0081), such that the artificial eye lens is supported as rims of two opposite surfaces of the lens are in contact with one surface of the frame and the support parts (Fig 27).
RE. Claim 5, Kahook discloses: a support structure (Figure 40, device 30) for supporting an artificial eye lens (Fig 1, intraocular lens 22 of device 20; [0049]; Kahook discloses combining intraocular devices disclosed intraocular devices as needed for improved support [0005] and [0106] also refer to Figs 17 and 27 for combined configurations) in an eyeball [0004], the artificial eye lens being implanted into the eyeball so as to be substituted for an eye lens [0109], the support structure comprising: a frame (Fig 41, Scaffold 34) extending in an arc shape concentric (Figure 41, stabilizing feature 48) with a lens of the artificial eye lens, having an opening portion therein (Annotated Figure 41 below, scaffold 34 and the space between stabilizing feature 48), disposed adjacent to a rim (Fig 41, intracapsular scaffold 34) of the lens of the artificial eye lens or disposed to support a rim of one side surface of the lens (Fig 41); a plurality of support parts (Fig 41, support feature 46 [0104]) disposed to be spaced apart from one another in a circumferential direction of the frame (Fig 41) and configured to support the artificial eye lens to prevent the artificial eye lens from separating from the support structure [0104]; and a plurality of fixing parts (Fig 42, 28) extending outward from the frame in a diameter direction of the frame and having tips inserted and fixed into tunnels formed in a sclera of the eyeball ([105] lines 5-7 and [0048], support in sclera), wherein the artificial eye lens comprises the lens (Fig 1, intraocular lens 22; [0049]),
Kahook fails to disclose a plurality of haptic parts extending outward from the lens in a diameter direction of the lens and configured to come into contact with a capsular sac, wherein the support parts are each formed in a ring shape fixed to the frame, and wherein the artificial eye lens is supported as the haptic parts of the artificial eye lens are inserted into the rings.
But Reich discloses a similar intraocular device (Abstract). Reich teaches a plurality of haptic parts (Reich Fig 4, haptics 115) extending outward from the lens in a diameter direction of the lens (Reich Fig 4, lens 100) and configured to come into contact with a capsular sac, wherein the support parts are each formed in a ring shape fixed to the frame (Reich [0033], capable of contacting capsular sac), and wherein the artificial eye lens is supported as the haptic parts of the artificial eye lens are inserted into the rings ([0104] Kahook teaches support Fig 41, support feature 46 can also be rings; haptics capable of functioning as claimed).
Therefore, it would have been obvious for one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify ocular device of Kahook to incorporate a plurality of haptic parts extending outward from the lens in a diameter direction of the lens and configured to come into contact with a capsular sac, wherein the support parts are each formed in a ring shape fixed to the frame, and wherein the artificial eye lens is supported as the haptic parts of the artificial eye lens are inserted into the rings, as suggested and taught by Reich in order to provide support to the sulcus (Kahook [0104]).
RE. Claim 6, the combination of Kahook and Reich discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the entire support structure is formed by injection molding using synthetic resin (Kahook [0093]), and wherein the fixing part (Kahook Fig 42, 28) has higher rigidity than the frame (Kahook [0076], teaches use different modulus for parts as needed).
RE. Claim 7, the combination of Kahook and Reich discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein a tip side of the fixing part (Kahook Fig 42, 28) has the same curvature as a sclera and is formed along a curved line concentric with the frame (capable of having the same curvature).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahook in view of Reich, and further in view of Wortz et al. (US 9358103 B1), herein referred to as Wortz.
RE. Claim 8, the combination of Kahook and Reich discloses the invention substantially as claimed and as discussed above with respect to claim 1, but fails to disclose wherein a thread and a needle are sequentially coupled to the tip of the fixing part.
But Wortz discloses a similar ocular implant device (prosthetic capsular device 7000). Wortz teaches wherein a thread (Fig 71D, suture 7162) and a needle (Fig 71D, arrow head structure 7163) are sequentially coupled to the tip of the fixing part (Fig 71D, coupling portion 7138, Col 87, lines 8-25).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the combination of Kahook and Reich to incorporate wherein a thread and a needle are sequentially coupled to the tip of the fixing part, as taught and suggested by Wortz in order to allow coupling of devices as needed (Wortz Col 86, lines 30-41)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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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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/A.F./ Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799