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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/14/2025 has been considered by the Examiner and made of record in the application file.
Election/Restrictions
Applicant’s election without traverse of claims 1-10, 14, and 29-39 in the reply filed on 02/17/2026 is acknowledged.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
Specification
The disclosure is objected to because of the following informalities:
In the title, examiner suggests “Ophthalmic Lens for Myopia Control”
The Brief Description of Drawings on page 9 does not include descriptions for Figs. 5-9.
Appropriate correction is required.
Claim Objections
Claims 9 and 38 are objected to because of the following informalities: examiner suggests "between . Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claims 4 and 33, the limitation “the variable toric power is defined by the equation: Toric Power = 0.0642(r)3 - 0.1063(r)2 - 0.018(r), where r is equal to the radius from lens center” is not enabled.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to: (A) The breadth of the claims; (B) The Nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure (see In re Wands, 858 F.2d 7331, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
In the instant case, the claims state that Toric Power = 0.0642(r)3 - 0.1063(r)2 - 0.018(r), and page 15 of the specification states that this equation is shown in Fig. 5. However, the calculated values from this formula do not match what is shown in Fig. 5 and it is unclear what the units of the radius and the toric power are meant to be when used with this equation. It is assumed that since the radius is always referred to in millimeters, and that is what is shown in Fig. 5, that r in this equation is in millimeters. The toric power as shown in Fig. 5 has units of diopters D, which as stated in page 2 of the specification, has units of inverse meters. Fig. 5 indicates that at a radius of approximately 4mm, the toric power is approximately -6D. If r = 4 is input into the equation, the result is approximately 2.3. If r = 0.004 is input into the equation, the result is approximately -0.00007. Neither of these values are -6. Without knowing the units of toric power, r, and each coefficient in the equation, one would not be able to make a contact lens with this power profile. Further, a plot of 0.0642(r)3 - 0.1063(r)2 - 0.018(r) is shown below.
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There is an obvious disparity between the output of the equation shown above, and the graph shown in Fig. 5 which supposedly shows the output of the equation. It is further impossible to know which region of this plot applies to the power profile of the contact lens without knowing the units of any variable or coefficient in the equation. Thus, the breadth of the limitations (Wands factor A) exceeds the nature of the invention (Wands factor B) beyond what one skilled in the art (Wands factor D) could predictably arrive at (Wands factor E). There is no disclosure, teaching, or suggestion in the specification to support this limitation (Wands factors F & G). Therefore, one of ordinary skill in the art would be unable to arrive at the claimed invention without undue experimentation (Wands factor H) using the instant application disclose, see MPEP 2164.01(a).
For the purposes of examination, the examiner will assume the equation Toric Power = 0.0642(r)3 - 0.1063(r)2 - 0.018(r) is the plot shown above, wherein the power increases radially.
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 4, 10, 33, and 39 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.
Regarding claims 4 and 33, the limitation “the variable toric power is defined by the equation: Toric Power = 0.0642(r)3 - 0.1063(r)2 - 0.018(r), where r is equal to the radius from lens center” raises clarity issues. It is unclear how this limitation should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the above claim limitations.
For similar reasons as stated in the 112(a) rejection above, it is unclear what the variable toric power profile is supposed to be. There is an obvious disparity between the output of the equation shown above and Fig. 5, which supposedly shows the output of the equation. Further, without knowing the units of toric power, r, and each coefficient as used in this equation, it is impossible to know what the metes and bounds of a power profile defined by this equation are.
For the purposes of examination, the examiner will assume the equation Toric Power = 0.0642(r)3 - 0.1063(r)2 - 0.018(r) is the plot shown above, wherein the power increases radially.
Regarding claims 10 and 39, the limitation “the lens has a myopia control efficacy that is greater than a comparable spherical, single vision lens of the same optical power without said variable toric power profile” raises clarity issues. It is unclear how this limitation should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the above claim limitations.
It has been held “when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear” Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008); see MPEP 2173.05(g).
For the purposes of examination, examiner assumes this limitation is inherent. The examiner respectfully suggests canceling the claims.
Applicant should clarify the claim limitations as appropriate. Care should be taken during revision of the description and of any statements of problem or advantage, not to add subject-matter which extends beyond the content of the application (specification) as originally filed.
If the language of a claim, considered as a whole in light of the specification and given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection of the claims under 35 U.S.C. 112, second paragraph, is appropriate. See MPEP 2173.05(a), MPEP 2143.03(I), and MPEP 2173.06.
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.
Claim(s) 1-3, 5-7, 10, 29-32, 34-36, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu et al. (US 20220179239 A1), hereinafter Chu.
Regarding independent claim 1, Chu discloses a contact lens (100; Fig. 1; ¶0021), comprising:
a lens center (11; Fig. 1; ¶0021), and a shape defined by a lens outer peripheral edge (outer edge of 100 shown in Fig. 1 at distance R);
an optic zone (10; Fig. 1; ¶0021) surrounding said lens center (11) (Fig. 1; ¶0021) and having an optic zone outer periphery (outer edge of 10 shown in Fig. 1 at distance r1), said optic zone (10) having an optical power selected to correct a myopic condition of a user of said lens (¶0024); and
wherein the lens (100) has a toric power at the lens center (11) that is less than a toric power at the optic zone outer periphery (outer edge of 10) (Fig. 3; ¶0031-¶0033), and has a variable toric power that increases radially across at least a portion of the lens (100) to at least the optic zone outer periphery (outer edge of 10) (Fig. 3; ¶0031-¶0033),
wherein the variable toric power has a predetermined power profile that induces positive field-of-view averaged blur anisotropy for said user at or in front of a retinal plane of said user (since the power profile is similar to that of the equation given in the instant application and with a similar radial change in magnitude of power as what is shown in Fig. 5 of the instant application, it must also have the same function of inducing positive field-of-view averaged blur anisotropy for said user at or in front of a retinal plane of said user, also see ¶0024 and ¶0027).
Regarding independent claim 29, Chu discloses a contact lens for slowing the progression of myopia in a wearer, comprising:
a single vision lens (100; Fig. 1; ¶0021) having a lens center (11; Fig. 1; ¶0021) and a shape defined by a lens outer peripheral edge (outer edge of 100 shown in Fig. 1 at distance R), an optic zone (10; Fig. 1; ¶0021) surrounding said lens center (11) (Fig. 1; ¶0021) within the lens outer peripheral edge (Fig. 1; ¶0021) and defined by an optic zone outer periphery (outer edge of 10 shown in Fig. 1 at distance r1), said optic zone (10) having a predetermined optical power selected to correct a myopic condition of said wearer (¶0024); and
a variable toric power profile applied to at least a portion of the optic zone (10) (Fig. 3; ¶0031-¶0033), the toric power profile configured to induce positive field-of-view averaged blur anisotropy for said wearer at or in front of a retinal plane of the wearer (since the power profile is similar to that of the equation given in the instant application and with a similar radial change in magnitude of power as what is shown in Fig. 5 of the instant application, it must also have the same function of inducing positive field-of-view averaged blur anisotropy for said wearer at or in front of a retinal plane of said wearer, also see ¶0024 and ¶0027).
Regarding claims 2 and 30, Chu discloses the contact lens according to claims 1 and 29, as set forth above. Chu further discloses the field-of-view averaged blur anisotropy is positive at the retinal plane across 0 to 40 degrees field of view (since the power profile is similar to that of the equation given in the instant application and with a similar radial change in magnitude of power as what is shown in Fig. 5 of the instant application, it must also have the same function of inducing positive field-of-view averaged blur anisotropy at the retinal plane across 0 to 40 degrees field of view, also see ¶0024 and ¶0027).
Regarding claim 31, Chu discloses the contact lens according to claim 29, as set forth above. Chu further discloses the toric power profile is a variable toric power profile that increases radially from said lens center (11) (Figs. 1, 3; ¶0031-¶0033).
Regarding claims 3 and 32, Chu discloses the contact lens according to claims 1 and 31, as set forth above. Chu further discloses the variable toric power continuously increases from lens center (11) to the optic zone outer periphery (outer edge of 10) (Figs. 1, 3; ¶0031-¶0033).
Regarding claims 5 and 34, Chu discloses the contact lens according to claims 1 and 31, as set forth above. Chu further discloses the lens (100) further comprises a lens center region (12; Fig. 1; ¶0026) centered around said lens center (11) within the optic zone (10) (Fig. 1; ¶0026), and having a lens center region (12) diameter (Fig. 1; ¶0026), wherein the lens (100) has zero toric power in the lens center region (12) (Fig. 3; ¶0031-¶0033) and the variable toric power extends from the lens center region (12) radially outward to the optic zone outer periphery (outer edge of 10) (Fig. 3; ¶0031-¶0033).
Regarding claims 6 and 35, Chu discloses the contact lens according to claims 5 and 34, as set forth above. Chu further discloses the lens center region (12) diameter is designed to match an average pupil diameter of a predetermined population (¶0004, ¶0026), as required by claim 6, and the lens center (12) diameter substantially matches an average pupil diameter of a predetermined population (¶0004, ¶0026), as required by claim 35.
Regarding claims 7 and 36, Chu discloses the contact lens according to claims 5 and 34, as set forth above. Chu further discloses the lens center region (12) diameter is between 3 and 5 mm (¶0026).
Regarding claims 10 and 39, Chu discloses the contact lens according to claims 1 and 31, as set forth above. Chu further discloses the lens has a myopia control efficacy that is greater than a comparable spherical, single vision lens of the same optical power without said variable toric power profile (inherent, see 112(b) rejection above).
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) 4 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 20220179239 A1).
Regarding claims 4 and 33, Chu discloses the contact lens according to claims 1 and 31, as set forth above. Chu does not explicitly disclose the variable toric power is defined by the equation: Toric Power = 0.0642(r)3 - 0.1063(r)2 - 0.018(r), where r is equal to the radius from lens center.
However, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955), see MPEP 2144.05. In this case Chu has all the claimed elements of a contact lens, fulfilling the general conditions of the claim. Further, the power profile shown in Fig. 3 of Chu is very similar to a plot of the equation Toric Power = 0.0642(r)3 - 0.1063(r)2 - 0.018(r). One would be motivated to have the toric power vary radially according to the above equation for the purpose of achieving a desired blurring in the peripheral region starting at the appropriate distances to control the development of myopia (¶0005). Examiner additionally notes that although Chu discloses an equation using an exponential, that curves can be fit using multiple different functions, and one could fit the curve shown in Fig. 3 of Chu using a Ar3+Br2+Cr function as well.
Therefore, it would have been obvious to an ordinarily skilled artisan before the effective filing date of the claimed invention for the toric power to be defined by the equation: Toric Power = 0.0642(r)3 - 0.1063(r)2 - 0.018(r), for the purpose of achieving a desired blurring in the peripheral region starting at the appropriate distances to control the development of myopia (¶0005).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 20220179239 A1) in view of Collins et al. (US 20100328604 A1), hereinafter Collins.
Regarding claim 14, Chu discloses the contact lens according to claim 1, as set forth above. Chu is silent regarding where the variable toric power profile, namely Chu does not disclose the variable toric power profile is on a front surface of the lens.
However, Collins teaches a similar contact lens for controlling myopia with a variable toric power profile (Fig. 6), and further discloses the variable toric power profile is on a front surface of the lens (¶0082). There are only a few possibilities as to where the power profile is applied – either on the front surface, the back surface, or both surfaces. It has been held that where there are only a finite number of predictable identifiable solutions, it would have been obvious to a person of ordinary skill in the art to try the known options within his or her technical grasp. KSR International Co. v Teleflex Inc., 82 USPQ2d 1385 (2007).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the variable toric power profile to be on a front surface of the lens since there are only three possible solutions and since it has been held that where there are only a finite number of predictable identifiable solutions, it would have been obvious to a person of ordinary skill in the art to try the known options within his or her technical grasp for the purpose of slowing or shopping myopia progression (¶0008 of Collins).
Claim(s) 8-9 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 20220179239 A1) in view of Lam et al. (US 20220404639 A1), hereinafter Lam.
Regarding claims 8 and 37, Chu discloses the contact lens according to claims 5 and 34, as set forth above. Chu does not disclose the variable toric power profile between the lens center region and the optic zone outer periphery is interrupted by at least one radial segment across which the toric power is zero.
However, Lam teaches a similar contact lens for controlling myopia with a variable power profile (Fig. 1; ¶0052), wherein the variable power profile between the lens center region and the optic zone outer periphery is interrupted by at least one radial segment (121; Fig. 1; ¶0052) across which the power is zero (Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chu to incorporate at least one radial segment interrupting the variable toric power profile across which the power is zero for the purpose of employing a stepwise increment of power in the defocusing zones to have an improved lens for slowing myopia progression (¶0011-¶0013).
Regarding claims 9 and 38, Chu discloses the contact lens according to claims 5 and 34, as set forth above. Chu does not disclose the variable toric power profile between lens center region and the optic zone outer periphery is interrupted by first and second radial segments across which the toric power is zero.
However, Lam teaches a similar contact lens for controlling myopia with a variable power profile (Fig. 1; ¶0052), wherein the variable power profile between the lens center region and the optic zone outer periphery is interrupted by first (121; Fig. 1; ¶0052) and second radial segments (122; Fig. 1; ¶0052) across which the power is zero (Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chu to incorporate first and second radial segments interrupting the variable toric power profile across which the power is zero for the purpose of employing a stepwise increment of power in the defocusing zones to have an improved lens for slowing myopia progression (¶0011-¶0013).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Curatolo et al. (US 20230221579 A1), Shimojo et al. (US 20210318556 A1), Brennan et al. (US 20180329229 A1), Griffin et al. (US 20170227788 A1), Brennan et al. (US 20160062144 A1), Wei et al. (US 20140211147 A1), Back et al. (US 20130201444 A1), Wooley et al. (US 20120327363 A1), Varnas (US 20110037944 A1), and Griffin (US 20050068494 A1) disclose similar ophthalmic lenses with radially variable power profiles. Brennan '229, Brennan '144, Back, and Wooley disclose the power becomes more negative as the radius increases.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATASHA NIGAM whose telephone number is (571)270-5423. The examiner can normally be reached Monday - Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at (571)272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATASHA NIGAM/Examiner, Art Unit 2872 March 12th, 2026
/George G. King/Primary Examiner, Art Unit 2872