DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
2. Applicant’s arguments (see Remarks dated 05/09/2025) with respect to claims 1-22 have been fully considered, but they are not persuasive.
On pages 6-7, applicant alleges that Ho fails to disclose “wherein a series of points defining centres of curvature of the add power region form a segment of an annulus, the add power region thereby focuses light from distant point object to form a focused arc at the proximal focal surface.” Applicant also argues in support of a “toroidal add power region” which is not a claimed feature.
However, when at least one point is taken to represent a center of curvature of each of Ho’s nasal and temporal optic zones, the two points are considered to form a segment of an annulus along the surface of the lens, which is annularly shaped. Further, the add power region inherently focuses light from distant point objects to form a focused arc at the proximal focal surface, when the lens is directed toward an arc-shaped object or objects.
On page 10, the applicant alleges that Brennan “provides no teaching of add power variation around an annular treatment zone, and provides no teaching of an add power region that spans less than 75% of the annular region.”
However, Brennan’s Figs. 5A-B depict treatment zone 508, which is explicitly described as “having a power profile comprising an ADD power” (Brennan - Abstract). An “add power variation,” as argued by applicant, is not claimed. Further, the examiner has not argued that Brennan discloses an add power region that spans <75% of the area of the annular region. Instead, the examiner has relied on case law to suggest restricting the size of this region. The applicant should argue against the merits of this case law to overcome the rejection of record.
Claim Rejections - 35 USC § 103
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
4. Claims 1-2, 6, 9-13, 15-16, 18, and 20-22 are rejected under 35 USC 103 as being unpatentable over Ho et al. (WO 2012012826 A1).
Regarding claim 1, Ho discloses a contact lens (Fig. 8) for use in preventing or slowing the development or progression of myopia (Abstract), the lens including:
an optic zone having an optic axis (Fig. 8, 301); and
a peripheral zone surrounding the optic zone (Fig. 8, 302), the peripheral zone having a variation in thickness configured to control rotation of the lens (page 8 lines 23-28);
wherein the optic zone comprises:
a central region (Fig. 8, 303), the central region having a base power provided by at least one surface having a curvature (page 12 lines 27-28), the central region thereby focusing light from distant point objects to a distal focal surface (Fig. 8), said light forming a blur circle or ellipse as it passes through a proximal focal surface (page 9 lines 7-8); and
an annular region circumferentially surrounding the central region (Fig. 8, region surrounding 303) and including an add power region (Fig. 8, 304-305) having an add power provided by at least one surface having a curvature, the add power being 0.5 D or more (page 9 lines 15-23);
wherein a series of points defining centres of curvature of the add power region form a segment of an annulus (page 9 line 24; page 10 line 6), the add power region thereby focusing light from distant point objects to form a focused arc at the proximal focal surface (resulting from the power of the zones).
Ho fails to explicitly disclose wherein the area of the add power region is less than 75% of the area of the annular region.
However, it would have been an obvious matter of choice to modify Ho such that the area of the add power region was less than 75% of the area of the annular region, since such a modification would have involved a mere change in the size of the component. A change of size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). It would have been obvious to modify Ho in this way, motivated by accommodating the vision needs of a user.
Regarding claim 2, Ho fails to explicitly disclose wherein the area of the add power region is less than 25% of the area of the annular region.
However, it would have been an obvious matter of choice to modify Ho such that the area of the add power region was less than 25% of the area of the annular region, since such a modification would have involved a mere change in the size of the component. A change of size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). It would have been obvious to modify Ho in this way, motivated by accommodating the vision needs of a user.
Regarding claim 6, Ho discloses wherein annular region further comprises a lower add power region having a curvature providing an add power of between 0 D and 5.0 D (page 9 lines 15-23).
Regarding claim 9, Ho fails to disclose wherein the add power region is a continuous region having an area that is approximately 50% of the area of the annular region, and the area of the base power region is a continuous region having an area that is approximately 50% of the annular region.
However, it would have been an obvious matter of choice to modify Ho such that the add power region was a continuous region having an area that is approximately 50% of the area of the annular region, and the area of the base power region was a continuous region having an area that is approximately 50% of the annular region, since such a modification would have involved a mere change in the size of the component. A change of size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). It would have been obvious to modify Ho in this way, motivated by accommodating the vision needs of a user.
Regarding claim 10, Ho discloses wherein the add power region has an asymmetric power profile (page 11 line 24-27).
Regarding claim 11, Ho discloses wherein the lower add power region has an asymmetric power profile (page 11 line 24-27).
Regarding claim 12, Ho discloses wherein the annular region has a substantially circular outer circumference (Fig. 8).
Regarding claim 13, Ho discloses wherein the annular region has a substantially elliptical outer circumference (Fig. 8).
Regarding claim 15, Ho discloses wherein the central region is substantially circular in shape (Fig. 8) and has a diameter of between 2 and 7 mm (page 12 lines 17-19).
Regarding claim 16, Ho discloses wherein the annular region extends radially outwards from a perimeter of the central region by between 0.5 and 1.5 mm (page 10 lines 22-23).
Regarding claim 18, Ho discloses wherein the lens comprises an elastomer material, a silicone elastomer material, a hydrogel material, or a silicone hydrogel material (page 13 line 6), or mixtures thereof.
Regarding claim 20, Ho discloses a method of manufacturing a contact lens (Fig. 10, 1003), the method comprising:
forming a contact lens (Fig. 8), the lens including an optic zone (Fig. 8, 301) and a peripheral zone surrounding the optic zone (Fig. 8, 302), the peripheral zone having a variation in thickness configured to control rotation of the lens (page 8 lines 23-28), the optic zone comprising:
wherein the optic zone comprises:
a central region (Fig. 8, 303), the central region having a base power provided by at least one surface having a curvature (page 12 lines 27-28), the central region thereby focusing light from distant point objects to a distal focal surface (Fig. 8), said light forming a blur circle or ellipse as it passes through a proximal focal surface (page 9 lines 7-8); and
an annular region circumferentially surrounding the central region (Fig. 8, region surrounding 303) and including an add power region (Fig. 8, 304-305) having an add power provided by at least one surface having a curvature, the add power being 0.5 D or more (page 9 lines 15-23);
wherein a series of points defining centres of curvature of the add power region form a segment of an annulus (page 9 line 24; page 10 line 6), the add power region thereby focusing light from distant point objects to form a focused arc at the proximal focal surface (resulting from the power of the zones).
Ho fails to explicitly disclose wherein the area of the add power region is less than 75% of the area of the annular region.
However, it would have been an obvious matter of choice to modify Ho such that the area of the add power region was less than 75% of the area of the annular region, since such a modification would have involved a mere change in the size of the component. A change of size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). It would have been obvious to modify Ho in this way, motivated by accommodating the vision needs of a user.
Regarding claim 21, Ho discloses a method of reducing progression of myopia, comprising: providing a contact lens according to claim 1 to a myopic person who is able to accommodate for varying near distances (column 4 lines 18-28).
Regarding claim 22, Ho discloses using a ballasting means to orient the lens such that the add power region focuses light at an identified target region of the person's retina (column 8 line 28).
5. Claims 1, 5, and 14 are rejected under 35 USC 103 as being unpatentable over Brennan et al. (EP 3514613 A1).
Regarding claim 1, Brennan discloses a contact lens for use in preventing or slowing the development or progression of myopia ([0001]-[0002]), the lens including:
an optic zone having an optic axis (Fig. 5A, 502); and
a peripheral zone surrounding the optic zone (Fig. 5A, 504), the peripheral zone having a variation in thickness configured to control rotation of the lens ([0044]);
wherein the optic zone comprises:
a central region (Fig. 5A, 506), the central region having a base power provided by at least one surface having a curvature ([0043]), the central region thereby focusing light from distant point objects (Fig. 9D, 944) to a distal focal surface (Fig. 9D, 942), said light forming a blur circle or ellipse as it passes through a proximal focal surface ([0043]); and
an annular region circumferentially surrounding the central region (Figs. 5A-B, 508 and the space between zones 508) and including an add power region (Figs. 5A-B, 508) having an add power provided by at least one surface having a curvature ([0043]), the add power being 0.5 D or more (claim 6);
wherein a series of points defining centres of curvature of the add power region form a segment of an annulus ([0062], the add region would not be perfectly circular as a result of asphericity, and would therefore contain points along its surface with different centers of curvature), the add power region thereby focusing light from distant point objects to form a focused arc at the proximal focal surface (Figs. 5A-B).
Brennan fails to explicitly disclose wherein the area of the add power region is less than 75% of the area of the annular region.
However, it would have been an obvious matter of choice to modify Brennan such that the area of the add power region was less than 75% of the area of the annular region, since such a modification would have involved a mere change in the size of the component. A change of size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). It would have been obvious to modify Brennan in this way, motivated by accommodating the vision needs of a user.
Regarding claim 5, Brennan discloses wherein the add power region has a curvature providing an add power of 5.0 D or more ([0049]).
Regarding claim 14, Brennan discloses wherein the curvatures are curvatures of the anterior surface of the lens (Fig. 5B).
6. Claims 3-4 are rejected under 35 USC 103 as being unpatentable over Brennan in view of Ho et al. (US 20190219839 A1, hereinafter Ho ‘839).
Regarding claim 3, Brennan fails to explicitly disclose wherein the variation in thickness of the peripheral zone is symmetric about a lens diameter, wherein the lens diameter divides the annular region into two halves, and wherein the add power region is confined to one half of the annular region.
However, Ho ‘839 teaches a similar contact lens which is used to treat myopia (Abstract), wherein a variation in thickness of a peripheral zone is symmetric about a lens diameter ([0105]), wherein the lens diameter divides an annular region into two halves ([0105]), and wherein an add power region is confined to one half of the annular region ([0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Brennan and Ho ‘839 such that the variation in thickness of the peripheral zone was symmetric about a lens diameter, wherein the lens diameter divided the annular region into two halves, and wherein the add power region was confined to one half of the annular region, motivated by accommodating the vision needs of a user.
Regarding claim 4, modified Brennan discloses wherein each half of the annular region is divided into an upper quadrant and a lower quadrant (Brennan - Fig. 5B), and wherein the add power region is confined to a single quadrant (Brennan - Fig. 5B).
7. Claims 7-8, 17, and 19 are rejected under 35 USC 103 as being unpatentable over Brennan in view of Back et al. (US 20210055573 A1).
Regarding claim 7, Brennan fails to explicitly disclose wherein the annular region further comprises a base power region, having the curvature providing the base power and centred on the centre of curvature of the central region.
However, Back teaches a similar ophthalmic lens which is used to treat myopia ([0005]), wherein the annular region further comprises a base power region (Fig. 16, 712), having the curvature providing the base power ([0084]-[0085]) and centred on the centre of curvature of the central region (Fig. 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Brennan and Back such that the annular region was to further comprises a base power region, having the curvature providing the base power and centred on the centre of curvature of the central region, motivated by accommodating the vision needs of a user.
Regarding claim 8, modified Brennan discloses wherein at least 25% of the area of the annular region has the base power ([0357]).
Regarding claim 17, Brennan fails to disclose wherein the base power is between 0.5 D and -15.0 D.
However, Back teaches a similar ophthalmic lens which is used to treat myopia ([0005]), wherein the base power is between 0.5 D and -15.0 D ([0423]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Brennan and Back such that the base power was between 0.5 D and -15.0 D, motivated accommodating the vision needs of a user.
Regarding claim 19, Brennan fails to disclose wherein the lens is formed using a lathing process.
However, Back teaches a similar ophthalmic lens which is used to treat myopia ([0005]), wherein the lens is formed using a lathing process ([0345]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Brennan and Back such that the lens was formed using a lathing process, motivated by precisely tailoring a lens to accommodate the vision needs of a user.
Conclusion
8. THIS ACTION IS MADE FINAL. 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daniel Jeffery Jordan whose telephone number is 571-270-7641. The examiner can normally be reached 9:30a-6:00p.
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, Stephone Allen can be reached at 571-272-2434. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D. J. J./Examiner, Art Unit 2872
/STEPHONE B ALLEN/Supervisory Patent Examiner, Art Unit 2872
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