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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 and 14-18, in reply filed on 08/26/2026 is acknowledged.
Claims 8-13 and 19-27 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: the “memory” of Figure 3, first referenced in the specification at paragraph 30 and numbered as 250. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 6, 7, 15 and 18 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.
The term “configured” in claims 6, 7, 15 and 18 is a relative term which renders the claim indefinite. The term “configured” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. Specifically, the term configured suggests modification of the microcontroller (claim 6), the periocular ring (claim 7 and 15) and package (claim 18), but neither the instant claims nor the specification disclose how the respective components are modified. Thus, it is not clear how far from the base structure one can deviate and still meet the requirement of the claim. For the purposes of examination “configure to” will be interpreted as “capable of”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doshi (US 2019/0125662 A1, publication date 05/02/2019).
Doshi relates to “medical devices, such as but not limited to contact lenses, [that] can be made having a coating made at least in part using printing technologies to provide drug storage and drug release structures” [abstract], such a structure is represent by the excerpt of Figure 1 reproduced below (see Sheet 1 of 11, Figure 1):
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In Example 31, Doshi discloses a “[p]rintable formulation for ink - jet printing a drug reservoir with hyaluronic acid” [0633] which also comprises hydrogels (see Table at paragraph [0635]). “This printable formulation is then used to print a drug reservoir layer including hyaluronic acid (HA) and barrier layer on the surface of a premade dry soft contact lens” (i.e., coated under-lid device) [0631].
“Soft contact lenses are made of soft, flexible plastics that allow oxygen to pass through the cornea” (i.e., polymer substrate; instant claim 2), as evidenced by FDA at paragraph 1 of page 1.
The prior art anticipates instant claims 1, 2, and 5 because it discloses an under-lid device (i.e., contact lens) coated with a hydrogel comprising hyaluronic acid. The contact lens suffices as a polymer substrate as evidenced by FDA. Additionally, because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. under-lid device.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doshi (US 2019/0125662 A1, publication date 05/02/2019) as applied to claims 1, 2 and 5.
Doshi does not anticipate instant claim 4 because it does not disclose that the coated layer is an eye-contacting region.
Doshi discloses “[i]n another aspect of the present invention, the one or more coatings can optionally dispersed therein nanoparticles having a particles size less than about 50 nm, a nanoencapsulated ophthalmic drug from which the ophthalmic drug is able to diffuse away from and migrate away from the contact lens and into the post - lens tear film” (i.e., eye-contacting region is coated) [0199].
Given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, before the effective filling date of the claimed invention, to have selected and combined known components for their established functions with predictable results by following the teachings of Doshi. MPEP 2143 and 2144.06(I). Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling date of the claimed invention, to have coated the eye contacting region of the contact lens discussed above with the coating layer comprising hyaluronic acid and a hydrogel, as discussed above.
2) Claim(s) 1, 2, and 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 2020/0306537 A1, publication date 10/01/2020) in view of Chang et al. (Molecules, 2021, v. 26, 2485).
Regarding instant claims 1, 2, and 5-7, Gutierrez relates to a device for dry-eye treatment [title] and discloses Dry Eye-Disease (DED) “is characterized by insufficient tear volume on the ocular surface of a patient, which is generally caused by insufficient tear production or excessive tear evaporation” [0003]. According to Gutierrez the device discloses therein address DED by “stimulating the lacrimal gland to stimulate tear production” [0018]. Specifically, Gutierrez claims a “periocular ring configured to be worn on an eye of a user comprising: the periocular ring having an opening; wherein, when the periocular ring is worn on the eye of the user, a portion of the eye extends through the opening of the periocular ring” (i.e., instant claim 7) [p. 10, claim 1]. The ring also comprises “a plurality of electrodes spaced along the periocular ring; and a microcontroller operably coupled to the plurality of electrodes; wherein the microcontroller is configured to activate the plurality of electrodes to stimulate a lacrimal gland of the user” (i.e., positioned under eye lid and instant claims 6) [p. 10, claim 1]. “In some embodiments and as illustrated in FIG. 5, a portion of the gland stimulator assembly 20 and/or a portion of the sensor assembly 58 are disposed on a body of polymer substrate 66 to form the ring 15. […] Often, the polymer substrate 66, the gland stimulator assembly 20, and the sensor assembly 58 are encapsulated in a soft flexible biocompatible material 74 suitable for ocular wear, such as polymeric material like […] silicone hydrogel” (i.e., polymer substrate coated in a hydrogel; limitations of instant claims 1 and 2) [0030]. Figure 5 on Sheet 3 of 7 is reproduced below:
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Gutierrez does not disclose hyaluronic acid.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang teaches hyaluronic acid can be applied to silicon hydrogel contact lenses which “have better oxygen permeability, but their hydrophobic characteristics may irritate eyes. When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2]. In some cases, it was “reported that HA incorporated into hydrogel and silicone hydrogel contact lenses continuously released HA for at least 3 weeks” [p. 8, para. 6]. In short, “[t]he incorporation of HA into contact lenses not only aids the treatment of dry eye but also serves as a wetting or comfort agent” [p. 8, para. 4].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the silicone encapsulated device taught by Gutierrez with the hyaluronic acid of Chang. One would have been motivated to combine these prior art elements because Chang discloses hyaluronic acid can aid in the treatment of dry eye when applied to silicone hydrogel contact lenses by slowing tear removal, which Gutierrez specifically identifies as a cause of dry eye. One would have had an expectation of success because Chang discloses hyaluronic acid may be absorbed into silicone hydrogels. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a device coated in a hydrogel comprising hyaluronic acid. Wherein the device comprises one or more electrodes and a microcontroller operably coupled to the of electrodes, and wherein the microcontroller is configured to activate the electrodes to stimulate a lacrimal gland of the user (instant claim 6). Wherein the device comprises a periocular ring configured to be worn on an eye of a user, the periocular ring having an opening, wherein a portion of the eye extends through the opening of the periocular ring when the periocular ring is worn on the eye of the user (instant claim 7). The device of prior art is intended to be positioned under the eye-lid and therefore suffices as an “under-lid device”. Additionally, because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. under-lid device.
Regarding instant claim 4, as discussed above Gutierrez discloses “the polymer substrate 66, the gland stimulator assembly 20, and the sensor assembly 58 [of Figure 5] are encapsulated” in a silicone hydrogel [0030]. In producing this embodiment disclosed by Gutierrez, as discussed above, a skilled artisan would have reasonably understood “encapsulated” in a silicone hydrogel to mean the silicone hydrogels covers all surfaces, including the eye-contacting surfaces, of the polymer substrate, the gland stimulator assembly, and the sensor assembly. Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have coated at least one eye-contacting region of the under-lid device with the hydrogel.
3) Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 2020/0306537 A1, publication date 10/01/2020) in view of Chang et al. (Molecules, 2021, v. 26, 2485) as applied to claims 1, 2, and 4-7 above, and further in view of Omidian et al. (US 6,960,617 B2, publication 11/01/2005) and Park et al. (US 5,750,585, publication date 05/12/1998).
Gutierrez and Chang, which are taught above, differ from the instant claims insofar as they do not teach a superporous hydrogel. However, Gutierrez desires a hydrogel that is soft and flexible (see lines 10-12 of para. [0030]).
Omidian discloses “[s]uperporous hydrogels having improved elasticity and mechanical strength properties” [abstract]. Omidian notes that “[f]aster and greater water absorption are achieved due to the presence of the pores within the SPH [superporous hydrogel] structure” [col. 1, lines 34-36]. Omidian discloses superporous hydrogels have biomedical applications (i.e., biocompatible) [col. 32, line 59].
Park relates to super absorbent hydrogel foams [title] and discloses “[a]s the hydrogel swells, the pore size of the hydrogel increases which enhances uptake of aqueous solutions and the diffusion of compounds out of the hydrogel. These properties have allowed use of hydrogels as controlled drug release systems and as absorbent materials. However, the rate of swelling of dried hydrogels upon exposure to an aqueous solution is limited by diffusion of water into the glassy polymer matrix. Conventional dried hydrogels have relatively small pore sizes resulting in slow swelling and release or absorption of liquids” [col. 1, lines 21-31].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified the device taught by Gutierrez and Chang to comprise superporous hydrogel, as taught by Omidian and Park. One would have been motivated to modify the device of Gutierrez and Chang for the improved absorption and drug diffusion associated with the larger pores of superporous hydrogels, as disclosed by Omidian and Park. One would have had an expectation of success because Omidian disclose the superporous hydrogels have improved elastic properties, i.e., are flexible, and are biocompatible. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the under-lid device taught by Gutierrez and Chang, as discussed above, to comprise a superporous hydrogel coating.
4) Claim(s) 14-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 2020/0306537 A1, publication date 10/01/2020) in view of Chang et al. (Molecules, 2021, v. 26, 2485) as applied to claims 1, 2, and 4-7 above, and further in view of Newman et al. (US7832551B2, date of patent 11/16/2010).
Gutierrez and Chang, which are taught above, differ from the instant claims insofar as they do not teach a kit. As discussed above, Chang discloses “[w]hen contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20] and that a “contact lens wearer must have a container or receptacle to store a currently used set of contact lenses when they are not being worn, such as when the wearer is sleeping. The storage container should enable the wearer to store the lenses in a suitable hydrating and anti-microbial solution and thus must be resealable” [col. 1, lines 30-35]. The contact lens package disclosed by Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16]. This is represented by Figure 14 on Sheet 4 of 15 and reproduce below:
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Where 94 is the cap, 96 is the temporary seal [col. 10 lines 25-30], 6 is the contact lens and 8 is the contact lens fluid [col. 8, lines 33-34].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the under-lid device taught by Gutierrez and Chang with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices which are placed directly on the eye, e.g., contact lenses, so as to not introduce unwanted contamination into the eye. One would have had an expectation of success because Gutierrez and Chang desire soaking the device in a hyaluronic acid solution. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided a kit comprising the under-lid device taught by Gutierrez and Chang, as discussed above, a hydrating solution comprising hyaluronic acid, and a package for both the under-lid device and the hydrating solution. Wherein the package includes a storage space for the hydrating solution that is capable of allowing storage of the under-lid device.
5) Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 2020/0306537 A1, publication date 10/01/2020) in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US7832551B2, date of patent 11/16/2010) as applied to claims 1, 2, 4-7, 14-16 and 18 above, and further in view of Omidian et al. (US 6,960,617 B2, publication 11/01/2005) and Park et al. (US 5,750,585, publication date 05/12/1998).
Gutierrez, Chang and Newman, which are taught above, differ from the instant claims insofar as they do not teach a superporous hydrogel. However, Gutierrez desires a hydrogel that is soft and flexible (see lines 10-12 of para. [0030]).
Omidian discloses “[s]uperporous hydrogels having improved elasticity and mechanical strength properties” [abstract]. Omidian notes that “[f]aster and greater water absorption are achieved due to the presence of the pores within the SPH structure” [col. 1, lines 34-36]. Omidian discloses superporous hydrogels have biomedical applications (i.e., biocompatible) [col. 32, line 59].
Park relates to super absorbent hydrogel foams [title] and discloses “[a]s the hydrogel swells, the pore size of the hydrogel increases which enhances uptake of aqueous solutions and the diffusion of compounds out of the hydrogel. These properties have allowed use of hydrogels as controlled drug release systems and as absorbent materials. However, the rate of swelling of dried hydrogels upon exposure to an aqueous solution is limited by diffusion of water into the glassy polymer matrix. Conventional dried hydrogels have relatively small pore sizes resulting in slow swelling and release or absorption of liquids” [col. 1, lines 21-31].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified the device taught by Gutierrez and Chang to comprise superporous hydrogel, as taught by Omidian and Park. One would have been motivated to modify the device of Gutierrez and Chang for the improved absorption and drug diffusion associated with the larger pores of superporous hydrogels, as disclosed by Omidian and Park. One would have had an expectation of success because Omidian disclose the superporous hydrogels have improved elastic properties, i.e., are flexible, and are biocompatible. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the under-lid device taught by Gutierrez and Chang, as discussed above, to comprise a superporous hydrogel coating.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11008413 B1 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims recite “ An eye-mountable composition, comprising a non-silicon-containing hydrogel” [claim 1], and “An eye-mountable device, comprising an electronics platform embedded in the eye-mountable composition of claim 1” [claim 6].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices that placed directly on the eye, e.g., contact lenses, so as to not introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both.
2) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9761874B2 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims teach a device comprising electrode embedded in a hydrogel [claims 1 and 3].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
3) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9572522B2 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims recite “An eye-mountable device comprising: a transparent polymeric material; a substrate at least partially embedded within the polymeric material” [claim 1] “wherein the polymeric material includes an electrolyte-absorbant silicon hydrogel” [claim 9].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
4) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10135076B1
in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims recite “A body-mountable device comprising: a shaped polymeric material; a substrate at least partially embedded within the shaped polymeric material” [claim 1] that can be “be removably mounted over a corneal surface of the eye” [claim 2] and “further comprises a protective layer, wherein the protective layer” [claim 4] “wherein the protective layer comprises a hydrogel” [claim 5].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
5) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10028702B2
in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims teach “a second lens that has a second topographical feature, wherein embedded in the second lens is an electronic structure” [claim 1]. “wherein a material of each of the first lens and the second lens comprises a hydrogel” [claim 8].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
6) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9289954B2
in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims disclose “curing the second amount of polymerizable material to form an over-molded polymer layer such that the ring-shaped structure is at least partially enclosed in the eye-mountable device” [claim 1], “wherein the over-molded polymer layer comprises a hydrogel material or a silicone elastomer” [claim 8].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
7) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9901247B2
in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims teach an eye-mountable device comprising “a second polymer layer over the first polymer layer” [claim 1] “wherein the first polymer layer and the second polymer layer comprise a hydrogel material” [claim 8].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
8) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9757056B1 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims teach an eye-mountable device comprising “a second polymer layer over the first polymer layer and the sensor apparatus” [claim 1] “wherein the first and second polymer layers comprise a hydrogel material or a silicone elastomer” [claim 3].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
9) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10488677B2 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims teach an eye-mountable device comprising “an electronic apparatus on a first layer of a rigid, gas-permeable polymeric material” [claim 1] “wherein the rigid gas-permeable polymeric material is mounted on or within a hydrogel” [claim 19].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
10) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10423010B2 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims “An ophthalmic device, comprising: a rigid insert; and an enclosure enveloping the rigid insert” [claim 13] “wherein the enclosure is formed from a hydrogel or silicone hydrogel” [claim 24].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
12) Claims 1-7 and 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17971871 (US20230135281A1) in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims disclose “An ophthalmic device comprising: a reservoir having an interior configured to hold a therapeutic; a metal electrode configured to cover an opening of the reservoir and to receive an electrical signal that electro dissolves the metal electrode to release the therapeutic from the reservoir; and a body comprising a hydrogel-based material configured to encapsulate the reservoir and the metal electrode” [claim 1].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang and because the conflicting claims desire a therapeutic. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
This is a provisional nonstatutory double patenting rejection.
13) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11813452B2 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The copending claims recite “A device configured to be located underneath an eyelid, positioned between the eyelid and a surface of an eye, and worn by a user for treating a medical condition, the device comprising: a first surface configured to face a portion of a sclera of the eye and to be in contact with the surface of the eye; [and] a second surface” [claim 1] “wherein the first surface and the second surface comprise a covering selected from one of a silicone elastomer or a silicone hydrogel” [claim 9].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
14) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10365504B2 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims recite “forming a soft polymer layer such that the rigid, gas-permeable polymer layer is fully enclosed within the formed soft polymer layer, wherein the soft polymer layer is mountable to a corneal surface of an eye” [claim 2] “wherein the soft polymer layer comprises a silicone hydrogel” [claim 3].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
15) Claims 1-7 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11866531B2 in view of Chang et al. (Molecules, 2021, v. 26, 2485) and Newman et al. (US 7832551 B2, date of patent 11/16/2010).
The conflicting claims disclose a “lens material for use in an electrowetting ophthalmic device, the lens material comprising a copolymer” [claim 1] further comprising a silicone hydrogel encasing the copolymer shaped to contact a corneal surface of an eye when the ophthalmic device is mounted to the eye” [claim 18].
The conflicting claims do not disclose hyaluronic acid or hydroxypropyl methylcellulose.
Chang relates to applications of hyaluronic acid (HA) in ophthalmology and contact lenses [title] and discloses “HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye” [abstract]. According to Chang “HA is biocompatible and effective at retaining moisture on contact lens. HA has been applied in the contact lens field for almost 20 years” [p. 8, para. 1]. Chang discloses that “[b]ecause wearing contact lenses for prolonged periods may cause dry eye, HA-soaked contact lenses retain moisture, thus solving this problem” [p. 8, para. 3]. Chang discloses “When contact lenses soaked in multipurpose solution absorb HA, HA can decrease the surface roughness of the lens. HA-modified contact lenses exhibit enhanced surface water retention, reduce protein adsorption, and slow tear removal, which considerably increases comfort” (internal citations omitted) [p. 8, para. 2].
Newman discloses a “contact lens package that is reusable as a case to store a contact lens between uses includes a lid, a base, one or more receptacles for a contact lens case” [abstract]. Newman discloses that “[b]ecause contact lenses are placed directly on the eye, it is important that they not introduce any unwanted contamination into the eye” [col. 1, lines 18-20]. The case according to Newman comprises “a bottom member having a well with an inside”, “a temporary seal comprising a generally moisture-proof film sealed across the top rim to seal the opening, thus defining a volume within the package, the volume containing a contact lens and contact lens fluid” and “a cap secured to the bottom member covering the temporary seal” [col. 3, lines 8-16].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the hyaluronic acid of Chang with the hydrogel device of the conflicting claims for the improved comfort discussed in Chang. One would have had an expectation of success because the conflicting claims disclose a hydrogel for application to the eye which is very similar to a contact lens. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the device of the conflicting claims with the case discloses by Newman, wherein the fluid of the case comprises the hyaluronic acid of Chang. One would have been motivated because Newman teaches it is important to properly store devices placed directly on the eye, e.g., contact lenses, so as not to introduce unwanted contamination into the eye. One would have had an expectation of success because the cases of Newman are specifically for devices that may be applied to the eye. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided an under-lid device coated in hydrogel comprising hyaluronic acid and a kit comprising the device, a hyaluronic acid solution and a package for both. The device taught by the conflicting claims and Chang suffices as an “under-lid device” because it comprises a device coated in a hydrogel comprising hyaluronic acid.
Conclusion
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/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
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