*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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on July 24, 2025 has been entered.
Priority
Present application is a continuation of 16/241,127 filed on 01/07/2019, which is a
continuation of PCT/US2016/041079 filed on 07/06/2016.
Claim Status
Claims 1-27 are pending and examined. Claims 16 and 25-27 were
amended.
Withdrawn Claim Rejections — 35 USC § 112
Rejection of claim 16 are withdrawn because the claim was amended by deleting PLURONIC.
Claim Rejections — 35 USC § 102/103
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.
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.
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.
Claims 1-3, 5-10, and 13-24 are rejected under 35 U.S.C. 102(a) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Cooper (US 2010/0226963 Al Published September 9, 2010 — of record in IDS dated 08/26/2022).
The claims encompass a method of increasing the surface temperature on the external surface of a treated contact lens that is on the eye of a subject.
The teachings of Cooper are related to a composition and a method of using said composition for treating eyes (Abstract). The composition contains a copolymer and a pharmaceutically acceptable carrier (paragraph 0006). In one embodiment, the composition is part of a kit containing a contact lens and the composition (paragraph 0009). The composition can be contacted with an external body surface, particularly external surface of the eye (paragraph 0015). The composition is suitable for use in a method of treating inflammatory conditions of the eye (paragraph 0018). The copolymer is a graft copolymer PLL-g-PEG (paragraph 0022). The ability to reduce or prevent bacterial adhesion to biological surfaces such as skin or hair is expected to render these compositions useful in the treatment of chronic blepharitis (paragraph 0125). Example 1 teaches a topical formulation containing 1% F127, 1% PLL-g-PEG, 1% glycerin, sterile water for injection, sodium phosphate buffer, mannitol to adjust osmolarity, where the composition has a pH between 6.5 and 7.5 and osmolarity of 274-350 mOsm/kg. The formulation was applied to a contact lens and tested, where one drop was placed on each side of the contact lens and the lens was placed in a human eye and the patient wore the contact lens for 8 hours (paragraphs 0134-0138). According to paragraph 0099, the concentration is based on wt./wt. %.
Regarding claim 1, the claimed invention is anticipated by Cooper’s method in example 1 because the exemplified method teaches the same steps as claimed. The method teaches contacting the eye of a patient with a lens treated with pharmaceutical composition comprising 1 wt./wt. % of PLL-g-PEG, where the patient wore the treated contact lens for 8 hours. As evidenced by Example 1 of the instant specification pages 56-57, the pharmaceutical composition tested by applicant is identical to Cooper’s pharmaceutical composition in example 1. The method according to instant specification requires applying a drop of the composition to each side of the contact lens, applying the lens to the eye of a patient, and allowing the patient to wear the contact lens for 8 hours, which are the same steps as Cooper’s method of treating and applying the lens to the patient. Therefore, as evidenced by applicant’s specification, Cooper’s method of applying one drop of the composition to each side of the lens and allowing the patient to wear the treated lens for 8 hours meets the limitation that requires “wherein said contacting is effected in an amount and for a duration so as to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said subject as compared to an untreated contact lens that is on the eye of said patient”.
The phrase “wherein said treated contact lens is in association with a pharmaceutical composition comprising a copolymer having a positively charged moiety and a hydrophilic moiety” is met because Cooper teaches a contact lens comprising a pharmaceutical composition comprising PLL-g-PEG which is known to have a cationic backbone comprised of PLL and grafted with hydrophilic PEG.
The intended use of the claimed method is to increase the surface temperature on the external surface of a treated contact lens that is on the eye of a subject as compared to an untreated contact lens that is on the eye of a subject. The claimed intended use would have been accomplished by Cooper’s method because Cooper teaches the same method steps as claimed.
In the present case, increasing the surface temperature as claimed is a result of a property
of the pharmaceutical composition comprising PLL-g-PEG, and the same effect would have been observed in Cooper’s method because Cooper teaches contacting a contact lens comprising a pharmaceutical composition comprising PLL-g-PEG with the eye of a subject. As evidenced by page 25 of the present specification, a graft copolymer PLL-g-PEG is useful in formulations for use in the methods of present invention. As evidenced by pages 56-57 of the instant specification, applicant’s composition is identical to Cooper’s composition used in the method of treating a patient by applying a contact lens treated with the composition.
The “thereby” clause at the end of the claim describes an intended result of a method step positively recited. The effect of Cooper’s method would have been the same as claimed because Cooper’s method requires the same method steps as claimed method.
Per MPEP 2112.02(I):
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated.
Per MPEP 2111.04:
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Regarding claim 2, the “wherein” clause describes an intended result of a method step positively recited. The effect of Cooper’s method would have been the same as claimed because Cooper’s method is the same as claimed method.
Regarding claim 3, PLL-g-PEG is a graft copolymer.
Regarding claim 5, PEG is a hydrophilic moiety which is non-ionic.
Regarding claim 6, the “wherein” clause describes an intended result of a method step positively recited. The effect of Cooper’s method would have been the same as claimed because Cooper’s method is the same as claimed method.
Regarding claim 7, the “wherein” clause describes an intended result of a method step positively recited. The effect of Cooper’s method would have been the same as claimed because Cooper’s method is the same as claimed method.
Regarding claim 8, the “wherein” clause describes an intended result of a method step positively recited. The effect of Cooper’s method would have been the same as claimed because Cooper’s method is the same as claimed method.
Regarding claim 10, PLL-g-PEG is a graft copolymer comprising a cationic backbone PLL and PEG as side chains, which are water soluble and nonionic.
Regarding claims 13 and 14, the concentration ranges of copolymer are anticipated because they encompass 1 wt./wt. %.
Regarding claims 15 and 16, Cooper’s composition in example 1 contains F127, which is a block copolymer containing PPO block attached to a PEO block on each end (paragraph 0089).
Regarding claim 17, Cooper’s composition in example 1 contains glycerin, which is an emollient.
Regarding claim 18, Cooper teaches combining the formulation with a multi-purpose contact lens solution and storing the lens overnight, and teaches the subject wearing the lens the next day comfortably (Example 1, specifically paragraph 0138).
Regarding claims 19 and 20, the “wherein” clauses describe the effect of the claimed method. The method of Cooper encompasses the same active method steps and it would have been reasonable to conclude that the method steps have the same effect as claimed method steps.
Claim 21 recites the location wherein the increase in temperature is observed and claims 22-24 recite methods used to measure the increase in temperature. The claims do not require an active method step of measuring the temperature increase. The increase in temperature in Cooper’s method could have been measured at the conjunctiva as recited in claim 21 and could have been measured using methods recited in claims 22-24.
In the event that claims 1-3, 5-10, 13-17, and 19-24 are not found anticipated by Cooper, the claims are rejected as obvious as follows.
Regarding claim 1, it would have been prima facie obvious to a person of ordinary skill
in the art before the effective filing date of the claimed invention to have treated the eye of a patient comprising contacting the eye with a contact lens treated with a pharmaceutical composition comprising 1 wt./wt. % of PLL-g-PEG where the lens is treated by applying a drop of the composition to each side of the lens followed by placing the treated lens on eye for 8 hours, with a reasonable expectation of success because Cooper teaches a method of treating the eye of a patient comprising contacting the eye of a patient with a contact a lens treated with a formulation containing 1 wt./wt. % of PLL-g-PEG, wherein the lens is treated by applying a drop of the formulation to each side of the lens, placing the treated lens on the eye of a patient and allowing the patient to wear the treated contact lens for 8 hours.
The phrase “to increase the surface temperature on the external surface of a treated contact lens that is on the eye of a subject as compared to an untreated contact lens that on the eye of a subject” describes the purpose of the method. Cooper does not teach whether or not applying the pharmaceutical composition comprising PLL-g-PEG increases the surface temperature as claimed. However, it would have been reasonable to expect Cooper’s treatment method to have the same effect as claimed method because Cooper’s method teaches the same steps as claimed.
In the present case, increasing the surface temperature as claimed is a result of a property
of the pharmaceutical composition comprising PLL-g-PEG, and the same effect would have been observed in Cooper’s method because Cooper teaches contacting a contact lens comprising a pharmaceutical composition comprising PLL-g-PEG with the eye of a subject. As evidenced by page 25 of the present specification, a graft copolymer PLL-g-PEG is useful in formulations for use in the methods of present invention. As evidenced by pages 56-57 of the instant specification, applicant’s composition is identical to Cooper’s composition used in the method of treating a patient by applying a contact lens treated with the composition.
The phrase “wherein said treated contact lens is in association with a pharmaceutical composition comprising a copolymer having a positively charged moiety and a hydrophilic moiety” is met because Cooper teaches a contact lens comprising a pharmaceutical composition comprising PLL-g-PEG which is known to have a cationic backbone comprised of PLL and grafted with hydrophilic PEG.
Regarding the phrase “wherein said contacting is effected in an amount and for a duration so as to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said subject as compared to an untreated contact lens that is on the eye of said subject”, Cooper’s Example 1 teaches applying one drop of the composition to each side of the lens and teaches the patient wearing the treated lens for 8 hours (paragraph 0138). As evidenced by instant specification Example 1 on pages 56-57, applicant’s method requires the same composition as Cooper’s Example 1 and teaches applying a drop to each side of the lens, applying the lens to the eye of a patient and having the patient wear the lens for 8 hours. In view of these teachings, it would have been reasonable to conclude that an amount and a duration of application in Cooper’s method in Example 1 is sufficient to accomplish the intended purpose of applicant’s method.
Additionally, Cooper teaches that the concentration of graft copolymer in the formulation ranges from 0.001 to 40% by weight of formulation. The concentration range of Cooper’s compositions is the same as present applicant’s concentration range and Cooper teaches applying the graft copolymer via a contact lens. Based on these teachings and evidence from the present application, it would have been reasonable to expect that Cooper’s contacting is effected in an amount and for a duration that is sufficient to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said subject as compared to an untreated contact lens that is on the eye of said subject.
The phrase “thereby increasing the surface temperature on the external surface of a treated contact lens that is on the eye of a subject as compared to an untreated contact lens that is on the eye of a subject” describes an intended result of the claimed method, and it would have been reasonable to expect Cooper’s method to have the same effect as claimed method because Cooper’s method teaches the same method steps as claimed.
See MPEP 2112 and 2111.
Regarding claim 2, the “wherein” clause describes an intended result of the claimed method, and it would have been reasonable to expect Cooper’s method to have the same effect as claimed method because Cooper teaches the same method steps as claimed. It would have been reasonable to expect Cooper’s method to increase the temperature of the ocular surface of the eye of said subject in contact with said treated contact lens because Cooper’s method teaches the same steps as claimed.
Regarding claim 3, PLL-g-PEG is a graft copolymer.
Regarding claim 5, PEG is a hydrophilic moiety which is non-ionic.
Regarding claim 6, it would have been reasonable to expect the copolymer to create an electrostatic adhesion between the copolymer and the eye in Cooper’s method because Cooper teaches the same steps as claimed. The biological surface is interpreted as referring to the surface of the eye.
Regarding claim 7, it would have been reasonable to expect the copolymer to create a covalent adhesion between the copolymer and the eye surface in Cooper’s method because Cooper teaches the same steps as claimed. The biological surface is interpreted as referring to the surface of the eye.
Regarding claim 8, PLL-g-PEG comprises a cationic backbone (PLL) and it would have been reasonable to expect the copolymer to create an electrostatic adhesion with the contact lens.
Regarding claim 10, PLL-g-PEG is a graft copolymer comprising a cationic backbone PLL and PEG as side chains, which are water soluble and nonionic.
Regarding claims 13 and 14, the claimed concentration ranges are obvious because they encompass 1 wt./wt.%, which Cooper teaches in example 1. It would have been further obvious to have varied the concentration in the range of 0.001-40 wt. % in Cooper’s method of treating the eye with a treated contact lens because Cooper teaches a method of treating the eye comprising contacting the eye with a lens comprising a formulation comprising PLL-g-PEG in a concentration of 0.001-40 % by weight (paragraph 0003). The claimed concentration ranges are obvious because they overlap with 0.001-40 wt. %.
Regarding claims 15 and 16, Cooper’s example 1 composition contains F127. Additionally, Cooper teaches that the composition comprises additional components such as PLURONIC gelling agents including F127 (paragraph 0093).
Regarding claim 17, Cooper’s example 1 composition contains glycerin, which is an emollient. Additionally, it would have been obvious to have modified the composition above by adding a preservative and a surfactant, with a reasonable expectation of success because Cooper teaches that the copolymers can be used in combination with preservatives and surfactants (paragraph 0093).
Regarding claim 18, it would have been obvious to have stored the contact lens in the formulation comprising PLL-g-PEG, with a reasonable expectation of success because Cooper
teaches combining the formulation with a multi-purpose contact lens solution and storing the lens overnight (Example 1, specifically paragraph 0138) and teaches storing a contact lens for at least 1 hour in the pharmaceutical formulation (paragraph 0008).
Regarding claims 19 and 20, the “wherein” clauses describe the effect of the claimed method. The method of Cooper encompasses the same active method steps and it would have been reasonable to conclude that the method steps have the same effect as claimed method step.
Claim 21 recites the location wherein the increase in temperature is observed and claims 22-24 recite methods used to measure the increase in temperature. The claims do not require an active method step of measuring the temperature increase. The increase in temperature in Cooper’s method could have been measured at the conjunctiva as recited in claim 21 and could have been measured using methods recited in claims 22-24.
Claims 1-25 and 27 are rejected under 35 U.S.C. 103 as obvious over Cooper (US 2010/0226963 Al Published September 9, 2010 — of record in IDS dated 08/26/2022).
The teachings of Cooper are relied upon as summarized above.
Claims 1-3, 5-10, and 13-24 are obvious over Cooper as described above.
Regarding claim 4, it would have been obvious to have used a block copolymer in Cooper’s method because Cooper teaches an embodiment where the copolymer is a block copolymer and contains at least one cationic block and at least one water soluble and non-ionic block (paragraph 0022).
Regarding claim 9, it would have been obvious to have covalently immobilized the graft copolymer to the lens in order to prolong the biological effect of the formulation with a reasonable expectation of success because Cooper teaches that extraocular devices such a extended wear contact lenses have prolonged biological use and further teaches covalently bonding the graft copolymer to the lens in order to ensure that the benefit does not wear off over time (paragraph 0131).
Regarding claim 11, it would have been obvious to have replaced PLL-g-PEG with a graft copolymer that contains a water soluble nonionic backbone and cationic side chains, with a reasonable expectation of success because Cooper teaches that in various embodiments, the copolymer is a graft copolymer and contains a water soluble nonionic backbone and cationic side
chains (paragraph 0022).
Regarding claim 12, it would have been obvious to have used a block copolymer comprising a water soluble anionic block and a water soluble cationic block, with a reasonable expectation of success because Cooper teaches an embodiment of a block copolymer comprising at least one block which is hydrophobic and at least one block which is water soluble and anionic, cationic, or nonionic (paragraph 0084).
Regarding claim 25, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have treated blepharitis by contacting the eye with a contact lens exposed to a formulation containing 0.001-40 wt. % of PLL-g-PEG, with a reasonable expectation of success because Cooper teaches a pharmaceutical composition comprising 0.001-40 wt. % of PLL-g-PEG and a method of treating blepharitis by contacting the composition with the eye. It would have been obvious to have contacted the composition with the eye by contacting the eye with a contact lens containing the composition and wearing the contact lens for 8 hours because Cooper teaches formulating the composition as a kit wherein the kit contains a contact lens and the composition and teaches the patient wearing the contact lens for 8 hours. It would have been obvious to have treated chronic blepharitis because Cooper teaches that the composition is suitable for treating chronic blepharitis.
Combining prior art elements according to known methods to obtain predictable results supports obviousness.
The phrase “comprising increasing the temperature of the affected contact-lens wearing eye” describes the effect of the method, and it would have been reasonable to expect Cooper’s treatment method to have the same effect as claimed method because Cooper’s method teaches the same steps as claimed.
The step of “wherein said increasing the temperature of the affected contact-lens wearing eye comprises treating said contact lens with a copolymer having a positively charged moiety and a hydrophilic moiety” is obvious because Cooper teaches a step of contacting a contact lens with a pharmaceutical composition comprising PLL-g-PEG, which contain a positively charged moiety PLL and a hydrophilic moiety PEG.
The claim is interpreted as requiring a step of contacting the treated lens with the eye. The step would have been obvious because Cooper teaches contacting the eye with a contact lens comprising the pharmaceutical composition comprising PLL-g-PEG.
Regarding the phrase “wherein said contacting is effected in an amount and for a duration so as to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said patient as compared to an untreated contact lens that is on the eye of said patient”, Cooper teaches a method of treating an eye comprising contacting the eye with a lens comprising a formulation comprising PLL-g-PEG in a concentration of 0.001-40 % by weight (paragraph 0003) and Example 1 specifically teaches a patient wearing the treated contact lens for 8 hours (paragraph 0138). As evidenced by present application, the concentration of graft copolymer in the formulation ranges from 0.001 to 40% by weight of formulation and the contact lens is worn for 8 hours. The concentration range and duration of wearing the lens taught by Cooper is the same as applicant’s concentration range and duration of wearing the treated lens. Based on these teachings and evidence from the present application, it would have been reasonable to expect that Cooper’s contacting is effected in an amount and for a duration so
as to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said subject as compared to an untreated contact lens that is on the eye of said subject.
The phrase “thereby treating blepharitis in said patient” describes an intended result of the claimed method, and it would have been reasonable to expect Cooper’s method to have the same effect as claimed method because Cooper’s method teaches the same method steps as claimed and Cooper’s intended purpose of the method is to treat blepharitis.
Regarding claim 27, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have treated dry eye syndrome in a patient by contacting the eye of the patient with a contact lens comprising a formulation containing 0.001-40 wt. % of PLL-g-PEG and allowing the patient to wear the contact lens for 8 hours, with a reasonable expectation of success because Cooper teaches a pharmaceutical composition comprising 0.001-40 wt. % of PLL-g-PEG and a method of treating dry eye syndrome by contacting the composition with the eye (paragraph 0015). It would have been obvious to have contacted the composition with the eye by contacting the eye with a contact lens containing the composition because Cooper teaches formulating the composition as a kit wherein the kit contains a contact lens and the composition and in example 1 teaches treating a lens with the formulation, applying the treated lens to the eye of a patient and allowing the patient to wear the lens for 8 hours. It would have been obvious to have treated dry eye syndrome because Cooper teaches that the composition is suitable for treating dry eye syndrome. Combining prior art elements according to known methods to obtain predictable results supports obviousness.
The phrase “by increasing the temperature of the affected contact-lens wearing eye” describes the purpose of the method, and it would have been reasonable to expect Cooper’s treatment method to have the same effect as claimed method because Cooper’s method teaches the same steps as claimed.
The step of “wherein said increasing the temperature of the affected contact-lens wearing eye comprises treating said contact lens with a copolymer having a positively charged moiety and a hydrophilic moiety” is obvious because Cooper teaches a step of contacting a contact lens with a pharmaceutical composition comprising PLL-g-PEG.
The claim is interpreted as requiring a step of contacting the treated lens with the eye. The step would have been obvious because Cooper teaches contacting the eye with a contact lens comprising the pharmaceutical composition comprising PLL-g-PEG.
Regarding the phrase “wherein said contacting is effected in an amount and for a duration so as to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said patient as compared to an untreated contact lens that is on the eye of said patient”, Cooper teaches a method of treating the eye of a patient comprising contacting the eye with a lens comprising a formulation comprising PLL-g-PEG in a concentration of 0.001-40 % by weight (paragraph 0003) and Example 1 specifically teaches a patient wearing the treated contact lens for 8 hours (paragraph 0138). As evidenced by present application, the concentration of graft copolymer in the formulation ranges from 0.001 to 40% by weight of formulation and contact lens is worn for 8 hours. The concentration range and duration of wearing the contact lens taught by Cooper is the same as applicant’s concentration range and duration of wearing the contact lens. Based on these teachings and evidence from the present application, it would have been reasonable to expect that Cooper’s contacting is effected in an amount and for a duration so as to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said subject as compared to an untreated contact lens that is on the eye of said subject.
The two “thereby” clauses at the end of the claim describe an intended result of the claimed method, and it would have been reasonable to expect Cooper’s method to have the same effect as claimed method because Cooper’s method teaches the same method steps as claimed.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Cooper as applied to claims 1-25 and 27 above, and further in view of Ashley (WO 2003/088906 Published October 30, 2003).
Claim 26 is drawn to a method of treating chalazion in a patient comprising the claimed steps.
The teachings of Cooper are relied upon as summarized above. Cooper does not teach chalazion.
The teachings of Ashley are related to ocular rosacea which is characterized by inflammation of the eyelids, referred to as blepharitis. Blepharitis is categorized anatomically into anterior and posterior blepharitis. Posterior blepharitis is mainly related to dysfunction of the meibomian glands. Alterations in secretory metabolism and function lead to disease. The meibomian secretions become more wax like and begin to block the gland orifices. The stagnant material becomes a growth medium for bacteria and can seep into the deeper eyelid tissue layers, causing inflammation. These processes lead to gland plugging, inspissated material, formation of chalazion and meibomianitis (from page 1 line 28 to page 2 line 10).
The teachings of Cooper and Ashley are related to blepharitis and it would have been obvious to have combined them because they are in the same field of endeavor.
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date of the claimed invention to have treated blepharitis by contacting the eye with a contact lens exposed to a formulation containing 0.001-40 wt. % of PLL-g-PEG and allowing the patient to wear the contact lens for 8 hours, with a reasonable expectation of success because Cooper teaches a pharmaceutical composition comprising 0.001-40 wt. % of PLL-g-PEG and a method of treating blepharitis by contacting the composition with the eye. It would have been obvious to have contacted the composition with the eye by contacting the eye with a contact lens containing the composition because Cooper teaches formulating the composition as a kit wherein the kit contains a contact lens and the composition and in example 1 specifically teaches applying a treated contact lens to the eye and allowing the patient to wear the lens for 8 hours. It would have been obvious to have treated chronic blepharitis because Cooper teaches that the composition is suitable for treating chronic blepharitis. Cooper does not limit blepharitis by anatomical location, and it would have been reasonable to interpret Cooper as encompassing treatment of anterior and posterior blepharitis. It would have been obvious to have treated posterior blepharitis associated with meibomian gland dysfunction that leads to chalazion, with a reasonable expectation of success because it was known from Ashley that posterior blepharitis is mainly associated with meibomian gland dysfunction which leads to chalazion. Thus, it would have been obvious to have treated chalazion with Cooper’s method as described above. Combining prior art elements according to known methods to obtain predictable results supports obviousness.
The phrase “by increasing the temperature of the affected contact-lens wearing eye” describes the purpose of the method, and it would have been reasonable to expect Cooper’s treatment method to have the same effect as claimed method because Cooper’s method teaches the same steps as claimed.
The step of “wherein said increasing the temperature of the affected contact-lens wearing eye comprises treating said contact lens with a copolymer having a positively charged moiety and a hydrophilic moiety” is obvious because Cooper teaches a step of contacting a
contact lens with a pharmaceutical composition comprising PLL-g-PEG.
The claim is interpreted as requiring a step of contacting the treated lens with the eye. The step would have been obvious because Cooper teaches contacting the eye with a contact lens comprising the pharmaceutical composition comprising PLL-g-PEG.
Regarding the phrase “wherein said contacting is effected in an amount and for a duration so as to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said patient as compared to an untreated contact lens that is on the eye of said patient”, Cooper teaches a method of treating an eye comprising contacting the eye with a lens comprising a formulation comprising PLL-g-PEG in a concentration of 0.001-40 % by weight (paragraph 0003) and Example 1 specifically teaches a patient wearing the treated contact lens for 8 hours (paragraph 0138). As evidenced by present application, the concentration of graft copolymer in the formulation ranges from 0.001 to 40% by weight of formulation and the treated lens is worn for 8 hours. The concentration range and duration of wearing the lens taught by Cooper is the same as present applicant’s concentration range and duration of wearing the lens. Based on these teachings and evidence from the present application, it would have been reasonable to expect that Cooper’s contacting is effected in an amount and for a duration so as to increase the surface temperature on the external surface of said treated contact lens that is on the eye of said subject as compared to an untreated contact lens that is on the eye of said subject.
The two “thereby” phrases at the end of the claim describe an intended result of the claimed method, and it would have been reasonable to expect the prior art method to have the same effect as claimed method because the prior art method teaches the same method steps as claimed.
Double Patenting Rejections
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.
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,135,242 B2 in view of Cooper.
Patented claim 1 is drawn to a method for increasing the temperature of an ocular surface,
comprising contacting the ocular surface of a mammal with a pharmaceutical composition comprising a copolymer having both positively charged and hydrophilic moieties, wherein said contacting is effected in an amount and for a duration so as to increase surface temperature from a meaningful baseline, where the meaningful baseline is defined by the claim.
The claim does not teach a contact lens.
The teachings of Cooper are relied upon as summarized above.
It would have been obvious to have combined the teachings of patented claims and Cooper because both are related to treating an eye.
Regarding present claim 1, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method in patented claim 1 in view of Cooper by treating a contact lens with the pharmaceutical composition followed by contacting the treated contacted lens with the ocular surface, with a reasonable expectation of success because Cooper teaches a method of treating an eye with a contact lens that comprises a copolymer selected from PLL-g-PEG. The purpose of the presently claimed method is to increase the surface temperature of the external surface of a treated contact lens that is on the eye of a subject as compared to an untreated contact lens that is on the eye of a subject. The claimed purpose would have been achieved by patented method modified by Cooper because patented method modified by Cooper teaches the same method steps as presently claimed method.
Regarding present claim 2, patented claim 1 teaches that the purpose of the method is to increase the temperature of an ocular surface.
Regarding present claim 3, patented claim 2 requires a graft copolymer.
Regarding present claim 4, patented claim 3 requires a block copolymer.
Regarding present claim 5, patented claim 4 requires the hydrophilic moiety that is nonionic or anionic.
Regarding present claim 6, patented claim 5 requires the copolymer that creates an electrostatic adhesion between the copolymer and the biological surface.
Regarding present claim 7, patented claim 6 requires the copolymer that creates a covalent adhesion between the copolymer and the biological surface.
Regarding present claim 8, it would have been reasonable to expect PLL-g-PEG to create electrostatic adhesion with the contact lens considering PLL is cationic.
Regarding present claim 9, it would have been obvious to have covalently bonded the copolymer with the contact lens because Cooper teaches covalently bonding the copolymer to the lens in order to prolong the effects of the copolymer.
Regarding present claim 10, patented claim 7 requires the copolymer that is a graft copolymer and comprises a cationic backbone and side chains that are water soluble and nonionic.
Regarding present claim 11, patented claim 8 requires the copolymer that is a graft copolymer and comprises a water soluble non-ionic backbone and cationic side chains.
Regarding present claim 12, patented claim 9 teaches the copolymer is a block copolymer and comprises at least one cationic block and at least one block which is water soluble and ionic.
Regarding present claim 13, patented claim 11 requires that the copolymer is present in the concentration range of 0.001 to 40% by weight of said composition.
Regarding present claim 14, patented claim 12 requires that the copolymer is present in the concentration range of 0.001 to 25% by weight of said composition.
Regarding present claim 15, patented claim 13 requires the composition to comprise a
second polymer.
Regarding claim 16, patented claim 14 requires the composition to further comprise a block copolymer composed of nonionic triblock copolymers composed of a central hydrophobic chain of polyoxypropylene (poly(propylene oxide)) flanked by two hydrophilic chains of polyoxyethylene (poly(ethylene oxide)).
Regarding present claim 17, patented claim 22 requires the composition to further comprise one or more of a surfactant, a preservative, and a pharmaceutical ingredient selected from the group consisting of: demulcents, emollients, sodium chloride, and vasoconstrictors. Regarding present claim 18, it would have been obvious to have stored the contact lens in the formulation comprising PLL-g-PEG, with a reasonable expectation of success because Cooper teaches combining the formulation with a multi-purpose contact lens solution and storing the lens overnight (Example 1, specifically paragraph 0138) and teaches storing a contact lens for at least 1 hour in the pharmaceutical formulation of Cooper’s invention (paragraph 0008).
Regarding present claims 19 and 20, the “wherein” clauses describe the effect of the claimed method. The patented method modified with Cooper encompasses the same active method steps and it would have been reasonable to conclude that the method step has the same effect as claimed method step.
Present claim 21 recites the location wherein the increase in temperature is observed and present claims 22-24 recite methods used to measure the increase in temperature. The claims do not require an active method step of measuring the temperature increase. The increase in temperature in Cooper’s method could have been measured at the conjunctiva as recited in claim 21 and could have been measured using methods recited in claims 22-24.
Regarding present claim 25, patented claim 27 requires a method of increasing the
surface temperature of the eyelid margin to treat blepharitis of the eye of a mammal by contacting said eye with a contact lens exposed to a formulation containing a multifunctional graft copolymer such that the surface temperature of the eyelid margin increases 0.1 degree Celsius. It would have been prima facie obvious to a person skilled in the art to have selected PLL-g-PEG as the multifunctional graft polymer, with a reasonable expectation of success because treating chronic blepharitis with a contact lens treated with a pharmaceutical composition comprising PLL-g-PEG was known from Cooper. PLL-g-PEG is a multifunctional graft copolymer. A person skilled in the art would have been capable of determining the concentration of PLL-g-PEG and duration of exposure to the eye in order to treat blepharitis. Additionally, Cooper teaches suitable concentrations of PLL-g-PEG and duration of wearing the treated contact lens.
Regarding present claim 26, it would have been obvious to have practiced a method of treating chalazion using the method of patented claim 1, with a reasonable expectation of success because patented claim 17 teaches topically administering the composition of claim 1 to an eye of a subject to treat chalazion. It would have been reasonable to expect the claimed effects of the method to be present in the patented method as modified by Cooper because the two methods require the same steps practiced on the same patient population.
Regarding present claim 27, it would have been obvious to have practiced a method of treating dry eye syndrome using the method of patented claim 1, with a reasonable expectation of success because patented claim 17 teaches topically administering the composition of claim 1| to an eye of a subject to treat dry eye. It would have been reasonable to expect the claimed effects of the method to be present in the patented method as modified by Cooper because the two methods require the same steps practiced on the same patient population.
Response to Arguments
In the remarks dated July 24, 2025 applicant traversed the rejections.
Applicant’s arguments were fully considered but are not persuasive for the following reasons.
Applicant’s argument that Cooper does not teach every claimed limitation is not persuasive because limitations to which the applicant is referring would have been present in Cooper’s method because Cooper’s method teaches the same method steps as claimed. The effects and the intended use of the claimed method, such as increasing the surface temperature of the contact lens, would have been present in Cooper’s method because Cooper’s method requires treating a lens with a pharmaceutical composition and applying the treated lens to the eye of a patient for 8 hours. As evidenced by instant specification, the composition in Example 1 is identical to Cooper’s composition in Example 1 and both compositions are applied to the contact lens in the same manner (one drop on each side of the lens) and subsequently applied to the eye and worn for 8 hours. Any effects observed by the applicant while practicing applicant’s method would have been present in Cooper’s method, absent evidence to the contrary. The amount and the duration in Cooper are the same as applicant’s amount (one drop of a composition on each side of a lens where the composition contains 0.001-40 wt. % or 1 wt. % of PLL-g-PEG) and duration (8 hours). Cooper does not have to teach the effects of the method observed by the applicant in order to render the claimed method obvious.
Cooper’s method meets all of the structural limitations of the claimed method, and the effects observed by the applicant would have been present in Cooper’s method.
In response to applicant's argument that the claimed method increases the temperature of a lens, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into a