-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 .
Applicant’s response dated April 28, 2026 is acknowledged.
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 1-12, 14-17, and 19-35 are pending and examined. Claims 28-35 were newly added. Claims 13 and 18 were canceled. Claims 1 and 25-27 were amended.
Withdrawn Claim Rejections - 35 USC § 102
Anticipation rejections are withdrawn because the claims were amended to require a contact lens that is contacted with a pharmaceutical composition only after its placement on the surface of the eye of the patient, which is not exemplified by Cooper.
New and Maintained Claim Rejections - 35 USC§ 103
Modified as Necessitated by Amendment
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 1-12, 14-17, 19-25, 27, 32, 33, and 35 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 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 % Fl 27, 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, 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 in Example 1 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. It would have been obvious to have modified the method in Example 1 by placing a drop of the formulation into the eye followed by placing the contact lens into the eye, with a reasonable expectation of success because Cooper teaches providing the formulation as eye drops and a drop to be used prior to placing the lens in the eye (paragraph and 0131). It is apparent from Cooper’s claim 21, that Cooper intended to include embodiments where the formulation is directly applied to the eye. In view of this teaching, it would have been obvious to have administered the formulation directly to the eye followed by placing the contact lens on the eye. Cooper is not limited by the exemplified embodiment where a drop is placed into the contact lens which is subsequently administered to the eye. One of skill in the art would have interpreted Cooper to encompass embodiments where a drop is administered to the eye followed by placing a contact lens on the eye. This embodiment meets the claimed limitations because the contact lens is only contacted with the formulation after the placement of the lens on the surface of the eye in which a drop of the formulation had been administered prior to contacting with the contact lens.
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 with a
pharmaceutical composition comprising PLL-g-PEG on 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 to the eye treated with the composition.
The phrase "wherein said treated contact lens is a contact lens that is contacted with a pharmaceutical composition comprising a copolymer having a positively charged moiety and a hydrophilic moiety, only after its placement on the surface of the eye of said subject" is met because Cooper teaches administering a drop of the formulation to the eye prior to placing a contact lens on the eye.
Regarding the phrase "placing a treated contact lens on said eye of said subject for a duration sufficient to increase the surface temperature of the external surface of said treated contact lens relative to that of an untreated contact lens", Cooper's Example 1 teaches allowing the patient to wear 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 said composition and a contact lens to a patient’s eye where 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 the
treated contact lens that is on the eye of said subject as compared to that of the untreated contact lens that is on the eye of said 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 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 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
surf ace 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 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 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 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 14, the claimed concentration range is obvious because it encompasses 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 Fl27 (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 claims 19 and 20, the "wherein" clauses describe the effect of the claimed method. Cooper’s method 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.
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 placing a drop of the composition in the eye followed by placing a contact lens and wearing the contact lens for 8 hours because Cooper teaches administering a drop of a composition into the eye followed by placing a contact lens into the eye and having the patient wear 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 eye of said patient" 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 "placing a treated contact lens on said affected eye of said patient for a duration sufficient to increase the temperature of the external surface of said treated contact lens relative to that of an untreated contact lens“ is obvious because Cooper teaches a step of contacting the eye of a patient with a drop of a pharmaceutical composition comprising PLL-g-PEG in a concentration of 0.001-40 % by weight (paragraph 0003), which contain a positively charged moiety PLL and a hydrophilic moiety PEG, 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 “wherein said treated contact lens is a contact lens that is contacted with a pharmaceutical composition comprising a copolymer having a positively charged moiety and a hydrophilic moiety only after said placement on the surface of said affected eye of said patient” is met because Cooper teaches embodiments where a drop of the formulation is administered to the eye of a patient followed by placement of a contact lens on the eye, and the contacting of the formulation and the contact lens would have only occurred after the placement of the contact lens on the surface of the eye.
The phrase “thereby increasing the external surface temperature of the treating contact lens on said affected eye of said patient as compared to that of the untreated contact lens and increasing the temperature of said affected eye” describes an intended result of a method step positively recited. In the instant case, Cooper teaches the same method steps as claimed and the would have been the same as instantly claimed because method steps are met.
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 drop of a formulation containing 0.001-40 wt.% of PLL-g-PEG followed by placing a contact lens on the eye 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 administering a drop of the composition into the eye followed by placing a contact lens on to the eye because Cooper teaches an embodiment where the formulation is provided as a drop to be used prior to placing the lens in the eye (paragraph 0131). In example 1, Cooper teaches 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 "comprising increasing the temperature of the affected eye of said patient" 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 "placing a treated contact lens on said affected eye of said patient for a duration sufficient to increase the temperature of the external surface of said treated contact lens relative to that of an untreated contact lens“ is obvious because Cooper teaches a step of contacting the eye of a patient with a drop of a pharmaceutical composition comprising PLL-g-PEG in a concentration of 0.001-40 % by weight (paragraph 0003), which contain a positively charged moiety PLL and a hydrophilic moiety PEG, 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 “wherein said treated contact lens is a contact lens that is contacted with a pharmaceutical composition comprising a copolymer having a positively charged moiety and a hydrophilic moiety only after said placement on the surface of said affected eye of said patient” is met because Cooper teaches embodiments where a drop of the formulation is administered to the eye of a patient followed by placement of a contact lens on the eye, and the contacting of the formulation and the contact lens would have only occurred after the placement of the contact lens on the surface of the eye.
The "thereby" clause 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.
Regarding claims 32, 33, and 35, Cooper teaches using the formulation as rewetting drops (paragraph 0131). The skilled artisan would have understood this teaching to mean that Cooper intended to administer the formulation as a drop to a contact lens that is already placed on the eye of subject. Thus, the claimed limitations are obvious because it would have been obvious to have applied the contact lens to the eye of a subject and applied a drop of the formulation to the contact lens that is on the eye. Furthermore, Cooper does not limit the order in which the combination of formulation and contact lens is administered to the patient and there are three ways in which the two components can be administered. Cooper exemplified placing a drop of the formulation on a contact lens and subsequently applying the combination to the eye. Alternatively, it would have been obvious, in view of the teachings in paragraph 0131, to apply a drop of the formulation into the eye first followed by applying a contact lens or applying a contact lens to the eye followed by applying a drop of the formulation onto the contact lens that has been placed on the eye.
Claims 26 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper as applied to claims 1-12, 14-17, 19-25, 27, 32, 33, and 35 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 l 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, 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 placing a drop of the composition in the eye followed by placing a contact lens and wearing the contact lens for 8 hours because Cooper teaches administering a drop of a composition into the eye followed by placing a contact lens into the eye and having the patient wear 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.
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 "comprising increasing the temperature of the affected eye of said patient" 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 "placing a treated contact lens on said affected eye of said patient for a duration sufficient to increase the temperature of the external surface of said treated contact lens relative to that of an untreated contact lens“ is obvious because Cooper teaches a step of contacting the eye of a patient with a drop of a pharmaceutical composition comprising PLL-g-PEG in a concentration of 0.001-40 % by weight (paragraph 0003), which contain a positively charged moiety PLL and a hydrophilic moiety PEG, 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 “wherein said treated contact lens is a contact lens that is contacted with a pharmaceutical composition comprising a copolymer having a positively charged moiety and a hydrophilic moiety only after said placement on the surface of said affected eye of said patient” is met because Cooper teaches embodiments where a drop of the formulation is administered to the eye of a patient followed by placement of a contact lens on the eye, and the contacting of the formulation and the contact lens would have only occurred after the placement of the contact lens on the surface of the eye.
The phrase “thereby increasing the external surface temperature of the treating contact lens on said affected eye of said patient as compared to that of the untreated contact lens and increasing the temperature of said affected eye” describes an intended result of a method step positively recited. In the instant case, Cooper teaches the same method steps as claimed and the would have been the same as instantly claimed because method steps are met.
The phrase "thereby treating said chalazion 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 chalazion.
Regarding claim 34, Cooper teaches using the formulation as rewetting drops (paragraph 0131). The skilled artisan would have understood this teaching to mean that Cooper intended to administer the formulation as a drop to a contact lens that is already placed on the eye of subject. Thus, the claimed limitations are obvious because it would have been obvious to have applied the contact lens to the eye of a subject and applied a drop of the formulation to the contact lens that is on the eye. Furthermore, Cooper does not limit the order in which the combination of formulation and contact lens is administered to the patient and there are three ways in which the two components can be administered. Cooper exemplified placing a drop of the formulation on a contact lens and subsequently applying the combination to the eye. Alternatively, it would have been obvious, in view of the teachings in paragraph 0131, to apply a drop of the formulation into the eye first followed by applying a contact lens or applying a contact lens to the eye followed by applying a drop of the formulation onto the contact lens that has been placed on the eye.
Maintained 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 Langi, 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 l.32l(c) or l.32l(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 l.32l(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 LB. I.
For a reply to a non-final Office action, see 37 CFR 1.11 l(a). For a reply to final Office action,
see 3 7 CFR 1.113 ( c). A request for reconsideration while not provided for in 3 7 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/ AIN26) 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 autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12, 14-17, 19-27, and 32-35 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 as described above in order to arrive at the claimed invention. 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 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 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 I 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 I I 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.
Regarding claims 32-35, Cooper teaches using the formulation as rewetting drops (paragraph 0131). The skilled artisan would have understood this teaching to mean that Cooper intended to administer the formulation as a drop to a contact lens that is already placed on the eye of subject. Thus, the claimed limitations are obvious because it would have been obvious to have applied the contact lens to the eye of a subject and applied a drop of the formulation to the contact lens that is on the eye. Furthermore, Cooper does not limit the order in which the combination of formulation and contact lens is administered to the patient and there are three ways in which the two components can be administered. Cooper exemplified placing a drop of the formulation on a contact lens and subsequently applying the combination to the eye. Alternatively, it would have been obvious, in view of the teachings in paragraph 0131, to apply a drop of the formulation into the eye first followed by applying a contact lens or applying a contact lens to the eye followed by applying a drop of the formulation onto the contact lens that has been placed on the eye.
Allowed Claims
Claims 28-31 are allowed because it would not have been obvious to the skilled artisan to modify Cooper’s method by measuring the temperature of the ocular surface as required by claim 28.
Response to Arguments
Applicant’s arguments submitted in the remarks dated April 28, 2026, 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 the office action has been modified to address the newly added claims and newly added limitations. Cooper is not limited by its exemplified method where a drop of a formulation is applied to a contact lens in vitro followed by placing the combination on to the eye. It is apparent from Cooper’s teachings as a whole that Cooper intended applying a drop of the formulation on the eye followed by applying a lens to the eye, and by placing a contact lens to the eye followed by applying a drop to the contact lens placed on the eye (paragraph 0131). It is also noted that claims 1 and 25-27 are not limited to the embodiment comprising placing a contact lens on to the eye and then administering the formulation to the lens that has been placed on the eye. The claims require contacting of the lens and the formulation to occur on the eye, which encompasses an embodiment where a drop of the formulation is administered to the eye and the contact lens is subsequently placed on the eye that has been treated with the formulation.
Double patenting rejections are maintained because applicant did not provide reasons for traversing the rejection and stated that a terminal disclaimer will be filed once the claims are otherwise found allowable.
Applicant’s rebuttal (on pages 18-19) to examiner’s arguments is not persuasive because Cooper teaches treating a contact lens in vivo as required by the claims and the examiner maintains that the intended purpose of the claimed method and the effects of the claimed method would have been present in Cooper’s method because Cooper’s method meets all of the structural requirements of the claimed method.
Conclusion
Claims 28-31 are allowed. Claims 1-12, 14-17, 19-27, and 32-35 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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