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 .
Claims 30-49 are presented for examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 44-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 44-46 are indefinite as to the expression “OSDI”. The phrase fails to set forth the intended meaning.
Claim 48 is indefinite as to the expression “PAM”. The phrase fails to set forth the intended meaning.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 30-49 are is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Alster (U.S. Patent 9,463,201) and as evidenced by Mierdel et al. (Ocular optical aberrometer for clinical use), Gus et al. (Potential acuity meter accuracy in cataract patients) and Ocular Surface Disease Index (OSDI) Questionnaire (submitted by the applicant).
Regarding claim 30, Alster et al. teach the use of selenium disulfide for the treatment of meibomian gland and removal of keratinized obstruction of the meibomian gland. See column 1, lines 20- 27, column 4, line 7, column 8, line 52, and column 10, lines 38-58, Example 3. The administration, which reaches the eyelid margin of the patient is taught in column 2, lines 1-10 and claims 1-3. The use of a carrier is taught in column 2, lines 18-20 and claim 27. Alster et al., do not specifically teach the improvement of vision using selenium disulfide. However, the improvement of vision is the inherent property of applying selenium disulfide to the eye or the eyelid of a subject as taught by Alster. Measuring of the vison improvement is considered to be within the skill of artisan as evidenced by Mierdel et al. and Gus et al. and Ocular Surface Disease Index (OSDI) Questionnaire (submitted by the applicant). The means for measuring the vision improvement do not create a patentably distinct method of improving vison.
Regarding claim 31, Alster et al. teaches the periodical administration of selenium disulfide to the eye of the subject. See column 1, lines 47-49 and claim 8.
Regarding claim 32, Alster et al. teach the administration of once a day for two weeks. See column 3, lines 1-10.
Regarding claim 33, Alster et al. teach the administration of once a day for several weeks, which encompasses one month. See column 3, lines 1-10.
Regarding claim 34, Alster et al. teach the administration of selenium sulfide once a week. See column 3, lines 1-10.
Regarding claim 35, Alster teaches the administration of selenium disulfide of twice a week. See column 4, lines 48-51.
Regarding claim 36, the determination of the patient population is considered to be within the skill of artisan. Furthermore, Alster teaches that Meibomian gland dysfunction can lead to posterior blepharitis, which is not dry eye.
Regarding claim 37, Alster does not teach that the patient wears a contact lens.
Regarding claims 38-39, Alster et al. teach the composition comprises 0.1% to 10% selenium disulfide. In some embodiments, the composition comprises at least 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, or greater selenium disulfide. See column 10, lines 38-46.
Regarding claim 40, the administration to different parts of the eye, such as conjunctiva, would have been obvious to a person skilled in the art in the art.
Regarding claim 41, the use of a suspension is taught in column 10, lines 54-56.
Regarding claim 42, Alster et al. teach that the composition is hydrophilic. See claim 14.
Regarding claim 43, Alster et al. teach the composition comprises an oleaginous base. See claim 15.
Regarding claim 44-46 the use of a specific questionnaire and measuring the visual function is considered to be within the skill of artisan. Furthermore, (Ocular surface disease index (OSDI) (submitted by the applicant), Mierdel et al. and Gus et al. teach the use of a questionnaire, PAM and Aberrometer in determining visual improvement.
Regarding claim 47, the use of selenium disulfide as taught by Alster et al., which is used for treating dry eye is expected to help with the visual acuity and performing daily activities, such as reading, driving at night and working with a computer.
Regarding claims 48 and 49, using different measuring means for measuring visual acuity is considered to be within the skill of artisan as evidenced by the article by Gus et al., which teaches PAM for measuring visual acuity as claimed in claim 38 and article by Mierdel, which teaches Aberrometer for measuring visual acuity as claimed in claim 49.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
7. Claim(s) 30-49 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Alster et al. (U.S. Patent 9,463,201) in view of Goto et al. (Impaired Functional Visual Acuity of Dry Eye Patients) and further in view of Wong et al. (submitted by the applicant), Ocular Surface Disease Index (OSDI) Questionnaire (submitted by the applicant), Mierdel et al. (Ocular optical aberrometer for clinical use) and Gus et al. (Potential acuity meter accuracy in cataract patients).
The claims are drawn to A method of improving vision in an individual in need thereof, the method comprising providing to the individual a composition comprising selenium disulfide in an ophthalmically or pharmaceutically acceptable vehicle or carrier, the composition being administered to the eyelid or the eye of the individual in a manner suitable to deliver the selenium disulfide to an eyelid margin of the eyelid or ocular surface of the individual wherein the vision improvement of the individual is measured using:
a. a questionnaire about their visual function; b. a subjective measure; or c. an objective measure.
Regarding claim 30, Alster et al. teach the use of selenium disulfide for the treatment of meibomian gland and removal of keratinized obstruction of the meibomian gland (column 1, lines 20- 27, column 4, line 7, column 8, line 52, and column 10, lines 38-58, Example 3. The administration, which reaches the eyelid margin of the patient is taught in column 2, lines 1-10 and claims 1-3. The use of a carrier is taught in column 2, lines 18-20 and claim 27. Alster et al., do not specifically teach the improvement of vision using selenium disulfide. However, Goto et al. teach the visual function of dry eye patients becomes abnormal with ocular surface irregularity when the eye is kept open for 10–20 seconds. Our data indicate impaired visual function in dry eye patients while gazing. Functional visual acuity may be important in daily activities. See the abstract. It would have been obvious to use selenium disulfide used for treating dry eye and use it for improving vision motivated by the teachings of Goto which teaches dry eye attributes to lower visual acuity. Measurement of vision improvement is taught by (Ocular surface disease index (OSDI), submitted by the applicant, Gus et al. and Mierdel et al., which teach that OSDI, PAM and Aberrometer for measuring visual acuity as old and well known.
Regarding claim 31, Alster et al. teach the periodical administration of selenium disulfide to the eye of the subject. See column 1, lines 47-49 and claim 8.
Regarding claim 32, Alster et al. teach the administration of once a day for two weeks. See column 3, lines 1-10.
Regarding claim 33, Alster et al. teach the administration of once a day for several weeks, which encompasses one month. See column 3, lines 1-10.
Regarding claim 34, Alster et al. teach the administration of selenium sulfide once a week. See column 3, lines 1-10.
Regarding claim 35, Alster teaches the administration of selenium disulfide of twice a week. See column 4, lines 48-51.
Regarding claim 36, Wong et al. teach the use of selenium disulfide (Selsun) for the treatment of marginal blepharitis. See the abstract. The application to the eyelid is taught in the summary. Such use will inherently improves the vison. Wong does not teach that the patient has dry eye syndrome.
Regarding claim 37, Alster does not teach that the patient wears a contact lens.
Regarding claims 38 and 39, Alster et al. teach the composition comprises 0.1% to 10% selenium disulfide. In some embodiments, the composition comprises at least 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, or greater selenium disulfide. See column 10, lines 38-46.
Regarding claim 40, the administration to different parts of the eye, such as conjunctiva, would have been obvious to a person skilled in the art in the art.
Regarding claim 41, the use of a suspension is taught in column 10, lines 54-56.
Regarding claim 42, Alster et al. teach that the composition is hydrophilic. See claim 14.
Regarding claim 43, Alster et al. teach the composition comprises an oleaginous base. See claim 15.
Regarding claim 44-46 the use of a specific questionnaire and measuring the visual function is taught by (Ocular surface disease index (OSDI), submitted by the applicant. The specific improvement in vison is the inherent property of using the same composition as claimed herein by ophthalmic administration for the treatment of dry eye as taught by Alster et al.
Regarding claim 47, Goto et al. teach that Stable visual acuity after extended periods of eye opening for 10–20 seconds without blinking may be important in daily activities, especially in dry eye patients. Dry eye is not only a simple disorder causing patients’ discomfort with deteriorated quality of life, but also causes impaired visual function in daily life. Therefore, the use of selenium disulfide as taught by Alster et al., which is used for treating dry eye is expected to help with the visual acuity and performing daily activities.
Regarding claims 48 and 49, Gus teaches the use of PAM for measuring visual acuity as claimed in claim 48. Mierdel teaches Aberrometer for measuring visual acuity as claimed in claim 49.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 30-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-18 of U.S. Patent No. 9,463,201. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap. The claims of the instant application are drawn to a method improving vision using a composition comprising selenium disulfide and a pharmaceutically acceptable carrier, wherein the composition is administered to the eyelid or eye of an individual. The claims of the U.S. Patent are drawn to a method for treating meibomian gland dysfunction in a patient in need thereof, comprising topically administering to the patient a composition that reaches the eyelid margin of the patient, wherein the composition comprises a therapeutically-effective amount of selenium disulfide. The improvement of the vision is the inherent property of claims of the U.S. Patent, which uses the same composition as the claimed invention by topical ophthalmic administration. The measurement of visual acuity is considered to be within the skill of the artisan, as evidenced by Mierdel et al., Gus et al and (Ocular surface disease index (OSDI), submitted by the applicant. Measurement of the visual acuity does not create a patentably distinct method of use.
Claims 30-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,517,586. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap. The claims of the instant application are drawn to a method improving vision using a composition comprising selenium disulfide and a pharmaceutically acceptable carrier, wherein the composition is administered to the eyelid or eye of an individual. The claims of the U.S. Patent are drawn a method for treating a disease or disorder in or around the eye in an individual in need thereof, the method comprising: administering a therapeutically effective amount of a pharmaceutical composition to an ocular surface, surrounding ocular tissues, or a combination thereof of the individual; wherein the pharmaceutical composition comprises a therapeutically effective amount of selenium disulfide (SeS.sub.2); and wherein the pharmaceutical composition is administered within an hour of bedtime or at nighttime. The administration at bedtime or nighttime are within the scope of the claims of the instant application. The use or questionnaire to any other method for measuring the vision improvement is considered to be within the skill of artisan, as evidenced by Mierdel et al., Gus et al. and (Ocular surface disease index (OSDI), submitted by the applicant. Measuring the vison improvement does not create a patentably distinct method of use.
Claims 30-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 46-65 of copending Application No. 18,075,161 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of the instant application are drawn to a method improving vision using a composition comprising selenium disulfide and a pharmaceutically acceptable carrier, wherein the composition is administered to the eyelid or eye of an individual. The claims of the copending application are drawn to a method for treating a disease or disorder in or around the eye of an individual in need thereof, the method comprising:
administering a therapeutically effective amount of a pharmaceutical composition to an ocular surface, surrounding ocular tissues, or a combination thereof of the individual,
wherein the pharmaceutical composition comprises a therapeutically effective amount of selenium disulfide (SeS2); and
wherein the pharmaceutical composition is administered at bedtime or within an hour of bedtime. Administering at bedtime or within an hour of bedtime is within the scope of the claims of the instant application. Measuring the improvement of the vision is considered to be within the skill of artisan, as evidenced by Mierdel et al., Gus et al and (Ocular surface disease index (OSDI)”, submitted by the applicant. Such measurement does not create a patentably distinct method of use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617