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 .
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 1-3, 5-6 and 13-28 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 1-3, 5-6 and 13-28 are considered indefinite because the claims refer to the particular findings of a subject or subjects, which is fairly subjective and cannot be positively defined by the limitations as claimed.
The claims require that a subject show a decreases in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score.
Page 5 of the instant specification states:
As used herein, “clinical signs or symptoms of blepharitis” include redness and burning sensation of the eyes, itching, gritty irritation of the eyelids, flaking of skin around the eyes, redness and swelling of the eyelids, crusted scales on the eyelashes, frothy tears, sensitivity to light, loss of eyelashes, misdirected growth of eyelashes, a greasy appearance to the eyelids, sticky secretions near the eyelashes, dry eye sensation, redness in the eyelid margins, tearing, and any combination thereof.
As used herein, the “total clinical signs and symptom score” refers to the score obtained by addition of the “individual clinical sign and symptom score” associated with blepharitis, such as eyelid swelling, eyelid redness, eyelid debris, and eyelid irritation. Wherein, the “individual clinical sign and symptom score” are evaluated and scored using a 0 to 3 grading scale. For blepharitis, the individual clinical scores (eyelid swelling, eyelid redness, eyelid debris) are evaluated and scored using a 0 to 3 grading scale (in general, 0=none, 1=mild, 2=moderate, and 3=severe). The symptom of eyelid irritation is also evaluated and graded by the participant using a 0 to 3 grading scale (0=almost none of the time—≤25% of the time; 1=occasionally—26-50% of the time; 2=frequently—51-75% of the time; 3=almost all of the time—≥76% of the time). The individual clinical sign and symptom score and the total clinical signs and symptom score of subjects are measured at each scheduled visit. For the purpose of present invention, the efficacy analysis is based on whether or not a subject's Day 15 total clinical signs and symptom score had decreased by at least 2 units from Day 1 (baseline) score, with no increase in individual sign and symptom score.
The scope of the claims is unclear.
There is no distinction between total and individual clinical signs and symptoms and the grading of the participant is subjective. One subject may grade a symptom as mild while a different subject with the same symptom may consider it moderate. There does not appear to be a clear delineation of grading criteria, and therefore, the claim appears indefinite because the bounds for determining the method steps is unclear.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 4-5, 7-12 and 16-19 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Bowman et al. (US 2010/0227842).
With respect to claims 4 and 7, Bowman et al. (hereinafter “Bowman”) discloses a composition comprising 0.1% w/w of dexamethasone in an ophthalmically acceptable vehicle for use in the treatment of active, symptomatic (cl. 7) blepharitis as set forth in [0001-0007].
As to claim 5, Bowman discloses a composition administered to a subject suffering from blepharitis two times a day [0019] for at least 14 days as set forth in [0066].
With reference to claim 8, Bowman discloses a kit comprising:
(a) a composition comprising about 0.1% w/w of dexamethasone in an ophthalmically acceptable vehicle [0052]; and
(b) instruction for using the said composition for the treatment of blepharitis, ocular pain or both as set forth in [0055].
As to claim 9, Bowman discloses a kit wherein the kit further comprises a delivery device for administering the composition, a cleaning apparatus and a cleaning solution as set forth in [0053].
Regarding claim 10, Bowman discloses a kit wherein the delivery device for administering the composition is selected from a bottle, a dropper, a cup, specialized eye-wash apparatus, wetted towel and sponge as set forth in [0053].
With respect to claim 11, Bowman discloses a kit wherein the cleaning apparatus is selected from a towel, pad, cloth, brush and sponge as set forth in [0053].
As to claim 12, Bowman discloses a kit wherein the cleaning solution is selected from purified water, a detergent solution and a boric acid solution as set forth in [0053].
Regarding claims 16-19, Bowman discloses a method of treating blepharitis (cl. 17), an ocular infective condition, comprising administering to an affected eye an effective amount, considered as 0.1% w/w [0007] of a glucocorticoid (cl. 18) as an active ingredient (cl. 19), in an ophthalmically acceptable vehicle [0007,0022] for a sufficient period of time as set forth in [0066].
Claim 13 is rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Lindstrom et al. (US 2013/0165419).
With reference to claim 13, Lindstrom et al. (hereinafter “Lindstrom”) discloses a method of preventing ocular pain [0029] in a subject undergoing ocular surgery [0026, 0038] comprising administering to an affected eye of a subject a composition comprising 0.1% w/w of dexamethasone [0114] in an ophthalmically acceptable vehicle as set forth in [0008].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman et al. (US 2010/0227842).
With respect to claims 1-2, Bowman discloses a method of treating active, symptomatic (cl. 2) blepharitis [0001-0007] comprising administering to an affected eye of a subject a composition comprising 0.1% w/w of dexamethasone in an ophthalmically acceptable vehicle as set forth in [0006-0007].
The difference between Bowman and claim 1 is the explicit recitation that the subject shows a decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score.
While Bowman is silent as to a specific decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score, one of ordinary skill in the art would reasonably expect the composition of Bowman to produce the same result with respect to the decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score since Bowman discloses the same composition as that disclosed to produce the desired decrease in total clinical signs and symptom score.
It is noted that:
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
As to claim 3, Bowman discloses a composition administered to a subject suffering from blepharitis two times a day [0019] for at least 14 days as set forth in [0066].
With reference to claim 6, Bowman teaches the invention substantially as claimed as set forth in the rejection of claim 4.
The difference between Bowman and claim 6 is the explicit recitation that the subject shows a decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score.
While Bowman is silent as to a specific decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score, one of ordinary skill in the art would reasonably expect the composition of Bowman to produce the same result with respect to the decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score since Bowman discloses the same composition as that disclosed to produce the desired decrease in total clinical signs and symptom score.
It is noted that:
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With respect to claim 20-21, Bowman discloses a method of treating active, symptomatic (cl. 21) blepharitis [0001-0007] comprising administering to an affected eye of a subject an effective amount of an active ingredient in an ophthalmically acceptable vehicle for a sufficient period of time as set forth in [0018].
The difference between Bowman and claim 21 is the explicit recitation that the subject shows a decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score.
While Bowman is silent as to a specific decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score, one of ordinary skill in the art would reasonably expect the composition of Bowman to produce the same result with respect to the decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score since Bowman discloses the same composition as that disclosed to produce the desired decrease in total clinical signs and symptom score.
It is noted that:
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 22, Bowman discloses a method wherein the active ingredient in the ophthalmically acceptable vehicle is administered two times a day [0019] for at least 14 days as set forth in [0066].
As to claim 23, Bowman discloses a method wherein the active ingredient consists essentially of a glucocorticoid as set forth in [0022].
With reference to claim 24, Bowman discloses a method wherein the effective amount of the active ingredient is 0.1% w/w of the active ingredient as set forth in [0019].
Claims 14-15 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Lindstrom et al. (US 2013/0165419).
With reference to claim 14, Lindstrom teaches the invention substantially as claimed as set forth in the rejection of claim 13.
The difference between Lindstrom and claim 14 is the explicit recitation that the subject shows a decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score.
While Lindstrom is silent as to a specific decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score, one of ordinary skill in the art would reasonably expect the composition of Lindstrom to produce the same result with respect to the decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score since Bowman discloses the same composition as that disclosed to produce the desired decrease in total clinical signs and symptom score.
It is noted that:
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
As to claim 15, Lindstrom teaches the invention substantially as claimed as set forth in the rejection of claim 13.
The difference between Lindstrom and claim 15 is the provision that the composition is administered two times a day, one day prior surgery, on the day of surgery and 14 days post-surgery.
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the composition of Lindstrom as often as desired because Lindstrom teaches that the treated may be administered as many times each day as necessary as set forth in [0109].
With reference to claim 25, Lindstrom discloses a method of preventing ocular pain [0029] in a subject undergoing ocular surgery [0026, 0038] comprising administering to an affected eye of a subject an effective amount of an active ingredient in an ophthalmically acceptable vehicle [0095-0097] for a sufficient period of time as set forth in [0003].
The difference between Lindstrom and claim 25 is the explicit recitation that the subject shows a decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score.
While Lindstrom is silent as to a specific decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score, one of ordinary skill in the art would reasonably expect the composition of Lindstrom to produce the same result with respect to the decrease in total clinical signs and symptom score at day 15 by at least 2 units from day 1 with no increase in individual clinical sign and symptom score since Bowman discloses the same composition as that disclosed to produce the desired decrease in total clinical signs and symptom score.
It is noted that:
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
As to claim 26, see the rejection of claim 15.
With respect to claim 27, Lindstrom discloses a method wherein the active ingredient consists essentially of a glucocorticoid as set forth in [0041].
With reference to claim 28, Lindstrom discloses a method wherein the effective amount of the active ingredient is 0.1% w/w of the active ingredient as set forth in [0114].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brubaker et al. (US 2010/0022465) discloses a method of treating blepharitis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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/MICHELE KIDWELL/ Primary Examiner, Art Unit 3781