DETAILED ACTION
Election/Restrictions
Applicant’s election of species for ocular graft-versus-host disease in the reply filed on 01/28/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon review, the election of species is expanded to include dry eye and Sjogren’s.
Status of Application
Applicant has elected the species for ocular graft-versus-host disease for the examination.
Upon review, the election of species is expanded to include dry eye and Sjogren’s.
Due to restriction, based on election of species, claims 4 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species.
Claims 1-16 are pending.
Claims 1-3, 5-16 are present for examination at this time.
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.
Claim 13 is 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.
Claim 13 recites the limitation "the corticosteroid composition comprises from 0.05% to 1% corticosteroid" in claim 8. There is insufficient antecedent basis for this limitation in the claim as it is broader than that of claim 8 which is to loteprednol etabonate ointment.
Claim 14 is 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.
Claim 14 recites the limitation "the corticosteroid composition" in claim 8. There is insufficient antecedent basis for this limitation in the claim as it is broader than that of claim 8 which is to loteprednol etabonate ointment.
Claims 9-10, 13, 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims recite percent values “%” without units of measure wherein it is unclear what the percent is directed to. For purposes of examination, it is treated as % w/w.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 recites the limitation " the corticosteroid composition comprises from 0.05% to 1% corticosteroid " which is broader than the recited loteprednol etabonate ointment of claim 8 and fails to further limit the claim. Applicant may cancel the claim(s), amend the claim to place the claim in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14 recites the limitation "the corticosteroid composition" which is broader than the recited specific loteprednol etabonate ointment of claim 8 and fails to further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-3, 5-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (U.S. Pat. Pub. 2018/0064728) in view of Jain et al. (U.S. Pat. Pub. 2019/0000871) and Sabti et al. (Punctal occlusion is safe and efficient for the treatment of keratoconjunctivitis sicca in patients with ocular GvHD-abstract only)
Rejection:
Chang et al. teaches treating a neurodegenerative condition like the exemplified ocular graft-versus-host disease with the topical administration of a composition containing progesterone (sex steroid) to the forehead, like the exemplified 1% progesterone gel that was 0.5-1mg per dose (abstract, Figure 2, Example 3-6, [100-116, 147]). The composition can be applied more than once per day [45] with the sex steroid i.e. progesterone, at a dose from 0.001-30mg/day [48]. Example 3 had topical application of 1% progesterone gel for ocular graft-versus-host disease twice a day (0.5-1mg per dose, twice a day=1mg-2mg day), Example 5 had topical application of 1% progesterone gel for ocular graft-versus-host disease once a day (0.5-1mg per dose once a day=0.5mg-1mg day, see full document specifically areas cited).
Chang et al. does not expressly teach the topical administration of a corticosteroid to the eye with punctal plugs, but does teach treating ocular graft-versus-host disease with progesterone and combination therapy.
Jain et al. teaches treating inflammatory ocular condition like ocular graft-versus-host disease (oGVHD) with the topical administration of heparin and optionally a second active like a steroid such as loteprednol etabonate from about 0.01-about 2%w/w and typically from about 0.05-about 1%w/w (abstract, claims 8-9,[15, 17, 19, 56, 58-59, 68], i.e. Example 15 and 27). The steroid can be given once a day [124] and the composition can be in the form of an ointment [11, 13] and the inclusion of substances capable of treating ocular surface disorders like punctal plugs [105].
Sabti et al. teaches that punctal plugs achieve significant improvement in symptoms in ocular GVHD.
Wherein it would be obvious to one of ordinary skill in the art to topically administer corticosteroids to the eye with punctal plugs as suggested by Jain et al. and Sabti et al. and produce the claimed invention; as it is prima facie obvious to incorporate known means for treating ocular graft-versus-host disease (oGVHD) and its dry eye symptoms - like corticosteroids (i.e. loteprednol etabonate and heparin in ointment with punctal plugs) for their additive effects with a reasonable expectation of success. While the prior art does not teach the exact claimed value for the steroid (i.e. 0.5% loteprednol etabonate) instantly claimed for claim 16, it is embraced by the prior art range (about 0.05-about 1%w/w) wherein it would be prima facie obvious to optimize within the taught range as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 1-3, 5-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (U.S. Pat. Pub. 2015/0216877) in view of Jain et al. (U.S. Pat. Pub. 2019/0000871).
Rejection:
Chang et al. teaches treating dry eye syndrome (aka keratoconjunctivitis sicca) with the topical administration of a composition containing progesterone to the forehead (claims 22-26, 28-30). The progesterone is from about 0.05-about 4%w/w progesterone like about 0.1-about 2.0%w/w progesterone and the exemplified 1% progesterone composition (claims 28-29 and Example 2), can be applied at least once a day or twice a day [30], and where the effective amount of progesterone is from about 0.05-5mg (claim 30) which can be per dose or application ([25], twice a day=0.10-10mg day). It can be in combination with one or more additional therapies including punctal plugs and steroids [27]. Example 3 exemplifies treating dry eye with 1% progesterone with punctal plugs ([46], see full document specifically areas cited).
Chang et al. does not expressly teach the topical administration of a corticosteroid to the eye, but does teach treating the dry eye in combination with one or more additional therapies like corticosteroids.
Jain et al. teaches treating inflammatory ocular conditions like dry eye including dry eye caused by ocular graft-versus-host disease (oGVHD), with the topical administration of heparin and optionally a second active like a steroid such as loteprednol etabonate from about 0.01-about 2%w/w and typically from about 0.05-about 1%w/w (abstract, claims 8-9, [15, 17, 19, 29, 56, 58-59, 68], Figure 2, i.e. Example 1, 11-12, 15,27). The steroid is exemplified to be in combination with the heparin (example 11) and it is known that steroid can be given once a day [124], and the composition can be in the form of an ointment [11, 13].
Wherein it would be obvious to one of ordinary skill in the art to topically administer corticosteroids to the eye as suggested by Jain et al. and produce the claimed invention; as Chang et al. teaches the inclusion of corticosteroids and it is prima facie obvious to incorporate the known topical means for applying corticosteroids for treating dry eye such as the dry eye from ocular graft-versus-host disease (oGVHD) with corticosteroids (i.e. loteprednol etabonate and heparin in ointment) for their additive effects with a reasonable expectation of success. While the prior art does not teach the exact claimed value for the steroid (i.e. 0.5% loteprednol etabonate) instantly claimed for claim 16, it is embraced by the prior art range (about 0.05-about 1%w/w) wherein it would be prima facie obvious to optimize within the taught range as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
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 1-3, 5-8, 12, 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 8, 13-14 of U.S. Patent No. 10098895 in view of Jain et al. (U.S. Pat. Pub. 2019/0000871) and Sabti et al. (Punctal occlusion is safe and efficient for the treatment of keratoconjunctivitis sicca in patients with ocular GvHD-abstract only).
The patented claims are directed to a method of treating ocular graft-versus-host disease with the topical administration of a sex steroid that is progesterone or testosterone, and/or a cannabinoid. The dependent patented claims are directed to the dose of the sex steroid like progesterone and the composition form.
The patented claims does not expressly teach the topical administration of a corticosteroid to the eye with punctal plugs, but does teach treating ocular graft-versus-host disease with progesterone and combination therapy.
Jain et al. teaches treating inflammatory ocular condition like ocular graft-versus-host disease (oGVHD) with the topical administration of heparin and optionally a second active like a steroid such as loteprednol etabonate from about 0.01-about 2%w/w and typically from about 0.05-about 1%w/w (abstract, claims 8-9,[15, 17, 19, 56, 58-59, 68], i.e. Example 15 and 27). The steroid can be given once a day [124] and the composition can be in the form of an ointment [11, 13] and the inclusion of substances capable of treating ocular surface disorders like punctal plugs [105].
Sabti et al. teaches that punctal plugs achieve significant improvement in symptoms in ocular GVHD.
Wherein it would be obvious to one of ordinary skill in the art to topically administer corticosteroids to the eye with punctal plugs as suggested by Jain et al. and Sabti et al. and produce the claimed invention; as it is prima facie obvious to incorporate known means for treating ocular graft-versus-host disease (oGVHD) and its dry eye symptoms - like corticosteroids (i.e. loteprednol etabonate and heparin in ointment with punctal plugs) for their additive effects with a reasonable expectation of success. While the prior art does not teach the exact claimed value for the steroid (i.e. 0.5% loteprednol etabonate) instantly claimed for claim 16, it is embraced by the prior art range (about 0.05-about 1%w/w) wherein it would be prima facie obvious to optimize within the taught range as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 9-11, 13, 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 8, 13-14 of U.S. Patent No. 10098895 in view of Jain et al. (U.S. Pat. Pub. 2019/0000871) and Sabti et al. (Punctal occlusion is safe and efficient for the treatment of keratoconjunctivitis sicca in patients with ocular GvHD-abstract only) as applied to claims 1-3, 5-8, 12, 14-15 above, further in view of Chang et al. (U.S. Pat. Pub. 2018/0064728).
The teachings of the patented claims in view of Jain et al. and Sabti et al. are addressed above.
The patented claims in view of Jain et al. and Sabti et al. does not expressly teach the concentration of the progesterone applied to the forehead.
Chang et al. teaches that topical administration of a composition containing progesterone (sex steroid) to the forehead, can be at 1% progesterone gel that was 0.5-1mg per dose (abstract, Figure 2, Example 3-6, [100-116, 147]). Example 3 had topical application of 1% progesterone gel for ocular graft-versus-host disease twice a day (0.5-1mg per dose, twice a day=1mg-2mg day), Example 5 had topical application of 1% progesterone gel for ocular graft-versus-host disease once a day (0.5-1mg per dose once a day=0.5mg-1mg day).
Wherein it would be obvious to one of ordinary skill in the art to topically administer the progesterone at 5% as suggested by Chang et al. and produce the claimed invention; as it is prima facie obvious to incorporate the progesterone at its known concentration with a reasonable expectation of success.
Claims 1-2, 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10251835 in view of Jain et al. (U.S. Pat. Pub. 2019/0000871) and Sakai (When Artificial Tears are not Enough).
The patented claims are directed to a method of treating Sjogren’ syndrome (dry eye from Sjogren’s) with the topical administration of progesterone to the forehead. The dependent patented claims are directed to the dose of the progesterone.
The patented claims does not expressly teach the topical administration of a corticosteroid to the eye with punctal plugs, but does teach treating Sjogren’s syndrome with progesterone.
Jain et al. teaches treating inflammatory ocular condition like dry eye such as Sjogren’s syndrome with the topical administration of heparin and optionally a second active like a steroid such as loteprednol etabonate from about 0.01-about 2%w/w and typically from about 0.05-about 1%w/w (abstract, claims 8-9, [15, 17, 19, 58-59, 76], i.e. Example 22). The steroid can be given once a day [124] and the composition can be in the form of an ointment [11, 13] and the inclusion of substances capable of treating ocular surface disorders like punctal plugs [105].
Sakai teaches that punctal plugs are tiny devices inserted into the tear duct so the eyes retain more of their natural moisture and can be temporary or permanent. achieve significant improvement in symptoms in ocular GVHD.
Wherein it would be obvious to one of ordinary skill in the art to topically administer corticosteroids to the eye with punctal plugs as suggested by Jain et al. and Sakai and produce the claimed invention; as it is prima facie obvious to incorporate known means for treating dry eye such as Sjogren’s - like corticosteroids (i.e. loteprednol etabonate and heparin in ointment with punctal plugs) for their additive effects with a reasonable expectation of success.
Claims 1-2, 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-12 of U.S. Patent No. 9925201 in view of Jain et al. (U.S. Pat. Pub. 2019/0000871) and Sakai (When Artificial Tears are not Enough).
The patented claims are directed to a method of treating ocular surface conditions like Sjogren’ syndrome (dry eye from Sjogren’s) with the topical administration of progesterone to the forehead. The dependent patented claims are directed to the dose and concentration of the progesterone.
The patented claims does not expressly teach the topical administration of a corticosteroid to the eye with punctal plugs, but does teach treating Sjogren’s syndrome with progesterone.
Jain et al. teaches treating inflammatory ocular condition like dry eye such as Sjogren’s syndrome with the topical administration of heparin and optionally a second active like a steroid such as loteprednol etabonate from about 0.01-about 2%w/w and typically from about 0.05-about 1%w/w (abstract, claims 8-9, [15, 17, 19, 58-59, 76], i.e. Example 22). The steroid can be given once a day [124] and the composition can be in the form of an ointment [11, 13] and the inclusion of substances capable of treating ocular surface disorders like punctal plugs [105].
Sakai teaches that punctal plugs are tiny devices inserted into the tear duct so the eyes retain more of their natural moisture and can be temporary or permanent. achieve significant improvement in symptoms in ocular GVHD.
Wherein it would be obvious to one of ordinary skill in the art to topically administer corticosteroids to the eye with punctal plugs as suggested by Jain et al. and Sakai and produce the claimed invention; as it is prima facie obvious to incorporate known means for treating dry eye such as Sjogren’s - like corticosteroids (i.e. loteprednol etabonate and heparin in ointment with punctal plugs) for their additive effects with a reasonable expectation of success.
Conclusion
Claims 1-3, 5-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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