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 .
Status
Applicant’s response dated 20 August 2025 to the previous Office action dated 04 June 2025 is acknowledged. Pursuant to amendments therein, claims 1-5, 7-14, and 16-24 are pending in the application.
The drawing objection made in the previous Office action is withdrawn in view of applicant’s submission of acceptable replacement sheets.
The claim objections made in the previous Office action is/are withdrawn in view of applicant’s claim amendments.
New rejections under 35 U.S.C. 112 are made herein in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 102 made in the previous Office action is/are withdrawn in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 103 made in the previous Office action is/are withdrawn in view of applicant’s claim amendments, but new (modified) rejection(s) under 35 U.S.C. 103 is/are made herein in view of applicant’s claim amendments.
The double patenting rejections made in the previous Office action is/are withdrawn in view of applicant’s claim amendments, with the exception of the double patenting rejection set forth below which is maintained.
Drawings
The drawings were received on 20 August 2025. These drawings are acceptable.
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 1-5, 7-14, and 16-18 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 10 recite the broad recitation “one or more nonionic surfactants” (i.e., can comprise only one, two, or three surfactants), and the claims also recite that the one or more nonionic surfactants comprise 4 specific nonionic surfactants (i.e., cannot comprise only one, two, or three surfactants) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 2-5, 7-9, 11-14, and 16-18 are rejected as depending upon claims 1 or 10 without remedying such deficiency.
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 5 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 5 fails to include all the limitations of claim 1 upon which it depends in that claim 1 requires polysorbate 80 yet claim 5 limits the “one or more nonionic surfactants” to not include polysorbates.
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
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 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.
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.
Claims 1-5 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horn (US 2014/0378401 A1; published 25 December 2014; of record).
Horn discloses an ophthalmic drug delivery composition comprising from about 1% to about 15% w/v nonionic surfactant, one or more non-Newtonian high blend viscosity enhancing, non-gelling agents and from about 0.025% to about 0.90% sodium chloride (claim 1) wherein the viscosity agent is from 0.5% to 0.8% w/v HPMC (claim 3) wherein the composition further comprises a therapeutic agent (claim 9) wherein the therapeutic agent is cyclosporine-A (i.e., an active ingredient having logP value of about 4 or more and solubility in deionized water of about 100 ppm or less at 25°C) (claim 10) wherein a preferred embodiment comprises 2% w/v cyclosporine, 5% w/v poloxamer 407 (i.e., nonionic surfactant), 0.25% w/v NaCl, at a pH of 6.0 (Example 7; paragraphs [0297]-[0298]) wherein tonicity adjustors such as sodium chloride, mannitol, glycerin, or combinations thereof are present such as at concentrations of 0.1-1% w/v (paragraph [0249]) wherein the composition may further comprise 1-100 mM citrate or phosphate or sorbate buffer (paragraphs [0035]-[0036]) wherein the nonionic surfactant is preferably polysorbate 80, polyoxyl castor oil, poloxamer 407, poloxamer 188, cyclodextrin, or combinations thereof (paragraph [0033]) wherein nonionic surfactants may be present in concentrations of about 12% w/v or less (paragraph [0106]) wherein the pH of the composition is preferably within a range of 4.0 to 8.0 (paragraph [0114]) wherein the composition may include water (paragraph [0243]) wherein in the composition may include viscosity enhancer such as HPMC (paragraphs [0030], [0032]) such as 0.5-1% w/v HPMC (paragraphs [0044]) wherein the composition may have low concentrations below 0.5% w/v of therapeutic agent (paragraph [0020]) wherein the composition may include preservatives (paragraph [0243]) such as benzalkonium chloride (BAK) (paragraph [0248]) wherein the composition may further comprise a mucoadhesive at a concentration of about 0.5-10% w/v (paragraph [0042]) wherein a mucoadhesive may be CARBOPOLs or cellulose derivatives (paragraph [0043]) wherein cellulose derivatives include hydroxypropyl methyl cellulose (HPMC) (paragraphs [0044], [0134]).
Regarding the claimed recitation of about 1.25-2% w/v HPMC or carbomer viscosity enhancer, 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 follow the suggestions of Horn as discussed above and to make the composition of Horn as discussed above with about 0.5-10% w/v CARBOPOL (i.e., carbomer) or HPMC (i.e., viscosity enhancers) mucoadhesive, with a reasonable expectation of success. Such range of about 0.5-10% w/v overlaps the claimed range of about 1.25-2% w/v, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding the claimed recitations of nonionic surfactant concentrations of about 1-5% w/v polysorbate 80, about 0.1-2% w/v poloxamer 407, about 0.1-5% w/v poloxamer 188, and about 0.001-1% w/v polyoxyl castor oil, 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 follow the suggestions of Horn as discussed above and to make the composition of Horn wherein it comprises about 1% to about 15% w/v or about 12% w/v or less nonionic surfactants of polysorbate 80, poloxamer 407, poloxamer 188, and polyoxyl castor oil, with a reasonable expectation of success. Such ranges of about 1-15% w/v or about 12% w/v or less overlap the claimed ranges of about 1-5, about 0.1-2, about 0.1-5, and about 0.001-1% w/v, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding the claimed recitation of not containing oil, Horn does not disclose oil as a required ingredient in the composition of Horn, and thus 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 follow the suggestions of Horn as discussed above and to make the composition of Horn as discussed above without oil, with a reasonable expectation of success.
Claims 1-5, 7-14, 16-19, and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horn as applied to claims 1-5 and 10-14 above, and further in view of Yu et al. (US 2004/0185068 A1; published 23 September 2004; of record).
Horn is relied upon as discussed above.
Horn does not disclose magnesium chloride as in claims 7-9, 16-19, and 21-24.
Yu et al. discloses ophthalmic compositions including administration of therapeutics to the eye (abstract) wherein tonicity agents are added thereto in amounts ranging from about 0.001 to 2.5 w/v% such as magnesium chloride and/or mannitol to provide sufficient tonicity for maintaining ocular tissue integrity and to approximate the osmotic pressure of normal tear fluid (paragraphs [0079]-[0080]) wherein viscosity modifying agents such as HPMC are added thereto in concentrations of about 0.01-5% w/v (paragraph [0137]).
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 combine the teachings of Horn and Yu et al. by adding about 0.001 to 2.5 w/v% magnesium chloride and/or mannitol as in Yu et al. to the composition of Horn as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to provide sufficient tonicity for maintaining ocular tissue integrity and to approximate the osmotic pressure of normal tear fluid, and because Horn teaches adding tonicity adjustors, and because it is prima facie obvious to combine equivalents (e.g., tonicity adjustors in ophthalmic compositions) known for the same purpose per MPEP 2144.06(I). Such concentration range overlaps the claimed concentration ranges of magnesium chloride of about 0.01-0.5, about 0.05-0.5, about 0.05-0.212, about 0.212, about 0.05% w/v, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I). Such concentration range also overlaps the claimed concentration ranges of mannitol of about 1.25-1.75% w/v in claim 19 and about 1.25% w/v in claim 21, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
It also 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 follow the suggestions of Horn as discussed above and to include in the composition of Horn in view of Yu et al. as discussed above 0.1-1% w/v sodium chloride tonicity adjustor, with a reasonable expectation of success. Such range overlap the claimed range of about 0.35% w/v in claim 21, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claims 19 and 21-24, it also 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 follow the suggestions of Horn as discussed above and to include in the composition of Horn in view of Yu et al. as discussed above low concentrations below 0.5% w/v of therapeutic agent such as cyclosporine-A, with a reasonable expectation of success. Such concentration range overlaps the claimed ranges of about 0.05-0.09, about 0.09, about 0.05, and about 0.075% w/v cyclosporine-A, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Further regarding claims 19 and 21, the concentration range of less than about 12% w/v of nonionic surfactants in the composition of Horn in view of Yu et al. as discussed above overlap the claimed ranges, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Further regarding claim 19, it also 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 follow the suggestions of Horn as discussed above and to include in the composition of Horn in view of Yu et al. as discussed above water as well as 1-100 mM citrate and sorbate buffer, wherein the composition has a pH of 4-8, with a reasonable expectation of success, given that it is prima facie obvious to combine equivalents known for the same purpose (e.g., buffers) per MPEP 2144.06(I). Such concentration range of citrate buffer overlaps the claimed range of about 4 mM, and such pH range of 4-8 overlaps the claimed range of about 7, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I). Regarding the claimed concentration range of about 0.1% w/v sorbate, 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 optimize buffering in the composition of Horn in view of Yu et al. as discussed above by varying the concentration of sorbate therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that sorbate was a known buffering agent.
Further regarding the claimed recitations of about 1.25-2% w/v HPMC or carbomer viscosity enhancer, and about 1.35% w/v HPMC, it also 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 follow the suggestions of Yu et al. as discussed above and to include in the composition of Horn in view of Yu et al. as discussed above viscosity modifying agents such as HPMC in concentrations of about 0.01-5% w/v, with a reasonable expectation of success, given that Horn suggests including therein viscosity enhancer such as HPMC, and given that ranges (e.g., concentration ranges of HPMC viscosity modifiers) may be disclosed in multiple prior art references per MPEP 2144.05(I). Such range overlaps the claimed ranges of about 1.25-2% and about 1.35% w/v, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Claims 1-5, 7-14, and 16-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horn in view of Yu et al. as applied to claims 1-5, 7-14, 16-19, and 21-24 above, and further in view of Matsumura et al. (US 2013/0102977 A1; published 25 April 2013; of record).
Horn and Yu et al. are relied upon as discussed above.
Horn and Yu et al. do not disclose potassium sorbate as in claim 20.
Matsumura et al. discloses an ophthalmic composition (title) that may contain a drug (paragraphs [0062]-[0071]) wherein suitable preservatives therein include benzalkonium chloride and potassium sorbate (paragraph [0078]) wherein potassium sorbate may be included therein in a concentration of 0.1 g/100 mL (i.e., 0.1% w/v) (paragraph [0137]).
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 combine the teachings of Horn, Yu et al., and Matsumura et al. by substituting the 0.1% w/v potassium sorbate for the benzalkonium chloride in the composition of Horn and thus in the composition of Horn in view of Yu et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because Horn suggests including therein preservatives such as benzalkonium chloride, and benzalkonium chloride and potassium sorbate are equivalent preservatives as suggested by Matsumura et al., and substitution of equivalents known for the same purpose is prima facie obvious per MPEP 2144.06(II).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7-14, 16-19 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,583,496.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ranges overlap.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617