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 of the Application
Claims 11-24 are pending.
Amendment necessitated new claim rejection as set forth below.
Objection
Claims 23 and 24 are objected as these claims are recited together as one claim with two different numbers. Each claim needs to start from separate lines and not coupled together.
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 11-14, 16-18, 21 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 pre-AIA the applicant regards as the invention.
Claims 11-14, 16-18, 21 are indefinite because:
Independent Claims 11 and 18 recites “beta-cyclodextrin derivative”. It is unclear, what applicant implies by derivative.
For compact prosecution, the derivative has been interpreted as compounds as in the instant claims 15 and 19.
Since the dependent claims doesn’t cure the above deficiency, these claims are also indefinite.
Appropriate correction required.
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 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 11-24 and elected species are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Young (US 2017/0266220 A1) as evidenced by Hunter (US 5851777) and evidenced by Phosphate buffer recipe (www.aatbio.com/resources/buffer-preparations-and-recipes/phosphate-buffer-ph-5-8-to-7-4; downloaded on 09/18/2025).
Young discloses steroidal-androgen-free ophthalmic composition in the form of solution, ointment, emulsion consisting of beta-cyclodextrin derivative with preferred embodiment of (2-hydroxypropyl)-beta-cyclodextrin (HP-beta-CD) and sulfobutylether-beta-cyclodextrin as sole active pharmaceutical active ingredient, present as w/v 5%, 10%, 20% with sodium phosphate buffer, such as 10mM, 20mM, 30mM etc. and water (entire application, especially abstract, paragraphs 0010, 0011, 0012, 0014, 0029, 0093, 0098-0102, 0111, 0117, 0122, 0144, 0150-0347). The cited prior art discloses clinical trial example wherein vehicle or control consist of 9.5% sulfobutylether-beta-cyclodextrin (SBE), sodium phosphate buffer (dibasic and monobasic) (buffer agent) and water (see paragraph 0185), wherein control surprisingly gives better result than the tested drug NS2) (also see paragraph 0322 provides preparation of composition with HP-beta-CD) (entire application, especially abstract, paragraphs 0010, 0011, 0012, 0014, 0029, 0093, 0098-0102, 0111, 0117, 0122, 0144, 0150-0347). As evidenced by Hunter, phosphate buffer is prepared by dissolving 25mM sodium phosphate (0.29%), 50mM sodium chloride (0.29%) in water (col 16, lines 25-26). Thus, Young’s sodium phosphate buffer also has NaCl. Further, Young teaches method of preparing buffer and adjusting pH (0117 and 0122), which also provides evidence for presence of NaCl in final prepared buffer.
As further evidenced by Phosphate buffer recipe, phosphate buffer is prepared using 25mM sodium phosphate and pH is adjusted using HCl and NaOH, which also provides evidence for presence of NaCl in final prepared buffer.
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With regard to the limitation in instant claims, “artificial tear or lubricant”, since the cited prior art teaches same composition with same ingredients as in instant claims, the composition of the prior art must be capable of being useful as “artificial tear or lubricant”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims 11-24
Since the cited prior art reads on all the limitations of the instant claims 11-24, these claims are anticipated.
Claims 11-24 and elected species are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Priestley (WO 2018/091859 A1) as evidenced by Hunter (US 5851777) and evidenced by Phosphate buffer recipe (www.aatbio.com/resources/buffer-preparations-and-recipes/phosphate-buffer-ph-5-8-to-7-4; downloaded on 09/18/2025).
Priestley discloses steroidal-androgen-free ophthalmic composition in the form of solution, eye drops consisting of beta-cyclodextrin derivative with preferred embodiment of (2-hydroxypropyl)-beta-cyclodextrin (HP-beta-CD) as sole active pharmaceutical active ingredient, present as w/v 10%, 12.5% with sodium phosphate buffer, sodium chloride (for tonicity) and water (entire application, especially abstract, page 1, 9, 10, 13-20, 22, 25-30). The cited prior art discloses example of a clinical trial with the composition consisting of 10% w/v HP-beta-CD, sodium phosphate monobasic buffer (buffer agent), such as w/v 0.374 %, 0.460%, 0.474%, 0.560% and water (entire application, especially abstract, page 1, 9, 10, 13-20, 22, 25-30).
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As evidenced by Hunter, phosphate buffer is prepared by dissolving 25mM sodium phosphate (0.29%, w/v), 50mM sodium chloride (0.29%; w/v%) in water (col 16, lines 25-26). Thus, Priestley’s sodium phosphate buffer also has NaCl. Further, as evidenced by Hunter, Priestly buffer also expected to have same w/v % as monobasic sodium phosphate, i.e., w/v 0.374 %, 0.460%, 0.474%, 0.560% (within limitation of the instant claims).
As further evidenced by Phosphate buffer recipe, phosphate buffer is prepared using 25mM sodium phosphate and pH is adjusted using HCl and NaOH, which also provides evidence for presence of NaCl in final prepared buffer.
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Thus, the cited prior art reads on all limitations of the instant claims.
With regard to the limitation in instant claims, “artificial tear or lubricant”, since the cited prior art teaches same composition with same ingredients as in instant claims, the composition of the prior art must be capable of being useful as “artificial tear or lubricant”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims 11-24.
Since the cited prior art reads on all the limitations of the instant claims 11-24, these claims are anticipated.
Response to Arguments
Applicant’s amendment, IDS and remarks, filed on 08/11/2025, have been fully considered but not found persuasive.
Applicant argued over rejection under 112b that derivatives are now clear from amended claims.
This is not found persuasive as it is not clear from the amended claims what applicant imply by derivatives.
Applicant argued that Young does not teach presence of NaCl in sodium phosphate buffer, and Hunter teaches Phosphate buffer saline (PBS) and it is not sodium phosphate buffer. Applicant argued that paragraph 0117 of Young does not teaches presence of NaCl in sodium phosphate buffer and 0122 paragraph of Young does teach adjusting pH with NaOH and HCl, however, that also does not necessarily include NaCl.
This is not found persuasive and the instant claims are anticipated over the cited prior art. This is because (1) Applicant only argued but provided no evidence how Phosphate buffer saline (PBS) is different from sodium phosphate buffer.
An argument by the applicant is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art.
Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c) for examples of applicant statements which are not evidence and which must be supported by an appropriate affidavit or declaration;
(2) most importantly, applicant provided neither evidence nor any persuasive argument that why NaOH and HCl will not react to form NaCl or when used to adjust pH will not form NaCl; (3) Argument is further moot in view of new rejection as set forth above.
Applicant similarly argued that Priestly does not teach presence of NaCl in sodium phosphate buffer, and Hunter teaches Phosphate buffer saline (PBS) and it is not sodium phosphate buffer.
This is not found persuasive and the instant claims are anticipated over the cited prior art. This is because (1) Applicant only argued but provided no evidence how Phosphate buffer saline (PBS) is different from sodium phosphate buffer.
An argument by the applicant is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art.
Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c) for examples of applicant statements which are not evidence and which must be supported by an appropriate affidavit or declaration;
(2) Argument is further moot in view of new rejection as set forth above.
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.
Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623