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 .
DETAILED ACTION
Claims 1, 2, 10, 13-16, 31, 32, 35 and 37-44 are pending in the instant application.
Election/Restrictions
Applicant’s election with traverse of Group I,
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in the reply filed on January 15, 2026 was acknowledged in the previous Office Action. The requirement was deemed proper and therefore made FINAL in the previous Office Action.
Claims 31, 32, 35 and 37-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 15, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 3, 2026 was filed after the mailing date of the non-final Office Action on May 8, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
As a result of the current amendments to the claims per the Amendment filed August 3, 2026, the following rejections apply.
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 is indefinite as being incomplete by its dependence on cancelled claim 5. See MPEP §608.01(n)(V).
Response to Amendment
The Declaration under 37 CFR 1.132 filed
August 3, 2026 is insufficient to overcome the rejection of claims 1, 2, 10, 13-16, and 40-44 based upon anticipation under 35 USC 102(a)(1) and obviousness under 35 USC 103 as set forth in the last Office action because: deVries et al. disclose each and every element of the instant claimed invention. deVries et al. disclose a method for treating eyelid diseases such as blepharitis (column 16, lines 28-30 and 44) comprising administering to the eye of a subject in need thereof an aqueous pharmaceutically stable ophthalmic formulation, or composition, consisting essentially of 0.1 weight percent of oxymetazoline hydrochloride (column 9, lines 7-9 and 57-59). deVries et al. disclose that the formulation can include therapeutic agents, excipients, carriers, etc. and that the carrier can be a gel (column 11, lines 58-67; and column 15, lines 12-16). There is no difference between the method of use instantly claimed and the disclosure in deVries et al. There does not appear to be any unexpected results in the Declaration under 37 CFR 1.132 since deVries et al. has already disclosed that blepharitis can be treated in a subject in need thereof by administering in the eye of the subject a pharmaceutical composition, or formulation, comprising 0.1 weight percent of oxymetazoline hydrochloride. Therefore, the Declaration under 37 CFR 1.132 is not persuasive.
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.
Claims 1, 10, 13-15, 40, 42 and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by deVries et al. {US Patent 10,799,481}.
deVries et al. disclose a method for treating eyelid diseases such as blepharitis (column 16, lines 28-30 and 44) comprising administering to the eye of a subject an aqueous pharmaceutically stable ophthalmic formulation consisting essentially of 0.1 weight percent of oxymetazoline hydrochloride (column 9, lines 7-9 and 57-59). deVries et al. disclose that the formulation can include therapeutic agents, excipients, carriers, etc. and that the carrier can be a gel (column 11, lines 58-67; and column 15, lines 12-16). deVries et al. disclose the importance of water content in the formulation (column 13, lines 50-55). deVries et al. disclose that the pharmaceutical composition can be administered once or twice a day and in one drop per eye (column 4, lines 8-35; and column 17, lines 6-61). Therefore, deVries et al. anticipate the instantly currently amended claimed invention.
Response to Arguments
Applicant's arguments filed August 3, 2026 have been fully considered. Applicant argues that the instant claimed invention is directed to a method of treating blepharitis in a subject whereas deVries et al. is focused upon the treatment of ptosis and that deVries et al. include the word “blepharitis” once in a list of ocular conditions.
In response, although the disclosure of deVries et al. focuses on the treatment of ptosis, deVries et al. clearly states that his pharmaceutical formulation, or composition, can be administered for the treatment of other eyelid diseases (column 16, lines 28-30). deVries et al. specifically discloses that blepharitis is a disease which can be treated in a subject by administering his pharmaceutical formulation, or composition (column 16, lines 35-39 and 44). Therefore, Applicant’s argument is not persuasive.
Applicant argues that deVries et al. give no indication of an appropriate concentration of oxymetazoline to be used in the treatment of blepharitis.
In response, deVries et al. repeatedly disclose “0.1 wt % oxymetazoline hydrochloride” in his aqueous pharmaceutically stable ophthalmic formulation which can be administered in the eye of a subject in need thereof for the treatment of an eyelid disease. See in deVries et al. column 8, lines 23-25 and 58-60; column 9, lines 7-9; column 10, lines 65-67; column 11, lines 13-15; and independent claims 1, 13 and 20 in columns 39-40. deVries et al. disclose that after “a process of evaluating a number of agents over a range of concentration of such agents”, he arrived at the concentration of oxymetazoline HCl 0.1 wt% and determined that this concentration was highly effective that produces surprising treatment outcomes as determined by both Leicester Peripheral Field Test (LPFT) performance and Marginal Reflex Distance Test (MRD-1) performance (column 15, lines 41-47 and 52-58). Therefore, Applicant’s argument is not persuasive.
Applicant argues that deVries et al. do not disclose each and every element of the claimed invention.
In response, instant independent currently amended claim 1 is directed to treating blepharitis in a subject in need thereof comprising administering a therapeutically effect amount of a pharmaceutical composition comprising about 0.1 wt % oxymetazoline hydrochloride to an eye of the subject. As stated in the above anticipation rejection, deVries et al. disclose a method for treating eyelid diseases such as blepharitis (column 16, lines 28-30 and 44) comprising administering to the eye of a subject an aqueous pharmaceutically stable ophthalmic formulation consisting essentially of 0.1 weight percent of oxymetazoline hydrochloride (column 9, lines 7-9 and 57-59). deVries et al. disclose each and every element of the instant claimed invention. The anticipation rejection is deemed proper and therefore, the rejection is maintained.
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, 2, 10, 13-16, and 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over deVries et al. {US Patent 10,799,481}, taken alone, and in further view of the teachings in Silverberg et al. {US Patent 8,357,714}.
Determination of the scope and content of the prior art (MPEP §2141.01)
Applicant currently claims a method of treating blepharitis in a subject in need thereof, comprising administering a therapeutically effective amount of a pharmaceutical composition comprising about 0.1 weight percent oxymetazoline hydrochloride to an eye of the subject.
deVries et al. teach a method for treating eyelid diseases such as blepharitis and ptosis (column 16, lines 17-30, 44 and 45) comprising administering to the eye of a subject an aqueous pharmaceutically stable ophthalmic formulation consisting essentially of 0.1 weight percent of oxymetazoline hydrochloride (column 9, lines 7-9 and 57-59). deVries et al. teach that the formulation can include therapeutic agents, excipients, carriers, etc. and that the carrier can be a gel (column 11, lines 58-67; and column 15, lines 12-16). deVries et al. teach the importance of water content in the formulation (column 13, lines 50-55). deVries et al. teach that the pharmaceutical composition can be administered once or twice a day and in one drop per eye (column 4, lines 8-35; and column 17, lines 6-61). deVries et al. teach that oxymetazoline hydrochloride is an alpha-adrenergic agonist (column 2, lines 9-19).
Ascertainment of the difference between the prior art and the claimed invention (MPEP §2141.02)
The difference between some aspects of the instant currently claimed invention and the teachings in deVries et al. is that deVries et al. do not teach if a therapeutically effective amount of oxymetazoline affects pupil size (as found in instant claim 41) or whether or not the subject has an allergic ocular condition calling for treatment of the eye with oxymetazoline, does not have eyelid swelling and has not undergone refractive eye surgery (as found in instant claims 16 and 44).
Finding of prima facie obviousness--rational and motivation
(MPEP §2142-2143)
However, Silverberg teaches a method for treating ptosis by administering to the eye of a subject one or more drops once or twice a day of a pharmaceutical composition comprising oxymetazoline hydrochloride (column 2, lines 8-30 and 42-45; column 3, lines 14-30; column 6, lines 13-33; and column 8, lines 4-27). Silverberg teaches a pharmaceutical composition comprising 0.1 weight percent oxymetazoline and an ophthalmologically acceptable carrier (column 7, lines 28-44). Silverberg teaches that “[O]xymetazoline is a well-known potent alpha adrenergic agonist” and Silverberg cites numerous teachings in the prior art for its various ophthalmic uses (column 5, line 13 through to column 6 lines 12). Silverberg teaches, and claims, a method for treating ptosis in a subject comprising administering to the eye of the subject an effective amount oxymetazoline, which does not affect the pupil size (column 2, lines 43-53; and claim 1 in column 24). Silverberg teaches that the subject does not have an allergic ocular condition calling for treatment of the eye with oxymetazoline (column 2, lines 17-19). Silverberg further teaches, and claims, that the subject does not have eyelid swelling and has not undergone refractive eye surgery (column 2, lines 19-22; and claim 7 in column 24).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the instant claimed invention, to treat blepharitis in a subject in need thereof comprising administering to the eye of the subject, a therapeutically effective amount of oxymetazoline. A person of ordinary skill in the art would have been motivated to utilize the method of treating eyelid diseases such as blepharitis and ptosis as taught in deVries et al., taken alone, and in further view of the teachings in Silverberg for treating ptosis, which treatment is also taught by deVries et al., to arrive at the instant claimed method of use with the expectation of treating blepharitis. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
Response to Arguments
Applicant's arguments filed August 3, 2026 have been fully considered. Applicant disagrees with the characterization of deVries et al. in that the Examiner stated that “deVries et al. teach a method for treating eyelid diseases such as blepharitis and ptosis”. Applicant also argues deVries et al. is focused on the treatment of ptosis and that deVries et al. include the word “blepharitis” once in a list of ocular conditions. Applicant further argues that oxymetazoline is known to cause rather than treat dry eye.
In response, deVries et al. do teach methods for treating eyelid diseases such as blepharitis and ptosis. Applicant’s attention is directed to column 16, lines 28-45 (reproduced in-part below).
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Further, deVries et al. has indicated that blepharitis is an eye disorder or eye disease which can be treated (column 16, lines 28-30 and 33-35), not a treatment for dry eyes as Applicant has argued. Therefore, Applicant’s arguments are not persuasive.
Applicant argues that blepharitis and ptosis are distinct conditions with differing pathophysiology. Applicant argues that deVries et al. would not have provided a person having ordinary skill in the art the requisite reasonable expectation of success that oxymetazoline could be used to treat blepharitis.
In response, the evidence for a reasonable expectation of success in the method of treating blepharitis as currently claimed is supplied by deVries et al. MPEP §2143.02 states the following:
2143.02 Reasonable Expectation of Success Is Required [R-01.2024]
[Editor Note: This MPEP section is applicable regardless of whether an application is examined under the AIA or under pre-AIA law. For applications subject to the first inventor to file (FITF) provisions of the AIA , the relevant time is "before the effective filing date of the claimed invention". For applications subject to pre-AIA 35 U.S.C. 102, the relevant time is "at the time of the invention". See MPEP § 2150 et seq. Many of the court decisions discussed in this section involved applications or patents subject to pre-AIA 35 U.S.C. 102. These court decisions may be applicable to applications and patents subject to AIA 35 U.S.C. 102 but the relevant time is before the effective filing date of the claimed invention and not at the time of the invention.]
I. OBVIOUSNESS REQUIRES A REASONABLE EXPECTATION OF SUCCESS
Where there is a reason to modify or combine the prior art to achieve the claimed invention, the claims may be rejected as prima facie obvious provided there is also a reasonable expectation of success. The reasonable expectation of success requirement refers to "the likelihood of success" in combining or modifying prior art disclosures to meet the limitations of the claimed invention. See Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1375, 2023 USPQ2d 1100 (Fed. Cir. 2023) and Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367, 119 USPQ2d 1171, 1176 (Fed. Cir. 2016). See MPEP § 2143 for guidance on rationales for modifying or combining the prior art. In In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986), the Board affirmed a rejection of claims directed to a method of treating depression with amitriptyline (or nontoxic salts thereof) as prima facie obvious. The prior art disclosed that amitriptyline is a compound known to possess psychotropic properties and that imipramine is a structurally similar psychotropic compound known to possess antidepressive properties. Additional prior art, suggested that these compounds would have been expected to have similar activity because the structural difference between them involved a known bioisosteric replacement, and because a research paper comparing the pharmacological properties of these two compounds suggested clinical testing of amitriptyline as an antidepressant. The court affirmed the Board’s determination, finding that the teachings of the prior art provided a sufficient basis for a reasonable expectation of success.) In Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. & Inter. 1989) (the claims were directed to a process of sterilizing a polyolefinic composition with high-energy radiation in the presence of a phenolic polyester antioxidant to inhibit discoloration or degradation of the polyolefin. Appellant argued that it is unpredictable whether a particular antioxidant will solve the problem of discoloration or degradation. However, the Board found that because the prior art taught that appellant’s preferred antioxidant is very efficient and provides better results compared with other prior art antioxidants, there would have been a reasonable expectation of success.).
As discussed above, reasonable expectation of success can be implicitly shown via the prior art teachings or as part of the obviousness analysis. See Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1376-77, 2023 USPQ2d 1100 (Fed. Cir. 2023) ("[W]e can reasonably discern that the Board considered and implicitly addressed reasonable expectation of success based on the arguments and evidence presented to the Board on motivation to combine."). In this decision, the court found the Board’s explanation on why the patent owner's arguments and evidence presented on motivation to combine were not persuasive implicitly addressed reasonable expectation of success and was supported by substantial evidence. On the other hand, depending on the situation (e.g., the technology, the prior art teachings and the obviousness analysis), reliance on an implicit showing of reasonable expectation of success may not be sufficient to establish a prima facie showing of obviousness. Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1344, 2021 USPQ2d 862 (Fed. Cir. 2021) (A finding that a patent challenger in an inter partes review had demonstrated a motivation to combine references does not necessarily imply that the challenger had also met its burden of showing a reasonable expectation of success in achieving a claimed method of treatment.). In this case, the court found that the challenged method of treating claims "contain limitations related to their intended purpose for treating vasomotor symptoms [as stated in the preamble], and thus those limitations are undoubtedly relevant to the reasonable expectation of success." Id. at 1345. In other words, the court found that the preamble was limiting and applicable to reasonable expectation of success. However, the limitations in the preamble were not addressed in the motivation to combine analysis. Any obviousness rejection should include, either explicitly or implicitly, an indication of a reasonable expectation of success.
Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
Additionally, efficacy is not a requirement for prior art enablement. MPEP §2121(I) and (III), reproduced below in-part.
2121 Prior Art; General Level of Operability Required to Make a Prima Facie Case [R-01.2024][AltContent: rect]
I. PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING [AltContent: rect]
When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP § 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012).
III. EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENT [AltContent: rect]
A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See also MPEP § 2122.
Therefore, the burden is shifted to Applicant and Applicant must present persuasive factual evidentiary showing that there was no reasonable expectation of success. Applicant has failed to do so.
Applicant has argued the experimentally demonstrated treatment of blepharitis with oxymetazoline in Figures 1 and 2 of the instant specification and the showing in the Declaration by Mark Silverberg filed under 37 CFR 1.132, which was submitted on August 3, 2026.
In response, the Declaration under 37 CFR 1.132 filed August 3, 2026 was found insufficient for the reasons stated above. All of Applicant’s arguments and experimental showings have been considered but have not been found persuasive. The obviousness rejection under 35 USC 103 is deemed proper and therefore, the rejection is maintained.
Conclusion
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.
This application contains claims 31, 32, 35 and 37-39 drawn to an invention nonelected with traverse in the reply filed on January 15, 2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP §821.01.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
October 6, 2026
Book XXIX, page 31
