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, 5, 8, 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 is acknowledged. The traversal is on the ground(s) that: (1) Groups I and II are unified in that Groups I-II meet the requirements for Unity of Invention; and (2) non-elected Group II shall be considered for rejoinder if the Group I claims are found to be allowable.
Applicant’s arguments have been considered but have not been found persuasive. 37 CFR § 1.475 has been followed in that unity of invention shall be fulfilled when there is a technical relationship among the inventions if the inventions involve one or more of the same or corresponding special technical features. As stated in 37 CFR § 1.475, “The expression "special technical features" shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.” On pages 5-6 of the Lack of Unity requirement dated November 21, 2025, the technical feature of oxymetazoline was identified and that oxymetazoline was not a special technical feature as it does not make a contribution over the prior art in view of deVries et al. {US 2020/0353083}. Therefore, unity of invention is not fulfilled.
Applicant further argues that if the invention of elected Group I is allowable, than non-elected Group II should be rejoined. In response, MPEP §821.04(b) states “if applicant elects a claim(s) directed to a product which is subsequently found allowable, withdrawn process claims which depend from or otherwise require all the limitations of an allowable product claim will be considered for rejoinder”. Applicant did not elect the product invention of Group II but elected the method of use invention of Group I. Therefore, rejoinder of Group II is not applicable in the instant application.
The requirement is still deemed proper and is therefore made FINAL.
Claims 31, 32, 35 and 37-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Examiner has considered the Information Disclosure Statement filed on September 22, 2023.
The submission is in compliance with the provisions of
37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 5, 8, 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 claimed invention.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 5, 8, 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 claims a method of treating blepharitis in a subject in need thereof, comprising administering a therapeutically effective amount of oxymetazoline, or a pharmaceutically acceptable salt thereof, 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 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 claims 2 and 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 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.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
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
May 5, 2026
Book XXIX, page 31
Prosecution Insights