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 . Claims 3-5 are pending in this application.
Response to Amendment
Applicant’s amendment filed 09/23/2026 in response to the previous Office Action (06/24/2026) is acknowledged. Rejection of claims 1-3 under 35 U.S.C. 112(b) (item 7) has been obviated. The prior art rejection under 35 U.S.C. 102(a)(1) (item 5) has been maintained and modified. Upon further review of the case, it is also deemed necessary to raise new issues that need further rejection.
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 (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 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 3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. CN101947215 A. Cited reference teaches Nobiletin (retinal vasodilator) and a method of treating “retinopathy” that is the same as applicants.
PNG
media_image1.png
567
1404
media_image1.png
Greyscale
Since the prior art teaches the prior art compound (Nobiletin) and a method of treating “retinopathy” in general that includes all diseases of retina, the prior art rejection is proper.
Response to arguments
Applicant’s argument filed 09/23/2026 has been fully considered but it is not persuasive.
Applicants argue:
PNG
media_image2.png
345
948
media_image2.png
Greyscale
PNG
media_image3.png
92
814
media_image3.png
Greyscale
Applicants further argue that Li does not disclose or suggest that nobiletin improves retinal circulation, dilates retinal blood vessels, increases retinal blood flow, or treats/prevents retinal stenosis or occulsion. The examiner disagrees with applicants’ arguments. Li teaches a method of treating “retinopathy” using nobiletin that is the same as applicants. Retinopathy refers to disease-related damage to the retina, the light-sensitive tissue at the back of the eye. The retina is richly supplied by a complex network of arteries, veins, and capillaries that deliver oxygen, nutrients, and remove waste. Abnormalities in these vessels are a major cause of retinopathy, and changes in retinal circulation can directly impair retinal function.
Retinopathy is linked to retinal circulatory disturbance, stenosis or occlusion of retinal blood vessels because the retina depends on a continuous supply of oxygen and nutrients from its blood vessels to function properly.
Note that retinopathy is any damage to the retina of the eyes, which may cause vision impairment and refers to retinal vascular disease, or damage to the retina caused by abnormal blood flow. Since Li teaches the treatment of retinopathy in general, it anticipates claims 3 and 5 that are drawn to a method of treating/preventing retinal circulatory disturbance, stenosis or occlusion of a retinal blood vessel.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3 and 5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of retinal circulatory disturbance and treatment of stenosis or occlusion of a retinal blood vessel, does not reasonably provide enablement for the prevention of retinal circulatory disturbance and prevention of stenosis or occlusion of a retinal blood vessel. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. It has been recited in claims 3 and 5, the prevention of retinal circulatory disturbance and prevention of stenosis or occlusion of a retinal blood vessel but the specification is not enabled for such a scope.
A number of factors are relevant to whether undue experimentation would be required to practice the claimed invention, including “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
(1). Breadth of Claims: Claims 3 and 5 are directed to prevention of retinal circulatory disturbance and prevention of stenosis or occlusion of a retinal blood vessel that comprises administering nobiletin to a subject.
(2). Direction of Guidance: Applicants claim the prevention of retinal circulatory disturbance and prevention of stenosis or occlusion of a retinal blood vessel, but the amount of direction or guidance is minimal. There is no guidance for the prevention of retinal circulatory disturbance and prevention of stenosis or occlusion of a retinal blood vessel in the specification.
(3). State of Prior Art: There is no evidence of record that nobiletin is in use for prevention of retinal circulatory disturbance and prevention of stenosis or occlusion of a retinal blood vessel.
(4). Working Examples: There is no working example that indicates the prevention of retinal circulatory disturbance and prevention of stenosis or occlusion of a retinal blood vessel.
(5). Nature of the Invention and Predictability: The invention is directed to prevention of retinal circulatory disturbance and prevention of stenosis or occlusion of a retinal blood vessel. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(6). The Relative Skill of Those in the Art: The relative skill is extremely very low. To this day, the only means available is treatment of retinal circulatory disturbance or the treatment of stenosis or occlusion of a retinal blood vessel, but not the prevention of a healthy patient from getting said diseases.
(7). The Quantity of Experimentation Necessary: Immense, because to this day no one was able to prevent a healthy patient from getting a retinal circulatory disturbance or stenosis or occlusion of a retinal blood vessel in the first place. Prevention of a healthy patient from getting a retinal circulatory disturbance or stenosis or occlusion of a retinal blood vessel has never been accomplished or even researched. Thus, no guidance from the success of others is available from this experimentation.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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 supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Kahsay Habte/
Primary Examiner, Art Unit 1624
October 13, 2026
