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 .
DETAIL ACTION
This office action is a response to the following:
PNG
media_image1.png
102
392
media_image1.png
Greyscale
As filed, claims 1-19 are pending, wherein claim 1 is an independent claim.
Election/Restrictions
Applicant’s election without traverse of Group II – Claims 1-5, 12, 13, 18, and 19 in the reply filed on 11/7/2025 is acknowledged.
Claims 6-11 and 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/7/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/7/2023; 9/6/2023; 3/28/2024; 6/21/2024; and 10/31/2024 has been considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112(b)
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 3 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.
Regarding claim 3, the term "preferably" renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim Interpretation
With regards to the intended use statement, such as “for use in the treatment and/or prevention of myopia and/or amblyopia”, in claims 4, 5, 13, and 19, they have not been accorded patentable weight for prior art purpose because such statement is a mere statement of purpose or use for the instantly claimed method of treatment.
The Examiner finds that any prior art compound having the same structure as the compound of instant formula (I) and can treat the same instantly claimed vision-impairing eye diseases would be capable of performing the intended use, according to the guidance in MPEP 2111.02(II).
Claim Rejections - 35 USC § 102
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, 12, 13, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foreign Patent No. CN1475214A (see IDS filed 4/7/2023) and its machine-generated English translation, hereinafter Ni.
Regarding claims 1-5, 12, 13, 18, and 19, Ni, for instance teaches the use penehyclidine hydrochloride in an eye drop, which is known to administer on an ocular surface, for treating ophthalmic diseases, such as iritis, keratitis, etc. The concentration of penehyclidine hydrochloride ranges from 0.025-3% or 0.03-3%. All of which meet all the limitations of these claims.
In addition, the Examiner, according to the guidance in MPEP 2131.02(III), also finds that a person skill in the art, reading the disclosures of Ni (as shown below), would “at once envisage” the instantly claimed arrangement or combination, which is what Ni teaches above.
PNG
media_image2.png
178
702
media_image2.png
Greyscale
(paragraph 0002 of the Eng. Translation)
PNG
media_image3.png
138
652
media_image3.png
Greyscale
PNG
media_image4.png
122
722
media_image4.png
Greyscale
(paragraph 0003 of the Eng. Translation)
PNG
media_image5.png
128
724
media_image5.png
Greyscale
PNG
media_image6.png
134
684
media_image6.png
Greyscale
(paragraph 0013 of the Eng. Translation)
PNG
media_image7.png
144
712
media_image7.png
Greyscale
(paragraph 0039 of the Eng. Translation)
PNG
media_image8.png
94
744
media_image8.png
Greyscale
(paragraph 0040 of the Eng. Translation)
Lastly, the Examiner would like to note that the machine-generated English translation of Ni contains multiple typographical errors, by indicating that penehyclidine hydrochloride is pentoxyverine hydrochloride. The Chinese characters of the abovementioned compound in Ni are the same, but the English translation are different. After careful consideration, the Examiner finds that Ni teaches penehyclidine hydrochloride not pentoxyverine hydrochloride.
PNG
media_image9.png
48
408
media_image9.png
Greyscale
(paragraph 0003 of the Eng. Translation)
PNG
media_image10.png
384
706
media_image10.png
Greyscale
(paragraph 0002 of Eng. Translation)
Claim Objections
Claims 4, 5, 12, 13, 18, and 19 are objected to because of the following informalities:
Regarding claims 4, 13, and 19, the claims recite the phrase, “wherein the method is for use in the treatment and/or prevention of myopia and/or amblyopia”.
Such expression can be clarified by reciting -- wherein vision-impairing eye disease are myopia and/or amblyopia --.
Regarding claim 5, the claim recites the phrase, “wherein the method is for use in the treatment and/or prevention of myopia and/or amblyopia, the myopia and/or amblyopia comprising”.
Such expression can be clarified by reciting -- wherein
Regarding claim 12, the claim recites the phrase, “administering the pharmaceutical composition according to claim 6”. The Examiner finds that claim 6 is not eligible for rejoinder and thus, the Examiner would recommend the Applicant to incorporate all the limitations from claim 6 into claim 12.
Regarding claim 18, the claim recites the phrase, “administering the ophthalmic preparation according to claim 14”. The Examiner finds that claim 14 is not eligible for rejoinder and thus, the Examiner would recommend the Applicant to incorporate all the limitations from claim 14 into claim 18.
Appropriate correction is required.
Conclusion
Claims 1-5, 12, 13, 18, and 19 are rejected.
Claims 4, 5, 12, 13, 18, and 19 are objected.
Claims 6-11 and 14-17 are withdrawn.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 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, Clinton Brooks can be reached at (571)270-7682. 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.
/PO-CHIH CHEN/Primary Examiner, Art Unit 1621