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 .
Response to Election/Restriction filed on September 15, 2025 is acknowledged.
Claims 1-7 and 29-36 are pending in this application.
Restriction
Applicant’s election without traverse of Group 1 (claims 1-7) and the election of Formula III as the species of the general formula I, age-related macular degeneration (AMD) as the species of a retinal degenerative disease, 5 mg/ml as the species of an effective amount, and 4 times per day as the species of rate of administration in the reply filed on September 15, 2025 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Claims 29-36 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Age-related macular degeneration (AMD) is not a species under Group Invention 1 (please see page 5, paragraph 9). Claim 3 is withdrawn from further consideration as being drawn to a nonelected species. A search was conducted on Formula III, and this is well known in the art. Claims 1-2 and 4-7 are examined on the merits in this office action.
Objections
5. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The document describes methods of using...” at line 1 of the abstract. Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract is recommended to be amended to recite, ‘Methods of using…are described.”
6. The use of the trademark AAGPTM has been noted in this application at paragraphs [0005]-[0006] of instant specification US 2023/0338464. The use of the trademark RESTASIS® has been noted in this application at paragraph [0009] of instant specification US 2023/0338464. These should be capitalized wherever they appear and be accompanied by the generic terminologies.
Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant’s cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
7. Claim 5 is objected for the following: Claim 5 recites, “…wherein said effective amount is from about from about 0.01 mg/ml to about…” The phrase “from about” is repeated. Applicant is required to correct this error.
8. Claim 6 is objected for the following: Claim 6 recites, “…wherein said effective amount is with from about…” Applicant should delete the term “with” from the claim.
9. Claim 7 is objected for the following: Applicant is recommended to amend the claim to recite, “The method of claim 1, wherein the compound of formula I is administered at least once, twice, three time, or four times per day.”
Rejections
U.S.C. 112
10. 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.
11. Claims 1-2 and 5-7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
12. Claim 1 recites, the terms “CH2Ph”, “C(=O)-Bn”, “or protected alcohol function”. It is unclear what these terms are referring to since the “Ph”, “Bn” and “protected alcohol function” are not clearly defined. Because claims 2 and 5-7 depend from indefinite claim 1 and do not clarify the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
13. Claim 2 recites, “The method of any one of claim 1, wherein said subject is a human subject.” It is unclear what applicant is referring to with the recitation “of any one of claim 1”. Claim 1 is a single claim. Therefore, the metes and bounds of the claim is unclear.
14. Claims 5-6 recite the limitation "said compound of formula I, formula II or formula III" in the claims. There is insufficient antecedent basis for this limitation in the claims. Claim 5 depends from claim 1, and claim 6 depends from claim 5, which depends from claim 1. Claim 1 only recites and defines formula I. Therefore, there is lack of antecedent basis for formula II and formula III.
U.S.C. 112(d)
15. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
16. Claims 5-6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
17. Claim 5 recites, “The method of claim 1, wherein said effective amount is from about from about 0.01 mg/ml to about 5 mg/ml of said compound of formula I, formula II or formula III.” Claim 5 depends from claim 1. Claim 1 does not recite formula II and formula III. Therefore, claim 5 does not further limit claim 1. Additionally, claim 6 is also rejected under 35 U.S.C. 112(d).
U.S.C. 103
18. 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.
19. 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.
20. 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.
21. Claims 1-2 and 4-6 is/are rejected under 35 U.S.C. 103 as being obvious over Young reference (WO 2017130148, filed with IDS) is view of eyewire (https://eyewire.news/articles/protokinetix-aagp-dry-eye-therapy-testing-results/?c4src=article.infinite-scrool, 1/6/2020, page 1, enclosed).
The applied reference has a common Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
22. Young reference teaches the same compound of formula III (see paragraph [010], for example). Young reference teaches the anti-aging glycopeptide (AAGPTM) and this compounds are gem difluorinated C-glycopeptides (see paragraph [0004]). Young reference teaches the same effective amounts (i.e., 0.1 mg/ml to about 5 mg/ml; 1 mg/ml to 5 mg/ml) (see paragraph [0119], for example). Young reference teaches administering the compound to a subject, a mammal, preferably a human (see paragraph [0122]).
The difference between the Young reference and instant claim is that the Young reference does not teach a method of treating dry eye disease.
23. However, eyewire reference teaches:
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(see page 1).
24. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Young and eyewire to administer the compound of formula III to treat dry eye disease. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since eyewire teaches that the effect AAGP on the treatment of dry eye disease is being analyzed.
It has been held that under KSR that “obvious to try” may be an appropriate test under 103. The Supreme Court stated in KSR, When there is motivation “to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727,_,82 USPQ2d 1385, 1397 (2007). The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. Exemplary rationales that may support a conclusion of obviousness include:
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Please note that the list of rationales provided is not intended to be an all-inclusive list, nor do they need to all be present to make a case for obviousness. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel based upon the findings of the prior art.
In the instant case, (A) above has been presented to demonstrate combining of prior art teachings to arrive at the instantly claimed invention. Further consideration shows that the combination for (A) also embraces (B), as well as (C), (D), (F) and (G). For example, (G) is quite relevant, but not limited to (G).
In conclusion, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of foregoing discussion, the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence to the contrary.
25. Claims 1-2 and 4-7 is/are rejected under 35 U.S.C. 103 as being obvious over Young reference (WO 2017130148, filed with IDS) is view of eyewire (https://eyewire.news/articles/protokinetix-aagp-dry-eye-therapy-testing-results/?c4src=article.infinite-scrool, 1/6/2020, page 1, enclosed), as applied to claims 1-2 and 4-6 above, further in view of Coursey et al (Translational Vision Science & Technology, October 2018, 7(24): pp. 1-20, enclosed).
26. The teachings of Young in view of eyewire is described above. The difference between the references and the instant claim is that the references do not teach the frequency of administration of the compound of formula III.
27. However, Coursey et al teach treatment of dry eye disease (DED). Coursey et al teach that there are a number of nonpharmaceutical treatments for DED, ranging from artificial tears, punctal plugs, and autologous serum drops, all of which can offer temporary relief for mild cases of dry eye…The most established and broadly used is Restasis (cyclosporine A [CsA] ophthalmic emulsion 0.05%...Patients with severe DED frequently have a poor response to normal twice per day application of Restasis, even after several months of treatment, and often benefit from an increased dosing application of three or four times per day…(see all of page 2).
28. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Young, eyewire and Coursey et al to optimize the treatment of dry eye disease, since eyewire teaches that AAGP is being analyzed for treatment of dry eye disease, and Coursey et al teach the frequency of eye drop administration. One of ordinary skill in the art would be motivated to optimize the treatment frequency with a reasonable expectation of success, since Coursey et al teach that more frequent applications increase the therapeutic drug concentration in the conjunctiva and cornea, which improves the outcome through more effectively reducing inflammation by controlling inflammatory mediators. The MPEP states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).” One of ordinary skill in the art would be motivated with a reasonable expectation since “the normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages”.
CONCLUSION
No claim is allowed.
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/JULIE HA/Primary Examiner, Art Unit 1654
1/13/2026