DETAILED ACTION 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. Election /Restrictions Applicant's election with traverse of Group I in the reply filed on 11/25/25 is acknowledged. The traversal is on the ground(s) that the diseases are closely interconnected and are different stages of a single disease continuum. This argument was found persuasive and the Restriction requirement is withdrawn. Claims 10-26 are under consideration. Claim Objections Claim 20 objected to because of the following informalities: “is a formulation” is duplicated. Appropriate correction is required. 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 10-26 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 treatment of chemically induced dry eye, alleviating the associated corneal damage and corneal opacity and treatment of bacterial keratoconju n ctivitis with SEQ ID NO: 2 , does not reasonably provide enablement for treatment of all dry eye syndrome, all keratoconjunctivitis and alleviating all corneal damage and opacit y with SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. As stated in MPEP 2164.01(a), “there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue. ” The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands , 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as: 1. the nature of the invention; 2. the breadth of the claims; 3. the state of the prior art; 4. the relative skill of those in the art; 5. the predictability or unpredictability of the art; 6. the amount of direction or guidance presented [by the inventor]; 7. the presence or absence of working examples; and 8. the quantity of experimentation necessary [to make and/or use the invention. (1) The Nature of the Invention and (2) The Breadth of the claims Claim 10 is drawn to treating dry eye syndrome with SEQ ID NO: 1. Claim 16 is drawn to treatment of keratoconjunctivitis with SEQ ID NO: 1. Claim 21 is drawn to a method of alleviating corneal damage and corneal opacity with SEQ ID NO: 1. The claims will be given its broadest reasonable interpretation. The applicable rule for interpreting the claims is that “each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description.” See MPEP 2163(II)(1), citing In re Morris , 127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). The instant specification defines “treatment” as [PGPUB0043]: As used herein, the term “treatment” refers to all actions that can relieve or beneficially change the symptoms of dry eye syndrome by administering the composition of the present invention. In view of this rule, claims 10-20 are drawn to treatment of all forms of dry eye and keratoconjunctivitis. Claims 21-26 are drawn to alleviating all forms of damage to the corneal and corneal opacity. (3) The state of the prior art and (5) The predictability or unpredictability of the art The instant specification is enabling for treatment of chemically induced dry eye and alleviating the associated corneal damage and corneal opacity with peptide 1. The specification is also enabled for the treatment of bacterial keratoconjunctivitis with peptide 1 . does not reasonably provide enablement for treatment of all dry eye syndrome, all keratoconjunctivitis and alleviating all corneal damage and opacit y with SEQ ID NO: 1 . However, the dry eye syndrome, keratoconjunctivitis, corneal damage and opacity are caused by many different pathogens and diseases/disorders. For example dry eye syndrome includes multiple etiologies, such as aqueous deficient (e.g. Sjogrens), neurotrophic and autoimmune. The Dry eye specialist ( https://dryeyespecialist.com/neurotrophic-keratitis/ > accessed 12/19/25) teach that neurotrophic keratitis is a problem with the surface of the eye resulting from a decrease in corn e al sensitivity caused by damage to the corneal nerves. Therefore, the model of BAK induced inflammatory dry eye (instant specification) does not reasonable predict efficacy across all dry eye types especially neurotrophic or dry eye caused by autoimmune disease. Keratoconjunctivitis can be caused by bacteria, viruses, fungus and allergies. The American academy of Ophthalmology ( https://www.aao.org/eye-health/diseases/what-is-fungal-keratitis > accessed 12/19/25) teaches the types of keratoconjunctivitis can be caused by amoebic keratitis, bacterial keratitis, herpes keratitis and photokeratitis (due to intense UV radiation exposure). The American academy of Ophthalmology teaches treatment of fungal keratitis includes antifungal eye drops and oral medication. Surgery may also be necessary. It would be highly unlikely and require undue experimentation to determine if instantly claimed SEQ ID NO: 1 would be able to treat fungal or viral keratitis. With respect to alleviating all corneal damage ad opacity: corneal damage and opacity can result from trauma, burns, infection, dystrophy, neurotrophic damage and scarring. The instant specification disclose alleviation of corneal damage and opacity associated with chemically induced dry eye. However, there was no indication that the instant peptides would have the ability to alleviate corneal damage and opacity in all etiologies. Therefore, the state of the art at the time of the application is that the re is no one treatment for all dry eye syndromes, keratoconjunctivitis, corneal damage and opacity . It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Furthermore, the claimed eye conditions can have distinct etiologies . Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art. (4) The relative skill of those in the art MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc ., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu , 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high. (6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples The applicant provided sufficient guidance or direction regarding the potential treatment of chemically induced dry eye, alleviating the associated corneal damage and corneal opacity and treatment of bacterial keratoconjunctivitis with SEQ ID NO: 2 , does not reasonably provide enablement for treatment of all dry eye syndrome, all keratoconjunctivitis and alleviating all corneal damage and opacity with SEQ ID NO: 1. Applicants provide Table 1 which discloses that SEQ ID NO: 2-6 have antibacterial activity against P. aeruginosa and S. aureus. Example 3 discloses treatment of a mouse model of chemically induced dry eye with peptide 1. Example 4 discloses peptide 1 alleviated the associated keratoconjunctivitis. Example 5 discloses peptide 1 alleviated the associated corneal damage and opacity from the chemically induced dry eye. In contrast, the applicant provides little in way of direct - ion or guidance regarding treating dry eye, keratoconjunctivitis or corneal damage/opacity caused by autoimmune disease or neurotrophic. (8) The quantity of experimentation necessary (to make and/or use the invention) Owing to the factors listed above, especially in points 6 and 7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor. 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. The instant breadth of the claim is broader than the disclosure, specifically, the instant claims are directed to the treatment of dry eye, keratoconjunctivitis and alleviating corneal damage and opacity , but the specification, prior art or instant disclosure does not provide support for this. In conclusion, the instant application is enabled for treatment of chemically induced dry eye, alleviating the associated corneal damage and corneal opacity and treatment of bacterial keratoconjunctivitis with SEQ ID NO: 2 , does not reasonably provide enablement for treatment of all dry eye syndrome, all keratoconjunctivitis and alleviating all corneal damage and opacity with SEQ ID NO: 1. 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 appl icant regards as his invention. Claim s 10, 16 and 21 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. Claims 10, 16 and 21 are rejected because the limitation “a D-type methionine” is unclear. MPEP 2172 states: The addition of the word “type” to an otherwise definite expression (e.g., Friedel-Crafts catalyst) extends the scope of the expression so as to render it indefinite. This rejection can be overcome if the claims are amended to “and m is D-methionine”. Closet art of record The closest art is Lee et al. (USPN 10,421,781). Lee et al. teach the peptides of SEQ ID NO: 1-3 as antibacterial and immune regulator peptides. However, there is no teaching or suggestion to administer the peptides for treating dry eye syndrome, keratoconjunctivitis, corneal damage or opacity. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT TARA L MARTINEZ whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1470 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 8:00-5:00 . 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TARA L MARTINEZ/ Examiner, Art Unit 1654