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 without traverse of dry eye and SEQ ID NO: 2 in the reply filed on 6/8/26 is acknowledged.
Claims 1-14 are pending.
Claims 1-14 read on the elected species and are under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: an “the” should be inserted before “step” in line 1.
Claim 1 is objected to because of the following informalities: “…as these” should be amended to “as tyrosine, tryptophan or phenylalanine”.
Claim 1 is objected to because of the following informalities: the claim should be amended to “a pharmaceutical composition comprising SEQ ID NO: 1 a.s an active ingredient, wherein Xaa1 and Xaa1 are…”
Claim 2 is objected to because of the following informalities: “an N-terminus of an amino acid sequence of the SEQ ID NO: 1” should be amended to “the N-terminus of the peptide sequence of SEQ ID NO: 1”.
Claim 5 is objected to because of the following informalities: “a C-terminus of an amino acid sequence of the SEQ ID NO: 1” should be amended to “the C-terminus of the peptide sequence of SEQ ID NO: 1”.
Claim 6 is objected to because of the following informalities: “the” should be removed before “SEQ ID NO: 1” in line 1.
Claim 6 is objected to because of the following informalities: the claim should be amended to “wherein SEQ ID NO: 1 is selected from the group consisting of…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-5 and 7-14 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.
Claim 1 is indefinite because the metes and bounds of the limitation “…and non-natural amino acids having the same properties as these” are unclear. The claim does not specify which properties of Tyr, Trp or Phe must be possessed by the non-natural amino acids. The specification states that non-natural amino acids having physically, chemically or functionally similar characteristics to natural amino acids and further states [PGPUB0026]:
“According to one embodiment of the present invention, an amino acid having the same characteristics as tyrosine, tryptophan and phenylalanine may be an amino acid having aromatic characteristics.”
However, applicants are providing an example or embodiment, not a clear definition. The specification does not define the claimed term or provide direction for determining whether a particular non-natural amino acid falls within the scope of the claim. It is unclear if any non-natural amino acids having a benzene ring or having an aromatic ring would be encompassed by the claim. Furthermore, the claim and specification fail to identify which property of the non-natural amino is relevant. Accordingly, one of ordinary skill in the art would not be able to determine which non-natural amino acids are encompassed by the claim.
Claims 2 and 5 are unclear because the limitation “…is a compound that plays the role of a single bond or link…”. It is unclear what structures play the role of a single bond. Furthermore, a single bond is not a compound rending the language of claims 2 and 5 confusing. One of ordinary skill in the art would not be able to determine the scope of the claimed linker.
Claims 2-5 and 7-14 depend from claim 1 and do not clarify the point of confusion. Therefore, claims 2-5 and 7-14 are also rejected.
Claim Rejections - 35 USC § 112
Claims 1-14 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 dry eye with SEQ ID NO: 1-4, does not reasonably provide enablement for all ocular diseases. 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
Claim 1 is drawn to a method for treating ocular diseases comprising the step of administering SEQ ID NO: 1 as an active ingredient, wherein the sequence of SEQ ID NO: 1, the Xaa1 and Xaa2 is any one selected from the group consisting of Tyr, Trp, Phe and non-natural amino acids having same properties as these.
(2) The Breadth of the claims
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 {PGPUB0047]:
In the present invention, “treatment” refers to any action in which symptoms of an ocular disease are ameliorated or beneficially changed by administering a composition according to the present invention.
The instant specification defines “ocular disease” as [PGPUB0042]:
The term “ocular disease” in the present specification refers to disorders and conditions affecting the eyes. In one embodiment of the present invention, an ocular disease may be one or more diseases selected from the group consisting of keratoconjunctivitis sicca (KCS), atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC), glaucoma, keratitis, corneal epithelium erosion, uveitis, intraocular inflammation, dry eye syndrome, dry-eye syndrome ocular infections, ocular infections, ocular allergy, corneal or conjunctival lesions, diabetic macular edema, and age-related macular degeneration. For example, an ocular disease may be dry eye syndrome or dry-eye syndrome ocular infections, but is not limited thereto.
In view of this rule, claim 1 is drawn to treatment of all disorders or conditions affecting the eyes.
(3) The state of the prior art and (5) The predictability or unpredictability of the art
The instant application is enabling for treatment of dry eye. However, eye diseases and disorders are diverse with differing etiologies and pathologies.
For example, with respect to treatment of stroke, according to Merck Manual, an infection of bacterial conjunctivitis is treated with antibiotic eye drops or ointment (<Infectious Conjunctivitis - Eye Disorders - Merck Manual Consumer Version> accessed 6/23/26).
The Cleveland clinic (<Eye Cancer: Symptoms, Types & Treatment> accessed 6/23/26) teaches eye cancers start in cells inside the eyeball and nearby structures like eyelids and tear ducts. The Cleveland clinic teaches that include radiation as well as surgery.
It would be highly unlikely that a single peptide would be able to treat all eye diseases and disorders. The state of the art is that different ocular conditions are treated differently. For example, an infection with an antibiotic and cancer with radiation.
Adding to the complexity are the many different diseases encompassed by the “ocular diseases”.
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Given this fact, historically the development of new drugs has been difficult and time-consuming. 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.
Thus, for treating all ocular diseases with a single agent, it would be highly unpredictable given the art and the breadth of the claims.
(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 dry eye. Applicants provide data showing tear volume increased after administration of PEG-BH1028. Applicants provide data disclosing the protective effects of the PEG-BHD1028 on the epithelium as measuring by corneal thickness. The specification discloses the PEG-BHD1028 exhibited a dose-dependent antiapoptotic effect in the cornea and conjunctiva of mice in a dry eye model (see Examples 1-10).
In contrast, the applicant provides little in way of direction or guidance regarding treating other ocular diseases. There was no disclosure of treatment of infections of the eye, cancer or AMD. Therefore, the specification and working examples provided by the applicant support treatment of dry eye.
(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 all ocular diseases with SEQ ID NO: 1, but the specification, prior art or instant disclosure does not provide support for this.
Closest art
The closest art is USPN 10,561,705 (same inventors). The USPN claims peptides identical to instantly claimed SEQ ID NO: 1-4. However, the USPN is not art because the reference does not teach or suggest the peptides for treating ocular diseases. There was no mention of eye diseases or conditions in the specification of the USPN. The USPN also does not mention administering the peptides to the eye. Therefore, a person of ordinary skill in the art would not have a motivation to administer the peptides of the USPN for treatment of ocular diseases. The method of using the peptides for treatment of ocular disease is not obvious in view of the USPN. Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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