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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 22-24 and 29, are drawn to methods for treating, relieving or alleviating ocular surface diseases and/or conditions, the method comprising administering products comprising alanyl-glutamine.
Group II, claims 25-28, are drawn to an ophthalmic composition comprising alanyl-glutamine.
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Species A: Specific method indicating the following:
1. whether the method improves eye health (see claims 22-23 and 29) or improves eye aesthetics (see claim 24);
2. and if for eye health, then a single and specific disease and/or condition to be treated, relieved, alleviated or prevented, associated to a single and specific cause (see claims 22-24);
3. whether the ocular surface diseases and/or conditions of non-dry eyes are driven by physical alteration to the eye (i.e., ocular trauma, post-surgical complications) or driven by an underlying systemic disease (i.e., diabetes, meibomian gland dysfunction, etc.).
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: 22-29.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of alanyl-glutamine, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of CN 109771370A (cited in the IDS filed on 06/04/2024). CN 109771370A discloses an anterior chamber perfusate for intraocular surgery, which is an ophthalmic balanced salt solution comprising 0.217-1.090 mg/mL L-alanyl-L-glutamine (equivalent to alanyl-glutamine dipeptide), wherein the perfusate not only protects from ischemia and hypoxia, but also can provide nutrients; when acting on corneal endothelial cells, the perfusate can provide nutrients for corneal endothelial cells, protect the cells from surgical stress, improve the anti-oxidation and anti-apoptosis abilities of the cells and alleviate postoperative corneal swelling (see description, paragraphs 0003-0011). As such, CN 109771370A discloses the dipeptide (i.e., special technical feature) shared by Group I and Group II, and thus the dipeptide alanyl-glutamine is not a special technical feature as it does not make a contribution over the prior art
During a telephone conversation with Hai Han on July 17, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 22-24 and 29; wherein the ocular surface diseases and/or conditions to be treated, relieved or alleviated are associated with ocular congestion. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 25-28 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 23 is withdrawn from further consideration by the Examiner, 37 CFR 1.142(b), as being drawn to a non-elected species.
The Examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application claims status as a 371 (National Stage) of PCT/CN2022/133753 filed November 23rd, 2022, and claims priority under 119(a)-(d) to Chinese Application No. CN202111450922.9 filed on December 1st, 2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Chinese Application No. CN202111450922.9, which papers have been placed of record in the file. Please note that the Chinese Application No. CN202111450922.9 is in a foreign.
Claim Status
Claims 1-21 were originally filed and amended on 05/30/2024.
The amendment filed on 05/30/2024 cancelled claims 1-21, and added new claims 22-29.
Claim Interpretation
Pursuant to MPEP 2111, the pending claims must be "given their broadest reasonable interpretation consistent with the specification."
The instant specification teaches that “ocular congestion” refers to the redness of the whites of the eyes when the blood vessels of the bulbar conjunctiva and scleral tissue become dilated, congested, blood stasis, or hemorrhaged under certain circumstances (see instant specification, pg. 4, last paragraph). As such, the term “ocular congestion” is being interpreted as to ocular redness or dilation of blood vessels in the conjunctiva (i.e., medical term “conjunctival hyperemia”).
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 06/04/2024, 08/02/2024 and 10/22/2025 have been considered by the Examiner.
Claim Objections
Claim 29 is objected to because of the following informalities: requires composition of withdrawn claim 25. Claim 25 is not under examination. To overcome this objection, claim 29 must include all the limitations of withdrawn claim 25. In order to advance prosecution, claim 29 will be interpreted as including all the limitations of claim 25. Appropriate correction is required.
Improper Markush Grouping
Claims 22 and 29 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of ocular surface diseases and/or conditions is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The ocular surface diseases and/or conditions to be treated, relieved or alleviated are attributed to a laundry list of medical conditions, which do not share a common underlying cause. Stated differently, some of the conditions listed are caused by systemic diseases such as diabetes, others are attributed to functional vision issues (i.e., myopia, meibomian gland dysfunction), surgical complications (i.e., surgically related recurrent corneal epithelial erosion, ocular trauma and/or post-surgical tissue repair and healing); and environmental issues (i.e., conjunctivitis, ocular congestion).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
1. Claims 22, 24 and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In the instant case, the claims are broadly directed to methods for treating, relieving or alleviating ocular surface diseases and/or conditions associated with ocular congestion. The method comprises: administering to a subject a therapeutically effective amount of alanyl-glutamine, as recited in instant claim 22; or administrating to the eyes of a subject an effective amount of alanyl-glutamine for health care purposes (i.e., a method for health), as recited in instant claim 24; and also administering to a subject a therapeutically effective amount of the ophthalmic composition of claim 25, as recited in instant claim 29. Thus the scope of claims 22 and 29 encompass the genus of ocular surface disease and/or conditions associated to ocular congestion; and the scope of claim 24 encompasses the genus of health care.
The written description requirement may be met by provided a representative number of species of the genus and/or in light of the state of the art. With regard to the state of the art, WillsEye Hospital, teaches that in eyes with ocular surface disease, epithelial layer (i.e., the conjunctiva (clear covering of the white of the eye) and the cornea (clear covering over the colored iris and black pupil)) is damaged (see WillsEye Hospital, retrieved from https://www.willseye.org/ocular-surface-disease/, on 07/20/2026, pp. 1-4, first available online on 06/16/2021). This damage may result from a wide variety of conditions involving the eye, the eyelids, and even the rest of the body (see WillsEye Hospital, pg. 1). Damage to the epithelium can cause pain, redness, poor vision, and ultimately can lead to permanent corneal or conjunctival injury. Treatment depends on the underlying cause of the ocular surface disease (see WillsEye Hospital, pg. 1).
Singh et al. teach that the vasodilatation of conjunctival micro vessels is clinically reported as hyperemia (or redness) (see pg. 7, third paragraph). Singh et al. also teach that conjunctival hyperemia is caused by a pathological vasodilatory response of the microvasculature in response to inflammation due to a myriad of infectious and non-infectious etiologies (see Singh et al. Ocul Surf. 2021, 21:134-144 at pg. 1, abstract). Thus, the state of the prior art recognizes that there is a multitude of underlying eye conditions that manifest as ocular congestion (i.e., conjunctival hyperemia or eye redness).
The art also teaches that Ocular Surface Disease is a collection of diseases affecting the cornea, conjunctiva and tear film; and although there are many parts in the eyes, the cornea, conjunctiva and glandular network in the epithelial layer are the parts of the eye most frequently impacted by ocular surface disease (see Eye Physicians, retrieved from https://www.myeyephysicians.com/eye-care/ocular-surface-disease/ on 07/21/2026, first available online on 07/23/2024).
Some types of ocular surface disease include: dry eye syndrome, when tear production is inadequate or of low quality, resulting in discomfort, redness and impaired vision; conjunctivitis, commonly referred to as pink eye, this is an inflammation of the conjunctiva, the thin membrane covering the white portion of the eye; pterygium, a non-cancerous conjunctival growth that overlaps the cornea, typically brought on by too much sun exposure; blepharitis, inflammation of the eyelids, usually around the lash base; corneal ulcers and abrasions, wounds or infections, which can lead to discomfort, redness, and problems with vision; pinguecula, a yellow-colored growth on the conjunctiva, generally on the side nearest the nose, that’s frequently brought on by sun exposure; neurotrophic keratitis, a degenerative disorder that decreases corneal sensitivity and is caused by nerve damage; and meibomian gland dysfunction, when your Meibomian glands may not be producing enough oil, leading to irritation of the eyelids and dry eyes (see Eye Physicians, pg. 2). Eye physicians also teach that depending on the exact type, ocular surface disease have a range of symptoms, from temporary to persistent, and the common signs of OSD include: dryness, redness, irritation, tearing, blurry vision, light sensitivity, discharge, foreign body sensation, eye fatigue, eye rubbing (see Eye Physicians, pg. 4). As such, the prior art provides ample support that the term ocular surface disease and/or conditions encompass a vast array of diseases and/or conditions and that most those conditions are associated with ocular congestion (i.e., eye redness or conjunctival hyperemia).
With respect to a method for health care, it goes without saying that this genus is extremely broad and encompasses preventing, diagnosing, treating, and curing physical and mental health illnesses. Thereby the specific embodiments taught in the instant specification are not sufficient for the skilled artisan to envisage what constitutes a method for health care, the method comprising administrating to the eyes of a subject an effective amount of alanyl-glutamine, as recited in instant claim 24.
The written description requirement may be met by providing a representative number of species of the genus. In the instant case, the specification teaches Example 3 - Test on the Effectiveness on relieving pinkeye (see instant specification, pg. 25) and Example 4 - Test on the effectiveness on relieving ocular congestion caused by: (1) cataract surgery (see instant specification, pp. 27-28); (2) other types of diseases (see instant specification, pg. 28), and (3) lifestyle or eye makeup (see instant specification, pg. 29). Although the specification mentions ocular congestion caused by other types of diseases, it is silent about the types of diseases. Additionally, it is noted that Example 4 describes relieving ocular congestion (i.e., the associated sign or symptom), however the example is silent about relieving ocular surface disease and/or condition. As such, the instant specification teaches relieving pinkeye (i.e., ocular surface conditions associated with ocular congestion) and ocular congestion as a result of cataract removal (i.e., post-surgical tissue repair). However the working examples reduced to practice (i.e., Example 3 and Example 4) are not a representative number of the genus of ocular surface diseases and/or conditions associated with ocular congestion.
Thus, the scope of claims 22 and 29 encompasses treating, relieving or alleviating any ocular surface disease and/or condition associated with ocular congestion. However, the instant specification does not reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention. The instant specification fails to provide a representative number of ocular surface diseases and/or conditions associated with ocular congestion, which can be treated, relieved or alleviated by administering to a subject a therapeutically effective amount of alanyl-glutamine, or an ophthalmic composition comprising alanyl-glutamine.
Since the claims require a large genera of possible diseases and/or conditions to be treated, relieved or alleviated, the Specification must sufficiently demonstrate possession of a representative number of diseases and/or conditions associated with ocular congestion, that are successfully treated, relieved or alleviated by administering a therapeutically effective amount of alanyl-glutamine; sufficient to allow one of skill in the art to identify possession of the full scope of the invention.
Applicants do not have sufficient breadth of disclosure, namely a representative number of species of ocular surface diseases and/or conditions associated with ocular congestion necessary to effectively demonstrate possession of the invention, for the exceptionally large genus of ocular surface diseases and/or conditions disclosed in claims 22 and 29.
The species described are insufficient to serve as representative of the entire genus. The nature of experimentation necessary to identify the diseases and/or conditions associated to ocular congestion that can be treated, relieved or alleviated with an therapeutically effective amount of alanyl-glutamine would be unusually high and the motivation to test all diseases and/or conditions would therefore be very low. Taking into consideration the factors outlined above, including the nature of the invention, the state of the art, the guidance provided by the Specification, it is concluded that the specification does not demonstrate sufficient written description to indicate possession of the invention as recited in the claims. Thus, the specific embodiments taught in the instant specification are not sufficient for the skilled artisan to envisage what constitutes a method for treating, relieving or alleviating ocular surface disease and/or conditions associated with ocular congestion by administering to a subject a therapeutically effective amount of alanyl-glutamine.
Accordingly, claims 22, 24 and 29 do not meet the written description requirement.
2. Claims 22 and 29 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 relieving pinkeye (i.e., an ocular surface condition associated with ocular congestion) and ocular congestion (i.e., ocular redness or dilation of blood vessels in the conjunctiva (i.e., medical term “conjunctival hyperemia”), does not reasonably provide enablement for treating, relieving or alleviating any ocular surface disease and/or condition associated with ocular congestion. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected to make and/or use the invention. Specifically, the method claims are drawn to treating, relieving or alleviating any ocular surface disease and/or condition associated with ocular congestion, the method comprising administering to a subject a therapeutically effective amount of alanyl-glutamine.
To address whether sufficient evidence supports the determination that the disclosure does not satisfy the enablement requirement and whether undue experimentation might be needed, the below factors are considered:
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of the claims: The claims encompass treating, relieving or alleviating any ocular surface disease(s) and/or condition(s) associated with ocular congestion (i.e., ocular redness). Additionally, the breadth of the claim exacerbates the complex nature of the subject matter to which the present claim is directed, because of the vast number of possible ocular surface diseases and/or conditions associated with ocular congestion.
The nature of the invention: The invention pertains to a method for treating, relieving or alleviating, which comprises administering to a subject a therapeutically effective amount of alanyl-glutamine. Since ocular surface diseases and/or conditions encompasses a wide range of specific conditions, determining the exact standard of care requires specific categorization of each disease. However, administering a therapeutically effective amount of alanyl-glutamine is not the standard of care.
The state of the prior art: The art teaches an ophthalmic pharmaceutical composition that comprises L-Alanyl-L-Glutamine suspended or dissolved in an isoosmotic solution suitable for human eyes, and which can be used for relieving dry eye disease (DED) symptoms and/or improving and/or treating DED (see CA3089344A1 Publication Date 08/01/2019, abstract). However, the art is silent about a method for treating, relieving or alleviating any ocular surface diseases and/or conditions associated with ocular congestion by administering an a therapeutically effective amount of alanyl-glutamine.
The level of one of ordinary skill: Practitioners in this art (medical clinicians, pharmacists, doctors and/or pharmaceutical chemists) would presumably be highly skilled in the art for treating, relieving or alleviating ocular surface diseases and/or conditions associated with ocular congestion.
The level of predictability in the art: The instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., treating, relieving or alleviating ocular surface diseases and/or conditions associated with ocular congestion), then there is a lack of predictability in the art. Moreover, it is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court has indicated that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species (e.g., relieving pinkeye), what other species will work. In the instant case, Applicants do not demonstrate that any ocular surface disease and/or condition associated with ocular congestion can be treated, relieved or alleviated by administering a therapeutically effective amount of alanyl-glutamine.
The amount of direction provided by the inventor: The specification does not enable any person skilled in the art to which it pertains to use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification with regard to the actual treating, relieving, or alleviating of any ocular surface diseases and/or conditions associated with ocular congestion as recited in the claims. Applicants fail to provide the guidance and information required to ascertain whether the claimed administration of a therapeutically effective amount of alanyl-glutamine to a subject, treats, relieves or alleviates any ocular surface disease and/or condition associated with ocular congestion without resorting to undue experimentation. Applicants' limited disclosure is noted but is not sufficient to justify claiming treating, relieving or alleviating any ocular surface disease and/or condition associated with ocular congestion, as claimed.
The existence of working examples: The specification does not articulate administering to a subject of a therapeutically effective amount of alanyl-glutamine for treating, relieving or alleviating any ocular surface disease and/or conditions associated with ocular congestion. Instead, one of the working examples pertains the effectiveness of relieving pinkeye (see instant specification, pg. 25, Example 3). The rest of the working examples pertain to relieving ocular congestion (i.e., the associated sign/symptom) caused by cataract surgery, or by other (unspecified) types of diseases, or by lifestyle or eye makeup (see instant specification, pp. 27-29, Example 4). Therefore, relieving the associated sign/symptom does not equate to relieving the ocular surface disease and/or condition. Lastly, Example 5, relies on the growth rates of corneal cells grown in vitro after administration of 0.05% ophthalmic solution comprising alanyl-glutamine, as proof that the ophthalmic solution inhibited the immune response of cell growth and promoted the growth of corneal cells (see instant specification, pg. 31, first paragraph). Applicants appear to rely on the assumption that by providing evidence that the ophthalmic composition inhibited the immune response of cell growth and promoted the growth of corneal cells in vivo translates to treating, relieving or alleviating corneal ulcers in a subject. However, such an assumption cannot be made because there is no indication that a therapeutically effective amount of alanyl-glutamine would exhibit such result in a subject. Thus, the working examples lack evidence that administering to a subject a therapeutically effective amount of alanyl-glutamine, is an effective method for treating, relieving or alleviating any ocular surface disease and/or conditions associated with ocular congestion.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: Due to the breadth of the claim, treating, relieving or alleviating any ocular surface disease and/or condition associated with ocular congestion in a subject by administering the claimed therapeutically effective amount of alanyl-glutamine would require substantive experimentation, given that alanyl-glutamine is not the standard of care for ocular surface diseases and/or conditions; and given that ocular surface disease and/or conditions associated with ocular congestion encompasses a myriad of diseases and/or conditions.
After applying the Wands factors and analysis to claims 22 and 29, in view of the Applicant' s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claims 22 and 29 would not be enabled by the written disclosure for a method for treating, relieving or alleviating ocular surface diseases and/or conditions associated with ocular congestion by administering to a subject a therapeutically effective amount of alanyl-glutamine. Therefore, claims 22 and 29 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to treat, relieve or alleviate any ocular surface disease and/or condition associated with ocular congestion.
Applicants can overcome the instant rejection by amending claims 22 and 29 to recite the specific ocular surface disease and/or condition treated, relieved or alleviated.
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.
3. Claims 22, 24 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA 3089344 A1 Publication Date: August 1st 2019 (herein after “Liu et al.”); as evidenced by WO 93/02663 Publication Date: February 18th 1993 (herein after “WO 93/02663”).
Regarding claims 22, Liu et al. disclose a method of relieving dry eye disease (DED) symptoms and/or improving DED and/or treating DED in a patient suffering from DED therefrom, the method comprising administering an ophthalmic formulation prepared according to any of claims 1 to 6, to said patient (see pg. 17, claim 9). Wherein the ophthalmic pharmaceutical composition comprising L-Alanyl-L-Glutamine suspended or dissolved in an isosmotic solution that is suitable for eyes (see pg. 15, claim 1).
As such, Liu et al.’s method of relieving dry eye disease (DED) symptoms and/or improving DED and/or treating DED in a patient suffering from DED anticipates the instantly claimed method for treating, relieving or alleviating ocular surface diseases and/or conditions (i.e., DED) associated with ocular congestion (i.e., ocular redness or conjunctival hyperemia and/or dilation of blood vessels in the conjunctiva).
Regarding claim 24, Liu et al.’s method of treating DED in a patient suffering from DED therefrom, also anticipates the instantly claimed method for health care wherein the method comprises administrating to the eyes of a subject an effective amount of alanyl-glutamine. Since Liu et al.’s method comprises administering an ophthalmic formulation to a subject suffering from dry eye disease, it must naturally follow that the ophthalmic solution comprising an effective amount of alanyl-glutamine is administered to the eyes of a subject for the health care of the eyes. As such, Lui et al.’s disclosure anticipates the instantly claimed method for beauty and/or health care as recited in instant claim 24.
Regarding claim 29, as previously discussed, claim 29 is interpreted as including all the limitations of claim 25. As such, with respect to wherein the method comprises administering to a subject a therapeutically effective amount of the ophthalmic composition comprising alanyl-glutamine and an ophthalmologically acceptable excipient, wherein the ophthalmic composition is in the form of eye drops, suspensions, gels, eye ointments, emulsions, eye pads, eye patches, eye masks, eye creams, sprays, injections or implants:
Liu et al. claim that the pharmaceutical composition comprising L-Alanyl-L-Glutamine suspended or dissolved in an isosmotic solution that is suitable for eyes (see pg. 15, claim 1). And that the osmotic agent is selected from one or more of the following: sodium chloride, potassium chloride, boric acid, borax, sodium sulfate, potassium sulfate, sodium nitrate, potassium nitrate, sodium acetate, mannitol, glycerin, propylene glycol, 2-( 4-octylphenylethyl)-2-amino-propylene glycol hydrochloride and glucose (see pg. 15, claim 3).
Liu et al. also claim a method of preparing the pharmaceutical composition, which includes packing into sterilized eye drop bottles under aseptic manufacturing environment (see pg. 16, claim 7). Thereby constituting wherein the ophthalmic composition is in the form of eye drops as recited in instant claim 25.
As evidenced by WO93/02663, ophthalmic compositions generally consist of at least one active principle, and an excipient containing at least one inorganic or organic osmotic agent which imparts to the preparation an osmotic pressure corresponding to that of the lacrimal fluid (see pg. 1, lines 8-12). The osmotic pressure of the lachrymal fluid is equivalent to that of a 0.93% NaCl solution (see pg. 1, lines 12-14). Thus an inorganic osmotic agent commonly employed in ophthalmic preparations is sodium chloride (see pg. 1, lines 15-16); and examples of organic osmotic agents commonly employed in ophthalmic formulations include hydrogenated hexoses such as mannitol and sorbitol (see pg. 1, lines 16-19).
Accordingly, Liu et al.’s disclosure as evidenced by WO93/02663 reads on the instantly claimed ophthalmic composition comprising alanyl-glutamine and an ophthalmologically acceptable excipient (i.e., sodium chloride), wherein the ophthalmic composition is in the form of eye drops.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
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, 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.
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.
/CLAUDIA ESPINOSA/ Patent Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
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