DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14 are pending and represent all claims currently under consideration.
Priority
This application claims priority to PRO 63/610,074.
Claims 1-14 are considered to have an effective filing date of 12/14/2023.
Information Disclosure Statement
The information disclosure statement filed 01/16/2025 has been considered.
Claim Objections
Claims 1, 7, 10, and 13 are objected to because of the following informalities. Appropriate correction is required.
Regarding claim 1, “under examination of with an polarized” should read “under examination with a polarized”.
Regarding claim 7, “claim 1 wherein” should read “claim 1, wherein”.
Regarding claim 10, “consisting of:” should read “consisting of”.
Regarding claim 13, “hyaluronate, about” should read “hyaluronate, and about”.
Specification
The use of the term Pataday, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are 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 commercial marks.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
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 2-8 and 10-13 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.
Regarding claims 2-8 and 10-13, the claims recite the limitation "the dissolvable ocular insert". There is insufficient antecedent basis for this limitation in the claims.
Regarding claim 7, the recitation of “wherein the at least one second mucoadhesive polymer are HP guar, HPMC and combinations thereof” is unclear. It is the Examiner’s interpretation that this claim was intended to read “wherein the at least one second mucoadhesive polymer is selected from the group consisting of HP guar, HPMC and combinations thereof” in order to be consistent with the wording of the other dependent claims.
Regarding claims 10-12, the claims recite the limitation "the softener". There is insufficient antecedent basis for this limitation in the claims.
Regarding claim 10, the term “derivative” is a relative term which renders the claim indefinite. The term “derivative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far one can deviate from the parent compound without the “derivative” being so far removed therefrom as to be considered a different compound.
Regarding claim 11, the claim recites the limitation "the polymeric film". There is insufficient antecedent basis for this limitation in the claims. Therefore, it is unclear what weight percent is being referred to. For the purpose of examining the prior art, the Examiner has interpreted the claimed weight percentages as a percent by weight of the ocular insert.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1, 5-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ketelson (US 12102559 B2).
Regarding claim 1, Ketelson teaches an eye insert comprising a plasticizer and mucoadhesive polymers which can be a combination of sodium hyaluronate (i.e., a first mucoadhesive polymer from the claimed list) and HP guar (i.e., a second mucoadhesive polymer from the claimed list), wherein the mucoadhesive polymers are present in an amount of from 80% to 90% w/w (Ketelson, claim 1).
Ketelson teaches the insert may include one or more pharmaceutically active agents, such as atropine or olopatadine (Ketelson, column 6, lines 10-24), and exemplifies an insert formulation comprising 0.175 g of atropine in a total of 5.425 g of components by weight (Ketelson, table 17), which would result in 3.2% by weight of an active agent. It would be reasonable to one of ordinary skill in the art to utilize olopatadine in the same amount, which lies within the claimed range.
While Ketelson does not specify the type of microscope as claimed, Ketelson teaches a morphology of the insert is tested with an appropriate microscope to note if any undissolved particulate or haziness was observed (Ketelson, column 9, lines 36-41), and teaches examples which are clear, transparent, and uniform (Ketelson, table 2), suggesting no visible recrystallization was noted. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Ketelson is considered to be analogous to the claimed invention, because both Ketelson and the instant invention are in the same field of ocular inserts. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the claimed invention based on the teachings of Ketelson under the meaning of 35 U.S.C. 103.
Regarding claim 5, Ketelson teaches all the elements of the current invention as applied to claim 1. As above, Ketelson teaches an eye insert comprising sodium hyaluronate (Ketelson, claim 1).
Regarding claim 6, Ketelson teaches all the elements of the current invention as applied to claim 5. As above, Ketelson teaches an eye insert comprising sodium hyaluronate (Ketelson, claim 1).
Regarding claim 7, Ketelson teaches all the elements of the current invention as applied to claim 1. As above, Ketelson teaches an eye insert comprising HP guar (Ketelson, claim 1).
Regarding claim 8, Ketelson teaches all the elements of the current invention as applied to claim 7. Ketelson teaches polymers that may be used in the inserts include HPMC (Ketelson, column 4, lines 13-20).
Regarding claim 9, Ketelson teaches all the elements of the current invention as applied to claim 1. As above, Ketelson teaches the mucoadhesive polymers are present in an amount of from 80% to 90% w/w (Ketelson, claim 1).
Regarding claim 10, Ketelson teaches all the elements of the current invention as applied to claim 1. Ketelson teaches a plasticizer or softener which is PEG (Ketelson, claim 1).
Regarding claim 11, Ketelson teaches all the elements of the current invention as applied to claim 10. Ketelson teaches the plasticizer or softener is present in an amount of from 5-25% w/w (Ketelson, claim 2).
Regarding claim 12, Ketelson teaches all the elements of the current invention as applied to claim 10. As above, Ketelson teaches a plasticizer or softener which is PEG (Ketelson, claim 1).
Regarding claim 14, Ketelson teaches polymeric eye inserts may be made by solution casting (Ketelson, column 6, lines 28-31), and exemplifies preparing a solution, then casting the solution into a petri dish and drying (i.e., casting the solution in a mold to obtain the ocular insert; Ketelson, column 18, lines 17-39). Ketelson teaches an eye insert comprising a plasticizer and mucoadhesive polymers which can be a combination of sodium hyaluronate (i.e., a first mucoadhesive polymer from the claimed list) and HP guar (i.e., a second mucoadhesive polymer from the claimed list), wherein the mucoadhesive polymers are present in an amount of from 80% to 90% w/w (Ketelson, claim 1).
Ketelson teaches the insert may include one or more pharmaceutically active agents, such as atropine or olopatadine (Ketelson, column 6, lines 10-24), and exemplifies an insert formulation comprising 0.175 g of atropine in a total of 5.425 g of components by weight (Ketelson, table 17), which would result in 3.2% by weight of an active agent. It would be reasonable to one of ordinary skill in the art to utilize olopatadine in the same amount, which lies within the claimed range.
Claims 2-4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable Ketelson (US 12102559 B2) as applied to claims 1, 5-12, and 14, and further in view of de Juan (US 8939948 B2).
Regarding claim 2, Ketelson teaches all the elements of the current invention as applied to claim 1. As above, Ketelson teaches the insert may include one or more pharmaceutically active agents, such as olopatadine (Ketelson, column 6, lines 10-24). Ketelson does not, however, specify a range for an appropriate amount. De Juan teaches an eye insert comprising a therapeutic amount of a therapeutic agent (de Juan, abstract), teaches therapeutic agents to include olopatadine (de Juan, table 1), and teaches the therapeutic agent can be provided in an amount of from about 0.1% to about 50% of the insert matrix (de Juan, column 64, lines 26-35), which encompasses the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Ketelson and de Juan are both considered to be analogous to the claimed invention, because Ketelson, de Juan, and the instant invention are in the same field of ocular inserts. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insert of Ketelson to optimize the amount of active agent within the range taught by de Juan, because Ketelson does not specify an appropriate range, while de Juan teaches a range of therapeutic known to be used in the art.
Regarding claim 3, Ketelson teaches all the elements of the current invention as applied to claim 2. As above, Ketelson teaches the insert may include one or more pharmaceutically active agents, such as olopatadine (Ketelson, column 6, lines 10-24). De Juan teaches therapeutic agents to include olopatadine (de Juan, table 1), and teaches the therapeutic agent can be provided in an amount of from about 0.1% to about 50% of the insert matrix (de Juan, column 64, lines 26-35), which encompasses the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insert of Ketelson to optimize the amount of active agent within the range taught by de Juan, because Ketelson does not specify an appropriate range, while de Juan teaches a range of therapeutic known to be used in the art.
Regarding claim 4, Ketelson teaches all the elements of the current invention as applied to claim 3. As above, Ketelson teaches the insert may include one or more pharmaceutically active agents, such as olopatadine (Ketelson, column 6, lines 10-24). De Juan teaches therapeutic agents to include olopatadine (de Juan, table 1), and teaches the therapeutic agent can be provided in an amount of from about 0.1% to about 50% of the insert matrix (de Juan, column 64, lines 26-35), which encompasses the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insert of Ketelson to optimize the amount of active agent within the range taught by de Juan, because Ketelson does not specify an appropriate range, while de Juan teaches a range of therapeutic known to be used in the art.
Regarding claim 13, Ketelson teaches all the elements of the current invention as applied to claim 1. Ketelson teaches an insert comprising approximately 40% w/w of sodium hyaluronate, 10% w/w of PEG, and 40% w/w of HP guar (Ketelson, claim 3), and teaches HP guar and HPMC as alternatives (Ketelson, lines 19-22). Therefore, it would have been reasonable to one of ordinary skill in the art to utilize HPMC in the same amount.
While Ketelson does not specify about 10% of olopatadine, Ketelson teaches the insert may include one or more pharmaceutically active agents, such as olopatadine (Ketelson, column 6, lines 10-24). De Juan teaches therapeutic agents to include olopatadine (de Juan, table 1), and teaches the therapeutic agent can be provided in an amount of from about 0.1% to about 50% of the insert matrix (de Juan, column 64, lines 26-35). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insert of Ketelson to optimize the amount of active agent within the range taught by de Juan, because Ketelson does not specify an appropriate range, while de Juan teaches a range of therapeutic known to be used in the art.
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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