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 .
Response to Amendment
Applicant’s amendment filed 11 March 2026 is not compliant with 37 CFR 1.121 as claims 1, 6 and 7 were previously amended in the amendment filed 24 October 2025 (to include required Sequence identifiers). The claim set which has been filed on 11 March 2026 does not reflect the previous amendment.
Applicant should also note that claim set which was filed on 24 October 2025 was also noncompliant with 37 CFR 1.121 as it did not include the amendments which were made in the preliminary amendment filed 17 February 2023.
As the only compliant amendment to the claims occurred on 24 October 2025, this is the claim set which will be used for examination. Both of the claim sets from 11 March 2026 and 24 October 2025, although included in the file contents, have NOT been entered and are annotated as such. In response to this Office action, Applicant should make all amendments to the claims in reference to the claim set which was submitted on 17 February 2023 (preliminary amendment).
Election/Restrictions
Applicant's election with traverse of Group I and the species of SEQ ID NO:8 for the penetratin derivative and pembrolizumab as the drug species in the reply filed on 11 March 2026 is acknowledged. The traversal is on the ground(s) that Group II constitutes a process of use of the product of Group I, and unity of invention exists under 37 CFR 1.475(b)(2). This is not found persuasive because as was pointed out in the Lack of Unity mailed on 11 February 2026, while Groups I and II both require the technical feature of a composition comprising a drug and a derivative of a wild-type cell-penetrating peptide (penetratin), this technical feature which is shared does not make a contribution over the prior art in view of CN 108976288 A (cited on the Search report and in the written opinion for the PCT from which the instant application is a 371 filing). Because the technical feature was known in the prior art before the effective filing date of the claimed invention, it is not considered a special technical feature and cannot serve to unify the two inventions.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-12 and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11 March 2026.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statements (IDS) submitted on 17 February 2023, 24 March 2023 and 01 December 2025 have considered by the examiner.
Drawings
The drawings are objected to because they do not comply with 37 CFR 1.84 (a)(1), (l), (p) and (u).
Briefly, the figures appear to be presented in grayscale and not in black ink on a white background, resulting in fuzzy text or faint features/lines which are difficult to see (see 37 CFR 1.84(a)(1), (l) and (p). Figures 1, 2, 6-11 and 13 all have multiple panels which are not separately labeled (see 37 CFR 1.84(u)). Figures 1, 9 and 10 have text which cannot be read because the font size is too small (see 37 CFR 1.84(p)).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Page 12 of the specification at [0062]-[0066] refers to R8, which is a polyarginine sequence with 8 units of arginine. Paragraph [0063] refers to R6, which is a polyarginine sequence with 6 units of arginine. These are amino acid sequences which are encompassed by the Sequence rules and therefore, require a sequence identifier.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The use of the term WatersXBridge™ (see [0075]), 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.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see [0076]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The substitute specification, filed 24 October 2025, is objected to because it includes more than just the specification. The filing should have been limited to the specification, but the claims begin on the last page of the specification (page 34) which is improper. The filing also includes the abstract which begins on the last page of the claims, which is also improper. Applicant should file a clean copy of the specification which does NOT include the claims or the abstract. Any new set of claims or new abstract should be submitted independently and not appended to any other portion of the application.
Claim Objections
Claims 1, 6 and 7 are objected to because of the following informalities: the claims include amino acid sequence with no reference to the appropriate Sequence identifier. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the claim is grammatically difficult. Portion (i) recites “a drug having positive charge”; it is suggested that the article “a” be inserted before “positive”. Portion (ii) recites “a derivative of a wild-type cell-penetrating peptide penetratin, the derivative of the wild-type cell-penetrating peptide penetratin has the following amino acid sequence”; it is suggested that the term “wherein” precede the recitation of “the derivative”. The wherein clause of portion (ii) recites “and their combinations”; it is suggested that this be amended to “and combinations thereof”. 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 1-9 and 13-16 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1-9 and 13-16 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 a composition comprising a drug having a positive charge under physiological pH conditions and a derivative of penetratin, does not reasonably provide enablement for a composition for treating ocular diseases as broadly claimed. 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 use the invention commensurate in scope with these claims.
The instant claims are directed to compositions for treating ocular diseases wherein the compositions comprise a drug having a positive charge under physiological conditions and a derivative of a wild-type cell-penetrating peptide penetratin with a particular formula. The elected “drug” is pembrolizumab and the cell-penetrating peptide derivative has the amino acid sequence of SEQ ID NO:8.
The instant claims are not enabled for their full scope as the drug (elected species) which is included in the composition is not one that treats ocular diseases. The composition specifically recites that it is intended for treating ocular diseases, therefore the composition must be capable of treating ocular diseases. Pembrolizumab is an antibody that blocks PD-1 protein on immune cells and is considered an immune checkpoint inhibitor. It is not an antibody which is used to treat ocular diseases. Additionally, the prior art reports that vision loss and other ocular toxicities are rare, but detrimental side effects of immune checkpoint inhibitors (see Telfah et al. J Oncol Pharm Pract. 25(6): 1540-46, 2019). Therefore, the instant claims are not enabled for a composition for treating ocular diseases wherein the composition comprises pembrolizumab.
The instant claims are broadly directed to a composition for treating ocular diseases comprising (i) a drug having positive charge under physiological pH conditions and (ii)a derivative of a wild-type cell-penetrating peptide penetratin with a particular formula. However, the instant claims are not enabled for a composition which would treat any and all ocular diseases wherein the composition comprises a drug having a positive charge under physiological conditions. Part (ii) of the composition is a protein that improves uptake of the drug, but this component has no effect on ocular diseases. Part (i) of the composition merely requires that the drug have a positive charge under physiological pH. However, not all drugs which have a positive charge under physiological pH are capable of treating ocular diseases. While the prior art teaches that drugs with a positive charge are able to interact with negatively charged corneal and conjunctival cell membranes (see Loscher et al. Pharmaceutics 2022, 14, 134. https://doi.org/10.3390/pharmaceutics14010134), this does not mean that any and all drugs with a positive charge will be capable of treating ocular diseases. The drug must have an effect in the eye that would treat an ocular disease and the sole property of being positively charged does not provide for the ability to treat an ocular disease. For example, claim 9 recites a number of drugs which are all positively charged, but not all of the “drugs” which are listed treat ocular diseases. Claim 9 lists NISTmab as a drug to be included in the claimed composition however, NISTmab is a “test molecule” and does not have any therapeutic effect. Claim 9 also lists “nanobody” but this is a generic recitation and not all nanobodies will be suitable for inclusion in a composition for treating ocular diseases because the ability of a nanobody to treat ocular disease would depend on the antigen to which the nanobody binds. Claim 9 includes many other “drugs” which are not compatible with treating ocular diseases, such as trastizumab and cetuximab. Additionally, some of the “drugs” which are listed have ocular side effects which result in eye disorders, such as nivolumab which can trigger uveitis, optic neuritis, dry eye and retinal detachment. This is not an exhaustive list, but clearly exemplary of the lack of enablement for the full scope of the claimed invention. Therefore, the claims are not enabled for the reasons provided.
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.
Claim 8 is 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 8 recites “wherein the drug is a peptide or a protein drug”. However, the metes and bounds of what is intended by “peptide” versus “protein” are unclear and indefinite. A “peptide” may be smaller than a “protein”, but it is still a protein. Therefore, it is not clear what would be a peptide versus a protein such that one of ordinary skill in the art would be able to determine the metes and bounds of the claim.
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.
Claims 3 and 6-7 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.
Claim 3 is not further limiting of claim 1 as the recitation of “at least two” does not materially limit the subject matter of claim 1. All of the variable amino acids are to be elected from the recited list and the recitation of “at least two” either broadens the claim (meaning the other position could be something not recited) or it merely repeats the same selections of claim 1.
Claims 6-7 are broader than the claim from which they depend because the peptides which are included in the claims include substitutions for X1 and X2 which are not listed in the formula in claim 1. Specifically, the peptides in claims 6-7 include a “Q” or glutamine but the formula of claim 1 does not recite glutamine (Q) as an option. Therefore, claims 6-7 are broader than the claim from which they depend.
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.
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.
Claim(s) 1-9 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/224053 (Wei et al.) (US PGPUB 2020/0237925 referenced as English translation).
Wei et al. disclose a composition for intraocular drug delivery (eye drop administration) comprising a lipophilic derivative of wild-type penetrating peptide penetratin (see [0001]). While Wei et al. do not explicitly recite a composition which is a solution or a suspension (claim 2), the disclosure of Wei et al. clearly teaches that solutions/suspensions are intended (see [0005] and [0008]) especially in view of claim 1 which states that the penetratin derivative “can be used as an ocular absorption enhancer to achieve intraocular drug delivery through a non-invasive route” which clearly indicates application to the eye which is typically achieved through means such as eye drops. Additionally, Examples 7-9 administered the penetratin/drug composition in the form of a solution. The various penetratin derivatives of Wei et al. are disclosed in Table 1 and include the elected species of RWIKIWFWWRRMKWKK (SEQ ID NO:8) (see 289-W in Table 1). Wei et al. teach compositions for treating ocular diseases comprising the penetratin derivative and a drug (see [0018]-[0019]) including monoclonal antibodies known for treating ocular conditions (see [0022]). While [0023] indicates that “proteins with negative charges under physiological conditions” are encompassed in order to form non-covalent nanocomplexes, the teachings of Wei et al. are not so limited because the isoelectric point of bevacizumab is between 8.3 and 8.8 which means it would have a positive charge under physiological pH conditions. Therefore, Wei et al. anticipate the instant claims.
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.
Claim(s) 1 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/224053 (Wei et al.) (US PGPUB 2020/0237925 referenced as English translation) in view of WO 2019/0015521 A1 (Roizman).
The disclosure of Wei et al. is provided above. Wei et al. do not disclose molar ratios of the penetratin derivative and the drug for the claimed composition.
Roizman disclose compositions for treating eye diseases and disorders comprising cell penetrating peptides and therapeutic agents (see title). The cell penetrating peptide (CPP) is disclosed as including penetratin and derivatives, the composition is disclosed as an eye drop and the therapeutic agents include a number of different types of agents but aflibercept, bevacizumab and ranibizumab are all disclosed and all have an isoelectric point that would result in the drug having a positive charge under physiological pH conditions (see [0003]-[0006]). Roizman teach that the composition comprising the therapeutic agent and the cell-penetrating peptide (TDS) is in a molar ratio of CP to the therapeutic agent from about 1:1 to about 20:1 (see disclosure at page 129, embodiments 63 and 66 and page 133, embodiments 95-97).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of Wei et al. with a molar ratio of cell-penetrating peptide (penetratin derivative) and drug with a ratio of about 1:1 to about 20:1 as taught by Roizman because Roizman teach compositions of cell-penetrating peptides and drugs for treating ocular conditions and Roizman teach that these ratios are desirable. One of ordinary skill in the art would have a reasonable expectation of success in applying these molar ratios of Roizman to the compositions of Wei et al. because the compositions are analogous and therefore, the ratios would be compatible with the components in the claimed composition. Additionally, it would only require routine optimization to determine the most optimal ratio for the components based on the teachings of Roizman. Therefore, the invention as a whole would have been obvious before the effective filing date of the claimed invention, absent evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,213,591 in view of WO 2019/0015521 A1 (Roizman). Although the claims at issue are not identical, they are not patentably distinct from each other because compositions for treating ocular diseases which comprise the penetratin derivative having the amino acid sequence of SEQ ID NO:2 (or SEQ ID NO:57, which is identical to that of SEQ ID NO:8 of the instant application and the elected species) and a protein with a positive charge at physiological pH would have been obvious over the disclosure of Roizman.
As pointed out above, Roizman disclose compositions for treating eye diseases and disorders comprising cell penetrating peptides and therapeutic agents (see title). The cell penetrating peptide (CPP) is disclosed as including penetratin and derivatives, the composition is disclosed as an eye drop and the therapeutic agents include a number of different types of agents but aflibercept, bevacizumab and ranibizumab are all disclosed and all have an isoelectric point that would result in the drug having a positive charge under physiological pH conditions (see [0003]-[0006]). Roizman teach that the composition comprising the therapeutic agent and the cell-penetrating peptide (TDS) is in a molar ratio of CPP to the therapeutic agent from about 1:1 to about 20:1 (see disclosure at page 129, embodiments 63 and 66 and page 133, embodiments 95-97).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the penetratin derivative of ‘591 (claimed in claims 1-2) in the composition of Roizman to arrive at a composition for treating ocular diseases. It would have been obvious to substitute the penetratin derivative of ‘591 for the CPP of Roizman because the penetratin derivative of ‘591 is another species of CPP which would serve the same function as the CPP molecules of Roizman. Therefore, the instant claims are not patentably distinct from the claims of ‘391.
Claims 1-9 and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10-12 and 14 of U.S. Patent No. 11,826,431 in view of WO 2019/0015521 A1 (Roizman). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘431 are directed to compositions which comprise the penetratin derivative having the amino acid sequence of SEQ ID NO:2 (which is identical to the formula in the instant claims) with a medicament/drug for treating retinal disease and optic nerve diseases (see claim 4). Claim 14 of ‘431 recites that the drug is bevacizumab which is a protein with a positive charge at physiological pH and used to treat ocular diseases. Therefore, claims 1-9 are not patentably distinct from the claims of ‘431.
‘431 does not claim molar ratios of the penetratin derivative and the drug in the claimed compositions. However, instant claims 13-16 would be obvious over the claims of ‘431 in view of Roizman. As pointed out above, Roizman disclose compositions for treating eye diseases and disorders comprising cell penetrating peptides and therapeutic agents (see title). The cell penetrating peptide (CPP) is disclosed as including penetratin and derivatives, the composition is disclosed as an eye drop and the therapeutic agents include a number of different types of agents but aflibercept, bevacizumab and ranibizumab are all disclosed and all have an isoelectric point that would result in the drug having a positive charge under physiological pH conditions (see [0003]-[0006]). Roizman teach that the composition comprising the therapeutic agent and the cell-penetrating peptide (TDS) is in a molar ratio of CPP to the therapeutic agent from about 1:1 to about 20:1 (see disclosure at page 129, embodiments 63 and 66 and page 133, embodiments 95-97).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the penetratin derivative of ‘431 (claimed in claims 1-4) in the composition of Roizman to arrive at a composition for treating ocular diseases. It would have been obvious to substitute the penetratin derivative of ‘431 for the CPP of Roizman because the penetratin derivative of ‘431 is another species of CPP which would serve the same function as the CPP molecules of Roizman. Therefore, the instant claims are not patentably distinct from the claims of ‘431.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
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