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 .
Priority
This application filed 09/18/2023 is a National Stage entry of PCT/EP2022/057205, international filing date: 03/18/2022 and claims foreign priority to PCT/EP2021/056996, filed on 03/18/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/18/2023 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
The claim listing filed 04/04/2024 is pending. Claims 12-15 and 21-22 are cancelled. Claims 1, 7-11, 16, 18-20, 23-26 are currently amended. Claims 1-11, 16-20 and 23-26 are pending and under examination.
Drawings
The drawings are objected to because Fig 1 is missing the X-axis. 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 - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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 incorporation-by-reference paragraph, 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 disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 45, line 22; page 4, lines 32 and 34; page 5, lines 1 and 2. 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.
Claim Objections
Claims 23 and 24 are objected to because of the following informalities: Examiner respectfully requests addition of a period to the end of the sentence. Appropriate correction is required.
Claim Interpretation
Claim 1 recites “a ferritin variant polypeptide, wherein at least one..four” “with respect to SEQ ID NO: 1”. The claim does not recite “consisting of” SEQ ID NO: 1. Accordingly, Examiner interprets the sequence encompassing at least 1-4 lysine substitutions at positions 54, 72, 87, 144, but not excluding deletions/substitution at positions not recited in the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, 16, 18-20, 23-26 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 9 recites the broad recitation “non-basic amino acid”, and the claim also recites “preferably E or Q” which is the narrower statement of the range/limitation.
Accordingly, in claim 1, the claim recites the broad limitation “lysine residues”, and the claim also recites “ preferably ..at position 54, 72, 87 and/or 144” which is a narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Instant claim 10 recites the broad recitation “deleted or substituted”, and the claim also recites “preferably substituted with serine” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 9 and 11, the term “according to” in line 2 is indefinite, by not particularly pointing to the sequences as listed. This is unclear and ambiguity arises. For prior art purpose, the Examiner interprets the term “according to” as “of”.
Claims 1-11, 16, 18-20, 23-26 are rejected because they are dependent upon the rejected claim and/or are indefinite in scope.
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.
Claim 26 is 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.
As stated in § MPEP 2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’. These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5.The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation needed to make or use the invention based on the
disclosure.
See in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The eight Wands
factors are applied to claim 26 as follows:
The breadth of the claims and the nature of the invention
Claim 26 is directed to a method of treatment comprising administering the polypeptide of claim 1 to a patient in need thereof. Embodiments of the instant specification disclose method of treating, preventing, diagnosing by administering an effective amount of the polypeptide to a subject in need thereof (see lines 4-11, page 3). The specification reduces to practice experiments to teach Q11E mutant-Dox and Q11E-Q15E mutant-Dox on viability of tumor cells in vitro (Fig 7). The specification does not teach a method of treatment to a patient in need thereof, using the ferritin variant as claimed.
As such, scope of “treating” encompasses prevention of disease to reduction of disease progression to alleviation of symptoms of disease. Therefore, “treating” as claimed, also encompasses 100% prevention of disease. The specification provides no evidence that the peptide in claim 1 can treat or prevent disease in a subject. Accordingly, claim 26 is unduly broad with respect to a method of treating or preventing a disease.
The State of the Prior Art
The prior art in the field of treating or preventing a range of diseases as disclosed in the embodiments of the instant specification (see page 3, line 3) is non-existent using the peptide as claimed. Although in Example 9, Braca teaches that tumor-bearing animals treated with the HFt fusion polypeptide were free of disease and survived after 100 days from therapy initiation [0082], there is no prior art that teaches peptide of claim 1 for treatment or prevention.
The Level of Skill in the Art
Practitioners in this art (clinicians, scientists) would presumably be highly skilled in the art for prevention or treatment of disease in a subject.
The Level of Predictability in the Art
It is noted that the therapeutics art is unpredictable, requiring each embodiment to be
individually assessed for clinical benefit. The amount of guidance or direction needed to enable
the invention is inversely related to the amount of knowledge in the state of the art as well as the
predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Prior art has investigated therapeutics for hyperproliferative conditions such as cancer. Despite successes, approaches to identify potential peptide therapeutics, analogous screening, etc, there are no therapeutics that have successfully passed the stages of in vitro screening towards 100% prevention or treatment. This is because the art is unpredictable and there is no precedent for peptide treatment of a general disease state. It is not obvious from the instant disclosure, of a specific method that can achieve prevention or treatment of a subject using the peptide as claimed.
The Amount of Direction Provided by the Inventor and The Presence or Absence of Working Examples
The instant specification does not provide adequate guidance with regard to the actual
treatment or prevention or the effective amount of the peptide that is required to treat or prevent disease in a subject. Applicant’s limited disclosure is noted but is not sufficient to justify claiming treatment or prevention in a subject broadly. Absent a reasonable a priori expectation of success for using the peptide in a method of treatment, one skilled in the art would have to extensively test the peptide on a representative number of subjects, determine dosing using different concentrations of peptide and ascertain a prevention or treatment standard. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is claimed in its current scope, because the specification provides inadequate guidance to do otherwise.
The amount of direction or guidance presented in the specification is very limited. As discussed
in “[t]he Level of Predictability in the Art” section supra, the specification teaches working
examples examining in vitro viability of tumor cells (See Fig 7). However as noted in the “Breadth of the
Claims and Nature of Invention” section, treatment and prevention encompass 100% prevention. As such the examples used in the specification are not indicative of the desired result of 100% prevention
of disease.
It is further noted that Applicant provides no data, examples, figures, etc. demonstrating that
the peptide is capable of prevention or treatment. In the absence of such information, a
person of ordinary skill in the art would reasonably require undue quantity of experimentation.
Conclusion of Enablement Analysis 35 USC § 112(a)
MPEP § 2164.01(a), 4th paragraph states that “A conclusion of lack of enablement means that,
based on the evidence regarding each of the above factors, the specification, at the time the application
was filed, would not have taught one skilled in the art how to make and/or use the full scope of the
claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510,
1513 (Fed. Cir. 1993).
After applying the Wands factors and analysis to claim 26, in view of the applicant’s entire
disclosure, it is concluded that the practice of the invention as claimed in claim 26 would not be
enabled by the written disclosure. Therefore claim 26 is rejected under 35 U.S.C. §112(a) for
failing to disclose sufficient information to enable a person of skill in the art to practice a method of treatment or prevention on a patient in need thereof.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 9-11, 16-20, 23-26 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Aldo Braca, hereinafter Braca (US2021/0403515A1; PCT filed Nov. 5, 2018).
Regarding claims 1-4 and 6, Braca teaches a fusion protein based on the heavy chain of human ferritin (see [0002], line 8). The first domain comprises the amino acid sequence of the heavy chain of native human ferritin or a variant thereof having at least 90% identity with the amino acid sequence of the heavy chain of native human ferritin ([0006](a)). Braca teaches native human ferritin, SEQ ID NO: 1, which is a 100% sequence match to SEQ ID NO: 1 in the instant claim. Braca specifically teaches SEQ ID NO: 18, a human ferritin (HFt) Glu variant of length 183 amino acids, wherein positions 54, 72 and 144 are Glu residues (i.e. non-basic amino acid ‘E’).
Regarding claim 9, Braca teaches SEQ ID NO: 18, wherein the sequence contains Glu residues at 54, 72 and 144 (i.e. non-basic amino acid ‘E’) and mutations excluding positions 54, 72, 87 and/or 144. For example, compare position 12 in SEQ ID NO: 18 as taught in Braca to position 12 in SEQ ID NO: 1 in the instant application.
Regarding claim 10, Braca teaches serine residues in SEQ ID NO: 18, at positions 91, 103 and 131.
Regarding claim 11, Braca teaches SEQ ID NO: 18 with mutations outside positions 54, 72, 87 and/or 144.
Regarding claims 16 and 17, Braca teaches expression vectors containing the HFt gene [0064][0065]. In particular Braca teaches genetic constructs (i.e. vector) of single nucleic acid sequence (for instance DNA) that encode for HFt sequence (i.e. polypeptide) [0052][0012][0013][0002].
Regarding claim 18, Braca teaches conjugation of drug molecules (mitoxantrone or pixantrone) with ferritin variants, Hft-Glu-MP-PASE (see Fig 3, Fig 4, Fig 13)
Regarding claim 19, embodiments of the specification teach “complex” comprising at least one polypeptide and/or at least one conjugate (page 21, line 16). As noted, Braca teaches a complex of polypeptides and drug molecules as illustrated in Fig 3, Fig 4, Fig 13.
Regarding claim 23, Braca teaches therapeutic molecules covalently bound to the inner cavity or to the surface of HFt [0054]. Braca teaches auristatins as therapeutic molecule [0055].
Regarding claim 24, Braca teaches localization of HFt fusion polypeptide in colon cancer cell lines in Fig 7 and Fig 8 [0021][0022].
Regarding claim 25 Braca teaches pharmaceutical composition comprising fusion protein in combination with at least one pharmaceutically acceptable excipient, carrier or diluent (see claim 13). Braca teaches therapeutic and/or diagnostic molecules are encapsulated in the inner cavity of the HFt nanoparticle or are covalently bound to the surface of the HFt nanoparticle [0054].
Regarding claim 26, Braca teaches administering to a subject for the treatment a hyperproliferative disease, including cancer [0060]. In Example 9, Braca teaches injection (i.e. administration) of tumor-bearing mice with Hft fusion polypeptide twice a week for three weeks [0082]. Braca teaches that animals treated with the HFt fusion polypeptide were free of disease and survived after 100 days from therapy initiation [0082].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-11, 16-20 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Aldo Braca, hereinafter Braca (US2021/0403515A1; PCT filed Nov. 5, 2018).
Regarding claims 1-4, 6, 9-11, 16-20, 23-26, the teachings of Braca have been set forth above.
Regarding claims 5 and 7, Braca teaches SEQ ID NO: 18 human ferritin (HFt) Glu variant wherein positions 54, 72 and 144 are Glu residues (i.e. non-basic amino acid ‘E’). Braca does not teach position 87 is deleted or substituted with a non-basic amino acid.
Braca teaches that to improve and facilitate binding of positive drugs within the ferritin cavity, cysteine residues are removed from the protein surface and additional negatively charged residues selected from glutamate or aspartate, introduced in the protein cavity. In this way, it is possible for positively charged motif, e.g drugs, linkers, fluorophores, etc, to bind in a very effective manner to the internal cavity ([0010];[0077] see Example 8; Fig 11 and Fig 12; claim 3). Braca teaches that in the heavy chain of human ferritin, at least one cysteine or negative residue (aspartate or glutamate) is inserted in the internal cavity of the protein, preferably two, three or four cysteine or aspartate or glutamate are inserted in the internal cavity of the protein [0030]. As taught in Braca, the internal cavity of human ferritin is defined as any residues not exposed to the solvent [0031].
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, 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 modify the ferritin variant polypeptide of Braca, and introduce non-basic amino acid at position 87, to create the peptide as in the instant application.
One motivated to do so would have a reasonable expectation of success, as Braca teaches that negatively charged residues, in the protein cavity, binds in a very effective manner to positively charged motif, e.g drugs, linkers, fluorophores, etc ([0010];[0077] see Example 8; Fig 11 and Fig 12; claim 3).
Thus, one would have recognized that applying the teaching of Braca, would have yielded predictable results and improved the drugs/ linkers/fluorophore-binding function of the peptide as claimed (See MPEP § 2143 I(A)(D)).
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 1-11, 16-20 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5, 7-10, 12, 13-15 of copending Application No. 17/906092; see claim set 03/17/2026 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, copending application ‘092 claims ferritin variant sequence comprising the amino acid sequence SEQ ID NO: 81, which meets the limitation of the claim (see claims 1, 3, 4 and 5 in the reference application).
Regarding claims 2-11, copending application ‘092 teaches SEQ ID NO: 64, SEQ ID NO: 70, SEQ ID NO: 78 to SEQ ID NO: 80 and SEQ ID NO: 87 which meet the limitations of the claims (see claim 3).
Regarding claims 16-20 and 23, see claims 7-10 and 12 in the copending application ‘092.
Regarding claims 24-25, see claims 13-15 in the copending application ‘092.
Claims 1-11, 16-20 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 15, 17-21 of copending Application No. 17/931576; claim set 01/13/2026 (reference application) in view of Aldo Braca, hereinafter Braca (US2021/0403515A1; PCT filed Nov. 5, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of Braca have been set forth above.
Regarding claims 18-20 and 23-26, copending Application No. ‘576 claims iron binding protein and active ingredient are covalently bound; claim targeted delivery system wherein the iron binding protein is ferritin; anticancer drug is auristatin (see claims 1-8, 15, 17-21).
Claims 1-11, 16-20 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 12, 13, 15, 16, 17, 18, 19, 20 of copending Application No. 18/951987; claim set 01/09/2025 (reference application) in view of Aldo Braca, hereinafter Braca (US2021/0403515A1; PCT filed Nov. 5, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of Braca have been set forth above.
Regarding claims 18-20 and 23-26, copending Application No. ‘987 claims iron binding protein and active ingredient are covalently bound; claim targeted delivery system wherein the iron binding protein is ferritin; anticancer drug is auristatin (see claims 1, 11, 12, 13, 15, 16, 17, 18, 19, 20).
Claims 1-11, 16-20 and 23-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 14, 17, 29 and 30 of copending Application No. 17/745016; claim set 06/22/2025 (reference application) in view of Aldo Braca, hereinafter Braca (US2021/0403515A1; PCT filed Nov. 5, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of Braca have been set forth above. Also please note Braca teaches therapeutic and/or diagnostic molecules encapsulated in the inner cavity of HFt [0054].
Regarding claims 18-20 and 23-26, copending Application No. ‘016 claims iron binding protein and active ingredient are covalently bound; claim targeted delivery system wherein the iron binding protein is ferritin (see claims 1, 13, 14, 17, 29 and 30).
Claims 1-11, 16-20 and 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 15, 20, 21 of U.S. Patent No.11464879 in view of Aldo Braca, hereinafter Braca (US2021/0403515A1; PCT filed Nov. 5, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other.
The teachings of Braca have been set forth above. Notably, Braca teaches sequestering active ingredient within the cavity of nanoparticle or covalently binding [0059].
Regarding claims 18-20 and 23-26, reference patent claims iron binding protein and active ingredient are not covalently or not non-covalently bound; claim targeted delivery system wherein the iron binding protein is ferritin; drug is anticancer drug (see claims 1, 13, 15, 20, 21).
Claims 1-11, 16-20 and 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25, 26, 27, 28, 38, 39, 43, 44, 46, 47, 48, 49, 50 of U.S. Patent No.12485192 in view of Aldo Braca, hereinafter Braca (US2021/0403515A1; PCT filed Nov. 5, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other.
The teachings of Braca have been set forth above. Notably, Braca teaches sequestering active ingredient within the cavity of nanoparticle or covalently binding [0059].
Regarding claims 18-20 and 23-26, reference patent claims iron binding protein and active ingredient are not covalently or not non-covalently bound; claim targeted delivery system wherein the iron binding protein is ferritin (see claims 25, 26, 27, 28, 38, 39, 43, 44, 46, 47, 48, 49, 50).
Conclusion
No claim is allowed.
Correspondence
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/ARCHANA VARADARAJ/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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