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 .
Application Status
The action is written in response to applicant’s correspondence received on 2/12/2024. Claims 47-66 are currently pending in the instant application.
Priority
The instant application is a continuation of U.S. Patent Application 16/613,025, which is a U.S. National Phase Application of 371 of PCT/US2018/032800, filed on 5/15/2018. The PCT application claims priority to US Provisional Patent Application 62/507,565. The claim to US Provisional patent application 62/507,565 is acknowledged.
Specification
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 drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Currently, Fig. 8-1 of the drawings include two different sequences/sequencing results exceeding 10 nucleotides in length with no corresponding SEQ ID NOs in the figure or the brief description of the drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
The use of the term Xeloda®, Ara-C®, Gemzar®, and Alimta®, which is a trade name or a mark used in commerce, has been noted in this application (see paragraph 0069 of the specification). 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because in Fig. 13, they fail to show the GFP signals for the two TREs as described in the specification. Due to the density of the results and figure size, it is impossible to distinguish the two lines representing the two promoters from each other.
Furthermore, in Fig. 29, the black dots and triangles are not included in the figure legend and it is unclear what these data points represent. As a result, it is unclear what the proper interpretation of the data illustrated in Figs. 13 and 29 are.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Claim Interpretation
Regarding claim 47 of the instant application, applicant does not provide a specific length for the transcription factor response element (TRE) in the claim. Looking to the specification for guidance, applicant discloses “transcription factor response elements” as short sequences of DNA within a gene promoter region that are able to bind specific transcription factors and regulate transcription of genes. Furthermore, applicant states they may also be a short (50-1500 bp) region of DNA that can be bound by proteins (see paragraph 0045 of the instant specification). Examiner will interpret the length of the TRE to be between 50-1500 bp.
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 51, 55, and 66 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 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.
Regarding claims 51 and 55, the instant claims are a new claims which recite a vector comprising a sequence, or a sequence linked to the TRE and minimal promoter, encoding a payload. Here, the instant specification does not provide guidance on what defines a “payload” and the term “payload” is immensely broad. Unless defined, these claims are rejected as introducing new subject material that is not support by the instant specification.
Regarding claim 66, the instant claim is a new claim which recites a negative limitation wherein the CAR is not encoded by a sequence encoding a payload. Looking to the specification for guidance, there is no support, absent evidence to the contrary, which describes this negative limitation. Therefore, this new claim is rejected as introducing new subject matter to the instant claim set.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 60-66 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claims 60-66, the instant claims are drawn to a cell, which can be any cell, including cells within the human organism, that are unmodified or naturally occurring. Therefore, “a cell” recited in claim 60 reads on a product of nature and all dependent claims are rejected. Applicant can overcome this rejection by specifying an “isolated” cell.
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.
(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.
Claims 47-48, 53, 56, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masignani et al. (US 8,758,764 B2, Published 6/24/2014).
Regarding claim 47 and 48, Masignani teaches SEQ ID NO: 1327, a nucleotide sequence which has a portion that is 75 nucleotides that have 100% identity with SEQ ID NO: 7 of the instant application, as shown below.
Regarding claim 53, Masignani teaches nucleic acids of the invention may be part of a vector (see column 26, line 1).
Regarding claim 56, Masignani teaches where vectors may be…”viral vectors”, which is designed to result in the production of a recombinant virus or virus-like particle (see column 26, line 4).
Regarding claim 60, Masignani teaches a host cell includes an individual cell or cell culture which can be or has been a recipient of exogenous nucleic acids, such as that from a vector (see column 26, line 8).
The claims above are drawn to a composition, such as a transcription factor response element. Given the open-ended language of the claim with the TRE having “at least 90% sequence identity” with SEQ ID NO: 7, fragments of sequences that share 90% identity with SEQ ID NO: 7 will be sufficient to satisfy the claimed limitations, even if the prior art teaches longer sequences.
In view of the foregoing, claims 47-48, 53, 56, and 60 are rejected under 102(a)(1) as being anticipated by Masignani. Applicant could potentially overcome this rejection by amending to recite 90% sequence identity over the “full length of SEQ ID NO: 7”.
Double Patenting
Statutory Double Patenting
Claims 47-55 and 60-63 are directed to the same invention as that of claims 1-11, and 13-20 of commonly assigned US11851649B2. Under 35 U.S.C. 101, more than one patent may not be issued on the same invention.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims such that the reference and the instant application no longer contain claims directed to the same invention.
The inventions of the instant application and the issued patent are indistinct as the claims are both drawn to a composition comprising a vector with a TRE that is at least 98% identical to SEQ ID NO: 7 of the instant application (SEQ ID NO: 7 of the issued patent). Though claims 47-48 are drawn to a sequence with at least 90% sequence identity and 95% sequence identity to SEQ ID NO:7 of the instant application, the issued patent’s SEQ ID NO:7 has 100% identity, which is encompassed by these claims. Furthermore, both instant application and issued patent recites a vector with an IL2 minimal promoter and further encoding a payload. While the payload is specified in the issued patent, as well as the specific viral vector being different, the breath of the independent claims of the instant application encompass the composition of the issued patent, currently withstand.
Nonstautory 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 47-64, provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 85-90, 95-97, and 100-102 of copending Application No. 18/293,330. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is directed to a composition and the co-pending application is directed to a method of use with a composition that is patentably indistinct from the composition of the instant application.
Regarding the composition taught by the co-pending application, applicant discloses a polynucleotide comprising a first nucleic acid sequence consisting of linked transcription response elements (TREs) and a second nucleic acid sequence encoding a CAR, thereby to increase the activity of a cell. The first polynucleotide of the copending application can be any TRE, wherein, both SEQ ID NO: 7 of the instant and copending application have 100% identity. The specification of the copending application discloses where the first nucleic acid comprises a minimal promoter linked to the TRE, wherein the minimal promoter is an IL-2 minimal promoter (see paragraph 0010 of the copending specification). Claim 51 of the instant application recites wherein the TRE and minimal promoter are operably linked to a sequence encoding a payload. The copending application recites where a second nucleic acid sequence encodes a chimeric antigen receptor (CAR) which is encompassed by the breadth of a “payload”.
Furthermore, the copending application recites in claim 95 where the polynucleotide is encoded within a viral vector, which is also disclosed by claim 53 of the instant application. Both application recites where the vector is in a cell (claim 100 of copending application and claim 60 of the instant application), the cell being a T cell or hematopoietic stem cell, wherein the cell is further selected from a CD4+ or a CD8+ T cell. Absent evidence to the contrary, it is clear the method of increasing an activity of a cell, recited in the copending application, encompasses the composition of the instant application, wherein the copending application is merely intended use of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID YU whose telephone number is (571)272-1118. The examiner can normally be reached Monday-Friday 7:30 am -5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T.Y./Examiner, Art Unit 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635
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