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 .
DETAILED ACTION
1. Applicant’s election of Group II (claims 31-33) in the reply filed on 6/10/26 is acknowledged.
Applicants argue – “Pursuant to the procedures set forth in the Official Gazette notice dated March 26, 1996, (1184 O.G. 86) and MPEP §821.04, the withdrawal of the restriction requirement as it relates to method claim 34 (Group III) and the rejoinder and examination of method claim 34 is respectfully requested upon the identification of allowable subject matter within the claims of elected Group II.”
Regarding Claim 34, the Examiner will consider rejoinder of the claim at the time of allowance.
2. Claims withdrawn:
Claims 1, 21-30 & 34-39 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
3. Priority
Receipt is acknowledged of papers (foreign priority filed 12/21/2021) submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
4. Claims 31-33 are under examination in this Office Action.
5. Drawings
The drawings filed on 2/4/25 are acknowledged.
6. IDS(s) filed 2/4/25 & 2/4/25 are acknowledged. Signed copies of the IDS(s) are provided with this Office Action.
7. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
8. 35 U.S.C. § 112, first paragraph (Written Description)
Claims 31-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to the following genus claims.
31. A genetically modified mammalian cell comprising a gene encoding a polypeptide comprising: an amino acid sequence represented by SEQ ID NO:1, or an amino acid sequence with at least 80% sequence identity to SEQ ID NO:1, such as at least 90% sequence identity to SEQ ID NO:1, such as at least 95% sequence identity to SEQ ID NO:1, such as at least 99% sequence identity to SEQ ID NO:1.
32. The genetically modified mammalian cell according to claim 31, wherein the mammalian cell further comprises one or more genes selected from the group consisting of: (a) a gene encoding a polypeptide comprising an amino acid sequence represented by SEQ ID NO:2, (b) a gene encoding a polypeptide comprising an amino acid sequence represented by SEQ ID NO:3, (c) a gene encoding a polypeptide comprising an amino acid sequence represented by SEQ ID NO:11, and (d) a gene encoding a polypeptide comprising an amino acid sequence represented by SEQ ID NO:12, and combinations thereof.
33. The genetically modified mammalian cell according to claim 31, wherein the mammalian cell further comprises a gene encoding a polypeptide comprising an amino acid sequence represented by SEQ ID NO:11 and/or a gene encoding a polypeptide comprising an amino acid sequence represented by SEQ ID NO:12.
The claims are described by a genus variants of any of the SEQ ID Nos. 1-3, 11 & 12 with no functionality associated with the variants. No representative sequences are described.
The instant specifications describes - A genetically modified mammalian cell comprising genes encoding a combination of amino acid sequences of SEQ ID NO:1 (HS3ST4), SEQ ID NO: 2 (NDST1), SEQ ID NO: 3 (NDST2), SEQID NO: 11 (NDST3) and SEQ ID NO: 12 (NDST4), wherein the combination of amino acid sequences when treated heparan sulfate having increased anticoagulant activity compared to heparan sulfate which is not treated with said combination of amino acid sequences.
No representative sequences are described – nor are variants of SEQ ID Nos. 1-3, 11 & 12 modified by 20% and with no associated function. The specification does not contain any disclosure or description of the structure and function of all DNA/protein sequences that are at least 80% identical to SEQ ID Nos. 1-3, 11 & 12, or a derivative derived from such a sequence(s) by insertion, deletion or substitution, and encoding a protein which has the desired enzymatic activity.
The 5 species disclosed are not representative of the genus claimed. According to MPEP 2163, to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v.Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed.Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe aninvention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what isclaimed."). Thus, an applicant complies with the written description requirement "bydescribing the invention, with all its claimed limitations, not that which makes it obvious,"and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966."Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents" of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case is discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
Moreover, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
9. Claim Rejections - 35 USC § 112 (second paragraph)
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 31-33 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 pre-AIA the applicant regards as the invention.
Claims 31-33 recite the phrase “represented by…”numerous times – while it is not clear what other representative sequences are? It is suggested to delete the phrase “represented by” from the claims to overcome this rejection.
10. 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) 31-33 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO 2018/112434 (referenced in the IDS filed 2/4/25).
WO 2018/112434 teaches in some embodiments a composition or a method comprising a cell line genetically modified to be transgenic for one or more heparan sulfate glucosamine 3-O-sulfotransferase 4 (HS3ST4, AF105378)), of SEQ ID NO: 1; N-Deacetylase And N-Sulfotransferase 1 (NDST1, U18918) of SEQ ID NO: 2, N-Deacetylase And N-Sulfotransferase 2 (NDST2, U18918) of SEQ ID NO: 3, N-Deacetylase And N-Sulfotransferase 3 (AF074924) of SEQ ID NO:11 or N-Deacetylase And N-Sulfotransferase 4 (NDST4, AB036429) of SEQ ID NO:12. The respective enzymes are given in - See [0003] for example and Table 6. The 5 enzymes are 100% identical to the corresponding enzymes. Paragraph [121] disclose various cell types including mammalian cells that can be used in various combinations for transforming the genes encoding the various enzymes. The reference anticipates the claims.
11. US 20250154476 A1 is the PG Pub of the instant application.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B Mondesi can be reached on 408 918 7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940
Prosecution Insights