DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on April 21, 2026, has been received and entered.
Claim Disposition
3. Claims 1-76 have been cancelled. Claims 77-94 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statements filed on April 21, 2026, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Claim objection
5. Claims 77-94 are objected to for the following informalities:
For clarity and consistency it is suggested that claim 77 is amended to recite “…polypeptide [[being]] is positioned between……cytotoxic moiety, wherein the sortase recognition site comprises SEQ ID NO: 66”. The dependent claims hereto are also included.
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.
6. Claims 77-94 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention is directed to “a cell targeted cytotoxic construct comprising products such as a ligand, linking polypeptides, for example, however, no structural limitations are recited. In addition, the claimed invention has no functional limitations. No structure function correlation is made, and the claims encompass a large variable genus (i.e. ligands, linking polypeptides, spacer, cytotoxic moiety, see claim 77 for example) that is not adequately described.
The claimed invention as directed to a cell-targeted cytotoxic construct that encompasses a large variable genus of cells, sortase recognition site, spacer, auristatin, toxin or chemotherapeutic, and composition. For example, the term “auristatin” does not clearly provide the following means (i) only auristatin E, auristatin F, AEB, AEVB, AEFP, MMAE, MMAF, eleuthorobin, netropsin, podophyllotoxins, and maytansiods including maytansine and DMI, and combretestatins or (ii) any auristatin analog (for example, see Maderna et al, 2015. In addition, the structural and functional properties of auristatin E, auristatin F, AEB, AEVB, AEFP, MMAE, MMAF, eleuthorobin, netropsin, podophyllotoxins, and maytansiods including maytansine and DMI, and combretestatins are not disclosed by the specification. Therefore the invention as claimed is not adequately described. The dependent claims hereto are also included.
The claimed invention is not commensurate in scope with the disclosure and no correlation is made between structure and function. A large variable genus of products, expression products and organism are encompassed in the claims as well as modifications that are not described. The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. 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, 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.
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.
7. Claims 77-94 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.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection under 112, first paragraph of record remains for the reasons stated above and herein.
Applicant traverses the rejection by stating that the components recited in the claims (referred to by applicant as ‘elements’) have well known structures. This argument is not persuasive because no correlation is made between structure and function as required in the written description guidelines and the claims encompass a large variable genus that applicant has not demonstrated possession of the entire genus.
The specification states the following.
[00117]…RSPO1 and RSPO2 have been identified as the ligands for both LGR5 and LGR6 receptors to which they bind with high affinity.
This statement provides no structural information for the terms “RSPO1” and “RSPO2” which are both types of R-spondin. The skilled artisan would not know the metes and bounds of the recited invention. It is assumed that the term “R-spondin” means any polypeptide comprising an N-terminal secretory signal peptide, 2 tandem furin-like cysteine-rich (Fu-CRD) domains, a thrombospondin type 1 repeat (TSP) domain, and a C-terminal basic amino acid-rich (BR) domain that binds to any marker for stem cells in the gut (LGR5) or any polypeptide that binds to skin and Fallopian tube epithelium (LGR6). The claimed invention also encompasses human LGR4, however, the dependent claims provide the information missing from the independent claim which should be the most comprehensive claim. The invention set forth in claim 77 is overly broad and not limited by these embodiments or what is in the art.
Applicant is reminded that the written description requirement ‘… serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, 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). The claimed invention does not provide sufficient description of the claimed invention set forth in claims 77 and the dependent claims hereto. Applicant is urged to consider proposed amendments to bring the application in condition for allowance.
Conclusion
9. No claims are presently allowable.
10. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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