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 December 9, 2025, has been received and entered.
Claim Disposition
3. Claims 1-15 have been cancelled. Claims 16-28 have been added and are pending. Claims 1-16-22 are under examination. Claims 23-28 are withdrawn from consideration as directed to a non-elected invention.
Abstract Objection
4. The abstract is objected to for the following informalities:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Appropriate correction is required.
Claim objection
5. Claims 16-22 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 16 is amended to define all the variables in the formula (note that Q, E and G are not defined) and recite that the amino acid sequence is set forth in SEQ ID NOs:1 to 4, 47, 51-52 and 62.
For clarity and consistency it is suggested that claim 17 is amended to read, “….SEQ ID NOs: 1 to 4…..”. Further, claim 17 is objected to for the recitation of non-elected subject matter.
For clarity and precision of claim language it is suggested that claim 21 is amended to read, “The peptide tag of claim 16 [[A tagged protein comprising]] operably linked to a recombinant protein, wherein the recombinant protein is an enzyme, a cytokine, an antibody or a fluorescent protein.
For clarity claim 22 should be amended to add a period (.).
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 16-22 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) contain 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 peptide tag of 9-18 amino acid residues and a tagged protein’. The claimed invention is described with a structure, however is devoid of a function. The claimed invention is not adequately defined with the large variable genus of structures encompassed in the claims with respect to the changing variables in the Formula I. No correlation is made between structure and function because note that the specific structures are recited in a dependent claim and there are no indicia as to how the peptide tag is being used (specific activity is assigned to the peptide that has changing variables). It is noted that claim recites a tagged protein comprising the peptide tag and operably linked to a recombinant protein that can be an antibody, an enzyme, a cytokine or a fluorescent protein. This does not inform an ordinary skilled worker of ‘what tagged protein’ or what recombinant protein is operably linked to the variable tag. It is well established in the art that a single amino acid change can be detrimental to the structure-function relationship of the protein so much so that the protein can be rendered inactive or not functional in the manner asserted.
The claimed invention does not inform an ordinary skilled worker of the metes and bounds of the claims. There is also no clear structure-function correlation provided. The claimed invention is overly broad and encompasses large variable genus of enzymes. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, 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 structures, 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).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims which is vast with respect to the peptide with 6 to 50 residues and several changes, with no asserted activity.
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 16- 22 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.
Claims 16 and the dependent claims hereto are indefinite because the formulas define all variables except Q, E and G. The variables in the formula must be identified/defined in full for the formulas for completeness and clarity.
Claim 22 is incomplete, thus indefinite because it is missing a period. MPEP 608.01(m) requires claims to be a full sentence, beginning with a capital letter and ending with a full stop. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Where a claim sets for a plurality of elements or steps, each element or step of the claims should be separated by a line indentation, 37 CFR 1.75(i).
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.
8. Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 102 a(1) as being anticipated by JP 2014-500866 A (of record in the application).
The claimed invention is directed to a peptide disclosed as being SEQ ID NO:3 for example. The JP document discloses an acyl donor glutamine-containing tag comprising an amino acid sequence selected from SEQ ID NOs:47, 52 and 55 and thus practically discloses a peptide comprising the amino acid sequence (see paragraphs [0027] and [0036] which indicate that the acyl donor glutamine-containing tag is included in an Fc-containing polypeptide conjugate. The peptide has the sequence defined in claims 1 and 2 of the instant application comprising 6 to 50 amino acids. The protein in the art is defined as being useful. Therefore, the limitations of the claims are met by the reference.
Response to Arguments
9. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. The rejections remain but have been modified to reflect changes made to the claims. The objection to the abstract was not specifically addressed, thus remains. New claims 16-22 are rejected under 112 first and second paragraph because some issues remain and because some new issues have been instituted, for example a missing period in claim 22. The claimed invention remains drawn to a genus of structures not adequately described (suggestions have been made to place the application in better form). Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 102 a(1) as being anticipated by JP 2014-500866 A (of record in the application) based on the breath of the claims and the structures in the Markush group (see the above suggestions for amendments to reduce the remaining issues). The amendment filed on December 9, 2025 resolved some but not all issues raised, thus a final is being issued as attempts to resolve them telephonically was not successful (see attached interview summary).
Conclusion
10. No claims are presently allowable.
11. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. 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