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 28, 2025, has been entered.
Claim Disposition
3. Claims 4, 13, 15-17, 19-20, 22-28 and 38-39 are cancelled. Claims 1-3, 5-12, 14, 18, 21, 29-33 and 37 are pending and are under examination.
Claim Objection
4. Claims 1-3, 5-12, 14, 18, 21, 29-33 and 37 are objected to because of the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “…..compared to a wild type human DAO……”.The dependent claims hereto are also included.
For clarity and consistency it is suggested that claim 5 is amended to read, “…6 or 7[[,or 8]] amino acid substitutions…..”, because the Markush list provided in the claim has 7 substitutions.
For clarity and precision of claim language it is suggested that claim 7 is amended to read, “….comprising a GAG binding domain of an amino acid sequence selected from the group consisting of…..” because the recombinant human DAO is set forth in SEQ ID NO: 1 with substitutions.
Claim 10 is objected to because the acronym ‘AUC’ need to be spelled out in the first occurrence. For clarity claim 10 should be amended to read, “…wherein
For clarity and precision of claim language it is suggested that claim 21 is amended to read, “…..DAO is [[incorporated into]] a pharmaceutical composition comprising the recombinant human DAO and one or more……”.
For clarity and precision of claim language it is suggested that claim 8 is amended to read, “……at position 168 [[corresponding to the numbering]] of SEQ ID NO: 1.
For clarity it is suggested that claim 33 is amended to read,
“ A method of treating chronic allergic conditions in a subject, comprising:
administering an effective amount of the recombinant human DAO of claim 1 to the subject, wherein the DAO is internalized by endothelial cells, wherein the chronic allergic conditions are selected from the group consisting of acute urticaria, asthma……….. and wherein administering the recombinant human DAO reduces histamine to treat chronic allergic conditions”.
Appropriate correction is required.
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.
5. Claims 1-3, 5-12, 14, 18, 21, 29-33 and 37 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.
Claim 1 is indefinite for recitation of ‘with decreased glycosaminoglycan binding affinity’ because the claim does not establish if the decrease is to interfere with pathological processes like atherosclerosis, inflammation and infection or to regulate physiological functions such as protein transport and cell signaling. It is also not clear from the claim language that the decrease is as a result of the modification at the respective positions. The dependent claims hereto are also included.
Claims 33 and 37 are indefinite because the methods does not provide a nexus because the disorder and the treatment. The metes and bounds of the claimed treatment method is unclear.
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 1-3, 5-12, 14, 18, 21, 29-33 and 37 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 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 as amended is directed to a recombinant human diamine oxidase (DAO) with decreased glycosaminoglycan (GAG) binding affinity compared to a wild type (set forth in SEQ ID NO:1) of human DAO and the recombinant DAO comprises at least one amino acid modification of any one of amino acids at positions 568-575 of the GAG binding domain with reference to SEQ ID NO: 1 (see claim 1). The product of claim 1 is recited with a decreased GAG binding affinity compared to the wildtype but the claimed invention does not indicate that the modification results in the decrease of GAG binding affinity or how this reflects as an active activity for the enzyme such as having said modification results in reduced histamine. The claimed invention is also directed to a method of treating a subject having a medical condition by administering an effective amount of the recombinant human DAO of claim 1 and a list of conditions are provided in a Markush that relate to respiratory disorders such as asthma and allergic issues such as hay fever and itching, but there is no nexus made between the product and the method of treatment (such as associated with excess histamine). The claimed invention is not adequately described because it encompasses a modified structure and is devoid of an activity. The language in the claim is also open so not restricted to the mutations recited. In addition, the decreased activity is not defined with respect to a quantifiable amount (i.e. 1.5 fold) nor is the decrease defined relative to function of the enzyme. There is no clear nexus made between the recombinant structures and a function relationship. It is noted that claim 9 recites that the modified DAO has increased half-life compared to the wild type, however claim 1 is not limited to that and this does not clearly establish that activity for the enzyme has been garnered with the modification. Additionally, if the mutation endows an increased plasma half-life (see claim 9) and the fusion of claim 14 would ostensibly be for the same purpose, are both needed or concurrently utilized; the claimed invention does not inform an ordinary skilled worker of an activity for the recombinant DAO.
The claimed invention requires a product that is not adequately described because there is no structure-function correlation provided for the broad variable genus encompassed in the claims. 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 fusion protein that encompasses mutants and fragments with no asserted activity.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot.
Note that new objections have been instituted for the reasons set forth above. In addition, new rejections have been instituted based on amendments made to the claims.
Conclusion
8. No claims are presently allowable.
9. 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, Monday- Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652