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 October 2, 2025, has been received and entered.
Claim Disposition
3. Claims 4-5 have been cancelled. Claims 9-10 have been added. Claims 1-3 and 6-10 are pending and are under examination.
Claim objection
4. Claims 1-3 and 6-10 are objected to for the following informalities:
For clarity it is suggested that claim 1 is amended to recite “administering a pegylated arginase and an asparaginase to the individual in need thereof…..”. The dependent claims hereto are also included.
For clarity and precision of claim language it is suggested that claims 9 and 10 are amended to read, “…wherein the….”.
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.
5. Claims 1-2 and 6-10 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 method of treating a disease or condition susceptible to arginine depletion in an individual in need thereof, comprising administering a modified arginase to the individual in need thereof, administering an asparaginase to the individual in need thereof….”, however, the claimed invention is not adequately described because there is no defined disease or condition; there are no indicia as to whether the two administration occurs simultaneously or separately and then the method concludes with ‘wherein the PEG-modified arginase and the asparagine depleting compound in combination provide a synergistic effect and the “asparagine depleting compound was not mentioned in the claim before or that administration was in combination. The claimed invention is not adequately described with respect to the modified arginase. It is recited that the modified arginase comprises a monosubstituted PEG-modified human arginase covalently coupled to a single polyethylene glycol moiety. This does not clearly define for example the modified human arginase, or what amount is effective to produce the desired effect (see claim 2 that provides the specific one). In addition, the claimed invention is not adequately described with respect to a nexus between administering a modified arginase for a condition or disease susceptible to arginine depletion and administering an asparaginase and then a glutamine depleting compound. Therefore, the claimed invention is not adequately described and encompasses a large variable genus of products, with no structure-function correlation.
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 of products or diseases or conditions, 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.
6. Claims 1-3 and 6-10 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 and the dependent claims hereto are indefinite for the recitation of “ disease or condition susceptible to arginine depletion” with no specific disease or condition to inform an ordinary skilled worker of the metes and bounds of this claim. The art recognizes that arginine deficiency can refer to a number of conditions including for example, arginase-1-deficiency, arginine vasopressin deficiency and arginine:glycine amidinotransferase deficiency. The ordinary skilled worker does not know what is inventive or being claimed and should not have to guess what is being claimed. Note also that asparaginase and aminotransferase is being included with no more specifics.
Claim 1 lacks clear antecedent basis for the recitation of “the asparagine depleting compound”. In addition, claim 1 is ambiguous for the recitation of “administering a PEG-modified arginase….,
administering an asparaginase to the individual in need thereof” and there is no indicia that the administration of both compound are together, or simultaneous or in combination and the claimed method end point is that the PEG-modified arginase and the asparaginase depleting compound in combination provide a synergistic effect. The dependent claims thereof are included.
Claim 1 is also not clear because it does not state that the disease or condition is ‘intracellular arginine depletion’.
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 the rejections of record under 112 first, second and 103 remains for the reasons stated above and herein. Applicant traverses the rejections and state that solely to expedite the claims have been amended. However, the amendments made did not obviate the rejections of record. The claimed method of objective remains inadequately defined and too broad. The method is to a treatment so the ordinary skilled worker should not have to guess what disorder or disease is being treated and with what specific product (shown in claim 2 not the independent claim).The method also does not clearly link the two administration steps or provide the express products used. Further, there is no clear antecedent basis for all of the claimed limitations. Thus, the 112 first and second paragraph rejections remain and have been amended to reflect changes made to the claims. Arginine depletion increases susceptibility to serious infections in preterm newborns for example, or can affect cancer patients but does the claimed invention envisage all of these and in different populations.
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). A claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may also be subject to rejection under 35 U.S.C. 112, para. 1, as not enabling, or under 35 U.S.C. 112, para. 2. In re Collier, 397 F.2d 1003 (CCPA 1968)”.
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 enzymes, 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).
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 on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652