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 September 15, 2025, has been received and entered. Applicant is reminded to not gray out the amendments made in the claims because it is difficult to read. Amendments should not be in boldface either, just underlined or strike outs are the appropriate annotations.
Claim Disposition
3. Claims 2, 4 and 21-27 have been cancelled. Claims 1, 3 and 5-20 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statements filed on May 22, 2025 and April 1, 2025, have 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 1, 3 and 5-20 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to delete “wherein the viral infection comprises”. The dependent claims hereto are also included.
For clarity claim 11 should be amended as follows, “……abacavir, [[acyclovir ,]] adefovir…” and instead recite “……abacavir, acyclovir, adefovir…”, to remove extra space.
For clarity and precision of claim language it is suggested that claim 16 is amended to define the effective amount in the first and second treatment and the time period for each one. The dependent claims hereto are also included.
For clarity and consistency it is suggested that claim 19 is amended to read, “….uricase comprises [[of]] rasburicase….…”. In addition, the acronym should be spelled out (ALLN).
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 1, 3 and 5-20 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 for treating a health consequence caused by a viral infection in a subject….comprising administering a therapeutically effective amount of a uric acid lowering agent (UALA), wherein the viral infection is by a corona virus or an influenza and the health consequence comprises acute kidney injury, acute vascular injury or acute pulmonary injury. The claimed invention lacks adequate written description because there are no one to one correspondence between a specific corona virus and for example acute vascular injury. The art generally recognizes that influenza can lead to acute kidney injury, acute vascular injury or acute pulmonary injury but the art also recognizes that covid 19 relates to acute vascular injury but not all of the corona viruses. In addition, the claimed invention is not adequately described as set forth in claim 1 especially with the recitation of, “….wherein the viral infection comprises wherein the health consequence comprises….” There are no indicia as to what is comprised.
The claimed method of treatment does not define how much of the UALA is considered sufficient to be administered, does not define the enzyme inhibitors claimed or uricosuric agent.
The claimed invention encompasses a broad variable genus of diseases, agents and viral infections that are not adequately described. In addition, note that claims 9 and 10 encompass a genus of anti-inflammatory agents and anti-viral agents. It is noted that claim 11 provides a laundry list of anti-viral agents, however, no one to one correspondence to demonstrate the desired results. Therefore, the claimed invention is not adequately described and encompasses a large variable genus of products.
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 agents or health consequences or viral infections or anti-oxidant, 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 1, 3 and 5-15 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 an incomplete statement, “wherein the viral infection comprises wherein….”, because nothing is identified in association with this clause.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn objections/rejecitons will not be discussed herein as applicant’s comments are moot. Note that the rejections under 112, first and second paragraph remains but have been altered to reflect modifications made to the claims.
Applicant traverses the rejections stating that amendments have been made to the claims. Although amendments were made, these were not sufficient to obviate all the rejections of record and the amendments introduced new rejections as well. Thus for the reasons stated above the rejections remain.
Conclusion
9. No claims are presently allowable.
10. 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.
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 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOPE A ROBINSON/Primary Examiner, Art Unit 1652