DETAILED ACTION
Claims 1-12, submitted 21 February 2024, are pending in the application. Claims 1 and 3-6 are under examination in the instant Office Action. Claims 2 and 7-12 are withdrawn.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1 and 3-6, in the reply filed on 01 May 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claims 3-6 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “pretreating the animal with Retrorsine”, and the claim also recites “preferably, the dose of Retrorsine is 10-50 mg/kg animal body weight; more preferably, the dose of Retrorsine is 20-40 mg/kg animal body weight; further preferably, the dose of Retrorsine is 25-35 mg/kg animal body weight.” which is the narrower statement of the range/limitation. Claim 4 recites the broad recitation “administering a low dose of Nitisinone every day for 4-10 days”, and the claim also recites “preferably, administering a low dose of Nitisinone every day for 5, 6, 7, 8 or 9 days” which is the narrower statement of the range/limitation. This claim also recites the broad recitation “the low dose is 0.008-0.08 mg/kg animal body weight/day”, and the claim also recites “preferably, the low dose is 0.01-0.05 mg/kg animal body weight/day” which is the narrower statement of the range/limitation. Claim 5 recites the broad recitation “the high dose is 0.3-1.2 mg/kg animal body weight/day”, and the claim also recites “preferably, the high dose is 0.35-1 mg/kg animal body weight/day” which is the narrower statement of the range/limitation. Claim 6 recites the broad recitation “wherein the animal is a mammal that is at least twice larger in size than a mouse”, and the claim also recites “preferably, the animal comprises an animal selected from the group consisting of: rat, rabbit, monkey, pig, guinea pig, dog; preferably, the animal is an animal wherein the interleukin 2 receptor gamma gene and the recombination activating gene 2 are destroyed” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bial et al. (WO 2013/032918 A1).
Bial teaches a method wherein a Fah-/- rat is maintained on a pharmacologic inhibitor of phenylpyruvate dioxygenase, such as NTBC (nitisinone) or methyl-NTBC to inhibit or avoid liver dysfunction (pg. 25, Lines 15-17). Bial also teaches wherein the dose of NTBC when administered is the Fah-/- rat is about 0.2 mg/kg to about 2.0 mg/kg per day (pg. 25, Lines 29-30) which overlaps with the administered range with step 2 of instant claim 1 which recites wherein the high dose is 0.25-1.5 mg/kg animal body weight/day. This also reads on the limitation of instant claim 6, which recites “wherein the animal is a mammal that is at least twice larger in size than a mouse, preferably, the animal comprises an animal selected from the group consisting of : rat…”.
Bial does not teach wherein nitisinone is administered over a set period of time, however, through routine experimentation, one having ordinary skill in the art would have been motivated to develop an optimal plasma concentration in a subject as Bial states “Treatment with NTBC blocks the tyrosine catabolism pathway at this step and prevents the accumulation of succinylacetone, a pathognomonic metabolite that accumulates in Fah-deficient humans and animals.” (pg. 14, Lines 13-15). This rationale also applies to instant claim 4 and instant claim 5 which further limit the period of time that nitisinone are administered.
Regarding claim 3, Bial teaches an embodiment wherein, prior to transplantation with heterologous hepatocytes, retrorsine is administered to induce a suitable model for liver injury (pg. 23, Lines 19-22).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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, James H Alstrum-Acevedo can be reached at 571-272-5548. 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.
JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./ Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights