DETAILED ACTION
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 .
Specification
The disclosure is objected to because of the following informalities:
In page 7, line 28; page 8, line 3; page 14, line 3; page 22, lines 18 and 21; page 32, lines 24 and 27; page 33 lines 4, 7, 13, and 20, “Sinestrin” should read “Sinistrin”.
In page 7, line 30, the brief description of the drawings lists a “Fig. 22”. However, the drawings show “FIG. 22A” and “FIG. 22B”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
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.
Claim 17 is 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. This is a written description rejection.
Regarding claim 17, the specification provides insufficient written description to support the genus of “a molecule for the treatment of renal injury, wherein the molecule is identified with [[a]]the method according to claim 5”. The claim 17 is reach-through claim and only describe molecules to be discovered and not molecules applicant had possession of before the effective filing date of the claimed invention. A definition by function alone does not appear to sufficiently describe the claimed invention because it is only an indication of what the molecules will do rather than what they are. See MPEP 2163.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
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 8, 11, 13, and 17 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.
Regarding claims 8 and 13, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 is also rejected because the limitation “in which renal injury has been induced in the same way” is vague and confusing. It is unclear which steps are included in “the same way”.
Regarding claim 11, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 17, the boundaries of a molecule for the treatment of renal injury is not clearly limited by the claim language.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 5, 9, 11-13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (Hypertension 2011; cited on PTO-892) in view of Byrom (British Journal of Experimental Pathology 1963; cited on PTO-892) and Shock-Kusch et al. (Kidney International, 2011; cited on PTO-892).
Regarding claims 2 and 11, Zhong discloses a method for creating a renal injury model induced by infusing angiotensin (Ang) II (renal injury inducer) into mice (test subject) (see page 315, Experimental Animals and Protocols).
Zhong does not disclose the administration of a bolus of a renal injury inducer. Zhong does not disclose the administration of fluorescent molecule to determine the development of the TF.
Byrom discloses a method comprising a single intravenous(IV) injection (bolus) of Ang (renal injury inducer) into rats (test subject) to evaluate its toxic effect on the kidney (renal injury) (see page 7, The experiment; page 11, SUMMARY).
Schock-Kusch discloses a method comprising the administration of fluorescein isothiocyanate (FITC)-sinistrin (pharmaceutically suitable fluorescent molecule) as a biomarker and the measurement of the development of the TF to analyze renal function in renal injury mouse models such as UNX and PKD/Mhn (see page 1254, abstract; page 1255, PROOF OF PRINCIPLE; page 1256, Table 1). The molecular weight of FITC-sinistrin is ≤ 15 kDa.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the Ang II of Zhong as an IV bolus injection and administer the FITC-sinistrin to determine the degree of renal injury by determining the development of the TF. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Byrom teaches a single bolus of Ang can induce renal damage and Schock-Kusch teaches FITC-sinistrin can be used to determine the development of the TF as a biomarker in a renal injury model.
Regarding claims 5, 9, 12, 13, and 17, in addition to the teachings of Zhong discussed above, Zhong discloses a method for testing a candidate molecule comprising administration of angiotensin-converting enzyme 2 (ACE2) (candidate molecule) intraperitoneally and deduction of its therapeutic effect on Ang II-induced renal disease in the renal injury mouse model (see page 314, Abstract; page 315, Experimental Animals and Protocols).
Regarding claim 17, Zhong also discloses that treatment with recombinant human ACE2 reverses Ang II-induced renal NADPH oxidase activation and proinflammatory changes (see page 316).
Zhong does not disclose further IV administration of a second bolus of renal injury inducer.
In addition to the teachings of Byrom discussed above, Byrom discloses a method comprising two (IV) injections (boli) of Ang (same renal injury inducer), separated by an interval of 10 minutes (administered in sequence), into rats (test subject) to evaluate its toxic effect on the kidney (renal injury) (see page 7, The experiment; page 11, SUMMARY).
Schock-Kusch is discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer the Ang II of Zhong as a bolus or two boli of injection and administer the FITC-sinistrin to determine the effect of candidate molecule such as ACE2 on renal injury. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Byrom teaches two separate boli of Ang can induce renal damage and Schock-Kusch teaches FITC-sinistrin can be used to assess the renal function. Zhong teaches the renal injury mouse model can be used to identify, test, or characterize a candidate molecule for the treatment of renal injury.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong, Byrom, and Shock-Kusch as applied to claims 2, 5, 9, 11-13, and 17, and further in view of Cyanagen SRL (EP 2944326 A1; cited on IDS filed Jul 8, 2022).
Regarding claims 7 and 8, in addition to the teachings of Zhong discussed above, Zhong discloses a method for testing a candidate molecule by comparing the subjects treated with ACE2 (candidate molecule) with control subjects treated with placebo (administration of a placebo instead) (see page 315, Experimental Animals and Protocols; page 317, Figure 2).
Byrom and Shock-Kusch are discussed above.
None of Zhong, Byrom, and Shock-Kusch discloses a method for screening a population of candidate molecules.
Cyanagen SRL discloses a method for screening pharmaceutical compounds (candidate molecules) suitable for treatment of chronic kidney diseases (renal injury) in a mammal (test subject) (see ¶ 61; ¶ 62; claim 17).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to develop a method for screening candidate molecules for treatment of renal injury using the method of Zhong in view of Byrom and Shock-Kusch. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Cyanagen SRL teaches renal injury models can be used for screening candidate molecules and Zhong, Byrom, and Shock-Kusch teach a renal injury model for testing a candidate molecule can comprise administering a bolus of Ang II (renal injury inducer), administering FITC-sinistrin (pharmaceutically suitable fluorescent molecule) for the determination of development of the TF, and administering a candidate molecule such as ACE 2 into the test subjects including control subjects.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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, Michael G Hartley can be reached at 571-272-0616. 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.
/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618