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 .
Response to Amendment
The 2026 March 3 amendment containing claims 1-6, 14-18, and 22-29 is examined on the merits. The 35 U.S.C. 112(a) written description rejection is overcome because applicants have support for a 15-PGDH inhibitor claim (page 29, paragraph [0089] to page 38, paragraph [0112]). The 35 U.S.C. 112 (b) rejection regarding claims 13 and 18 are overcome because claim 13 has been cancelled and claim 18 recites metabolites recited in the specification (pages 22-23, paragraph [0067]). The 35 U.S.C. 102 rejections are overcome because both references do not describe a newly added joint injury, disease, disorder, or condition
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.
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.
Claims 1-6, 14-18, and 25-29 are rejected due to the incorporation of essential material in the specification by improper reference to an unpublished U.S. application, foreign application or patent, or to a publication. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The attempt to incorporate subject matter into this application by reference to EP 2838533 is ineffective because the selection of a small molecule from table 2 of EP 2838533 appears arbitrary based on the language “i.e….” (specification, page 29, paragraph 1)
Response to Arguments
This rejection is maintained because this statement implies picking and choosing agents from table 2 of EP 2838533.
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 1-6, 14-18, and 22-29 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.
Claims 1-6, 14-18, and 25-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the structural elements of a 15-hydroxyprostaglandin inhibitor. These claims do not recite clear metes and bounds of a 15-hydroxyprostaglandin inhibitor. Although 15-hydroxyprostaglandin inhibitor are discussed in the specification, these definitions do not limit the claim (page 27, paragraph [0082] to page 38, paragraph [0112]).
Claims 22-24 each recite at least one limitation that is a 15-PGDH inhibitor. There is insufficient antecedent basis for this limitation in these claims because parent claim 1 does not specify the elemental metes and bounds of a 15-PGDH inhibitor.
Response to Arguments
This rejection is maintained because the examples in the specification do not limit claim interpretation under broadest reasonable interpretation. NA (Biochemical Pharmacology, 2011, 82, 1352-1360) describes five different classes of compounds that inhibit 15-PGDH (pages 1358-1359). Since these compounds inhibit 15-PGDH, are they intended to work in the recited method of use? Without clear metes and bounds for the active agent, these claims remain unclear. Five different classes of compounds that have the ability to inhibit 15-PGDH have different structural requirements.
Conclusion
Claims 1-6, 14-18, and 22-29 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: Markowitz (US 20150072998, published 2015 March 12) describes a method of increasing bone density, treating osteoporosis, promoting healing of fractures, or promoting healing a bone with a compound of claim 91-99. Claim 96 recites SW033291. Markowitz does not describe treating a newly added joint injury, disease, disorder, or condition of claim 1.
Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
Prosecution Insights