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 Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 101 rejections are withdrawn:
Claims 1-9 were rejected as being directed to non-statutory subject matter.
The following 35 U.S.C. 112 rejections are withdrawn:
Claims 1-9 were rejected 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
The following 35 U.S.C. 103 rejections are withdrawn:
Claim(s) 1-14 were rejected under 35 U.S.C. 103 as being unpatentable over Brodie et al. (WO 2018/083700)
The Applicant’s amendments changing the claims from Use-Claims to Method-Claims necessitated the above withdrawals. Also the Applicants amendments to muscle stem cells with the specific markers removed the rejection of Brodie et al. In particular PAX7 is not typically found in mesenchymal stem cells but specific for muscle satellite cells (see Seale et al., abstract and Sincennes, pg. 2, left column 1st full paragraph). All arguments drawn to these rejections are now considered moot.
New Rejections Necessitated by Amendment
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.
Claim 1-3, 5-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating or alleviate the obesity and the metabolic diseases listed in claim 3, does not reasonably provide enablement for prevention of obesity or metabolic diseases nor does it provide enablement for alleviation or treatment of metabolic diseases that do not result from high fat and glucose intake such as gout or hypokalemia. The Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988). These factors include, but are not limited to:
The breadth of the claims; and (B) The nature of the invention;
The claims are drawn to a composition for prevention of obesity or metabolic disorders comprising administering a composition comprising a murine or human derived muscle stem cell with the following markers: CD31-, CD34-, CD45-, CD29+, EGFR+, PAX7+. The term “metabolic disorder” is broad. The specification defines it below:
Metabolic disorder is a state of the body, is the body's absorption, digestion, excretion of substances appear pathological disorders, resulting in imbalance between supply and demand. (Specification pg. 13, lines 5-10)
This definition also includes gout and hypokalemia (Specification, pg. 13, lines 10-11).
The state of the prior art; (D) The level of one of ordinary skill; and (E) The level of predictability in the art;
The art does not generically teach using muscle stem cells for treating the metabolic disorders or obesity and appears to be silent on muscle stem cells with the claimed marker pattern. The art is silent to using muscle stem cells to treat obesity or metabolic disorders.
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and
The Applicant provides no working examples on preventing obesity or metabolic diseases or treating metabolic diseases unrelated to glucose and fat metabolism. These would include gout or hypokalemia. The Applicant provides excellent examples of administering the claimed stem cells to treat the following:
obesity (See Fig 6 and Fig 8A);
insulin/blood glucose levels (See Fig 7); and
fatty liver (see Fig 9).
However they do not provide any evidence if the claimed cells would treat metabolic disorders not caused by fat or glucose metabolism.
Also the Applicant provided no evidence to prevent obesity or metabolic disorders. The examples that generated Figs 6-9 were for animal models where the conditions are predisposed. Figs 6-9 also show that while the administration of the claimed muscle stem cells reduce the effect of the high fat diet or glucose uptake, they did not show they reduced the effects to equal that of the controls. Fig 6 shows mice on a high fat diet stilled weighed significantly more than the normal diet control. It would be expected that preventing would produce results identical to that of the normal diet control. A similar scenario appears in Fig 7 where the blood glucose and cholesterol levels decrease after stem cell treatment but not close to the normal diet control. Fig 8A shows that subcutaneous fat for the stem cells treated subjects was elevated over the control diet. Fig 9 A-B show the livers of the stem cell treated subjects weight more than the control diet. From these results, it is not clear if the composition is preventing obesity or the tested metabolic diseases.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
There is predictability in the Applicant’s disclosure that one of ordinary skill would use this invention for the entire scope claimed.
In the instant case several of these factors are missing and do not provide assurance that the disclosure is enable and that undue experimentation would be needed to make and use this invention.
Suggested Claim Amendments
If the claims were amended to remove prevention and limit the claims to alleviate and/or treat obesity or the metabolic diseases listed in claim 3, the case would be closer to allowance. If the Applicant considers this acceptable, an interview can be conducted to see if an Examiner’s amendment is possible at this time.
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.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
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.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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