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 .
NEW GROUND OF REJECTION NECESSITATED BY THE AMENDMENT
2. 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.
Claim 10 is 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. This claim is indefinite because in light of the amendment, ‘the differentiation’ lacks proper antecedent basis in independent claim 1. Correction is required.
MAINTAINED REJECTION
3. Claims 1-4, 6-13, and 21-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 1 12, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the ad, and (8) the breadth of the claims.”
(1) the quantity of experimentation necessary: given the limited experimentation disclosed in the specification, mostly involving an animal model and cell lines, a great deal of undue experimentation would be required to practice the claimed method of differentiating a malignant uterine tumor from a non-malignant tumor by measuring the level of TTR, DUOX2, and/or GPR179 RNA or protein in a biological sample of serum, uterine tissue, urine, or stool from a mammal, especially a human. The only data in the specification that pertains to patients involves tissue sections from only three patients, and analysis is only qualitative (degree of staining); further, results with DUOX2 were inconclusive. Based on the limited studies presented, the skilled artisan would not be enabled to practice a properly validated diagnostic method using level of any one of the recited RNAs or proteins to statistically correlate with a uterine tumor using a serum, uterine tissue, urine, or stool sample from a mammal or human patient. To validate such a method would require undue experimentation using a significant number of mammals or humans and extensive statistical analysis. The claims cover both methods of measuring level of RNA and protein, and the limited data in the specification only relates to protein detection. As known to one of ordinary skill in the art, levels of RNA and protein corresponding to any particular gene do not necessarily correlate in any given biological system. Thus, not only is the specification insufficient to validate any diagnostic test regarding proteins, but no data whatsoever is presented regarding RNAs.
(2) the amount of direction or guidance presented: for the reasons noted above, the specification at best indicates that TTR, DUOX2, and GPR179 might serve as useful biomarkers in the future with respect to differentiating LMS from UFs.
(3) the presence or absence of working examples: as noted above, the specification only provides working examples using cell lines, an animal model, and a few tissue sections.
(4) the nature of the invention: the invention relates to diagnostic methods of differentiating a malignant uterine tumor from a non-malignant tumor by measuring one or more of three particular RNA or protein biomarkers.
(5) the state of the prior art: the prior art teaches some diagnostic methods correlating expression of certain RNA or protein biomarkers with certain cancers and other diseases.
(6) the relative skill of those in the art: the level of skill in the art is deemed to be high.
(7) the predictability or unpredictability of the art: methods of determining which RNAs or proteins serve as reliable biomarkers for various cancers and other diseases are highly unpredictable.
(8) the breadth of the claims: the claims are broadly drawn, encompassing both RNA and protein biomarkers corresponding to TTR, DUOX2, and GPR179 in relation to a uterine tumor.
Based on the above considerations, it is concluded that undue experimentation would be required to carry out the claimed methods using both RNA and protein biomarkers corresponding to TTR, DUOX2, and GPR179 in relation to a uterine tumor.
REPLY TO ARGUMENTS
4. With respect to the above rejection, the arguments of the response filed 05/21/26 have been fully considered, but are not found persuasive. The claims have been amended so as to be limited to uterine tumors and serum, uterine tissue, urine, or stool samples, but the rejection takes the position that even these more limited embodiments are not enabled by the specification, for the specific reasons provided in the rejection. The response is silent as to why the claims as amended are enabled in light of the Wands factor analysis and conclusion set forth in the rejection, which the Office argues weighs in favor of non-enablement.
CONCLUSION
5. Claims 1-4, 6-13, and 21-27 are free of the prior art, but they are rejected for other reasons. No claims are allowable.
6. 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.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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08/06/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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