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 .
Detailed Action
Claims 1-10 are currently pending.
Claim Objections
Claims 1-2, 4-7, and 9-10 are objected to because of the following informalities:
Claim 1 should recite “or a pharmaceutically” instead of “and a pharmaceutically”.
Claim 1 should read “structural formula” instead of “structure formula”.
Claims 2 and 7: “administrating” should instead read “administering”.
Claims 2 and 6: “the” and “a pharmaceutical” salt should be standardized to read either “the” or “a” in both instances.
Claim 4: “is cerebral tumor” should instead read “is a cerebral tumor”.
Claims 5 and 9: “is cerebral glioma” should instead read “is a cerebral glioma” in each instance.
Claim 10:
Step (1) –
“after heating stopped” should instead read “then after heating is stopped”
“with dichloromethane/methanol” should read “with a dichloromethane/methanol”
Step (2) –
“with dichloromethane/methanol” should read “with a dichloromethane/methanol”
“a white solid a compound” should instead read “a white solid of a compound”
Step (3) –
“with oil pump” should read “with an oil pump”
Step (4) –
The comma following “successively” in the last line should be removed.
Appropriate correction is required.
35 USC § 112(a) Scope of Enablement Considerations
The methods of treatment as claimed are enabled. As applicant presents only a single boron carrier compound for use in boron neutron capture therapy to treat cancer, it is not undue to one of ordinary skill in the art to assay the one compound for said therapeutic use in a tumor as claimed. The level of skill in the oncological and pharmaceutical arts is high, exceeding the skill of such routine assay experimentation with one compound.
Claim Rejections - 35 USC § 112(b)
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 regards as the invention.
In the final Step (4) of the method of Claim 10, applicant recites “DMF solution containing 20% piperidine”. “20%” is not further described as by weight, by volume, by mol fraction or any other concrete units. For example, 20% piperidine in DMF might be % w/w or % w/v or % v/v but the claim does not specify which of the units the 20% value refers to. Therefore, no clear metes and bounds are established with respect to the % value.
In the final Step (4) of the method of Claim 10, the following is recited “adding the above mixture to the resin mixture.” “the resin mixture” phrase lacks antecedent basis as no such resin mixture is previously described. It is unclear what such a “resin” is in the context of the method. The specification also fails to further describe such a resin mixture.
Closest Prior Art
The closest art to the examined compound is found in Bachovchin (US5776902). Bachovchin teaches Compounds 85-87 which share a cyclic boronate-phenylene structural motif (PDF Page 10, Fig. 5D). Also, Compound 87
PNG
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251
176
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features an ester linked to the phenylene like that of the claimed compound. However, the oxo-substituted heterobicycle is not present. The compound is shown merely as an intermediate to yield a boronic acid. “[I]f the prior art merely discloses compounds as intermediates in the production of a final product, one of ordinary skill in the art would not ordinarily stop the reference synthesis and investigate the intermediate compounds with an expectation of arriving at claimed compounds which have different uses. In re Lalu, 747 F.2d 703, 223 USPQ 1257 (Fed. Cir. 1984).” See MPEP 2144.09 IV. Bachovchin does not teach or suggest the addition of the heterobicycle of the claimed compound.
(It is also noted that a dative bond between N and B is not explicitly drawn in Bachovchin, but is present in the claims.)
Conclusion
Claims 3 and 8 are allowable. Claim 10 is rejected. Claims 1-2, 4-7, and 9-10 are objected to.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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