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
Applicant’s arguments, filed 2/23/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection
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.
Claims 1-4, 6-10 and 18-21 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 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.
The application does not describe how to determine if the sample upon which analysis is made is non-pathological. “Non-pathological” means without any disease or condition. Although methods are described in the application for determining the presence or absence of pancreatic cancer cells or pancreatic dysplasia cells, there is no description of how the method can be used to determine that the cells are without any disease or condition, as encompassed by the claim. Further, there is no support in the application for “comprises at least one dimension having at least one dimension spanning at least 10 contiguous epithelial cells.” The application does not contemplate this recitation. Further, the application does not describe what aspect of the exfoliated sheet of cancer cells and epithelial or other cells from the pancreas are measured to determine that they are “2x enriched,” what they are enriched with, and what parameter or value indicates a 2x enrichment verses not a 2x enrichment.
Claim Rejections - 35 USC § 112
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 1-4, 6-10 and 18-21 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. The recitation in claim 1 “epithelial or other cells from the pancreas” is unclear as “epithelial or other cells from the pancreas” include all cells from the pancreas. It’s unclear why the claim particularly mentions epithelial cells separately as the claim encompasses all cells from the pancreas, and unclear how reciting epithelial cells separately limits the claim. Further regarding claim 1, it’s unclear what “at a level more than 2x enriched” means as the claim does not recite what quality or aspect of the cells is being measured in the claim to determine that the cells are at a level more than 2x enriched compared to the level of epithelial or other cells in an otherwise identical sample obtained from a subject, that has not been isonated. Further regarding claim 1, the use of the phrase “or is non-pathological” is unclear. The claim recites “the sample contains pancreatic cancer cells or pancreatic dysplasia cells, or is non-pathological.” “Non-patholocal” means without any disease or condition. As the determination is only directed to the presence or absence of pancreatic cancer cells or pancreatic dysplasia cells, it’s unclear how the method can determine that the that the cells are without any disease or condition, as encompassed by the term “or is non-pathological.” Further regarding claim 21, the recitation “is collected within than 5 minutes or less” is nonsensical. As the term is nonsensical, the artisan would not know what is encompassed by the recitation.
Notes and Comments
No prior art against the invention was found.
Conclusion
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.
/PAUL W DICKINSON/ Primary Examiner, Art Unit 1618
May 30, 2026
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