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 .
Election/Restrictions
Applicant's election with traverse of Group III (claims 232-240) in the reply filed on 6/26/26 is acknowledged. The traversal is on the ground(s) that it is not a burden to search all the groups. This is not found persuasive because each of the three groups are separately classified and reasons supporting patentable distinctness between each of the claimed inventions has not been contradicted. Applicant has not pointed out any specific reason why the burdens and reasons in the restriction requirement were not proper.
The requirement is still deemed proper and is therefore made FINAL.
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 232-240 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.
Claim 232 line 4 requires “the portion”. It is not clear what this refers to or if it lacks antecedent basis. The claim is treated as the nucleic acid is released back in the “one phase”.
Claims 232-240 are not clear as what does determining the nucleic acid result in. There is no conclusion to the method to know what the determining the nucleic acid in the phases means or does.
Claims 232-240 are not clear as what nucleic acid is determined in the last line of claim 232. The two or more phases are clear but the aliquot/portion of lines 4-5 with the released nucleic acid is not included and it is not clear if that was meant to be in the determining.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 232-240 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10, 12-14, 16-20, and 23-28 of U.S. Patent No. 11535902. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a similar method of a multiphase system. Claims 232-240 are drawn to multiphase system and determining the nucleic acid in at least a first and second phase as claimed in patent claims 1-4, and 18-20. For claims 234-235, the limitations of blood and saliva are claimed in claims 24-25. For claims 236-239, while the partition coefficient is not taught per se, the determining of nucleic acid concentration is claimed for two phases and the aliquot as well as free nucleic acid as claimed in claims 13 and 17-20. For claim 239, the determining can be done by PCR, see patent claim 16. For claim 240, the agent is a virus as claimed in patent claim 23.
Thus, the application claims are obvious over the patent claims.
Claims 232-240 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 11-18, 23-24, and 28-30 of U.S. Patent No. 11866795. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a similar method of a multiphase system. Claims 232-240 are drawn to multiphase system and determining the nucleic acid in at least a first and second phase as claimed in patent claims 1-4, 11-18. For claims 234-235, the limitations of blood and saliva are claimed in claims 23-24. For claims 236-239, while the partition coefficient is not taught per se, the determining of nucleic acid concentration is claimed for two phases and the aliquot as well as free nucleic acid as claimed in claims 28-30. For claim 239, the determining can be done by PCR, see patent claim 14. For claim 240, the agent is a virus as claimed in patent claim 10.
Thus, in the patent claims, both free nucleic acid and virus nucleic acid are determined.
Thus, the application claims are obvious over the patent claims.
Claims 232-240 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10, 12-14, 16-20, and 23-28 of U.S. Patent No. 12351882. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a similar method of a multiphase system. Claims 232-240 are drawn to multiphase system and determining the nucleic acid in at least a first and second phase as claimed in patent claims 1-4, 10, and 18-20. For claims 234-235, the limitations of blood and saliva are claimed in claims 24-25. For claims 236-239, while the partition coefficient is not taught per se, the determining of nucleic acid concentration is claimed for two phases and the aliquot as well as free nucleic acid as claimed in claims 10-15 and 17-20. For claim 239, the determining can be done by PCR, see patent claim 16. For claim 240, the agent is a virus as claimed in patent claim 10.
Thus, the application claims are obvious over the patent claims.
Conclusion
Citation of closest prior art:
Ching et al. (WO2019144966) teach a two phase system but do not teach or make obvious a system with an aliquot removed and assayed.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon, Tues, Thurs, Fri..
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1648
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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