DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election of the invention of Group II (claims 4-10) in the reply filed on 06/26/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 1-3 and 11-23 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions. (and species)
Claims 4-10 are presently under consideration.
3. Claim 4 is objected to as being dependent on a non-elected claim. It is suggested that Applicant rewrite the claim in independent form to include the relevant limitations of the base claim and any intervening claims.
4. 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.
5. Claims 4-10 are rejected under 35 U.S.C. 112(b) 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.
(i) Claim 4 depends on claim 1, and as such encompasses the limitations of claim 1, which is indefinite in the recitation of anti-NaV1.5 autoantibodies “being biomarkers” for the diagnosis of Brugada Syndrome. Claim 1 is limited to only those anti-NaV1.5 autoantibodies which are biomarkers for diagnosis of Brugada Syndrome but does not specify how to distinguish the autoantibodies which are biomarkers from the autoantibodies which are not biomarkers.
(ii) Claim 4 is further indefinite for the following reasons:
A method claim comprises a preamble which sets forth the purpose of practicing the method, and at least one method step, which specifies that manner of practicing the method. In the present case, the term “assaying,” intended to specify the method step, is more generic that the term “detecting” in the preamble of the claim, and as such the term “assaying” is insufficiently specific to define the method step.
(iii) Claim 4 is further indefinite in the recitation of “assaying” a biological sample, because it is unknown what the sample is being assayed for.
(iv) Claim 5 is indefinite in the recitation of “one or more antigens that specifically binds to the autoantibodies directed against NaV 1.5 channel,” because the nature of the antigens is unknown. The genus of antigens the specifically bind to anti-NaV1.5 autoantibodies is not limited NaV1.5 epitopes, because a single antibody may specifically bind more than one target, as a person skilled in the art would be aware.
(v) Claim 7 is indefinite in the recitation of “binding sites of extracellular loops,” which is subject to alternative interpretations. It may refer (a) to cites of some other protein which bind to NaV1.5 extracellular loops, or (b) to sites on NaV1.5 extracellular loops bound by an unidentified substance.
(vi) Claim 8 is indefinite as being in improper Markush format. The Office recommends the use of the phrase "selected from the group consisting of ..." with the use of the conjunction "and" rather than "or" in listing the species. See MPEP 803.02.
(vii) Claim 10 is indefinite, because the recitation of “the probe” lacks proper antecedent basis in the base claim.
(viii) Claims 5-10 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. The following is a quotation 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.
7. Claim 9 is rejected under 35 U.S.C. 112(a) because the specification, while being enabling for the recited method wherein the biological sample is plasma, whole blood, serum or peripheral blood, does not reasonably provide enablement for the recited method wherein the biological sample is PBMCs.
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 without undue experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
The claim is directed to a method of detecting autoantibodies in a biological sample. Antibodies can be present in the liquid fractions of blood, including serum and plasma, but not in blood cells, as a person skilled in the art would be aware. The abbreviation “PBMC” stands for “peripheral blood mononuclear cells,” which do not contain antibodies, and therefore a skilled artisan would reasonably conclude that experimentation aimed at detecting autoantibodies in PBMC would be unsuccessful, and as such unnecessary, improper and undue.
8. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
9. Claims 4-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-10 of copending application USSN 19505110.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘110 which are directed to the same method as presently claimed, and recite the all of the limitations of instant claims 4-10 in claims 5-10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Conclusion: no claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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