Office Action 1: Non-Final Rejection (2024-12-02)
Rejection types: 112 - Written Description/Enablement, Double Patenting

CLAIMS:
WHAT IS CLAIMED IS:

1\. A device comprising:
a reaction vessel to contain a liquid including at least one of a sample liquid and a reaction solution; and
a heating element connected to and disposed in the reaction vessel, the heating element being connected to an adapter nucleic acid structured to bind to an extraction nucleic acid, wherein the extraction nucleic acid is at least partly complementary to the nucleic acid from the sample liquid, and wherein the heating element is heatable to a temperature that is equal to or higher than a denaturing temperature of the nucleic acid bound to the extraction nucleic acid.

2\. The device of claim 1, wherein the heating element comprises the extraction nucleic acid bound to the adapter nucleic acid such that the extraction nucleic acid is indirectly bound to the heating element.

3\. The device of claim 1, wherein the heating element is formed as part of the reaction vessel and is disposed in the reaction vessel such that the liquid is to cover the heating element, and wherein the reaction vessel comprises at least one opening for at least one of (i) adding the sample liquid to the reaction vessel or (ii) removing the reaction solution from the reaction vessel.

4\. The device of claim 3, wherein the heating element is a wire with an electrically conductive body which has an extent R, perpendicular to a direction of current flow, in every spatial direction perpendicular to the direction of current flow, the extent R being at least 0.2 pm and at most 0.5 mm.

5\. The device of claim 1, wherein the device has multiple heating elements, each of the multiple heating elements including a wire disposed within the reaction vessel.
6\. The device of claim 1, wherein the device is configured to carry out an amplification reaction to copy the nucleic acid extracted from the sample liquid, wherein the heating of the heating element is effected such that only an area immediately surrounding the heating element is locally heated at least to the denaturing temperature.

7\. The device of claim 1, further comprising at least one primer for a polymerase chain reaction for copying the nucleic acid extracted from the sample liquid, the primer being bound to the heating element.

8\. The device of claim 1, wherein the extraction nucleic acid is adapted for a polymerase chain reaction for copying the nucleic acid extracted from the sample liquid.

9\. The device of claim 1, wherein the heating element is configured to be brought in contact with the sample liquid, such that the sample liquid surrounds the heating element, and to connect to the extraction nucleic acid when the extraction nucleic acid is provided in the sample liquid.

10\. The device of claim 1, wherein the device is configured such that the heating element is heatable in a manner that only the heating element and an area immediately surrounding the heating element are heated to the denaturing temperature or to a higher temperature at which the nucleic acid that binds the extraction nucleic acid at least partly melts or denatures.

11\. The device of claim 1, wherein the device is configured such that the heating element is heatable by at least one heating process, which is effected such that the heating of the heating element per heating process and across all the heating processes increases an average temperature of a reaction solution by no more than 50C.

12\. The device of claim 1, wherein the adapter nucleic acid is bound directly to a surface of the heating element via a thiol bold.

13\. The device of claim 1, further including an electrical circuit to apply electrical pulses to the heating element to effect the heating, in a heating zone of the liquid, extending no more than 100 micrometers from the heating element, and to effect cooling in the heating zone by distribution of input energy supplied by the heating element to the remainder of the liquid in the reaction vessel.

14\. An apparatus comprising:
a reaction vessel to contain a liquid including at least one of a sample liquid and a reaction liquid;
a heating element connected to and disposed in the reaction vessel such that the liquid is to cover the heating element;
an adapter nucleic acid connected to the heating element, wherein the adapter nucleic acid is structured to bind an extraction nucleic acid is at least partly complementary to a nucleic acid from the sample liquid; and
an electrical circuit to heat the heating element to a temperature that is equal to or higher than a denaturing temperature of the nucleic acid that binds the extraction nucleic acid.

15\. The apparatus of claim 14, wherein the electrical circuit is to apply electrical voltage or current pulses to the heating element to heat the heating element and, in response, cause the heating element to heat and to input energy to a heating zone of the liquid.

16\. The apparatus of claim 15, wherein the electrical circuit is to effect cooling in the heating zone of the liquid by discontinuance of the application of the electrical voltage or current pulses to distribute the input energy supplied by the heating element to the remainder of the liquid in the reaction vessel.

17\. The apparatus of claim 14, wherein the heating element includes a wire that is disposed within the reaction vessel such that the sample liquid is to surround the heating element on multiple surfaces of the wire.

18\. The apparatus of claim 14, wherein the heating element is anchored to the reaction vessel.

19\. The apparatus of claim 14, further including:
a plurality of reaction vessels, including the reaction vessel, wherein the heating element includes a wire that passes through and in each of the plurality of reaction vessels and is connected to the electrical circuit; and a plurality of adapter nucleic acids, including the adapter nucleic acid, connected to the wire.

20\. The apparatus of claim 19, wherein the electrical circuit is to apply an electrical pulse to the wire such that the electrical pulse is sent through each of the plurality of reaction vessels in a serial manner, and in response, to heat the heating element. -56- -57- -58- -59- 4878-2271-1883.2

OFFICE ACTION:
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 .
OBJECTIONS
2.	The specification is objected to because of the following informality: the continuation information must be updated to indicate the issue of the parent ‘579 application as U.S. 11,584,925.
3.	Claim 12 is objected to because of the following informality: ‘bond’ is misspelled as ‘bold.’  Correction is required.
NON-PRIOR ART REJECTIONS
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.
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 1-20 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.
A)	These claims are indefinite because ‘the nucleic acid from the sample liquid’ and ‘the nucleic acid bound to the extraction nucleic acid’ in independent claim 1 lack proper antecedent basis.  Correction is required.
B)	Claims 7-8 are further indefinite because ‘the nucleic acid extracted from the sample liquid’ lacks proper antecedent basis.  Correction is required.
C)	Claim 10 is further indefinite because ‘the nucleic acid that binds the extraction nucleic acid’ lacks proper antecedent basis.  Correction is required.
D)	Claims 14-20 are further indefinite because the third element beginning with ‘an adapter nucleic acid’ in independent claim 14 is not recited in a complete phrase; thus, it cannot be determined what is encompassed.  Clarification is required.
5.	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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
6.	Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,584,925.  Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim and the pending claims are related as species-genus.  That is, the pending claims are slightly broader than the patented claim in that they lack some language in the preamble, and recite the word ‘connected’ rather than ‘bound’ in referring to the relationship between the heating element and the adapter nucleic acid.
ALLOWABLE SUBJECT MATTER
7.	Claims 1-20 are free of the prior art, but they are rejected for other reasons.  The closest prior art and the reasons for allowance were established during prosecution of the parent ‘579 application.
CONCLUSION
8.	No claims are allowable.
9.


NEXT OFFICE ACTION: EXAMINER’S COMMENTS
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.	The terminal disclaimer filed on 01/30/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US ‘925 has been reviewed and is accepted.  The terminal disclaimer has been recorded.
3.

CITED REFERENCE SUMMARIES: Ref US11584925: Claims:
1. Device for extracting a nucleic acid from a sample liquid, the device comprising:
a reaction vessel to contain a liquid including at least one of a sample liquid and a reaction solution; and
a heating element connected to and disposed in the reaction vessel, the heating element being connected to an extraction nucleic acid, wherein the extraction nucleic acid is at least partly complementary to the nucleic acid from the sample liquid, and wherein the heating element is heatable to a temperature that is equal to or higher than a denaturing temperature of the nucleic acid bound to the extraction nucleic acid.
2. Device according to claim 1, wherein the heating element comprises at least one adapter nucleic acid bound to the heating element and the extraction nucleic acid such that the extraction nucleic acid is indirectly bound to the heating element.
3. Device according to claim 1, wherein the heating element is connected to the reaction vessel and is formed as part of the reaction vessel and is disposed in the reaction vessel such that the liquid is to cover the heating element, and wherein the reaction vessel comprises at least one opening for one or both of (i) filling the sample liquid into the reaction vessel and (ii) removing the reaction solution from the reaction vessel.
4. Device according to claim 3, wherein the heating element is a wire with an electrically conductive body which has an extent R, perpendicular to a direction of current flow, in every spatial direction perpendicular to the direction of current flow, the extent R being at least 0.2 μm and at most 0.5 mm.
5. Device according to claim 1, wherein the device has multiple heating elements, the multiple heating elements each including a wire disposed within the reaction vessel.
6. Device according to claim 1, wherein the device is configured to carry out an amplification reaction to copy the nucleic acid extracted from the sample liquid, wherein the heating of the heating element is effected such that only an area immediately surrounding the heating element is locally heated at least to the denaturing temperature.
7. Device according to claim 1, further comprising at least one primer for a polymerase chain reaction for copying the nucleic acid extracted from the sample liquid, the primer being bound to the heating element.
8. Device according to claim 1, wherein the extraction nucleic acid is adapted for a polymerase chain reaction for copying the nucleic acid extracted from the sample liquid.
9. Device according to claim 1, wherein the heating element is configured to be brought in contact with the sample liquid, such that the sample liquid surrounds the heating element, and to connect to the extraction nucleic acid when the extraction nucleic acid is provided in the sample liquid.
10. Device according to claim 1, wherein the device is configured such that the heating element is heatable in a manner that only the heating element and an area immediately surrounding the heating element are heated to the denaturing temperature or to a higher temperature at which the nucleic acid bound to the extraction nucleic acid at least partly melts or denatures.
11. Device according to claim 1, wherein the device is configured such that the heating element is heatable by at least one heating process, which is effected such that the heating of the heating element per heating process and across all the heating processes increases an average temperature of a reaction solution by no more than 5° C.
12. Device according to claim 1, wherein the extraction nucleic acid is bound directly to a surface of the heating element via a thiol bold or a sulphur bond.
13. Device according to claim 1, further including an electrical circuit to apply electrical pulses to the heating element to effect the heating, in a heating zone of the liquid, extending no more than 100 micrometers from the heating element, and to effect cooling in the heating zone by distribution of input energy supplied by the heating element to the remainder of the liquid in the reaction vessel.
14. An apparatus comprising:
a reaction vessel to contain a liquid including at least one of a sample liquid and a reaction liquid;
a heating element connected to and disposed in the reaction vessel such that the liquid is to cover the heating element;
an extraction nucleic acid connected to the heating element, wherein the extraction nucleic acid is at least partly complementary to nucleic acid from the sample liquid; and
an electrical circuit to heat the heating element to a temperature that is equal to or higher than a denaturing temperature of the nucleic acid bound to the extraction nucleic acid.
15. The apparatus of claim 14, wherein the electrical circuit is to apply electrical voltage or current pulses to the heating element to heat the heating element and, in response, cause the heating element to heat and to input energy to a heating zone of the liquid.
16. The apparatus of claim 15, wherein the electrical circuit is to effect cooling in the heating zone of the liquid by discontinuance of the application of the electrical voltage or current pulses to distribute the input energy supplied by the heating element to the remainder of the liquid in the reaction vessel.
17. The apparatus of claim 14, wherein the heating element includes a wire that is disposed within the reaction vessel such that the sample liquid is to surround the heating element on multiple surfaces of the wire.
18. The apparatus of claim 14, wherein the heating element is anchored to the reaction vessel.
19. The apparatus of claim 14, further including:
a plurality of reaction vessels, including the reaction vessel, wherein the heating element includes a wire that passes through and in each of the plurality of reaction vessels and is connected to the electrical circuit; and
a plurality of extraction nucleic acids, including the extraction nucleic acid, connected to the wire.
20. The apparatus of claim 19, wherein the electrical circuit is to apply an electrical pulse to the wire such that the electrical pulse is sent through each of the plurality of reaction vessels in a serial manner, and in response, to heat the heating element.