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 .
Claim Rejections - 35 USC § 101
Claims 1-6,8,9,11-16,18,19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-6,8,9 are for a method, and claims 11-16,18,19 are for an apparatus. Thus, they fall into statutory categories of invention.
Step 2A, Prong 1
Claim 1 is considered to set forth an abstract idea in the form of a mental process. That is, the steps of using a first set of criteria including identifying true RR interval, and using a second set of criteria, and determining are all considered to be steps that can be performed in the mind, of with pencil and paper, and thus are mental processes. Similarly, claim 11 also sets forth an abstract idea in the form of a mental process. Like claim 1, claim 11 includes the steps of using a first set of criteria including identifying true RR intervals, and using a second set of criteria, and determining. Such steps are all considered to be steps that can be performed in the mind, or with pencil and paper, and thus are mental processes. Further, The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). See MPEP 2106.04(a).
Step 2A, Prong 2
Claim 1 includes, other than the abstract idea, the step of obtaining. Such step is considered to be data gathering for use with the abstract idea, and thus does not integrate the abstract idea into a practical application. Similarly, other than the abstract idea, claim 11 includes electrodes, sensing circuitry, and a processor. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). See MPEP 2106.05(f). There are no steps or apparatus, in claims 1, and 11, that use a particular machine, improve the functioning of a computer, technology or technical field, or treat a particular medical condition. Claims 2,3,4,8,12,13,14,18 also do not integrate the abstract idea into a practical application. The subject matter of these claims only further defines the mental steps, but otherwise does not improve the functioning of a computer of technical field, or treat a disease, or use a particular machine. Claims 5,6,9,15,16,19 also do not integrate the abstract idea into a practical application. Theses claims only set forth a field of use, such as for atrial fibrillation detection, or the use of an IMD, or the use of a pacemaker or ICD. These elements are not particular machines, but rather are general elements, like a processor, that are used to either gather data for or apply the abstract idea.
Claims 7,10,17,20,21 are considered to integrate the abstract idea into a practical application. For example, claims 7,17 include preventing or limiting transmitting if a false positive arrhythmia is detected, which is considered to integrate the abstract idea into a practical application. Further, claims 10,20 include inhibiting delivery of therapy if a false positive arrythmia was detected, which is considered to integrate the abstract idea into a practical application. Similarly, claim 21 includes preventing transmission of data that is determined to be false positive detection, which is considered to integrate the abstract idea into a practical application.
Step 2B
Claim 1 include the step of obtaining a list of sensed intervals. Such step is considered to be data gathering, which his well understood and routine way of providing data for the abstract idea. See Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (2010) (well-known random analysis techniques to establish the inputs of an equation were token extra-solution activity); Flook, 437 U.S. at 593-95, 198 USPQ at 197 (a formula would not be patentable by only indicating that is could be usefully applied to existing surveying techniques); Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d 1315, 1328-29, 121 USPQ2d 1928, 1937 (Fed. Cir. 2017) (the use of a well-known XML tag to form an index was deemed token extra-solution activity). See MPEP 2106.05(g). Similarly, the electrodes, processor and sensing circuitry of claim 11, by themselves and considered as a whole, are well understood, routine and conventional apparatus. Further, re claims 5,6,9,15,16,19, these claims set forth use of the abstract idea in an IMD, cardiac monitor, LCP or ICD that are all considered to be well known devices that are routinely used in the art. Such devices are used only to generally link the abstract idea to a particular technology that is well understood and conventional. Similarly, claims 2,3,4,8,12,13,14,18 only further define the abstract idea and do not include elements that are anything other than well known, conventional and routine in the art.
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 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.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,559,242. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are considered to be obvious variants of the claims of the ‘242 patent. For example, re application claim 1, see patent claims 1,4. Re application claim 2, see patent claim 2. Re application claim 3, see patent claim 2. Re application claim 4, see patent claim 8. Re application claim 5, see patent 6. Re application claim 6, see patent claim 6. Re application claim 7, see patent claim 7. Re application claim 8, see patent claim 8. Re application claim 9, see patent claim 9. Re application claim 10, it is considered to have been obvious to deliver therapy if the patient needs therapy, such as for fibrillation. Similarly, it is considered to have been obvious to not deliver therapy if in fact the patient is not experiencing an arrhythmia. Re application claim 11, see patent claims 13,14. Re application claim 12, see patent claim 2. Re application claim 13, see patent claim 2. Re application claim 14, see patent claim 8. Re application claim 15, see patent claim 4. Re application claim 16, see patent claim 17. Re application claim 17, see patent claim 16. Re application claim 18, see patent claim 15. Re application claim 19, see patent claim 17. Re application claim 20, it is considered to have been obvious to deliver therapy if the patient needs therapy, such as for fibrillation. Similarly, it is considered to have been obvious to not deliver therapy if in fact the patient is not experiencing an arrhythmia. Re application claim 21, see patent claims 13,14,16.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 12,042,292. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are considered to be obvious variants of the claims of the ‘242 patent. For example, re application claim 1, see patent claims 1,2,3. Re application claim 2, see patent claim 4. Re application claim 3, see patent claim 5. Re application claim 4, see patent claim 11. Re application claim 5, atrial fibrillation is a well-known type of fibrillation and would have been obvious to detect in order to treat the patient expeditiously. Re application claim 6, see patent claim 12. Re application claim 7, see patent claim 10. Re application claim 8, see patent claim 11. Re application claim 9, see patent claim 12. Re application claim 10, see patent claim 15. Re application claim 11, see patent claims 17,18,19. Re application claim 12, see patent claim 20. Re application claim 13, see patent claim 20. Re application claim 14, see patent claim 11. Re application claim 15, atrial fibrillation is a well-known type of fibrillation and would have been obvious to detect in order to treat the patient expeditiously. Re application claim 16, see patent claim 25. Re application claim 17, see patent claim 26. Re application claim 18, see patent claim 11. Re application claim 19, see patent claim 12. Re application claim 20, see patent claim 15. Re application claim 21, see patent claims 17,18,19,26.
Conclusion
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/Scott M. Getzow/Primary Examiner, Art Unit 3792