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 Interpretation
Several of the depending claims recite recitations of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. These recitations sometimes lead to prior art that is capable of performing said intended use, functional limitation or the like, but the prior art might not or explicitly disclose said intended use or functional limitation.
It should be noted a recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963). Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971).
In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971).
A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
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.
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Claims 1-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,813,450. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim language basically differs in that the patented recites a first and second electrode while the present application recites at least two electrodes.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1-5, 7-21, and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muccio et al. (U.S. Patent Application Publication 2008/0097530).
Regarding claims 1, 13-14 and 17, Muccio et al. disclose a wearable garment and system comprising:
a flexible material ("flexible, non-conductive fabric such as Lycra and/or spandex," see [0025] for example) configured to wrap around a portion of a user's body (see figures 1-6), the flexible material comprising:
o an interior surface (surface configured to be worn immediately next to and/or touching the skin, see figures 1-6) configured to contact the user's body, and
o an opposite exterior surface (surface configured to be worn immediately next to and/or touching external environment - the opposite surf ace from the interior surface, see figures 1-6);
an attachment mechanism in the form of a tightening strap (for example the "belt," see [0044], or the wrap/strap clearly shown in figures 5 and 6 and labeled element 32) configured to hold the flexible material in place on the user's body,
with respect to claim 14 the wrap/device shown in figures 5-6 is a belt that wraps around the patient and therefore forms a sleeve;
a first electrode (a first of the plurality of "electrodes 50," see for example [0025], [0032] figures 1-6) positioned at the interior surface and configured to contact a targeted part of the user's body;
a second electrode (a second of the plurality of "electrodes 50," different from the first electrode, see for example [0025]-[0032] figures 1-6) positioned at the interior surface and configured to contact a targeted part of the user's body;
a first electrode connector ( comprising a first of "connectors 60" operably/electrically coupled to the first electrode, see [0029]-[0030] and figures 1-6) positioned at the exterior surface and operably connected to the first electrode; and
a second electrode connector ( comprising a second of "connectors 60" operably/electrically coupled to the second electrode, different from the first electrode connector, see [0029]-[0030] and figures 1-6) positioned at the exterior surface and operably connected to the second electrode,
wherein the first and second electrodes are configured to deliver a therapeutic signal from an electrotherapeutic device ("programmable electrical stimulation device 20," see [0024, [0028 and figures 1-6) via the first and second electrode connectors for forming a therapeutic signal configured to reduce pain (see abstract, [0005], [0023], [0032], and [0034] for example) at a treatment site by simultaneously sending a first signal from the first electrode to the second electrode and sending a second signal from the second electrode to the first electrode.
Regarding claims 2 and 18, Muccio et al. disclose the invention including the first and
second electrodes each comprises a conductive fabric electrode ("a silver coated fabric"
[0024], or electrode embedded in fabric [0025]).
Regarding claims 3 and 19, Muccio et al. disclose the invention including the electrode
includes a smooth raised portion (tissue contacting side of the electrode) to contact the
user's body and a lower portion (the opposite side - opposite the tissue contacting side of
the electrode) that does not contact the user's body (see figures 1-6).
Regarding claims 4 and 20, Muccio et al. disclose the invention including the first
electrode connector (a first of “connector 60”, see [0029] and figure 4 for example) and the second electrode connector (a second of “connector 60”, see [0029] and figure 4 for example) are coupled to the electrode fabric at the lower portion (see figures 1-6). It should be noted the word "coupled" may be properly interpreted broader than Applicant intends it to be. "Coupled" includes merely present in the same device/system.
Regarding claims 5 and 21, Muccio et al. disclose the invention including the electrode
fabric is positioned over a compression material, wherein the compression material
includes a thickness that forms the raised portion of the electrode (see figures 1-6 in light
of the above or preceding rejections, also see the Lycra and Spandex in [0025], [0043], and the stretch fabric in [0044]).
Regarding claim 7, Muccio et al. disclose the invention including the conductive fabric
electrode is flexible to wrap around the targeted part of the user's body (see [0028] and figures 1-6).
Regarding claims 8-12 and 23-24, Muccio et al. disclose the invention including 1) the
flexible material comprises an application area and an attachment mechanism for
securing the application area to the user's body, 2) the flexible material is configured to
be separately worn on both right and left limbs, 3) the attachment mechanism is an elastic
strap, and wherein the elastic strap provides compression directly over the application
area to maintain electrical contact with targeted part of the user's body (the hem areas of
each individual piece making up the whole system/suit/device, see figures 1-6), and 4)
comprising a wire management (the portion of the "programmable electrical stimulation
device 20" responsible for the individual, separate, and independent electrical signals, see
figures 1-6, especially figure 1) feature configured to route a wire connected to the first or
second electrode connector. Additionally Muccio et al. disclose the invention including: 1) comprising a wire management (the portion of the "programmable electrical stimulation device 20" responsible for the individual, separate, and independent electrical signals, see figures 1-6, especially figure 1) feature configured to route a wire connected to the first or second electrode connector, 2) the wire management feature comprises a channel configured to receive a portion of a wire (the "multiple channels," see [0028] and figure 1).
Regarding claim 7, Muccio et al. disclose the invention including the conductive fabric
electrode is flexible to wrap around the targeted part of the user's body (see [0028] and figures 1-6).
Regarding claim 15, Muccio et al. disclose the claimed invention, see figures 1 and 11. It should be noted claim 15 recites a recitation “configured to be applied to a user's shoulder,” which is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and have been treated accordingly as noted above.
Regarding claim 16, Muccio et al. disclose the claimed invention, see figures 1-11.
Additionally, Muccio et al. disclose separate electrode (3rd electrode), see figures 1-11.
It should be noted claim 16 recites two recitations: A) “configured to wrap around a user's remaining section of an amputated limb,” and B) “configured to be applied to a distal end of the user's remaining section of the amputated limb” of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed and have been treated accordingly as noted above.
Regarding claim 25, Muccio et al. disclose a method comprising:
providing a flexible garment (“garment 30” made from “flexible, non-conductive fabric such as Lycra and/or spandex,” see [0025] and figures 1-10) comprising at least two electrodes (a first and second of the plurality of "electrodes 50," see for example [0025], [0032] figures 1-10);
providing an electrotherapeutic device ("programmable electrical stimulation device 20," see [0024, [0028 and figures 1-10) operably connected to the at least two electrodes;
positioning the flexible garment with respect to a user's body (see figures 1-11) such that the at least two electrodes are each in contact with a targeted part of the user's body (“apply additional external pressure to the electrodes 50 for the purpose of maintaining complete or nearly complete contact with the skin of the wearer of the garment,” see [0025]); and
forming a therapeutic signal (A) “each electrode 50 delivers precisely controlled stimulation current to the user of the system 10,” see [0025], and B) “an electrical wire 56 is attached to the silver-treated material 54 for the purpose of transmitting a controlled stimulation current into and through the silver-treated material to the individual using the wearable item,” see [0027]) configured to reduce pain (see abstract, [0005], and [0023] for example) at a treatment site.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Muccio et al. (U.S. Patent Application Publication 2008/0097530) as applied to claims 1, and 17 above, and further in view of Kiani et al. (U.S. Patent Application Publication 2016/0121099).
Regarding claims 6 and 22, Muccio et al. show the invention above,
but fail to explicitly recite "the first electrode connector and the second electrode connector each comprise a stud on the exterior surface and a rivet on the interior surface, and wherein the rivet includes a coating of non-conductive material.
Like Muccio et al., Kiani et al. disclose a device/system for delivering electrical stimulation to a patient's/person's skin via a sleeve device (200) and electrodes and teach providing the electrodes with panels (312 and 313, see figure 3B-3D, and [0147]-[0153]) that are permanently and/or adjustably connected to the electrodes via rivets ("rivets," see [0148], [0158], and [0224]) in order to provide a known and workable manner of providing adjustably to the electrode to the device (see [0039]- [[0041], [0160] for example).
With respect to the recited stud(s), the examiner takes Official Notice, since it is extremely well known many embodiments of rivets comprise both 1) rivet "tubes" and 2) stud "pins" as a means of fastening.
If applicant does not traverse the examiner's assertion of official notice or applicant's traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner's assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate," see MPEP 2144.03C.
Therefore at the time of the invention it would have been obvious to one of ordinary skill in the art to modify the invention of Muccio et al., as taught by Kiani et al., to provide the device/system with panels that are permanently and/or adjustably connected to the electrodes via rivets - or rivets and studs in order to provide a known and workable manner of providing adjustably to the electrode to the device.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Muccio et al. (U.S. Patent Application Publication 2008/0097530) as applied to claim 25 above, and further in view of Official Notice.
Regarding claim 26, Muccio et al. show the invention above including the providing the flexible garment in the configuration of sleeve (see “sleeve” [0025] figure 1).
but fail to explicitly recite pulling the sleeve over a part of the body and sliding the sleeve to a desired position.
However, the examiner is taking Official Notice of the claimed step of “pulling the sleeve over a part of the body and sliding the sleeve to a desired position” since it is extremely well known step/technique for placing a therapeutic sleeve garment in the desired location.
If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate,” see MPEP 2144.03C.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Muccio et al., as taught by taking Official Notice, to pull the sleeve over a part of the body and sliding the sleeve to a desired position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792