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 .
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of prior U.S. Patent No. 11,103,696. This is a statutory double patenting rejection.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,191,951 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,191,951 B2 has been found to anticipate each and every element of the present invention, for instance both provide a device for electrical stimulation of one or more components of a periodontal complex and surrounding tissue of a tooth, comprising: at least two electrodes of a rigid, electrically conductive material in a fixed spatial relationship configured for application to oral mucosa and attached gingiva adjacent to, and along a periodontal ligament of, a root structure of a single tooth; an electrical circuit configured for electrical connection to the at least two electrodes, the electrical circuit having an output providing an electrical stimulus comprising a waveform in accordance with stimulation parameters.
As set forth above, the present invention is not viewed to be patentably distinct from US 11,191,951 B2.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,969,590 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,969,590 B2 has been found to anticipate each and every element of the present invention, for instance both provide a device for electrical stimulation of one or more components of a periodontal complex and surrounding tissue of a tooth, comprising: at least two electrodes of a rigid, electrically conductive material in a fixed spatial relationship configured for application to a periodontal complex or to tissue surrounding a periodontal complex; an electrical circuit configured for electrical connection to the at least two electrodes, the electrical circuit having an output providing an electrical stimulus comprising a waveform in accordance with stimulation parameters.
As set forth above, the present invention is not viewed to be patentably distinct from US 11,969,590 B2.
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 9-11 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.
Claims 9-11 recites the limitation "wherein the switch" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-8, 12 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soong et al. (US 2009/0287284 A1).
As to claim 1, Soong et al. discloses a device for electrical stimulation (Abstract) of one or more components of a periodontal complex and surrounding tissue of a tooth ([0017]; “gum tissue”), comprising: at least two electrodes of a rigid, electrically conductive material in a fixed spatial relationship (electrode spheres, depicted as 114 in Figures 1-4) configured for application to oral mucosa and attached gingiva adjacent to, and along a periodontal ligament of, a root structure of a single tooth ([0017]); an electrical circuit configured for electrical connection to the at least two electrodes ([0011-0012, 0019-0020]; since electrical stimulation is provided by the electrodes, there is inherently an electrical circuit for providing the stimulation), the electrical circuit having an output providing an electrical stimulus comprising a waveform in accordance with stimulation parameters ([0011-0012]).
As to claim 2, Soong et al. discloses the device applies therapeutic stimulation ([0011]) and stimulation to gum tissue ([0017]). The functional language and introductory statement of intended use of claim 2 has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Soong et al. utilizes electrical stimulus as claimed by the Applicant, Soong et al. is therefore capable of being used in electrical stimulus for a periodontal complex of a tooth. In addition nothing prevents Soong et al. from providing electrical stimulus that is considered “therapeutically effective”. Therefore, the electrical stimulus is capable of being therapeutically effective electrical stimulus for a periodontal complex of a tooth.
As to claim 3, Soong et al. discloses the device applies therapeutic stimulation ([0011]) and stimulation to gum tissue ([0017]). The functional language and introductory statement of intended use of claim 3 has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Soong et al. utilizes electrical stimulus as claimed by the Applicant, Soong et al. is therefore capable of being used in electrical stimulus for relieving periodontal pain. In addition nothing prevents Soong et al. from providing electrical stimulus that is considered “therapeutically effective”. Therefore, the electrical stimulus is capable of being therapeutically effective electrical stimulus for relieving periodontal pain.
As to claim 4, Soong et al. discloses the device applies therapeutic stimulation ([0011]) and stimulation to gum tissue ([0017]). The functional language and introductory statement of intended use of claim 4 has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Soong et al. utilizes electrical stimulus as claimed by the Applicant, Soong et al. is therefore capable of being used in electrical stimulus for affecting tooth movement. In addition nothing prevents Soong et al. from providing electrical stimulus that is considered “therapeutically effective”. Therefore, the electrical stimulus is capable of being therapeutically effective electrical stimulus for affecting tooth movement.
As to claim 5, Soong et al. discloses a housing configured to be handheld and wherein the at least two electrodes are mounted in a first end of the housing (Figures 1-4).
As to claim 6, Soong et al. discloses the at least two electrodes (“A” and “B” in Figure 1) comprises: a base (connecting collar, depicted as 110 in Figures 1 and 3) having a first mechanical connector and a first electrical connection ([0016]; “The connecting collar 110 may connect the electro-stimulation portion 106 with the body portion 104 via a threaded connection, snap-on connection or other means for interconnecting the portions in a fixed relationship”), wherein the at least two electrodes are mounted in the base (Figures 1 and 3); and wherein the housing has a second mechanical connector having a mating configuration with the first mechanical connector of the base and a second electrical connection having a mating configuration with the first electrical connection of the base ([0016]; “The connecting collar 110 may connect the electro-stimulation portion 106 with the body portion 104 via a threaded connection, snap-on connection or other means for interconnecting the portions in a fixed relationship. Extending from the collar portion 110 are a pair of rigid curved members 112”); whereby the base is removably connectable to the housing (Figures 1-4; [0016]).
As to claim 7, Soong et al. discloses the electrical circuit is mounted in the housing ([0011-0012, 0019-0020]; since electrical stimulation is provided by the electrodes, there is inherently an electrical circuit in the housing for providing the stimulation).
As to claim 8, Soong et al. discloses the electrical circuit is mounted in the housing and the output of the electrical circuit is connected to the second electrical connection of the housing (Figures 1-4; [0011-0012]).
As to claim 12, Soong et al. discloses electrical stimulus, which necessarily includes a waveform. Furthermore, waveforms necessarily have operational parameters, such as a pulse frequency. Therefore, any waveform necessarily has a “pulse frequency”. And as such, a waveform with a plurality of pulses would also necessarily have a pulse frequency. Therefore, Soong et al. necessarily discloses a waveform with a plurality of pulses would also necessarily have a pulse frequency.
As to claim 17, Soong et al. discloses a device for electrical stimulation of one or more components of periodontal complexes and surrounding tissues of a plurality of teeth (Abstract; [0017]), comprising: a housing shaped to be placed around the plurality of teeth (Figure 1-4); a plurality of pairs of electrodes in a fixed spatial relationship (electrode spheres, depicted as 114 in Figures 1-4), mounted at locations along the housing corresponding to positions of the teeth, such that, when the housing is positioned to surround the plurality teeth, each pair of electrodes is placed in contact with oral mucosa and attached gingiva adjacent to, and along a periodontal ligament of, a root structure of corresponding one of the plurality of teeth ([0017]; “gum tissue”); an electrical circuit configured for electrical connection to the plurality of pairs of electrodes ([0011-0012, 0019-0020]; since electrical stimulation is provided by the electrodes, there is inherently an electrical circuit for providing the stimulation), the electrical circuit having an output providing an electrical stimulus comprising a waveform in accordance with stimulation parameters ([0011-0012]).
As to claim 18, Soong et al. discloses a process for electrical stimulation of one or more components of a periodontal complex and surrounding tissue of a tooth (Abstract), comprising: placing electrodes of a device on oral mucosa and attached gingiva adjacent to, and along a periodontal ligament of, a root structure of a single tooth ([0017]; “gum tissue”), the electrodes comprising at least two electrodes of a rigid, electrically conductive material in a fixed spatial relationship (electrode spheres, depicted as 114 in Figures 1-4) configured for application to oral mucosa and attached gingiva adjacent to, and along a periodontal ligament of, a root structure of a single tooth ([0017]); and activating the device to generate an electrical stimulus while the electrodes of the device are placed ([0011-0012]).
As to claim 19, Soong et al. discloses electrodes that engage with the gum tissue ([0017]). The functional language and introductory statement of intended use of claim 19 has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Soong et al. utilizes placing the electrode along the gum tissue as claimed by the Applicant, Soong et al. is therefore capable of being used in “moving the electrodes” along the tissue. In addition nothing prevents Soong et al. from moving the electrodes on the gingiva and along a periodontal ligament of, a root structure of a single tooth. Therefore, the electrodes of Soong et al. are capable of moving “on the gingiva and along a periodontal ligament of, a root structure of a single tooth”.
As to claim 20, Soong et al. discloses positioning electrodes on gum tissue ([0017]). Therefore, in order to dispense electrical stimulation to a portion of the gum tissue, the electrodes would necessarily have to be maintained “substantially stationary” during application.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9-11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Soong et al. (US 2009/0287284 A1).
As to claims 9-11, Soong et al. discloses the invention substantially as claimed with an electrical stimulation device having at least two electrodes for providing electrical stimulation to a patient (Abstract; Figures 1-4), but does not explicitly disclose “a switch”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the housing to include a switch, such as a mechanical and electromechanical switch, since they are extremely common and well known in electrical and electrical stimulation devices as a means for switching the device between and ON or OFF state. Furthermore, such a modification would provide the predictable results of activating the device and controlling the delivery of stimulation for appropriate operation of the device.
As to claim 13, Soong et al. discloses providing electrical stimulation, which necessarily includes a waveform with a pulse frequency, but does not explicitly disclose “the waveform comprises a first plurality of pulses of a positive polarity at the pulse frequency in a first envelope, and a second plurality of pulses of a negative polarity at the pulse frequency in a second envelope, and a transition between the first and second plurality of envelopes occurring at a transition frequency”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the pulse polarity, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of optimizing the electrical stimulation to meet specific patient therapeutic needs and requirements.
As to claim 14, Soong et al. discloses providing electrical stimulation, which necessarily includes a waveform with a pulse frequency, but does not explicitly disclose the pulse frequency is in a range of 1 kHz to 12 kHz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the pulse frequency to a range of 1kHz to 12 kHz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of optimizing the electrical stimulation to meet specific patient therapeutic needs and requirements.
As to claim 15, Soong et al. discloses providing electrical stimulation, which is a current of electrical stimulus, but does not explicitly disclose the current is less than ten milliamperes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the current of the electrical stimulus, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of optimizing the electrical stimulation to meet specific patient therapeutic needs and requirements.
As to claim 16, Soong et al. discloses providing electrical stimulation which necessarily has a duration, but does not explicitly disclose the duration is an amount of time greater than ten seconds and less than twenty minutes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the duration of the electrical stimulus since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of optimizing the electrical stimulation to meet specific patient therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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