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 .
DETAILED ACTION
Double Patenting
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,940,310. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are directed to obvious variations and broadening of claims 1-25 of U.S. Patent No. 10,940,310.
Present claim 1 is an obvious broadening of claims 1 and 4 of U.S. Patent No. 10,940,310 by eliminating a handheld stimulator.
Present claim 2 is an obvious broadening of claims 3 and 4 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is delivered in response to one or more symptoms of rhinitis.
Present claim 3 is an obvious equivalent of claim 3 of U.S. Patent No. 10,940,310 wherein the one or more symptoms of rhinitis comprise one or more of itching, sneezing, congestion, runny nose, post-nasal drip, mouth breathing, coughing, fatigue, headache, anosmia, phlegm, throat irritation, periorbital puffiness, watery eyes, ear pain, and fullness sensation.
Present claim 4 is an obvious equivalent of claim 6 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is delivered more than once per day on a scheduled basis.
Present claim 5 is an obvious equivalent of claims 1 and 3 of U.S. Patent No. 10,940,310 wherein the nasal tissue is nasal mucosa.
Present claim 6 is an obvious equivalent of claim 1 of U.S. Patent No. 10,940,310 wherein the nasal mucosa is adjacent to the nasal septum.
Present claim 7 is an obvious electrode construct of claim 7 of U.S. Patent No. 10,940,310 wherein the electrode is a hydrogel electrode.
Present claim 8 is an obvious electrode control construct of claims 1 and 7 of U.S. Patent No. 10,940,310 wherein the electrode is electrically connected to a control subsystem configured to control the electrical stimulus delivered via the electrode.
Present claim 9 is an obvious broadening of a handheld stimulator of claims 1 and 13 of U.S. Patent No. 10,940,310 wherein the electrode is positioned on a stimulator probe and the control subsystem is positioned in a stimulator body, and wherein the stimulator probe is releasably connected to the stimulator body.
Present claim 10 is an obvious equivalent of claim 8 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is a biphasic pulse waveform.
Present claim 11 is an obvious handheld stimulator construct of claims 1 and 13 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is delivered by an electrode of a stimulator comprising a control subsystem to control the electrical stimulus.
Present claim 12 is an obvious broadening of claims 3 and 4 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is delivered in response to one or more symptoms of rhinitis.
Present claim 13 is an obvious equivalent of claims 3 and 4 of U.S. Patent No. 10,940,310 wherein the one or more symptoms of rhinitis comprise one or more of itching, sneezing, congestion, runny nose, post-nasal drip, mouth breathing, coughing, fatigue, headache, anosmia, phlegm, throat irritation, periorbital puffiness, watery eyes, ear pain, and fullness sensation.
Present claim 14 is an obvious equivalent of claim 12 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is pulsed.
Present claim 15 is an obvious broadening of claim 6 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is delivered at least once daily during a treatment period.
Present claim 16 is an obvious broadening of claim 6 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is delivered on a scheduled basis during the treatment period.
Present claim 17 is an obvious equivalent of claim 8 of U.S. Patent No. 10,940,310 wherein the electrical stimulus is a biphasic pulse waveform.
Present claim 18 is an obvious equivalent of claim 9 of U.S. Patent No. 10,940,310 wherein the biphasic pulse waveform is symmetrical.
Present claim 19 is an obvious equivalent of claim 10 of U.S. Patent No. 10,940,310 wherein the waveform has a varying peak to peak amplitude.
Present claim 20 is an obvious equivalent of claim 11 of U.S. Patent No. 10,940,310 wherein the waveform has a varying frequency.
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, 4, 5, 6, 8, 10, 11 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lamensdorf et al (US 2015/0174406).
Regarding claim 1, Lamensdorf discloses a method for treating inflammation of the mucous membranes of the nose, rhinitis, comprising:
delivering an electrical stimulus via an electrode to treat rhinitis in a patient in need thereof, wherein the electrode is in contact with nasal tissue of the patient during delivery of the electrical stimulus, see paragraph [0546].
Regarding claims 4, 15 and 16, the electrical stimulus is delivered more than once per day on a scheduled basis, see paragraph [0238].
Regarding claim 5, Lamensdorf discloses the nasal tissue is nasal mucosa, see paragraph [0546].
Regarding claim 6, Lamensdorf discloses the device is positioned in the nasal cavity, see paragraph [0005], wherein the nasal mucosa is adjacent to the nasal septum.
Regarding claim 8, Lamensdorf discloses the electrode is electrically connected to a
control subsystem 34 configured to control the electrical stimulus delivered via the electrode 38, see paragraph [0341].
Regarding claim 10, Lamensdorf discloses the electrical stimulus is a biphasic pulse
waveform, see paragraph [0405].
Regarding claim 11, Lamensdorf discloses a method for treating inflammation of the mucous membranes of the nose, rhinitis, comprising:
delivering an electrical stimulus to nasal tissue of a subject to improve rhinitis of the subject, wherein the electrical stimulus is delivered by an electrode 38 of a stimulator comprising a control subsystem 34 to control the electrical stimulus, see paragraph [0341].
Regarding claim 14, Lamensdorf discloses the electrical stimulus is pulsed, see paragraph [0405].
Regarding claim 17, Lamensdorf discloses the electrical stimulus is a biphasic pulse waveform, see paragraph [0405].
Regarding claim 18, Lamensdorf discloses the biphasic pulse waveform is symmetrical, see paragraph [0405].
Regarding claim 19, Lamensdorf discloses the waveform has a varying peak to peak amplitude, see paragraph [0405].
Regarding claim 20, Lamensdorf discloses the waveform has a varying frequency, see paragraph [0405].
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 2, 3, 7, 9, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lamensdorf et al (US 2015/0174406).
Regarding claims 2 and 12, one of ordinary skill in the art would have found it obvious to deliver the electrical stimulus in response to one or more symptoms of rhinitis because inflammation of the mucous membranes of the nose are associated with a posterior nasal nerve and Lamensdorf suggests it was well known to deliver a Non Steroidal Anti-inflammatory Drug for inflammation, see paragraph [0009]. The skilled artisan would have been motivated to provide electrical stimulation from electrodes 38 to achieve a similar anti-inflammatory response using neural stimulation in response to one or more symptoms of rhinitis to reduce inflammation.
Regarding claims 3 and 13, the symptoms of rhinitis commonly comprise one or more of itching, sneezing, congestion, runny nose, post-nasal drip, mouth breathing, coughing, fatigue, headache, anosmia, phlegm, throat irritation, periorbital puffiness, watery eyes, ear pain, and fullness sensation.
One of ordinary skill in the art would have found it obvious to provide electrical stimulation through electrodes 38 to alleviate the above symptoms of rhinitis because these symptoms are associated with mucous membrane tissue inflammation and are readily treatable using the device disclosed in Lamensdorf Fig. 1.
Regarding claim 7, Lamensdorf teaches coating electrodes 38 with a biocompatible material, see paragraph [0348]. One of ordinary skill in the art would have found it obvious to make the electrodes 38 as hydrogel electrodes to enhance the surface area of the electrodes as suggested by Lamensdorf.
Regarding claim 9, Lamensdorf teaches the electrodes 38 may comprise probes, see paragraph [0348]. One of ordinary skill in the art would have found it obvious to position the electrodes 38 on a stimulator probe 36 with the control subsystem 34 positioned in a stimulator body, and wherein the stimulator probe 36 is releasably connected to the stimulator body because making a device integral or separable are obvious structural adaptations. See MPEP 2144.04 V.
B. Making Integral
In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice."); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form "a single integral and gaplessly continuous piece." Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.).
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C. Making Separable
In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Manuel whose telephone number is (571) 272-4952.
The examiner can normally be reached on regular business days.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George Manuel/
Primary Examiner
Art Unit: 3792
1/15/2026