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 .
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 22-36, 43-45, 47-48 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.
Regarding claim 22, the phrase “one or more first electrodes” renders the claim indefinite because the claim as written includes the possibility of just one electrode. The claim then further states “the one or more first electrodes includes a line of electrodes”. One electrode cannot be a line of electrodes; it is unclear what number of electrodes are being claimed.
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 22-24, 29, 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karell (US Pre-Grant Publication 2009/0012573), hereinafter ‘Karell’.
Regarding claim 22, Karell teaches a method of treating a subject (abstract, improving breathing and treating a respiratory disorder), the method comprising:
providing external respiratory support to the subject ([0004], CPAPs utilized);
providing gas flow to a nasal cavity via a gas outlet (nasal passageways 12, Fig. 1A) of a nasal stimulator ([0018], nasal passageway may be connected to CPAP), wherein the nasal stimulator comprises one or more first electrodes (electrode 18, Fig. 1A), and the one or more first electrodes includes a line of electrodes transverse to the gas outlet (see Fig. 1A, electrodes 18 transverse to nasal passageways 12); and
delivering an electrical current from a first electrode of the one or more first electrodes ([0018], stimulator 16 energizes electrode 18 to stimulate muscles or nerves).
Regarding claim 23, Karell teaches the method of claim 22, further comprising:
wherein electrical stimulation, gas flow, or both, are delivered in synchrony with the external respiratory support ([0018], nasal passageway may be connected to CPAP during stimulation).
Regarding claim 24, Karell teaches the method of claim 22, further comprising:
wherein providing gas flow and delivering an electrical current stimulates a nasal nerve ([0018], stimulates nerves), the external respiratory support is provided via a mechanical ventilator ([0004], CPAPs utilized), and the nasal nerve is stimulated during a breath assisted by the mechanical ventilator ([0018], nasal passageway may be connected to CPAP during stimulation).
Regarding claim 29, Karell teaches the method of claim 22, further comprising:
wherein delivering the electrical current from the first electrode of the one or more first electrodes increases a compliance of a lung or an airway ([0018], enhance respiratory patency).
Regarding claim 31, Karell teaches the method of claim 22, further comprising:
positioning the nasal stimulator within a nasal cavity of the subject ([0005], secured in nasal cavity), wherein the nasal stimulator further includes a gas inlet (Fig. 3, gas can enter via right side of the airway 20) and an occlusion device (Fig. 3, airflow resistors 26, [0020], [0011], airflow resistance means can be a balloon valve); and
inflating the occlusion device ([0011], airflow resistance means can be a balloon valve);
wherein stimulating the nasal nerve via gas flow to the nasal cavity includes stimulating the nasal nerve with a gas flowing from the gas outlet to the gas inlet ([0019], CPAP utilized via the airway).
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.
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 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Karell (US Pre-Grant Publication 2009/0012573) in view of Cipollone et al. (US Pre-Grant Publication 2011/0094518), hereinafter ‘Cipollone’.
Regarding claim 25, Karell teaches the method of claim 22, including the use of a CPAP to provide respiratory support [0004]. Karell does not specifically disclose that the gas flow is greater during an inspiration phase as compared to an expiration phase.
Cipollone teaches a system for ventilatory support (abstract), further comprising:
wherein the gas flow to the nasal cavity is greater during an inspiration phase of the breath assisted by the mechanical ventilator compared to an expiration phase of the breath (Fig. 30J, first amplitude delivered during inspiration 3511 and second amplitude delivered during expiratory 3513, [0131]).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Cipollone to include an increased gas flow during inspiration. Doing so would allow for a clinically efficacious effect, as recognized by Cipollone [0131].
Regarding claim 28, Karell teaches the method of claim 22, further comprising:
the nasal stimulator is positioned within a nasal cavity of the subject ([0005], secured in nasal cavity).
Karell does not specifically teach that positive pressure ventilation is delivered.
Cipollone teaches a system for ventilatory support (abstract), further comprising:
wherein external respiratory support includes delivering positive pressure ventilation ([0131], positive end-expiratory pressure (PEEP)) via a tracheal endoscope (gas delivery tube 2115, Fig. 21, [0085], ventilation gas delivered to trachea 459).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Cipollone to include a tracheal endoscope that delivers positive pressure ventilation. Doing so would create a clinically efficacious effect on the lung/airways, as recognized by Cipollone.
Claims 26-27, 36 are rejected under 35 U.S.C. 103 as being unpatentable over Karell (US Pre-Grant Publication 2009/0012573) in view of Evans et al. (US Pre-Grant Publication 2019/0001127), hereinafter ‘Evans’.
Regarding claim 26, Karell teaches the method of claim 24, but does not teach effects of the stimulation on the hippocampus.
Evans teaches a method for stimulating a nerve (abstract), further comprising:
wherein stimulating a nasal nerve during a breath assisted by the mechanical ventilator stimulates hippocampus neurogenesis, mitigates hippocampus neuroinflammation, or both ([0020], mitigates the degree of apoptosis in the hippocampus).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Evans to include effects of the stimulation on the hippocampus. Doing so would help treat patients with cognitive injury, as recognized by Evans [0004].
Regarding claim 27, Karell teaches the method of claim 24, but does not teach the stimulation causing modulation of other components.
Evans teaches a method for stimulating a nerve (abstract), further comprising:
wherein stimulating a nasal nerve during a breath assisted by the mechanical ventilator modulates the activity of: a brain stem; a cortical respiratory area; a respiratory motor cortex; a prefrontal cortex; a nasal-bronchial reflex; a hypothalamus; a trigemal nerve; a facial nerve; a suprachiasmatic nucleus; or a combination thereof ([0024], brain stem signaling pathway).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Evans to include effects on the brain stem due to stimulation. Doing so would help control inflammation and immunity, as recognized by Evans [0024].
Regarding claim 36, Karell teaches the method of claim 31, but does not teach the types of nasal nerves modulated.
Evans teaches a method for stimulating a nerve (abstract), further comprising:
wherein the nasal nerve includes: an olfactory bulb receptor; a maxillary branch of a trigeminal nerve; a mandibular branch of a trigeminal nerve; an afferent nerve connected to an olfactory bulb receptor, a maxillary branch of a trigeminal nerve, or a mandibular branch of a trigeminal nerve; an afferent nerve of a nasal-bronchial reflex; an efferent nerve connected to an olfactory bulb receptor, a maxillary branch of a trigeminal nerve, or a mandibular branch of a trigeminal nerve; or a combination thereof ([0071], stabilizing afferent signaling).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Evans to include stimulating a specific portion of a nasal nerve. Doing so would help reduce and prevent brain injury, as recognized by Evans [0071].
Claims 30, 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Karell (US Pre-Grant Publication 2009/0012573) in view of Barbut et al. (US Pre-Grant Publication 2013/027465), hereinafter ‘Barbut’.
Regarding claim 30, Karell teaches the method of claim 22, but fails to teach that the gas does not enter lungs of the subject.
Barbut teaches a method for inter-nasally delivering nitric oxide (abstract), further comprising:
wherein gas that is used to generate the gas flow does not enter lungs of the subject ([0007], preventing inhalation of nitric oxide into the lungs).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Barbut to include gas that does not enter the lungs of a subject. Doing so would help prevent pulmonary vasodilation, as recognized by Barbut [0007].
Regarding claim 32, Karell teaches the method of claim 31, but fails to teach that an air-tight seal is formed between the nasal cavity and nasal stimulator.
Barbut teaches a method for inter-nasally delivering nitric oxide (abstract), further comprising:
wherein inflating the occlusion device (anterior occlusion device 328, Fig. 3) includes forming an air-tight seal between the nasal cavity and the nasal stimulator ([0038, 0046], occlusion prevents nitric oxide inhalation).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Barbut to include an air-tight seal between the nasal cavity and stimulator. Doing so would allow a gas to build up in the nasal cavity, as recognized by Barbut [0046].
Regarding claim 33, Karell and Barbut teach the method of claim 32. Barbut teaches the method further comprising:
wherein the occlusion device is a first occlusion device (anterior occlusion device 428, Fig. 4), the air-tight seal is a first air-tight seal, the nasal stimulator further comprises a second occlusion device (posterior occlusion device 426, Fig. 4), and the method further comprises inflating the second occlusion device thereby forming a second air-tight seal between the nasal cavity and the nasal stimulator ([0047], [0038], occlusion prevents nitric oxide inhalation).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Barbut to include two air-tight seals between the nasal cavity and stimulator. Doing so would allow a gas to build up in the nasal cavity, as recognized by Barbut [0046].
Regarding claim 34, Karell and Barbut teach the method of claim 33. Barbut teaches the method further comprising:
wherein inflating the first and second occlusion devices forms a sealed-off length of a nasal passage between the first air-tight seal and the second air-tight seal (Fig. 4).
The Examiner notes that the space between two occlusion devices would necessarily form a sealed-off length of a nasal passage since both ends are blocked.
Regarding claim 35, Karell and Barbut teach the method of claim 34. Barbut teaches the method further comprising:
wherein the gas flowing from the gas outlet to the gas inlet is within the sealed-off length of the nasal passage (Fig. 4, [0038], prevent nitric oxide inhalation while maintaining high concentration in nasal cavity).
Claims 43-45, 47-50 are rejected under 35 U.S.C. 103 as being unpatentable over Karell (US Pre-Grant Publication 2009/0012573) in view of Ackermann et al. (US Pre-Grant Publication 2014/0316485), hereinafter ‘Ackermann’.
Regarding claim 43, Karell teaches the method of claim 22, but does not teach electrodes supported on an occlusion device.
Ackermann teaches a system/method for nasal/sinus tissue stimulation (abstract), further comprising:
wherein the nasal stimulator comprises an occlusion device (electrode regions 2704 are expanded, Fig. 27B), and the first electrode of the one or more first electrodes (electrodes 2704, Figs. 27A, 27B) is supported on the occlusion device ([0205], another device such as a balloon catheter expands electrodes 2704).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Ackermann to include electrodes located on an occlusion device. Doing so would allow for the electrodes to anchor in the nasal cavity and be positioned in contact with nasal tissue for stimulation, as recognized by Ackermann [0205].
Regarding claim 44, Karell teaches the method of claim 22, but does not teach electrodes supported on two occlusion devices.
Ackermann teaches a system/method for nasal/sinus tissue stimulation (abstract), further comprising:
the nasal stimulator further comprises a first occlusion device (electrode region 2704, Fig. 27B) and a second occlusion device (additional electrode region 2704, Fig. 27B);
the first electrode of the one or more first electrodes is supported on the first occlusion device ([0205], another device such as a balloon catheter expands electrodes 2704, Figs. 27A, 27B); and
the nasal stimulator further comprises a second electrode supported on the second occlusion device (additional electrode region 2704, Fig. 27B).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Ackermann to include electrodes located on two occlusion devices. Doing so would allow for the electrodes to anchor in the nasal cavity and be positioned in contact with nasal tissue for stimulation, as recognized by Ackermann [0205].
Regarding claim 45, Karell and Ackermann teach the method of claim 44. Ackermann teaches the method further comprising:
wherein delivering the electrical current from the first electrode includes generating an electric field between the first electrode and the second electrode ([0096], bipolar stimulation).
The Examiner notes that bipolar stimulation implies that one electrode is a return electrode and one is an active electrode, and that the presence of a return electrode would necessarily generate an electric field.
Regarding claim 47, Karell teaches the method of claim 22, further comprising:
wherein the line of electrodes is a first line of electrodes (electrode 18, Fig. 1A).
Karell fails to teach that there is a second gas outlet with a second line of electrodes transverse to it.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to duplicate the first line of electrodes transverse to a first gas outlet to produce a second line of electrodes transverse to a second gas outlet. One of ordinary skill would have found it obvious to try duplicating the lines of electrodes with a reasonable expectation of stimulating both nostrils. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), MPEP 2144.01(VI)(B).
Karell fails to further tech that an electric field is generated between two electrodes.
Ackermann teaches the method further comprising:
delivering the electrical current from the first electrode includes generating an electric field between the first electrode and a second electrode of the one or more second electrodes ([0096], bipolar stimulation).
The Examiner notes that bipolar stimulation implies that one electrode is a return electrode and one is an active electrode, and that the presence of a return electrode would necessarily generate an electric field.
Regarding claim 48, Karell teaches the method of claim 22, but fails to teach generation of an electric field between an electrode on the nasal stimulator and an electrode on a dermal patch.
Ackermann teaches the method further comprising:
wherein delivering the electrical current from the first electrode includes generating an electric field between the first electrode and a second electrode supported on a dermal patch configured for placement on skin ([0216], pad electrode can be affixed to an external portion of nose to act as a return electrode).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Ackermann to include generating an electric field between nasal stimulator electrodes and dermal patch electrodes. Doing so would allow for the delivery of stimulation in a single nostril, as recognized by Ackermann [0216].
Regarding claim 49, Karell teaches a method of treating a subject (abstract, improving breathing and treating a respiratory disorder), the method comprising:
providing external respiratory support to the subject ([0004], CPAPs utilized); and
providing gas flow to a nasal cavity via a nasal stimulator (nasal passageways 12, Fig. 1A), ([0018], nasal passageway may be connected to CPAP).
Karell does not specifically teach electrodes supported on two occlusion devices.
Ackermann teaches a system/method for nasal/sinus tissue stimulation (abstract), further comprising:
the nasal stimulator further comprises a first occlusion device (electrode region 2704, Fig. 27B);
a second occlusion device (additional electrode region 2704, Fig. 27B);
one or more first electrodes supported on the first occlusion device ([0205], another device such as a balloon catheter expands electrodes 2704, Figs. 27A, 27B); and
a second electrode supported on the second occlusion device (additional electrode region 2704, Fig. 27B); and
delivering an electrical current from a first electrode of the one or more first electrodes, wherein delivering the electrical current includes generating an electric field between the first electrode and the second electrode ([0096], bipolar stimulation).
The Examiner notes that bipolar stimulation implies that one electrode is a return electrode and one is an active electrode, and that the presence of a return electrode would necessarily generate an electric field.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Ackermann to include electrodes located on two occlusion devices. Doing so would allow for the electrodes to anchor in the nasal cavity and be positioned in contact with nasal tissue for stimulation, as recognized by Ackermann [0205].
Regarding claim 50, Karell teaches a method of treating a subject (abstract, improving breathing and treating a respiratory disorder), the method comprising:
providing external respiratory support to the subject ([0004], CPAPs utilized); and
providing gas flow to a nasal cavity via a nasal stimulator (nasal passageways 12, Fig. 1A), ([0018], nasal passageway may be connected to CPAP).
Karell does not specifically teach generation of an electric field between an electrode on the nasal stimulator and an electrode on a dermal patch.
Ackermann teaches a system/method for nasal/sinus tissue stimulation (abstract), further comprising:
delivering an electrical current from a first electrode supported on the nasal stimulator, wherein delivering the electrical current from the first electrode includes generating an electric field between the first electrode and a second electrode supported on a dermal patch configured for placement on skin ([0216], pad electrode can be affixed to an external portion of nose to act as a return electrode).
The Examiner notes that the presence of a return electrode would necessarily generate an electric field.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Karell to incorporate the teachings of Ackermann to include generating an electric field between nasal stimulator electrodes and dermal patch electrodes. Doing so would allow for the delivery of stimulation in a single nostril, as recognized by Ackermann [0216].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (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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/E.L.O./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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