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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/2/25 has been entered.
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.
Claim(s) 1, 2, 4, 5, 8-12, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Alverez (WO 2014/142970 hereafter Alverez) in view of Katsumasa et al (JPH08107936A hereafter Katsumasa) and Perricone (US 2014/0271810 A1 hereafter Perricone).
Alverez discloses a method of regenerating and stimulating hair growth, treating hair loss, skin conditions or wound healing (claim 13, 27, all such methods would regenerate hair growth) in a target area of a subject comprising conducting an initial treatment phase followed by a personal treatment phase where the initial phase include subcutaneous application of CO2 to the scalp [claim 1, 13, 20 and 27]. The method allows for additional maintenance treatment phases including an initial phase and a personal phase that are conducted after the initial; treatment both comprising subcutaneous application of CO2 to the scalp [claims 23]. These steps can be repeated up to 40 times with the intervals between treatments being anywhere from 6 to 120 hours [claim 23], meeting the limitation of claim 12. The initial treatment phase and the personal phase are performed after an interval with the additional repeating maintenance phase repeating after 60-120 hours [0095-0097], this meets the “occurs after the initial phase and after the at least one maintenance phase” limitations. This series of repeating initial and personal phases would meet the limitations of initial treatment followed by maintenance treatment phases [0086-0087]. Additionally, one or more treatments are applied to the target area before after or during the carbon dioxide treatment, including galvanic, heat or electrical stimulation, which are provided in a kit comprising the device [0062]. These treatment include nutrients topically applied to the skin including growth factors, analgesics, antibiotics [0092, 0099], meeting the limitations of claims 4, 6 and 8.
While the reference discloses a method for rejuvenating hair by applied CO2 to the scalp along with other energy methods including galvanic energy, which is a high energy treatment, the reference is silent to the specific high frequency ozone of claims 5 and 11. However, the application of high frequency ozone to the scalp for hair restoration is known in the art as seen in the Katsumasa.
Katsumasa discloses a high frequency ozone generator applied to the scalp for hair restoration (claims 1,2). The device operates at 50hz (Table 3), meeting the limitations of claim 5. It would have been obvious to include the high energy ozone of Katsumasa into the treatment method of Alverez as it would have solved the same problem.
The combination of prior art discloses a hair restoration and rejuvenation method comprising application of subcutaneous CO2 and the further application of an additional energy to the scalp. Alverez discloses the application or consumption of a variety of topical formulations comprising peptides and in the form of creams, lotions and transdermal dosage forms [0099-0100]. The reference is silent to the specific application of nitric oxide, however the application of nitric oxide is known in the art of hair restoration as see in the Perricone patent.
Perricone discloses a hair treatment method comprising the application of nitric oxide topically or transdermally [abstract], meeting the limitations of claim 2. The nitric oxide formulation can be applied via a cream, lotion of other transdermal means [0010] and can be applied to a subject that may have lost hair due to baldness, trauma or chemotherapy and thus in need of hair rejuvenation [0018]. The formulation may furth comprise enhancers and nutrients such as antioxidants, phospholipids and stabilizers [0085-0087]. These would be present in a kit presentation [0088]. While primarily applied topically, the formulation is also effective as an oral dosage form [0083]. It would have been obvious to include the nitric oxide of Perricone into the method of Alverez as they solve the same problem.
With these aspects in mind it would have been obvious to combine the prior art in order to produce a stable method of rejuvenating hair and the scalp. It would have been obvious to combine the high frequency ozone of Katsumasa in order to improve the hair and scalp rejuvenation of the Alvera as they solve the same problem. Further, Alverez discloses that high energy can further be applied in addition to the CO2, and such the inclusion of high frequency would have been an obvious modification. It would have been obvious to include the nitric oxide of the Perricone as it also would have solved the problem of rejuvenating hair as found in Alverez. One of ordinary skill in the art would have been motivated to combine the disclosures of the prior art with an expected result of a stable means of rejuvenating hair and the scalp.
Claim(s) 1, 3, 4 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Alverez (WO 2014/142970 hereafter Alverez) in view of Katsumasa et al (JPH08107936A hereafter Katsumasa) and Silwa et al (US 2007/0016117 hereafter Silwa).
As discussed above the combination of Alverez and Katsumasa discloses a method of rejuvenating hair. The combination discloses the application of high frequency energy applied to the scalp to rejuvenating hair, yet is silent to the application of ultrasonic or vibration energy. However, as seen in the Silwa patent, ultrasonic or vibration energy is known in the art.
Silwa discloses an ultrasonic or vibratory energy apparatus for at least one ultrasonically, vibrationally, thermally or ablatively treating at least a first portion of at least at least one hair, follicle or root-region or scalp comprising: an ultrasonic or vibratory energy transduction-means or energy source capable of producing or providing ultrasonic or vibratory excitation energy (claim 1), wherein the hair is held in place via a suction means (claim 11), meeting the limitations of claims 3, Silwa teaches that light energy is also applied, which includes infrared energy in order to warm the treatment area and enhance blood flow (0134, 0152), meeting the limitations of claims 6. Silwa discloses that the energy frequency is from 10 Hertz to 100 MHz (claim 5) as such overlapping the 25 MHz to 27 MHz of claims 7. Where claimed ranges overlap r lie inside the ranges discloses by the prior art, a prima facie case of obvious exist, See MPEP 2144.05. The energy of Silwa is disclosed as pulsing and electromagnetic energy (claims 24, 27), further meeting the limitation of claim 7.
With these aspects in mind it would have been obvious to combine the prior art in order to produce a stable method of rejuvenating hair and the scalp. It would have been obvious to combine the high frequency ozone of Katsumasa in order to improve the hair and scalp rejuvenation of the Alvera as they solve the same problem. Further, Alverez discloses that high energy can further be applied in addition to the CO2, and such the inclusion of high frequency would have been an obvious modification. It would have been obvious to include the energy of the Silwa into the combination as they solve the same problem for rejuvenating hair. One of ordinary skill in the art would have been motivated to combine the disclosures of the prior art with an expected result of a stable means of rejuvenating hair and the scalp.
Claim(s) 1 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alverez (WO 2014/142970 hereafter Alverez) in view of Katsumasa et al (JPH08107936A hereafter Katsumasa) and Perricone (US 2014/0271810 A1 hereafter Perricone) and discussed above, further in view of Loscalzo et al (US 2004/0081642 hereafter Loscalzo).
As discussed above the combination of Alverez, Katsumasa and Perricone discloses a method of rejuvenating hair comprising subcutaneous administration of CO2, high energy ozone and nitric oxide. Alverez further discloses the application of a plurality of vitamin and nutrients, and a treatment device comprising microneedles and components packaged together in a kit (0062). Katsumasa discloses the high energy ozone generator operates at a frequency of 50 Hz, meeting the limitations of claim 17. The combination however does not disclose the application of the specific compound glutathione along with the plurality of vitamins in a kit configuration. However the application of such as combination is known in the art as seen in the Loscalzo patent.
Loscalzo discloses a treatment of inflammatory disease with a series of transdermal patch comprising a therapeutically effective amount of at least one antioxidant including small molecule antioxidant and vitamins such as glutathione and a combination of vitamin C, E and cysteine, tocopherol and mixtures thereof (claim 128, 147, 148). Multiple patches can be applied to the body (0009) meeting limitations of claim 15 and 16. The reference further discloses the use of nitric oxide, where the compound can be applied orally or transdermally (0172, claim 57). It would have been obvious to combine the compounds of Loscalzo into the combination as they comprise similar compounds for solving the same problem.
With these aspects in mind it would have been obvious to combine the prior art in order to produce a stable method of rejuvenating hair and the scalp. It would have been obvious to combine the high frequency ozone of Katsumasa in order to improve the hair and scalp rejuvenation of the Alvera as they solve the same problem. Further, Alverez discloses that high energy can further be applied in addition to the CO2, and such the inclusion of high frequency would have been an obvious modification. It would have been obvious to include the combination of nutrient, vitamins and small molecule compounds of Loscalzo as they solve the same problem for rejuvenating hair. One of ordinary skill in the art would have been motivated to combine the disclosures of the prior art with an expected result of a stable means of rejuvenating hair and the scalp.
Claim(s) 1, 14, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Alverez (WO 2014/142970 hereafter Alverez) in view of Katsumasa et al (JPH08107936A hereafter Katsumasa) and Perricone (US 2014/0271810 A1 hereafter Perricone) and discussed above, further in view of KJean (Rotator Cuff Surgery-4 weeks post-op, Page 8, Shoulder Problems, Forums, patient, publication date:2016, hereafter KJean).
As discussed above the combination of Alverez, Katsumasa and Perricone discloses a method of rejuvenating hair comprising subcutaneous administration of CO2, high energy ozone and nitric oxide. Alverez further discloses the application of a plurality of vitamin and nutrients, and a treatment device comprising microneedles and components packaged together in a kit (0062). The combination, while disclosing a kit configuration is silent to the addition of further inclusion of shoulder straps and wedge pillows. However the inclusion of these features in a hair stimulating device are known in the art as seen in the KJean reference.
KJean discloses a posture shoulder strap ad wedge pillow applied to devices in order to help patients shoulder pain (page 6). It would have been obvious to include these features to the kit configuration in order to ease application of the microneedle device.
With these aspects in mind it would have been obvious to combine the prior art in order to produce a stable method of rejuvenating hair and the scalp. It would have been obvious to combine the high frequency ozone of Katsumasa in order to improve the hair and scalp rejuvenation of the Alvera as they solve the same problem. Further, Alverez discloses that high energy can further be applied in addition to the CO2, and such the inclusion of high frequency would have been an obvious modification. It would have been obvious to include shoulder and head support for the handheld device in the kit of the combination in order to make a more comfortable application experience.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Regarding Alverez, the amendments state that the personal phase occurs after the initial and maintenance phase in each to her initial treatment and maintenance phases of the therapy. Alverez discloses that the initial phase can be followed by an additional step which can include topical application of nutrients or additional energy, vibration or applications, which would include the application of high frequency ozone, ultrasonics, nitric oxide or additional steps. Alverez sats these steps are repeated up to 40 times. These disclosures along with supporting disclosures from Katsumara and Perricone would render the claims obvious as the combination would be obvious as they all solve the same problem.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618