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 .
Status of Claims
Claims 1-15 are pending, of which claim 1 is independent. All claims are examined on the merits.
Claim Objections
Claim 8 is objected to because of the following informalities:
Re Claim 8, the word “collecting” is misspelled.
Appropriate correction is required.
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 1, 3-12, 15 are rejected under 35 U.S.C. 103 as being unpatentable over West (Liposuction for the Treatment of Obstructive Sleep Apnea; Clinicaltrials.gov ID: NCT01117974; retrieved from https://clinicaltrials.gov/study/NCT01117974?tab=history&a=4) in view of Abad et al. (Automatic Video Analysis for Obstructive Sleep Apnea Diagnosis, Sleep. 2016 Aug 1;39(8):1507-15) and REALSELF ("What's the usual average volume (ml) of fat removed from neck liposuction?" retrieved from https://www.realself.com/question/toronto-usual-average-volume-ml-fat-neck-liposuction).
Re Claim 1, West discloses a method of treating obstructive sleep apnea/hypopnea syndrome, comprising:
determining a patient is a candidate for treatment (see page 9 of attached copy of the reference, under Inclusion Criteria: “Subjects must have documented mild to moderate obstructive sleep apnea (OSA) syndrome within the last year from the Northwestern University Sleep Clinic” and “Subjects must be a good candidate for neck liposuction as determined by the study physician”), wherein the determining comprises
(b) excluding non-respiratory sleep disorders and airway anomalies (see page 9 under Exclusion Criteria: “Subjects with non-apnea sleep disorders such as restless leg syndrome, insomnia, circadian rhythm disorders”); and
performing submental liposuction on the patient (see e.g., page 6 under Brief Summary).
West does not explicitly disclose (a) determining the patient has at least three respiratory events during one hour of sleep, the respiratory events selected from the following: apnea, hypopnea, gasping, choking. Abad discloses that the standard for determining if a patient has obstructive sleep apnea is based on the apnea hypopnea index (AHI), which is the observed number of apnea events within an hour, and that those with 5 or more apnea/hypopnea events are considered to have obstructive sleep apnea (see e.g., page 1508 left column last paragraph). It would have been obvious to one skilled in the art at the time of filing to modify with Abad because it is a well-established medical methodology that patients with at least 5 apnea/hypopnea is a patient suffering from obstructive sleep apnea.
West also does not disclose that wherein the performing comprises removing at least 10 milliliters of fat. REALSELF discloses that the volume of fat removed during neck liposuction vary greatly, but in an average patient 25-100 mL is removed (see responses from Dr. Nancy de Kleer and Dr. Atul Kesarwani). It would have been obvious to one skilled in the art at the time of filing to modify West with REALSELF since neck liposuction is already a well known procedure and a medical professional would have the know-how to determine the amount of fat to be removed based on the particular patient’s size and needs.
Re Claims 3-7, West, Abad, and REALSELF combine to disclose claim 1, and with the disclosure from REALSELF, it is also known that the performing submental liposuction comprises removing at least 15 milliliters, at least 20 milliliter, at least 25 milliliters, at least 30 milliliters, and at least 50 milliliters of fat (see responses from Dr. Nancy de Kleer and Dr. Atul Kesarwani).
Re Claims 8-10, West, Abad and REALSELF combine to disclose claim 1. West and REALSELF do not expressly disclose filming the patient for at least one hour while the patient is asleep, wherein the filming comprises collecting video and audio recordings. Abad discloses a method of determining if a patient has obstructive sleep apnea by collecting video and audio recordings of the patient while the patient is sleeping (e.g., see Fig. 4). Abad’s methodology further comprises excluding non-respiratory sleep disorders (as AHI is counter/measured and therefore non-AHI, or non-respiratory events, are necessarily excluded) and witnessing (evident from Fig. 4) loud snoring, apnea, hypopnea, gasping, or choking. It would have been obvious to one skilled in the art at the time of filing to modify with Abad’s diagnostic methodology because it is less intrusive (see e.g., Introduction section in Abad).
Re Claims 11-12, West, Abad and REALSELF combine to disclose claim 1. West and REALSELF do not explicitly disclose not affixing a cable or cannula to the patient during the determining the patient has at least three respiratory events during one hour of sleep. Abad discloses using image analysis of video captured of the patient to determine if the patient has obstructive sleep apnea, which implies that no cable or cannula is affixed to the patient. Since Abad discloses that the image analysis method is an effective way to determine OSA, one skilled in the art would find it obvious at the time of filing to employ this methodology because it is less intrusive while providing the needed reliability (See page 1512 under DISCUSSION: “The results of our work propose SleepWise as an innovative and reliable system for the diagnosis of OSA.” Also see page 1508 under Material, which shows that SleepWise does not employ the use of cannulas or cables, but rather only relying on video images.)
Re Claim 15, West, Abad and REALSELF combine to disclose claim 1. While none of the references discloses determining the patient is biologically female, but the patient can only be biologically female or male. A person of ordinary skill has good reason to pursue the known options (opting for a female or male patient for the clinical trial) within his or her technical grasp. If this leads to the anticipated success (the patient meets the inclusion criteria of the clinical trial), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over West, Abad and REALSELF as applied to claim 1 above, and further in view of Chen et al. (US 2011/0009752).
Re Claim 2, West, Abad and REALSELF combine to disclose claim 1 but none explicitly discloses performing an endoscopic examination of the patient's airway. West discloses that patients with airway anomalies are excluded from the clinical trial (see page 10 “Subjects with large tonsils/adenoids or an abnormal airway exam as determined by the study physician”) but does not disclose that this is achieved by performing an endoscopic examination of the patient’s airway. Chen discloses using endoscopy to image the tissue structures of an airway of the patient as an improved method in diagnosing obstructive sleep apnea (see [0011] and [0020]). It would have been obvious to one skilled in the art at the time of filing to modify West with the endoscopy disclosed by Chen since it is a known method to allow the physician to determine if the patient has anomalies in the airway that would disqualify the patient for the trial.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over West, Abad and REALSELF as applied to claim 1 above, and further in view of Grote et al. (US 2007/0281005).
Re Claims 13-14, West, Abad, and REALSELF combine to disclose claim 1 but they do not expressly disclose determining the patient has a first oxygen saturation level; determining the patient has a second oxygen saturation level less than the first oxygen saturation level , wherein the second oxygen saturation level is less than 90%, during at least one of the at least three respiratory events. Grote discloses a method to treat obstructive sleep apnea where the methodology to determine the effectiveness of the treatment (i.e., whether the patient is still suffering from obstructive sleep apnea) is evaluated based on the number of respiratory events (represented by AHI, see Table 1) as well as a monitoring of the oxygen saturation level during the events (Table 1), where it is tracked how many times the oxygen saturation level drops below 90% per hour. It would have been obvious to one skilled in the art at the time of filing to modify West with the methodology of tracking/determining obstructive sleep apnea by incorporating the oxygen saturation monitoring taught in Grote because such monitoring is a well-known reliable methodology used in the field and this improves accuracy of the determination process.
Conclusion
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/SUSAN S SU/Primary Examiner, Art Unit 3781 23 January 2026