033Notice 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
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).
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Claims 2-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,137,871 in view of Goldfain US 2015/0133732.
Regarding claim 2, ‘871 discloses a method for classifying a tympanic membrane, the method comprising (see claim 1 lines 1-2):receiving, from an interrogation system, one or more datasets relating to the tympanic membrane (claim 1 lines 3-4); determining a set of parameters from the one or more datasets (claim 1 lines 5-6); and outputting a classification of the tympanic membrane based on a trained classifier model derived from the set of parameters (claim 1 lines 11-13)
‘871 does not explicitly disclose wherein the classifier model is operable to distinguish viral from bacterial effusion.
Goldfain discloses a classifier model to distinguish viral from bacterial effusion (see paragraph 0022, distinguish between bacterial or viral fluid).
‘871 and Goldfain are analogous art because they are from the same field of endeavor of otoscopy.
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to combine ‘871 and Goldfain to differentiate between viral and bacterial effusion. The motivation would be to determine the best type of treatment for the effusion.
Claims 3-27 are similarly mapped and analyzed to claims 1-19.
Claims 2-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,361,434 in view of Goldfain US 2015/0133732.
Regarding claim 2, ‘434 discloses a method for classifying a tympanic membrane, the method comprising (see claim 1 lines 1-2):receiving, from an interrogation system, one or more datasets relating to the tympanic membrane (claim 1 lines 3-4); determining a set of parameters from the one or more datasets (claim 1 lines 5-6); and outputting a classification of the tympanic membrane based on a trained classifier model derived from the set of parameters (claim 1 lines 9-13)
‘434 does not explicitly disclose wherein the classifier model is operable to distinguish viral from bacterial effusion.
Goldfain discloses a classifier model to distinguish viral from bacterial effusion (see paragraph 0022, distinguish between bacterial or viral fluid).
‘434 and Goldfain are analogous art because they are from the same field of endeavor of otoscopy.
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to combine ‘434 and Goldfain to differentiate between viral and bacterial effusion. The motivation would be to determine the best type of treatment for the effusion.
Claims 3-27 are similarly mapped and analyzed to claims 1-19.
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.
Claims 2-3, 5-16, and 18-27 are rejected under 35 U.S.C. 103 as being unpatentable over Boppart et al. US 9,867,528 (cited in the IDS, hereinafter “Boppart”) in view of Douglas et al US 2015/0065803 (hereinafter “Douglas”, cited in the IDS) and further in view of Goldfain US 2015/0133732.
Regarding claim 2, Boppart discloses a method for classifying a tympanic membrane (see col. 7 lines 11-35 which discloses measuring a mobility of a tympanic membrane of a person)
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, the method comprising: receiving, from an interrogation system, one or more datasets relating to the tympanic membrane (see col. 7 lines 11-17 measuring mobility of a tympanic membrane, a) illuminating the tympanic membrane with a broadbeam optical beam and b)interfering light scattered by the tympanic membrane); determining a set of parameters from the one or more datasets (see above col. 7 lines 19-25 step c, modulating an air pressure internal to the ear canal, as shown in col. 5 lines 51-59 [see above] this is done pneumatically d, quantifying a geometrical characteristic of the tympanic membrane based on the interferometric signal); and outputting a classification of the tympanic membrane based on a
Boppart does not explicitly disclose wherein the classifier model is a trained classifier model.
Douglas Is in the field of the detection and analysis of tympanic membranes using a handheld imaging device (para 0005)
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and teaches wherein the classifier model comprises a trained machine learning algorithm para 0175).
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It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Boppart with the teachings of Douglas to use a trained classifier for the motivation of machine learning allowing for better processing of the tympanic membrane.
Boppart nor Douglas do not explicitly disclose wherein the classifier model is operable to distinguish viral from bacterial effusion.
Goldfain discloses an otoscopic instrument with a laser light source (paragraph 0002) that has the advantage that it can generate a light patter on the tympanic membrane in order to facilitate distinction between a healthy ear and an infected ear or between bacterial or viral fluid (see paragraph 0022)
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Goldfain is in the same field of endeavor as Boppart and Douglas of the detection and analysis of tympanic membranes using a handheld imaging device (para 0005)
Before the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to combine Boppart, Douglas, and Goldfain to distinguish between viral and bacterial effusions. The motivation would be to decide if an antibiotic would be an effective treatment or not.
Regarding claim 3, Boppart discloses the interrogation system comprises an optical coherence tomography system (see col. 9 lines 18-34 OCT images).
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Regarding claim 5, at least one parameter of the set of parameters is related to a dynamic property (see above col. 7 lines 19-25 step e quantifying a geometrical characteristic of the tympanic membrane based on the interferometric signal which is interpreted as a dynamic property).
Regarding claim 6, wherein at least one parameter of the set of parameters is related to a static position of the tympanic membrane (see above col. 7 lines 20-22 quantifying a geometrical characteristic of the tympanic membrane based on the interferometric signal).
Regarding claim 7, Douglas teaches a machine learning algorithm (see paragraph 0175)
Regarding claim 8, Douglas teaches wherein the machine learning algorithm comprises one or more of linear regressions, logistic regressions, classification and regression tree algorithms, support vector machines (SVMs), naive Bayes, K-nearest neighbors, random forest algorithms, boosted algorithms such as XGBoost and LightGBM, neural networks, convolutional neural networks, and recurrent neural networks (see paragraph 0175).
Regarding claim 9, Douglas teaches supervised learning (see paragraph 0175).
Regarding claim 10, Boppart discloses wherein the datasets comprise one or more optical images (see col. 9 lines 18-34, OCT images).
Regarding claim 11, Boppart discloses that the one or more dataset are taken in response to a pneumatic excitation (see col. 7 lines 11-35 step c).
Regarding claim 12, Boppart discloses wherein the classifier model is operable to distinguish acute otitis media, acute otitis media with effusion, middle ear effusion, chronic otitis media, chronic suppurative otitis media, a bacterial infection, a viral infection, no effusion, and an unknown classification (col. 7 lines 5-10).
Regarding claim 13, Boppart discloses wherein the interrogation system comprises an imaging system, and wherein the one or more datasets comprises one or more images of the tympanic membrane (see col. 9 lines 18-34 OCT images of the tympanic membrane).
Regarding claim 14, Boppart discloses wherein the one or more images of the tympanic membrane comprise one or more optical coherence tomography images, one or more infrared images, one or more ultrasound images, or one or more optical images (see col. 9 lines 18-34 OCT images).
Claims 15-16 are similarly analyzed to claims 2-3.
Claims 18-19 are similarly analyzed to claim 13-14.
Claims 20-27 is similarly analyzed to claim 5-12.
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Boppart in view of Douglass in view of Goldfain and further in view of Voie et al. US 2007/0129632 (hereinafter “Voie”, cited in the IDS).
Regarding claim 4, as discussed above Boppart discloses the invention of claim 2, but does not explicitly disclose that the interrogation system comprises an ultrasound-based measurement system.
However, Voie is in the field of medical ultrasound apparatus and methods (para 0002)
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and teaches that the one or more images of the tympanic membrane comprises one or more ultrasound images (applying imaging ultrasound and analyzing the echo signals comprises processing the echo signals to provide an image [i.e. the one or more images of the tympanic membrane comprises one or more ultrasound images], claim 9, and paragraph 0045)
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It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Boppart, Douglass, and Goldfain with the teachings of Voie for the purpose of evaluating ear disorders (Voie para 0002).
Claim 17 is similarly analyzed to claim 4.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN B STREGE whose telephone number is (571)272-7457. The examiner can normally be reached M-F 9-5 (PST).
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/JOHN B STREGE/ Primary Examiner, Art Unit 2669
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