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 .
Response to Amendment
This action is in response to the remarks filed on 04/18/2025.
The amendments filed on 04/18/2025 have been entered. Applicant has presently canceled claim 20. Accordingly claims 1-19 and 21-36 are pending. Claims 15-19, 21, 23-24, 26, and 32-36 are presently amended. Claims 1-14 were previously withdrawn from consideration.
The previous objections to the claims have been withdrawn in light of applicant's amendments.
Some of the previous rejections of the claims under 35 U.S.C 112(b) have been withdrawn in light of applicant's amendments. However there are two remaining rejections that were not addressed with the present amendments which are detailed below.
The previous rejection of claims 15, 24-27, and 30-36 under 35 U.S.C. 101 have been withdrawn in light of applicant’s amendments.
Response to Arguments
Applicant's arguments filed 04/18/2025 have been fully considered but they are not persuasive. In particular, applicant argues the following regarding Makower.
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Examiner respectfully disagrees. Enlarging the passageway, i.e. the pneumatized cavity, results in changing, i.e., manipulating, the barometric pressure. The delivery of a pressure expandable stent is used for this manipulation.
Claim Objections
Claim 34 is objected to because of the following informalities:
Regarding claim 34, the limitation “the size the anatomical feature” should be changed to –the size of the anatomical feature--.
Appropriate correction is required.
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 15-19 and 21-36 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 15, the limitation “anatomical features” in line 9 of the claim renders the claim indefinite because it is unclear if these anatomical features are the same or different than the singular anatomical feature previously recited in the claim. Further clarification is required.
Regarding claim 17, the limitation “a dilating device” in line 4 renders the claim indefinite because it is unclear whether this is the same or different as the dilating device recited previously in line 2 of claim 17 or in claim 16. For the present purposes of examination, they have been interpreted as being the same. Further clarification is required.
Claims dependent upon a claim rejected under 35 U.S.C. 112(b) are also rejected under the same statute because they each inherit the indefiniteness of the claim(s) they respectively depend upon.
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 15-19, 21-22, 24-30, and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Anusha et al., “Anatomical variations of the sphenoid sinus and its adjacent structures: a review of existing literature”, Surg. Radiol. Anat. 2014, Vol. 36, pp. 419-427, published online October 22, 2013 (applicant submitted prior art via the IDS, hereinafter “Anusha”) in view of Makower et al. (US 2005/0240147, October 27, 2005, hereinafter “Makower”).
Regarding claim 15, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Anusha discloses a method of treating disorders (“The sphenoid sinus, one of the posterior groups of sinuses, has long been regarded as a ‘neglected sinus’ due to the anatomical location, poor understanding and
poor accessibility, till the advent of endoscopes and modern imaging techniques. Increasing knowledge and greater understanding of this sinus has permitted an evolution in surgical practices and boundaries.” Abstract) comprising:
obtaining a medical image of an individual (“The relevant structures may be visualized on CT scan which is ordered prior to endoscopic sinus surgery, especially when addressing the sphenoid sinus. All the paranasal sinuses from the frontal sinus anteriorly to the sphenoid sinus posteriorly are visualized on the CT images.” Page 425), wherein the medical image comprises an image of a pneumatized cavity (“Pneumatization may extend into the anterior clinoid process or greater wing of sphenoid. The sphenoid sinus [cavity] usually attains its mature size by the age of 14 [30]. High-resolution CT may show pneumatization of the sphenoidal sinuses as early as 2 years” page 420);
identifying an anatomical feature within the pneumatized cavity, wherein the anatomical feature is selected from one or more of: pneumatization (“High-resolution CT may show pneumatization of the sphenoidal sinuses as early as 2 years” page 420), ostium size (“the vertical, horizontal and oblique distances of the sphenoid ostium from various points serve as good guides to access the ostium during sinus surgery.” page 421), dehiscence (“The dehiscence and protrusion of the neurovascular structures are closely associated with the extent of sphenoid sinus pneumatization” page 422), injury, inflammation (“In its course, the optic nerve is the least nourished in its optic canal. It is at this area that it is the most susceptible to injury via direct inflammation of the sinus disease” page 422), bony remodeling, and irritation;
identifying a disorder in the individual (“One point worthy to note is that CT scans are conventionally used as the first choice of imaging modality for uncomplicated sphenoid sinus pathology” page 420), wherein the disorder is characterized by anatomical features that allow for a stimulation of at least one nerve or reflex arc due to a barometric pressure within the pneumatized cavity (“A sphenoid sinus that is highly pneumatized may cause anatomical distortion, therefore caution must be exercised during sellar opening to avoid damaging the optic nerve or carotid artery” page 420; also see “Optic nerve: dehiscence and protrusion” section on page 422).
Anusha fails to disclose manipulating the barometric pressure within the pneumatized cavity of an individual.
However, Makower teaches, in the same field of endeavor, manipulating the barometric pressure within the pneumatized cavity of an individual (“a device 160 and method for delivery of a pressure expandable stent 166” [0186]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with manipulating the barometric pressure within the pneumatized cavity of an individual as taught by Makower in order to treat sinusitis ([0001] of Makower).
Regarding claim 16, Anusha discloses the limitations of claim 15 as stated above and Anusha further discloses wherein the individual suffers from one or more of neuropathy and neuralgia caused by the stimulation of the at least one nerve due to the barometric pressure in the pneumatized cavity associated with the at least one ostium (“Optic nerve injury resulting in blindness” page 422). While Anusha discloses endoscopic procedures, Anusha fails to explicitly disclose navigating a dilating device to the pneumatized cavity of the individual.
However, Makower teaches, in the same field of endeavor, navigating a dilating device to the pneumatized cavity of the individual (“methods which are designed for minimally invasive entry into the sinus passageways or regional ducts under image and/or endoscopic guidance to provide local therapy such as dilation” [0132]; also see “with the balloon inflated and the stent expanded so as to open or dilate the occluded region within the nose, nasopharynx or paranasal sinus” [0090]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with navigating a dilating device to the pneumatized cavity of the individual as taught by Makower in order to treat sinusitis ([0001] of Makower).
Regarding claim 17, Anusha modified by Makower discloses the limitations of claim 16 as stated above, in particular Makower was relied on to teach navigating the dilating device to the pneumatized cavity. Makower further teaches, in the same field of endeavor, navigating the dilating device to the pneumatized cavity of an individual by: inserting a dilating device into a nostril; and passing the dilating device through a nasal cavity (“the intranasal tube 402 is inserted through the nostril into one nasal cavity” [0142]; also see “The catheter 72 is advanced into a passageway such as a nostril, nasal cavity” [0166]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with navigating the dilating device to the pneumatized cavity of an individual by: inserting a dilating device into a nostril; and passing the dilating device through a nasal cavity as taught by Makower in order to treat sinusitis ([0001] of Makower).
Regarding claim 18, Anusha modified by Makower discloses the limitations of claim 16 as stated above, in particular Makower was relied on to teach the dilating. Although Makower further teaches, in the same field of endeavor, dilating an ostium of the individual, wherein dilating the at least one ostium relieves the barometric pressure within the pneumatized cavity, wherein relieving the barometric pressure within the pneumatized cavity alleviates at least one of the one or more of neuropathy and neuralgia (“dilate or enlarge a sinus ostium” [0197]), Anusha modified by Makower fails to explicitly disclose dilating an ostium of the individual to at least 3mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide dilation to at least 3 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 19, Anusha modified by Makower discloses the limitations of claim 16 as stated above, in particular Makower was relied on to teach the dilation of the at least one ostium. Makower further teaches, in the same field of endeavor, wherein the at least one ostium is selected from: maxillary sinus ostium, frontal sinus ostium, ethmoid sinus ostium, sphenoid sinus ostium (“The paranasal sinuses include frontal sinuses, ethmoid sinuses, sphenoidal sinuses and maxillary sinuses.” [0003]; also see [0115]-[0118]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with wherein the at least one ostium is selected from: maxillary sinus ostium, frontal sinus ostium, ethmoid sinus ostium, sphenoid sinus ostium as taught by Makower in order to treat sinusitis ([0001] of Makower).
Regarding claim 21, Anusha modified by Makower discloses the limitations of claim 15 as stated above, in particular Makower was relied on to teach the manipulating of the barometric pressure. Makower further teaches, in the same field of endeavor, wherein the barometric pressure is manipulated by one of the following: restricting at least one ostium associated with the pneumatized cavity (“balloon 164 is deflated and the stent 166 is radially compressed to a collapsed configuration, around the deflated balloon 164. The catheter 162 with the balloon 164 deflated and the collapsed stent 166 mounted thereon is advanced into a passageway such as a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc. that is to be stented. Thereafter, the balloon 164 is inflated causing the stent 166 to expand to a size that frictionally engages the surrounding tissue so as to hold the stent 166 in place, as shown in FIG. 5G". In some instances the procedure will be performed for the purpose of enlarging a passageway (e.g., an ostium, meatus, etc.) and the stent 166 will be expanded to a diameter that is sufficiently large to cause the desired enlargement of the passageway and the stent will then perform a scaffolding function, maintaining the passageway in such enlarged condition. After the stent 166 has been fully expanded and implanted” [0186); changing the barometric pressure within the pneumatized cavity and assessing one or more of neuropathy and neuralgia of the individual wherein a change of severity of at least one of the one or more of neuropathy and neuralgia due to the manipulated barometric pressure indicates the individual possesses the disorder.
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with wherein the barometric pressure is manipulated by one of the following: restricting at least one ostium associated with the pneumatized cavity; changing the barometric pressure within the pneumatized cavity and assessing one or more of neuropathy and neuralgia of the individual wherein a change of severity of at least one of the one or more of neuropathy and neuralgia due to the manipulated barometric pressure indicates the individual possesses the disorder as taught by Makower in order to treat sinusitis ([0001] of Makower).
Regarding claim 22, Anusha modified by Makower discloses the limitations of claim 21 as stated above and Makower further teaches, in the same field of endeavor, wherein restricting the at least one ostium further comprises placing a restricting device in at least one ostia associated with the pneumatized cavity, wherein the restricting device is selected from the group consisting of a plug, a balloon, and a dam (“balloon 164” [0186]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with wherein restricting the at least one ostium further comprises placing a restricting device in at least one ostia associated with the pneumatized cavity, wherein the restricting device is selected from the group consisting of a plug, a balloon, and a dam as taught by Makower in order to treat sinusitis ([0001] of Makower).
Regarding claim 24, Anusha further discloses wherein the pneumatized cavity is a nasal cavity or tympanic cavity (“sphenoid sinus” Abstract; also see “Nasal endoscopy” page 419).
Regarding claim 25, Anusha discloses the limitations of claim 15 as stated above but fails to disclose wherein the disorder is neurosensorial sinonasal disease, and the neurosensorial sinonasal disease may be selected from one of either vasomotor rhinitis or glosopharngyl neuralgia.
However, Makower teaches, in the same field of endeavor, wherein the disorder is neurosensorial sinonasal disease (“Additionally or alternatively to substances directed towards local delivery to affect changes within the sinus cavity, the nasal cavities provide unique access to the olfactory system and thus the brain. Any of the devices and methods described herein may also be used to deliver substances to the brain or alter the functioning of the olfactory system.” [0181]), and the neurosensorial sinonasal disease may be selected from one of either vasomotor rhinitis or glosopharngyl neuralgia (“treat rhinitis, nasal polyps, nasal inflammation, and other disorders of the ear, nose and throat” [0176])
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with wherein the disorder is neurosensorial sinonasal disease, and the neurosensorial sinonasal disease may be selected from one of either vasomotor rhinitis or glosopharngyl neuralgia as taught by Makower in order to treat ear, nose, and throat disorders ([0001] of Makower).
Regarding claim 26, Anusha further discloses wherein the at least one nerve is selected from: Olfactory Nerve (CN I), Trigeminal Nerve (CN V), Facial Nerve (CN VII), Nasopalatine Nerve, Nasociliary Nerve, Facial nerve (VII), Chorda tympani, or Tympanic plexus (“maxillary nerve” page 425; examiner notes that the maxillary nerve is a part of the trigeminal nerve).
Regarding claim 27, Anusha further discloses wherein the medical image is obtained by at least one of the following: a camera, an endoscope, a telescope, an ultrasound, OCR, MRI, CT, PET, X-ray and an image guided surgery system (“a magnetic resonance imaging (MRI) scan is a mandatory second choice” page 420; also see “computed tomographic (CT) imaging” page 425).
Regarding claim 28, Anusha modified by Makower discloses the limitations of claim 16 as stated above, in particular Makower was relied on to teach dilating. Makower further teaches, in the same field of endeavor, wherein the dilating step is accomplished using at least one of the following: calipers, a drill (“a drill (e.g., a tissue drill, bone drill, or trephine device)” [0085]), a shaver, a piliating punch, a stanberger punch, thru-cut forceps (“a forceps device 790” [0200]), a balloon (“balloon catheter” [0090]), and a sponge.
Regarding claim 29, Anusha modified by Makower discloses the limitations of claim 16 as stated above and Anusha further discloses wherein the neuropathy and neuralgia include one or more of: pain, changes in vision, changes in ability to smell, changes in balance, and migraine (“Optic nerve injury resulting in blindness” page 422).
Regarding claim 30, Anusha further discloses wherein the at least one nerve is exposed due to hyperpneumatization of the pneumatized cavity (“Protrusion of the optic nerve in most studies was defined as a bulging of the optic canal into the sphenoid sinus cavity so as to cause exposure of more than half of the circumference of the nerve, with or without defects in the bony margins” page 423).
Regarding claim 32, Anusha discloses the limitations of claim 15 as stated above but fails to disclose wherein the anatomical feature identified is the ostium size and wherein at least one of the following: the effect of the ostium size and location on pressure and ventilation within the pneumatized cavity is calculated by a computer assisted algorithm, and an ideal ostium size needed for a desired pressure and ventilation within the pneumatized cavity is determined by computer assisted algorithm.
However, Makower teaches, in the same field of endeavor, wherein at least one of the anatomical features identified is the ostium size (“remodeling or changing the shape, size or configuration of a sinus ostium” [0043]). and wherein at least one of the following: the effect of the ostium size and location on pressure and ventilation within the pneumatized cavity is calculated by a computer assisted algorithm (“Imaging of the draining contrast agent may be used to diagnose drainage impairment and to identify the specific anatomical structures that are causing the impairment of drainage. Thereafter, the guide catheter may be reinserted into the frontal sinus ostium and the working device(s) 202 may be used to modify the structures that have been identified and impairments to drainage. Thereafter, the contrast injection and imaging steps may be repeated to assess whether the procedure(s) performed have overcome or corrected the drainage problem that had been initially diagnosed.” [0235]; also see “Data from a preoperative CT scan or other anatomical mapping procedure is downloaded into a computer and special sensors known as localizers are attached to the surgical instruments. Thus, using the computer, the surgeon can ascertain, in three dimensions, the precise position of each localizer-equipped surgical instrument at any given point in time. This information, coupled with the visual observations made through the standard endoscope, can help the surgeon to carefully position the surgical instruments to avoid creating CSF leaks and to avoid causing damage to nerves or other critical structures.” [0033] ),and an ideal ostium size needed for a desired pressure and ventilation within the pneumatized cavity is determined by computer assisted algorithm.
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with wherein at least one of the anatomical features identified is the ostium size and wherein at least one of the following: the effect of the ostium size and location on pressure and ventilation within the pneumatized cavity is calculated by a computer assisted algorithm,and an ideal ostium size needed for a desired pressure and ventilation within the pneumatized cavity is determined by computer assisted algorithm as taught by Makower in order to treat sinusitis ([0001] of Makower).
Regarding claim 33, Anusha further discloses wherein identifying the disorder comprises determining the size of the anatomical feature (“Madiha et al. [50] reported 58 % of the 50 ostias in their 25 cadaveric dissections to be oval in shape, and the remainder round. 68 % of the ostia was more than 4 mm in size, whereas the balance were less than 4 mm in size.” page 421).
Regarding claim 34, Anusha further discloses wherein determining the size the anatomical feature comprises at least one of the following: determining a pneumatization of the pneumatized cavity (“High-resolution CT may show pneumatization of the sphenoidal sinuses as early as 2 years” page 420); and determining an ostium size of the pneumatized cavity (“Madiha et al. [50] reported 58 % of the 50 ostias in their 25 cadaveric dissections to be oval in shape, and the remainder round. 68 % of the ostia was more than 4 mm in size, whereas the balance were less than 4 mm in size.” page 421).
Regarding claim 35, Anusha further discloses wherein identifying the disorder further comprises at least one of the following: identifying a smaller than average or occluded ostium and pneumatized cavity hyperpneumatization, wherein the smaller than average or occluded ostium increases a risk of an abnormal pressure within the pneumatized cavity, and wherein hyperpneumatization of the pneumatized cavity increases a risk of an exposed nerve susceptible to stimulation due to the abnormal pressure caused by the smaller than average ostium (“The extent of surgery is often determined by the extent of sphenoid sinus pneumatization, which occasionally could be very extensive and involving adjacent structures” page 420; also see Madiha et al. [50] reported 58 % of the 50 ostias in their 25 cadaveric dissections to be oval in shape, and the remainder round. 68 % of the ostia was more than 4 mm in size, whereas the balance were less than 4 mm in size.” page 421); and modeling ventilation based on the size of the ostium and pneumatization of the pneumatized cavity, wherein subnormal ventilation prevents pressure normalization, and increases risk of an abnormal pressure within the pneumatized cavity and increases a risk of an exposed nerve susceptible to stimulation due to the abnormal pressure.
Regarding claim 36, Anusha further discloses wherein during simulation at least one of the following: the reflex arc stimulated is the vestibulocular reflex or the trigeminalcardiac reflex; and the stimulation is trigeminal stimulation via pressure change in the pneumatized cavity (“The sphenoid sinus is surrounded by neurovascular structures; being the internal carotid artery (ICA), optic nerve (ON), maxillary nerve and vidian nerve.” Page 419; also see “the pneumatization of sphenoid sinus” Abstract).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Anusha in view of Makower as applied to claim 15 above and further in view of Salazar et al. (US 2019/0374280, December 12, 2019, hereinafter “Salazar”).
Regarding claim 23, Anusha modified by Makower discloses the limitations of claim 15 as stated above but fails to disclose at least one of the following: detecting the at least one nerve signal in the at least one nerve; detecting at least one nerve signal using at least one of the group consisting of: electromyography and electrocardiography; monitoring the at least one nerve signal; detecting the at least one nerve signal selected from the following: part of a reflex arc, located in the efferent portion of the reflex arc, and located in the afferent portion of the reflex arc; assessing the at least one nerve signal; manipulating the at least one nerve in the reflex arc; manipulating the at least one nerve to increase the reflex arc; preventing simulation of the at least one nerve; and ablating the at least one nerve or a part of the reflex arc.
However, Salazar teaches, in the same field of endeavor, at least one of the following: detecting the at least one nerve signal in the at least one nerve; detecting at least one nerve signal using at least one of the group consisting of: electromyography and electrocardiography; monitoring the at least one nerve signal; detecting the at least one nerve signal selected from the following: part of a reflex arc, located in the efferent portion of the reflex arc, and located in the afferent portion of the reflex arc; assessing the at least one nerve signal; manipulating the at least one nerve in the reflex arc; manipulating the at least one nerve to increase the reflex arc; preventing simulation of the at least one nerve; and ablating the at least one nerve or a part of the reflex arc (“Surgical instrument (200) may further include a nerve sensor configured to detect a condition of the nerve being treated by probe (204), and which communicates with ablation system processor (252). FIG. 4 shows a first exemplary nerve sensor in the form of a pair of annular detection electrodes (228, 230) positioned at a distal end of probe shank (206). Detection electrodes (228, 230) are spaced axially from one another and are operable to deliver a low-power neuro-stimulating signal to a nerve positioned in contact with detection electrodes (228, 230) to thereby detect presence of the nerve. In that regard, first detection electrode (228) is operable as a transmitting electrode and second detection electrode (230) is operable as a receiving electrode. Throughout ablation of a nerve, detection electrodes (228, 230) may be activated to deliver the stimulating signal to the nerve. As long as the nerve remains substantially intact and unablated so as to contact both detection electrodes (228, 230) simultaneously, the neuro-stimulating signal will pass from first electrode (228) to second electrode (230) via the nerve, thereby indicating to ablation system processor (252) that the nerve is at least partially intact and thus not yet fully ablated. Once the nerve has been fully ablated, the neuro-stimulating signal will no longer pass through the nerve to second detection electrode (230), and thus ablation system processor (252) will detect that nerve ablation is complete.” [0042]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with at least one of the following: detecting the at least one nerve signal in the at least one nerve; detecting at least one nerve signal using at least one of the group consisting of: electromyography and electrocardiography; monitoring the at least one nerve signal; detecting the at least one nerve signal selected from the following: part of a reflex arc, located in the efferent portion of the reflex arc, and located in the afferent portion of the reflex arc; assessing the at least one nerve signal; manipulating the at least one nerve in the reflex arc; manipulating the at least one nerve to increase the reflex arc; preventing simulation of the at least one nerve; and ablating the at least one nerve or a part of the reflex arc as taught by Salazar in order to treat intractable rhinitis ([0002] of Salazar).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Anusha in view of Makower as applied to claim 15 above and further in view of SOUADIH, K., Ben Salem, D., & Belaid, A. (2019). Automatic segmentation of the sphenoid sinus in CT-scans volume with DeepMedics 3D CNN architecture. Medical Technologies Journal, 3(1), 334–346 (hereinafter “Souadhi”).
Regarding claim 31, Anusha discloses the limitations of claim 15 as stated above but fails to disclose wherein identifying the anatomical feature within the pneumatized cavity utilizes at least one of artificial intelligence and machine learning to at least one of the following: identify the anatomical feature, access the effect and degree of pressure change within the pneumatized cavity, and superimposing the anatomical feature identified on the medical image.
However, Souadhi teaches, in the same field of endeavor, wherein identifying an anatomical feature within the pneumatized cavity utilizes at least one of artificial intelligence and machine learning to at least one of the following: identify the anatomical feature, access the effect and degree of pressure change within the pneumatized cavity, and superimposing the anatomical feature identified on the medical image (“Our automatic sphenoid sinus segmentation method consists of three main steps, where the result of the step is the input of another one. The first step is a preprocessing step; we create and transform automatically the images volume given from a PACS to an image of the region of interest. Then, we perform a segmentation with 3D Deep CNN [14] that we adapted and parameterized to produce highly accurate sinus segmentation. Finally, postprocessingbased on mathematical morphology operations to perform a sinus measurement and refine a segmentation (Figure.1).” page 336).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Anusha with wherein identifying an anatomical feature within the pneumatized cavity utilizes at least one of artificial intelligence and machine learning to at least one of the following: identify the anatomical feature, access the effect and degree of pressure change within the pneumatized cavity, and superimposing the anatomical feature identified on the medical image as taught by Souadih in order to investigate target and risk structures (page 343 of Souadih).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797