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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/460,931, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The stabilizing wings of the medicine and air injection apparatuses and the flashback chamber fluidly connected to the first port of claim 13 are not reflected in the specification or drawings of the provisional application that benefit is claimed to. Accordingly, claims 13-24 are not entitled to the benefit of the prior application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
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Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0036], line 4, “the first balloon 29 is coupled to the and the second balloon 39,” should read “the first balloon 29 is coupled to the second balloon 39”.
Paragraph [0027] and Figure 2A show the medicine injection apparatus 20 as being associated with the first balloon 29 through conduit 22, and paragraph [0030] and Figure 2B show the air injection apparatus 30 as being associated with the second balloon 39 through conduit 32. Figure 3A shows 39 as interior of 29. Claim 1 also refers to the interior bladder as being configured to receive ambient air, and the permeable, expanding member configured to house the interior bladder as being configured for selective communication of a medical fluid. However, paragraph [0036] describes the first balloon as being interior to the second balloon (lines 3-4: “The first balloon 29 is situated within the second balloon 39”). It is suggested that the specification, drawings, and claims be reviewed to ensure the consistency of the claim language with respect to what is shown in the figures and disclosed int the specification. For the purposes of examination, the second balloon 39 will be interpreted as being interior to the first balloon 29 as shown in Figure 3A.
In paragraph [0046], line 5, “the first balloon 29 may be pressurized via the air injection apparatus 30,” should read “the second balloon 39 may be pressurized via the air injection apparatus 30.”
Appropriate correction is required.
Claim Objections
Claim 13 is objected to because of the following informalities:
In line 3, “a first port configured selective coupling” should read “a first port configured for selective coupling”.
In line 6, “medicine” should read “the medicine”.
Line 15 reads “a second pair of stabilizing wings”. This is improper claim language, since a first pair was never mentioned.
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 9 and 13-24 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.
Claims 9 and 21 recites the limitation "the nasal cavity" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the medicine" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claims 14-24 are rejected on the basis of their dependency on claim 13.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Manasco (WIPO Publication WO 2022/040450).
Regarding claim 1, Manasco discloses a nasal insert system for treating epistaxis (epistaxis treatment system 100 in paragraph [0029]), the system comprising:
an expanding interior bladder configured to selectively receive ambient air (expander 120 in paragraph [0034]);
a permeable, expanding member (nasal packing 110 in paragraph [0030]; paragraph [0031] discloses that the nasal packing is perfectly capable of absorbing blood and will also swell or expand upon absorbing fluid) configured to house the expanding interior bladder (paragraph [0034] discloses that the expander 120 may be disposed internally to the nasal packing 110), wherein the permeable, expanding member is configured for selective communication of medical fluid (paragraph [0036], lines 1-2); and
a tubular-shaped gauze sleeve fitted over the permeable, expanding member (paragraph [0032], lines 1-8).
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) 2-4, 7-8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Manasco in view of Göbel (US Patent 10,952,737).
Regarding claim 2, Manasco discloses the nasal insert system of claim 1.
However, Manasco is silent to the permeable, expanding member being formed of an elongated first portion and an elongated second portion, and that the elongated first portion and the elongated second portion forming along a pinch line.
Göbel teaches an expanding member (balloon body 3 in Fig. 1) formed of an elongated first portion (distal portion 3a in Fig. 1) and an elongated second portion (proximal portion 3b), wherein the elongated first portion and the elongated second portion form along a pinch line (constriction 7 in Fig. 1).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the permeable, expanding member of Manasco to have the elongated first and second portions formed along a pinch line as taught by Göbel because Göbel teaches that this orientation is advantageous because it ensures the balloon conforms to the space, such that an optimally uniform transmission force to the adjacent mucosa is possible (Col. 5, lines 33-39).
Regarding claim 3, Manasco in view of Göbel teaches the nasal insert system of claim 2, and Göbel further teaches that the elongated first portion and the elongated second portion each have a substantially tubular interior shape (Col. 6, lines 15-17 and Col. 6, lines 33-35).
Regarding claim 4, Manasco in view of Göbel teaches the nasal insert system of claim 3, and Göbel further teaches that the elongated first portion and the elongated second portion are in fluid communication (Fig. 1 shows 3a and 3b are connected to each other, as the diameter of the constriction 7 tapers to a diameter of 5-12 mm as disclosed in Col. 4, lines 39-41, but 3a and 3b are still in communication).
Regarding claim 7, Manasco in view of Göbel teaches the nasal insert system of claim 4, and Manasco further discloses that the permeable, expanding member has a substantially oval-shaped cross-sectional shape (paragraph [0030], lines 8-10).
Regarding claim 8, Manasco in view of Göbel teaches the nasal insert system of claim 4, and Manasco further discloses that the permeable, expanding member has a substantially circular-shaped cross-sectional shape (paragraph [0030], lines 8-10).
Regarding claim 12, Manasco in view of Göbel teaches the nasal insert system of claim 2, and Manasco further discloses that the gauze sleeve comprises a fabric with a loose weave, having holes from which medicine may pass through (paragraph [0032], lines 1-5).
Claim(s) 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Manasco in view of Göbel as applied to claims 2-4 above, and further in view of Jacobson (US 2019/0094609).
Regarding claim 5, Manasco in view of Göbel teaches all of the claimed limitations set forth in claim 4, as discussed above, including that the permeable, expanding member may have any cross-sectional shape (paragraph [0030], lines 8-10), but is silent as to the specifics of the permeable, expanding member having a heart-shaped cross-sectional shape.
Jacobson teaches balloons that can be uniquely shaped, concentric, or eccentric, and the shape can be optimized for a particular target anatomical structure. One such example can be seen in Figs. 6A-6D, where an eccentrically-shaped balloon has a cross-sectional shape that appears to be substantially heart-shaped. Based on Jacobson’s teaching that balloons can be eccentrically shaped in any unique manner (paragraph [0038], lines 1-10), including kidney-shaped as shown in Fig. 6, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this known technique that is disclosed by Jacobson to modify and improve the permeable, expanding member disclosed by Manasco in view of Göbel to have a heart-shaped cross-sectional area in order to yield a balloon conformable to target a desired area of the nasal cavity, such as “little’s area”.
Regarding claim 6, Manasco in view of Göbel teaches all of the claimed limitations set forth in claim 4, as discussed above, including that the permeable, expanding member may have any cross-sectional shape (paragraph [0030], lines 8-10), but is silent as to the specifics of the permeable, expanding member having a substantially figure-eight-shaped cross-sectional shape.
As discussed above, Jacobson teaches balloons that can be uniquely shaped, concentric, or eccentric, and the shape can be optimized for a particular target anatomical structure (paragraph [0038], lines 1-10), and one such example is shown in Figs. 6A-6D. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this known technique that is disclosed by Jacobson to modify and improve the permeable, expanding member disclosed by Manasco in view of Göbel to have a substantially figure-eight-shaped cross-sectional area in order to yield a balloon conformable to target a desired area of the nasal cavity.
Claim(s) 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Manasco in view of Göbel as applied to claim 2 above, and further in view of Morriss (US Patent 9,867,972).
Regarding claim 9, Manasco in view of Göbel teaches all of the claimed limitations set forth in claim 2, as discussed above, but fails to teach that the permeable, expanding member comprises a plurality of pores in a top and front position corresponding to “little’s area” of the nasal cavity.
Morriss discloses a permeable, expanding member (foam contact element 30 in Fig. 2B) comprising a plurality of pores in a top and front position (pores 38 in Fig. 2B, see below).
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Morriss discloses that the positioning of the pores is to ensure delivery of the therapeutic agent to the target tissue, which in this particular embodiment is nasopharyngeal mucosa tissue (Col. 10, lines 43-50). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this teaching of Morriss to modify and improve the permeable, expanding member disclosed by Manasco in view of Göbel to have the pores orientated in a top and front position corresponding to “little’s area” of the nasal cavity, in order to improve the delivery of medication or treatment fluid to a specific treatment area such as “little’s area” of the nasal cavity.
Regarding claim 11, Manasco in view of Göbel teaches all of the claimed limitations set forth in claim 2, as discussed above, but fails to disclose that the permeable, expanding member comprises a plurality of pores comprising evenly spaced perforations configured to allow a selected medical fluid to extravasate and saturate the gauze sleeve.
Morriss discloses a permeable, expanding member (foam contact element 30 in Fig. 2B) comprising a plurality of pores (pores 38 in Fig. 2B) comprising evenly spaced perforations (see annotated Fig. 2B above) configured to allow a selected medical fluid to extravasate and saturate the gauze sleeve (Col. 10, lines 43-48), for the advantage of ensuring delivery of the therapeutic agent to the target tissue. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this teaching of Morriss to modify and improve the permeable, expanding member disclosed by Manasco in view of Göbel to have the pores be evenly spaced to provide saturation of the gauze sleeve.
Claim(s) 10 are rejected under 35 U.S.C. 103 as being unpatentable over Manasco in view of Göbel as applied to claim 2 above, and further in view of Gerrans (US 2015/0290438).
Regarding claim 10, Manasco in view of Göbel teaches all of the claimed limitations set forth in claim 2, as discussed above, but fails to teach the permeable, expanding member having a plurality of localized pores associated with an area less than half of a top surface area of the permeable, expanding member.
Gerrans teaches a permeable, expanding member (outer balloon 114 in Fig. 8B) comprising a plurality of localized pores (openings 118 in Fig. 8B) associated with an area less than half of a top surface area of the permeable, expanding member (see below).
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Gerrans discloses that the purpose of having the openings in such an orientation relative to the rest of the catheter assembly is to allow for more precise delivery of the agent to the targeted tissue by preventing or minimizing the agent from exiting the targeted area (paragraph [0107], lines 11-13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this orientation of openings on the surface of the balloon that is disclosed by Gerrans to modify and improve the permeable, expanding member disclosed by Manasco in view of Göbel to provide more effective delivery of the fluid to the target tissue.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Manasco (WIPO Publication WO 2022/040450) in view of Fayerberg (US 2021/0220628) and in view of Vouillamoz (US 2017/0216519) and in view of Chang (EP 2532384) and in further view of Chan (US 2017/0119414).
Regarding claim 13, Manasco discloses a nasal insert system for treating epistaxis (epistaxis treatment system 100 in paragraph [0029]), the system comprising:
a medicine injection apparatus (reservoir 150 and fluid coupling 155 in paragraph [0036]) including:
a first port configured for selective coupling to a medical delivery device (release mechanism 160 in paragraph [0036]),
a conduit configured to communicate medicine into the nasal insert (fluid coupling 155 in paragraph [0036]; paragraph [0037], lines 1-2);
an air injection apparatus (paragraph [0034], lines 18-23 discloses that the expander may be a balloon that is inflated by a fluid from a delivery configuration such as a bladder) including:
a second conduit coupled to the nasal insert (paragraph [0034], lines 18-23 discloses that the fluid may be delivered to the balloon via a tubular member);
wherein the nasal insert comprises:
an expanding interior bladder configured to selectively receive ambient air (expander 120 in paragraph [0034]);
a permeable, expanding member (nasal packing 110 in paragraph [0030]; paragraph [0031] discloses that the nasal packing is perfectly capable of absorbing blood and will also swell or expand upon absorbing fluid) configured to house the expanding interior bladder (paragraph [0034] discloses that the expander 120 may be disposed internally to the nasal packing 110), wherein the permeable, expanding member is configured for selective communication of medical fluid (paragraph [0036], lines 1-2); and
a tubular-shaped gauze sleeve fitted over the permeable, expanding member (paragraph [0032], lines 1-8).
However, Manasco is silent to the specifics of the first port having a check valve configured for one-way fluid communication of the medicine into the nasal insert, and fails to disclose a flashback chamber fluidly connected to the first port configured for viewing medicine communicating therethrough, stabilizing wings configured to provide a surface area for taping down the medicine injection apparatus, a second pair of stabilizing wings configured to provide a surface area for taping down the air injection apparatus, and a second port configured for selective coupling to an air delivery device having a two-way valve configured to permit selective air motion in both directions into the nasal insert.
Fayerberg discloses a first port (port 16 in Fig. 1) configured for selective coupling to a medical delivery device (paragraph [0027], lines 12-14), the first port including a check valve, configured for one-way communication of the medicine into a nasal insert (paragraph [0027], lines 15-18).
Fayerberg discloses that having a one-way valve or a check valve, allows fluids to be injected into the delivery device and also prevents backflow of the fluid(s) (paragraph [0027], lines 15-18). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this known technique that is disclosed by Fayerberg to modify and improve the first port disclosed by Manasco in order to allow better control of treatment fluid to the medicine injection apparatus and prevent backflow of fluid.
Vouillamoz teaches a medication injection apparatus (cartridge 100 in Fig. 1) having a flashback chamber (transparent viewing window 118) fluidly connected to the first port (protrusion 110 in Fig. 2) configured for viewing medicine communicating therethrough.
Vouillamoz teaches that the transparent portion is helpful to indicate the fill level of fluid in the cartridge (paragraph [0041]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medication injection apparatus disclosed by Manasco in view of Fayerberg to include the transparent viewing window disclosed by Vouillamoz in order to view the communication of medicine and yield a medication injection apparatus that is configured for viewing the fill level of medicine.
Chang discloses a similar balloon catheter device for delivery to the sinus, including an expanding interior member configured to receive ambient air (balloon 1404 in Fig. 15) and a permeable, expanding member (porous outer sheath 1406 in Fig. 15). Chang further discloses a pair of stabilizing wings (202 and 204 in Fig. 3D) configured to provide a surface area for taping down the air injection apparatus and medicine injection apparatus to the patient’s body. Col. 15, lines 14-15 disclose that stabilizing member 200 can be used to stabilize one or more working devices, and Col. 13, lines 1-2 disclose that a balloon catheter is used as an example of a working device.
Chang further discloses that stabilizing devices help facilitate insertion of working devices in the nose for ease in performing the respective procedures (paragraph [0012]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the stabilizing wings taught by Chang to the air and medication injection apparatuses disclosed by Manasco in view of Fayerberg and Vouillamoz in order to stabilize the device to help facilitate insertion into the nose, and yield an easier process of using the device.
Chan discloses an air injection apparatus (bladder member 513 in Figs. 15A and 15B) having a second port configured for selective coupling to an air delivery device (lumen 532 in Fig. 15A), the second port comprising a two-way valve (two-way valve 516 in Fig. 15A) configured to permit selective air motion in both directions into the nasal insert (paragraph [0104]).
Chan discloses that the two-way valve is configured to prevent inflation fluid from being expelled from the bladder member without a sufficient compression force on the bladder member, and when the bladder member is released, the two-way valve permits the pressurized medium to flow back into bladder member 513 when sufficient compression force is provided. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this second port including a two-way valve taught by Chan to modify and improve the air injection apparatus disclosed by Manasco in view of Fayerberg, Vouillamoz, and Chang in order to improve control of the flow of air through the air injection apparatus.
Claim(s) 14-16, 19-20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in further view of Chan as applied to claim 13 above, and further in view of Göbel.
Regarding claim 14, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in further view of Chan discloses the nasal insert system of claim 13.
However, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in further view of Chan is silent to the permeable, expanding member being formed of an elongated first portion and an elongated second portion, and that the elongated first portion and the elongated second portion forming along a pinch line.
Göbel teaches an expanding member (balloon body 3 in Fig. 1) formed of an elongated first portion (distal portion 3a in Fig. 1) and an elongated second portion (proximal portion 3b), wherein the elongated first portion and the elongated second portion form along a pinch line (constriction 7 in Fig. 1).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the permeable, expanding member of Manasco to have the elongated first and second portions formed along a pinch line as taught by Göbel because Göbel teaches that this orientation is advantageous because it ensures the balloon conforms to the space, such that an optimally uniform transmission force to the adjacent mucosa is possible (Col. 5, lines 33-39).
Regarding claim 15, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches the nasal insert system of claim 14, and Göbel further teaches that the elongated first portion and the elongated second portion each have a substantially tubular interior shape (Col. 6, lines 15-17 and Col. 6, lines 33-35).
Regarding claim 16, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches the nasal insert system of claim 15, and Göbel further teaches that the elongated first portion and the elongated second portion are in fluid communication (Fig. 1 shows 3a and 3b are connected to each other, as the diameter of the constriction 7 tapers to a diameter of 5-12 mm as disclosed in Col. 4, lines 39-41, but 3a and 3b are still in communication).
Regarding claim 19, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches the nasal insert system of claim 16, and Manasco further discloses that the permeable, expanding member has a substantially oval-shaped cross-sectional shape (paragraph [0030], lines 8-10).
Regarding claim 20, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches the nasal insert system of claim 16, and Manasco further discloses that the permeable, expanding member has a substantially circular-shaped cross-sectional shape (paragraph [0030], lines 8-10).
Regarding claim 24, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches the nasal insert system of claim 14, and Manasco further discloses that the gauze sleeve comprises a fabric with a loose weave, having holes from which medicine may pass through (paragraph [0032], lines 1-5).
Claim(s) 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel as applied to claims 14-16 above, and further in view of Jacobson.
Regarding claim 17, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches all of the claimed limitations set forth in claim 16, as discussed above, including that the permeable, expanding member may have any cross-sectional shape (paragraph [0030], lines 8-10), but is silent as to the specifics of the permeable, expanding member having a heart-shaped cross-sectional shape.
Jacobson teaches balloons that can be uniquely shaped, concentric, or eccentric, and the shape can be optimized for a particular target anatomical structure. One such example can be seen in Figs. 6A-6D, where an eccentrically-shaped balloon has a cross-sectional shape that appears to be substantially heart-shaped. Based on Jacobson’s teaching that balloons can be eccentrically shaped in any unique manner (paragraph [0038], lines 1-10), including kidney-shaped as shown in Fig. 6, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this known technique that is disclosed by Jacobson to modify and improve the permeable, expanding member disclosed by Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel to have a heart-shaped cross-sectional area in order to yield a balloon conformable to target a desired area of the nasal cavity, such as “little’s area”.
Regarding claim 18, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches all of the claimed limitations set forth in claim 16, as discussed above, including that the permeable, expanding member may have any cross-sectional shape (paragraph [0030], lines 8-10), but is silent as to the specifics of the permeable, expanding member having a substantially figure-eight-shaped cross-sectional shape.
As discussed above, Jacobson teaches balloons that can be uniquely shaped, concentric, or eccentric, and the shape can be optimized for a particular target anatomical structure (paragraph [0038], lines 1-10), and one such example is shown in Figs. 6A-6D. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this known technique that is disclosed by Jacobson to modify and improve the permeable, expanding member disclosed by Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel to have a substantially figure-eight-shaped cross-sectional area in order to yield a balloon conformable to target a desired area of the nasal cavity.
Claim(s) 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel as applied to claim 14 above, and further in view of Morriss.
Regarding claim 21, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches all of the claimed limitations set forth in claim 14, as discussed above, but fails to teach that the permeable, expanding member comprises a plurality of pores in a top and front position corresponding to “little’s area” of the nasal cavity.
Morriss discloses a permeable, expanding member (foam contact element 30 in Fig. 2B) comprising a plurality of pores in a top and front position (pores 38 in Fig. 2B, see below).
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Morriss discloses that the positioning of the pores is to ensure delivery of the therapeutic agent to the target tissue, which in this particular embodiment is nasopharyngeal mucosa tissue (Col. 10, lines 43-50). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this teaching of Morriss to modify and improve the permeable, expanding member disclosed by Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel to have the pores orientated in a top and front position corresponding to “little’s area” of the nasal cavity, in order to improve the delivery of medication or treatment fluid to a specific treatment area such as “little’s area”.
Regarding claim 23, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches all of the claimed limitations set forth in claim 14, as discussed above, but fails to disclose that the permeable, expanding member comprises a plurality of pores comprising evenly spaced perforations configured to allow a selected medical fluid to extravasate and saturate the gauze sleeve.
Morriss discloses a permeable, expanding member (foam contact element 30 in Fig. 2B) comprising a plurality of pores (pores 38 in Fig. 2B) comprising evenly spaced perforations (see annotated Fig. 2B above) configured to allow a selected medical fluid to extravasate and saturate the gauze sleeve (Col. 10, lines 43-48), for the advantage of ensuring delivery of the therapeutic agent to the target tissue. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this teaching of Morriss to modify and improve the permeable, expanding member disclosed by Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel to have the pores be evenly spaced to provide saturation of the gauze sleeve.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel as applied to claim 14 above, and further in view of Gerrans.
Regarding claim 22, Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel teaches all of the claimed limitations set forth in claim 14, as discussed above, but fails to teach the permeable, expanding member having a plurality of localized pores associated with an area less than half of a top surface area of the permeable, expanding member.
Gerrans teaches a permeable, expanding member (outer balloon 114 in Fig. 8B) comprising a plurality of localized pores (openings 118 in Fig. 8B) associated with an area less than half of a top surface area of the permeable, expanding member (see below).
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Gerrans discloses that the purpose of having the openings in such an orientation relative to the rest of the catheter assembly is to allow for more precise delivery of the agent to the targeted tissue by preventing or minimizing the agent from exiting the targeted area (paragraph [0107], lines 11-13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this orientation of openings on the surface of the balloon that is disclosed by Gerrans to modify and improve the permeable, expanding member disclosed by Manasco in view of Fayerberg and in view of Vouillamoz and in view of Chang and in view of Chan and in further view of Göbel in order to provide more effective delivery of the fluid to the target tissue.
Conclusion
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/AIDAN L NATHAN/ Examiner, Art Unit 3783
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
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