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 .
Election/Restrictions
Applicant’s election without traverse of Species A, subspecies ii (Claims 52-64, 66-70) in the reply filed on 1/8/2026 is acknowledged.
Claims 65, 71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/8/2026.
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 52, 56, 58 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180110797 Li et al. (hereinafter Li).
Regarding claim 52, Li discloses a method of treating an aneurysm (abstract, paragraph 114-115), comprising:
positioning a distal portion of an elongated member (118, Fig. 1, 3) near or within an aneurysm (302) (Fig. 2-3, paragraph 119);
introducing an embolic composition (310/314) into a lumen of the elongated member using an injector device (116) coupled to a proximal portion of the elongated member (paragraph 117, Fig. 1, embolic composition 314 is delivered through the elongated member 118 from the injector device 116 via a coupler 130 at a proximal portion of the elongated member), and
delivering the embolic composition into the aneurysm via the elongated member (paragraph 128, Fig. 2, 6-7).
Li further teaches that when the lumen of the elongated member is narrow, a substantial amount of pressure may be required to move the embolic composition through the lumen (para. 121, the injection syringe 116 is configured to withstand high pressure, such as at least 500 psi).
Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to configure the injector device to apply a pressure of at least 10,000 psi as claimed to deliver the embolic composition through the elongated member to the aneurysm, because delivery pressure is a known result-effective variable and increasing pressure to achieve transport through a narrow lumen would have been a predictable optimization within the skill of the art.
Regarding claim 56, Li teaches the limitations of claim 52, and further teaches wherein the injector device (116) comprises an injector body (120, Fig. 1) coupled to a tip (122, Fig. 1).
Regarding claim 58, Li teaches the limitations of claim 56, and further teaches wherein the tip comprises a body having a distal opening, a proximal opening, and an internal lumen extending between the distal and proximal openings (it is implied that the tip 122 comprises a body having distal opening, a proximal opening and a lumen extending between the distal and proximal openings in order for the embolic composition to be transported from the injection syringe 116 to the coupler 130 of the first catheter 118 and into the aneurysm as described in paragraph 117).
Claim 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 20110286925 Lerouge et al. (hereinafter Lerouge).
Regarding claim 53, Li teaches the limitations of claim 52.
Li is silent on wherein the embolic composition comprises a storage modulus of at least 80 Pa at 37°C within a linear viscoelastic range of the embolic composition.
However, Lerouge teaches using an embolic composition (embolizing hydrogel, abstract, paragraph 2, 36-37) for treating aneurysms (paragraph 7, 21, 36-37) wherein the embolic composition comprises a storage modulus of at least 80 Pa at 37°C (Fig. 13, paragraph 30, at time 0 the embolic composition with an STS concentration of either 1, 2, or 3% has a storage modulus greater than 80 Pa) within a linear viscoelastic range of the embolic composition (paragraph 69).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Lerouge to provide an embolic composition with appropriate mechanical, biocompatibility, biodegradation and gelation properties to add sclerosing properties and prevent recanalization processes and promotes fibrosis as disclosed by Lerouge (paragraph 4, 36, 47).
Regarding claim 54, the combination of Li and Lerouge teaches the limitations of claim 53, and Lerouge teaches further comprising loading the embolic composition into the injector device, wherein the embolic composition comprises the storage modulus of at least 80 Pa at 37 0C within the linear viscoelastic range of the embolic composition before being loaded into the injector device (paragraph 23, 46, precursor solutions are mixed outside of the catheter to form the mixed hydrogel forming solution before being injected; just after mixing, the hydrogel with chitosan/STS has a storage modulus of 1357 Pa).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 20160256170 Busold et al. (hereinafter Busold).
Regarding claim 55, Li teaches the limitations of claim 52.
Li does not expressly teach delivering the embolic composition into the aneurysm at a rate of at least 0.2 milliliters per minute.
However, Busold teaches using an embolic composition (foam polymer, abstract, paragraph 9-10) for treating aneurysms and discloses dispensing the foam polymer at a rate not exceeding 1 mL/min (paragraph 164).
It would have been obvious to one of ordinary skill in the art to modify Li with the teachings of Busold to achieve a delivery rate of at least 0.2 milliliters per minute, because the rate of embolic delivery is a result-effective variable and optimizing that rate to a workable value would have been a matter of routine skill. The claimed rate is within the range taught by Busold and would have been expected to provide the predictable result of controlled embolic delivery into the aneurysm.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 20170014569 Flanagan et al. (hereinafter Flanagan).
Regarding claim 57, Li teaches the limitations of claim 56.
Li is silent on wherein the injector body and the tip are made at least partially out of a metallic material.
However, Flanagan teaches a pressurized injector catheter system for delivering a therapeutic gel to a treatment location (abstract, paragraph 4) that comprises a injector device (Fig. 2) having an injector body (120) and a tip (130) that are made of a metallic material (paragraph 80).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the injector body and tip of Li using the materials as taught by Flanagn, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 20160101269 Benz.
Regarding claim 59, Li teaches the limitations of claim 58.
Li is silent on wherein at least a portion of the distal opening has a diameter of less than 0.025 inches.
However, Benz teaches a medical syringe for delivering fluid (abstract, paragraph 2, 26) wherein the injection device, or syringe (10, Fig. 1) comprises a tip (23) having a distal opening (24) and wherein the diameter of the distal opening ranges between 0.0100 inches to 0.1000 inches (paragraph 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Benz to achieve a distal opening having a diameter of less than 0.025 inches because the diameter of the distal opening is a result-effective variable and optimizing the diameter to a workable value would have been a matter of routine skill. The claimed diameter is within the range taught by Benz and would have been expected to provide the predictable result of controlled embolic delivery into the aneurysm.
Claims 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of US 20020169473 Sepetka et al. (hereinafter Sepetka).
Regarding claim 63, Li teaches the limitations of claim 52.
Li is silent on further comprising deploying a neck cover from the elongated member while the distal portion of the elongated member is positioned near or within the aneurysm such that the neck cover self-expands to assume a first expanded state within the aneurysm.
However, Sepetka teaches an aneurysm treatment device (abstract, paragraph 2, 9) comprising an elongated member (10, Fig. 5) and a neck cover (32) deployed from the elongated member while the distal portion of the elongated member is positioned near or within the aneurysm such that the neck cover self-expands to assume a first expanded state within the aneurysm (Fig. 5-10, paragraph 10, 114-115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Sepetka in order to further protect the neck of the aneurysm and completely isolate the aneurysm from the parent vessel as disclosed by Sepetka (paragraph 114).
Regarding claim 64, the combination of Li and Sepetka teaches the limitations of claim 63, and Sepetka teaches wherein delivering the embolic composition (130, Fig. 10) into the aneurysm causes the neck cover to transform into a second expanded state, the second expanded state having a smaller interior volume than the first expanded state (Fig. 10, paragraph 134, as the embolic composition fills the cavity of the neck cover 32, it expands to occupy the interior volume thereby transforming the neck cover 32 into a second expanded state that has a smaller interior volume than the first expanded state).
Claims 66-68, 70 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Lerouge and further in view of Busold.
Regarding claim 66, Li discloses a method of treating an aneurysm (abstract, paragraph 114-115), the method comprising:
positioning a distal end of an elongated shaft (118, Fig. 1, 3) in an aneurysm cavity (302) (Fig. 2-3, paragraph 119);
introducing an embolic composition (310/314) into a lumen of the elongated shaft using an injector device (116), wherein the injector device is coupled to a proximal portion of the elongated shaft (paragraph 117, Fig. 1, embolic composition 314 is delivered through the elongated member 118 from the injector device 116 via a coupler 130 at a proximal portion of the elongated member); and
delivering an embolic composition into the aneurysm cavity (paragraph 128, Fig. 2, 6-7).
Li is silent on wherein the embolic composition has a storage modulus of at least 80 Pa at 37°C within a linear viscoelastic range of the embolic composition, and wherein the embolic composition is delivered into the aneurysm cavity at a rate of at least 0.2 milliliters per minute.
However, Lerouge teaches using an embolic composition (embolizing hydrogel, abstract, paragraph 2, 36-37) for treating aneurysms (paragraph 7, 21, 36-37) wherein the embolic composition comprises a storage modulus of at least 80 Pa at 37°C (Fig. 13, paragraph 30, at time 0 the embolic composition with an STS concentration of either 1, 2, or 3% has a storage modulus greater than 80 Pa) within a linear viscoelastic range of the embolic composition (paragraph 69).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li with the teachings of Lerouge to provide an embolic composition with appropriate mechanical, biocompatibility, biodegradation and gelation properties to add sclerosing properties and prevent recanalization processes and promotes fibrosis as disclosed by Lerouge (paragraph 4, 36, 47).
Furthermore, Busold teaches using an embolic composition (foam polymer, abstract, paragraph 9-10) for treating aneurysms and discloses dispensing the foam polymer at a rate not exceeding 1 mL/min (paragraph 164).
It would have been obvious to one of ordinary skill in the art to modify Li with the teachings of Busold to achieve a delivery rate of at least 0.2 milliliters per minute, because the rate of embolic delivery is a result-effective variable and optimizing that rate to a workable value would have been a matter of routine skill. The claimed rate is within the range taught by Busold and would have been expected to provide the predictable result of controlled embolic delivery into the aneurysm.
Regarding claim 67, the combination of Li, Lerouge and Busold teaches the limitations of claim 66. Li further teaches that when the lumen of the elongated member is narrow, a substantial amount of pressure may be required to move the embolic composition through the lumen (para. 121, the injection syringe 116 is configured to withstand high pressure, such as at least 500 psi).
Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to configure the injector device to apply a pressure of at least 10,000 psi as claimed to deliver the embolic composition through the elongated member to the aneurysm, because delivery pressure is a known result-effective variable and increasing pressure to achieve transport through a narrow lumen would have been a predictable optimization within the skill of the art.
Regarding claim 68, the combination of Li, Lerouge and Busold teaches the limitations of claim 66, and Li further discloses wherein the injector device (116) includes a tip (122, Fig. 1), and wherein the tip comprises a body having a distal aperture (it is implied that the tip 122 comprises a body having distal aperture in order for the embolic composition to be transported from the injection syringe 116 to the coupler 130 of the first catheter 118 and into the aneurysm as described in paragraph 117).
Regarding claim 70, the combination of Li, Lerouge and Busold of claim 66, and Lerouge teaches further comprising loading the embolic composition into the injector device, wherein the embolic composition comprises the storage modulus of at least 80 Pa at 37 °C within the linear viscoelastic range of the embolic composition before being loaded into the injector device (paragraph 23, 46, precursor solutions are mixed outside of the catheter to form the mixed hydrogel forming solution before being injected; just after mixing, the hydrogel with chitosan/STS has a storage modulus of 1357 Pa).
Allowable Subject Matter
Claims 60-62 and 69 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: No prior art references alone or in combination with other references teaches each and every limitation of the dependent claims. The closest art of record is Li and US 3802433 Raven.
Regarding claim 60, Li teaches the limitations of claim 58. Raven teaches an infusion cannula assembly (abstract, col. 1 line 55-68) with an injection device (Fig. 1-2) having a tip (tip portion 2) and first elongated shaft (14) and a second elongated shaft (1) that is fixed to the outer surface of the first elongated shaft and the second elongated shaft is wider than the distal opening (at a portion proximal to the distal opening the second elongated shaft is wider than the distal opening as seen in Fig. 2), however the first elongated shaft does not extend through the distal opening of the tip.
Claims 61-62 are objected to as being dependent on objected claim 60.
Regarding claim 69, the combination of Li, Lerouge and Busold teaches the limitations of claim 68. Raven teaches an infusion cannula assembly (abstract, col. 1 line 55-68) with an injection device (Fig. 1-2) having a tip (tip portion 2) and first elongated shaft (14) and a second elongated shaft (1) that is fixed to the outer surface of the first elongated shaft and the second elongated shaft is wider than the distal opening (at a portion proximal to the distal opening the second elongated shaft is wider than the distal opening as seen in Fig. 2), however the first elongated shaft does not extend through the distal opening of the tip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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