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 .
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 1-8 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.
Claim 1 recites the limitation "the photon-activatable gel" in line 12. There is insufficient antecedent basis for this limitation in the claim, and it is unclear if “the photon-activatable gel” is the same as or different from “a photon-activatable patch”. For examination purposes, the structures will be interpreted as the same. Claims 2-8 are rejected for the same reasons as claim 1 by virtue of dependency on claim 3.
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 1-2, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Burke et al (US 2005/0033409) in view of Kronholz et al. (US 5,803,895) and Couvillon, JR et al. (US 2007/0225564).
Regarding claim 1, an invention relating to aneurysm treatment implant, Burke discloses (Figs. 16-18) a method of treating a cerebral aneurysm of a patient (Par. 0066-0067) comprising the steps of: providing a stent delivery system, wherein the stent delivery system comprises a microcatheter (174) comprising a proximal end portion [i.e. the portion of the microcatheter outside the body] and a distal end portion [i.e. microcatheter distal tip portion] (Par. 0109); positioning the delivery system within a cerebral vessel so that the distal end of the catheter is disposed at a neck of the aneurysm (Par. 0110); deploying an intracranial stent (68; Par. 0109-0110), wherein the intracranial stent comprises: a proximal end (70); a distal end (72); a tubular sidewall (74) extending between the proximal end and the distal end; and a patch (28) covering at least a portion of the sidewall (Par. 0086); and activating the gel on the stent using an application that changes the environment [i.e. change in temperature or pH] (Par. 0001 & 0079), wherein when the activatable gel is activated the gel expands and covers the aneurysm orifice to seal the aneurysm off from a parent circulation (Par. 0072 & 0086). However, Burke fails to disclose wherein the distal end portion is covered by a radiation-shielding element; and wherein the patch is a photon-activatable gel activated by a photon source.
In the analogous art of catheters, Kronholz teaches a body of a catheter system incorporating one or more substances having a high atomic number such as lead, and that provide a shielding effect (Col. 3, lines 59-64).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burke to wherein the distal end portion is covered by a radiation-shielding element. Doing so would provide a radiation shielding effect (Col. 3, lines 63-64), as taught by Kronholz.
In the analogous art of medical devices with hydrogels, Couvillon teaches a hydrogel [i.e. photon-activatable gel] expands when activated by application of x-ray photons [i.e. electromagnetic radiation-emitting light source] to the gel (Par. 0060), and a hydrogel [i.e. a thermo-activatable gel] expands when activated by application of heating device to the gel (Par. 0047) are equivalent structures known in the art. Note, dictionary.com defines electromagnetic radiation as "radiation consisting of electromagnetic waves, including radio waves, infrared, visible light, ultraviolet, x-rays, and gamma rays". Given Couvillon teachings about x-ray photon-activatable gel configured to expand when activated by application of x-ray photons to the gel, it would be obvious that wherein the patch is a photon-activatable gel activated by a photon source applied internal or external to a patient's body would expand a photon-activatable gel. Official notice unsupported by documentary evidence should only be taken by the examiner where the facts asserted to be well-known, or to be common knowledge in the art are capable of instant and unquestionable demonstration as being well-known. As noted by the court in In re Ahlert, 424 F.2d 1088, 1091, 165 USPQ 418, 420 (CCPA 1970), the notice of facts beyond the record which may be taken by the examiner must be "capable of such instant and unquestionable demonstration as to defy dispute" (citing In re Knapp Monarch Co., 296 F.2d 230, 132 USPQ 6 (CCPA 1961)).
Therefore, because these two hydrogels are configured to expand when activated by application that changes their environment were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute thermos-activatable hydrogel activated by application of heating device for the photon-activatable hydrogel activated by application
of x-ray photon.
Regarding claim 2, Burke, as modified by Kronholz and Couvillon, discloses wherein activating the photon-activatable gel comprises activating the photon-activatable gel using x-ray photons external to the patient's body [see Couvillon paragraphs 0060].
Regarding claim 6, Burke, as modified by Kronholz and Couvillon, discloses the method of claim
1. It should be noted that Duggal fails to further disclose wherein the step of activating
the photon-activable gel further comprises the step of activating the photon-activatable
gel using a light source comprising xenon-plasma.
However, the choice of designing the method step to use the light source comprising: an LED or xenon-plasma is a finite number of options. This instant application does not recite any criticality or advantage to having xenon-plasma over LED. As such the step of activating the photon-activatable gel using light source comprising of xenon-plasma is considered a mere design choice and it appears the
photon source of Couvillon would work equally well regardless of the photon source being LED or xenon-plasma. Through experimentation, one of ordinary skill can determine what configuration is most effective based on the intended use of the device. Under KSR reasoning, it would have been obvious for one having ordinary skill in the art before the effective filing date to try different photon sources (particularly when there is a finite number of options) to find the most effective photon source. KSA international Co. V. Teleflex inc., 550 US. S98, 82 USPO2d L385 (2007).
Regarding claim 8, Burke, as modified by Kronholz and Couvillon, discloses wherein the radiation shielding element is configured to prevent contact of photon source with the activatable portion until it is desired [see Kronholz Column. 3, lines 63-64].
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Burke et al (US 2005/0033409) in view of Kronholz et al. (US 5,803,895) and Couvillon, JR et al. (US 2007/0225564), as applied to claim 1 above, and further in view of Thilwind et al. (US 2011/0190695).
Regarding claim 3, Burke, as modified by Kronholz and Couvillon, discloses the method of claim 1. Burke fails to disclose wherein the step of activating the photon-activatable gel further comprises the step of activating the photon-activatable gel using light emitting diodes (LED).
In a similar field of endeavor, which is hydrogels, Thilwind teaches an expansile photon-activatable gel material [i.e. hydrogel]; wherein the photon-activatable gel material is activated by light emitting diodes (LED) (Par. 0047-0048).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burke, in view of Kronholz and Couvillon, to have the step of activating the photon-activatable gel further comprises the step of activating the photon-activatable gel using light emitting diodes (LED). Doing so would provide controlled expansion and contraction of the hydrogel (Par. 0013), as taught by Thilwind.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Burke et al (US 2005/0033409) in view of Kronholz et al. (US 5,803,895) and Couvillon, JR et al. (US 2007/0225564), as applied to claim 1 above, and further in view of Ganz al. (US 2001/0049464).
Regarding claims 4-5, Burke, as modified by Kronholz and Couvillon, discloses the method of claim 1. It should be noted that Burke fails to disclose wherein the step of activating the photon-activable gel further comprises the step of activating the photon-activatable gel using a light source comprising quartz [Claim 4]; or wherein the step of activating the photon-activable gel further comprises the step of activating the photon-activatable gel using a light source comprising tungsten-halogen [Claim 5].
However, the choice of designing the method step to use the light source comprising: an LED, quartz, or tungsten-halogen is a finite number of options. This instant application does not recite any criticality or advantage to having quartz or tungsten-halogen over LED. As such the step of activating the photon-activatable gel using light source comprising of quartz or tungsten-halogen is considered a mere
design choice and it appears the photon source of Couvillon would work equally well regardless of the photon source being LED, quartz, or tungsten-halogen. Through experimentation, one of ordinary skill can determine what configuration is most effective based on the intended use of the device. Under KSR reasoning, it would have been obvious for one having ordinary skill in the art before the effective filing date to try different photon sources (particularly when there is a finite number of options) to find the
most effective photon source. KSA international Co. V. Teleflex inc., 550 US. S98, 82 USPO2d L385 (2007).
In the analogues art of photon sources, Ganz teaches an ultraviolet light source can be tungsten, halogen, or quartz iodide lamp (Par. 0047). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burke, in view of Kronholz and Couvillon, to have the step of activating the photon-activable gel further comprises the step of activating the photon-activatable gel using a light source comprising quartz or tungsten-halogen, as taught by Ganz. Couvillon discloses the photon source being ultraviolet is desired (Par. 0060), thus Ganz's quartz or tungsten-halogen photon light source would have provided Couvillon with a sufficient means ultraviolet photon source.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Burke et al (US 2005/0033409) in view of Kronholz et al. (US 5,803,895) and Couvillon, JR et al. (US 2007/0225564), as applied to claim 1 above, and further in view of Belson (US 2007/0135803).
Regarding claim 7, Burke, as modified by Kronholz and Couvillon the method of claim 1. Burke fails to further disclose wherein the distal end portion of the microcatheter further comprises at least one temperature sensor.
In the similar field of catheters, Belson teaches wherein the distal end portion of the microcatheter further comprises at least one temperature sensor (Par. 0288-0289 & 0571).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burke, in view of Kronholz and Couvillon, to have wherein the distal end portion of the microcatheter further comprises at least one temperature sensor. Doing so would determine a portion of the catheter is in contact with the body tissue (Par. 0522), as taught Belson.
Claims 9 & 10 rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (US 2010/0142163) in view of Kronholz et al. (US 5,803,895), Hunter et al. (US 2005/0142163) and Couvillon, JR et al. (US 2007/0225564),
Regarding claim 9, an invention relating to aneurysm treatment implant, Duggal discloses (Figs. 10A-B) a method of treating a cerebral aneurysm (Par. 0058-0059) comprising the steps of: providing a coil delivery system, wherein the coil delivery system comprises a microcatheter (142) comprising a proximal end portion [i.e. the portion of the microcatheter outside the body] and a distal end portion [i.e. microcatheter tip] (Par. 0083); positioning the delivery system within a cerebral vessel so that the distal end of the catheter is disposed at a neck of the aneurysm (Fig. 10A); deploying an embolic coil (40) into the aneurysm cavity (Par. 0083). However, Duggal fails to disclose wherein the distal end portion is covered by a radiation-shielding element; and an embolic coil coated with a photon-activatable gel material; and activating the photon-activatable gel on the coil using a photon source, wherein activation of the gel leads to physical enlargement of the embolic coil within the aneurysm cavity causing isolation of the aneurysm from the circulation.
In the analogous art of catheters, Kronholz teaches a body of a catheter system incorporating one or more substances having a high atomic number such as lead, and that provide a shielding effect (Col. 3, lines 59-64).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burke to have wherein the distal end portion is covered by a radiation-shielding element. Doing so would provide a radiation shielding effect (Col. 3, lines 63-64), as taught by Kronholz.
In the analogous art of vaso-occlusive coil implants, Hunter teaches an embolic coil coated with an activatable gel material; and activating the activatable gel on the coil, wherein activation of the gel leads to physical enlargement of the embolic coil within the aneurysm cavity causing isolation of the aneurysm from the circulation (Par. 0793).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duggal, to have a coil is at least partially coated with a hydrogel and activating the hydrogel, wherein activation of the hydrogel leads to physical enlargement of the coil within the cavity of the aneurysm thereby isolating the aneurysm from the vessel. Doing so would allow the aneurysm sac to be filled (Par. 0793), as taught by Hunter. However, Hunter fails to further teach the hydrogel comprises a photon-activatable gel material and activating the photon-activatable gel material using a photon source.
In the analogous art of medical devices with hydrogels, Couvillon teaches the hydrogel comprises a photon-activatable gel material and activating the photon- activatable gel material using a photon source (Par. 0060). Note, dictionary.com defines electromagnetic radiation as "radiation consisting of electromagnetic waves, including radio waves, infrared, visible light, ultraviolet, x-rays, and gamma rays".
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duggal, in view of and Hunter, to have the hydrogel comprises a photon-activatable gel material and activating the photon-activatable gel material using a photon source. Doing so would have been obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results to one of ordinary skill in the art (MPEP 2143). Specifically, contracting and expanding of the hydrogel outer layer of the implant (Par. 0060), as taught by Couvillon.
Regarding claim 10, Duggal, as modified by Kronholz, Hunter, and Couvillon, discloses wherein activating the photon-activatable gel comprises activating the photon-activatable gel using x-ray photons external to the patient's body [see Couvillon paragraphs 0060].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (US 2010/0142163) in view of Kronholz et al. (US 5,803,895), Hunter et al. (US 2005/0142163) and Couvillon, JR et al. (US 2007/0225564), as applied to claim 9 above, and further in view of Thilwind et al. (US 2011/0190695).
Regarding claim 11, Duggal, as modified by Kronholz, Hunter, and Couvillon, discloses the method of claim 9. Burke fails to disclose wherein activating the photon-activatable gel comprises activating the photon-activatable gel using light emitting diodes (LED).
In a similar field of endeavor, which is hydrogels, Thilwind teaches an expansile photon-activatable gel material [i.e. hydrogel]; wherein the photon-activatable gel material is activated by light emitting diodes (LED) (Par. 0047-0048).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duggal, in view of Kronholz, Hunter, and Couvillon, to have the step of activating the photon-activatable gel further comprises the step of activating the photon-activatable gel using light emitting diodes (LED). Doing so would provide controlled expansion and contraction of the hydrogel (Par. 0013), as taught by Thilwind.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (US 2010/0142163) in view of Kronholz et al. (US 5,803,895), Hunter et al. (US 2005/0142163) and Couvillon, JR et al. (US 2007/0225564), as applied to claim 9 above, and further in view of Ganz al. (US 2001/0049464).
Regarding claims 12-13, Duggal, as modified by Kronholz, Hunter, and Couvillon, discloses the method of claim 1. It should be noted that Burke fails to disclose wherein activating the photon-activable gel comprises activating the photon-activatable gel using a light source comprising quartz [Claim 12]; or wherein activating the photon-activable gel comprises activating the photon-activatable gel using a light source comprising tungsten-halogen [Claim 13].
However, the choice of designing the method step to use the light source comprising: an LED, quartz, or tungsten-halogen is a finite number of options. This instant application does not recite any criticality or advantage to having quartz or tungsten-halogen over LED. As such the step of activating the photon-activatable gel using light source comprising of quartz or tungsten-halogen is considered a mere
design choice and it appears the photon source of Couvillon would work equally well regardless of the photon source being LED, quartz, or tungsten-halogen. Through experimentation, one of ordinary skill can determine what configuration is most effective based on the intended use of the device. Under KSR reasoning, it would have been obvious for one having ordinary skill in the art before the effective filing date to try different photon sources (particularly when there is a finite number of options) to find the
most effective photon source. KSA international Co. V. Teleflex inc., 550 US. S98, 82 USPO2d L385 (2007).
In the analogues art of photon sources, Ganz teaches an ultraviolet light source can be tungsten, halogen, or quartz iodide lamp (Par. 0047). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duggal, in view of Kronholz, Hunter, and Couvillon, to have the step of activating the photon-activable gel further comprises the step of activating the photon-activatable gel using a light source comprising quartz or tungsten-halogen, as taught by Ganz. Couvillon discloses the photon source being ultraviolet is desired (Par. 0060), thus Ganz's quartz or tungsten-halogen photon light source would have provided Couvillon with a sufficient means ultraviolet photon source.
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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-10 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,290,457. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims 19/086,073
9
10
Claims
US Patent No.
12,290,457
1
1
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 22, 2026
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