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.
Claim 18 is 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 18 recites the limitation "wherein contracting the suction head from the expanded configuration to the closed configuration includes…”". There is insufficient antecedent basis for this limitation in the claim. No such step of contracting has been previously defined. Instead, the step of going from the expanded configuration to the closed configuration was previously defined as “closing”. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 18 as - - wherein closing the suction head from the expanded configuration to the closed configuration includes… - -.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 5, 7-9, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freudenthal et al (US 2006/0155305).
Freudenthal et al discloses the following limitations:
Claim 1. A method of using a suction device to remove an object (2) from a subject's body ([0018], [0062]), the suction device including an expandable suction head (20, 110) at a distal end of a conduit (25, 40, 131) ([0065], [0066], [0083]-[0086], [0091], [0101]), the method comprising:
extending the suction device through a lumen of a medical device (50) and into the subject's body ([0062]);
expanding the suction head from a contracted configuration (Figs. 14, 25a) to an expanded configuration (Figs. 15, 25c, 25d) within the subject's body ([0077], [0082], [0083]);
applying suction to move the object into the expanded suction head ([0106]);
preventing the object from moving proximally beyond the expanded suction head (though Freudenthal et al does not explicitly use the word ‘prevent’, Freudenthal et al discloses in [0078] moving the object (2) into a first collecting basket (10), wherein the first collecting basket is then drawn into the cited expandable suction head (20). “After the collecting baskets have been released, the clot is captured using the first collecting basket and the latter is drawn back into the second collecting basket 20 together with the clot. For further recovery of the clot, both collecting baskets, in the state with one drawn into the other, are then drawn back into the channel element. Here, contraction of both collecting baskets takes place and, in this way, the clot is squeezed.” In other words, the object (2) is held in the baskets within catheter (50) and therefore the first collecting basket (10) prevents the object (2) from moving proximally beyond the expanded suction head as the object is held and squeezed in the baskets. Freudenthal et al further discloses in [0097] the mass of the object (2) remains in the basket, indicating the object has been prevented from moving proximally beyond the expanded suction head); and
removing the suction device with the object from the subject's body (0062], [0075], [0078], [0079]).
Claim 2. The method of claim 1, wherein expanding the suction head includes transforming the suction head from a contracted configuration (Fig. 25a) within the lumen to an expanded configuration (Figs. 15, 25c, 25d) outside the lumen ([0062] – “The first and second collecting baskets and the catheter 40 can be drawn into a channel element 50”, [0083] – “In the upper part of the drawing in FIG. 15, the collecting basket is shown pushed out of the channel element 50 inside a vessel, and it has already been partially pushed over the object 2.”).
Claim 5. The method of claim 1, wherein removing the suction device includes removing the suction device through the lumen of the medical device (50) ([0078]).
Claim 7. The method of claim 1, wherein the suction head is self-expandable ([0089], [0091]).
Claim 8. The method of claim 1, further comprising, before removing the suction device with the object from the subject's body, closing the suction head to retain the object within the suction head (Fig. 25e; [0097]; “both collecting baskets are drawn completely into the catheter and compressed therein”; wherein the compressed is interpreted as the closing of the suction head).
Claim 9. The method of claim 1, wherein the object includes one or more stone fragments ([0018]).
Claim 17. A method of removing an object (2) from a subject's body ([0018], [0062]), the method comprising:
inserting a medical device (50) with a lumen into the subject's body ([0062]);
extending a suction device into the subject's body through the lumen, the suction device including an expandable suction head (20, 110) at a distal end of a conduit (25, 40, 131) ([0065], [0066], [0083]-[0086], [0091], [0101]);
expanding the suction head from a contracted configuration (Figs. 14, 25a) within the lumen to an expanded configuration (Figs. 15, 25c, 25d) outside the lumen ([0077], [0082], [0083]);
applying suction to move the object into the expanded suction head ([0106]);
preventing the object from moving proximally beyond the expanded suction head (though Freudenthal et al does not explicitly use the word ‘prevent’, Freudenthal et al discloses in [0078] moving the object (2) into a first collecting basket (10), wherein the first collecting basket is then drawn into the cited expandable suction head (20). “After the collecting baskets have been released, the clot is captured using the first collecting basket and the latter is drawn back into the second collecting basket 20 together with the clot. For further recovery of the clot, both collecting baskets, in the state with one drawn into the other, are then drawn back into the channel element. Here, contraction of both collecting baskets takes place and, in this way, the clot is squeezed.” In other words, the object (2) is held in the baskets within catheter (50) and therefore the first collecting basket (10) prevents the object (2) from moving proximally beyond the expanded suction head as the object is held and squeezed in the baskets. Freudenthal et al further discloses in [0097] the mass of the object (2) remains in the basket, indicating the object has been prevented from moving proximally beyond the expanded suction head);
closing the suction head from the expanded configuration to a closed configuration (Fig. 19; [0086]); and
removing the suction device with the object from the subject's body (0062], [0075], [0078], [0079], [0086]).
Claim 19. The method of claim 17, wherein, in the expanded configuration, the suction head includes a hemispherical shape (Fig. 16; wherein this shape illustrated in Freudenthal et al is substantially the same shape as that of Fig. 5C in applicant’s figure, described as a hemispherical shape).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal et al in view of Saadat et al (US 2009/0054803).
Claim 3. Freudenthal et al discloses the invention substantially as claimed above but fails to disclose expanding the suction head from a contracted configuration to an expanded configuration includes applying heat or current to the suction head.
Rather, Freudenthal et al discloses the suction head as being made of Nitinol and self-expanding ([0091]). However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely controlling expansion of a suction head, Saadat et al teaches a suction head made of Nitinol, wherein the suction head can either be self-expanding or heat-activated ([0130, [0131]). Therefore, since both Freudenthal et al and Saadat et al are directed to expandable Nitinol heads, it would have been obvious to substitute one known expansion mechanism (heat-activated) for another (self-expanding) to achieve the predictable result of opening the head reliably within the body.
Claim(s) 4 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal et al in view of Saadat et al as applied to claim 3 above, and further in view of Chanduszko et al (US 2009/0299403).
Claim 4. The combination discloses the invention substantially as claimed above but fails to disclose the mechanism for removal or collapsing of the heat activated suction head, including contracting the suction head from the expanded configuration to a closed configuration by removing the applied heat or current.
However, Chanduzsko et al teaches material properties of a shape memory expandable devices, wherein the device can be cooled and then can be brought to its straight configuration for removal ([0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the suction head of the combination such that the suction head is configured to contract in response to removal of the applied heat (e.g. cooled) based upon the teachings of Chanduszko to provide a means for collapsing the suction head into a smaller profile for removal.
Claim 18. Freudenthal et al discloses the invention substantially as claimed above but fails to disclose expanding the suction head from a contracted configuration to an expanded configuration includes applying heat or current to the suction head.
Rather, Freudenthal et al discloses the suction head as being made of Nitinol and self-expanding ([0091]). However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely controlling expansion of a suction head, Saadat et al teaches a suction head made of Nitinol, wherein the suction head can either be self-expanding or heat-activated ([0130, [0131]). Therefore, since both Freudenthal et al and Saadat et al are directed to expandable Nitinol heads, it would have been obvious to substitute one known expansion mechanism (heat-activated) for another (self-expanding) to achieve the predictable result of opening the head reliably within the body.
The combination further fails to disclose the mechanism for removal or collapsing of the heat activated suction head, wherein closing the suction head from the expanded configuration to a closed configuration includes removing the applied heat or current.
However, Chanduzsko et al teaches material properties of a shape memory expandable devices, wherein the device can be cooled and then can be brought to its straight configuration for removal ([0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the suction head of the combination such that the suction head is configured to contract in response to removal of the applied heat (e.g. cooled) based upon the teachings of Chanduszko to provide a means for collapsing the suction head into a smaller profile for removal.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal et al in view of Diamant et al (US 2013/0261638).
Claim 6. Freudenthal et al discloses the invention substantially as claimed above, including the suction device is drawn into the catheter for removal of the suction device ([0078]) but fails to disclose removing the suction device includes removing the medical device along with the suction device from the urinary tract.
However, in a similar field of endeavor, Diamant et al teaches a method of removing kidney stones from a patient’s urinary tract ([0003], [0018]), wherein it is well known in this field that upon completion of the procedure, the catheter (equivalent of catheter 50 of Freudenthal et al) is removed along with the basket (equivalent of suction head in Freudenthal et al) to thereby remove the entire device together ([0004]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the Freudenthal et al such that removing the suction device includes removing the medical device along with the suction device from the urinary tract based upon the teachings of Diamant et al as the medical device disposed around the suction head during removal allows for the kidney stone to be immobilized within the suction head during removal ([0004]).
Claim(s) 10-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal et al in view of Esiner (US 2016/0030070).
Claim 10. Freudenthal et al discloses a method of removing a kidney stone (2) ([0018], [0062]) from a subject, the method comprising:
inserting a medical device (50) with a lumen into the subject ([0062]);
extending a suction device through the lumen and into the subject’s body ([0062]), the suction device including an expandable suction head (20, 110) at a distal end of a conduit (25, 40, 131) ([0065], [0066], [0083]-[0086], [0091], [0101]);
expanding the suction head from a contracted configuration (Figs. 14, 25a) within the lumen to an expanded configuration (Figs. 15, 25c, 25d) outside the lumen ([0077], [0082], [0083]);
applying suction to move the stone into the expanded suction head ([0106]);
preventing the stone from moving proximally beyond the expanded suction head (though Freudenthal et al does not explicitly use the word ‘prevent’, Freudenthal et al discloses in [0078] moving the object (2) into a first collecting basket (10), wherein the first collecting basket is then drawn into the cited expandable suction head (20). “After the collecting baskets have been released, the clot is captured using the first collecting basket and the latter is drawn back into the second collecting basket 20 together with the clot. For further recovery of the clot, both collecting baskets, in the state with one drawn into the other, are then drawn back into the channel element. Here, contraction of both collecting baskets takes place and, in this way, the clot is squeezed.” In other words, the object (2) is held in the baskets within catheter (50) and therefore the first collecting basket (10) prevents the object (2) from moving proximally beyond the expanded suction head as the object is held and squeezed in the baskets. Freudenthal et al further discloses in [0097] the mass of the object (2) remains in the basket, indicating the object has been prevented from moving proximally beyond the expanded suction head); and
removing the suction device with the stone from the body (0062], [0075], [0078], [0079]).
Freudenthal et al discloses the removal of kidney stones ([0018]) from the kidneys ([0062]) but fails to disclose removing the kidney stones from the subject’s urinary tract, wherein the treatment is performed in the urinary tract and the stone removed therefrom. However, in a similar field of endeavor, Esiner teaches a method of removing a kidney stone from a subject, wherein the method is performed in the urinary tract and the stone is removed therefrom as the urinary tract is where the stones are most likely to become entrapped ([0004], [0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Freudenthal et al to remove a kidney stone from a subject’s urinary tract based upon the teachings of Esiner as this is where the body passage lumen narrows from the kidneys and the kidney stones can cause significant pain and damage to the patient ([0004]).
Claim 11. The combination discloses the invention substantially as claimed above, wherein Freudenthal et al discloses inserting a medical device includes inserting an endoscope ([0030], [0088]) but fails to disclose the endoscope is a ureteroscope into the urinary tract. However, Esiner further teaches the step of inserting a ureteroscope (134) into the urinary tract for visualization of the kidneys tone ([0032]; Fig. 7). Therefore, in light of Freudenthal et al’s disclosure of the general device being used with an endoscope, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the endoscope of Freudenthal et al to a ureteroscope as taught by Esiner to allow a scope of the appropriate size to fit into the urinary tract for direct visualization of the kidney stones for removal.
Claim 12. The combination discloses the invention substantially as claimed above, wherein Freudenthal et al discloses in the expanded configuration, a cross-sectional area of the suction head transverse to a longitudinal axis of the suction head decreases from the distal-most end of the suction head to a proximal end of the suction head (Fig. 2, 16, 17, 29).
Claim 14. The combination discloses the invention substantially as claimed above, wherein Freudenthal et al discloses a cross-sectional area of the suction head transverse to a longitudinal axis of the suction head is greater in the expanded configuration (Fig. 15) than in the contracted configuration (Fig. 14) (the head flares opened to a larger configuration in the expanded configuration to entrap the object as most notably seen in Fig. 15).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal et al in view Esiner as applied to claim 10 above, and further in view of Diamant et al.
Claim 13. The combination discloses the invention substantially as claimed above, wherein Freudenthal et al discloses the suction device is drawn into the catheter for removal of the suction device ([0078]) but fails to disclose removing the suction device includes removing the medical device along with the suction device from the urinary tract.
However, in a similar field of endeavor, Diamant et al teaches a method of removing kidney stones from a patient’s urinary tract ([0003], [0018]), wherein it is well known in this field that upon completion of the procedure, the catheter (equivalent of catheter 50 of Freudenthal et al) is removed along with the basket (equivalent of suction head in Freudenthal et al) to thereby remove the entire device together ([0004]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the combination such that removing the suction device includes removing the medical device along with the suction device from the urinary tract based upon the teachings of Diamant et al as the medical device disposed around the suction head during removal allows for the kidney stone to be immobilized within the suction head during removal ([0004]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal et al in view of Esiner as applied to claim 10 above, and further in view of Saadat et al.
Claim 15. The combination discloses the invention substantially as claimed above but fails to disclose expanding the suction head from a contracted configuration within the lumen to an expanded configuration outside the lumen includes applying heat or current.
Rather, Freudenthal et al discloses the suction head as being made of Nitinol and self-expanding ([0091]). However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely controlling and activating a suction head, Saadat et al teaches a suction head made of Nitinol, wherein the suction head can either be self-expanding or heat-activated ([0130, [0131]). Therefore, since both Freudenthal et al and Saadat et al are directed to expandable Nitinol heads, it would have been obvious to substitute one known expansion mechanism (heat-activated) for another (self-expanding) to achieve the predictable result of opening the head reliably within the body.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freudenthal et al in view of Esiner and Saadat et al as applied to claim 15 above, and further in view of Chanduszko et al.
Claim 16. The combination discloses the invention substantially as claimed above but fails to disclose the mechanism for removal or collapsing of the heat activated suction head, including contracting the suction head from the expanded configuration to a closed configuration by removing the applied heat or current.
However, Chanduzsko et al teaches material properties of a shape memory expandable devices, wherein the device can be cooled and then can be brought to its straight configuration for removal ([0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the suction head of the combination such that the suction head is configured to contract in response to removal of the applied heat (e.g. cooled) based upon the teachings of Chanduszko to provide a means for collapsing the suction head into a smaller profile for removal.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11013522.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11806031.
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of the claims of the instant application are to be found in the claims of the patents. Thus the differences between the claims of the instant application and the claims of the patents lie in the fact that the patent claims include many more elements and is thus much more specific. Thus, the inventions of the claims of the patents are in effect a “species” of the “generic” invention of the claims of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claims are anticipated by the claims of the patents, they are not patentably distinct from the claims of the patents.
Allowable Subject Matter
Claim 20 is 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: The closest prior art of record, Freudenthal et al, discloses the invention substantially as claimed above. The prior art fails to disclose, either singly or in combination, the claimed method, comprising inter alia, a distal end of the medical device includes a camera, and wherein, in the expanded configuration, the suction head includes an offset shape including, in a cross-sectional view, a straight first side, and an angled second side, wherein the straight first side is adjacent to the camera. Applicant discloses the advantage of this configuration, as shown in Fig. 5D, as advantageous in preventing blocking of a camera or a light source at the distal end of the ureteroscope ([0033] of the published application). Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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