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 .
Specification
The disclosure is objected to because of the following informalities:
¶ 32 of Applicant’s specification recites “These larger ports 30 can be used to remove local CSV”. This appears to be a typo of the term “CSF”.
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 1-11 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.
Claim 1 recites the limitation "the site of insertion" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “a length that extends from the site of insertion to reach a treatment region of the patient” which recites a human organism in the form of the insertion site and treatment region of the patient. This should be corrected to –a length configured to extend from the site of insertion to reach a treatment region of the patient--.
Claim 8 recites “a rostrocaudal length” which recites a human organism as “rostocaudal” is an anatomical term using a human body. This should be corrected to –the pattern is configured to arrange slits along a rostrocaudal length when in use--.
Claims 2-7 and 9-11 are rejected via their dependency on claim 1.
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.
Claims 1-4, and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morris et al. (US 2004/0176743 A1).
Regarding claim 1, Morris discloses a therapeutic agent delivery catheter system (Fig. 1; Abstract) comprising: an elongate tube (catheter body 14) defining a lumen therein (lumen 26) formed from a biocompatible material (¶ 18 indicates the catheter body is constructed from biocompatible materials) and sized to insert into a patient (¶s 3 and 15 describe insertion into a body), the tube having a length configured to extend from the side of insertion to reach a treatment region of the patient (¶s 3 and 15); and
a pattern of slits that penetrates an outer wall of the tube (slits 22; Figs. 2A-B show how the slits penetrate the outer wall of the tube), the slits being small enough to remain closed to contain a solution of therapeutic agent, and being configured to open in response to a pressure pulse in the lumen and emit a therapeutic agent solution from each slip in the pattern of slits (Abstract, ¶s 4-6 and 21-24).
The limitations of the pattern of slits specifically emitting a “microjet” of therapeutic agent are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Morris has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. it is configured to open in response to a pressure pulse in the lumen and emit a microjet of therapeutic agent).
Regarding claim 2, Morris further discloses the slits are evenly distributed along a longitudinal axis of the catheter over distance determined by the treatment region (the arrangement of the slits in Fig. 1 are interpreted as being evenly distributed in a pair; ¶s 24-27 describe how the slit arrangements are designed around device function, and therefore the treatment and treatment site the catheter is intended for).
Regarding claim 3, Morris further discloses the pattern arranges slits at different radial angles around a circumference of the elongate tube (Fig. 1 shows the slits 22A and B at different radial positions; also see ¶ 27).
Regarding claim 4, Morris further discloses the patent includes adjacent slits that are radially offset from each other (Fig. 1 shows the slits 22A and B at different radial positions and are adjacent; also see ¶ 27).
Regarding claim 6, Morris further discloses the elongate tube has a diameter of an intracranial catheter (¶s 15, 29, and Figs. 5-7 show how the device is used as an intracranial catheter).
Regarding claim 7, Morris further discloses the catheter system connected to a port and control system (¶s 16 and 36-37; Abstract, also ¶s 4-6 and 21-24).
The limitations of the port and control system are configured to deliver one or more pressure pulses sufficient to open the slits are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Morris has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the port and control system would be configured to deliver one or more pressure pulses sufficient to open the slit, particularly as the slits are already configured to open under appropriate pressure).
Regarding claim 8, Morris further teaches the tube is sized for intrathecal treatment (Fig. 6 implanted in the spine).
The limitations of the pattern arranges slits along a rostrocaudal length are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Morris has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the port and control system would be configured to deliver one or more pressure pulses sufficient to open the slit).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Morris.
Regarding claim 5, Morris does not explicitly teach the adjacent slits are radially offset from each other at an angle of 120o to 180o.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Morris to have an offset angle of 120o to 180o since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Morris would not operate differently with the claimed angle as Morris already acknowledges explicitly providing an angular offset between the slits. Further, applicant places no criticality on the range claimed, only indicating that the angles are preferable (¶ 26 of Applicant’s specification).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Morris, as applied to claim 1, and further in view of Casey (US 2008/0097341 A1).
Regarding claim 9, Morris further teaches comprising a round distal tip (distal end 18 is shown as rounded in).
Morris does not explicitly teach the rounded distal tip comprises a distal slit.
Casey further teaches a flow catheter (Figs. 1-2; Abstract), thus being in the same field of endeavor, with slit valves and a distal tip (Figs. 1-2 with slits 106; Abstract).
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 the tip of Morris to comprise the slits of Casey. Doing so would thus comprise a rounded distal tip comprising a distal slit. Doing so would be advantageous to allow and direct instruments therethrough, such as guidewires (¶s 9 and 12-13 of Casey).
Regarding claim 10, the combination of Morris and Casey does not explicitly teach the distal slit is smaller than the slits in the pattern of slits.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Morris and Casey to have the distal slit is smaller than the slits in the pattern of slits since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Morris and Casey would not operate differently with the claimed relative lengths between slits (¶s 6 and 30 of Morris discuss how the slit lengths can be readily modified). Further, applicant places no criticality on the relative dimensions claimed (¶ 25 of Applicant’s specification only indicates the relative dimensions are “preferable”).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Morris, as applied to claim 1, and further in view of Luther (US 5,522,807 A).
Regarding claim 11, Morris does not explicitly teach a second lumen and ports along the second lumen, the ports being openings sized to remove local fluid from the treatment region.
Luther teaches a dual lumen infusion/aspiration catheter (Fig. 1; Abstract) comprising a second lumen and ports along the second lumen (lumen 14) comprising ports being openings along the second lumen (slits 22 and 26).
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 the device of Morris to comprise a second lumen and ports along the second lumen. Doing so would be advantageous in allowing infusion and aspiration to wash other slits and mitigate formation of thrombus (Col. 5, lines 12-21 of Luther).
The limitations of the ports being sized to remove local fluid from the treatment region are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Morris and Luther has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the openings are sized to remove local fluid, particularly as Luther discloses an aspiration function).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781