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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the coverage of a cross-section of the long-tubular implanted medical device as recited in claim 12; the surface coverage of the long-tubular implanted medical device as recited in claim 13; and the magnetically conductive patch must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 1 recites “. The term “implanted” implies that the medical device has been inserted into the body, which contradicts the description and the drawings, which shows and describes a medical device outside of the body to be manufactured by a laser beam. The examiner suggests amending the claims to reflect the disclosure provided.
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 1-15 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 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: “magnetic traction force” recited in claim 2. The medical device as claimed could have an external force, such as gravity, be provided to the suspended end of the tubular medical device to ensure the device remains flat and straight while being held by a hand.
Claims 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: “covering material” recited in the specification pg. 5. The medical device as claimed could have a surface coverage based on the opening parts/struts of the stents.
Claim 7 recites the limitation "magnitude of the magnetic traction force" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 7 is dependent upon claim 1 which does not recite a magnetic traction force.
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, 8-9 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugimura et al. JP 2005-198853A.
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Sugimura discloses a method of keeping a long-tubular implantable medical device (4) flat and straight, wherein the long-tubular implantable medical device has a fixed end (5) and a suspended end; characterized in that an external force (applied by support 6) is applied to the suspended end of the long-tubular implanted medical device to ensure that the device remains flat and straight. Sugimura discloses wherein the supporting member (6) serves as a support unit thus as the holding means (5) grips the end tubular member (4), the tubular member is suspended and held in a flat and straight position by the supporting member (6).
As for claim 8, Sugimura depicts in Fig. 2 wherein the length of the device fixed at the fixed end of the implantable medical device is less than 2/3 the length of the medical device.
As for claim 9, Sugimura discloses wherein the fixing method for the fixed end of the implantable medical device includes clamping (5), physical interference fit, magnetic connection, and chemical fixation.
As for claim 15, Sugimura discloses that the long-tubular implantable medical device is a raw material (4) or semi-finished product (fig. 4) to be processed into a stent, or a finished stent product (fig. 12).
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(s) 6 and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sugimura et al. JP 2005-198853A as evident by Gluschenko et al. US 11096808.
As for claim 6, Sugimura discloses wherein the long-tubular implanted medical device (4) is a stent but does not specify a length of 5mm to 200mm. However, stents are well known to come in various sizes and shapes. the claimed length of 5mm to 200mm is well known in the art as evidence by Gluschenko who teaches a stent having a length between 5mm to 250mm (abstract). It therefore would have been anticipated and/or obvious by Sugimura to have a stent length of 5mm to 200mm as claimed.
As for claim 10, Gluschenko further teaches a stent outer diameter of 0.25-40mm (abstract). It therefore would have been anticipated and/or obvious by Sugimura to have a stent outer diameter of 1-20mm as claimed.
As for claim 11, Sugimura teaches a stent having a wall thickness but does not specify the thickness being 10µm to 600µm. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to modify the wall thickness of Sugimura to 10µm to 600µm as claimed as a mere design consideration through routine engineering depending on the use of the medical device.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugimura et al. JP 2005-198853A in view of Barry US 6673104.
As for claim 14, Sugimura discloses all the limitations as recited above but does not specify wherein the implantable medical device itself has magnetic conductivity or a magnetically conductive patch is added onto the implantable medical device. However, Barry teaches a magnetic stent (10) provided with magnetic conductivity or magnetically conductive patches (12, 18) to provide magnetic conductivity to the stent (10). It would have been obvious to one of ordinary skill in the art, before the effective filing date, to modify and/or substitute the stent of Sugimura with a magnetic stent as taught by Barry in order to provide a magnetic stent that can provide repair and/or support to surrounding tissues with magnetic properties (Barry, col. 2, lines 12-19).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYRONE V HALL JR whose telephone number is (571)270-5948. The examiner can normally be reached Mon.-Fri. 7:30am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Monica Carter can be reached at (571) 272-4475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TYRONE V HALL JR/Primary Examiner, Art Unit 3723
