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, 4, 7, 11, 13, 16 and 58-60 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.
The term “highly flexible” in claim 1 is a relative term which renders the claim indefinite. The term “highly flexible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation is attempting to describe the fiber made from the synthetic elastomer, however flexibility is relative and is usefully measure by tensile strength relative to Young’s Modulus and other physical trades of polymers under stress. For example different elastomers have different strengths, Young’s Modulus, elongation and breaking values, depending on the polymeric make up, but would be more flexible than steel or iron based structures. How high would fit the meets and bounds of “highly” flexible? As such the meets and bounds of claim 1, along with all subsequent depend claims cannot be determined.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 7, 11, 13, 59 and 60 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Martinson et al (WO 2006/055443 A2 hereafter Martinson).
Martinson teaches a medical device comprising a medical polymer including a synthetic elastomer, and one or more sensors including a pressure sensor and an accelerometer that detects vibration, and there the device is tubular in shape and has been woven [abstract, p. 2, lin. 10-15, pg. 22, lin. 8-13, claims], meeting limitations of claims 1 and 59. Additional sensors include Doppler, pressure sensors and fluid flow sensors [pg.36, lin. 8-25, 37, lin. 20-30, claims], meeting limitations of claim 4. The polymer is non-biodegradable such as polyurethane and methacrylates (pg. 20, lin. 15-25), meeting limitations of claims 7. The medical device, in addition to having sensors, comprises memory and a microprocessor attached to the sensors [pg. 2, lin. 20-30, claims], meeting the limitations of claims 11 and 13. The medical device is a vascular graft [pg. 12, lin. 17-25], meeting limitations of claim 60. These disclosures render the claims anticipated.
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) 1, 4, 7, 11, 13, 16 and 58-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Martinson et al (WO 2006/055443 A2 hereafter Martinson) in view of Surman et al (US 2011/0320142 hereafter Surman).
As discussed above, Martinson discloses a medical device with multiple sensors along the surface of the medical device along with a memory and microprocessor. The reference discloses that the sensors can be varied, but yet is silent to the specific density of the sensors per square centimeter of the medical device. The size of the medical device will determine the density of the sensors. A schematic shows that at least 4 sensors can be aligned along the length of the medical device [figures] and depending on the size would meet the limitations of claim 16. It would have been obvious to optimize the size, shape and density of the sensors applied to the medical device through routine experimentation by those of ordinary skill in the art to shape a medical device.
The reference is silent to how the fiber is formed, however electrospinning fibers for medical polymers is known in the art as seen in the Surman patent.
Surman discloses a temperature and pressure sensor that can fashion into an electrospun fiber [abstract, 0035]. The material can be used to determine fluid pressures in use [0034]. The polymers used in the composition include silicone polymers and methacrylic polymers [0038]. It would have been obvious to use electrospun fibers of Surman into the medical device of obvious to electrospun the fibers of Hoey as seen in the Surman as the polymers are the same and solve the same problem.
With these aspects in mind it would have been obvious to combine the prior art in order to provide a stable medical device. It would have been obvious to use the electrospun fibers of Surman in the medical device of Martinson as they are made from the same polymers and are useful in medical device, solving the same problem. It would have been obvious to optimize the number of sensors in order to provide sufficient data to medical staff and optimize care post implantation, enhancing medical treatment. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable medical device for monitoring health conditions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 7, 11, 13, 16 and 58-60 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618