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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/20/26 has been entered.
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) and Kumazawa et al (JP 2007-231051 A hereafter Kumazawa).
Martinson discloses 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.
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.
Regarding the glass transition temperature of the polymer, it is the position of the Examiner that such limitations can be found in the prior art where a low glass transition temperature for polymer resins is needed. Such low glass transition temperatures can be found in Kamazawa.
Kamazawa discloses a resin composition and molded articles (abstract). The molded articles comprises non-biodegradable polymer compositions comprising ethylene and polyurethane and acrylic blocks (claims). The blocks are combined [0034]. The combined polymers and copolymers has a wide range of glass transition temperatures as low as -60oC [0042]. A these are the same polymers as Martinson, it would have been obvious to include these into the molded articles of as they solve the same problem. The molded articles can be used as implants, or hand held devices, or a wide variety of uses [claims].
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 include the similar low glass transition polyurethane and methacrylate block monomer and copolymers of Kamazawa into the formulation of Martinson as they are similar and solve a similar problem. The reference establishes the level of skill int eh art regarding these polymers and their use in molded resin articles. 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, see Remarks, filed 7/20/26, with respect to the rejection(s) of claim(s) ) 1, 4, 7, 11, 13, 16 and 58-60 under 35 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited combination. Martinson and Surman, while discloses a medical device comprising the same polymers and incorporated sensors, is silent to the specific glass transition temperature of the newly amended claims. Kamazawa is included to address these new limitations.
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.
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/MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618
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