DETAILED ACTION
Claims 1-8 are pending and hereby under examination.
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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/121,243, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A hydrophilic material comprising 20,000 g/mol polyethylene glycol is not describe in provisional Application No. 62/121,243
The effective filing date of claims 7 and 8 is the same as the filing date of Application No. 15/053,308 – February 25, 2016.
Claim Objections
Claims 2-8 are objected to because of the following informalities:
Claim 1 refers to a “dissolvable hydrophilic material”, but claims 2-8 only refer to the “hydrophilic material”. Claims 2-8 should refer to the “dissolvable hydrophilic material” for consistent language.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tenerz (US 6167763) and Hastings (US 5450853), as evidenced by Cleveland Clinic (“Saline Solution”) and Yamaguchi et. al. (“Polyethylene Oxide (PEO) and Polyethylene Glycol (PEG) Polymer Sieving Matrix for RNA Capillary Electrophoresis”).
Regarding claims 1-6, Tenerz discloses a method for preparing a sensor wire, the method comprising:
providing a sensor wire configured for biological pressure measurement and comprising:
an elongated member (Fig. 4, tube 21), and
a pressure sensor configured for biological pressure measurement, the pressure sensor being mounted at a distal end portion of the elongated member (Fig. 4, sensor element 19 situated at distal end of tube 21), and
submerging the pressure sensor in saline solution (Col 5, lines 36-41, wherein blood is allowed in the free space around the sensor. Applicant defines the fluids that enter the tube as water, blood, or saline (Paragraph 0126). As evidenced by Cleveland Clinic, normal saline and human blood have the same balance of water and salt (Page 1, paragraph 5). As such, Tenerz submerging the pressure sensor in the blood would read on the limitation of submerging the pressure sensor in saline as the blood contains the same water/salt balance of saline).
Tenerz as evidenced by Cleveland Clinic fails to disclose a dissolvable hydrophilic material coated on a surface of the pressure sensor, whereby the hydrophilic material dissolves and causes the saline solution to contact the pressure sensor.
Regarding the limitations of claims 2-6, Tenerz discloses a pressure sensor membrane (Fig. 4, membrane M). Tenerz fails to disclose that the hydrophilic material is coated on a surface of the pressure sensor membrane. Tenerz also fails to disclose wherein the hydrophilic material comprises at least one of polyethylene glycol, polyvinvyl alcohol, polyvinylpyrrolidone, carboxymethyl cellulose, hydroxypropyl cellulose, a polysaccharide, and/or a salt, but particularly polyethylene glycol.
Tenerz and Hastings are in the same field of pressure sensors. Hastings teaches a pressure sensor with a dissolvable, water-soluble polymer that hardens when placed in the tubular member of the sensor to form an interface between the ferrofluid and the environment. The interface prevents evaporation of the ferrofluid, thereby protecting the sensor before use. When the guide wire and pressure sensor are used on a patient, the water soluble polymer dissolves for the sensor to become functional (Col 9, lines 35-48). Hastings suggests an example of a hydrophilic, dissolvable polymer as polyethylene oxide (PEO). While Hastings does not explicitly state polyethylene glycol (PEG), PEG is known to be the same structure of PEO, but PEO has a higher molecular weight, as evidenced by Yamaguchi (Page 3, Results and Discussion section, paragraph 1). The sensor with a membrane of Tenerz in combination with the polymer of Hastings, the polymer would necessarily be coated on the surface of the membrane of the sensor. As Tenerz discloses the guide wire with a pressure sensor and suggests protecting the sensor with an elastic medium (Col 6, line 62 – Col 7, line 6), Hastings teaches a dissolvable protective polymer to protect the sensor before use but will dissolve to expose the sensor. Tenerz would benefit from this dissolvable polymer to protect the sensor but dissolve and expose the sensor when in use. Therefore, 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 guide wire and pressure sensor of Tenerz as evidenced by Cleveland Clinic to incorporate the dissolvable, water-soluble polymer taught by Hastings as evidenced by Yamaguchi, the benefit being protecting the sensor before use and exposing the sensor while in use.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tenerz (US 6167763) and Hastings (US 5450853), as evidenced by Cleveland Clinic (“Saline Solution”) and Yamaguchi et. al. (“Polyethylene Oxide (PEO) and Polyethylene Glycol (PEG) Polymer Sieving Matrix for RNA Capillary Electrophoresis”) as applied to claims 1-2 above, and further in view of Steinberg (US 8980278).
Regarding claims 7-8, Tenerz as modified suggests the PEG and PEO are the same material, but fails to explicitly disclose wherein the hydrophilic material comprises 20,000 g/mol PEG.
Steinberg is reasonably pertinent to Tenerz and Hastings. Tenerz and Hastings are concerned with protecting a pressure sensor with a coating, with Hastings explicitly teaching the polyethylene oxide as the hydrophilic, dissolvable coating. Steinberg teaches a PEG and/or POE dissolvable polymer with a preferable molecular weight of about 300 g/mol to 10,000,000 g/mol, more preferably between 20 to 40 kilodaltons (20,000 – 40,000 g/mol) (Col 28, lines 37-49). Steinberg discusses that the increase in molecular weight will result in higher viscosity of the PEG and in the formation of a PEG gel (Col 4, lines 5-13). As Tenerz and Hastings are concerned with applying a hydrophilic, dissolvable PEG/PEO coating to the sensor, Steinberg teaches that a PEG/PEO polymer with a higher molecular weight, such as 20,000 – 40,000 g/mol will result in a high viscosity liquid and/or gel. This would benefit Tenerz modified by Hastings as the high viscosity liquid and/or gel would be a more stable coating prior to dissolving in saline/blood. Therefore, 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 sensor coating of Steinberg and Hastings as evidenced by Cleveland Clinic and Yamaguchi to incorporate the high molecular weight PEG/PEO polymer taught by Steinberg, the benefit being a more stable coating.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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