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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-12, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Strong (U.S. Patent 6,083,152) in view of Hunter et al (U.S. Patent Application Publication 2021/0370581, hereinafter “Hunter”). Regarding claim 1, Strong teaches a method of manufacturing a medical device, comprising:
providing a sheath (column 2 lines 5-6 detail a braid (sheath) placed over a spiral tube)
positioning the tube around the sheath, such that the inner first layer is closer to the sheath than the outer second layer is (column 2 lines 9-16 detail a two layered tube around the braided layer)
applying heat to the tube or the sheath, such that the inner first layer penetrates into the sheath (column 2 lines 17-21 details the application of heat to shrink the tube into the braided sheath)
Strong fails to teach a method of manufacturing a medical device comprising providing a tube including an inner first layer and an outer second layer wherein the inner first layer is more susceptible to melting than the outer second layer.
Hunter teaches a method of manufacturing a medical device comprising providing a tube including an inner first layer and an outer second layer wherein the inner first layer is more susceptible to melting than the outer second layer (paragraph 4 details an outer layer that contracts when exposed to heat and an inner layer that melts upon exposure to heat). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the tube of Strong with the inner layer being more susceptible to melting of Hunter in order to provide for proper sealing of the tubular layers about the inner component (inner layer fills all the gaps, and outer layer seals the inner layer in place while preventing melting out beyond the edges of the tube), as stated in paragraph 4 of Hunter.
Regarding claim 2, Strong further teaches a method wherein the sheath is a braided sheath (column 2 lines 5-6 detail a braid (sheath) placed over a spiral tube), and wherein applying heat to the tube or the sheath causes the inner first layer to penetrate into open spaces of the braided sheath (column 2 lines 17-21 details the application of heat to shrink the tube into the braided sheath).
Regarding claim 3, Strong and Hunter combined teach the limitations of claim 1, and Hunter further teaches a method wherein the inner first layer includes a non-cross linked polymer (paragraph 50 lists non-cross linked polymers that can make up the inner layer). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the inner layer of Strong to be non-cross linked in order to produce an inner layer that is more susceptible to melting in comparison with a cross-linked outer layer, creating a tighter heat shrink fit over the inner member.
Regarding claim 4, Strong and Hunter combined teach the limitations of claims 1 and 3, and Strong further teaches a method wherein the outer second layer includes a cross linked polymer (column 2 lines 9-16 detail the outer layer being composed of a cross linked polymer).
Regarding claim 5, Strong further teaches a method wherein the tube includes an adhesive layer between the inner first layer and the outer second layer (column 2 lines 52-55 detail use of activated solvents (adhesive layer) to cross link the two layers into one tubular polymeric section).
Regarding claim 6, Strong further teaches a method wherein the inner first layer is chemically bonded to the outer second layer (column 2 lines 52-55 details cross linking (chemical bonding) the two layers into one tubular polymeric section).
Regarding claim 7, Strong and Hunter combined teach the limitations of claim 1, and Hunter further teaches a method wherein, as heat is applied to the tube, the outer second layer contacts the sheath and inhibits the inner first layer from flowing deeper into the sheath (paragraph 4 details physical properties of a two layer heat shrink tube, where the outer layer contracts around a melting inner tube layer and the outer layer prevents overflow of the inner layer). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the heat shrink tube of Strong with an outer layer that contacts the sheath and prevents the inner first layer from flowing further into the sheath in order to provide for proper sealing of the tubular layers about the inner component (inner layer fills all the gaps, and outer layer seals the inner layer in place while preventing melting out beyond the edges of the tube), as stated in paragraph 4 of Hunter.
Regarding claim 8, Strong fails to explicitly disclose wherein the inner first layer thickness is equal to or less than the sheath thickness.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to set the thickness of the inner first layer to be equal to or less than the sheath thickness 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 sheath and layer configuration would not operate differently with the claimed thickness of the first inner layer being equal to or less than the thickness of the sheath. Further, Applicant places no criticality on the range claimed, indicating that, in paragraph 7 of the applicant’s specification, “the sheath may have a sheath thickness and the first layer may have a first layer thickness. The first layer thickness may be equal to or less than the sheath thickness”, without stating a reason for doing so that disqualifies another range from being used.
Regarding claim 9, Strong and Hunter combined teach the limitations of claim 1, and Hunter further teaches a method wherein the inner first layer includes a first material, wherein the outer second layer includes a second material, and wherein each of the first material and the second material is from a same family of elastomers (paragraphs 45 and 50 detail, respectively, materials to be used to make up the outer and inner layers, and among other families of elastomers, both list fluoropolymers). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the layers of Strong with the fluoropolymer materials of Hunter in order to create a two layer configuration with similar overall properties, but the ability to control specific properties such as melting temperature depending on the elastomer chosen within the fluoropolymer family, allowing the two layers to work together while each having a different purpose (inner layer melts first while outer layer contracts around it).
Regarding claim 10, Strong and Hunter combined teach the limitations of claim 1, and Hunter further teaches a method wherein the tube is positioned directly around the sheath (paragraph 6 and 54 detail use of the heat shrink tubing to encapsulate any underlying components), such that the tube directly contacts the sheath (the tubing is designed to directly contact the underlying component after heat is applied, shrinking the tubing to cover the underlying component). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the tubing of Strong with the direct contact with the underlying component of Hunter in order to create an adaptable heat shrink tubing that may be used in a variety of encapsulation implementation, whereas Strong requires a layer of adhesive between the sheath and tube.
Regarding claim 11, Strong fails to explicitly disclose a method wherein the outer second layer has a greater molecular weight than the inner first layer.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the outer second layer have a greater molecular weight than the inner first layer 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 outer and inner layers would not operate differently with the claimed difference in molecular weight. Further, Applicant places no criticality on the range claimed, indicating that, in paragraphs 7 and 36 of the applicant’s specification that the outer second layer may have a greater molecular weight than the inner first layer, without stating a reason for said weight relationship or that a different relationship would not work.
Regarding claim 12, Strong fails to explicitly disclose a method wherein the outer second layer has a higher durometer than the inner first layer.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to set the durometer of the outer second layer has a higher than that of the inner first layer 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 inner and outer layers would not operate differently with the claimed higher durometer of the outer second layer than that of the inner first layer. Further, Applicant places no criticality on the range claimed, indicating that, in paragraph 36 of the applicant’s specification, the claimed durometer relationship may be created, without stating a reason for the durometer relationship or that a different one would not work.
Regarding claim 15, Strong further teaches a method wherein heat is applied to the sheath, such that the sheath inductively heats the tube (abstract details the placement of the tube over the braided sheath and the use of heat to shrink bond the tube to the sheath, if the entire system is heated as stated in the abstract, it is understood that the metallic braided sheath would, through contact with the tube, also inductively heat the tube as heat is applied to the overall system).
Regarding claim 16, Strong teaches a medical device shaft comprising:
a braided sheath (column 2 lines 5-6 detail a braid (sheath) placed over a spiral tube)
and wherein the inner first layer is bonded to the outer second layer by an adhesive or a chemical bond (column 2 lines 52-55 details cross linking (chemical bonding) the two layers into one tubular polymeric section)
Strong fails to teach a medical device shaft comprising:
a tube having an inner first layer and an outer second layer, wherein the inner first layer is more susceptible to melting than the outer second layer
wherein an inner surface of the outer second layer contacts an outer surface of the braided sheath,
wherein the inner first layer extends at least partially through a thickness of the braided sheath
Hunter teaches a medical device shaft comprising:
a tube having an inner first layer and an outer second layer, wherein the inner first layer is more susceptible to melting than the outer second layer (paragraph 4 details an outer layer that contracts when exposed to heat and an inner layer that melts upon exposure to heat)
wherein an inner surface of the outer second layer contacts an outer surface of the braided sheath (paragraph 4 details the melting of the inner layer into the gaps of the underlying component with the outer layer contracting to be fitted around the underlying component)
wherein the inner first layer extends at least partially through a thickness of the braided sheath (paragraph 4 details the melting of the inner layer to encapsulate the underlying component)
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the tube of Strong with the melting inner layer and contracting outer layer of Hunter in order to provide for proper sealing of the tubular layers about the inner component (inner layer fills all the gaps, and outer layer seals the inner layer in place while preventing melting out beyond the edges of the tube), as stated in paragraph 4 of Hunter.
Regarding claim 17, Strong and Hunter combined teach the limitations of claim 16, and Hunter further teaches a medical device wherein a material the inner first layer is more susceptible to melting than a material of the outer second layer (paragraph 4 details an outer layer that contracts when exposed to heat and an inner layer that melts upon exposure to heat). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the tube of Strong with the inner layer being more susceptible to melting of Hunter in order to provide for proper sealing of the tubular layers about the inner component (inner layer fills all the gaps, and outer layer seals the inner layer in place while preventing melting out beyond the edges of the tube), as stated in paragraph 4 of Hunter.
Regarding claim 18, Strong and Hunter combined teach the limitations of claim 16, and Hunter further teaches a medical device wherein the outer second layer is formed from a material configured to shrink when exposed to a predetermined temperature, and the inner first layer is formed from a material configured to become flowable when exposed to the predetermined temperature (paragraph 4 details an outer layer that contracts when exposed to heat and an inner layer that melts upon exposure to heat). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the tube of Strong with the inner layer being more susceptible to melting of Hunter in order to provide for proper sealing of the tubular layers about the inner component (inner layer fills all the gaps, and outer layer seals the inner layer in place while preventing melting out beyond the edges of the tube), as stated in paragraph 4 of Hunter.
Regarding claim 19, Strong teaches a medical device shaft comprising:
a coil or flexible tube (column 2 line 4 details a spiral tube)
a braided sheath radially surrounding the coil or flexible tube (column 2 lines 5-6 detail a braid (sheath) placed over a spiral tube)
an outer second layer comprising a crosslinked polymer, wherein the inner first layer is bonded to the outer second layer (column 2 lines 9-16 detail the outer layer being composed of a cross linked polymer and column 2 lines 52-55 detail cross linking (chemical bonding) the two layers into one tubular polymeric section).
Strong fails to teach:
an inner first layer comprising a non-crosslinked polymer
wherein the inner first layer extends at least partially through a thickness of the braided sheath and terminates at a point radially outward of an outer surface of the coil or flexible tube
wherein an inner surface of the outer second layer contacts an outer surface of the braided sheath
Hunter teaches:
an inner first layer comprising a non-crosslinked polymer (paragraph 50 lists non-cross linked polymers that can make up the inner layer)
wherein the inner first layer extends at least partially through a thickness of the braided sheath and terminates at a point radially outward of an outer surface of the coil or flexible tube (paragraph 4 details the melting of the inner layer into the gaps of the underlying component to coat said component, and as the coil/flexible tube is radially within the underlying component, the inner layer would terminate radially outward of an outer surface of the coil/flexible tube)
wherein an inner surface of the outer second layer contacts an outer surface of the braided sheath (paragraph 4 details the melting of the inner layer into the gaps of the underlying component with the outer layer contracting to be fitted around the underlying component)
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the inner layer of Strong to be non-cross linked in order to produce an inner layer that is more susceptible to melting in comparison with a cross-linked outer layer, creating a tighter heat shrink fit over the inner member, and to modify the layers so that the inner layer terminates radially outward of the coil/flexible tube while the outer layer contacts the braided sheath in order to completely encapsulate, without gaps, the underlying component in order to ensure a proper seal during use of the medical device.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Strong and Hunter in view of Yamasaki et al (U.S. Patent Application Publication 2019/0351639, hereinafter “Yamasaki”). While Strong and Hunter combined teach the limitations of claim 1, they fail to teach a method wherein the inner first layer includes an inhibitor. Yamasaki teaches a method wherein the inner first layer includes an inhibitor (paragraph 76 details the use of inhibitors within the inner layer of the heat shrink tube). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the inner layer of Strong and Hunter with the inhibitor of Yamasaki in order to preserve the final heat shrink wrapped device, as the copper inhibitor of Yamasaki promotes device longevity within use.
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Strong and Hunter in view of Luning et al (U.S. Patent Application Publication 2020/0306502, hereinafter “Luning”). Regarding claim 14, while Strong and Hunter combined teach the limitations of claim 1, they fail to teach a method wherein the outer second layer is vulcanized. Luning teaches a method wherein the outer second layer is vulcanized (paragraph 23 details using a vulcanized material to compose the outer layer). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the outer layer of Strong and Hunter to be made of up vulcanized material like that of Luning in order to preserve the final heat shrink wrapped device, as the vulcanization of the outer layer material in Luning creates a more durable polymer layer.
Regarding claim 20. Strong and Hunter combined teach the limitations of claim 19, but fail to teach a medical device shaft wherein the inner first layer includes an inhibitor or the outer second layer is vulcanized. Luning teaches a medical device shaft wherein the outer second layer is vulcanized (paragraph 23 details using a vulcanized material to compose the outer layer). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the outer layer of Strong and Hunter to be made of up a vulcanized material like that of Luning in order to preserve the final heat shrink wrapped device, as the vulcanization of the outer layer material in Luning creates a more durable polymer layer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM EST Monday-Friday.
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 Carey can be reached at 5712707235. 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.
/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights