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 .
Status of Claims
The examiner acknowledges the amendments to claims 1, 7-8, and 11-12 and the cancellation of claims 6 and 10. Claims 1-5, 7-9, and 11-13 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 7-9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Giles (US 20180008251) in view of Mather (US 20080085946) and Liu (IEEE Transactions on Applied Superconductivity (2016) volume 26 4402804).
Regarding Claims 1-5 and 11,
Giles teaches a device in which a tube has a chiral helix cut into the tube (Paragraph 35, reads upon a thread-like device) in which the tubular device is comprised of a shape memory polymer (Paragraph 26) which may be a polyurethane (Paragraph 26) and that this material can be controlled using Joule heating with wires connecting the ends of the shape memory material (Paragraph 283), which reads on a heat conducting device.
Giles does not teach that the shape memory polymer is a polyurethane that contains a mercaptoester. However, Mather teaches a shape memory polymer comprised of NOA 63 (Paragraph 65, Examples 1-8) which contains allyl ether capped polyurethanes and pentaerythritol tetra(3-mercaptopropionate), a multithiol component meeting the requirements of Component B of claim 3. As this particular composition is disclosed by the applicant in the specification as containing triallyl isocyanurate (multi alkene containing Component A of Claim 2 and 3) and providing especially good results (Spec. Page 12 Line 28 to Page 13 Line 3), it would logically follow that the polymer meets the requirements of claims 1-4. Additionally, Mather teaches that the polymer composition may include thermally and electrically conductive fillers (Paragraph 47), meeting the requirements of claim 5. Finally, Mather teaches that shape memory polymers can “memorize” a particular shape, be shaped into a temporary configuration under certain temperature or stress conditions, then revert back to their originally shape under thermal stimulus (Paragraph 2). One of ordinary skill in the art would recognize that the composition of Mather is a polyurethane based shape memory polymer and would thus fit the requirements laid out by Giles for the polymer composition. Finally, as Giles discloses that the tube is suitable as a conduit for delivery of therapeutic agents (Paragraph 47), it would necessarily follow that the tube would be solid in the longitudinal direction. As such, it would have been obvious prior to the effective filing date of the instant application to have used the polymer composition disclosed by Mather in the device disclosed by Giles for the suitability and requirements noted above.
With regard to the heat conducting member, Giles teaches temperature can be used to result in shape changing (Paragraph 35) and that Joule heating is an exemplary method for this shape change (Paragraph 211). Further, Giles teaches that this can be accomplished by attaching the shape memory element to wires (Paragraph 283). Because Giles discloses the use of Joule heating as well as describing the structure containing a shape-memory material that can be altered into different shapes, it would have been obvious to have arranged the device in such a fashion to meet the requirements of the instant claim. See MPEP 2144.04.VI.C.
Finally, with regard to the use of magnets and a magnetic field, Giles teaches displacement through the means of magnetic fields (Paragraph 36) and further notes that magnetic field strength may be used to change the local environment of the shape-memory material (Paragraph 214). However, Giles does not teach that the magnetic field controls the distal end of the device. Liu teaches the addition of magnetized NdBFe magnets into the catheter tip (Page 3, Left Column, Section D, first paragraph) which can then be manipulated using an external magnetic field (Page 3, Right Column, Section D, paragraphs 2 and 3). Liu teaches that this technique is useful for controlled delivery of therapeutics and for catheter control during cardiac surgeries (Page 1, Left Column, Introduction Section, first paragraph). The ordinarily skilled artisan would recognize that because Giles teaches the incorporation of magnetic materials into the device as well as their use for controlling the device, these magnets could be utilized in a fashion that allows for an external magnetic field to be used for control. As such, an ordinarily skilled artisan would be motivated to add this functionality to the device as taught by Giles in view of Maher in order to provide additional device control. As such, it would have been obvious to have combined the magnets as taught by Liu with the device of Giles prior to the effective filing date of the instant application to obtain the predictable result of a device comprised of a shape memory polymer that can be controlled through externally applied magnetic fields with a reasonable expectation of success.
Regarding Claim 7,
Giles teaches that wire 14119 used to apply current to the shape memory polymer 14116 is disposed inside of the shape memory polymer as shown in figures 43D and 43E (Paragraph 287).
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Regarding Claims 8 and 9,
Giles discloses in Figures 27A and 27B a camera 181 and light source 182 that are connected via conduits 184 and 185 (Paragraph 228) and further teaches that these conduits can be used for passage of instruments (Paragraph 228).
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Regarding Claims 12 and 13,
Giles in view of Mather teach the limitations of claim 5 above. Giles teaches that the shape memory material can be controlled through Joule heating (Paragraph 283) in which the proximal end is connected to one wire with the distal end containing a conductive band (Paragraph 283). Giles also teaches that this band can be made of a variety of metals or metal alloys (Paragraph 283). The wire connections read on electrodes, meeting the requirements of the instant claims. Further, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to have arranged the electrode across the thermoset materials as a matter of design choice.
In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice) MPEP2144.04(VI)(c)
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive for the following reasons.
On page 6, the applicant states that Giles does not teach or suggest a material that can be changed into a desired shape, but only into pre-shaped forms. The examiner disagrees. By virtue of the use of a shape-memory material that can be changed from one shape to another, the material, it would logically follow, would be capable of adopting a variety of different shapes, not simply a small selection. As Mather utilizes a material substantially similar to that of the applicants, this would appear to be the case.
Also on page 6, the applicant’s state that there would be no motivation to combine Giles and Mather. The examiner points out that Giles teaches the use of shape memory polymers, and while exemplifying a different polymer than that of the instant application, points out that the choice of polymer is not limited simply to this selection (Paragraph 214). Mather points out that the choice of shape memory polymer can alter the temperature at which the shape changes occur (Paragraph 2), providing the ordinarily skilled artisan the motivation to use a different material for applications in which a higher or lower temperature would be advantageous.
On pages 6 and 7, the applicant states that Giles does not teach a shape memory material that extends longitudinally and contains a heat conducting member. However, Giles teaches that the shape memory material is contained in the distal end of the device and also speaks its presence at the helix (Paragraph 214) and as such, would imply that this material is present along the longitudinal axis. Further, Giles discloses the use of Joule heating of this material as discussed in the above rejection. Because the heating element is described to be used in the alteration of the shape memory polymer, it would logically follow that it could be used along the entirety of the device containing this polymer.
On pages 7 and 8, the applicant argues that the wire in the presented figure would not represent the same element as the applicant. However, this claim has been cancelled and as such, the argument is moot.
Finally, on pages 10 and 11, the applicant argues that Giles and Liu cannot be combined without fundamentally changing the operation of the device taught by Giles. The examiner disagrees. In fact, Giles discloses multiple options for the maneuvering and motion of the device, including the use of magnets in the device. Giles does not in fact teach away from the addition of other control mechanisms and would appear to afford the ordinarily skilled artisan a large degree of freedom in terms of device modification and further discloses that the device contain a means for counteracting the shape transformation (Paragraph 35). As such, there would not appear to be any prohibition on the use of magnetic field control in addition to the dual helix design utilized by Giles, and when used in combination, would not fundamentally change the operation of the device, but rather would provide an additional control mechanism.
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 ADAM J BERRO whose telephone number is (703)756-1283. The examiner can normally be reached M-F 8:30-5.
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/A.J.B./ Examiner, Art Unit 1765
/HEIDI R KELLEY/ Supervisory Patent Examiner, Art Unit 1765