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 .
Response to Amendment
Examiner acknowledges the reply filed 05/06/2026. The response includes claim amendments and arguments, addressed below.
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.
Claims 1, 3, 5-7, 10 and 14-17 are rejected under 35 U.S.C. 103 as being anticipated by Ethelfeld et al (U.S. Pat. 2009/0048563 A1, hereinafter “Ethelfeld”) in view of Plastics Today (“PLA/TPU blends studied as shape memory polymers”, 2013, hereinafter “Plastics Today”).
Regarding claim 1, Ethelfeld discloses an instrument (a multi-material biological catheter shown in Figs. 16A-16B and described in para [0098]) for piercing skin of a user and carrying a medicament to the user (see Figs. 16C-16E, showing the catheter attached to a delivery device placed on the skin, and see para [0098] describing the catheter as “for subcutaneous drug delivery”), comprising:
a cylindrical body having an inner lumen for carrying the medicament (shown as catheter 1101 in Fig. 16A; catheters are known to be cylindrical with lumens, and such a lumen is also shown in Fig. 16A);
a piercing element secured to or formed on a distal end of the cylindrical body (see sharp tip shown in Fig. 16A) to pierce the skin of the user and position the instrument at least partially under the skin of the patient (see para [0098] disclosing that “the catheter walls are completely stiff and strong with a sharp cutting edge before insertion”); and
wherein the cylindrical body is coated with a dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user (see Fig. 16b, showing a support coating 1112 which is "formed from a material having an initial relative rigid state providing a support for the cannula during insertion through the skin of a subject, and a second relatively flexible state when subjected to body conditions" such as the influence of body temperature).
It is noted that Ethelfeld does not explicitly disclose that the cylindrical body is formed of a material that is rigid prior to exposure to body fluids and/or body heat and softens when the material is under the skin of the user. Further, as per claim 3, Ethelfeld does not explicitly disclose that such material is polytetrafluoroethylene (PTFE), high density polyethylene (HDPE), a polysaccharide, a polyhydroxyalkanoate (PHA), a polylactic acid.
Plastics Today discloses that polylactic acid (PLA) based blended materials (70% or 80% by weight PLA blended with TPU) were studied and shown to have successfully demonstrated promising shape memory properties. Plastics Today discusses these potential advantages in the area of medical devices, including catheters that are “stiff outside the human body and then [become] softer and more comfortable inside the human body”.
A skilled artisan would have found it obvious at the time of the invention to choose PLA as the material from which the cylindrical body is formed, with a reasonable expectation of success in providing a desired shape memory characteristic with advantageous mechanical properties that requires no more than commonly used medical plastic.
Further, it has been held that the selection of a known material based on its suitability for its intended use may support a prima facie obviousness determination in (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). In this case, the commonly used medical plastics PLA and TPU were shown to have suitable shape memory polymers for medical devices.
Regarding claim 5, Ethelfeld discloses the instrument of claim 2, wherein the piercing element includes at least a portion 1111/1112 (see Figs. 16A or 16B) that is hardened (see para [0098] disclosing that the portion 1111/1112 is a “support” that is initially “rigid” to provide support for the catheter during insertion through the skin of the subject).
Regarding claim 6, Ethelfeld discloses the instrument of claim 1, wherein the piercing element is coated with a hardening coating that is configured to dissolve or degrade when positioned under the skin of the user (see para [0098], disclosing that the catheter has two or more materials layered in the manner shown in Fig. 16A or 16B, and “one material” of the two or more materials is a “a bioplastic which is dissolved by the influence of the body or insulin”; therefore Ethelfeld contemplates that the cannula can either be on the interior or the exterior of the catheter).
Regarding claim 7, Ethelfeld discloses the instrument of claim 1, wherein the piercing element has a point or a sharpened edge (see Fig. 16A-16B and para [0098] disclosing the “sharp cutting edge” of the piercing element).
Regarding claim 10, Ethelfeld discloses a medicament delivery device, comprising:
a reservoir 2233 (see Fig. 28F) for storing medicament (such as insulin; see para [0034]);
instrument (a multi-material biological catheter shown in Figs. 16A-16B and described in para [0098]) for piercing skin of a user of the medicament delivery device and for remaining at least partially under the skin of the patient (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle); and
a piercing element secured to or formed on an end of the cylindrical body (see sharp tip shown in Fig. 16A) to pierce the skin of the user and position the instrument at least partially under the skin of the patient (see para [0098] disclosing that “the catheter walls are completely stiff and strong with a sharp cutting edge before insertion”); and
wherein the cylindrical body is coated with a dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user (see Fig. 16b, showing a support coating 1112 which is "formed from a material having an initial relative rigid state providing a support for the cannula during insertion through the skin of a subject, and a second relatively flexible state when subjected to body conditions" such as the influence of body temperature).
It is noted that Ethelfeld does not explicitly disclose that the cylindrical body is formed of a material that is rigid prior to exposure to body fluids and/or body heat and softens when the material is under the skin of the user.
Plastics Today discloses that polylactic acid (PLA) based blended materials (70% or 80% by weight PLA blended with TPU) were studied and shown to have successfully demonstrated promising shape memory properties. Plastics Today discusses these potential advantages in the area of medical devices, including catheters that are “stiff outside the human body and then [become] softer and more comfortable inside the human body”.
A skilled artisan would have found it obvious at the time of the invention to choose PLA as the material from which the cylindrical body is formed, with a reasonable expectation of success in providing a desired shape memory characteristic with advantageous mechanical properties that requires no more than commonly used medical plastic.
Further, it has been held that the selection of a known material based on its suitability for its intended use may support a prima facie obviousness determination in (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). In this case, the commonly used medical plastics PLA and TPU were shown to have suitable shape memory polymers for medical devices.
Regarding claim 14, Ethelfeld discloses the instrument of claim 11, wherein the piercing element includes at least a portion 1111/1112 (see Figs. 16A or 16B) that is hardened (see para [0098] disclosing that the portion 1111/1112 is a “support” that is initially “rigid” to provide support for the catheter during insertion through the skin of the subject).
Regarding claim 15, Ethelfeld discloses the instrument of claim 10, wherein the piercing element is coated with a hardening coating that is configured to dissolve or degrade when positioned under the skin of the user (see para [0098], disclosing that the catheter has two or more materials layered in the manner shown in Fig. 16A or 16B, and “one material” of the two or more materials is a “a bioplastic which is dissolved by the influence of the body or insulin”; therefore Ethelfeld contemplates that the cannula can either be on the interior or the exterior of the catheter).
Regarding claim 16, Ethelfeld discloses the instrument of claim 10, wherein the piercing element has a point or a sharpened edge (see Fig. 16A-16B and para [0098] disclosing the “sharp cutting edge” of the piercing element).
Regarding claim 17, Ethelfeld discloses the medicament delivery device of claim 10, wherein the medicament delivery device is configured for delivering insulin to the user (see para [0034]).
Claims 1, 7-10, 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeStefano (U.S. Pub. 2007/0088254 A1, hereinafter “DeStefano”) in view of Ethelfeld.
Regarding claim 1, DeStefano discloses an instrument (such as a cannula 110; see Fig. 3) for piercing skin of a user and carrying a medicament to the user (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle; and see para [0042] disclosing that insulin is delivered through the cannula), comprising:
a cylindrical body (taking the form of the cannula 110, which is known to be cylindrical) having an inner lumen for carrying the medicament (lumens are known to be present in cannulae);
a piercing element secured to or formed on a distal end of the cylindrical body to pierce the skin of the user and position the instrument at least partially under the skin of the patient (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle;); and
wherein the cylindrical body is formed of a material that is rigid prior to exposure to body fluids and/or body heat and softens when the material is under the skin of the user (see para [0030], disclosing that the cannula 110 is constructed from nitinol, which enters a soft and bendable martensite phase at body temperature of about 37 degrees C; and see para [0034], disclosing that the alloy becomes super-elastic, i.e., enters is martensite phase, when placed inside the human body).
It is noted that DeStefano does not appear to disclose that the cylindrical body is coated with a dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user.
Ethelfeld discloses an instrument (a multi-material biological catheter shown in Figs. 16A-16B and described in para [0098]) for piercing skin of a user and carrying a medicament to the user (see Figs. 16C-16E, showing the catheter attached to a delivery device placed on the skin, and see para [0098] describing the catheter as “for subcutaneous drug delivery”), comprising:
a cylindrical body having an inner lumen for carrying the medicament (shown as catheter 1101 in Fig. 16A; catheters are known to be cylindrical with lumens, and such a lumen is also shown in Fig. 16A);
wherein the cylindrical body is coated with a dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user (see Fig. 16b, showing a support coating 1112 which is "formed from a material having an initial relative rigid state providing a support for the cannula during insertion through the skin of a subject, and a second relatively flexible state when subjected to body conditions" such as the influence of body temperature).
A skilled artisan would have found it obvious at the time of the invention to modify the instrument of DeStefano so that the cylindrical body is coated with dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user, in order to provide an additional support for the needle or cannula upon insertion into the skin, while permitting the needle or cannula of DeStefano to perform its intended function of softening to its martensite phase when placed inside the human body (see DeStefano at para [0098]).
Regarding claim 7, DeStefano discloses the instrument of claim 1, wherein the piercing element has a point or a sharpened edge (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle).
Regarding claim 8, DeStefano discloses that the instrument includes one or more activatable elements that may be activatable to make at least a portion of the instrument rigid to facilitate piercing of the skin of the user (the one or more activatable elements are, for example, the nitinol material discussed above with respect to claim 7).
Regarding claim 9, DeStefano discloses that the one or more activatable elements includes at least one shape memory alloy component that becomes rigid when electricity is applied to the at least one shape memory alloy component (i.e., the shape memory alloy is the nitinol discussed above, which is known to enter its more rigid austenite phase when electricity is applied to it (due to Joule heating from the applied electricity)).
Regarding claim 10, DeStefano discloses a medicament delivery device, comprising:
a reservoir for storing medicament (not shown, but disclosed in para [0042] to hold insulin to be pumped through a tubing assembly 116 and into the cannula 110);
an instrument (such as a cannula 110; see Fig. 3) for piercing skin of a user and carrying a medicament to the user (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle; and see para [0042] disclosing that insulin is delivered through the cannula) and for remaining at least partially positioned under the skin of the user for carrying the medicament to the user, the instrument comprising:
a cylindrical body (taking the form of the cannula 110, which is known to be cylindrical) having an inner lumen for carrying the medicament (lumens are known to be present in cannulae);
a piercing element secured to or formed on a distal end of the cylindrical body to pierce the skin of the user and position the instrument at least partially under the skin of the patient (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle;); and
wherein the cylindrical body is formed of a material that is rigid prior to exposure to body fluids and/or body heat and softens when the material is under the skin of the user (see para [0030], disclosing that the cannula 110 is constructed from nitinol, which enters a soft and bendable martensite phase at body temperature of about 37 degrees C; and see para [0034], disclosing that the alloy becomes super-elastic, i.e., enters is martensite phase, when placed inside the human body),
and a fluid path (such as an infusion set 100; see Fig. 1) connecting the reservoir with the instrument so that the medicament may pass from the reservoir to the instrument.
It is noted that DeStefano does not appear to disclose that the cylindrical body is coated with a dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user.
Ethelfeld discloses an instrument (a multi-material biological catheter shown in Figs. 16A-16B and described in para [0098]) for piercing skin of a user and carrying a medicament to the user (see Figs. 16C-16E, showing the catheter attached to a delivery device placed on the skin, and see para [0098] describing the catheter as “for subcutaneous drug delivery”), comprising:
a cylindrical body having an inner lumen for carrying the medicament (shown as catheter 1101 in Fig. 16A; catheters are known to be cylindrical with lumens, and such a lumen is also shown in Fig. 16A);
wherein the cylindrical body is coated with a dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user (see Fig. 16b, showing a support coating 1112 which is "formed from a material having an initial relative rigid state providing a support for the cannula during insertion through the skin of a subject, and a second relatively flexible state when subjected to body conditions" such as the influence of body temperature).
A skilled artisan would have found it obvious at the time of the invention to modify the instrument of DeStefano so that the cylindrical body is coated with dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user, in order to provide an additional support for the needle or cannula upon insertion into the skin, while permitting the needle or cannula of DeStefano to perform its intended function of softening to its martensite phase when placed inside the human body (see DeStefano at para [0098]).
Regarding claim 16, DeStefano discloses the medicament delivery device of claim 10, wherein the piercing element of the instrument either has a point or a sharpened edge (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle).
Regarding claim 17, DeStefano discloses the medicament delivery device of claim 10, wherein the medicament delivery device is configured for delivering insulin to the user (see para [0042] disclosing that insulin is delivered through the cannula).
Regarding claim 18, DeStefano discloses that the instrument includes one or more activatable elements that may be activatable to make at least a portion of the instrument rigid to facilitate piercing of the skin of the user (the one or more activatable elements are, for example, the nitinol material discussed above with respect to claim 7).
Regarding claim 19, DeStefano discloses that the one or more activatable elements includes at least one shape memory alloy component that becomes rigid when electricity is applied to the at least one shape memory alloy component (i.e., the shape memory alloy is the nitinol discussed above, which is known to enter its more rigid austenite phase when electricity is applied to it due to Joule heating from the applied electricity).
Regarding claim 20, DeStefano discloses an insulin delivery device, comprising:
a reservoir for storing insulin (not shown, but disclosed in para [0042] to hold insulin to be pumped through a tubing assembly 116 and into the cannula 110);
a needle or cannula 110 (see Fig. 3) for piercing skin of a user of the insulin delivery device and for remaining at least partially positioned under the skin of the user for carrying the insulin to the user (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle; and see para [0042] disclosing that insulin is delivered through the cannula), the needle or cannula comprising:
a cylindrical body (taking the form of the cannula 110, which is known to be cylindrical) having an inner lumen for carrying the insulin (lumens are known to be present in cannulae);
a piercing element secured to or formed on a distal end of the cylindrical body to pierce the skin of the user and position the instrument at least partially under the skin of the patient (see para [0041], disclosing that the cannula 110 may be provided with a sharpened tip for piercing the skin without the need for an introducer needle;); and
wherein the cylindrical body is formed of a material that is rigid prior to exposure to body fluids and/or body heat and softens when the material is under the skin of the user (see para [0030], disclosing that the cannula 110 is constructed from nitinol, which enters a soft and bendable martensite phase at body temperature of about 37 degrees C; and see para [0034], disclosing that the alloy becomes super-elastic, i.e., enters is martensite phase, when placed inside the human body),
and a fluid path (such as an infusion set 100; see Fig. 1) connecting the reservoir with the needle or cannula so that the medicament may pass from the reservoir to the instrument.
It is noted that DeStefano does not appear to disclose that the cylindrical body is coated with a dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user.
Ethelfeld discloses an instrument (a multi-material biological catheter shown in Figs. 16A-16B and described in para [0098]) for piercing skin of a user and carrying a medicament to the user (see Figs. 16C-16E, showing the catheter attached to a delivery device placed on the skin, and see para [0098] describing the catheter as “for subcutaneous drug delivery”), comprising:
a cylindrical body having an inner lumen for carrying the medicament (shown as catheter 1101 in Fig. 16A; catheters are known to be cylindrical with lumens, and such a lumen is also shown in Fig. 16A);
wherein the cylindrical body is coated with a dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user (see Fig. 16b, showing a support coating 1112 which is "formed from a material having an initial relative rigid state providing a support for the cannula during insertion through the skin of a subject, and a second relatively flexible state when subjected to body conditions" such as the influence of body temperature).
A skilled artisan would have found it obvious at the time of the invention to modify the instrument of DeStefano so that the cylindrical body is coated with dissolvable or degradable coating that hardens the cylindrical body and that dissolves or degrades on a portion of the cylindrical body that is under the skin of the user, in order to provide an additional support for the needle or cannula upon insertion into the skin, while permitting the needle or cannula of DeStefano to perform its intended function of softening to its martensite phase when placed inside the human body (see DeStefano at para [0098]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over DeStefano, in view of Ethelfeld, further in view of Salehi et al (U.S. Pub. 2012/0289941 A1, hereinafter “Salehi”).
Regarding claim 12, it is noted that Ethelfeld, in view of Plastics Today, does not appear to disclose that the material, recited in claim 10, is polytetrafluoroethylene (PTFE).
Salehi discloses a medical device (stylet; see para [0104) that should have shape memory, and should be made from either a metal, a plastic or an alloy, where the plastic can be PTFE (see para [0104]).
Based on this teaching, a skilled artisan would have found it obvious at the time of the invention to choose PTFE as the material included in the cylindrical body that configured to soften upon being positioned at least partially under the skin of the user, with a reasonable expectation of success in providing a desired shape memory characteristic with advantageous mechanical properties that requires no more than commonly used medical plastic.
Further, it has been held that the selection of a known material based on its suitability for its intended use may support a prima facie obviousness determination in (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). In this case, PTFE was shown to have suitable shape memory polymers for medical devices.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over DeStefano, in view of Ethelfeld, further in view of Salehi.
Regarding claim 12, it is noted that DeStefano, in view of Ethelfeld, does not appear to disclose that the material, recited in claim 10, is polytetrafluoroethylene (PTFE).
Salehi discloses a medical device (stylet; see para [0104) that should have shape memory, and should be made from either a metal, a plastic or an alloy, where the plastic can be PTFE (see para [0104]).
Based on this teaching, a skilled artisan would have found it obvious at the time of the invention to choose PTFE as the material included in the cylindrical body or the piercing element that configured to soften upon being positioned at least partially under the skin of the user, with a reasonable expectation of success in providing a desired shape memory characteristic with advantageous mechanical properties that requires no more than commonly used medical plastic.
Further, it has been held that the selection of a known material based on its suitability for its intended use may support a prima facie obviousness determination in (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). In this case, PTFE was shown to have suitable shape memory polymers for medical devices.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot in view of the new grounds of rejection not relied upon in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. 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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 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, Chelsea Stinson can be reached at (571) 270-1744. 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.
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 05/19/2026
Prosecution Insights