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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/18/2026 has been entered.
Claim Objections
Claims 1, 10 and 20 are objected to because they recites "the dissolvable or degradable coating" which lacks antecedent basis in the claim (i.e., it appears before the mention of "a dissolvable or degradable coating" in each claim). The claims have not been rejected under 35 U.S.C. 112(b) because the scope of the would have been reasonably ascertainable by those skilled in the art. However, appropriate correction is required to provide antecedent basis for all claim terms, i.e., "a dissolvable or degradable coating" should be introduced in the claim before "the dissolvable or degradable coating".
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 6 and 15, the new matter is that "the piercing element is coated with a hardening coating that is configured to dissolve or degrade when positioned under the skin of the user." The piercing element with a pointed tip formed exclusively of the dissolvable or degradable coating, as recited in amended claim 1, was not described to be coated with another hardening coating. The hardening coating appears to coat only the cylindrical body (see Fig. 5B, step 524), not the piercing element.
For the purpose of examination, claims 6 and 15 will be interpreted to refer back to the coating recited in claims 1 and 10, respectively.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7 and 16, it is not clear how the limitation "the piercing element has a point or a sharpened edge" further limits respective claims 1 and 10, which was amended to recite that the piercing element, itself, includes "a pointed tip".
For the purpose of examination, claims 7 and 10 will be interpreted such that the piercing element terminates at a point or a sharpened edge.
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 Hague et al (U.S. Pat. 20020072720 A1, hereinafter “Hague”) in view of Plastics Today (“PLA/TPU blends studied as shape memory polymers”, 2013, hereinafter “Plastics Today”).
Regarding claims 1 and 6, Hague discloses an instrument 10 (see Fig. 1) for piercing skin of a user and carrying a medicament to the user, comprising:
a cylindrical body 300 having an inner lumen for carrying the medicament (see Figs. 6);
a piercing element (combination of cannula tip 304 and sharp tip 306; see Fig. 6) secured to or formed on a distal end of the cylindrical body (cannula tip 304 is formed at a distal end of the cylindrical body 300; see Fig. 6) to pierce the skin of the user and position the instrument at least partially under the skin of the patient (see para [0037], referring to a sharp tip "that is sufficiently sharp to allow substantially pain free insertion of the cannula 18 into the skin of the user”; the sharp tip in Fig. 6 performs the same function), the piercing element including a pointed tip 306 formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body (see Fig. 6, showing a coating 302 that extends the length of cannula 300 and then is formed into a pointed tip at 306; and see para [0047], disclosing that the coating 302 partially dissolves in use);
wherein the cylindrical body is coated with the same 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 para [0036], describing the aforementioned cannula to be "reinforced and stiffened" by the coating, and the coating provides a sharp tip that "pierces the skin and guides the stiffened cannula into the skin"; the coating then "dissolves in the bodily fluids of the user" such that the cannula "becomes flexible and dull so that there is minimal (or even a non-existent risk) of needle sticks upon removable of the infusion set from the skin of the user").
It is noted that Hague 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, Hague 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, Hague discloses the instrument of claim 1, wherein the piercing element includes at least a portion that is hardened (see para [0036], describing the aforementioned cannula to be "reinforced and stiffened" by the coating).
Regarding claim 7, Hague discloses the instrument of claim 1, wherein the piercing element terminates at a point or a sharpened edge (the aforementioned solid sharp tip 306).
Regarding claim 10 and 15, Hague discloses a medicament delivery device 10/1000/1010 (see Figs. 1/17/18), comprising:
a reservoir 16/1004/1102 (see Figs. 1/17/18) for storing medicament;
an instrument for piercing skin of a user and carrying a medicament to the user, the instrument comprising:
a cylindrical body 300/1008/1110 (see Figs. 1/17/18) having an inner lumen for carrying the medicament;
a piercing element (see Fig. 6, showing combination of cannula tip 304 and sharp tip 306; see Fig. 17, showing tip of cannula 1008 and sharp tip 1010; or see Fig. 18, showing tip of cannula 1110 and sharp tip 1114) secured to or formed on a distal end of the cylindrical body (in Figs. 6/17/18, the cannula tip is formed at 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 [0037], referring to a sharp tip "that is sufficiently sharp to allow substantially pain free insertion of the cannula 18 into the skin of the user”; the sharp tip in Figs. 6/17/18 perform the same function), the piercing element including a pointed tip 306 formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body (see Fig. 6, showing a coating 302 that extends the length of cannula 300 and then is formed into a pointed tip at 306; and see para [0047], disclosing that the coating 302 partially dissolves in use; see Fig. 17 showing coating 1010 with the same design; and see Fig. 18 showing coating 1114 with the same design);
wherein the cylindrical body is coated with the same 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 para [0036], describing the aforementioned cannula to be "reinforced and stiffened" by the coating, and the coating provides a sharp tip that "pierces the skin and guides the stiffened cannula into the skin"; the coating then "dissolves in the bodily fluids of the user" such that the cannula "becomes flexible and dull so that there is minimal (or even a non-existent risk) of needle sticks upon removable of the infusion set from the skin of the user").
It is noted that Hague 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, Hague discloses the device of claim 10, wherein the piercing element includes at least a portion that is hardened (see para [0036], describing the aforementioned cannula to be "reinforced and stiffened" by the coating).
Regarding claim 16, Hague discloses the device of claim 10, wherein the wherein the piercing element terminates at a point or a sharpened edge (the aforementioned solid sharp tip 306/1010/1114).
Regarding claim 17, Hague discloses the medicament delivery device of claim 10, wherein the medicament delivery device is configured for delivering insulin to the user (see para [0031]).
Regarding claim 20, Hague discloses an insulin delivery 10/1000/1010 (see Figs. 1/17/18 and para [0031]), comprising:
a reservoir 16/1004/1102 (see Figs. 1/17/18) for storing the insulin;
an needle or cannula for piercing skin of a user of the insulin delivery device and for remaining at least partially under the skin of the user for carrying the insulin to the user (as described below), the instrument comprising:
a cylindrical body 300/1008/1110 (see Figs. 1/17/18) having an inner lumen for carrying the insulin;
a piercing element (see Fig. 6, showing combination of cannula tip 304 and sharp tip 306; see Fig. 17, showing tip of cannula 1008 and sharp tip 1010; or see Fig. 18, showing tip of cannula 1110 and sharp tip 1114)) secured to or formed on a distal end of the cylindrical body (in Figs. 6/17/18, the cannula tip is formed at 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 [0037], referring to a sharp tip "that is sufficiently sharp to allow substantially pain free insertion of the cannula 18 into the skin of the user”; the sharp tip in Figs. 6/17/18 perform the same function), the piercing element including a pointed tip 306 formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body (see Fig. 6, showing a coating 302 that extends the length of cannula 300 and then is formed into a pointed tip at 306; and see para [0047], disclosing that the coating 302 partially dissolves in use; see Fig. 17 showing coating 1010 with the same design; and see Fig. 18 showing coating 1114 with the same design);
wherein the cylindrical body is coated with the same 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 para [0036], describing the aforementioned cannula to be "reinforced and stiffened" by the coating, and the coating provides a sharp tip that "pierces the skin and guides the stiffened cannula into the skin"; the coating then "dissolves in the bodily fluids of the user" such that the cannula "becomes flexible and dull so that there is minimal (or even a non-existent risk) of needle sticks upon removable of the infusion set from the skin of the user"); and
a fluid path connecting the reservoir with the needle or cannula so that the insulin may pass from the reservoir into the needle or cannula (see reservoir 16 in Fig. 1; the path through septum 100 in Fig. 17; and the neck of the syringe body 1102 through which fluid flows into the cannula 1110 in Fig. 18).
It is noted that Hague 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.
Claims 1, 5-10, 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 Hague.
Regarding claims 1 and 6, 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);
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 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, the piercing element including a pointed tip formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body, and the cylindrical body is coated with the same 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.
Hague discloses a medicament delivery device 10/1000/1010 (see Figs. 1/17/18), comprising:
a reservoir 16/1004/1102 (see Figs. 1/17/18) for storing medicament;
an instrument for piercing skin of a user and carrying a medicament to the user, the instrument comprising:
a cylindrical body 300/1008/1110 (see Figs. 1/17/18) having an inner lumen for carrying the medicament;
a piercing element (see Fig. 6, showing combination of cannula tip 304 and sharp tip 306; see Fig. 17, showing tip of cannula 1008 and sharp tip 1010; or see Fig. 18, showing tip of cannula 1110 and sharp tip 1114)) secured to or formed on a distal end of the cylindrical body (in Figs. 6/17/18, the cannula tip is formed at 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 [0037], referring to a sharp tip "that is sufficiently sharp to allow substantially pain free insertion of the cannula 18 into the skin of the user”; the sharp tip in Figs. 6/17/18 perform the same function), the piercing element including a pointed tip 306 formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body (see Fig. 6, showing a coating 302 that extends the length of cannula 300 and then is formed into a pointed tip at 306; and see para [0047], disclosing that the coating 302 partially dissolves in use; see Fig. 17 showing coating 1010 with the same design; and see Fig. 18 showing coating 1114 with the same design);
wherein the cylindrical body is coated with the same 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 para [0036], describing the aforementioned cannula to be "reinforced and stiffened" by the coating, and the coating provides a sharp tip that "pierces the skin and guides the stiffened cannula into the skin"; the coating then "dissolves in the bodily fluids of the user" such that the cannula "becomes flexible and dull so that there is minimal (or even a non-existent risk) of needle sticks upon removable of the infusion set from the skin of the user").
A skilled artisan would have found it obvious at the time of the invention to modify the instrument of DeStefano so that the piercing element includes a pointed tip formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body, and the cylindrical body is coated with the same 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, as taught in Hague, thus permitting the cannula to become flexible and dull so that there is minimal risk of needle sticks upon removable of the infusion set from the skin of the user, as taught in Hague; the modification would have also permitted 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 5, the combination of DeStefano and Hague discloses the instrument of claim 1, wherein the piercing element includes at least a portion that is hardened (see para [0036] of Hague, describing the aforementioned cannula to be "reinforced and stiffened" by the coating).
Regarding claim 7, the combination of DeStefano and Hague discloses the instrument of claim 1, wherein the piercing element terminates at a point or a sharpened edge (the aforementioned solid sharp tip 306).
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);
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 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, the piercing element including a pointed tip formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body, and the cylindrical body is coated with the same 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.
Hague discloses a medicament delivery device 10/1000/1010 (see Figs. 1/17/18), comprising:
a reservoir 16/1004/1102 (see Figs. 1/17/18) for storing medicament;
an instrument for piercing skin of a user and carrying a medicament to the user, the instrument comprising:
a cylindrical body 300/1008/1110 (see Figs. 1/17/18) having an inner lumen for carrying the medicament;
a piercing element (see Fig. 6, showing combination of cannula tip 304 and sharp tip 306; see Fig. 17, showing tip of cannula 1008 and sharp tip 1010; or see Fig. 18, showing tip of cannula 1110 and sharp tip 1114)) secured to or formed on a distal end of the cylindrical body (in Figs. 6/17/18, the cannula tip is formed at 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 [0037], referring to a sharp tip "that is sufficiently sharp to allow substantially pain free insertion of the cannula 18 into the skin of the user”; the sharp tip in Figs. 6/17/18 perform the same function), the piercing element including a pointed tip 306 formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body (see Fig. 6, showing a coating 302 that extends the length of cannula 300 and then is formed into a pointed tip at 306; and see para [0047], disclosing that the coating 302 partially dissolves in use; see Fig. 17 showing coating 1010 with the same design; and see Fig. 18 showing coating 1114 with the same design);
wherein the cylindrical body is coated with the same 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 para [0036], describing the aforementioned cannula to be "reinforced and stiffened" by the coating, and the coating provides a sharp tip that "pierces the skin and guides the stiffened cannula into the skin"; the coating then "dissolves in the bodily fluids of the user" such that the cannula "becomes flexible and dull so that there is minimal (or even a non-existent risk) of needle sticks upon removable of the infusion set from the skin of the user").
A skilled artisan would have found it obvious at the time of the invention to modify the instrument of DeStefano so that the piercing element includes a pointed tip formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body, and the cylindrical body is coated with the same 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, as taught in Hague, thus permitting the cannula to become flexible and dull so that there is minimal risk of needle sticks upon removable of the infusion set from the skin of the user, as taught in Hague; the modification would have also permitted 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);
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 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, the piercing element including a pointed tip formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body, and the cylindrical body is coated with the same 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.
Hague discloses a medicament delivery device 10/1000/1010 (see Figs. 1/17/18), comprising:
a reservoir 16/1004/1102 (see Figs. 1/17/18) for storing medicament;
an instrument for piercing skin of a user and carrying a medicament to the user, the instrument comprising:
a cylindrical body 300/1008/1110 (see Figs. 1/17/18) having an inner lumen for carrying the medicament;
a piercing element (see Fig. 6, showing combination of cannula tip 304 and sharp tip 306; see Fig. 17, showing tip of cannula 1008 and sharp tip 1010; or see Fig. 18, showing tip of cannula 1110 and sharp tip 1114)) secured to or formed on a distal end of the cylindrical body (in Figs. 6/17/18, the cannula tip is formed at 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 [0037], referring to a sharp tip "that is sufficiently sharp to allow substantially pain free insertion of the cannula 18 into the skin of the user”; the sharp tip in Figs. 6/17/18 perform the same function), the piercing element including a pointed tip 306 formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body (see Fig. 6, showing a coating 302 that extends the length of cannula 300 and then is formed into a pointed tip at 306; and see para [0047], disclosing that the coating 302 partially dissolves in use; see Fig. 17 showing coating 1010 with the same design; and see Fig. 18 showing coating 1114 with the same design);
wherein the cylindrical body is coated with the same 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 para [0036], describing the aforementioned cannula to be "reinforced and stiffened" by the coating, and the coating provides a sharp tip that "pierces the skin and guides the stiffened cannula into the skin"; the coating then "dissolves in the bodily fluids of the user" such that the cannula "becomes flexible and dull so that there is minimal (or even a non-existent risk) of needle sticks upon removable of the infusion set from the skin of the user").
A skilled artisan would have found it obvious at the time of the invention to modify the instrument of DeStefano so that the piercing element includes a pointed tip formed exclusively of a dissolvable or degradable coating at the distal end of the cylindrical body, and the cylindrical body is coated with the same 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, as taught in Hague, thus permitting the cannula to become flexible and dull so that there is minimal risk of needle sticks upon removable of the infusion set from the skin of the user, as taught in Hague; the modification would have also permitted 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 Hague, in view of Plastics Today, further in view of Salehi et al (U.S. Pub. 2012/0289941 A1, hereinafter “Salehi”); or over DeStefano, in view of Hague, further in view of Salehi.
Regarding claims 12, it is noted that Hague, in view of Plastics Today, does not appear to disclose that the material, recited in claim 10, is polytetrafluoroethylene (PTFE). Similarly, it is noted that DeStefano, in view of Hague 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.
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.
Conclusion
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 08/202/2026
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