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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Claim Rejections - 35 USC § 112
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 20 and all claims depending therefrom 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.
Claim 20 recites the limitation "the instrument" in line 5. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of examination, the limitation will be interpreted to refer to the “needle or cannula”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4-7, 10, 11 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ethelfeld et al (U.S. Pat. 2009/0048563 A1, hereinafter “Ethelfeld”).
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 at least one of the cylindrical body or the piercing element is configured to soften upon being positioned at least partially under the skin of the user (see Figs. 16C-16E and para [0098] disclosing that the catheter “is stiff before insertion and gets soft by influence of the body or insulin after insertion”).
Regarding claim 2, Ethelfeld discloses the instrument of claim 1, wherein the cylindrical body is formed of a material that softens when the material is under the skin of the user (see Figs. 16C-16E and para [0098] disclosing that “When inserted the influence from the body-temperature/humidity or influence from insulin makes the combination of materials soft within the body” and the catheter “is stiff before insertion and gets soft by influence of the body or insulin after insertion”).
Regarding claim 4, Ethelfeld discloses the instrument of claim 2, 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 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 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 at least one of the cylindrical body or the piercing element is configured to soften upon being positioned at least partially under the skin of the user (see Figs. 16C-16E and para [0098] disclosing that the catheter “is stiff before insertion and gets soft by influence of the body or insulin after insertion”); and
a fluid path (i.e., the path directly between the outlet of the reservoir and the inlet of the catheter) connecting the reservoir with the instrument so that the medicament may pass from the reservoir to the instrument.
Regarding claim 11, Ethelfeld discloses the instrument of claim 10, wherein the cylindrical body is formed of a material that softens when the material is under the skin of the user (see Figs. 16C-16E and para [0098] disclosing that “When inserted the influence from the body-temperature/humidity or influence from insulin makes the combination of materials soft within the body” and the catheter “is stiff before insertion and gets soft by influence of the body or insulin after insertion”).
Regarding claim 13, Ethelfeld discloses the instrument of claim 11, 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 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 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, 2, 7-11, 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”).
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 at least one of the cylindrical body or the piercing element is configured to soften upon being positioned at least partially 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).
Regarding claim 2, DeStefano discloses the instrument of claim 1, wherein the cylindrical body is formed of a material that softens when the material is under the skin of the user (as noted above, the nitinol which enters a soft and bendable martensite phase at body temperature of about 37 degrees C, i.e., when placed inside the human body).
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 at least one of the cylindrical body or the piercing element is configured to soften upon being positioned at least partially 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.
Regarding claim 11, DeStefano discloses the medicament delivery device of claim 10, wherein the cylindrical body of the instrument is formed of a material that is configured to soften upon the material being under the skin of the user (as noted above, the nitinol which enters a soft and bendable martensite phase at body temperature of about 37 degrees C, i.e., when placed inside the human body).
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 at least one of the cylindrical body or the piercing element is configured to soften upon being positioned at least partially 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 insulin may pass from the reservoir to the needle or cannula.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ethelfeld, in view of Plastics Today (“PLA/TPU blends studied as shape memory polymers”, 2013, hereinafter “Plastics Today”).
Regarding claim 3, it is noted that Ethelfeld does not appear to disclose that the material, which softens (or is so configured) when the material is under the skin of the user, 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”.
Based on this teaching, a skilled artisan would have found it obvious at the time of the invention to choose PLA 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, the commonly used medical plastics PLA and TPU were shown to have suitable shape memory polymers for medical devices.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over DeStefano, in view of Plastics Today (“PLA/TPU blends studied as shape memory polymers”, 2013, hereinafter “Plastics Today”).
Regarding claim 3, it is noted that DeStefano does not appear to disclose that the material, which softens (or is so configured) when the material is under the skin of the user, 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”.
Based on this teaching, a skilled artisan would have found it obvious at the time of the invention to choose PLA 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, the commonly used medical plastics PLA and TPU were shown to have suitable shape memory polymers for medical devices.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ethelfeld, in view of Salehi et al (U.S. Pub. 2012/0289941 A1, hereinafter “Salehi”).
Regarding claim 12, it is noted that Ethelfeld does not appear to disclose that the material, which softens (or is so configured) when the material is under the skin of the user, 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over DeStefano, in view of Salehi.
Regarding claim 12, it is noted that DeStefano does not appear to disclose that the material, which softens (or is so configured) when the material is under the skin of the user, 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.
Conclusion
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/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
12/18/2025