DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment to the claims filed 05 August 2026 has been entered. Claim(s) 1-6 and 8-17 is/are currently amended. Claim(s) 1-20 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the claims and/or rejections of claim(s) under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Interpretation
As noted in the prior Office action(s) (mailed 07 May 2026), the pending claims include at least one limitation that has/have been interpreted to invoke 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph).
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 2-4, 16 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claims 2-3 and claims dependent thereon, the limitations "wherein the piercing element is secured to the blunt sensor tip" and "wherein the piercing element is adhered to the blunt sensor tip" of claims 2 and 3 are indefinite. Claim 1 recites the piercing element comprises a coating covering a distal length of the sensor body formed by dipping the distal length (L) of the sensor body in a liquid bath, etc. Applicant discloses this process as claimed "achieve[s] good adhesion…on the sensor" (¶ [00136]). As Applicant discloses the process of claim 1 adheres the coating defining the piercing element to the sensor body, it is unclear how, if at all, the limitations of claims 2-3 further limit the sensor device of amended claim 1.
Regarding claim 4 and claims dependent thereon, the limitation "the piercing element is not secured to the blunt sensor tip, but is maintained in abutting contact therewith" is indefinite. As noted above with respect to claims 2-3, Applicant discloses the dipping process recited in amended claim 1 results in adhesion of the coating/piercing element to the distal length of the sensor body, which includes the blunt sensor tip thereof. As such, it is unclear how the piercing element can be both formed as required in claim 1 and "not secured to the blunt sensor tip" as required by claim 4.
Regarding claim 16 and claims dependent thereon, the limitation "the piercing element does not extend past the blunt sensor tip in the direction of the mounting unit, or extends only a nominal amount in said direction" is indefinite. Amended claim 1 requires the coating material that forms the piercing element to cover a distal length (L) of the sensor body. It is unclear how the coating material/piercing element can both cover a distal length of the sensor body and not extend past the blunt sensor tip in the direction of the mounting unit, as encompassed by claim 16. Additionally, the relationship between the distal length of claim 1, and the "nominal amount" of claim 16 is indefinite. Is this phrase intended to indicate the distal length of the sensor body as recited in claim 1 is only a "nominal amount" of the entire length of the entire sensor body?
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 pre-AIA 35 U.S.C. 112, first paragraph:
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.
Claim(s) 4-5 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 4-5 and claims dependent thereon, Applicant discloses various piercing element embodiments, including a piercing element formed by dip coating a distal length of the sensor body (e.g., ¶ [00136]), a discrete piercing element not secured to the sensor body, but merely abutting the blunt distal face of the sensor body and held in place with an outer sleeve or band (e.g., ¶ [0099]). However, Applicant fails to disclose a single embodiment in which the piercing element comprises the coating as recited in amended claim 1 and is not secured to the blunt sensor tip, but maintained in abutting contact therewith by a sleeve.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Amended claim 1 recites the piercing element, or coating forming said piercing element, covers a distal length of the sensor body and extends from the blunt sensor tip to form a sharp point, such that the limitations of claims 6-7 fail to further limit the subject matter of amended claim 1. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-3, 6-7, 11, 13-15 and 18-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2011/0077490 A1 (previously cited, "Simpson '490") in view of US 2002/0072720 A1 (previously cited, "Hague"); and/or over Simpson '490 in view of Hague and US 2011/0027453 A1 ("Boock").
Regarding claims 1-3, 6-7 and 13-15, Simpson '490 discloses and/or suggests a sensor device for measuring an analyte concentration in a host, comprising:
a sensor unit (in vivo portion, or sensor unit 160) comprising a sensor body (sensor body 120), at least one electrode, and a membrane covering at least a portion of the at least one electrode (e.g., ¶ 0156] sensor body 120 comprises a support member 130 that is comprised of one or more electrodes and a membrane 140 disposed over at least a portion of the support member 130), the sensor body having a tip (e.g., ¶ [0051] distal end), wherein the sensor body has a distal length (L) in the range of 0.1 mm to 4 mm (e.g., ¶¶ [0006]-[0008]);
a piercing element (tissue piercing element 110), the piercing element abutting the sensor body tip and configured to pierce tissue of the host (e.g., Fig. 1; ¶ [0051]; ¶ [0156]; etc.); and
a mounting unit spaced from the sensor body tip and configured to support the sensor device on an exterior surface of the host's skin (mounting unit 150).
Simpson '490 discloses/suggests the piercing element is secured/adhered to the sensor body tip (e.g., ¶ 0051] a tip portion, configured to pierce tissue, is attached to the distal end of the at least one electrode; ¶ [0157] sensor device may be substantially modular and formed of multiple separate components (e.g., the tissue piercing element, the sensor body, the mounting unit, the sensor electronics unit) that are detachable from each other wherein pressure-resistant bonds may be formed between the different components by, e.g., use of adhesives, to join the different pieces), and further appears to illustrate at least one embodiment in which the sensor body has a blunt sensor tip (e.g., Fig. 3B, illustrated outline of pocket 312 shaped and dimensioned to support the sensor body, as described in ¶ [0164]). In said illustrated embodiment, the piercing element covers a distal length (L) of the sensor body and extends distally from the blunt sensor tip to form a sharp point (see Fig. 3B). Simpson '490 additionally discloses at least one embodiment comprising a piercing element comprising a coating that covers at least a portion of the sensor body and a sharp tip that is formed of the coating material that is configured to dissolve upon insertion into a host (e.g., ¶ [0167] needle formed of a biodegradable material). However, Simpson '490 does not expressly disclose a coating material forming a piercing element extending distally from a blunt sensor tip to form a sharp point.
Hague discloses/suggests a device comprising sensor unit including a distal tip (insertable substantially insoluble flexible portion; ¶ [0007] insertable substantially insoluble flexible portion may be a sensor), wherein the tip is blunt (as illustrated in Figs. 1-13); and a piercing element comprising a coating material configured to rapidly (e.g., within a first day or three hours) dissolve upon insertion into a host (Abstract, soluble material coupled to the insertable insoluble flexible portion facilitates piercing the skin, then dissolves in the skin of the user; ¶ [0008] where the soluble material dissolves in the skin in under ten minutes, under 1 hour; ¶ [0036]; etc.), the coating material covering a distal length of the sensor body and extending distally from the blunt sensor tip to form a sharp point, wherein the coating is formed and secured/adhered to the sensor body by dipping the distal length of the sensor body in a liquid bath (¶ [0037], ¶ [0039], etc.), wherein the coating material is selected from the group consisting of a salt, a metallic salt, a sugar, a synthetic polymer, polylactic acid, polyglycolic acid, and a polyphosphazene (Abstract, where the soluble material is formed from a at least one saccharide, a protein, a starch, other biocompatible materials, or the like).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the sensor device of Simpson '490 with the sensor body comprising a blunt tip and the piercing element comprising a coating material, such as a sugar, covering and secured/attached to the length of sensor body, and extending distally from the blunt sensor tip to form a sharp point, wherein the coating material/piercing element is configured to rapidly (e.g., within three hours after insertion) dissolve upon insertion into a host as disclosed/suggested by Hague in order to substantially reduce or eliminate patient discomfort while the sensor is inserted (Hague, ¶ [0039]) and/or reduce or eliminate inadvertent sticks as the sensor device is removed (Hague, ¶ [0052]).
The limitation "wherein the coating material is formed by dipping the distal length (L) of the sensor body in a liquid bath having a viscosity below 100 cP and withdrawing the sensor body from the liquid bath at a withdrawal rate of 20 in/sec to 30 in/sec" is directed to the process by which the sensor device, or piercing element thereof, is made, i.e., a product-by-process limitation or element. See MPEP 2113. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Simpson '490 as modified discloses/suggests the sensor device as claimed, such that claim 1 is unpatentable.
Alternatively/Additionally, as noted above, Hague discloses the coating may be formed by dip coating (¶ [0037], ¶ [0039], etc.) and further discloses/suggests the coating thickness can be selected based on a variety of factors, included desired time for the coating the dissolve in the bodily fluids of the host (e.g., ¶ [0037]). Boock discloses/suggests a method comprising forming a coating material by dipping the distal length (L) of a sensor body (elongated conductive body, e.g., 310') in a liquid bath (e.g., ¶ [0144] partially or wholly submerging elongated conductive body 310' in a coating solution) having a viscosity below 100 cP (e.g., ¶ [0134]) and withdrawing the sensor body from the liquid bath at a withdrawal rate of 20 in/sec to 30 in/sec (e.g., ¶ [0137]). Boock discloses parameters of this process, including viscosity of the coating solution, the speed at which the rate at which the elongated conductive body is advanced through the coating solution, etc., affect the thickness profile of the material coated on the elongated conductive body (e.g., ¶ [0132], ¶ [0137]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the sensor device of Simpson '490 the coating material being formed by dipping the distal length (L) of the sensor body in a liquid bath having a viscosity below 100 cP and withdrawing the sensor body from the liquid bath at a withdrawal rate of 20 in/sec to 30 in/sec as disclosed and/or suggested by Boock in order to facilitate covering the sensor body, including the distal end thereof, with a coating material of a desired thickness (Boock, ¶ [0132], ¶ [0137]).
Regarding claim 11, Simpson '490 as modified discloses/suggests the coating material of the piercing element may comprise one or more layers of one or more polymers and/or bioactive agents coated onto the tissue piercing element (e.g., Hague, ¶ [0045] coating material may include additives and/or a covering layer having said additives; Simpson '490, ¶ [0163]; etc.), wherein said bioactive agents including therapeutic agents (i.e., drugs) (e.g., Simpson '490, ¶¶ [0229]-[0230]).
Regarding claim 18, Simpson '490 as modified discloses/suggests the mounting unit comprises a guiding portion configured to guide insertion of the sensor unit through the host's skin and to support a column strength of the sensor body such that the sensor unit is configured for insertion through the host's skin without substantial buckling (e.g., ¶ [0024]; claim 2; etc.).
Regarding claim 19, Simpson '490 as modified discloses/suggests the at least one electrode comprises a working electrode and a reference electrode (e.g., ¶ [0015]; claim 6; etc.).
Regarding claim 20, Simpson '490 as modified discloses/suggests the sensor body further comprises a support member configured to protect the membrane from damage during insertion of the sensor unit (e.g., ¶ [0016]; claim 7; etc.).
Claim(s) 8-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Simpson '490 in view of Hague (or Simpson '490 in view of Hague and Boock) as applied to claim(s) 1 above, and further in view of US 2007/0235331 A1 (previously cited, "Simpson '331").
Regarding claims 8-9 and 11, Simpson '490 as modified discloses/suggests the limitations of claim 1, as discussed above, and further discloses/suggests the coating material of the piercing element may comprise one or more layers of one or more polymers and/or bioactive agents coated onto the tissue piercing element (e.g., Hague, ¶ [0045] coating material may include additives and/or a covering layer having said additives; Simpson '490, ¶ [0163]; etc.). Simpson '490 as modified does not expressly disclose said bioactive agent(s) is configured to suppress wounding and/or promote rapid wound healing.
Simpson '331 discloses sensor devices including wound suppressing materials or drugs (¶ [0324] wound-suppressing agent, e.g., an anti-inflammatory, an immunosuppressive agent, an anti-infective agent, or a scavenging agent) and/or wound healing materials/drugs (¶ [0316]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the sensor device of Simpson '490 with the coating material of the piercing element comprising bioactive agent(s) and/or drugs, configured to suppress wounding and/or promote rapid wound healing as disclosed and/or suggested by Simpson '331 in order to surround the sensor with substantially normal tissue, thereby reducing non-constant noise (Simpson '331, ¶ [0322], ¶ [0280]).
Regarding claims 10 and 12, Simpson '490 as modified discloses/suggests the limitations of claim 1, as discussed above, and further discloses/suggests the coating material of the piercing element may comprise one or more layers of one or more polymers and/or bioactive agents coated onto the tissue piercing element (e.g., Hague, ¶ [0045] coating material may include additives and/or a covering layer having said additives; Simpson '490, ¶ [0163]; etc.). Simpson '490 as modified does not expressly disclose said bioactive agent(s) is configured to induce osmotic or oncotic pressure, or comprises a vascular endothelial growth factor.
Simpson '331 discloses sensor devices including a bioactive agent(s), such as a vascular endothelial growth factor (e.g., ¶ [0313]), configured to induce osmotic pressure or oncotic pressure (e.g., ¶ [0312] cause a local fluid influx at the wound site).
It would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the sensor device of Simpson '490 with the coating material of the piercing element comprising a vascular endothelial growth factor and being configured to induce osmotic pressure as disclosed/suggested by Simpson '331 in order to increase fluid bulk, bulk fluid flow and/or diffusion rates (and promoting glucose and oxygen influx), thereby decreasing non-constant noise (Simpson, '331, ¶ [0312]).
Claim(s) 16-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Simpson '490 in view of Hague (or Simpson '490 in view of Hague and Boock) as applied to claim(s) 1 above, and further in view of US 2011/0073475 A1 ("Kastanos") and US 4,936,835 A ("Haaga").
Regarding claim 16, Simpson '490 as modified discloses/suggests the limitations of claim 1, as discussed above, but does not expressly disclose the piercing element only a nominal amount in said direction, e.g., covers only the distal length of the sensor body.
Hague discloses/suggests embodiments in which the piercing element extends past the sensor body tip in the direction of the mounting unit, but stops short of an electrode of said sensor body (e.g., ¶ [0053] a coating 814 is applied over the cannula 806, except for a window area 816 over electrodes 818 of the sensor 804 to expose the sensor to the bodily fluids of the user present in the skin (or other tissues of the user) 888; or the cannula 806 may be omitted and the coating 814 may be applied directly to the sensor 804 and the substrate 820 that supports the electrodes 818 of the sensor 804). Kastanos, comparable to Hague, discloses a coating material covering only a distal length of a sensor body, such that the coating material extends only a nominal amount in a proximal direction and/or stops short of an electrode(s) of said sensor body (e.g., ¶ [0067] only the distal tip 231 is coated with the polymer coating). Haaga discloses a piercing element (tip 107) configured to cover only a portion of a blunt cylindrical body (103), disclosing length of the cylindrical body covered by the piercing element (i.e., length of base 108) provides a quality that can be optimized (e.g., col. 6, lines 9-12, securing the tip to the cylindrical body).
It would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the sensor device of Simpson '490 with the piercing element extending only a nominal amount in the direction of the mounting unit, e.g., stopping short of the electrode(s) of the sensor body, as disclosed/suggested by Hague and Kastanos in order to prevent the material forming the coating/piercing element from interacting or affecting the chemistry attached to the electrodes during storage or during dissolution of the coating (Hague, ¶ [0053]), while rendering the distal end capable of piercing the skin of a user for implantation of at least a portion of the distal end of the sensor body, unassisted by a sharp/separate introducer (Kastanos, ¶ [0067]). Additionally, since Haage discloses the length of the coverage/overlap of the two components provides a quality which can be optimized (e.g., ensuring the two components are securely fit together), the nominal amount being within the claimed distal length range of the sensor body would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Double Patenting
The nonstatutory double patenting ("NSDP") rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A NSDP rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional NSDP rejection provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a NSDP rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-3 and 6-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 8, 12-14 and 18-19 of USPN 11,457,870 in view of Hague, Kastanos, and Haaga; or over claim(s) 1, 8, 12-14 and 18-19 of USPN 11,457,870 in view of Hague, Kastanos, and Haaga, and further in view of Simpson '490 and/or Simpson '331.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim(s) 1, 8, 12-14 and 18-19 of USPN 11,457,870 recites each limitation of claims 1-3, 6-11 and 13-19 of the present application with the exception of the tip of the sensor body being blunt, the piercing element comprising a coating material configured to rapidly dissolve, wherein the coating material covers a distal length (L) of the sensor body, wherein L is in a range of 0.1 mm to 4 mm, the coating material extending distally from the blunt sensor tip to form a sharp point. As discussed with the prior art rejections above, Hague discloses a blunt sensor body, a piercing element comprising a coating material configured to rapidly dissolve that covers at least a distal length of the sensor body, but may stop short of an electrode of said sensor body, the coating material extending distally from the blunt sensor tip to form a sharp point. Kastanos discloses a comparable device in which only the distal end/length of the sensor body is coated and/or similarly stops short of an electrode of the sensor body. Haaga discloses/suggests the length of overlap between a cylindrical body and a piercing element provides a quality that can be optimized. The above-noted features would have been an obvious modification to claim(s) 1, 8, 12-14 and 18-19 of USPN 11,457,870 for at least the reasons discussed above.
With respect to the remaining limitations of claims 12 and 20, the above-noted claims 1, 8, 12-14 and 18-19 of USPN 11,457,870 as modified do not recite said features. However, said features are disclosed/suggested by Simpson '490 or Simpson '331 (or a combination thereof) and similarly would have been an obvious modification(s) for at least the reasons discussed in the prior art rejection(s) of record above.
Claim(s) 1-3 and 6-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 10 and 17-18 of USPN 12,089,933 in view of Hague, Kastanos, and Haaga, or over claim(s) 1, 10 and 17-18 of USPN 12,089,933 in view of Hague, Kastanos, and Haaga, and further in view of Simpson '490 and/or Simpson '331.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim(s) 1, 10 and 17-18 of USPN 12,089,933 recite each limitation of claims 1-3, 6-11 and 13-17 of the present application with the exception of the tip of the sensor body being blunt, the piercing element comprising a coating material configured to rapidly dissolve, wherein the coating material covers a distal length (L) of the sensor body, wherein L is in a range of 0.1 mm to 4 mm, the coating material extending distally from the blunt sensor tip to form a sharp point. As discussed with the prior art rejections above, Hague discloses a blunt sensor body, a piercing element comprising a coating material configured to rapidly dissolve that covers at least a distal length of the sensor body, but may stop short of an electrode of said sensor body, the coating material extending distally from the blunt sensor tip to form a sharp point. Kastanos discloses a comparable device in which only the distal end/length of the sensor body is coated and/or similarly stops short of an electrode of the sensor body. Haaga discloses/suggests the length of overlap between a cylindrical body and a piercing element provides a quality that can be optimized. The above-noted features would have been an obvious modification to claim(s) 1, 8, 12-14 and 18-19 of USPN 11,457,870 for at least the reasons discussed above.
With respect to the remaining limitations of claims 12 and 18-20, the above-noted claims 1, 10 and 17-18 of USPN 12,089,933 as modified do not recite said features. However, said features are disclosed/suggested by Simpson '490 or Simpson '331 (or a combination thereof) and similarly would have been an obvious modification(s) for at least the reasons discussed in the prior art rejection(s) of record above.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to the prior art rejections, Applicant contends neither Simpson '490 nor Hague teach the amended limitation "the coating material covering a distal length (L) of the sensor body, wherein Lis in a range of 0.1 mm to 4 mm, the coating material extending distally from the blunt sensor tip to form a sharp point, and wherein the coating material is formed by dipping the distal length (L) of the sensor body in a liquid bath having a viscosity below 100 cP and withdrawing the sensor body from the liquid bath at a withdrawal rate of 20 in/sec to 30 in/sec" (Remarks, pgs. 5-6).
The examiner respectfully disagrees. Hague, or Simpson '490 as modified thereby, discloses a piercing element comprising a coating material configured to dissolve upon insertion into a host, the coating material covering the length of the sensor body, including any arbitrarily defined distal length thereof, the coating material extending distally from the blunt sensor tip to form a sharp point. Further, Simpson '490 discloses the length of the sensor body is from about 0.1 mm to 10 mm, depending on the desired skin layer to be reached (e.g., ¶¶ [0006]-[0008]), such that the length of the sensor body covered by said coating material in Simpson '490 as modified encompasses embodiments in which the at least 0.1 to 4 mm of sensor body length is covered by the coating material.
The only claim element not disclosed/suggested by Simpson '490 or Hague is the recited process of forming the coating material. However, as discussed in the rejection of record above, this limitation is directed to a process by which the claimed product, or the piercing element thereof, is made, whereas determination of patentability of a product is based on the product itself. The burden is on Applicant to show a nonobvious difference once the Office provides a rationale tending to show that the claimed product appears to be the same or similar to that of the cited prior art. See MPEP 2113(II).
With respect to the double patenting rejections, Applicant "requests that the non-statutory double patenting rejections be held in abeyance" (Remarks, pg. 6).
A response to all outstanding rejections is necessary for a complete reply. See 37 C.F.R. 1.111(b). A request to hold double patenting rejections in abeyance is not a complete response to the outstanding NSDP rejections. A complete response to a NSDP rejection is either a reply by Applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) accompanied by a reply requesting reconsideration of the prior Office action. See MPEP 804(I)(B)(1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
