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 .
Status of Claims
Applicant's arguments, filed 11/24/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/24/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 51, 57-65, 67, and 70.
Applicants have introduced new claims 161-167.
Applicants have left claim 66 as previously presented/originally filed.
Applicants have canceled/previously canceled claims 1-50, 52-56, 68-69, and 71-160.
Claims 51, 57-67, 70, and 161-167 are the current claims hereby under examination.
Claim Interpretation - 35 USC § 112(f) - Withdrawn
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, filed 11/24/2025, with respect to the 112(f) interpretation of “an elongate insertion element” have been fully considered and are persuasive. Applicants have amended the claims, rendering the 112(f) interpretation moot. The 112(f) interpretation of “an elongate insertion element” has been withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
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.
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, filed 11/24/2025, with respect to claims 52-70 have been fully considered and are persuasive. Applicants have canceled the claims, rendering the 112(b) rejections moot. The 112(b) rejections of claims 52-70 have been withdrawn.
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 165 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th 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.
Regarding claim 165, the claim recites a process of sterilization. However, claim 51 is directed to a medical device system. The patentability of a product does not depend on its method of production. As such, the claim fails to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 51, 57, 59, 61-62, 64-65, 67, 70, and 165-167 are rejected under 35 U.S.C. 103 as being unpatentable over Gary Ashley Stafford (US 20140031655 A1) (previously cited, hereinafter referred to as Stafford, in view of Shah et al. (US 20160338734 A1) (previously cited), hereinafter referred to as Shah.
The claims are generally directed towards a medical device system comprising: a housing configured to be worn on skin of a host and including a distal surface for facing towards the skin and a proximal surface facing opposite the distal surface; an elongate analyte sensor coupled to the housing and configured to extend distally from the housing and be positioned in the skin of the host; and an elongate needle including a shaft extending along at least a portion of the elongate analyte sensor and a channel that at least the portion of the elongate analyte sensor is positioned in during a sterilization process applied to at least the portion of the elongate analyte sensor and the elongate needle, the elongate needle configured to be inserted into the skin with at least the portion of the elongate analyte sensor positioned in the channel to guide at least the portion of the elongate analyte sensor into the skin of the host, the shaft including a surface including a coating configured to reduce stiction produced based on the sterilization process with at least the portion of the elongate analyte sensor.
Regarding claim 51, Stafford discloses a medical device system (Abstract, Fig. 1, Fig. 4, para. [0002]) comprising:
a housing (Fig. 2, element 112, “mount”) configured to be worn on skin of a host (para. [0074], “applied to the user’s skin …”, para. [0076], “mount 112, together with sensor 114, and sensor electronics unit 113 comprises an on-body unit …”) and including a distal surface for facing towards the skin (Fig. 2, element 112, para. [0074], “a portion of the top surface of an adhesive tape located on the bottom surface of the mount 112 … applied to the user’s skin …” - the distal surface being the bottom surface) and a proximal surface facing opposite the distal surface (Fig. 2, element 112, para. [0076], “electronics unit 130 is fully seated on mount 112 …” - the proximal surface being the exposed portion of 112 in Fig. 2 and where element 130 is received);
an elongate analyte sensor (Fig. 4, element 114, “sensor”) coupled to the housing and configured to extend distally from the housing and be positioned in the skin of the host (para. [0074], “inserting sensor 114 into the user’s skin …”, para. [0076], “mount 112, together with sensor 114, and sensor electronics unit 113 comprises an on-body unit …”); and
an elongate needle (Fig. 6, element 440, “introducer”, para. [0078], “introducer sharp …”, para. [0083]) including a shaft (Fig. 6, element 405, “shaft”, para. [0078], para. [0083], “shaft portion can include a substantially sharp distal edge segment …”) extending along at least a portion of the elongate analyte sensor (para. [0083], “ sensor is retained within the shaft portion …”) and a channel that at least the portion of the elongate analyte sensor is positioned in during a sterilization process applied to at least the portion of the elongate analyte sensor and the elongate needle (Fig. 6, Fig. 8, Fig. 17, Fig. 21, Fig. 22, para. [0078], “mounted between U-shaped rails of introducer …” - the U-shaped rails and the opening of element 405 include a channel for housing the sensor. Note: the product-by-process element is not given patentable weight, as the patentably of the product does not depend on its method of production, but is based on the product itself), the elongate needle configured to be inserted into the skin with at least the portion of the elongate analyte sensor positioned in the channel to guide at least the portion of the elongate analyte sensor into the skin of the host (para. [0083], “shaft portion can include a substantially sharp distal edge segment to contact and pierce the skin of a user for transcutaneous placement of the sensor through the user’s skin … sensor is retained within the shaft portion …”).
Stafford teaches a lubricious coating process can be used to reduce friction and make insertion more smooth (para. [0092]). However Stafford does not explicitly disclose the shaft including a surface including a coating configured to reduce stiction produced based on the sterilization process with at least the portion of the elongate analyte sensor.
Shah teaches of an analogous elongate insertion needle including a shaft extending along at least a portion of an elongate analyte sensor and configured to be inserted into the skin to guide at least the elongate analyte sensor into the skin of the host (Fig. 2, para. [0009], para. [0084]). Shah further teaches the shaft including a surface including a coating configured to reduce stiction produced based on the sterilization process with at least the portion of the elongate analyte sensor (para. [0084], “lubricants or other materials may be added into the lumen … material with a low coefficient of friction” - a material with a low coefficient of friction will reduce stiction, or reduce the initial force to enable motion. Note: the product-by-process element is not given patentable weight, as the patentably of the product does not depend on its method of production, but is based on the product itself). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lubricous coating process and surface disclosed by Stafford to explicitly be a coating configured to reduce stiction produced based on the sterilization process with at least the portion of the elongate analyte sensor, as taught by Shah. This is because Shah teaches lubricants and other materials added into the lumen of the needle facilitate sensor withdrawal and does not damage or inhibit sensor operation (para. [0084]).
Regarding claim 57, modified Stafford discloses the medical device system of claim 51, wherein the coating comprises a lubricant (para. [0092], “lubricious coating process (i.e., a silicone coating …”).
Regarding claim 59, modified Stafford discloses the medical device system of claim 51, wherein the coating comprises a polymer (para. [0092], “lubricious coating process (i.e., a silicone coating …” - silicone is a polymer).
Regarding claim 61, modified Stafford discloses the medical device system of claim 51.
However, modified Stafford does not explicitly disclose wherein the coating comprises an inert material.
Shah further teaches the coating comprises an inert material (para. [0084], “lubricants or other materials may be added into the lumen … silane …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating to comprise an inert material, as taught by Shah. This is because Shah teaches an inert material, such as silane, allows for improved release of the sensor without damaging or inhibiting sensor operation (para. [0084]).
Regarding claim 62, modified Stafford discloses the medical device system of claim 51, wherein the coating is bonded to the shaft (para. [0092], “lubricious coating process (i.e., a silicone coating …”).
Regarding claim 64, modified Stafford discloses the medical device system of claim 51.
However, modified Stafford does not explicitly disclose wherein the coating is cured.
Shah further teaches the surface is made from polytetrafluorethylene (para. [0074]), which is known within the art to require curing. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating to be a coating that is cured, as taught by Shah. This is because Shah teaches polytetrafluorethylene is a suitable material for providing column strength when inserting a needle (para. [0074]), while also providing the known benefits of polytetrafluorethylene including non-stick properties.
Regarding claim 65, modified Stafford discloses the medical device system of claim 51, wherein the coating includes silicone (para. [0092], “lubricious coating process (i.e., a silicone coating …”).
Regarding claim 67, modified Stafford discloses the medical device system of claim 51.
However, modified Stafford does not explicitly disclose wherein the coating is configured to reduce hydrogen bonding with at least the portion of the elongate analyte sensor.
Shah further teaches the surface is made from polytetrafluorethylene (para. [0074]), which is a fluropolymer and is known to reduce hydrogen bonding. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating to be configured to reduce hydrogen bonding with at least the portion of the elongate analyte sensor, as taught by Shah. This is because Shah teaches materials like polytetrafluorethylene provide column strength, and is a fluoropolymer (para. [0074]). One of ordinary skill in the art would recognize the added benefit of column strength when puncturing the skin, and would recognize polytetrafluorethylene is known to reduce hydrogen bonding.
Regarding claim 70, modified Stafford discloses the medical device system of claim 51, wherein the channel has a C-shaped cross-section (Fig. 8, Fig. 17, Fig. 21, Fig. 22, - element 405 has a C-shaped cross-section).
Regarding claim 165, modified Stafford discloses the medical device system of claim 51, wherein the sterilization process is an ethylene oxide sterilization process (Note: the product-by-process element is not given patentable weight, as the patentably of the product does not depend on its method of production, but is based on the product itself. Modified Strafford teaches all elements of the product as outlined above).
Regarding claim 166, modified Stafford discloses the medical device system of claim 51, wherein the elongate analyte sensor includes an elongate sensing portion that is positioned within the channel (Fig. 6, element 114, para. [0069-0070], “plurality of electrodes can be disposed near the distal end of sensor …”, para. [0083], “ sensor is retained within the shaft portion …”) and an elongate contact portion that is coupled to the housing (Fig. 6, element 114, para. [0070], “sensor can include conductive traces extending from electrodes to corresponding, respective contacts to define the sensor electronic circuitry …”, para. [0076], “circuitry of sensor electronics unit makes electrical contact with the contacts on sensor 114 …”) and a bend that angles the elongate sensing portion with respect to the elongate contact portion (Fig. 6, element 114 - element 114 has a bend where the distal end of the sensor is (closest to element 403) and to where element 401 is).
Regarding claim 167, modified Stafford discloses the medical device system of claim 166, wherein the elongate sensing portion is a wire and the elongate contact portion is a wire (para. [0070], “each of the electrodes is formed from conductive material … wire … sensor can include conductive traces extending from electrodes to corresponding, respective contacts to define the sensor electronic circuitry …”).
Claims 58, 63, 66, and 161-164 are rejected under 35 U.S.C. 103 as being unpatentable over Gary Ashley Stafford (US 20140031655 A1) (previously cited), hereinafter referred to as Stafford, in view of Shah et al. (US 20160338734 A1) (previously cited), hereinafter referred to as Shah as applied to claim 51 and claim 65 above, and further in view of Boden et al. (US 20190184010 A1) (previously cited), hereinafter referred to as Boden.
Regarding claim 58, modified Stafford discloses the medical device system of claim 51.
However, modified Stafford does not explicitly disclose wherein the coating comprises one or more of a plating, a dip coating, or a deposition.
Boden teaches an analogous medical device system (Abstract). Boden the teaches the system comprises an elongate needle including a shaft extending along at least a portion of an elongate sensor and configured to be inserted into the skin to guide at least the elongate sensor into the skin of the host, the shaft including a surface including a coating configured to reduce stiction with the portion of the analyte sensor (para. [0239]). Boden further teaches the coating comprises one or more of a plating, a dip coating, or a deposition (para. [0239], “applied by conventional spray or dip coating …”. Additionally Note: the product-by-process element is not given patentable weight, as the patentably of the product does not depend on its method of production, but is based on the product itself. The coatings recited in the cited arts are capable of being applied by plating, dip coating, or deposition). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating process disclosed by modified Stafford to explicitly be dip coating, as taught by Boden. This is because Boden teaches dip coating is a conventional method for applying a biocompatible lubricious compound (para. [0239]).
Regarding claim 63, modified Stafford discloses the medical device system of claim 51.
However, modified Stafford does not explicitly disclose wherein the coating has a thickness upon the shaft of less than 1.5 micrometers.
Boden teaches an analogous medical device system (Abstract). Boden the teaches the system comprises an elongate needle including a shaft extending along a portion of an elongate sensor and configured to be inserted into the skin to guide the elongate sensor into the skin of the host, the shaft including a surface including a coating configured to reduce stiction with the portion of the analyte sensor (para. [0239]). Boden further teaches the thickness of the coating can be modified depending on the coating type, method, and application (para. [0239]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the coating disclosed by modified Stafford to explicitly be less than 1.5 micrometers, as taught by Boden. This is because Boden teaches the thickness of the coating will depend upon multiple variables, such as the type of coating, type of tissue, and coating method (para. [0239]), and one of ordinary skill in the art would recognize, the thickness of the coating can be optimized based on the manufacturing, design, and use applications.
Regarding claim 66, modified Stafford discloses the medical device system of claim 65.
However, modified Stafford does not explicitly disclose wherein the silicone comprises an aminofunctional dimethylsiloxane copolymer.
Boden teaches an analogous medical device system (Abstract). Boden the teaches the system comprises an elongate needle including a shaft extending along a portion of an elongate sensor and configured to be inserted into the skin to guide the elongate sensor into the skin of the host, the shaft including a surface including a coating configured to reduce stiction with the portion of the analyte sensor (para. [0239]). Boden further teaches the coating is silicone and comprises an aminofunctional dimethylsiloxane copolymer (para. [0239], “biocompatible silicone compounds such as … DOW Corning MDX4-4159 …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the silicone disclosed by modified Stafford to explicitly comprise an aminofunctional dimethylsiloxane copolymer, as taught by Boden. This is because Boden teaches DOW Corning MDX4-4159 is suitable a biocompatible lubricious coating for use when inserting sensors into the human body (para. [0239]).
Regarding claim 161, modified Stafford discloses the medical device system of claim 58.
However, modified Stafford does not explicitly disclose wherein the coating comprises the dip coating.
Boden further teaches the coating comprises the dip coating (para. [0239], “applied by conventional spray or dip coating …”. Additionally Note: the product-by-process element is not given patentable weight, as the patentably of the product does not depend on its method of production, but is based on the product itself. The coatings recited in the cited arts are capable of being applied by dip coating). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating process disclosed by modified Stafford to explicitly be dip coating, as taught by Boden. This is because Boden teaches dip coating is a conventional method for applying a biocompatible lubricious compound (para. [0239]).
Regarding claim 162, modified Stafford discloses the medical device system of claim 58.
However, modified Stafford does not explicitly disclose wherein the coating comprises the deposition.
Boden further teaches the coating comprises the deposition (para. [0239], “applied by conventional spray or dip coating …”. Additionally Note: the product-by-process element is not given patentable weight, as the patentably of the product does not depend on its method of production, but is based on the product itself. The coatings recited in the cited arts are capable of being applied by deposition). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating process disclosed by modified Stafford to explicitly be deposition, as taught by Boden. This is because Boden teaches deposition is a conventional method for applying a biocompatible lubricious compound (para. [0239]).
Regarding claim 163, modified Stafford discloses the medical device system of claim 162.
However, modified Stafford does not explicitly disclose wherein the deposition comprises a chemical vapor deposition.
Boden further teaches the deposition comprises a chemical vapor deposition (para. [0239], “applied by conventional spray or dip coating …”. Additionally Note: the product-by-process element is not given patentable weight, as the patentably of the product does not depend on its method of production, but is based on the product itself. The coatings recited in the cited arts are capable of being applied by chemical vapor deposition). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating process disclosed by modified Stafford to explicitly be the comprise a chemical vapor deposition, as taught by Boden. This is because Boden teaches deposition is a conventional method for applying a biocompatible lubricious compound (para. [0239]).
Regarding claim 164, modified Stafford discloses the medical device system of claim 58.
However, modified Stafford does not explicitly disclose wherein the coating includes parylene.
Shah further teaches the coating includes parylene (para. [0084]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coating disclose by modified Stafford to explicitly include parylene, as taught by Shah. This is because Shah teaches parylene is a suitable and known lubricant material for improving the ease of release of a sensor (para. [0084]).
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Gary Ashley Stafford (US 20140031655 A1) (previously cited), hereinafter referred to as Stafford, in view of Shah et al. (US 20160338734 A1) (previously cited), hereinafter referred to as Shah as applied to claim 51 above, and further in view of Luo et al. (“Thermal oxidation of Ti6Al4V alloy and its biotribological properties under serum lubrication”) (previously cited), hereinafter referred to as Luo.
Regarding claim 60, modified Stafford discloses the medical device system of claim 51.
However, modified Stafford does not explicitly disclose wherein the coating comprises a thermal oxide.
Luo teaches a coating process of a surface to reduce friction, the coating comprising a thermal oxide (pg. 67, Introduction, Fig. 6, pg. 70, 3.4. Biotribological behavior, pg. 70, Conclusion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate needle disclosed by modified Stafford to additionally include a thermal oxide coating, as taught by Luo. This is because Luo teaches titanium alloys provide high strength, however have high coefficients of friction, and the addition of a thermal oxide coating reduces the coefficient of friction (pg. 67, Introduction, Fig. 6, pg. 70, 3.4. Biotribological behavior, pg. 70, Conclusion), which one of ordinary skill in the art would recognize as a suitable lubricous coating.
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive.
Applicants have argued on pages 5-6 of Remarks, filed 11/24/2025, that “Stafford in view of Shah fail to disclose, teach, or suggest the features of independent Claim 51, as amended”.
The Examiner respectfully disagrees. As recited above, Stafford in view of Shah disclose the features of amended independent Claim 51. Applicants did not recite specifics regarding what features are not disclosed, taught, or suggested by Stafford in view of Shah.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791