DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment to the claims filed 06 February 2025 has been entered. Claim(s) 1 is/are currently amended. Claim(s) 8 and 20 has/have been canceled. Claim(s) 1-7 and 9-19 is/are pending.
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation ("BRI") using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked.
As explained in MPEP § 2181(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word "means," but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "tissue-piercing element" in the pending claims.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g., Fig. 2).
If Applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
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) 18 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 claim 18 and claims dependent thereon, there is insufficient antecedent basis for "the one or more drugs" in the claim. Claim 18 will be discussed with the understanding it is dependent on claim 17, which provides sufficient antecedent basis for the above-noted term.
Claim Rejections - 35 USC § 103
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:
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 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.
Claim(s) 1-3, 5 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0289788 A1 (Simpson '788).
Regarding claim 1, Simpson '788 discloses/suggests a system for measuring an analyte concentration (e.g., Figs. 4, 5, etc.), the system comprising:
a sensor (sensor unit including sensor body 412, e.g., ¶ [0007]; sensor 500; etc.) comprising at least one electrode (¶ [0007]; ¶ [0369]; etc.), and a membrane covering at least a portion of the at least one electrode (membrane 414; ¶ [0007]; etc.); and
a tissue-piercing element comprising a dissolvable material that dissolves after insertion into a host, the tissue-piercing element configured to pierce tissue of the host (dissolvable tissue-piercing tip 408; ¶ [0007]; Fig. 5, distal portion of needle 502 including sharp distal tip 506; etc.).
Simpson '788 does not expressly disclose the sensor of the above-noted embodiment has buckling strength of at least 0.040 lbf. However, Simpson '788 does disclose the sensor is designed or configured, e.g., in the form of mechanical/structural properties such as column strength, for direct insertion into the host, particularly skin thereof, by direct press insertion without buckling (e.g., ¶ [0328]). Simpson '788 further discloses a column strength capable of withstanding an axial load greater than about 0.5 Newtons (N) (~ 0.112 lbf), or greater than about 1 N, or greater than about 2 N, or greater than about 5 N, or greater than about 10 N, without substantial buckling are sufficient to achieve this function (e.g., ¶ [0336]). Accordingly, 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 system of Simpson '788 with the above-noted sensor having buckling strength of at least 0.040 lbf (e.g., by including a hardening agent in the membrane (¶ [0383]); by the sensor having a protective sheath (¶ [0418]) or protective outer layer (¶ [0427]) as a cover during insertion; embedding or encapsulating the sensor in a dissolvable needle (¶ [0342]); etc.) in order to enable the sensor to be directly pressed/inserted into the tissue (e.g., skin) without substantially buckling (Simpson '788, ¶ [0336]).
Regarding claim 2, Simpson '788 as modified discloses/suggests the sensor includes a sensor body (e.g., ¶ [0007]) coated with a sheath (e.g., Fig. 5, proximal portion of needle 502), wherein the sheath comprises the same dissolvable material that is in the tissue-piercing element or a different dissolvable material than in the tissue-piercing element (¶ [0342]; ¶ [0375]; etc.). Alternatively/Additionally, Simpson '788 as modified discloses/suggests the sensor includes a sensor body (e.g., sensor body 412), and further discloses embodiments in which a sensor body is coated with a dissolvable sheath (¶ [0427] protective outer layer 1134 comprising a dissolving material). 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 above-noted system of Simpson '788 with the sensor body being coated with a dissolvable sheath in order to facilitate providing the sensor body with the sufficient column/buckling strength needed for direct press insertion and/or to further shield and/or protect the sensor and/or membrane thereof during the sensor insertion procedure (e.g., ¶ [0427]).
Regarding claim 3, Simpson '788 as modified discloses/suggests the system further comprises a mounting unit (Fig. 4, having the same/comparable ex vivo portion as Fig. 1, which includes mounting unit 116), wherein the tissue-piercing element extends past the sensor body in the direction of the mounting unit, but stops short of the at least one electrode (e.g., ¶ [0368] tissue-piercing element 108 may comprise a coating that covers at least a portion of the sensor body 112, including the sensor tip 126. For example, with reference to FIG. 4, a length L of the distal end of the sensor body 412 and membrane 414 may be dipped in a liquid bath to coat enough of the sensor tip to achieve good adhesion without covering any electrodes on the sensor).
Regarding claim 5, Simpson '788 as modified discloses/suggests the dissolvable material and/or the different dissolvable material comprise an anti-inflammatory (e.g., ¶ [0372] one or more bioactive agents may be integrated into the dissolvable tip 408; ¶ [0378]; etc.; ¶ [0360] bioactive agents may include would-suppressing agents or compounds, including corticosteroids, such as dexamethasone).
Regarding claim 16, Simpson '788 as modified discloses/suggests the dissolvable material further comprises one or more materials configured to suppress wounding, to promote rapid wound healing, to induce osmotic pressure or oncotic pressure, or a combination thereof (e.g., ¶ [0372] bioactive agents may be integrated into the dissolvable tip 408; ¶ [0378]; ¶¶ [0014]-[0016]; ¶¶ [0049]-[0050]; ¶¶ [0358]-[0362]; etc.).
Regarding claims 17-18, Simpson '788 as modified discloses/suggests the dissolvable material further comprises one or more drugs, including dexamethasone (e.g., ¶ [0372] one or more bioactive agents may be integrated into the dissolvable tip 408; ¶ [0378]; etc.; ¶¶ [0360]-[0361] bioactive agents may include would-suppressing agents, such as an anti-inflammatory).
Regarding claim 19, Simpson '788 as modified discloses/suggests the tissue-piercing element has a base diameter Dtip and the sensor body has a diameter Dwire, and the ratio Dtip/Dwire is greater than 0.75 (¶ [0224] wherein a proximal end of the tissue piercing element has a diameter greater than a diameter of the sensor body, indicating the Dtip/Dwire ratio is at least 1).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson '788 as applied to claim(s) 1 above, and further in view of US 2011/0073475 A1 (Kastanos).
Regarding claim 4, Simpson '788 as modified discloses/suggests the sheath comprises the different dissolvable material than in the tissue-piercing element (¶ [0427] dissolvable protective outer layer may comprise, e.g., sugars; ¶ [0366] dissolvable tissue-piercing element may comprise, e.g., a salt).
Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Simpson '788 (e.g., of Fig. 4) with the sheath comprising a different dissolvable material than in the tissue-piercing element because Applicant has not disclosed that utilizing different dissolvable materials for the tissue-piercing element and sheath provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses, the sheath being of the same dissolvable material as the tissue-piercing element and the sheath being of different dissolvable materials as suitable alternatives (e.g., ¶ [0091]). As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the sheath and tissue-piercing element being of the same dissolvable material (e.g., as in the encapsulating dissolvable needle embodiments disclosed by Simpson '788) because either arrangement permits providing the sensor with suitable column strength (resistance to buckling) and protection of the membrane during insertion, with enhanced comfort during subsequent use (¶ [0427]).
Further alternatively/additionally, Kastanos discloses and/or suggests a comparable system comprising a sensor (sensor 101); a dissolvable tissue-piercing element (e.g., Fig. 3, distal portion of coated portion 330, including distal tip 231); and a dissolvable sheath (e.g., Fig. 3, proximal portion of coated portion 330, including distal tip 231). Kastanos further discloses coated portion may comprise different dissolvable materials along its longitudinal axis (e.g., ¶ [0070] a sensor having a varied flexibility along its longitudinal axis can be formed by coating polymers having different durometers at different sections of the substrate). 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 system of Simpson '788 (e.g., of Fig. 4) with the sheath comprising a different dissolvable material than in the tissue-piercing element as taught/suggested by Kastanos in order to provide an in vivo portion with varied flexibility along its longitudinal axis (Kastanos, ¶ [0070]).
Claim(s) 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson '788 as applied to claim(s) 1 above, and further in view of US 2002/0072720 A1 (Hague).
Regarding claim 6, Simpson '788 as modified discloses/suggests the limitations of claims 1, as discussed above, but does not disclose the dissolvable material has a rate of dissolution in phosphate buffer solution from about 20 mg/min to about 60 mg/min. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Simpson '788 with the dissolvable material has a rate of dissolution in phosphate buffer solution from about 20 mg/min to about 60 mg/min because Applicant has not disclosed that the claimed dissolution rate range in a phosphate buffer solution provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant discloses, "It should be understood that different molecular weights and combinations of these core materials can be used to make the final formulation for the tip/sheath for a particular application. While these variations can be made, the final product should have a tensile strength under various conditions and combinations to be in the range of from about 20 to about 90 MPa, Young's Modulus in the range of from about 1 to about 10 GPa, and a rate of dissolution in phosphate buffer solution from about 30 mg/min to about 60 mg/min" (¶ [0137]), without providing any indication/reasoning as to why any combined final product of these core materials "should" have these properties. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the inherent rate of dissolution of the disclosed dissolvable materials (or combinations thereof) disclosed/suggested by Simpson '788 because either arranging permits providing a sufficiently "rapidly"-dissolving tissue-piercing element (Simpson '788, ¶ [0007]).
Alternatively/Additionally, Applicant discloses/suggests the claimed dissolution rate in a phosphate buffer solution is estimated to correspond to a material that dissolves within 2-3 minutes of insertion in vivo (e.g., ¶ [0139]). Hague discloses/suggests a comparable system including an insertable element with a dissolvable coating, wherein the coating dissolves in the range of 5 to 20 minutes, or shorter periods of time under a minute, after insertion into a host (e.g., ¶ [0036]). 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 system of Simpson '788 with the dissolvable material has a rate of dissolution in phosphate buffer solution from about 20 mg/min to about 60 mg/min, such that the material dissolves within 2-3 minutes of insertion in vivo, as taught/suggested by Hague in order to increase comfort of the system in vivo (Hague, ¶ [0039]).
Regarding claim 11, Simpson '788 as modified discloses/suggests the limitations of claims 1, as discussed above, but does not disclose the dissolvable material comprises a protein at a weight percentage of about 46 wt.% or more based on the total weight of the dissolvable material.
Hague discloses/suggests a comparable system, wherein an in vivo portion thereof comprises a dissolvable material comprising a protein at a weight percentage of about 46 wt.% or more based on the total weight of the dissolvable material (e.g., ¶ [0006] soluble material is formed from a protein; claim 8; etc.).
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 system of Simpson '788 with the dissolvable material comprising a protein at a weight percentage of about 46 wt.% or more based on the total weight of the dissolvable material (e.g., consisting of only protein) as taught/suggested by Hague as a simple substitution of one suitable dissolvable material for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson '788 as applied to claim(s) 1 above, and further in view of WO 2009/094394 A1 (Prausnitz).
Regarding claim 7, Simpson '788 as modified discloses/suggests the limitations of claim 1, as discussed above, but does not expressly disclose the dissolvable material has a Young's modulus of from about 1 GPa to about 10 GPa as measured by method ASTM-D2370.
With respect to the limitation "as measured by the method ASTM-D2370," claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04. The above limitation does not limit the sensor device to any particular structure or property, but rather describes a method by which these properties are measured, or capable of being measured, and therefore does not limit the claim scope.
Prausnitz discloses and/or suggests a comparable system comprising an in vivo portion (microneedles) including a dissolvable material (pg. 2, lines 16-25, microneedles will dissolve or swell following insertion into the biological barrier) having a Young's modulus of from about 1 GPa to about 10 GPa (e.g., pg. 30, lines 8-15). Prausnitz discloses said in vivo portion is suitable for skin insertion without breaking and/or buckling (pg. 28, line 7 - pg. 29, line 27).
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 system of Simpson '788 with the dissolvable material has a Young's modulus of from about 1 GPa to about 10 GPa, e.g., as measured by method ASTM-D2370, as taught and/or suggested by Prausnitz in order to providing the tissue-piercing element, or in vivo portion of the system generally, with suitable column strength (resistance to buckling) during insertion (Prausnitz, pg. 28, line 7 - pg. 29, line 27).
Claim(s) 9-10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Simpson '788 as applied to claim(s) 1 above, and further in view of US 2017/0348218 A1 (Chen).
Regarding claims 9-10, Simpson '788 as modified discloses/suggests the limitations of claim 1, as discussed above, and further discloses/suggests the piercing tip material may comprise PVP or PVA, but does not expressly disclose the dissolvable material comprises PVA and one or more of PVP, a protein, or a polysaccharide.
Chen discloses/suggests a system comprising an in vivo portion (shafts) including a dissolvable material selected to provide the in vivo portion with e.g., desired mechanical strength, flexibility, and dissolution profile (¶ [0028], ¶ [0043]), wherein the dissolvable material includes PVA and PVP, a protein, such as gelatin, and/or a polysaccharide, such as carboxymethylcellulose (starch, CMC) (e.g., ¶ [0030]; ¶ [0043]).
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 system of Simpson '788 with the dissolvable material comprising PVA and one or more PVP, a protein, and a polysaccharide, such as PVA and gelatin, as taught/suggested by Chen as a simple substitution of one suitable dissolvable composition for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 12-13, Simpson '788 as modified discloses/suggests the limitations of claims 1, as discussed above, but does not disclose the dissolvable material comprises a polysaccharide, such as CMC, at a weight percentage from about 2 wt.% to about 10 wt.% based on the total weight of the dissolvable material. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Simpson '788 with the dissolvable material comprises a polysaccharide, such as CMC, at a weight percentage from about 2 wt.% to about 10 wt.% based on the total weight of the dissolvable material because Applicant has not disclosed that a polysaccharide, such as CMC, at a weight percentage from about 2 wt.% to about 10 wt.% based on the total weight of the dissolvable material, per se, provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses a polysaccharide may be an "optional" binder (e.g., ¶ [0085]), and CMC is one of many disclosed suitable polysaccharides (¶ [0081]). As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the dissolvable materials disclosed and/or suggested by Simpson '788 because either arrangement permits providing the sensor with suitable column strength (resistance to buckling) and protection of the membrane during insertion, with enhanced comfort during subsequent use (¶ [0427]).
Alternatively/Additionally, Chen discloses/suggests a system comprising an in vivo portion (shafts) including a dissolvable material including PVA and PVP, a protein, such as gelatin, and/or a polysaccharide, such as carboxymethylcellulose (starch, CMC) (e.g., ¶ [0030]; ¶ [0043]). Chen further discloses/suggests relative amounts and/or molecular weights of the components of the dissolvable material can be varied to adjust the dissolution time of said material (e.g., ¶ [0033], ¶ [0041]) and strength of said material (¶ [0028], ¶ [0043]). 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 system of Simpson '788 with the dissolvable material including, inter alia, a polysaccharide, such as starch or CMC, as taught/suggested by Chen as a simple substitution of one suitable dissolvable composition for another to yield no more than predictable results. See MPEP 2143(I)(B). Further, since Simpson '788 discloses the tissue-piercing element should dissolved rapidly (e.g., ¶ [0007]) and should provide sufficient strength for inserting the sensor without buckling (e.g., ¶ [0336]), and Chen discloses relative amounts of the components of the dissolvable material effect dissolution time and strength, the specific claimed range of the polysaccharide (e.g., CMC) comprising about 2 wt.% to about 10 wt.% based on the total weight of the dissolvable material 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).
Regarding claims 14-15, Simpson '788 as modified discloses/suggests the limitations of claims 1, as discussed above, but does not disclose the dissolvable material comprises from about 46 wt.% to about 49 wt.% PVA, from about 46 wt.% to about 49 wt.% gelatin, and from about 2 wt.% to about 8 wt.% CMC, or from about 91 wt. % to about 97 wt. % PVA and from about 3 wt. % to about 9 wt. % CMC.
Chen discloses/suggests a system comprising an in vivo portion (shafts) including a dissolvable material including one, two or three of PVA, gelatin and a polysaccharide (e.g., starch and/or CMC) (¶ [0030]; ¶ [0043]). Chen further discloses/suggests relative amounts and/or molecular weights of the components of the dissolvable material can be varied to adjust the dissolution time of said material (e.g., ¶ [0033], ¶ [0041]) and strength of said material (¶ [0028], ¶ [0043]).
Since Simpson '788 discloses the tissue-piercing element should dissolved rapidly (e.g., ¶ [0007]) and should provide sufficient strength for inserting the sensor without buckling (e.g., ¶ [0336]), and Chen discloses relative amounts of the components of the dissolvable material effect dissolution time and strength, as noted above, the specific claimed ranges of dissolvable material components as claimed 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) 1-7 and 9-19 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-3, 8, 11-13 and 17 of USPN 11,457,870 in view of Simpson '788, or Simpson '788 in view of Chen.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3, 8, 11-13 and 17 of USPN 11,457,870 anticipate the limitations of claims 1-4, 6-7, 9, 14, 16-17 and 19 of the present application with the exception of the sensor having buckling strength of at least 0.040 lbf. However, as noted with respect to the prior art rejections above, Simpson '788 discloses/suggests such a feature, such that it would have been obvious to modify claims 1-3, 8, 11-13 and 17 of USPN 11,457,870 with said feature in order to enable the sensor to be directly pressed/inserted into the tissue (e.g., skin) without substantially buckling (Simpson '788, ¶ [0336]).
Simpson '788 further discloses/suggests the features of claims 5 and 18 of the present application as discussed with respect to the prior art rejections above, and would have been an obvious modification(s) in order to suppress wounding (Simpson '788, ¶ [0358].
Chen discloses/suggests the dissolvable material compositions of claims 10-13 and 15 of the present application, as discussed with respect to the prior art rejections above and similarly would have been an obvious modification(s) for at least the reasons discussed above.
Claim(s) 1-7 and 9-19 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-8 and 10-19 of USPN 12,089,933 in view of Simpson '788.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 and 10-19 of USPN 12,089,933 anticipate the limitations of claims 1-7 and 9-19 of the present application with the exception of the sensor having buckling strength of at least 0.040 lbf. However, as noted with respect to the prior art rejections above, Simpson '788 discloses/suggests such a feature, such that it would have been obvious to modify claims 1-8 and 10-19 of USPN 12,089,933 with said feature in order to enable the sensor to be directly pressed or inserted into the tissue (e.g., skin) without substantially buckling (Simpson '788, ¶ [0336]).
Conclusion
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.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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