DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The substitute specification filed 4/13/26 has not been entered because of the following.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g). Relating to at least the amendment of claim 9, the cited publications on pages 30-31 should be incorporated as appropriate.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [e.g., pg. 31]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the sputtered metallic composition is deposited on a surface of the electrochemical analyte sensor…so that the electrochemical analyte sensor is made.” If the sputtered metallic composition is a component of the electrochemical analyte sensor, it is unclear how the sputtered metallic composition is also layered over the completed sensor unless the limitation implies there are multiple sputtered metallic compositions. To expedite prosecution, the sputtered metallic composition will be interpreted as layered over any of the base layer, conductive layer, analyte sensing layer, and/or the analyte modulating layer. Claims 2-10 are also rejected by virtue of dependency.
Claim 9 recites “wherein RAW264.7 macrophages in contact with the sputtered metallic composition exhibit inhibited differentiation…” which appears to be a functional result. It is unclear whether the limitation implies forming particular structures that are disclosed to perform the function of changing macrophage response or if the function is inherent to the claimed structure under the broadest reasonable interpretation. In other words, does the claim limitation imply some steps to form the sensor comprising gold or nanostructures with dimensions in a range from 1-1000 nm and max peak/valley heights in a rage of 1-100nm (“the surface composition comprises gold and/or an architecture comprising pillars, and/or is formed to comprise nanostructures with dimensions in a range from 1 nm - 1000 nm and max peak/valley heights in a range of 1 nm - 1000 nm, such that when exposed to the surface comprising the composition, RAW264.7 macrophages are influenced,” pg. 4, lines 16-19 of the Specification)? Or is the result inherent to the sputtered metallic composition comprising pillars as recited in claim 1? Clarification is requested. To expedite prosecution, the claim limitations will be interpreted as inherent to the explicitly claimed structure.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Srinivasan (WO 2018/170363).
Regarding claim 1, Srinivasan teaches a method of making an electrochemical analyte sensor (Figs. 2, 65) comprising:
providing a base layer (402, Fig. 2; block 6500, Fig. 65);
forming a conductive layer (404) over the base layer, wherein the conductive layer includes a working electrode (block 6502, Fig. 65);
forming an analyte sensing layer (410) over the conductive layer (block 6504, Fig. 65), wherein the analyte sensing layer includes a composition that can alter the electrical current at the working electrode in the conductive layer in the presence of an analyte (“analyte sensing layer 410 detectably alters the electrical current Isig at the working electrode 404 in the presence of an analyte,” pg. 53, lines 8-10);
forming an analyte modulating layer (412) over the analyte sensing layer (block 6506); and
forming a surface adapted to contact an in vivo environment (“pig in-vivo experiments using sensors with Pt pillars,” pg. 7, line 28), the surface comprising a sputtered metallic composition (“sputtering processes disclosed herein produce metal compositions,” pg. 12, line 11) having the following characteristics: the sputtered metallic composition is deposited on a surface of the electrochemical analyte sensor (the sputtering is deposited on the base layer, Fig. 5B; this meets the interpretation under the 112(b) rejection above) adapted to contact an in vivo environment (“implanting a analyte sensor embodiment disclosed herein into an in vivo environment,” pg. 19, line 26; it is noted that the sputtered metallic composition is not explicitly stated to be on the outermost surface of the sensor or in direct contact with the in vivo environment) using physical vapor deposition (PVD) process (Fig. 5A); and the sputtered metallic composition comprises pillars (block 506, Fig. 5B) and is disposed on the electrochemical analyte sensor so as to be in direct contact with the in vivo environment [pg. 28, lines 27-28; exposed region or aperture];
that the electrochemical analyte sensor (450) is made (block 6508, Fig. 65).
Regarding claim 2, Srinivasan teaches placing a substrate for the sensor surface (base substrate 516, Fig. 5A) adapted to contact an in vivo environment in a physical vapor deposition (PVD) chamber (sputtering apparatus 512, Fig. 5A); setting a pressure of a gas in the chamber (“particle collision is controlled by…pressure of the ionized gas,” pg. 38, lines 8-12) ; and depositing the sputtered metallic composition on the substrate using physical vapor deposition at the pressure (“sputter depositing metal under high pressure (in this case 200 mTorr),” pg. 39, line 5).
Regarding claim 3, Srinivasan teaches the sputtered metallic composition comprises at least one structured layer selected from a patterned layer (“micropatterned Pt pillars,” pg. 41, line 22), a roughened layer (“rough or non-uniform pillar architectures may also be fabricated,” pg. 41, lines 8-9), a non-uniform layer (pg. 41, lines 8-10), and a layer including voids (“sensors of varying thicknesses and processing conditions for sputtered porous platinum,” pg. 46, lines 28-29).
Regarding claim 4, Srinivasan teaches the sputtered metallic composition comprises gold (“nano/micro pillar structures comprising gold (Au),”pg. 8, lines 29-30; “any metal that is sputter or e-beam deposited could be used to create metal pillars…this includes, but is not limited to, gold,” pg. 39, lines 7-9).
Regarding claim 6, Srinivasan teaches the physical vapor deposition at a pressure in a range of 2-250 millitorr (“pressure over a range of 50-200 mTorr,” pg. 39, lines 25-26).
Regarding claim 7, Srinivasan teaches the sputtered metallic composition is formed to comprise nanostructures with dimensions in a range from 1 nm - 1000 nm and/or max peak/valley heights in a range of 1 nm - 1000nm (“pillars having diameters/widths in a range from 1nm -1000nm and heights in a range of 0-10 micrometers,” pg. 41, lines 4-6).
Regarding claim 8, Srinivasan teaches the physical vapor deposition comprises: ionizing the gas so as to form ionized gas particles (518, Fig. 5A); and accelerating the ionized gas particles onto a target comprising the sputtered metallic composition using an electric and/or magnetic field (“accelerating ionized gas particles 518 onto a target 520 comprising the metal composition 906 using an electric 524 and/or magnetic field 526,” pg. 52, lines 15-16) having a power in a range of 10 watts to 100 kilowatts (“sputtering conditions including 800 W power,” pg. 41, lines 24-25).
Regarding claim 9, because these features are interpreted as functions inherent to the claimed structure (see interpretation under the 112(b) rejection above), and Srinivasan teaches the claimed structure and method, Srinivasan is further considered to teach the functional limitations of claim 9.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan.
Regarding claim 5, Srinivasan teaches embodiments where the metallic composition comprises multiple metallic layers (“Pt Pillars to the underlying gold electrode surface,” pg. 46, lines 26-27; “the base substrate is initially coated with a thin film conductive layer by…surface sputtering…this conductive layer may be provided as a plurality of thin film conductive layers, such as an initial chrome-based layer suitable for chemical adhesion to a polyimide base substrate followed by subsequent formation of thin film gold-based and chrome-based layers in sequence,” pg. 16, lines 10-15). Srinivasan further suggests using different pressures to achieve the desired effects (“Increased particle collisions on the target and range of incident angles are achieved with increased pressure, resulting in increased porosity and roughness of the deposited film,” pg. 38, lines 13-15). Srinivasan does not explicitly teach or suggest the first layer deposited at a first pressure and the second layer deposited at a second pressure lower than the first pressure.
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sputtered metallic composition to comprise two layers, with the second layer deposited at a pressure lower than the first pressure. Since Srinivasan already teaches applying multiple sputtered conductive layers (“base substrate is initially coated with a thin film conductive layer by…surface sputtering…formation of thin film gold-based and chrome-based layers in sequence,” pg. 16, lines 10-15) and adjusting the pressure to achieve the desired properties (“rough or non-uniform pillar architectures may also be fabricated,” pg. 41, lines 8-9; “increased pressure, resulting in increased porosity and roughness of the deposited film,” pg. 38, lines 13-15; “low pressure and longer deposition time result in higher deposited film thickness,” pg. 39, line 26-27), having one pressure lower than another would be a matter of routine experimentation (“rough or high surface area designs may be advantageous,” pg. 3, line 7; Figs. 6-7).
Double Patenting
The nonstatutory double patenting 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 nonstatutory double patenting 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 rejection based on nonstatutory double patenting 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 nonstatutory double patenting (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 (e.g., 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.
Claims 1, 3-4, 7, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 11 of U.S. Patent No. 11,134,868. The claims are reproduced below for comparison. Although the claims at issue are not identical, they are not patentably distinct from each other because, the more specific patent claim(s) still anticipate the instant claim(s). Following the rationale in In re Goodman, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Additionally, while patent claim 11 does not explicitly recite that the sensor is for use in an in vivo environment, the limitation reads as an inherent functional limitation. Since the patent claim recites the same process for making the analyte sensor and the same analyte sensor structure, the patent claim can be interpreted as having the same sputtered metallic composition adapted to contact an in vivo environment. The limitations of instant claims 3 and 7 are taught by patent claims 1 and 11, wherein the pillars can be interpreted as a patterned layer. Instant claim 9 is considered inherent, as understood under the 112(b) rejection above.
Patent No. 11,134,868 claims
Instant claims
1. A method of making an analyte sensor apparatus, the method comprising the steps of:
providing a base substrate; and
sputtering a metal composition onto the base substrate from a target, wherein; the target comprises the metal composition, the target is located off the base substrate, and the sputtering comprises: accelerating ionized gas particles onto the target using at least one of an electric or magnetic field, the ionized gas particles having a pressure greater than a threshold pressure and colliding with the target to project the metal composition onto the base substrate and into a pillar shape so that: the pillars have a height in a range up to 10 micrometers and a width in a range of 1 nanometer-1000 micrometers, the pillars consist essentially of the metal composition, and the pillars form an electroactive surface of electrode;
forming an analyte sensing layer on the working electrode, wherein the analyte sensing layer detectably alters the electrical current at the working electrode in the presence of an analyte; and
forming an analyte modulating layer on the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of analyte therethrough; and
so that the analyte sensor apparatus is formed.
11. The method of claim 1, further comprising: forming a mask on a surface of the base substrate, wherein the mask comprises openings exposing portions of the surface of the base substrate; sputtering the metal composition onto the mask and onto the portions of the surface exposed by the openings, so as to form the pillars extending through the openings; and removing the mask, leaving the pillars on the base substrate.
4. The method of claim 1, wherein the metal composition comprises at least one metal selected from platinum, gold, silver, copper, titanium, chromium, and iridium.
1. A method of making an electrochemical analyte sensor comprising:
providing a base layer;
forming a conductive layer over the base layer, wherein the conductive layer includes a working electrode;
forming an analyte sensing layer over the conductive layer, wherein the analyte sensing layer includes a composition that can alter the electrical current at the working electrode in the conductive layer in the presence of an analyte;
forming an analyte modulating layer over the analyte sensing layer; and
forming a surface adapted to contact an in vivo environment, the surface comprising a sputtered metallic composition having the following characteristics: the sputtered metallic composition is deposited on a surface of the electrochemical analyte sensor adapted to contact an in vivo environment using physical vapor deposition (PVD) process; and the sputtered metallic composition comprises pillars and is disposed on the electrochemical analyte sensor so as to be in direct contact with the in vivo environment;;
so that the electrochemical analyte sensor is made.
3. The method of claim 2, wherein the sputtered metallic composition comprises as at least one structured layer selected from a patterned layer, a roughened layer, a non-uniform layer, and a layer including voids.
4. The method of claim 2, wherein the sputtered metallic composition comprises gold.
7. The method of claim 1, wherein the sputtered metallic composition is formed to comprise nanostructures with dimensions in a range from 1 nm - 1000 nm and/or max peak/valley heights in a range of 1 nm - 1000nm.
Claims 1, 3, 7, and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12,507,915. Although the claims at issue are not identical, they are not patentably distinct from each other because, the more specific patent claim(s) still anticipate the instant claim(s). Following the rationale in In re Goodman, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. See the double patenting rejection over U.S. Patent No. 11,134,868 above for additional reasonings.
Response to Arguments
Applicant's arguments filed 4/13/26 have been fully considered but they are not persuasive.
Applicant argues that Srinivasan teaches electrodes that are disposed within the interior of the sensors. Examiner submits that Srinivasan discloses the sputtered metallic composition comprises pillars and is disposed on the electrochemical analyte sensor so as to be in direct contact with the in vivo environment [pg. 28, lines 27-28; exposed region or aperture]. It’s also noted that the figure 3 of Srinivasan pointed to by Applicant appears to be the same as instant applicant fig.3. Furthermore, it appears the amended new limitation may correspond to features in instant application fig.2A which is considered Applicant Admitted Prior Art as exposed electrodes are generally well-known in the art for direct contact with interstitial fluid to reduce diffusion barriers and preserve current response.
Accordingly, the Double Patenting rejections remain in view of above and as indicated by claim 11 of US Patent 11134868 and claim 16 of US patent 12507915.
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 Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
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/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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