DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
2. The disclosure is objected to because of the following informalities: P19 of the PGPUB (corresponding to the final line of page 2 of the specification) should make the following correction for clarity purposes: “Preferably, the wall of sealing material is
Appropriate correction is required.
Claim Objections
3. Claims 1, 2, 5, 6, 9, and 10 are objected to for the following reasons.
A) Claims 1 and 9 are objected to for failure to join the series of clauses indented under “the at least one inclusion” with a proper conjunction (i.e., adding “and” after the second clause in the series).
B) Claim 1 is objected to for failure to join the series of clauses in terms of what the storage film comprises (i.e., “and” after “the support material; and”) in line 8.
C) Claims 2 and 10 each omits a conjunction for the series of clauses and should add “and” between the two clauses.
D) Claim 2 is objected to for lack of concision and duplicative terms for the same thing; correction can be completed as shown: “comprising a surface
E) Claim 5 recites, “the thickness (e) of the storage film…” A thickness has not previously been recited; however, given this is the first time it is recited, for clarity this should be “a thickness
F) Claim 6 is objected to as it includes an improper long break between “material” and “at least partially.” Note that patent claims print exactly as shown (see corresponding USPUB version also including this long break).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claim 1, and thus dependent claims 2-7; claim 4; claim 8; claim 9, and thus dependent claims 10-17, claim 10, claim 11, claim 12, and thus claims 13-14, claim 15, claim 16, and claim 17, 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.
A) Claims 1 and 9 each recite in part:
“…said wall of sealing material configured for allowing the compound of interest to pass or diffuse therethrough in a controlled manner, for example, according to a desired speed of passage or diffusion…”
The italicized language is exemplary claim language leading to confusion over the intended scope of the claim (MPEP § 2173.05(d)). As noted in MPEP 2173.05(D), exemplary claim language held to be indefinite because the intended scope of the claim is unclear includes:
“R is a halogen, for example, chlorine…”
Likewise, the above language is held indefinite because the intended scope of the claim is unclear. If not intended to limit the scope of the claim, Applicant could delete the language entirely; if intending to limit the scope, then the claim should be amended as follows: “in a controlled manner
It is noted that given claim 8 incorporates the subject matter of claim 1, it is also rejected concurrently for this reason.
B) Claims 1 and 9 each improperly use a series of dashes, circular bullet points, and square bullet points in order to define what component(s) are within/part of a given layer. As shown in the printing of the USPGUB claims, dashes and bullet points do not print in patent claims and are improper within a claim set. Accordingly, claims 1 and 9 as printed in the PGPUB appears to require that the at least one inclusion includes all of the named components (claim 1) and both claims 1 and 9 are also unclear in their meaning (and what component includes what other component(s)):
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Accordingly, the improper use of dashes and bullet points in claims 1 and 9 as filed renders the claims indefinite as the metes and bounds of the claims as presented are entirely unclear in the format shown above.
Within each of claims 1 and 9, Applicant should remove the dashes and bullet points and instead use proper indentation and numbering (and/or lettering) to properly indent/nest which components include the defined other components. A suitable example of a claim 1 correction (lacking strike-through or underlining which is required in the response) is presented below. Note that any manner that Applicant wants to indent and number/letter the claim is fine (i.e., Applicant is not limited to the option below), so long as the claim presented is clear and lacks improper components (e.g., dashes, bullet points) that do not print in US patent claims.
Example Correction of claim 1 only (lacking proper mark-up as required in the response)
An electrode, comprising:
a storage film comprising:
a layer of a support material comprising at least one inclusion, the at least one inclusion:
contains a compound of interest;
constitutes at least one individual reservoir enveloped, at least partially, in the layer of the support material; and
has the form of a cavity extending in the layer of the support material; and
a wall of sealing material sealing the at least one inclusion, said wall of sealing material configured for allowing the compound of interest to pass or diffuse therethrough in a controlled manner, for example according to a desired speed of passage; and
a porous layer at least partially covering the wall of sealing material, at least a portion of a surface of the porous layer constituting an active surface area of the electrode.
It is noted that given claim 8 incorporates the subject matter of claim 1, it is also rejected concurrently for this reason.
C) Claim 4 recites the limitation, “the catalyst” in line 6. There is insufficient antecedent basis for this limitation.
D) Claim 8 is unclear as to whether it is presenting a method or a product. Claim 8 should be corrected to:
“A battery or a sensor comprising the electrode according to claim 1.”
E) Claim 9 recites, “A method for the manufacture of an electrode comprising a storage film, said storage film comprising at least one inclusion, said method comprising the steps consisting of: [steps recited].
The transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("consisting of" defined as "closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith"). MPEP § 2111.03.
Thus, the transitional language of “the steps consisting of” excludes any step not specified in the claim. Accordingly, each of claims 10-17 adding additional steps are indefinite as the parent claim 9 uses the closed language of “consisting of” to define the steps included.
F) Claim 14 depends on claim 12 reciting “comprising a step consisting of filling the at least one inclusion with a compound of interest.” Claim 14 then adds additional requirements of the step of claim 12 which used the closed language of consisting of. Accordingly, claim 14 is rendered further indefinite as it is improper to add additional components.
Appropriate correction is required. For compact prosecution purposes, the claims will be examined as best as possible, wherein the use of “consisting of” within independent claim 9 will be examined as the controlling/independent claim such that claims 10-17 will not have a prior art rejection.
Claim Analysis
6. During patent examination, pending claims must be "given their broadest reasonable interpretation consistent with the specification." (MPEP 2111). “An electrode” in the disclosure is also termed a “biofunctional device” in the instant application (P26, 120- reference to the US PGPUB), and is not solely performing only the functionality of a classic electrode (i.e., a conductor through which electricity enters or leaves an object). The “electrode” of the instant application includes other components such as a storage film that may be an insulating material and holds a reactant in the reservoir (see P121; claim 4). Accordingly, the electrode as claimed has a component (porous conductive material 7 including carbon nanotubes and catalyst 8) that is functioning in a manner that would be classically defined as an electrode, wherein this component layer (7, 8) is being used in combination with other layers/components that are not classical “electrode” layers/components. Accordingly, prior art including multiple layers in combination with at least one functioning as a classic electrode is considered applicable to the claims, as is consistent with how the specification utilizes the term.
This analysis is further evidenced by Applicant’s own work: Nedellec et al., “Microcapsule-based biosensor containing catechol for the reagent-free inhibitive detection of benzoic acid by tyrosinase,” Biosensors and Bioelectronics, 180 (2021) 113137 (copy provided) in which an analogous construct (Scheme 1, reproduced below) having an analogous “storage film” of polyurethane holding microcapsules (“at least one inclusion”) containing catechol (“a compound of interest”) that are enveloped in the polyurethane film (“storage film”) is combined with a dispersion of carbon nanotubes and enzyme, is simultaneously referred to as a “biosensor structure” and “a bioelectrode” (see pages 1, 2):
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7. In view of the analysis of the interpretation of “electrode” above, it is noted that while the best prior art is applied below in the rejection of record, the construct claimed also reads on traditional constructs within metal-air batteries and fuel cells.
For example, within Zhang et al. (US 2011/0059355) teaches a metal-air battery including an “electrode” (116/110/108/106) with the constituents of:
a stainless steel layer 116 with a plurality of holes 120 (“a storage film comprising a layer of support material 116 comprising at least one inclusion/individual reservoir 120 at least partially enveloped in the layer of support material 116”) that contains a compound of interest (e.g., oxygen gas), the hole/inclusion/reservoir 120 has the form of a cavity extending in the layer of support material 116);
an oxygen-gas permeable membrane 108 (optionally also 110 which may also be excluded – P90) (“a wall of sealing material configured for allowing the oxygen (“compound of interest”) to pass/diffuse therethrough in a controlled manner; and
a porous layer cathode layer 106 constituting an active surface of the electrode (P90; Fig. 1; see entire disclosure):
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As another example, Ohma (US 2019/0165382) teaches an solid polymer electrolyte fuel cell including “an electrode” (3a/4a/5a) including:
an anode separator 5a (“storage film”) comprising a layer of support material comprising at least one inclusion that constitutes an individual reservoir entirely enveloped in the layer, has the form of a cavity extending in the layer of support material (i.e., the gas channels formed therein), and contains a compound of interest (hydrogen gas);
a gas diffusion layer (“GDL”) 4a (“a wall of sealing material configured for controlled diffusion”); and
a catalyst layer 3a (“a porous layer”) at least partially covering the GDL 4a (“wall of sealing material”) and having a surface constituting an active surface area of the electrode (P120-121):
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It is thus highly recommended that Applicant more clearly define the invention in the claims to avoid these traditional constructs from reading on the claimed subject matter.
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 1-4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eshoo et al. (US 2017/0258378).
Regarding claim 1, Eshoo teaches an enzyme detection device (“an electrode1”) 10, 110, 210 (at least Figs. 1-3, 6) comprising:
an impermeable barrier with a reactant storage reservoir 24/222 (“a storage film”) (P21, -23, 31, 33, 54-59) comprising:
a layer of a support material 24 comprising “at least one inclusion” 22, the at least one inclusion 22:
contains a reactant (“a compound of interest”) (P21; 39-42; Table 1);
constitutes at least one individual reservoir enveloped, at least partially, in the layer of the support material 24 (see Fig. 1; see also Fig. 6); and
has the form of a cavity extending in the layer of the support material (see Figs. 1); and
a wall 20 of sealing material sealing the at least one inclusion 22, said wall of sealing material configured for allowing the reactant (“compound of interest”) to pass or diffuse therethrough in a controlled manner (P21, 31, 45-46, 54-58), for example according to a desired speed of passage (P21) [note that in Fig. 2 embodiment said “wall of sealing material” may be both support 120 and membrane 114]; and
a porous layer (12 or 12/18) at least partially covering the wall 20 of sealing material, at least a portion of a surface of the porous layer (12, or 12/18) constituting an active surface area of the electrode (P22-26, 30, 32, 39-40, 49-52, 54-59; entire disclosure relied upon).
For convenience, Fig. 1 of Eshoo is reproduced below:
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Regarding claim 2, Eshoo teaches the electrode according to claim 1, comprising a surface, called release or liberation surface, from which the reactant (“compound of interest”) is released or liberated from the storage film 24/22 (P55, 58), said release surface:
comprises, at least partially, a surface of the wall 20 (Fig. 1) or 120/114 (Fig. 2) of sealing material (P55, 58; Fig. 2), [and]
is situated facing the porous layer (12, or 12/18) (Fig. 1) or (112, 112/118) (Fig. 2).
Regarding claim 3, Eshoo teaches the electrode according to claim 1, in which the porous layer (12 or 12/18) comprises an enzyme (“a (biological) catalyst”) (P3, 21, 23, 24, 32, 42; Table 1).
Regarding claim 4, Eshoo teaches the electrode in which:
the storage film 24/22 comprising the layer of a support material 24 is non-conducting (“insulating”) (P33, 46) and the porous layer (12 or 12/18) comprises carbon nanotubes (“a porous conductive material”) (P24) and [an] enzyme (“catalyst”) (“a (biological) catalyst”) (P3, 21, 23, 24, 32, 42; Table 1).
Regarding claim 6, Eshoo teaches the electrode according to claim 1, in which the storage film (Fig. 6 embodiment) 216/222/218 comprises a backing layer 218 (“an encapsulating material”) at least partially enveloping the at least one inclusion (storage reservoir 222) so that a surface of the backing layer 218 (“encapsulating material”) constitutes at least a portion of a wall of the at least one inclusion (storage reservoir 222) (see Fig. 6; P62).
Regarding claim 7, Eshoo teaches the electrode according to claim 1, in which the wall 20 (or 120/114 – Fig. 2) of sealing material is a porous or semi- permeable wall (i.e., Fig. 1 has at least one aperture 14; Fig. 2 teaches the use of a porous/semi-permeable membrane (P58).
Regarding claim 8, Eshoo teaches a use of the electrode according to claim 1, in a sensor or a battery (P3, 22, 37, 39-44, 54-70; entire disclosure relied upon).
Claim Rejections - 35 USC § 103
10. 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.
11. Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Eshoo et al. (US 2017/0258378) as applied to at least claim 1 above.
Regarding claim 5, Eshoo teaches the electrode according to claim 1, comprising one or more reactant storage reservoirs (“individual inclusions”) (P45). Eshoo does not illustrate the embodiment including a plurality of reservoirs; however, the individual reactant storage reservoir (“inclusion”) is illustrated as having an oblong shape extending mainly within a thickness direction of the storage film 22/24 (see Figs. 1-3, 6, 7-10). Furthermore, Eshoo teaches that, “…the exact size and configuration of such reservoirs may vary according to the analyte being tested for, the intended duration of the testing, the conditions under which the testing will occur, and the like” (P45).
Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to determine the appropriate shape and format of the taught plurality of reactant storage reservoirs (“individual inclusions”) (P45), especially given eShoo teaches that “…the exact size and configuration of such reservoirs may vary according to the analyte being tested for, the intended duration of the testing, the conditions under which the testing will occur, and the like” (P45), and to look to the known option taught/illustrated (Figs. 1-3, 6, 7-10) as a suitable example to implement in the plurality of reservoirs (“individual inclusions”) construct (P45).
It is furthermore noted that the court has held that changes in shape are considered a matter of design choice (MPEP 2144.04; In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)): The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.
12. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Eshoo et al. (US 2017/0258378).
Regarding claim 9, Eshoo teaches the electrode presented in product claim 1 (Figs. 1-3, 6), entirely incorporated into the instant rejection and not repeated here. A specific method of manufacture for these embodiments is not detailed; however, for an alternative embodiment (Figs. 7-10), the method is detailed in which:
the analogous reactant storage reservoir (“at least one cavity”) is formed in the material 316 of the analogous support material 316 (P63, 65; Figs. 7-10); and then
the analogous time-release membrane [i.e., “wall of sealing material sealing the reactant storage reservoir (“at least one cavity”) so as to form at least one inclusion in the layer of support material 316, said wall having the capability claimed] is deposited after the analogous reactant storage reservoir is formed (P66; Figs. 7-10).
Accordingly, applying these specific method steps of the embodiment taught in Figs. 7-10 to the alternative embodiments of Figs. 1-3, and 6 is considered prima facie obvious in terms of creating the analogous embodiment taught in Figs. 1-3 and 6.
The embodiment of Figs. 7-10 does not require the additional porous layer taught in Figs. 1-3 and 6 as the material 316 used to form the electrode is the material of the electrode (i.e., it’s made of double walled carbon nanotube layer on PET) (P65); however, the embodiment in Figs. 1-3 and 6 does have a porous layer (12 or 12/18) on the wall 20 of sealing material, at least a portion of a surface of the porous layer (12, or 12/18) constituting an active surface area of the electrode (P22-26, 30, 32, 39-40, 49-52, 54-59; entire disclosure relied upon). For convenience, Fig. 1 of Eshoo is reproduced below:
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Accordingly, one of ordinary skill in the art at the effective filing date of the invention is left to determine an appropriate manner of providing porous layer 12 (or 12/18) to the taught product, and the options for this include either: 1) forming said layer(s) (12 or 12/18) (directly) on the film of sealing material 20; or 2) pre-forming said layer(s) (12 or 12/18) and then combining them with the film of sealing material 20.
Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to select one of only two known possibilities given at the effective filing date of the invention, there is a need to determine a method by which the porous layer 12 (or 12/18) is combined with the remainder of the electrode; there are a finite number (2) of identified, predictable solutions as enumerated above, wherein one of ordinary skill in the art could have pursued these known potential solutions with a reasonable expectation of success.
The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
13. Claim 9 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Eshoo et al. (US 2017/0258378) in view of Nedellec et al., “Microcapsule-based biosensor containing catechol for the reagent-free inhibitive detection of benzoic acid by tyrosinase,” Biosensors and Bioelectronics, 180 (2021) 113137 (copy provided)
The Nedellec reference was published 3 March 2021, and thus qualifies as prior art unless Applicant perfects their claim to the foreign priority application having a priority date (12/9/2020) by way of filing an English language translation of the non-English language foreign application, wherein the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. See also MPEP 2304.01(c).
Regarding claim 9, the rejection above in section 11 is entirely incorporated into the present rejection and not repeated here.
Nedellec is additionally cited to teach that it is a known method technique within an analogous construct to form a porous layer capable of forming an electrode active surface area onto an analogous polyurethane film of sealing material holding microcapsules (“at least one inclusion”) (see p. 2) for controlled release of the catechol (“a compound of interest”) to the porous layer for reaction (pages 1, 2; Scheme 1; entire disclosure relied upon).
Therefore, for this additional reason, the forming of the analogous porous layer 12 (or 12/18) of Eshoo on the film of sealing material 20 (versus preforming and then combining them) is considered the application of a known method technique considered suitable for use given the analogous construct taught by Nedellec employing the same technique to achieve the analogous porous layer acting an electrode active surface.
Conclusion
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA J BARROW whose telephone number is (571)270-7867. The examiner can normally be reached Monday-Friday 9am - 6pm CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ula Ruddock can be reached at (571) 272-1481. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA J BARROW/ Primary Examiner, Art Unit 1729
1 See the claim analysis within section 6 of this Office Action for use of this term and its interpretation within the claims as is consistent with the instant application specification.
2 The claims will utilize the reference numerals of Fig. 1 for ease of reference; however, all corresponding reference numerals for the other embodiments of Figs. 2-3 and 6 for the same components are also applicable, as well as Figs. 2-3 and 6 when reference to Fig. 1 is made.