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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24th April 2026 has been entered.
Response to Amendment
The amendments filed 24th April 2026 has been entered. Claims 1, 11, 12 and 24 have been amended. Claims 26-28 are new. Claims 1-2, 5-16 and 22-28 are pending in this application, with claims 6-10 & 13-16 withdrawn.
Response to Arguments
Some of the rejections under 112(b) previously applied in the final rejection mailed 28th January 2026 have been maintained, as they have not been resolved.
Applicant’s arguments regarding the rejections under 35 U.S.C. 103:
Due to the numerous rejections under 112(a) & 112(b) being applied, art cannot be applied at this time.
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 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 broadest reasonable interpretation 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, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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: ‘a device adapted to process sensed electrochemical values’ in claim 5. The specification fails to provide structure for said device.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (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) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 11 & 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 11 and 12 as amended now recite ‘an ink including Ag/AgCl and KCl…’, in review of the specification, the ink is only mentioned as ‘Ag/AgCl ink’. From the specification, it appears that KCl is included in the reference membrane, not the ink. The specification does not provide support for ‘an ink including Ag/AgCl and KCl’ as currently amended and therefore introduces new matter.
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 1-2, 5, 11-12, 22-28 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 broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation ‘configured for ion and/or molecule on-body transdermal sensing’, then recites ‘for ion sensing or (bio) molecule sensing’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 1 & 11 recite ‘at least two solid microneedles or needles’ then later recited ‘providing at least one microneedle or needle’, it is unclear whether the at least one microneedle or needle is part of the ‘at least two solid microneedles or needles’ as previously recited or not, rendering claims 1 & 11 indefinite. Further claim 1 recites ‘at least one microneedle or needle’ twice in the claim making it unclear if each recitation refers to the same ‘at least one microneedle or needle’ or not.
Claim 1 recites ‘the microneedle or needle configured as the working electrode’, there is insufficient antecedent basis for this limitation in this claim.
Claim 1 recites ‘at least one microneedle or needle configured to function as a working electrode’ then later recites ‘the microneedle or needle configured as the working electrode’, it is unclear whether ‘the microneedle or needle configured as the working electrode’ is part of ‘the at least one microneedle or needle configured to function as a working electrode’, or a separate/new limitation of a microneedle or needle configured as the working electrode, rendering claim 1 indefinite.
Claim 1 recites ‘the KCl included in the reference membrane’, the previous recitation of ‘an ink comprising Ag/AgCl and KCl’ is unrelated to the reference membrane as it is related to an ink that comprises Ag/AgCl and KCl. Therefore, there is insufficient antecedent basis for the limitation of ‘the KCL included in the reference membrane’ in this claim.
Claim 1 recites ‘the reference membrane’ in line 24, there is insufficient antecedent basis for this limitation in this claim.
Claim 1 recites ‘the pseudoreference membrane’ in line 25, there is insufficient antecedent basis for this limitation in this claim.
Claim 1 recites ‘an Ag/AgCl layer coating to improve conductivity of the microneedle…’, it is unclear whether this is referring to the previously recited ‘a coating to improve conductivity of the microneedle…’ or a separate and distinct coating limitation, rendering claim 1 indefinite.
Claim 1 recites ‘coating said working electrode for ion sensing by coating the coating to improve the conductivity with an ion-to electron transducer layer, and coating the ion-to-electron transducer layer with an ion-selective membrane…’.. and further ‘coating said working electrode for (bio)molecule sensing by coating the coating to improve the conductivity with a mediator layer, and coating the mediator layer with an enzyme film, and coating the enzyme layer with an additional external film…’, it is unclear whether ‘the coating’ is the previously recited ‘Ag/AgCl layer coating to improve conductivity of the microneedle…’ or the previously cited ‘a coating to improve the conductivity of the microneedle…’ or a new separate coating. It’s unclear what the initial coating is, and whether the Ag/AgCl coating is applied or not. How many coatings are intended to be claimed? It is currently ambiguous.
Claim 1 recites ‘an Ag/AgCl layer coating’ in line 14, then later recites ‘an Ag/AgCl layer coating’ in line 19, it is unclear whether the second iteration of ‘an Ag/AgCl layer coating’ is the same or a separate coating, rendering claim 1 indefinite.
The term “improve” in claim 1 is a relative term which renders the claim indefinite. The term “improve” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitations regarding conductivity & potential stability is rendered indefinite as a result.
The term “potential” in claims 1 is a relative term which renders the claim indefinite. The term “potential” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation regarding ‘stability of the reference electrode or of the pseudoreference electrode’ is rendered indefinite as a result.
Claim 1 recites ‘the enzyme layer’, there is insufficient antecedent basis for this limitation in this claim.
Claim 1 recites ‘an additional external film for different purposes’, it is unclear what the intended scope is supposed to be, rendering claim 1 indefinite. What different purposes specifically?
Claims 1, 2 & 12 recite ‘(bio) molecule’, it is unclear whether the term in parentheses is required or not, rendering claim 1 indefinite.
The term “long-term” in claims 1 is a relative term which renders the claim indefinite. The term “long-term” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation regarding ‘electrochemical potential’ is rendered indefinite as a result.
Claim 2 recites ‘providing at least one solid microneedle or needle’, it is unclear whether this limitation is part of the previously recited ‘at least two solid microneedles or needles’ of claim 1 or not, rendering claim 2 indefinite.
Claim 5, Claim limitation ‘a device adapted to process sensed electrochemical values’ invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification offers no corresponding structure to achieve the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 11 recites ‘(micro)needle-substrate’, it is unclear whether the term in parentheses is required or not, rendering claim 11 indefinite.
It is noted that including “and/or” in claims 1, 11 & 12 renders some of the limitations optional. For example, in claim 1, under the broadest reasonable interpretation, the claim can be interpreted as comprising the step of “coating said working electrode for ion sensing by coating the coating to improve the conductivity with a ion-to-electron transducer layer, and coating the ion-to-electron transducer layer with an ion-selective membrane,” and the remaining limitations following the phrase “and/or” can all be interpreted as not necessarily required. To expedite prosecution, the claim will be interpreted as encompassing two embodiments: the combination of a working and pseudoreference electrodes for (bio)molecule sensing and, alternatively, the combination of a working and reference electrode for ion sensing.
Claims 1, 11 & 12 recite limitations that seem redundant. For example, Claim 1 recites “coating the reference electrode or the pseudoreference electrode with an external polymeric film”, “coating the reference membrane film with said external polymeric film”, and “coating said pseudoreference electrode…with said external polymeric film”. It seems the latter two limitations are merely reiterating the first limitation rather than reciting additional coating steps of the external polymeric film, and this interpretation will be followed to expedite prosecution. Applicant should amend the claims to clearly set forth the steps of the claim and indicate which steps comprise alternative sub-steps or options.
Claim 12 recites ‘at least three solid microneedles’, then later recites ‘providing at least one microneedle’, it is unclear whether the at least one microneedle or needle is part of the ‘at least three solid microneedles’ as previously recited or not, rendering claim 12 indefinite.
Claims 11 & 12 recites ‘the same patch’, this limitation implies more than one patch exists, but there is no recitation of a second patch in any way, rendering Claim 12 indefinite. Examiner interprets this limitation as an erroneous error during amendment, ‘the same patch’ is interpreted as ‘the patch’ or ‘said patch’.
Claim 22 recites ‘pairs of reference and working electrodes or pairs of pseudoreference and working electrodes’, it is unclear whether these pairs of electrodes are part of the ‘at least two solid microneedles or needles’ as previously recited in claim 5 (claim 1 by extension) or not, rendering claim 22 indefinite.
Claim 23 recites ‘one pair of reference and working electrodes, or one pair of pseudoreference and working electrodes… another pair of reference and working electrodes, or another pair of pseudoreference and working electrodes’, it is unclear whether these pairs of electrodes are part of the ‘pairs of reference and working electrodes or pairs of pseudoreference and working electrodes’ of claim 22 or not, further it is unclear whether these pairs of electrodes are part of the ‘at least two solid microneedles or needles’ as previously recited in claim 5 (claim 1 by extension) or not, rendering claim 23 indefinite.
Claim 24 ‘the microneedle’, there is insufficient antecedent basis for this limitation in this claim.
Claim 24 ‘the microneedle’, it is unclear whether this microneedle is part of the previously cited ‘at least two solid microneedles or needles’ of claim 1 or not, rendering claim 24 indefinite.
Claim 26 recites ‘Ag/AgCl ink’, there is insufficient antecedent basis for this limitation in this claim.
Claim 26 recites ‘on both the whole surface of the reference electrode or of the whole surface of the pseudoreference’, it is unclear whether the Ag/AgCl ink is applied on both or if only one is required, rendering claim 26 indefinite.
Claim 26 recites ‘on both the whole surface of the reference electrode or of the whole surface of the pseudoreference’, it is unclear what is considered the ‘whole surface’ and whether this includes potential internal surfaces as well as external or not.
Claim 26 recites ‘the pseudoreference’, there is insufficient antecedent basis for this limitation in this claim.
Claims 2, 5, 22-28 are rejected by virtue of dependence on rejected independent claims.
Conclusion
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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