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 .
The Applicants’ Amendment to the Claims, filed on June 29, 2026, is entered.
Claims 1-18, 20-21, and 23-27 are cancelled.
Claims 28-43 are new.
Claims 19, 22, and 28-43 are pending and under examination.
This is the First Office Action on the Merits of US18/402,684 filed on 01/02/2024 which claims US priority benefit of US Provisional 63/477,977 filed on 12/30/2022.
Election/Restrictions
Applicant’s election without traverse of Group I, in the reply filed on June 29, 2026, is acknowledged.
Applicant’s election without traverse of the Species:
polyvinylpyridine-based copolymer as the type of copolymers listed in claim 3 (corresponding to new claim 29) and
an anti-inflammatory agent as the type of therapeutic agents listed in claim 13 (corresponding to new claim 38),
in the reply, filed on June 29, 2026, is acknowledged.
Information Disclosure Statement
The IDS, filed on April 2, 2025, has been considered by the examiner.
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.
Claims 28, 31-32, 36-37, and 42-43 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 28 recites "the hydrophilic unit" in line 1 and “the hydrophobic unit” in line 3. There is insufficient antecedent basis for these limitations because claim 28 depends from claim 19. Base claim 19 recites “a plurality of hydrophilic units” and recites “a plurality of hydrophobic units” but does not refer to a singular form of such units. It is unclear which of the plurality of such units is providing antecedent basis for the singular units recited in claim 28.
Claims 31-32 each recite the term “mer%”. It is unclear what structure is intended/required by such term.
Claims 36-37 each recite the term “wherein the mol% crosslinking of the copolymer”. There is insufficient antecedent basis for this limitation because claims 36 and 37 depend from claim 19 which does not explicitly recite crosslinking of the copolymer. Instead, claim 19 recites a copolymer comprising a plurality of copolymer chains, wherein each of the plurality of copolymer chains comprises a backbone comprising a plurality of hydrophilic units and a plurality of hydrophobic units; a crosslinker crosslinking at least a portion of the hydrophilic units between respective copolymer chains; and a therapeutic agent”. It is unclear whether the limitation “wherein the mol% crosslinking of the copolymer” is intending to refer to the percentage of copolymer molecules that have crosslinking within the copolymer structure or the percentage of copolymer chains that are crosslinked to the hydrophilic units, or the percentage of hydrophilic units that are crosslinked to the copolymer chains.
Claim 42, recites “wherein the drug delivery composition comprises the therapeutic agent in a range of about 0.01 wt% - about 40 wt% based on a weight of the copolymer. However, claim 42 depends from claim 19 which requires that the drug delivery composition comprises: a copolymer, a crosslinker, and a therapeutic agent. It is unclear if the weight of the copolymer is intended to include the crosslinker.
Claim 43 recites the limitation "the hydrophilic unit of the copolymer" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because claim 43 depends from claim 19 which recites “a plurality of hydrophilic units” and recites “a crosslinker crosslinking at least a portion of the hydrophilic units between respective copolymer chains”. It is unclear which of the plurality of such units is providing antecedent basis for the singular unit recited in claim 43.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19, 22, 28-38, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al (US2018/0014761).
Regarding claim 19, Ouyang et al disclose an analyte sensor comprising:
an in vivo end comprising at least a first working electrode;
an active area upon a surface of the first working electrode for detecting an analyte;
a membrane permeable to the analyte that overcoats at least the active area;
a counter/reference electrode.
For example, the Abstract recites:
Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a membrane with low temperature sensitivity. The sensing layer is disposed on a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.
In addition, Ouyang et al disclose the analyte sensor comprising:
a drug delivery composition. (See para 0139-0140, 0094, 0095, 0163 “Drug Delivery System”). For example, para 0163 recites:
[0163] The subject invention also includes sensors used in sensor-based drug delivery systems. The system may provide a drug to counteract the high or low level of the analyte in response to the signals from one or more sensors. Alternatively, the system may monitor the drug concentration to ensure that the drug remains within a desired therapeutic range. The drug delivery system may include one or more (e.g., two or more) sensors, a processing unit such as a transmitter, a receiver/display unit, and a drug administration system. In some cases, some or all components may be integrated in a single unit. A sensor-based drug delivery system may use data from the one or more sensors to provide necessary input for a control algorithm/mechanism to adjust the administration of drugs, e.g., automatically or semi-automatically. As an example, a glucose sensor may be used to control and adjust the administration of insulin from an external or implanted insulin pump.
Further, Ouyang et al disclose that the drug delivery composition comprises: a copolymer comprising a plurality of copolymer chains, wherein each of the plurality of copolymer chains comprises a backbone comprising a plurality of hydrophilic units and a plurality of hydrophobic units. (See para 0025.) Also, see para 0127 just below:
[0127] A membrane may be formed by crosslinking in situ a polymer, modified with a zwitterionic moiety, a non-pyridine copolymer component, and optionally another moiety that is either hydrophilic or hydrophobic, and/or has other desirable properties, in an alcohol-buffer solution. The modified polymer may be made from a precursor polymer containing heterocyclic nitrogen groups. For example, a precursor polymer may be polyvinylpyridine or polyvinylimidazole. Optionally, hydrophilic or hydrophobic modifiers may be used to “fine-tune” the permeability of the resulting membrane to an analyte of interest. Optional hydrophilic modifiers, such as poly(ethylene glycol), hydroxyl or polyhydroxyl modifiers, may be used to enhance the biocompatibility of the polymer or the resulting membrane.
Further, Ouyang et al disclose that the drug delivery composition comprises: a crosslinker crosslinking at least a portion of the hydrophilic units between respective copolymer chains. (See para 0026.) Ouyang et al disclose the analyte sensor includes a membrane disposed on the sensing layer. Para 0035-0036 recites:
[0035] In certain embodiments, the analyte sensor includes a membrane disposed on the sensing layer, where the membrane includes a poly(styrene-co-maleic anhydride) polymer and a polyetheramine crosslinker.
[0036] In some instances, the poly(styrene-co-maleic anhydride) polymer (SMA polymer) has a styrene composition ranging from 10% to 90%, including from 25% to 90%, such as from 50% to 90%. For example, the SMA polymer may have a styrene composition of 75%. In some embodiments, the SMA polymer has a molecular weight of 1000 or more, such as 1500 or more, including 2000 or more. For instance, the SMA polymer may have a molecular weight of 1900.
Further, Ouyang et al disclose that the drug delivery composition may comprise a therapeutic agent such as insulin. (See para 0095; para 0163 just above.)
Regarding base claim 22, Ouyang et al discloses a sharp, comprising an analyte sensor and a drug delivery composition. (See para 0135; 0141, Fig5.)
[0141] An insertion device can be used to subcutaneously insert the sensor into the user. The insertion device is typically formed using structurally rigid materials, such as metal or rigid plastic. Materials may include stainless steel and ABS (acrylonitrile-butadiene-styrene) plastic. In some embodiments, the insertion device is pointed and/or sharp at the tip to facilitate penetration of the skin of the user. A sharp, thin insertion device may reduce pain felt by the user upon insertion of the sensor. In other embodiments, the tip of the insertion device has other shapes, including a blunt or flat shape. These embodiments may be useful when the insertion device does not penetrate the skin but rather serves as a structural support for the sensor as the sensor is pushed into the skin.
Regarding claim 28, Ouyang et al discloses that (a) the hydrophilic unit is selected from the group consisting of a pyridine unit, a pyridazine unit, a pyrimidine unit, a pyrazine unit, a triazine unit, an imidazole unit, and a pyrazole unit, and/or (b) the hydrophobic unit is selected from the group consisting of a non-heteroatom containing aromatic unit, an acyclic aliphatic unit, and a cyclic aliphatic unit. See para 0127:
[0127] A membrane may be formed by crosslinking in situ a polymer, modified with a zwitterionic moiety, a non-pyridine copolymer component, and optionally another moiety that is either hydrophilic or hydrophobic, and/or has other desirable properties, in an alcohol-buffer solution. The modified polymer may be made from a precursor polymer containing heterocyclic nitrogen groups. For example, a precursor polymer may be polyvinylpyridine or polyvinylimidazole. Optionally, hydrophilic or hydrophobic modifiers may be used to “fine-tune” the permeability of the resulting membrane to an analyte of interest. Optional hydrophilic modifiers, such as poly(ethylene glycol), hydroxyl or polyhydroxyl modifiers, may be used to enhance the biocompatibility of the polymer or the resulting membrane.
Regarding claim 29, Ouyang et al discloses that the copolymer is selected from the group consisting of a polyvinylpyridine-based copolymer, a polyvinylimidazole-based copolymer, and a combination thereof. (See para 0126-0127.)
Regarding claim 30, Ouyang et al discloses that the polyvinylpyridine-based copolymer is a polyvinylpyridine-co-polystyrene polymer. (See para 0043.)
Regarding claims 31 and 32, Ouyang et al discloses that the polyvinylpyridine-co-polystyrene polymer comprises about 1-50 mer% of styrene units (claim 31) and that the polyvinylpyridine-co-polystyrene polymer comprises about 1-30 mer% of styrene units. (claim 32). (See para 0068 just below.)
[0068] In some instances, the poly(4-vinylpyridine)-co-polystyrene polymer (PVPSty polymer) has a styrene composition ranging from 10% to 90%, including from 10% to 75%, such as from 10% to 50%. For example, the PVPSty polymer may have a styrene composition of 30%.
Regarding claim 33, Ouyang et al discloses that a weight average molecular weight of the copolymer is in a range of about 5 kD to about 1000 kD. See para 0036:
[0036] In some instances, the poly(styrene-co-maleic anhydride) polymer (SMA polymer) has a styrene composition ranging from 10% to 90%, including from 25% to 90%, such as from 50% to 90%. For example, the SMA polymer may have a styrene composition of 75%. In some embodiments, the SMA polymer has a molecular weight of 1000 or more, such as 1500 or more, including 2000 or more.
Regarding claim 34, Ouyang et al discloses that the crosslinker is an epoxide-polyether-epoxide crosslinker. In para 0052, Ouyang et al disclose a diglycidyl- functional epoxy crosslinker.
Regarding claim 35, Ouyang et al discloses that the crosslinker is a PEG diglycidyl ether crosslinker. (see para 0064.) Table 2 recites PEG200.
Regarding claim 36, Ouyang et al discloses that the mol% crosslinking of the copolymer is in a range of about 0.1 mol% - about 50 mol%. Ouyang et al recite: “By way of example, the polymer to crosslinker ratio by weight may range from 2:1 to 50:1, such as from 2:1 to 40:1, including from 2:1 to 30:1, or from 2:1 to 25:1, or from 3:1 to 22:1, or from 4:1 to 20:1 or from 5:1 to 15:1, and the like”. (See para 0074.)
Regarding claim 37, Ouyang et al discloses that the mol% crosslinking of the copolymer is in a range of about 0.1 mol% - about 30 mol%. Ouyang et al recite: “By way of example, the polymer to crosslinker ratio by weight may range from 2:1 to 50:1, such as from 2:1 to 40:1, including from 2:1 to 30:1, or from 2:1 to 25:1, or from 3:1 to 22:1, or from 4:1 to 20:1 or from 5:1 to 15:1, and the like”. (See para 0074.)
Regarding claim 38, Ouyang et al discloses that the therapeutic agent may be insulin/antiglycolytic or an anticlotting/anticoagulant agent. See para 0139-0140.
Regarding claim 43, Ouyang et al discloses that the crosslinker is bonded to the hydrophilic unit of the copolymer to form a charge. See para 0127:
[0127] A membrane may be formed by crosslinking in situ a polymer, modified with a zwitterionic moiety, a non-pyridine copolymer component, and optionally another moiety that is either hydrophilic or hydrophobic, and/or has other desirable properties, in an alcohol-buffer solution. The modified polymer may be made from a precursor polymer containing heterocyclic nitrogen groups. For example, a precursor polymer may be polyvinylpyridine or polyvinylimidazole. Optionally, hydrophilic or hydrophobic modifiers may be used to “fine-tune” the permeability of the resulting membrane to an analyte of interest. Optional hydrophilic modifiers, such as poly(ethylene glycol), hydroxyl or polyhydroxyl modifiers, may be used to enhance the biocompatibility of the polymer or the resulting membrane.
Thus, Ouyang et al disclose all of the elements of the present claims 19, 22, 28-38, and 43. However, the elements are not always disclosed in the same embodiment.
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to combine the elements of the analyte sensor and analyte sensor with the sharp insertion component as discussed above for the rationale of sensing an analyte in a subject’s blood and delivering a drug related to such analyte. For example, as suggested by Ouyang et al, glucose may be monitored and insulin may be delivered.
It would have been obvious for one of ordinary skill in the art to combine the elements of the analyte sensing system of Ouyang et al because these elements are preferred embodiments of Ouyang et al to achieve successful analyte sensing and potential drug delivery.
In view of the high level of skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the Ouyang et al reference before the effective filing date of the presently claimed invention would have had a reasonable expectation of success to follow the guidance of Ouyang et al to arrive at the presently claimed invention.
Thus, the claims as a whole are rendered obvious over Ouyang et al.
Claims 19, 22, 28-30, and 33-43 are rejected under 35 U.S.C. 103 as being unpatentable over Zou et al (US 2017/0191955, published 07/06/2017).
Regarding base claims 19 and 22, Zou et al disclose an analyte sensor comprising: an in vivo end comprising a working electrode. (See Abstract; para 0003, 0010; 0298, entire document). Zou et al disclose an active area upon a surface of the electrode for detecting an analyte. (See para 0039, 0044, 0048, 0064, 0066). Zou et al disclose a membrane permeable to the analyte that overcoats the active area. (See Abstract, para 0004-0005, 0054, 0123, 0200, 0332). Zou et al disclose a counter/reference electrode. (See para 0039, 0044, 0083). Zou et al disclose a drug delivery composition comprising: a copolymer comprising a plurality of copolymer chains, where each of the copolymer chains have a backbone comprising a plurality of hydrophilic units and hydrophobic units. (See para 0008, 0073, especially para 0191). Further, Zou et al disclose a crosslinker crosslinking a portion of the hydrophilic units between the copolymer chains. (See para 0008, 0105, 0106, 0118, 0120, 0156, 0163, especially para 0191). Zou et al disclose a therapeutic agent. (See para 0125).
Regarding base claim 22, Zou et al discloses a sharp, comprising an analyte sensor and a drug delivery composition. (See para 0062, 0073, 0075.)
Regarding claim 28, Zou et al discloses that (a) the hydrophilic unit is selected from the group consisting of a pyridine unit, a pyridazine unit, a pyrimidine unit, a pyrazine unit, a triazine unit, an imidazole unit, and a pyrazole unit, and/or (b) the hydrophobic unit is selected from the group consisting of a non-heteroatom containing aromatic unit, an acyclic aliphatic unit, and a cyclic aliphatic unit. (See para 0147).
Regarding claim 29, Zou et al discloses that the copolymer is selected from the group consisting of a polyvinylpyridine-based copolymer, a polyvinylimidazole-based copolymer, and a combination thereof. (See para 0191.)
Regarding claim 30, Zou et al discloses polyvinylpyridine-based copolymer and suggests a co-polymer being a polystyrene polymer. (See para 266-268.)
Regarding claim 33, Zou et al discloses that a weight average molecular weight of the copolymer is in a range of 25 kD to 5000 kD which is construed to meet the limitation of about 5 kD to about 1000 kD. (See para 0192).
Regarding claim 34, Zou et al discloses that the crosslinker is an epoxide-polyether-epoxide crosslinker. Zou et al disclose a diglycidyl- functional epoxy crosslinker. (See para 0118-0120, 0163-0164, 0243-0244.)
Regarding claim 35, Zou et al discloses that the crosslinker is a PEG diglycidyl ether crosslinker. (see para 0120.)
Regarding claim 36, Zou et al discloses that the mol% crosslinking of the copolymer is in a range of about 0.1 mol% - about 50 mol%. (See para 0120.)
Regarding claim 37, Zou et al discloses that the mol% crosslinking of the copolymer is in a range of about 0.1 mol% - about 30 mol%. (See para 0120.)
Regarding claim 38, Zou et al discloses that the therapeutic agent may be an anti- inflammatory agent. See para 0125.
Regarding claim 39, Zou et al discloses that the therapeutic agent is an anti- inflammatory agent. (See para 0125.)
Regarding claims 40-41, Zou et al discloses that the anti-inflammatory agent is dexamethasone. (See para 0125.)
Regarding claim 42, Zou et al discloses that the drug delivery composition may be insulin (para 0036). The therapeutic drug form of insulin has a molecular weight of about 6 kDa. Further, Zou et al discloses that a weight average molecular weight of the copolymer is in a range of 25 kD to 5000 kD (see para 0192). Thus, Zou et al is construed to meet the limitation of a therapeutic agent in a range of about 0.01 wt% - about 40 wt% based on a weight of the copolymer because 6kD is 0.12% of 5000 kD.
Regarding claim 43, Zou et al discloses that the crosslinker is bonded to the hydrophilic unit of the copolymer to form a charge. (See para 0118-0120, 0163-0164, 0243-0244.)
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to combine the elements of the analyte sensor and analyte sensor with the sharp insertion component as discussed above for the rationale of sensing an analyte in a subject’s blood and delivering a drug related to such analyte. For example, as suggested by Zou et al, glucose may be monitored and insulin may be delivered (see para 0068).
It would have been obvious for one of ordinary skill in the art to combine the elements of the analyte sensing system of Zou et al because these elements are preferred embodiments of Zou et al to achieve successful analyte sensing and potential drug delivery.
In view of the high level of skill in the art before the effective filing date of the presently claimed invention it is considered that one of ordinary skill in the art having the Zou et al reference before the effective filing date of the presently claimed invention would have had a reasonable expectation of success to follow the guidance of Zou et al to arrive at the presently claimed invention.
Thus, the claims as a whole are rendered obvious over Zou et al.
Conclusion
No claim is allowed.
Note that copending claims of Application No. 18/674,805 are related but are generic to the present claims. Also, U.S. Patent No. 8,268143 has related claims but these claims do not include the limitation of a drug delivery system and a therapeutic agent required of the present claims.
Related prior art which may be applied in a future office action if appropriate:
Vaddiraju et al in “Enhanced Glucose Sensor Linearity Using Poly(Vinyl Alcohol) Hydrogels” (Journal of Diabetes Science and Technology July 2009, Vol 3, No 4).
Behzadi et al (IDS ref).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CATHERINE S. HIBBERT
Primary Examiner
Art Unit 1658
/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658
Prosecution Insights