DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group II (Claims 9-13) in the reply filed on 3/12/2026 is acknowledged and is found persuasive. In light of the claim amendments filed 3/12/2026, the Requirement for Restriction mailed 2/18/2026 is withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/5/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required new drawings and all drawings must be fully supported by the specification as originally filed. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d).
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.
Regarding Claim 9, the claim limitation “means for generating a warning signal in case of rising tumor marker levels” is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, however, there is no corresponding structure in the specification for this element. Interpretation of this element is set forth in the 35 U.S.C. 112(b) rejection, below.
Regarding Claim 13, the claim limitation “means for rinsing the aptamer” is being interpreted as a reservoir as set forth in paragraph [0021] of the instant application.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities: “Method for determining…” and “Vaginal diagnostic ring…” should be amended to read “A method for determining” and “A vaginal diagnostic ring…”.
Claim 10 is objected to because of the following informality: “where tumor marker detection” should be amended to read “where the tumor marker detection”.
Appropriate correction is required.
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.
Claim 12 is 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.
Regarding Claim 12, as stated above in the interpreted under “Claim Interpretation”, the limitation “means for generating a warning signal in case of rising tumor marker levels” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, however, there is no corresponding structure in the specification for this element. Therefore, since the corresponding structure is not set forth in the written description, the claim fails to comply with the written description requirement.
Claims 1-13 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.
Regarding Claims 1 and 9, the limitation “or measurement therefor” renders the claim indefinite. It is unclear what the measurement is intended to be “for”, especially when coupled with the “or” limitation. For purposes of examination the indefinite limitation has been deemed to claim a diagnostic sensor “for performing an intravaginal diagnosis or intravaginal measurement”.
Regarding Claims 1 and 9, the limitation “the diagnostic device” in line 16 renders the claim indefinite. It is unclear if “the diagnostic device” refers to the previously claimed “diagnostic ring device” or “diagnostic sensor”. For purposes of examination the indefinite limitation has been deemed to claim that the ring device is “the diagnostic device”.
Regarding Claim 5, the limitation “determining other biochemical parameters in the vagina” renders the claim indefinite, because it is unclear what “other” biochemical parameters entail (e.g., other than what?). For purposes of examination the indefinite limitation has been deemed to claim the detection of parameters other than a tumor marker.
Claim 6 recites the limitation "the continuous monitoring". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the indefinite limitation has been deemed to claim simply “continuous monitoring”.
Claim 7 recites the limitation "the predetermined and posttreatment follow-up". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the indefinite limitation has been deemed to claim simply “predetermined and posttreatment follow-up".
The term “new detection” in claim 8 is a relative term which renders the claim indefinite. The term “new detection” 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. For purposes of examination the indefinite limitation has been deemed to claim a detection after a first detection.
Regarding Claim 12, as stated above in the interpreted under “Claim Interpretation”, the limitation “means for generating a warning signal in case of rising tumor marker levels” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, however, there is no corresponding structure in the specification for this element. Therefore, Claim 12 is rendered indefinite because the corresponding structure of what provides the warning signal are not defined and ambiguous. For purposes of examination the indefinite limitation has been deemed to claim any signal that could or does provide some sort of warning.
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.
Claim(s) 1, 5-7, 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/120402 A1 to Ligalli in view of “Tumor-associated hyaluronic acid: a new sensitive and specific urine marker for bladder cancer” to Lokeshwar et al. (hereinafter, Lokeshwar).
Regarding Claims 1 and 9, Ligalli discloses an apparatus and method for determining the presence of a circulating hormones in the human body, comprising detecting the hormones in the vagina with a vaginal diagnostic ring device (page 2, lines 10-11 “The means for gathering physiological data of a person carrying the device in her vagina may comprise… means for monitoring hormone levels, either in the cervical mucus or in the transudate of the vaginal mucosa, in particular… hyaluronic acid….”), wherein:
wherein the tumor marker originates from a part of the body that is not the vagina (The Abstract of the Lokeshwar paper explicitly states that hyaluronic acid (HA) is a well-known tumor marker that is produced by a tumor in the bladder (e.g., outside of the vagina. Therefore, HA is a well-established tumor marker, therefore, the prior art of Ligalli performs the detection of HA in the vagina with the vaginal ring device, and detects HA, which originates from a part of the body that is not the vagina); and
the vaginal diagnostic ring device comprises:
a diagnostic sensor (sensor 5) for performing an intravaginal diagnosis or measurement therefor (page 2, lines 10-18 “…means for gathering physiological data… means for measurement of hyaluronic acid…”),
wherein the device further comprises a first rigid member (first rigid member 101) having a first end (end of 101 touching 111) and second end (end of 101 touching 110);
a second rigid member (second rigid member 102) having a third (end of 102 touching 111) and fourth end (end of 102 touching 110);
a first flexible member (first flexible member 111) coupled between the first and third ends (ends of 101 and 102 touching 111);
a flexible part (flexible part 110) coupled between the second and fourth ends (ends of 101 and 102 touching 111);
wherein the first flexible member and/or flexible part are configured for allowing the device to be squeezed by bringing the second and fourth ends together (ends of 101 and 102 touching 111 are brought together as seen in FIG. 1 in the collapsed configuration) thereby transforming a shape of the device from an extended shape to a collapsed shape (see FIG. 1 which shows motion of the device from a circular extended shape to a collapsed shape) for allowing the device to be inserted into a vagina of a user at or near the fornix posterior vaginae (page 3, lines 20-23 “the ring will then defold after insertion with the rigid part settling smoothly in the deepest part of the vagina (fornix posterior) and the outer parts of the ring in flexible contact with the vaginal wall to prevent expulsion and enhance absorption”), said extended shape corresponding to a substantially oval or annular ring shape (page 14, lines 24-29 “Figure 1 illustrates the shape of the device used in accordance with the present invention in an extended (left) and collapsed state (right). This shape comprises a first rigid member 101, a second rigid member 102, a first flexible member 111, and a flexible part 110. Here, first flexible member 111 is made of an elastic material and comprises a recess 105 to allow first and second rigid member 101, 102 to move towards each other when device 100 is squeezed into the collapsed state.”) (see FIG. 1);
wherein at least one of the first flexible member and the flexible part is at least partially elastic such that the device is prebiased to assume the extended shape when no external force is being applied thereto (page 14, lines 27-29 “Here, first flexible member 111 is made of an elastic material and comprises a recess 105 to allow first and second rigid member 101, 102 to move towards each other when device 100 is squeezed into the collapsed state”) (see FIG. 1), characterized in that the diagnostic device is configured for detecting a tumor marker (The Abstract of the Lokeshwar paper explicitly states that hyaluronic acid (HA) is a well-known tumor marker that is produced by a tumor in the bladder (e.g., outside of the vagina. Therefore, HA is a well-established tumor marker, therefore, the prior art of Ligalli performs the detection of HA in the vagina with the vaginal ring device, and detects HA, which originates from a part of the body that is not the vagina).
Regarding Claim 5, Ligalli in view of Lokeshwar teach the apparatus and method as claimed in claims 1 and 9, further comprising the step of determining other biochemical parameters in the vagina (Ligalli: page 2, lines 10-18).
Regarding Claim 6, Ligalli in view of Lokeshwar teach the apparatus and method as claimed in claims 1 and 9, for use in the continuous monitoring of circulating tumor markers in oncologic patients (Ligalli: page 12, lines 25-32 and “1-4 weeks” at page 13, lines 27-31).
Regarding Claim 7, Ligalli in view of Lokeshwar teach the apparatus and method as claimed in claims 1 and 9, for use in the pretreatment and posttreatment follow-up of oncologic patients (Ligalli: the limitation “for use” renders the claim limitations as functional language, because the vaginal diagnostic ring device is capable of being used before and after treatment).
Regarding Claim 12, Ligalli in view of Lokeshwar each the apparatus and method as claimed in claims 1 and 9, further comprising means for generating a warning signal in case of rising tumor marking levels (Ligalli: page 4, lines 2-6 “The schedule can be pre-programmed and/or adjusted either remotely, based on wishes of the user (e.g. pain relief) or by the patient, a physician or nurse based on results of diagnostic tests transmitted to the outside world by the device, or by a direct adaptation in the release pattern by the device itself based on diagnostic measurements made by the device.”).
Claim(s) 2, 3, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ligalli in view of Lokeshwar as applied to Claim 1 above, and further in view of “Real-Time Monitoring of a Protein Biomarker” to Parolo et al. (hereinafter, Parolo) and “Neutrophil Gelatinase-Associated Lipocalin (NGAL): A Promising Biomarker for Cancer Diagnosis and A Potential Target for Cancer Therapeutics” to Monisha et al. (hereinafter, Monisha).
Ligalli in view of Lokeshwar teach the apparatus and method as claimed in claims 1 and 9 except for expressly disclosing wherein the tumor marker is detected by means of an aptamer, wherein the aptamer is present in a vaginal ring device.
However, Parolo teaches a device for monitoring the protein biomarkers NGAL continuously and in real-time in the human body by a device with aptamer-based sensor inserted in the human body (Abstact). Parolo teaches in the Abstract that NGAL is a protein indicative of acute renal injury. While Parolo does not expressly teach that NGAL is a tumor marker hormone, Monisha teaches in their Abstract the NGAL is a known tumor biomarker in bodily fluids, therefore, NGAL is a well-established tumor marker which originates from a part of the body that is not the vagina.
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify sensor in the vaginal ring device of Ligalli in view of Lokeshwar to be the aptamer-based NGAL sensor of Parolo and Monisha, as Parolo teaches in their Abstract that such a sensor would have supported a wash-free, real-time, high-frequency monitoring of NGAL concentrations and would fundamentally change how we detect, monitor and treat diseases.
Claim(s) 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ligalli in view of Lokeshwar as applied to claim 1 above, and further in view of “Achieving Reproducible Performance of Electrochemical, Folding Aptamer-Based Sensors on Microelectrodes: Challenges and Prospects” to Liu et al. (hereinafter, Liu).
Ligalli in view of Lokeshwar teach the apparatus and method as claimed in claims 1 and 9 except for expressly disclosing wherein the aptamer is rinsed after detection to be ready for a new detection. However, Liu teaches an aptamer based biological sensor (Abstract). Liu teaches under the description of FIG. 6 that the sensor can be rinsed. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the aptamer sensor of Ligalli in view of Lokeshwar to be rinsed, because Liu teaches under the description of FIG. 6 that this would have regenerated the sensor and signal therefrom.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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