DETAILED ACTION
Response to Arguments
Applicants’ arguments filed 9/21/2026 have been fully considered but they are not persuasive, except where otherwise noted.
Drawing Objections: Applicant argues that the drawings disclosed in EP 3359099 can be incorporated into the instant application. Examiner disagrees, there is no statement in the disclosure that suggests that EP 3359099, or any other reference, is incorporated by reference. A bare citation of a reference is not incorporation by reference. Furthermore, according to 37 CFR 1.57(g) “An incorporation by reference of essential material to an unpublished U.S. patent application, a foreign application or patent, or to a publication is improper under 37 CFR 1.57(d).” Therefore, the drawings and amendments to the specification filed 9/21/2026 are new matter.
35 U.S.C. 112(a) Rejections: Applicant argues that the E-AB biosensor at page 2, line 35 to page 3, line 4 provides the structure for the “means for generating a warning signal in case of rising tumor marker levels” of claim 12. Examiner disagrees and submits that the cited passage describes a signal indicting the amount of tumor marker bound to the aptamer, but it does not describe any structure or algorithm that determines that tumor marker levels are rising or that generates a warning signal in response to rising tumor marker levels. The rejection is maintained.
35 U.S.C. 112(b) Rejections: Applicant argues that the amendments overcome the rejections of claims 1-11 and 13. Examiner agrees, and those rejections are withdrawn. However, the rejection of claim 12 is maintained in light of the maintained 35 U.S.C. 112(a) rejection of claim 12.
35 U.S.C. 103 Rejections: Applicant argues that Ligalli is a vaginal drug delivery device and does not teach measuring a circulating tumor marker in the vagina. Examiner disagrees and submits that Ligalli discloses a strictly diagnostic embodiment (page 1, lines 27-28) that measures hyaluronic acid (page 2, line 18) in the vaginal wall and uses those measurements to calculate a serum level (page 11, lines 23-26). The hyaluronic acid is therefore circulating. Lokeshwar is relied upon to show that hyaluronic acid is already a well-known tumor marker, and one cannot show nonobviousness by attaching references individually when the rejection is based upon a combination of references.
Applicant argues that Lokeshwar detects hyaluronic acid in urine in vitro and does not teach that it is a circulating tumor marker. Examiner disagrees and submits that Lokeshwar is not relied upon for detecting a circulating marker in the vagina, Ligalli teaches and is relied upon for those claim limitations. Lokeshwar is relied upon only to show that hyaluronic acid is a known tumor marker originating from bladder tumor tissue, as part of the body that is not the vagina (Lokeshwar, Abstract).
Drawings/Specification Objections
The amendments file 9/21/2026 are objected to because it introduces new matter into the disclosure. The added material which is not supported by the original disclosure is as follows: the new drawing sheet and corresponding amendments to the specification, which reproduce FIG. 2 of EP 3359099. The specification as filed refers to EP 3359099 but does not incorporate it by reference, and essential material may not be incorporated by reference to a foreign publication. Applicant is required to cancel the new matter in reply to this Office action.
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 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.
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 8 and 12 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 claim 8, the limitation “the next” measurement lacks proper antecedent basis. For purposes of examination the indefinite limitation has been deemed to claim a subsequent detection after the aptamer is rinsed.
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
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 tumor marker (hyaluronic acid) in the human body, comprising detecting the tumor marker 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….”) (page 11, lines 23-26 “the measurements with the sensors are either made in the transudate of the vaginal wall and/or the cervical mucus. Certain parameters measured in the vagina can be used to calculate the level of the parameter in the serum.”), wherein:
the vaginal diagnostic ring device comprises:
a diagnostic sensor (sensor 5) for performing an intravaginal diagnosis or diagnostic measurement (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 a second end (end of 101 touching 110);
a second rigid member (second rigid member 102) having a third (end of 102 touching 111) and a fourth end (end of 102 touching 110);
a first flexible member (first flexible member 111) coupled between the first end and the third end (ends of 101 and 102 touching 111);
a flexible part (flexible part 110) coupled between the second end and the fourth end (ends of 101 and 102 touching 111);
wherein the first flexible member and/or the flexible part are configured for allowing the device to be squeezed by bringing the second end and the fourth end 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 vaginal diagnostic ring device from an extended shape to a collapsed shape (see FIG. 1 which shows motion of the vaginal diagnostic ring
device from a circular extended shape to a collapsed shape) for allowing the vaginal diagnostic ring device to be inserted into a vagina of a user at or near the fornix posterior vagina (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 vaginal diagnostic ring 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), and wherein the diagnostic sensor is configured for detecting a tumor marker (page 2, line 18 “means for measurement of hyaluronic acid.”).
Ligalli does not expressly disclose where the tumor marker originates from a part of the body that is not the vagina. However, Lokeshwar teaches where the tumor marker (hyaluronic acid) originates from a part of the body that is not the vagina (Abstract “the HA levels are also elevated (3-5 fold) in bladder tumor tissues”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to configure the hyaluronic acid sensor of Ligalli to detect hyaluronic acid as a tumor marker originating from the bladder, as taught by Lokeshwar, to provide noninvasive, sensitive and specific detect of bladder cancer (Lokeshwar, Abstract, “a simple, noninvasive yet highly sensitive and specific method for bladder cancer detection”).
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 biochemical parameters other than tumor markers 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 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 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 the next 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
