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 .
Status of Application
Receipt of the Preliminary Amendment dated August 13, 2024 is acknowledged.
Claims 1-7, 9-10, 12, 14-15, and 25-30 are pending in this application.
Claims 1-7, 9-10, 12, and 14-15 have been amended.
Claims 25-30 are new.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on August 13, 2024 has been acknowledged.
A signed copy is attached to this office action.
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.
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 4, 6,-7, 9-10, 12, 15, and 25 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 4, 9, 15, and 25, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim 9, the phrases "like" and “such as” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 12, the term “relatively low or negligible” is a relative term which renders the claim indefinite. The term “relatively low or negligible” 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.
Regarding claim 25, the claim is drawn to oxybutynin, however, the intended use of it includes the administration of solifenacin. It is unclear how this is possible.
Claims not specifically recited are included as they depends from and do not remedy the deficiency of the claims.
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:
Claims: 3
Limitation: the reservoir is configured to act in response
Structure: via handheld device/mobile device or independently/interactively by the ring itself
Also, this application includes one or more claim limitations that use the word "means," and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Such claim limitation(s) is/are:
Claims: 1, 3, 4, 5, 26
Limitation: a means for the controlled release of the compound
Structure: a controller or pump
Claims: 2, 9
Limitation: a means for gathering physiological data; means for gathering diagnostic data; means for measuring temperature, glucose levels and physio-chemical properties, means for monitoring medication levels; means for monitoring hormone levels; ; means for analyzing proteins or nucleic acids, means for detecting molecules, means for measurement of hyaluronic acid
Structure: one or more sensors
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 § 102
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.
Claims 1-3, 5-6, 9-10, 26, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ziv (US 2011/0034901).
Ziv discloses a device that delivers one or more substances into a vaginal lumen according to one of a plurality of release patterns. The device comprises a supporting structure, substance dispensers, and/or coupling elements which are configured to release one or more substances, for example, drugs, in manner designed to optimize treatment of one or more medical conditions (abstract). The Examiner has interpreted a supporting structure to be a housing, as recited in the instant claims.
The Examiner has interpreted coupling elements which are configured to release one or more substances as a means for the controlled release of the compound from the reservoir into the vagina, as recited in the instant claims.
The supporting structure includes a reservoir of the at least one substance (paragraph 0035).
Drugs which can be delivered via the device include anticholinergic drugs to reduce bladder contractions (paragraph 0103).
Regarding claim 2, the device further comprises a sensor configured for detecting a concentration of a substance, such as a metabolic substance, a pathogenic substance, a biological substance, a chemical substance, and the at least one medical substance (paragraph 0042). The Examiner has interpreted this to be physiological data.
Regarding claim 3, the device contains a controller configured to control a rate of release (paragraph 0045).
Regarding claim 5, the device has a configurable releasing mechanism configured for containing at least one medical substance and have a plurality of delivery configurations to actualize a plurality of predefined release patterns of the at least one medical substance (paragraph 0026).
Regarding claim 6, rate of release may be a constant rate of release, a variable rate of release, an absence of release, and/or a combination of the preceding rates of release (paragraph 0113).
Regarding claim 9, as noted above, the device further comprises a sensor configured for detecting a concentration of a substance, such as a metabolic substance, a pathogenic substance, a biological substance, a chemical substance, and the at least one medical substance (paragraph 0042).
Regarding claim 10, the transudate of the vaginal mucosa is the primary component of normal vaginal moisture and would be the baseline fluid within the vaginal canal.
Regarding claim 26, as noted above, the device comprising an anticholinergic drug is used to reduce bladder contractions.
Regarding claim 29, reducing bladder contractions, as disclosed by Ziv treats overactive bladder.
Therefore, the rejected claims are anticipated by Ziv.
Claim Rejections - 35 USC § 103
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 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ziv (US 2011/0034901) in view of Weiner et al. (US 2013/0066302).
The teachings of Ziv are discussed above.
While Ziv discloses a user may assemble, insert, position, treat by means of, and remove delivery device according to the requirements of treatment (paragraph 0101), he does not disclose the release is controlled remotely.
Weiner discloses drug delivery devices including a reservoir that are configured for placement within a vagina (abstract).
Regarding claim 4, Weiner discloses that the drug delivery device dispenses, from the reservoir, a substance, such as a reproductive hormone, semen, acidic buffer, fertility drug or other drug, effectively administered from within the organ. In some embodiments, the capsule has on-board sensors and control circuitry in wireless communication with an external processor functioning automatically or guided by a clinician or user, for decisions and timing in administering the substance (abstract). In one embodiment, Weiner et al. suggest that data produced by a sensor on their device can be used by a doctor remotely to plan drug administration (see paragraph [0066]).
Regarding claim 7, as noted above the clinician and user make decisions and timing of administration of the substance (abstract). Timing of the delivery is by a program to the implanted device (paragraph 0060).
Based on the overall teachings of Weiner, which teach drug delivery devices comprising sensors and control circuitry in wireless communication with a remote external processor guided by a clinician or user for directing decisions and timing in administering a drug, it would have been obvious to one of ordinary level of skill in the art at the time of filing to configure a drug delivery and diagnostic device placed in the vagina such that it can be remotely operated by a physician and provide for the on-demand release of a drug from a reservoir in the device in response to data produced by a sensor in the device, such as data related to the measurement of physiological data as discussed by Ziv.
Claims 12, 14-15, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Ziv (US 2011/0034901) and Schroder et al. (Absorption of Oxybutynin from Vaginal Inserts: Drug Blood Levels and the response of the Rabbit Bladder, Urology 56(6) 2000).
The teachings of Ziv are discussed above.
Ziv does not disclose oxybutynin as an anticholinergic drugs.
Schroder discloses vaginal administration of oxybutynin for the treatment of urge incontinence in order to overcome the uncomfortable anticholinergic side effects from oral administration.
Regarding claim 12, oxybutynin is known to have unwanted side effects in the gastrointestinal tracts, such as vomiting.
Regarding claim 14-15, 25, and 27, as noted above, oxybutynin is disclosed.
It is noted that claims 15 and 25 are drawn to oxybutynin. The recitation of for use in the treatment of and administration of are intended uses of the compound.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to use oxybutynin as the anticholinergic agent in Ziv since oxybutynin is well known for the treatment of urinary incontinence and the alternative form of drug administration reduces side effects and thus improves patient compliance.
Claims 14-15, 25, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ziv (US 2011/0034901) in view of Xu (CN 101648017).
The teachings of Ziv are discussed above.
Ziv does not disclose solifenacin as an anticholinergic drugs.
Xu discloses a pharmaceutical composition for vaginal delivery for the treatment of urogenital system and lower urinary tract disease. Urinary incontinence is disclosed (claim 9).
Regarding claims 14-15, 25, and 27-30, Oxybutynin and solifenacin are disclosed as the active agents (claim 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have utilized any of the agents disclosed by Xu since they are known anticholinergic agents for the treatment of urinary incontinence and can be administered vaginally.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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