DCT
5:16-cv-11810
Conceivex Inc v. Rinovum Women's Health Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Conceivex, Inc. (Michigan)
- Defendant: Rinovum Women's Health, Inc., The Stork Ib2C, Inc., and Rinovum Women's Health, LLC (Delaware)
- Plaintiff’s Counsel: Barnes & Thornburg
- Case Identification: 5:16-cv-11810, E.D. Mich., 05/20/2016
- Venue Allegations: Plaintiff alleges venue is proper as Defendants conduct business in the district, have engaged in acts causing injury to Plaintiff within the district, and have sufficient minimum contacts with the district.
- Core Dispute: Plaintiff alleges that Defendants’ THE STORK OTC Home Conception Device infringes a patent related to a cervical cap-style conception device with a specific collapsible structure.
- Technical Context: The technology concerns at-home medical devices designed to aid conception by positioning semen near the cervix to overcome common fertility challenges.
- Key Procedural History: The complaint alleges that in Defendants' filings with the Food & Drug Administration (FDA), Defendants identified Plaintiff's CONCEPTION KIT product as a "predicate device," which may be relevant to the question of pre-suit knowledge for the willfulness allegation.
Case Timeline
| Date | Event |
|---|---|
| 2007-03-28 | Earliest Priority Date for U.S. Patent No. 8,454,493 |
| 2013-06-04 | U.S. Patent No. 8,454,493 Issued |
| 2016-05-20 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,454,493 - "Conception Device and Related Methods," Issued June 4, 2013
The Invention Explained
- Problem Addressed: The patent describes challenges to fertility such as low semen counts, problems with semen motility, a tilted cervix, and a "hostile vaginal environment" that can impede conception ('493 Patent, col. 2:53-58). Prior art devices, such as those made of latex, could also damage semen ('493 Patent, col. 2:37-38).
- The Patented Solution: The invention is a conception device, typically made of silicone, comprising a dome with an annular rim for placement over the cervix ('493 Patent, col. 4:50-56). The key innovation is the dome’s specific structural design: it is a "unitary construction" with a thicker closed tip (first thickness), a thinner sidewall near the tip (second thickness), and a thicker sidewall near the rim (third thickness) ('493 Patent, col. 4:35-50). This differential thickness is designed to make the sidewall collapse in a "predefined manner" under natural compression, which "raise[s] a floor defined by an inner surface of the tip" toward the rim, thereby more effectively positioning semen against the cervical os, especially for users with a tilted cervix ('493 Patent, col. 4:29-34; col. 6:40-53).
- Technical Importance: The claimed collapsing mechanism provided a controlled way to concentrate semen at the cervix, improving upon simpler "form assuming" domes that could trap semen unpredictably or block the cervical opening ('493 Patent, col. 6:21-37).
Key Claims at a Glance
- The complaint asserts independent claims 1, 14, and 18 (Compl. ¶17).
- Independent Claim 1 (Device): A conception device comprising:
- an annular rim;
- a dome of "unitary construction" with a closed tip, base, and sidewall;
- the dome having a first thickness at the tip, a second (thinner) thickness at the sidewall near the tip, and a third thickness at the sidewall near the rim;
- the second thickness is less than both the first and third thicknesses;
- this structure causes the sidewall to be "collapsible...in a predefined manner" due to compression, which serves to "raise a floor defined by an inner surface of the tip toward the annular rim".
- Independent Claim 14 (Method): A method of increasing the likelihood of conception by:
- providing a conception device with the specific thickness variations described in claim 1;
- positioning the device's annular rim around the cervix;
- "collapsing" a portion of the sidewall in a "predefined manner" due to vaginal compression to "raise the floor...toward the cervix".
- Independent Claim 18 (Device): A conception device comprising largely the same structural and thickness limitations as claim 1, with the added limitation that the dome is "formed of a single material" and that the first and second thicknesses are "defined by the single material".
- The complaint reserves the right to assert various dependent claims (Compl. ¶17).
III. The Accused Instrumentality
Product Identification
The accused product is "THE STORK OTC Home Conception Device," specifically the "cervical cap" component of the device (Compl. ¶18). The complaint also accuses the "Accused Method" of using the device (Compl. ¶29).
Functionality and Market Context
The complaint alleges the Accused Product is a medical device for at-home use (Compl. ¶8). It is promoted as a "device that offers a relaxed and private way of using cervical cap insemination...to help with becoming pregnant" (Compl. ¶8). The complaint alleges that the Accused Product includes a conception device for positioning over a cervix to concentrate semen and is made of a silicone-based material suitable for use in the vagina (Compl. ¶¶19, 26). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'493 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A conception device for positioning over a cervix to concentrate semen and promote fertilization, the device comprising: an annular rim; | The Accused Product is a conception device for positioning over a cervix and includes an annular rim. | ¶19, ¶20 | col. 4:13-14 |
| and a dome formed of a unitary construction extending from the annular rim, the dome defining a receptacle area and including a closed tip, a base portion and a sidewall extending between the closed tip and the base portion, | The Accused Product's dome is alleged to be of a unitary construction, extending from the rim and defining a receptacle area with a closed tip, base, and sidewall. | ¶20, ¶21 | col. 4:19-23 |
| the unitary construction having a first thickness at the closed tip, having a second thickness at the sidewall proximate the closed tip, and having a third thickness at the sidewall proximate the annular rim, | The complaint alleges, on information and belief, that the Accused Product's unitary construction has this specific three-tiered thickness structure. | ¶21 | col. 4:35-41 |
| the second thickness being less than both the first thickness and the third thickness | The complaint alleges the second thickness of the Accused Product's construction is less than both the first and third thicknesses. | ¶22 | col. 4:41-43 |
| such that the sidewall is collapsible at a portion of the sidewall including the second thickness in a predefined manner due to compression by a vaginal cavity to raise a floor defined by an inner surface of the tip toward the annular rim... | The complaint alleges the Accused Product's sidewall is collapsible in a predefined manner due to compression, which raises a floor defined by the inner tip surface toward the rim. | ¶23 | col. 4:29-34 |
Identified Points of Contention
- Technical Questions: The complaint’s infringement allegations regarding the specific three-part thickness structure and the resulting collapsing function are made "on information and belief" (Compl. ¶¶21-23). A central question will be whether discovery yields evidence that the accused Stork device physically embodies this precise structure.
- Scope Questions: The case may turn on the functional language of the claims. The key question will be whether the accused device's operation, however it functions, constitutes "collaps[ing]...in a predefined manner...to raise a floor" as that phrase is construed in the context of the '493 patent.
V. Key Claim Terms for Construction
"collapsible...in a predefined manner...to raise a floor" (Claim 1)
- Context and Importance: This phrase captures the functional core of the invention. The definition of "predefined manner" and "raise a floor" will be critical to the infringement analysis. Practitioners may focus on this term because it distinguishes the invention from a simple, passively "form assuming" dome ('493 Patent, col. 6:21-23) and links the device’s structure to a specific functional outcome.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party arguing for a broader scope might point to the general description that the sidewall is "collapsible for proper positioning relative to the cervical os" ('493 Patent, col. 4:23-25), suggesting any controlled collapse that improves positioning could meet the limitation.
- Evidence for a Narrower Interpretation: A party arguing for a narrower scope could cite the detailed description explaining that the thinner top portion of the sidewall collapses while the more rigid base portion maintains its shape, causing the "apex of the dome 14 to come in contact with the opening of the cervical os in a more predictable manner" ('493 Patent, col. 6:42-46). This suggests the "predefined manner" is this specific, two-part action.
"unitary construction" (Claim 1)
- Context and Importance: This term relates to the physical makeup of the device. Its construction is critical because a device manufactured from multiple assembled pieces might fall outside the scope of the claim. Practitioners may focus on this term to explore potential non-infringement arguments based on the accused product’s manufacturing process.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not explicitly define "unitary construction." A party could argue it simply means the final product functions as a single unit, regardless of how it was formed.
- Evidence for a Narrower Interpretation: The specification discusses the handle being "integrally-molded with the annular rim" ('493 Patent, col. 4:59-60). This language, along with the figures depicting a seamless object, could support an interpretation that "unitary construction" requires the dome to be formed as a single, continuous piece of material, not assembled from separate parts.
VI. Other Allegations
- Indirect Infringement: The complaint alleges Defendants actively induce infringement by "instructing, directing, and encouraging their customers and others on how to use the Accused Product" with knowledge that such use infringes the '493 patent (Compl. ¶40).
- Willful Infringement: The complaint alleges willfulness based on both pre-suit and post-suit knowledge. Pre-suit knowledge is supported by the specific allegation that Defendants, in their FDA filings, identified Plaintiff's CONCEPTION KIT as a "predicate device" for their own Stork device (Compl. ¶9, ¶68). Post-suit willfulness is alleged based on continued infringement after the complaint was filed (Compl. ¶43, ¶44).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of technical correspondence: Does the accused Stork device actually possess the specific three-tiered wall thickness described in the '493 patent, and does it operate by collapsing in the "predefined manner" claimed? The complaint's allegations on these points are based on "information and belief" and will require factual proof.
- The case will likely involve a critical issue of claim scope: How will the court construe the functional limitation "collapsible...in a predefined manner...to raise a floor"? A narrow construction tied to the specific mechanism described in the patent's embodiments could significantly limit the scope of the claim, while a broader construction could more easily read on the accused device.
- A key question for willfulness and damages will be the impact of pre-suit knowledge: The allegation that Defendants identified Plaintiff's product as a "predicate device" in FDA filings provides a specific factual anchor for the claim of willful infringement that goes beyond boilerplate assertions. The strength of this evidence will be a primary focus.