DCT
1:12-cv-00279
Hemphill v. Johnson Johnson
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Allegra Hemphill (Washington, D.C.)
- Defendant: Johnson and Johnson (New Jersey)
- Plaintiff’s Counsel: Pro Se
- Case Identification: 1:12-cv-00279, D.D.C., 02/21/2012
- Venue Allegations: Venue is based on the allegation that Defendant conducts business within the District of Columbia.
- Core Dispute: Plaintiff alleges that Defendant’s "Stayfree" and "Carefree" brand feminine care products infringe a patent related to a disposable vaginal applicator or swab.
- Technical Context: The technology at issue concerns disposable applicators for internal vaginal cleansing or the application of substances, designed for improved hygiene, convenience, and portability.
- Key Procedural History: The complaint notes that the patent-in-suit was the subject of a reexamination requested by the inventor in 1998. The U.S. Patent and Trademark Office (PTO) denied the request, finding that the cited prior art did not raise a substantial new question of patentability. A Reexamination Certificate was subsequently issued in 1999, confirming the patentability of the original claims.
Case Timeline
| Date | Event |
|---|---|
| 1982-10-18 | ’720 Patent Priority Date |
| 1985-12-10 | ’720 Patent Issue Date |
| 1998-02-02 | Plaintiff requests reexamination of ’720 Patent |
| 1998-04-03 | PTO denies request for reexamination |
| 1999-01-26 | Reexamination Certificate for ’720 Patent issued |
| 2012-02-21 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 4,557,720 - Vaginal Applicator
The Invention Explained
- Problem Addressed: The patent’s background section identifies a need for a "truly portable, convenient and disposable internal vaginal cleaning device" that is small, compact, and simple to use (’720 Patent, col. 2:46-49). It notes that prior devices were often cumbersome, not easily disposable, or lacked an adequate handle structure for proper manipulation during use (’720 Patent, col. 2:50-55).
- The Patented Solution: The invention is a disposable vaginal swab with an integrated outer container. This container serves a dual purpose: it initially provides a sterile enclosure for the swab and, upon opening, transforms into a handle for using the swab (’720 Patent, col. 2:1-5). The complaint focuses on an embodiment, depicted in the patent’s Figures 8 and 9, where the outer container is comprised of segments defined by frangible seams that are "peeled away" to expose the swab and form the handle structure (’720 Patent, col. 2:19-22; Compl. ¶20).
- Technical Importance: The claimed invention sought to combine the functions of a sterile package and a user handle into a single, compact, and disposable unit, enhancing hygiene and ease of use for internal applicators.
Key Claims at a Glance
- The complaint asserts independent claims 1 and 2 (Compl. ¶10).
- Independent Claim 1 essential elements:
- A vaginal swab with an "outer housing"
- The housing includes an "annular band" at its open end and "a plurality of frangible seams"
- The seams define a pair of "removable members" and a pair of "housing segments hingably secured" to the annular band
- A "swab core member" with an "annular base" is secured inside the housing
- An "adsorbent member" is secured to the core member and enclosed by the housing
- Independent Claim 2 essential elements:
- A vaginal swab with an "outer housing" that includes an "inner case member" and an "outer case member"
- A "core member" with at least one layer of "porous material" secured to it
- A "housing means" for supporting and enclosing the core member
- The housing means has at least two portions that are "movable relative to one another" between a first position (enclosing the core) and a second position (exposing the core and forming a handle)
III. The Accused Instrumentality
Product Identification
"Stayfree" and "Carefree" brand feminine care products (Compl. ¶22).
Functionality and Market Context
The complaint alleges that these products are "vaginal swabs" designed to "dry or absorb material" for use within the "genital canal" (Compl. ¶¶22-23; Compl. Ex. 9). The allegations characterize the products as having three main components corresponding to the patent claims: a "layer of porous material," an "outer housing" that serves as a handle, and a "fairly rigid core member" (Compl. ¶23). Visual evidence attached to the complaint depicts the accused products as externally worn sanitary pads and pantiliners. For example, an image in Exhibit 9 shows a sanitary pad, which the complaint labels as "'the swab' 100" (Compl. Ex. 9).
IV. Analysis of Infringement Allegations
The complaint does not contain a formal claim chart but makes specific infringement allegations in its text and exhibits. The following tables summarize these allegations for each asserted independent claim.
’720 Patent Infringement Allegations (Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A vaginal swab comprised of an outer housing having a closed and open end on opposing ends, said housing including an annular band... | The product's backing, which is allegedly peeled away, is identified as the "outer container (annular band and annular base)." | ¶23.B; Ex. 10 | col. 6:58-62 |
| a plurality of frangible seams that together define a pair of removable members and a pair of housing segments... | The complaint does not provide sufficient detail for analysis of frangible seams or removable members. | -- | col. 6:62-64 |
| a swab core member... | The absorbent core of the sanitary pad is identified as the "'fairly rigid core member' (102)." Exhibit 11 depicts the pad's core. | ¶23.C; Ex. 11 | col. 7:1-2 |
| an adsorbent member secured to said core member... | The top layer of the sanitary pad is identified as the "'layer of porous material' (104)." Exhibit 9 presents an image of the pad's topsheet. | ¶23.A; Ex. 9 | col. 7:2-4 |
’720 Patent Infringement Allegations (Claim 2)
| Claim Element (from Independent Claim 2) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A vaginal swab comprising an outer housing including an inner case member and an outer case member... | The product's backing is identified as the "'outer housing' as a device that serves as a handle structure." | ¶23.B; Ex. 10 | col. 7:6-9 |
| a core member, at least one layer of a porous material secured to said core member... | The product's absorbent core and topsheet are identified as the "core member" and "porous material," respectively. | ¶23.A, ¶23.C | col. 7:10-11 |
| and housing means... having at least two portions movable... between first and second positions for enclosing said core member... and for both exposing said core member... and for forming a handle... | The complaint alleges the backing is "peeled away from an enclosing protecting relationship" to form a handle structure at the base of the "exposed swab." | Ex. 10 | col. 8:1-12 |
Identified Points of Contention
- Scope Questions: A central issue may be whether the term "vaginal swab," as used in a patent for an internal applicator, can be construed to encompass an externally worn sanitary pad. Further, the analysis raises the question of whether a sanitary pad's disposable adhesive backing constitutes an "outer housing" or "housing means" as claimed.
- Technical Questions: The infringement theory suggests that peeling the adhesive liner from a sanitary pad is equivalent to the claimed "housing means" with "movable" portions that transition from "enclosing" a core member to "exposing" it while "forming a handle." A point of contention may be whether these structures and functions are technically equivalent.
V. Key Claim Terms for Construction
The Term: "vaginal swab"
- Context and Importance: This term from the preamble is foundational to the infringement case. The applicability of the patent to the accused products, which appear to be external sanitary pads, depends entirely on this term's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plaintiff argues that the court should look to the patent’s specific structural features rather than a dictionary definition of "swab" (Compl. ¶19). This may suggest an argument that any absorbent article with certain structural features used for feminine hygiene could be a "vaginal swab."
- Evidence for a Narrower Interpretation: The patent is titled "Vaginal Applicator" and repeatedly discusses its use for "internal vaginal cleaning" and absorbing material "in the internal vaginal area" (’720 Patent, col. 2:47, col. 3:5-7). The figures consistently depict a device resembling a tampon applicator designed for internal use.
The Term: "outer housing" / "housing means"
- Context and Importance: The complaint maps this limitation to the backing and adhesive liner of the accused sanitary pads (Compl. ¶23.B; Ex. 10). The patent, however, describes a three-dimensional container that structurally encloses the swab and transforms into a handle. Practitioners may focus on whether a flat liner can meet this structural and functional limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that any layer that covers the absorbent core before use functions as a "housing."
- Evidence for a Narrower Interpretation: The patent specification describes the housing as being "essentially peeled away from its enclosing or protecting relationship about the swab itself with at least part of the outer container forming the handle structure" (’720 Patent, col. 2:19-22). Claim 1 requires the housing to have "frangible seams," "removable members," and "hingably secured" segments, suggesting a complex mechanical structure rather than a simple adhesive liner (’720 Patent, col. 6:61-65).
VI. Other Allegations
Indirect Infringement
The complaint makes a conclusory allegation of induced infringement (Compl. ¶26). It does not, however, allege specific facts, such as references to user manuals or marketing materials, that would demonstrate Defendant instructed others to use the accused products in an infringing manner.
Willful Infringement
The complaint alleges that Defendant had "long had full knowledge of Ms. Hemphill's rights" and that its infringement was therefore willful (Compl. ¶¶24, 27). To support pre-suit knowledge, the complaint alleges that Defendant’s legal officers telephoned the plaintiff in 1998 to "challenge her '720 Patent to a Reexamination" (Compl. ¶14).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "vaginal swab," which the patent consistently describes in the context of an internal applicator, be construed to cover the accused externally worn sanitary pads?
- A key evidentiary question will be one of structural and functional mismatch: does the adhesive liner and absorbent core of a sanitary pad perform the specific mechanical functions of the claimed "outer housing," particularly its claimed ability to move between positions to enclose, expose, and form a handle for manipulation during use?