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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND ALLEGRA D. HEMPHILL : v. : Civil Action No. DKC 99-654 : MCNEIL-PPC, INC. : MEMORANDUM OPINION Plaintiff Allegra Hemphill, proceeding pro se, alleges that Defendant Johnson & Johnson, Inc. ("Johnson and Johnson") :

manufactures and distributes products which infringe on her patent, U.S. Patent 4,557,720 ("the `720 patent").1 pending and ready for resolution are three motions. Presently Johnson &

Johnson Consumer Companies, Inc. ("JJCCI") has filed a Motion for Leave to Permissively Intervene. Defendant McNeil has filed both a Motion for Summary Judgment for Noninfringement and a Motion to Bifurcate. 2 hearing is deemed The issues are fully briefed and no Local Rule 105.6. For the

necessary.

following reasons, the court shall deny JJCCI's Motion for Leave

On February 14, 2000, this court ordered that McNeil-PPC, Inc. ("McNeil") replace Johnson & Johnson as the party defendant because McNeil is the entity responsible for the manufacture and distribution of the Stayfree, Carefree, and Serenity products at issue in this case. Paper No. 36. The issue of non-infringement is the sole issue in McNeil's summary judgment motion because Defendant does not argue the invalidity or unenforceability of Plaintiff's patent. Paper No. 57, 2 n.2.
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to Permissively Intervene and grant McNeil's Motion for Summary Judgment.3 I. Background Ms. Hemphill filed her application for the `720 patent with the Patent and Trademark Office ("PTO") on June 11, 1984, and her patent was subsequently issued on December 10, 1985. No. 46, Ex. D1. Paper

Bearing the title "Vaginal Applicator", the

`720 patent describes a disposable vaginal swab or refresher meant either to cleanse or to treat the vaginal area with Id., Col.

fragrances, medications, germicides, or deodorants. 1, lines 33-38.

The `720 Patent has two independent claims, but Id., Ex. B, The is as

only claim 2 is at issue in this litigation.

Deposition of Allegra Hemphill ("Hemphill Depo"), 10. description follows: a vaginal swab comprising an outer housing including an inner case member and an outer case member at least part of which is connected to and said overlies inner case member; a core member, at least one layer of porous material secured to said core member, and housing means for both supporting and enclosing said core member, said core member being secured to said housing means, having contained in claim 2 of the Applicator

In light of this court's decision to grant McNeil's Motion for Summary Judgment, Defendant's Motion to Bifurcate is no longer applicable, and thus, the motion will be denied as moot. 2

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at least two portions movable relative to one another between first and second positions for enclosing said core member when in said first position and for both, exposing said core member and the said porous padding secured thereto and for forming a handle for said swab when in said second position. Id., Ex. D1, Col. 7-8, lines 1-10. A. Prosecution of the `720 Patent During the prosecution phase, Plaintiff narrowed her claims to distinguish her invention from prior art cited by the

Examiner.

For example, Plaintiff clarified the distinction

between her invention and a patent awarded to M. Alvarez by explaining that: [t]he Alvarez device does not allow for an elongated structure for the swabbing element to be introduced into the vaginal cavity nor does it provide a sufficient handle structure. Id. , Ex. D10, PTO 00313. She also differentiated between the

porous material specified in the respective patents. Alvarez teaches that a moisture absorbent layer is exposed after the protective covering is removed. There is a distinct difference between Absorbent and Adsorbent, to ab as in Alvarez, absorb is to take in, suck up, swallow, engross wholly, to take up or receive by chemical or molecular actions as of gases or liquids, and to ad as in Hemphill to adsorb is to take up and hold, to gather gas or liquid or dissolved material on a surface.

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Id., Ex. D6, PTO 00336 (emphasis added). Additionally, Plaintiff distinguished the "housing" in her invention from the "housing" in the patent issued to Albert Gelardin for a Cosmetic Holder. Plaintiff noted:

[t]he Hemphill device, after removing the outer housing serves as a handle structure, and still serves as a function for the device, unlike Gelardin that states that the cover is completely removed. Id., Ex. D6, PTO 00342 (emphasis added). B. Reexamination of the `720 Patent On February 2, 1998, Plaintiff asked the PTO to re-examine her patent in light of the McNair patent ("McNair") for a Sanitary Napkin with wings. patent states as follows: The central element and side elements have fluid-impervious backing upon which is placed a thin layer adhesive which will not penetrate the absorbent materials placed thereon. The central element has a highlyabsorptive pad means whereas the absorptive means on the side panels may be minimal. The backing element of the central portion of the invention contains a strip of adhesive covered by a protective tape until use. Id., Ex. E2, AH 0222. Plaintiff differentiated her invention The description of the McNair

from McNair by stating that "Hemphill [vaginal swab] improves absorbing on the McNair cover sheet because of an adsorbency characteristic." Id., Ex. E1, AH 0230. 4 Thus, the McNair patent

required an absorbent porous sheet, whereas Plaintiff's patent specified adsorbent porous material. Ultimately, the PTO denied Plaintiff's request for

reexamination after finding that the McNair patent "did not raise a substantial new question of patentability.". AH 0227. "discloses Id., E4,

Specifically, the PTO stated that the McNair patent none of the structural features recited [in

Plaintiff's claims]" in light of Plaintiff's invention having a particular core member and housing. Id.

Plaintiff also applied for reexamination of her patent on May 20, 1998, this time over a patent held by Srinivasan, et al. Id., Ex. F2, U.S. Letters Patent No. 3,973,567 ("the Srinivasan patent"). The Srinivasan patent describes a "wrapped" sanitary

napkin that includes plastic outer packaging and a napkin that affixes to an undergarment using an adhesive. The patent

contains this description of the invention: A sanitary napkin having an adhesive element thereon for attaching to an undergarment is provided with means for protecting the napkin and the adhesive element prior to use and for disposing of the napkin after use. The means comprise providing the napkin with a wrapper sheet of flexible material overlying one major surface, and the sides of the napkin and at least partially overlapping on the second major surface of the napkin. The sheet is releasably adhered to and held in place by the adhesive element. 5

Id., Ex. F1, PTO 00509. The PTO granted Plaintiff's request for reexamination,

finding that "[a] substantial new question of patentability affecting Claim 2" was raised by the Srinivasan patent. Ex. F3, PTO 00481. Agreeing to compare the PTO claim 2 and Id., the the

Srinivasan

patent

more

closely,

acknowledged

possibility that Srinivasan had the claimed structure, such as "a core member surrounded by a layer of porous material, an outer housing, and housing means with 2 positions (one position that protects the core member and another position that exposes the core member for use)." Id.

In an effort to get her claim reissued, Plaintiff stated the Srinivasan patent lacked both the "housing means" and "a band" at the base of the core member, found in her invention. Ex. F4, PTO 00484. Id.,

Plaintiff emphasized that the missing band

was particularly significant to her invention because "[t]he band is the means or intermediary in both positions from the closed location to the open state", Id., Ex. F4, PTO 00486 (emphasis in original), allowing users "to keep sticky fingers off the fibers." Id., Ex. F2, PTO 00447. Furthermore,

Plaintiff distinguished her vaginal swab by stating: [i]t should be well understood that Hemphill does not behave, operate, or function like a sanitary napkin. 6 Srinivasan does not have the

components or parts to be vaginal swab." (emphasis in original). On January for 26, the 1999, `720 the PTO

Id., Ex F2, PTO 00451

issued

a

reexamination for the

certificate

Patent

over

Srinivasan

following reasons: Claim 1 of the patent to Hemphill (4557720) is considered patentable over the patent to Srinivasan, et al. (3973567) because Srinivasan simply does not disclose the claimed structure, such as an open end opposite a closed end, an annular band, and frangible seams. Claim 2 of the patent to Hemphill (4557720) is considered patentable over the patent to Srinivasan, et al., (3973567) because Srinivasan does not disclose the housing means of Hemphill and does not disclose a structure that could be considered equivalent to the housing means of Hemphill.

Id., Ex. F6, PTO 00490. According to Defendant, beginning in 1994 and continuing for the next four years, Plaintiff sent letters to Johnson & Johnson executives alleging that the company's sanitary and adult

napkins incorporate her patented technology. Plaintiff has alleged that the Stayfree

Specifically, napkin,

sanitary

Carefree sanitary napkin, and Serenity adult napkin product lines infringe upon her patent.4 Moreover, Plaintiff testified

Although Plaintiff mentions in her deposition testimony that Band Aid brand adhesive bandage products also infringe upon (continued...) 7

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that

she

considers

these

respective

product

lines

to

be

structurally equivalent to each other. 372-74, 376-77.

Id., Ex. B, 363, 368,

Defendant agrees that the three different product lines are nearly identical in design. Id., Ex. A, McCoy Decl.,

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Maryland Law