Please find below and/or attached an Office communication concerning this application or proceeding.

UNITED STA TES p A TENT AND TRADEMARK OFFICE

APPLICATION NO. FILING DATE

121778,710 05/12/2010

2101 7590 06/28/2016

Sunstein Kann Murphy & Timbers LLP 125 SUMMER STREET

BOSTON, MA 02110-1618

FIRST NAMED INVENTOR

Lise N. Halpern

UNITED STATES DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

Address: COMMISSIONER FOR PATENTS

P.O. Box 1450

Alexandria, Virginia 22313-1450 www .uspto.gov

ATTORNEY DOCKET NO. CONFIRMATION NO.

161 l/A59 6959

EXAMINER PERREAULT, ANDREW D

ART UNIT PAPER NUMBER 3788

NOTIFICATION DATE DELIVERY MODE

06/28/2016 ELECTRONIC

Please find below and/or attached an Office communication concerning this application or proceeding.

The time period for reply, if any, is set in the attached communication.

Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es):

[email protected]

BEFORE THE PATENT TRIAL AND APPEAL BOARD

Ex parte LISE E. HALPEM, TIM COSTELLO,

and JONATHAN WHITE

Appeal2014-002085

Application 12/778,7101

Technology Center 3700

Before JOSEPH A. FISCHETTI, BART A. GERSTENBLITH, and KENNETH G. SCHOPPER, Administrative Patent Judges.

GERSTENBLITH, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Lise E. Halpern et al. ("Appellants") appeal under 35 U.S.C. § 134(a)

from the Examiner's decision rejecting claims 1 and 4--20.2 We have

jurisdiction under 35 U.S.C. § 6(b).

1 _{Appellants identify "Haemonetics Corporation" as the real party in interest.}

Appeal Br. 4.

2 _{Claims 2 and 3 were cancelled prior to this appeal. Appeal Br. 6.}

Claims 21-25 were withdrawn pursuant to Appellants' non-election of those claims in the Response filed November 22, 2011.

Appeal2014-002085 Application 12/778,710

Claimed Subject Matter

Claims 1, 5, and 15 are the independent claims on appeal. Claim 1 is illustrative of the claimed subject matter, and is reproduced below.

1. A system for facilitating collecting donated blood, the

system comprising:

a plurality of kits, each kit comprising a closed container having a computer-readable representation of data including a unique identification of the kit, the container having disposed therewithin:

at least one sealed test tube, devoid of any blood product, having a computer-readable representation of data including the unique identification of the kit and an expiration date of the test tube; and

a release sheet substrate having a plurality of adhesive labels releasably attached thereto, each of the plurality of adhesive labels having a computer-readable representation of data including the unique identification of the kit; and

a computerized database storing, for each kit: the unique identification of the kit; and information that associates the unique

identification of the kit with the expiration date of the test tube in the kit having the earliest expiration date.

Appeal Br. 29 (Claims App.).

Rejections

Appellants seek review of the following rejections:

I. Claims 1 and 4--20 are rejected under 35 U.S.C. § 112, first

paragraph, as failing to comply with the written description requirement;

II. Claims 1 and 4--203 _{are rejected under 35 U.S.C. § 112, second}

paragraph, as indefinite;

3 _{The rejection heading identifies "[c]laims 14-20" as rejected under this} ground. Final Act. 4 (mailed Dec. 19, 2012). The heading appears to be a

Ill. Claims 1, 4, 5, 7-9, 14, and 16-20 are rejected under 35 U.S.C.

§ 103(a) as unpatentable over Knapp (US 2009/0291449 Al, pub. Nov. 26,

2009);

IV. Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable

over Knapp and Zylberberg (US 2009/0209933, pub. Aug. 20, 2009); and

V. Claims 10-13 and 15 are rejected under 35 U.S.C. § 103(a) as

unpatentable over Knapp and Bennett (EP 0832689 A2, pub. Apr. 1, 1998).

SUMMARY OF DECISION We REVERSE.

ANALYSIS

Rejection I

Claim 1 recites "at least one sealed test tube, devoid of any blood

product." Appeal Br. 29 (Claims App.). Independent claim 5 recites the same limitation and independent claim 15 recites a substantially identical

limitation. Id. at 30-32. The Examiner finds that the "specification does not

provide for such a limitation" and that the phrase "devoid of any blood product" is new matter. Final Act. 2--4 (mailed Dec. 19, 2012).

Appellants argue that the claims refer to a blood collection kit, and that before a blood collection kit is used to collect blood, a test tube of the

kit would have been devoid of any blood product. Appeal Br. 11.

typographical error because the body of the rejection specifically identifies

independent claims 1, 5, and 15 and dependent claims 2--4, 6-14, 16-20 as

rejected. Id.; see Appeal Br. 15, 17 (recognizing that the rejection applies to

claims 1 and 4--20).

Appeal2014-002085 Application 12/778,710

Appellants point to paragraph 3 64 _{of the Specification, which describes a kit}

that includes several "sealed evacuated test tubes." Id. at 12.

In response, the Examiner explains that a negative limitation must have basis in the original disclosure and that the mere absence of a positive recitation is not a basis for an exclusion. Ans. 2. In particular, the Examiner interprets Appellants' argument to be that "the lack of a blood product is implied." Id. at 3. The Examiner points to paragraph four of Appellants' Specification, which states "blood samples are drawn and introduced into one or more small sealed evacuated test tubes," in support of finding that "the tubes contain blood." Id. (citing Spec.

i-f

The Examiner's rejection ignores the term "evacuated" in Appellants' Specification. Paragraph 30 of Appellants' Specification describes the

contents of one embodiment of a kit, illustrated in Figure 1. The description

states that the kit includes "several pre-labeled sealed evacuated test tubes"

and Figure 1 shows empty test tubes. Spec.

i-f

correctly finds that blood may be introduced into the sealed evacuated test

tubes, Appellants' Specification and Figure 1 provide support for the phrase

"devoid of any blood product," as recited in independent claims 1, 5, and 15, and we find that one of ordinary skill in the art would understand from this disclosure that Appellants had possession of a test tube "devoid of any blood product." Accordingly, we do not sustain the rejection.

4 _{Appellant's citation appears to refer to the U.S. Patent Application}

Publication of the present application (US 2011/0281346 Al). Paragraph 36 of the published application corresponds to paragraph 30, respectively, of the Specification as filed. Our citations are to the Specification as filed.

Rejection II

Claims 1, 5, and 15 also recite "at least one sealed test tube ... having a computer-readable representation of data including ... an expiration date of the test tube." Appeal Br. 29-30, 32 (Claims App.). The Examiner finds this recitation to "contradict" an earlier statement made by Appellants that "the expiration date is not indicia" in a response filed June 5, 2012, and, thus, results in a failure by Appellants to particularly point out and distinctly claim the subject matter that Appellants regard as the invention. Final

Act. 4.

Appellants provide a detailed explanation of their arguments and the claim language to which the arguments were directed on pages 15-1 7 of the Appeal Brief. In short, Appellants' earlier statements were made in relation to a previous version of the claims that did not recite a computer-readable representation of data including an expiration date. Appeal Br. 15.

Appellants' position is consistent with the record.

Additionally, regardless of Appellants' argument directed to an earlier version of the claims, the meaning of the disputed limitation is not unclear. Accordingly, we do not sustain the rejection.

Rejection III

The Examiner determines that Knapp would have rendered the subject matter of claims 1, 4, 5, 7-9, 14, and 16-20 obvious to one of ordinary skill in the art at the time the invention was made. Final Act. 5-10. Regarding

claims 1 and 5, the Examiner finds Knapp discloses a test tube having a

computer-readable representation of data and finds "the test tube would have an expiration date" since "it is well known that specimens expire and that expired specimens present a threat to the user and therefore expiration dates

Appeal2014-002085 Application 12/778,710

are routinely identified." Id. at 5. Additionally, the Examiner finds that Knapp discloses "the unique identification of the kit is associated, in the computerized database, with at least the earliest of the expiration date of each of the at least one test tube (associated with a computer in

paragraphs 44, 52; the above intended use is able to be performed)." Id. at 6. Appellants raise several arguments in response to this rejection,

including that Knapp does not disclose or suggest "a computerized database storing, for each kit: the unique identification of the kit; and information that associates the unique identification of the kit with the expiration date of the test tube having the earliest expiration date." Appeal Br. 21.

Knapp expressly teaches "computerized" record keeping through the

use of computer-readable identifiers such as bar codes. Knapp

i-f

however, does not teach or suggest information associating the unique identification of the kit with the expiration date of the test tube having the earliest expiration date, and the Examiner does not find that such association would have been obvious. The Examiner's finding that "the above intended use is able to be performed" is unclear in that we are unable to tell what claim language the Examiner considers as reciting an intended use that "is able to be performed." Final Act. 6. The Examiner's response to

Appellants' argument does not appear to address this particular issue,

focusing instead on what data may be provided by a bar code. See, e.g.,

Ans. 5. Accordingly, we do not sustain the rejection.

Rejection IV

The Examiner determines that the combination of Knapp and Zylberberg would have rendered the subject matter of claim 6 obvious to one of ordinary skill in the art at the time of the invention. Final Act. 10-11.

Claim 6 depends from claim 5, and the Examiner does not rely upon Zylberberg as disclosing the limitation missing from Knapp that we

discussed in the context of Rejection III. Accordingly, for the reasons we discussed in the context of Rejection III, we do not sustain Rejection IV.

Rejection V

The Examiner determines that the combination of Knapp and Bennett would have rendered the subject matter of claims 10-13 and 15 obvious to one of ordinary skill in the art at the time of the invention. Final Act. 11-15. Claim 15 is similar to claims 1 and 5, at least because it recites "a

computerized database storing, for each kit ... the expiration date of the blood collection container having the earliest expiration date." Appeal

Br. 32, Claims App. The Examiner makes the same finding for claim 15 that we discussed above with respect to the similar limitation of claims 1 and 5.

See Final Act. 11-12. Accordingly, for the reasons we discussed with

respect to Rejection III; we do not sustain Rejection V. DECISION

We reverse the Examiner's decision rejecting claims 1 and 4--20 under 35 U.S.C. § 112, first paragraph.

We reverse the Examiner's decision rejecting claims 1 and 4--20 under 35 U.S.C. § 112, second paragraph.

We reverse the Examiner's decision rejecting claims 1 and 4--20 under 35 U.S.C. § 103(a).

REVERSED