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 .
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.
No claim limitation is 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 1-9 and 11-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2008/0319347 (Keren)(previously cited).
First Interpretation
With respect to claim 1, Keren teaches a finger lancing device comprising:
a body (the body 12 with its elastomeric self-sealing liquid-impermeable membrane; paragraph 0026 of Keren) having a chamber for receiving a finger, the body being flexible and comprising an elastomeric material (the elastomeric self-sealing liquid-impermeable membrane is flexible and an elastomeric material; paragraph 0026 of Keren); and
a lancing device comprising a lancing member actuator (the housing 32 of the puncturing unit 30 of Keren) for actuating a lancing member (the lancing element 35 of Keren) to lance the finger received in the chamber.
With respect to claim 2, Keren teaches the lancing member (the lancing element 35 of Keren), wherein the lancing member actuator (the housing 32 of the puncturing unit 30 of Keren) is configured to actuate the lancing member to lance the finger inserted into the chamber (paragraphs 0027-0028 of Keren).
With respect to claim 3, Keren teaches a wipe (the flange 18 or 18a of Keren) provided within the chamber for wiping the finger before lancing.
With respect to claim 4, Keren teaches that the wipe (the flange 18 or 18a of Keren) is provided on a wall of the chamber, the wipe being disposed between an end of the chamber for receiving the finger and the lancing member (see FIG. 3 of Keren for the relative positions of the end of the chamber, the flange 18 or 18a, and the lancing element 35 of Keren).
With respect to claim 5, Keren teaches an absorbent wipe (the wick member 19 of Keren) provided on a wall of the chamber for wiping away a first drop of blood.
With respect to claim 8, Keren teaches a capillary collection device (the strip 50 of Keren) for collecting a blood sample from the finger received in the chamber.
With respect to claim 9, Keren teaches that the capillary collection device (the strip 50 of Keren) has a fill line (the line demarked as region T of Keren) to indicate a volume of blood required.
With respect to claim 11, Keren teaches that the body is transparent (the body 12 of Keren is transparent; paragraph 0025 of Keren).
With respect to claim 12, Keren teaches a body (the body 12 with its elastomeric self-sealing liquid-impermeable membrane; paragraph 0026 of Keren) for a finger lancing device comprising a chamber for receiving a finger, wherein the body comprises a hole (the small opening 25 of Keren) for receiving a lancing device (the lancing element 35 of Keren), and wherein the body is flexible and comprises an elastomeric material (the elastomeric self-sealing liquid-impermeable membrane is flexible and an elastomeric material; paragraph 0026 of Keren).
With respect to claim 14, Keren teaches that the body further comprises a hole (the hole 14 or the hole in stopper wall 20 of Keren) for receiving a capillary collection device (the strip 50 of Keren).
With respect to claim 15, Keren teaches a second openable seal (the rubber flange 18 of Keren) configured to cover the hole for receiving the capillary collection device (the rubber flange 18 covers the periphery of the hole 14 of Keren).
With respect to claim 18, Keren teaches kit comprising the body (the body 12 with its elastomeric self-sealing liquid-impermeable membrane; paragraph 0026 of Keren) according to claim 12 and at least one of the lancing device (the lancing element 35 of Keren) and a capillary collection device (the strip 50 of Keren).
Second Interpretation
With respect to claim 1, Keren teaches a finger lancing device comprising:
a body (the body 12 with its elastomeric self-sealing liquid-impermeable membrane; paragraph 0026 of Keren) having a chamber for receiving a finger, the body being flexible and comprising an elastomeric material (the elastomeric self-sealing liquid-impermeable membrane is flexible and an elastomeric material; paragraph 0026 of Keren); and
a lancing device comprising a lancing member actuator (the housing 32 of the puncturing unit 30 of Keren) for actuating a lancing member (the lancing element 35 of Keren) to lance the finger received in the chamber.
With respect to claim 3, Keren teaches a wipe (the wick member 19 of Keren) provided within the chamber for wiping the finger before lancing.
With respect to claim 4, Keren teaches that the wipe (the wick member 19 of Keren) is provided on a wall of the chamber, the wipe being disposed between an end of the chamber for receiving the finger and the lancing member (FIG. 4 of Keren).
Third Interpretation
With respect to claim 1, Keren teaches a finger lancing device comprising:
a body (the body 12 with its rubber flange 18; paragraph 0025 of Keren) having a chamber for receiving a finger, the body being flexible and comprising an elastomeric material (the rubber flange 18 is flexible and an elastomeric material; see pages 1-2 of the attached webpage “Elastomers and Rubbers — What's the Difference” that discloses that rubber is an elastomer; paragraph 0025 of Keren); and
a lancing device comprising a lancing member actuator (the housing 32 of the puncturing unit 30 of Keren) for actuating a lancing member (the lancing element 35 of Keren) to lance the finger received in the chamber.
With respect to claim 2, Keren teaches the lancing member (the lancing element 35 of Keren), wherein the lancing member actuator (the housing 32 of the puncturing unit 30 of Keren) is configured to actuate the lancing member to lance the finger inserted into the chamber (paragraphs 0027-0028 of Keren).
With respect to claim 3, Keren teaches a wipe (the flange 18a of Keren) provided within the chamber for wiping the finger before lancing.
With respect to claim 4, Keren teaches that the wipe (the flange 18a of Keren) is provided on a wall of the chamber, the wipe being disposed between an end of the chamber for receiving the finger and the lancing member (see FIG. 3 of Keren for the relative positions of the end of the chamber, the flange 18a, and the lancing element 35 of Keren).
With respect to claim 5, Keren teaches an absorbent wipe (the wick member 19 of Keren) provided on a wall of the chamber for wiping away a first drop of blood.
With respect to claim 6, Keren teaches an openable seal (the membrane 17 of Keren), the openable seal being at an end of the chamber for receiving the finger.
With respect to claim 8, Keren teaches a capillary collection device (the strip 50 of Keren) for collecting a blood sample from the finger received in the chamber.
With respect to claim 9, Keren teaches that the capillary collection device (the strip 50 of Keren) has a fill line (the line demarked as region T of Keren) to indicate a volume of blood required.
With respect to claim 11, Keren teaches that the body is transparent (the body 12 of Keren is transparent; paragraph 0025 of Keren).
With respect to claim 12, Keren teaches a body (the body 12 with its rubber flange 18; paragraph 0025 of Keren) for a finger lancing device comprising a chamber for receiving a finger, wherein the body comprises a hole (the small opening 25 of Keren) for receiving a lancing device (the lancing element 35 of Keren), and wherein the body is flexible and comprises an elastomeric material (the rubber flange 18 is flexible and an elastomeric material; see pages 1-2 of the attached webpage “Elastomers and Rubbers — What's the Difference” that discloses that rubber is an elastomer; paragraph 0025 of Keren).
With respect to claim 13, Keren teaches a first openable seal (the membrane 17 of Keren) configured to cover the hole (the small opening 25 of Keren) for receiving the lancing device.
With respect to claim 14, Keren teaches that the body further comprises a hole (the hole 14 or the hole in stopper wall 20 of Keren) for receiving a capillary collection device (the strip 50 of Keren).
With respect to claim 16, Keren teaches a third openable seal (the membrane 17 of Keren), the third openable seal being configured to cover an end of the chamber for receiving the finger.
With respect to claim 17, Keren teaches that a wipe (the wick member 19 of Keren) for wiping the finger before lancing is provided on the third openable seal (the membrane 17 of Keren), on an inner side of the third openable seal (FIGS. 3-4 of Keren).
With respect to claim 18, Keren teaches kit comprising the body (the body 12 with its rubber flange 18; paragraph 0025 of Keren) according to claim 12 and at least one of the lancing device (the lancing element 35 of Keren) and a capillary collection device (the strip 50 of Keren).
Fourth Interpretation
With respect to claim 1, Keren teaches a finger lancing device comprising:
a body (the body 12 with its rubber flange 18; paragraph 0025 of Keren) having a chamber for receiving a finger, the body being flexible and comprising an elastomeric material (the rubber flange 18 is flexible and an elastomeric material; see pages 1-2 of the attached webpage “Elastomers and Rubbers — What's the Difference” that discloses that rubber is an elastomer; paragraph 0025 of Keren); and
a lancing device comprising a lancing member actuator (the housing 32 of the puncturing unit 30 of Keren) for actuating a lancing member (the lancing element 35 of Keren) to lance the finger received in the chamber.
With respect to claim 3, Keren teaches a wipe (the wick member 19 of Keren) provided within the chamber for wiping the finger before lancing.
With respect to claim 4, Keren teaches that the wipe (the wick member 19 of Keren) is provided on a wall of the chamber, the wipe being disposed between an end of the chamber for receiving the finger and the lancing member (FIG. 4 of Keren).
With respect to claim 6, Keren teaches an openable seal (the membrane 17 of Keren), the openable seal being at an end of the chamber for receiving the finger.
With respect to claim 7, Keren teaches that the wipe (the wick member 19 of Keren) is provided on an openable seal (the membrane 17 of Keren) disposed at an end of the chamber for receiving the finger, on an inner side of the openable seal (FIG. 4 of Keren).
Claim 12 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2014/0257066 (Suess).
With respect to claim 12, Suess teaches a body (the body 112 with its rubber padding 120 of Suess) for a finger lancing device comprising a chamber for receiving a finger, wherein the body comprises a hole (the opening 116 of Suess) for receiving a lancing device (the lancing device 170 of Suess), and wherein the body is flexible and comprises an elastomeric material (the rubber padding 120 is flexible and an elastomeric material; see pages 1-2 of the attached webpage “Elastomers and Rubbers — What's the Difference” that discloses that rubber is an elastomer; paragraph 0028 of Suess).
With respect to claim 18, Suess teaches kit comprising the body (the body 112 with its rubber padding 120 of Suess) according to claim 12 and at least one of the lancing device (the lancing device 170 of Suess) and a capillary collection device.
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.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Keren in view of U.S. Patent Application Publication No. 2015/0351676 (Faurie)(previously cited).
Keren teaches a body (the body 12 with its elastomeric self-sealing liquid-impermeable membrane; paragraph 0026 of Keren) having a chamber for receiving a finger; and a lancing device comprising a lancing member actuator (the housing 32 of the puncturing unit 30 of Keren) for actuating a lancing member (the lancing element 35 of Keren) to lance the finger received in the chamber. Faurie teaches a strip 259 of Faurie for removing a first drop of blood (paragraph 0033 of Faurie), which is categorized as containing contaminated materials (claim 18 of Faurie). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the strip 259 contact the area of the finger to be punctured and removed as disclosed by Faurie so as to remove the first drop of blood from the area so as to remove contaminated materials from the blood sample.
With respect to claim 3, the combination teaches or suggests a wipe (the strip 259 of Faurie1) provided within the chamber for wiping the finger before lancing.
With respect to claim 4, the combination teaches or suggests that the wipe (the strip 259 of Faurie) is provided on a wall of the chamber, the wipe being disposed between an end of the chamber for receiving the finger and the lancing member (the wipe would cover the area of puncture which would necessarily be located between an end of the chamber and the lancing member; FIGS. 6-6A of Faurie and FIG. 3 of Keren).
With respect to claim 5, the combination teaches or suggests an absorbent wipe (the strip 259 of Faurie) provided on a wall of the chamber for wiping away a first drop of blood.
Response to Arguments
The Applicant's arguments filed 11/3/2025 have been fully considered.
Claim objections
In view of the claim amendments filed on 11/3/2025, the claim objections are withdrawn.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 11/3/2025, the claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Prior art rejections based on Keren
The Applicant’s arguments with respect to the rejection of the claim have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of claim rejections that have been necessitated by the claim amendments filed on 11/3/2025.
Additionally, the Applicant asserts:
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This argument is not persuasive in view of the new grounds of rejection. According to the first and second interpretations of Keren, the body 12 of Keren with its elastomeric self-sealing liquid-impermeable membrane (paragraph 0026 of Keren) is interpreted to be the body of the claims. The elastomeric self-sealing liquid-impermeable membrane is a flexible component such that it makes the interpreted body of Keren flexible. Also, the elastomeric self-sealing liquid-impermeable membrane is made of elastomeric material which means that the interpreted body of Keren comprises an elastomeric material. With these interpretations, Keren teaches every feature of claims 1 and 12.
According to the third and fourth interpretations of Keren, the body 12 with its rubber flange 18 (paragraph 0025 of Keren) is interpreted to be the body of the claims. This flange 18 is a flexible component such that it makes the interpreted body of Keren flexible. Also, the rubber flange 18 is made of rubber, an elastomeric material (see pages 1-2 of the attached webpage “Elastomers and Rubbers — What's the Difference” that discloses that rubber is an elastomer). This means that the interpreted body of Keren comprises an elastomeric material. With these interpretations, Keren teaches every feature of claims 1 and 12.
The rejections of 2-9, 11, and 13-18 based on Keren are proper because the rejections of claims 1 and 12 are proper and the prior art teaches or suggests all the features of these claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Though the strip 259 of Faurie is disclosed for removing the first drop of blood after lancing, it is capable of wiping the finger before lancing when the finger is first inserted in the body of Keren.
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