DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/17/2026 has been entered.
Claims 1-24 remain pending and under prosecution.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Actuation portion (Claims 1-2 and 13-14), which refers to element 124 (functions to contact the skin/tissue/finger, vs. to actuate the operation of the device), best seen in Figure 32 (embodiment claimed in the instant invention)
Pumping member (Claims 6 and 18), which refers to element 136 (tabs or wings to clamp the skin/tissue/finger vs. any pressurized pumping mechanism), best seen in Figure 32 (embodiment claimed in the instant invention)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 8-10, 13, 15, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al (US Pub No. 20140236044) in view of Simons et al (US Pat No. 5971941).
In regard to Claims 1 and 13, Kelly et al disclose a device for obtaining a blood sample, the device comprising:
a holder 3 (housing – 0129) for receiving a sample source (skin – 0129), best seen in Figure 1,
the holder having an actuation portion 8 (0129) and a port – defined as opening that is placed on skin, best seen in Figure 7 (left side through which lancet 7 extends), as well as the opening that sit on top of test element 9, best seen in Figure 8-9 (0134),
a container engagement portion 15 (engagement arm – 0131) releasably connected to the holder, best seen in Figure 1-9, by a locking portion 50, 51, 60 (locking plate) of the holder, best seen in Figure 20-24 and 28-30 (0145, 0147); and
a collection container 14, being a tube shaped container 16 (capillary tube – 0135), best seen in Figure 1, 4, 5, removably connectable to the container engagement portion – “the retainer is adapted to allow the removal of the collector from the retainer” (0105), wherein it is also submitted that each component in multi-component devices are “removable” as broadly as has been claimed, the container defining a collection cavity 21, best seen in Figure 4 (0133),
wherein the container engagement portion allows the collection container to rotate between a first position in which the collection container is spaced from the port and not in fluid communication with the port, best seen in Figure 1-7, and
a second position in which the collection container is in fluid communication with the port on top of test element 9 – to deposit the collected sample onto the test element, best seen in Figure 8-9 – “ The user then moves the collector 14 into the delivery position” (0139).
However, Kelly et al do not expressly disclose the port configured for receiving a lancing housing, the lancing housing being separate from the holder.
It is noted that Kelly et al disclose lancet 7 positioned within holder 3 – “lancet 7 adapted to be positioned within the housing 3 prior to actuation of the membrane penetration device 5. The membrane penetration device 5 is actuated by contact with actuator 8 which releases the lancet such that the lancet extends beyond the housing 3 and can be utilized to penetrate a bodily membrane such as skin to release a bodily fluid such as blood. After actuation in the illustrated form the lancet retracts back into the housing to protect a user from further sticks” (0129), best seen in Figure 3-5 and 7.
Simons et al teach that it is well-known in the art to provide an analogous blood sampling device comprising holder 500 (lancing device) with a lancing housing 210 – “A lancet 216 is housed at rest inside the test cartridge 210” (Col.8: 44-Col.9: 27), best seen in Figure 3A-B and 4A-B, the lancing housing being separate from the holder (lancing device), best seen in Figure 3A-B and 4A-B, to effectively provide a disposable lancing housing with lancet 216 that can be removed and disposed of after use with the holder – “The lancing device 500 has a cartridge holder 502 with a recessed section 506 that accepts a bar-shaped test cartridge 210, similar to the bar-shaped test cartridge of FIG. 3A and FIG. 3B. The test cartridge 210 can be mounted in the cartridge holder 502 in a reproducible manner. That is, the test cartridge 210 can be repeatedly mounted and removed from the cartridge holder 502” (Col.10: 12-18).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kelly et al such that the port of Kelly et al defined as -- opening that is placed on skin, best seen in Figure 7 (left side through which lancet 7 extends), above – is configured for receiving a lancing housing, the lancing housing being separate from the holder, as taught by Simons et al, to effectively provide a disposable lancing housing that is separate from the holder to enable disposable of the lancet within the lancing housing after use with the holder of Kelly et al.
3, 15. Kelly et al disclose the device of claim 1, wherein the actuation portion 8 necessarily includes a contact member (0129).
8, 20. Kelly et al disclose the device of claim 1, wherein the sample source is a finger (0138).
9, 21. Kelly et al disclose the device of claim 8, wherein, with the finger received within the holder, the port is in communication with a portion of the finger – the opening that is placed on skin, best seen in Figure 7 (left side through which lancet 7 extends, 0129).
10, 22: Kelly et al disclose the container engagement portion 15 (engagement arm – 0131) and the holder 3 are connected via a ball joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and pocket pivot joint – “flange 17 and hinge pin 45 which engage the housing 3 such that the flange 17 abuts an internal shoulder or wall in the housing 3” is considered a pin and pocket pivot joint, best seen in Figure 27 (0144).
Claim(s) 2, 4-7, 11-12, 14, 16-19, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al in view of Simons et al as applied to Claims 1 or 13 above, further in view of Perez (US Pub No. 20020022789).
Kelly et al in combination with Simons et al disclose the invention above but do not expressly disclose:
2, 14: wherein the actuation portion is transitionable between a first position in which the holder defines a first ellipse shape and a second position in which the holder defines a second ellipse shape, wherein the second ellipse shape is different than the first ellipse shape.
4, 16: wherein the actuation portion is transitionable between a first position in which the contact member is in a disengaged position and a second position in which the contact member is in an engaged position.
5, 17: wherein, with the contact member in the engaged position, the contact member exerts a pressure on the sample source.
6, 18: wherein the actuation portion includes a pumping member for applying pressure to the sample source.
7, 19: wherein the pumping member comprises a pair of opposed tabs.
11, 23: wherein the holder comprises a living hinge that is connectable to the container engagement portion.
Perez et al teach that it is well-known in the art to provide an analogous actuation portion 600 (Figure 30-32) that functions to contact the skin/tissue/finger of the user as interpreted under 112(f) above, and functions to contact the skin/tissue/finger of the user to express the body fluid.
Perez et al teach:
2, 14: wherein the actuation portion 600 is transitionable between a first position in which the holder defines a first ellipse shape (no pressure is exerted on the skin/tissue/finger), best seen in Figure 30, and a second position in which the holder defines a second ellipse shape, wherein the second ellipse shape is different than the first ellipse shape, best seen in Figure 31-32, when the pressure exerted by the actuation portion constricts the skin and changes its shape (0125-0128).
4, 16: wherein the actuation portion 600 is transitionable between a first position in which the contact member 610 is in a disengaged position – no pressure is exerted on the skin/tissue/finger, best seen in Figure 30, and a second position in which the contact member 610 is in an engaged position – when the pressure exerted by the actuation portion constricts the skin and changes its shape, best seen in Figure 31-32 (0125-0128).
5, 17: wherein, with the contact member 610 in the engaged position, the contact member exerts a pressure on the sample source, best seen in Figure 31-32 (0125-0128).
6, 18: wherein the actuation portion includes a pumping member 610 for applying pressure to the sample source as interpreted under 112(f) above (tabs or wings to clamp the skin/tissue/finger), best seen in Figure 30-32 (0125-0128).
7, 19: wherein the pumping member comprises a pair of opposed tabs 610, best seen in Figure 30-32.
11, 23: wherein the holder (Figure 30-32) comprises a living hinge (0126 – “alternatively the proximal end 612 may be integrally formed with the sleeve 180 and pivot through the use of a live hinge or similar arrangement”).
Perez et al teach the actuation portion in the manner above to provide an effective mechanical mechanism to express the body fluid before or after sampling,
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kelly et al as modified by Simons et al such that the actuation portion is configured in the manner above as taught by Perez et al to effectively provide a mechanism to express the body fluid before or after sampling to enhance the sampling process, where in combination, regarding Claims 11 and 23, the living hinge as taught by Perez et al would thus be connectable to the container engagement portion as broadly as has been claimed.
In regard to Claim 12 and 24, Kelly et al in combination with Simons et al and Perez et al disclose the living hinge above but do not expressly disclose the living hinge is connected to the container engagement portion via a keyed snap-fit arrangement, a hook and snap-fit arrangement, a C-clip and snap-fit arrangement, or a peg and profiled engagement.
Kelly et al teach that engagement arm 15 and the holder 3 are connected via a keyed snap-fit arrangement – “flange 17 and hinge pin 45 which engage the housing 3 such that the flange 17 abuts an internal shoulder or wall in the housing 3” is considered a pin and pocket pivot joint, best seen in Figure 27 (0144). Thus, Kelly et al teach said keyed snap-fit arrangement as an effective connection means.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kelly et al as modified by Simons et al and Perez et al such that the living hinge is connected to the container engagement portion via a keyed snap-fit arrangement as taught by Kelly et al as an effective manner to connect the living hinge to the container engagement portion of Kelly et al.
Response to Arguments
Applicant's arguments filed with respect to Kelly et al have been fully considered but are moot because Simons et al has been set forth to provide a removable lancet housing, i.e. has a lancet disposed therein, such that when combined with Kelly et al, the port of Kelly et al as defined above is configured for receiving the lancing housing, the lancing housing being separate from the holder, to enable the lancet to be disposed of after use with the holder of Kelly et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached on (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
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