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.
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:
“first wicking element and second wicking element” in claim 3 whose corresponding structure is noted in [00032] as a strip of suitable paper.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dulaney (US 5413761 A; cited by applicant) in view of Bachtel (US 20260182974 A1).
With respect to claim 1, Dulaney discloses a bodily fluid sample device (see col 1 lines 6-8, diagnostic device for blood glucose monitoring and Fig. 1-5: #10) comprising:
a wand body having elongate configuration (see Fig. 1-5 and col 4 lines 39-44: structural spine #12 has elongate configuration); and
the wand body has a first body portion and a second body portion (see Fig. 1-5 and see col 4 lines 45-56: #12 has a first body portion #18 and a second body portion #22), the wand body being initially unitary (see Fig. 3 and see col 4 lines 45-56, zones #18 and #22 are initially unitary) but configured so that the first body portion and second body portion can be separated from one another (see Fig. 5 and see col 4 lines 45-56, zone #18 can be separated from zone #22).
Dulaney does not specifically disclose a first collection pad located on the first body portion and a second collection pad located on the second body portion.
Bachtel teaches a collection pad located on a body portion (see Fig. 2A and see paragraph 0052-0054: sample collection pad #218 located on handpiece #212) and further teaches that a device may hold multiple pads (see paragraph 0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dulaney with the teachings of Ennis to have added a collection pad because it would have resulted in the predictable result of absorbing fluid (Bachtel: see [0023]) and further because a device can hold multiple pads (Bachtel: see [0075]).
With respect to claim 2, all limitations of claim 1 apply in which Bachtel further teaches wherein the first collection pad and the second collection pad are adjacent to one another near a first end of the wand body (see Fig. 2A-2C, #218 is located at one end of the handpiece #212).
With respect to claim 3, all limitations of claim 2 apply in which Dulaney further discloses wherein each of the first body portion and the second body portion has a respective first wicking element and a second wicking element in fluid communication with the respective first collection pad and the second collection pad, the wicking elements providing a visual indication that a sample is present (see col 1 lines 47-50: the monitoring strip includes a plastic strip with an absorbent paper piece impregnated with an enzyme system as well as a color indicator compound which changes color which oxidized; and see Fig. 3 and see col 4 lines 45-56 paper #28 is interpreted to be the first wicking element and paper #30 is interpreted to be the second wicking element).
With respect to claim 4, all limitations of claim 3 apply in which Dulaney further discloses wherein the first wicking element and the second wicking element each have an elongate configuration (see Fig. 3 and Fig. 5).
With respect to claim 5, all limitations of claim 4 apply in which Dulaney further discloses wherein the first wicking element and the second wicking element comprises paper having dye that changes color when the sample is present (see Fig. 3 and see col 4 lines 45-56: paper #28 is interpreted to be the first wicking element and paper #30 is interpreted to be the second wicking element; and see col 1 lines 47-50: the monitoring strip includes a plastic strip with an absorbent paper piece impregnated with an enzyme system as well as a color indicator compound which changes color which oxidized).
With respect to claim 6, all limitations of claim 3 apply in which Dulaney further discloses wherein each of the first and second wicking elements extends under a respective first and second indicator window, the indicator windows being located near a second end of the wand body opposite the first end (see Fig. 3 and Fig. 5, indicator windows seen).
With respect to claim 7, all limitations of claim 3 apply in which Dulaney does not specifically disclose wherein the wand body has a multilayer configuration with the first and second wicking elements being sandwiched between two layers.
Bachtel teaches a wand body (see paragraph 0054 and Fig. 2A-2C: oral fluid collection device #210) that has a multilayer configuration with a wicking element (see Fig. 2A-2C and paragraph 0054-0056: #210 has multiple layers where wick #228 is sandwiched between longitudinal channels #220, #240 and reinforcing ribs #238.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dulaney with the teachings of Bachtel to have a multilayer configuration because it would have resulted in the predictable result of holding the device with collection pad and wick in a correct assembled position (Bachtel: see [0062]).
With respect to claim 8, all limitations of claim 1 apply in which Dulaney further discloses wherein the wand body defines a line of perforations at which the first body portion and the second body portion can be separated from each other (see Fig. 3 and Fig. 5, line of perforation #20).
With respect to claim 9, Dulaney discloses a bodily fluid sample device (see col 1 lines 6-8, diagnostic device for blood glucose monitoring and Fig. 1-5: #10) comprising:
a wand body having elongate configuration (see Fig. 1-5 and col 4 lines 39-44: structural spine #12 has elongate configuration);
the wand body has a first body portion and a second body portion (see Fig. 1-5 and see col 4 lines 45-56: #12 has a first body portion #18 and a second body portion #22), the wand body being initially unitary (see Fig. 3 and see col 4 lines 45-56, zones #18 and #22 are initially unitary) but configured so that the first body portion and second body portion can be separated from one another (see Fig. 5 and see col 4 lines 45-56, zone #18 can be separated from zone #22) ; and
each of the first body portion and the second body portion having a respective first wicking element and a second wicking element in fluid communication with the respective first collection pad and the second collection pad (see col 1 lines 47-50: the monitoring strip includes a plastic strip with an absorbent paper piece impregnated with an enzyme system as well as a color indicator compound which changes color which oxidized; and see Fig. 3 and see col 4 lines 45-56 paper #28 is interpreted to be the first wicking element and paper #30 is interpreted to be the second wicking element), the wicking elements providing a visual indication that a sample is present at a respective first and second indicator window (see Fig. 3 and Fig. 5, indicator windows seen).
Dulaney does not specifically disclose a first collection pad located on the first body portion and a second collection pad located on the second body portion, the first collection pad and the second collection pad being adjacent to one another near a first end of the wand body.
Bachtel teaches a collection pad located on a body portion (see Fig. 2A and see paragraph 0052-0054: sample collection pad #218 located on handpiece #212) and further teaches that a device may hold multiple pads (see paragraph 0075) wherein the collection pads are adjacent to one another near a first end of the wand body (see Fig. 2A-2C, #218 is located at one end of the handpiece #212).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dulaney with the teachings of Ennis to have added a collection pad because it would have resulted in the predictable result of absorbing fluid (Bachtel: see [0023]) and further because a device can hold multiple pads (Bachtel: see [0075]).
With respect to claim 10, all limitations of claim 9 apply in which Dulaney further discloses wherein the first wicking element and the second wicking element each have an elongate configuration (see Fig. 3 and Fig. 5).
With respect to claim 11, all limitations of claim 10 apply in which Dulaney further discloses wherein the first wicking element and the second wicking element comprises paper treated with dye that changes color when the sample is present (see Fig. 3 and see col 4 lines 45-56: paper #28 is interpreted to be the first wicking element and paper #30 is interpreted to be the second wicking element; and see col 1 lines 47-50: the monitoring strip includes a plastic strip with an absorbent paper piece impregnated with an enzyme system as well as a color indicator compound which changes color which oxidized).
With respect to claim 12, all limitations of claim 9 apply in which Dulaney further discloses wherein each of the first and second wicking elements extends under a respective one of the first and second indicator windows, the indicator windows being located near a second end of the wand body opposite the first end (see Fig. 3 and Fig. 5, indicator windows seen).
With respect to claim 13, all limitations of claim 9 apply in which Dulaney further discloses wherein the wand body has a multilayer configuration with the first and second wicking elements being sandwiched between two layers (see Fig. 3 and see col 4 lines 45-56: papers #28,#30 are sandwiched between layers).
With respect to claim 14, all limitations of claim 9 apply in which Dulaney further discloses wherein the wand body defines a line of perforations at which the first body portion and the second body portion can be separated from each other (see Fig. 3 and Fig. 5, line of perforation #20).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dulaney in view of Slowey (US 20060018800 A1).
With respect to claim 15, Dulaney discloses a method (see col 4 lines 9-10, method), the method comprising steps of:
providing a bodily fluid collection device having an elongate wand body with a first body portion and a second body portion having respective collection pads (see Fig. 1-5 and see col 4 lines 45-56: #12 has a first body portion #18 and a second body portion #22; and see Fig. 3 and see col 4 lines 45-56, #18, #22 includes a central blood sample deposition orifice #24, #26 with a layer of absorbent impregnated paper #28, #30 underneath for collection), the wand body being configured so that the first body portion and second body portion can be separated from one another (see Fig. 5 and see col 4 lines 45-56, zone #18 can be separated from zone #22);
collecting a sample at the collection pads (see Fig. 3 and see col 4 lines 45-56, #18, #22 includes a central blood sample deposition orifice #24, #26 with a layer of absorbent impregnated paper #28, #30 underneath for collection); and
separating the first body portion from the second body portion (see Fig. 5 and see col 4 lines 45-56, zone #18 can be separated from zone #22).
Dulaney does not specifically disclose collecting a saliva sample from a user, determining if the sample is sufficient; and separately storing the first body portion and the second body portion.
Slowey teaches collecting a saliva sample from a user (see paragraph 0002, obtaining saliva), determining if the sample is sufficient (see 0018, a sufficiency indicator informs one whether there is sufficient sample collected) and separately storing portions (see paragraph 0020: multiple chambers of sample is collected and stored separately).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dulaney with the teachings of Slowey to have collected saliva, and determined whether the collected saliva is sufficient and separately store the samples because it would have resulted in the predictable result of allowing a user to know whether enough sample is present for further testing or analysis and having two sample being stored separately allows testing for confirmation and also analysis (Slowey: see [0020]).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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