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 .
Response to Amendment
The response filed on 10/10/2015 is not in conformance with the Office's rules and regulations regarding claim amendments. In particular, claim list did not include claim 48 that was added by the amendment filed on 10/10/2025. Claim 48 is still considered to be pending. In an effort to continue prosecution, the amendments have been entered, but the Applicant should be mindful of the proper format for making amendments.
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 limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 9-11, 13-16, 18-22, 27, 30, 32-33, 36, and 47-48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “saliva” in line 20, but it is not clear if this recitation is the same as, related to, or different from “saliva” in claim 1, line 3. If they are the same, “saliva” in line 20 should be “the saliva”. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements), and any subsequent mention of “the saliva” should make it clear which recitation is being referred to.
Claims 2-7, 9-11, 13-16, 18-22, 27, 36, and 47-48 are rejected by virtue of their dependence from claim 1.
Claim 22 recites “a mating element of the device comprises a breakable seal which, when broken, allows collection of the saliva from the collection portion” in lines 1-3 but it is not clear what relation, if any, this recitation has with any of the recitations that have come before it.
Claim 27 recites “a pump configured to promote air flow from the vent” in lines 1-2, but this recitation seems to be contradictory to the recitation “wherein, during collection, the device is configured so that saliva can flow from the mouthpiece to the collection portion without application of vacuum or suction to the saliva” of claim 1, lines 20-21. It appears that the pump creates an application of vacuum or suction to the saliva during operation. If this is so, saliva is flowing from the mouthpiece to the collection portion during application of vacuum or suction. This contradiction renders claim 27 indefinite.
Claim 30 recites “saliva” in line 23, but it is not clear if this recitation is the same as, related to, or different from “saliva” in claim 30, line 5. If they are the same, “saliva” in line 23 should be “the saliva”. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements), and any subsequent mention of “the saliva” should make it clear which recitation is being referred to.
Claims 32-33 are rejected by virtue of their dependence from claim 30.
Claim 36 recites “the processor” in line 3 in which there is insufficient antecedent basis for this recitation in the claim.
Claim 36 recites “a processor” in line 4, but it is not clear if this recitation is the same as, related to, or different from “the processor” in claim 36, line 3. If they are the same, “a processor” in line 4 should be “the processor”. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements), and any subsequent mention of “the processor” should make it clear which recitation is being referred to.
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 1-6, 10-11, 13, 16, 18, 20-22, and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0196542 (Spiteri)(previously cited), in view of U.S. Patent Application Publication No. 2019/0076131 (Karlsson).
Spiteri teaches a device for collecting a saliva sample, comprising: (a) a hollow mouthpiece (the element A in the below annotated FIG. 2 of Spiteri) comprising an opening (the opening formed by the outer edge 16 in FIG. 2 of Spiteri) communicating with an internal space (the element B in the below annotated FIG. 2 of Spiteri), the mouthpiece comprising a pliable material (the plastics material; paragraph 0027 of Spiteri), and configured to receive the saliva through the opening such that the saliva can drop downwards through the opening and into the internal space; and (b) an elongate member positioned below and axially aligned with the mouthpiece comprising a proximal portion (the elements C and D in the below annotated FIG. 2 of Spiteri). Karlsson teaches a device for collecting an oral sample, comprising: a mouthpiece (the rubber intra oral member 11 of Karlsson) comprising an opening (the opening 13 of Karlsson) communicating with an internal space (the internal space inside the member 11 or the internal volume 21 of Karlsson), the mouthpiece is configured to receive saliva through the opening and into the space (paragraphs 0021-0023, 0025, 0031-0032, 0034-0038, 0048, and 0050-0055 of Karlsson). Karlsson also teaches a rigid member 12 that holds the member 11 steady in the person’s mouth. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the elements A and B in the below annotated FIG. 2 of Spiteri with the rubber intra oral member 11 and the rigid member 12 of Karlsson since it is simple substitution of one known element for another to obtain predictable results and/or to provide more comfort to the user.
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Annotated FIG. 2 of Spiteri
With respect to claim 1, the combination teaches or suggests a device for collecting a saliva sample, comprising:
(a) a hollow mouthpiece (the rubber intra oral member 11 of Karlsson) comprising an opening (the opening 13 of Karlsson) communicating with an internal space (the internal space inside the member 11of Karlsson), the mouthpiece comprising a pliable material (the rubber intra oral member 11 of Karlsson), and configured to receive saliva through the opening such that the saliva can drop downwards through the opening and into the internal space; and
(b) an elongate member positioned below and axially aligned with the mouthpiece comprising a proximal portion (the element D in the above annotated FIG. 2 of Spiteri; the element D is aligned with the rubber intra oral member 11 of Karlsson) positioned proximal to the mouthpiece and radially within a larger diameter distal portion (the element E in the above annotated FIG. 2 of Spiteri) such that a space (the element F in the above annotated FIG. 2 of Spiteri) exists between an outer wall of the proximal portion and an inner wall of the distal portion, further comprising one or more vents (the ventilation openings 32 of Spiteri), wherein:
(i) the proximal portion of the elongate member comprises a lumen (the element G in the above annotated FIG. 2 of Spiteri) communicating with the internal space and configured to receive the saliva from the internal space such that salivary bubbles burst as the saliva flows down through the lumen (the filter element 21 is capable of bursting salivary bubbles);
(ii) the distal portion of the elongate member comprises a collection portion comprising a collection space (the collection space 40 of Spiteri) configured to collect the saliva received into the lumen; and
(iii) the one or more vents comprise one or more apertures (the ventilation openings 32 of Spiteri) in fluid communication with the lumen (the element G in the above annotated FIG. 2 of Spiteri) and configured to allow air to pass therethrough and out of the device;
wherein, during collection, the device is configured so that saliva can flow from the mouthpiece to the collection portion without application of vacuum or suction to the saliva (no application of vacuum or suction is used);
wherein the entire opening of the mouthpiece can be inserted into a user's mouth, and the device has dimensions configured to allow the user to chew the mouthpiece when the mouthpiece is inserted into the user's mouth (the rubber intra oral member 11 of Karlsson has such dimensions).
With respect to claims 2-3 and 5-6, Spiteri does not provide particulars of the dimensions of device, except to provide ranges for the holes in the filter element (paragraph 0042 of Spiteri). Karlsson teaches that the rubber intra oral member can have different shapes and sizes (paragraph 0051 of Karlsson). This suggests that the dimensions of the device and its components are subject to change based on materials, cost, desired handling or bulkiness, and desired performance. As such, the dimensions of the device and its components are results-effective variables that would have been optimized through routine experimentation based on the materials, cost, desired handling or bulkiness, and desired performance. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the dimensions of the device and its components so as to obtain the desired handling or bulkiness and desired performance based on materials and cost.
Alternatively or additionally, the only difference between the structure of claimed device and the combination is the recitation of relative dimensions of the claimed device. However, it has been held that relative dimensions do not make a claimed device patentably distinct from a prior art device if there is no difference in performance (MPEP 2144.04(IV)(A) quoting In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.).
In view of the above, the features of “[t]he device of claim 1, having a length between about 5 cm and about 20 cm” of claim 2; “wherein the mouthpiece has a bulb shape that is wider than the elongate member at a point of communication” of claim 3 (in which the rubber intra oral member 11 of Karlsson has a bulb shape), “wherein the opening of the mouthpiece that communicates with the internal space has a volume of about 0.5 ml to about 5 ml” of claim 5; and “wherein the opening in the mouthpiece has a widest diameter of about 2 mm to about 10 mm” of claim 6 would have been obvious.
With respect to claim 4, the combination teaches or suggests that the mouthpiece comprises a material selected from rubber and a plastic (the rubber intra oral member 11 of Karlsson).
With respect to claim 10, the combination teaches or suggests that the lumen comprises surface features that promote bursting of the salivary bubbles (the filter element 21 is a surface feature of the element G in the above annotated FIG. 2 of Spiteri that is capable of promoting the breaking of bubbles in saliva).
With respect to claim 11, the combination teaches or suggests that the one or more apertures of the one or more vents (the ventilation openings 32 of Spiteri) are radially positioned with respect to a longitudinal axis of the lumen (the element G in the above annotated FIG. 2 of Spiteri).
With respect to claim 13, the combination teaches or suggests that the proximal portion (the element D in the above annotated FIG. 2 of Spiteri) and the distal portion (the element E in the above annotated FIG. 2 of Spiteri) are configured as barrels wherein the proximal barrel is fitted radially into the distal barrel (see FIG. 2 of Spiteri) and defines the space (the element F in the above annotated FIG. 2 of Spiteri) between the outer wall of the proximal portion and the inner wall of the distal portion, through which the air can vent from the device.
With respect to claim 16, the combination teaches or suggests that the one or more apertures (the ventilation openings 32 of Spiteri) are positioned between the mouthpiece (the rubber intra oral member 11 of Karlsson) and the collection space (the collection space 40 of Spiteri).
With respect to claim 18, the combination teaches or suggests that the elongate member and the mouthpiece are comprised in separate pieces, fitted together (the element D in the above annotated FIG. 2 of Spiteri and the rubber intra oral member 11 of Karlsson are separate pieces).
With respect to claim 20, the combination teaches or suggests that the proximal portion and the distal portion of the elongate member are comprised in separate pieces, fitted together (the element D in the above annotated FIG. 2 of Spiteri and the element E in the above annotated FIG. 2 of Spiteri are separate pieces, fitted together).
With respect to claim 21, although the combination teaches or suggests that the proximal portion and the distal portion of the elongate member are comprised in separate pieces, fitted together (the element D in the above annotated FIG. 2 of Spiteri and the element E in the above annotated FIG. 2 of Spiteri are separate pieces, fitted together), it has been found that making integral what was separate pieces is an obvious design choice (see MPEP 2144.04 citing to In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965): “The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the elongate member and the mouthpiece into a single piece since it creates a more robust structure. Thus, the feature of “wherein the proximal portion and the distal portion of the elongate member are comprised in a single piece” of claim 21 would have been obvious.
With respect to claim 22, the combination teaches or suggests that a mating element of the device comprises a breakable seal (the sealing element or member; paragraphs 0063, 0069, 0091, 0136-0137 of Spiteri) which, when broken, allows collection of the saliva from the collection portion (the collection space 40 of Spiteri).
With respect to claim 47, the combination teaches or suggests that the collection portion is split into two collectors (the collection space 40 of Spiteri splits into metered volumes 42 of Spiteri).
With respect to claim 48, the combination teaches or suggests that the device comprises a mating element distal to the mouthpiece comprising a sealed opening (the opening having the sealing element or member; paragraphs 0063, 0069, 0091, 0136-0137 of Spiteri) that can retain the saliva in the collection space until the device is mated with a processor (the assay unit 60 of Spiteri).
Claims 19 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view of U.S. Patent Application Publication No. 2012/0046574 (Skakoon)(previously cited).
With respect to claim 19, the combination teaches or suggests that the elongate member and the mouthpiece are comprised in separate pieces, fitted together (the element D in the above annotated FIG. 2 of Spiteri and the rubber intra oral member 11 of Karlsson are separate pieces). Skakoon teaches that a mouthpiece can be integrally attached to its connecting component (paragraph 0088 of Skakoon). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the elongate member and the mouthpiece into a single piece, as suggested by Skakoon, since it creates a more robust structure.
With respect to claim 36, Spiteri teaches that the samples are analyzed (paragraphs 0115 and 0147 of Spiteri). Skakoon teaches that saliva samples are analyzed for drugs of abuse (paragraphs 0003-0006 and 0082-0083 of Skakoon). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the collected saliva of the combination to detect for drugs of abuse, as suggested by Skakoon, since it provide useful information of a person’s condition to health professionals, law enforcement personnel, and government or private employers, among others (paragraph 0005 of Skakoon). Thus, the combination teaches or suggests a system for drug testing, comprising:
a device of claim 1 (see the above rejection of claim 1) comprising the saliva sample in the collection portion mated to the processor (the assay unit 60 of Spiteri);
a processor configured to mate with the device (see FIG. 2 of Spiteri), the processor configured to automatically extract a first portion of the saliva sample and a second portion of the saliva sample from the device (the metered volumes 42 enter the analysis unit 60 of Spiteri; paragraph 0133-0135 of Spiteri); and
a detector (the assay solutions or reagents of Spiteri; paragraphs 0130-0135 of Spiteri) configured to mate with the processor, the detector configured to analyze the first portion of the saliva sample to detect an amount of drug in the saliva sample (the drug detection of Skakoon).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view of U.S. Patent Application Publication No. 2012/0325721 (Plante)(previously cited).
The combination teaches or suggests that the proximal portion and the distal portion of the elongate member are comprised in separate pieces, fitted together (the element D in the above annotated FIG. 2 of Spiteri and the element E in the above annotated FIG. 2 of Spiteri are separate pieces, fitted together). Plante teaches that cylindrical, coaxial structures can be an integral piece (FIG. 1 and paragraph 0035 of Plante). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the proximal portion and the distal portion of the elongate member comprised in a single piece, as suggested by Plante, since it creates a more robust structure.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view of U.S. Patent Application Publication No. 2013/0118504 (Hermanson)(previously cited).
The combination teaches or suggests that there must be sufficient material in the sample to enable the analysis of saliva (paragraph 0008 of Spiteri). Hermanson teaches a mouthpiece comprising a composition including solutions of Xylitol (an artificial sweetener), saline, and citrus (paragraphs 0077-0078 and 0095 of Hermanson). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination so as to provide solutions of Xylitol (an artificial sweetener), saline, and citrus to the mouthpiece in order to ensure sufficient salivation for analysis.
With respect to claim 7, the combination teaches or suggests that the mouthpiece comprises a composition that promotes salivation (the solutions of Xylitol (an artificial sweetener), saline, and citrus of Hermanson).
With respect to claim 9, the combination teaches or suggests that the composition comprises citric acid, acetic acid, malic acid, fumaric acid, tartaric acid, sucrose, sodium chloride, or an artificial sweetener (the solutions of Xylitol (an artificial sweetener) and citrus of Hermanson).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view of U.S. Patent Application Publication No. 2018/0049724 (Cai)(previously cited).
Spiteri teaches a device for collecting a saliva sample, comprising the one or more vents comprise one or more apertures (the ventilation openings 32 of Spiteri) in fluid communication with a lumen (the ventilation openings 32 of Spiteri) and configured to allow air to pass therethrough and out of the device. Cai teaches that a ventilation tube 32 is attached to a vent 31 (paragraph 0075 of Cai). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the ventilation tube of Cai at the vent of Spiteri since it avoids the risk of contamination of healthcare (paragraph 0075 of Cai) and/or prevents inadvertent blocking of the vent.
With respect to claim 14, the combination teaches or suggests that the elongate member comprises an elongate portion communicating through the one or more apertures with a vent tube (the ventilation tube of Cai) oriented off-axis to the elongate member, wherein the vent tube comprises an aperture venting to the air (the exit port of the ventilation tube of Cai).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view of Cai, and further in view of WO 2011/033000 (Egger)(previously cited). Citations to Egger will refer to the machine English translation that accompanied the Office Action mailed on 8/6/2024.
The combination teaches or suggests that the elongate member comprises an elongate portion communicating through the one or more apertures with a vent tube (the ventilation tube of Cai) oriented off-axis to the elongate member, wherein the vent tube comprises an aperture venting to the air (the exit port of the ventilation tube of Cai). Egger teaches that gas-permeable, but liquid-impermeable membranes or filters or corresponding vent valves allow for the passage of air through vents (page 4 of Egger). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the gas-permeable, but liquid-impermeable membrane or filter or the vent valves of Egger in the ventilation tube of Cai since it will prevent spillage of the fluid through the ventilation tube.
With respect to claim 15, the combination teaches or suggests that the vent tube comprises a valve (the gas-permeable, but liquid-impermeable membrane or filter or the vent valves of Egger) to inhibit escape of the saliva from the vent tube (the ventilation tube of Cai).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view of Cai, and further in view of Skakoon.
The combination teaches or suggests that the elongate member comprises an elongate portion communicating through the one or more apertures with a vent tube (the ventilation tube of Cai) oriented off-axis to the elongate member, wherein the vent tube comprises an aperture venting to the air (the exit port of the ventilation tube of Cai). Skakoon teaches that a hydrophobic filter membrane, which will readily allow air to pass with little impediment, yet block liquids from passing under pressures encountered in normal use (paragraph 0076 of Skakoon). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the hydrophobic filter membrane of Skakoon in the ventilation tube of Cai since it will prevent spillage of the fluid through the ventilation tube.
With respect to claim 15, the combination teaches or suggests that the vent tube comprises a valve (the hydrophobic filter membrane of Skakoon) to inhibit escape of the saliva from the vent tube (the ventilation tube of Cai).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view of U.S. Patent Application Publication No. 2017/0080422 (Maaskant)(previously cited).
The combination teaches or suggests a device for collecting a saliva sample, comprising the one or more vents comprise one or more apertures (the ventilation openings 32 of Spiteri) in fluid communication with a lumen (the ventilation openings 32 of Spiteri) and configured to allow air to pass therethrough and out of the device. Maaskant teaches that a pump can be connected to a pump so as to control the removal of air (paragraph 0216 of Maaskant).1 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the pump of Maaskant at the vent of Spiteri since it provides control for air removal. Thus, the combination teaches or suggests a pump configured to promote air flow from the vent (the pump of Maaskant).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view of U.S. Patent Application Publication No. 2004/0082878 (Baldwin)(previously cited).
Spiteri teaches a device for collecting a saliva sample, comprising: (a) a hollow mouthpiece (the element A in the above annotated FIG. 2 of Spiteri) comprising an opening (the opening formed by the outer edge 16 in FIG. 2 of Spiteri) communicating with an internal space (the element B in the above annotated FIG. 2 of Spiteri), the mouthpiece comprising a pliable material (the plastics material; paragraph 0027 of Spiteri), and configured to receive the saliva through the opening such that the saliva can drop downwards through the opening and into the internal space; and (b) an elongate member positioned below and axially aligned with the mouthpiece comprising a proximal portion (the elements C and D in the above annotated FIG. 2 of Spiteri). Karlsson teaches a device for collecting an oral sample, comprising: a mouthpiece (the rubber intra oral member 11 of Karlsson) comprising an opening (the opening 13 of Karlsson) communicating with an internal space (the internal space inside the member 11 or the internal volume 21 of Karlsson), the mouthpiece is configured to receive saliva through the opening and into the space (paragraphs 0021-0023, 0025, 0031-0032, 0034-0038, 0048, and 0050-0055 of Karlsson). Karlsson also teaches a rigid member 12 that holds the member 11 steady in the person’s mouth. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the elements A and B in the above annotated FIG. 2 of Spiteri with the rubber intra oral member 11 and the rigid member 12 of Karlsson since it is simple substitution of one known element for another to obtain predictable results and/or to provide more comfort to the user.
The combination teaches or suggests that there must be sufficient material in the sample to enable the analysis of saliva (paragraph 0008 of Spiteri). Baldwin teaches chewing on the mouthpiece of a device stimulate saliva production (paragraph 0015 of Baldwin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination so as to include the chewing of the mouthpiece of the combination in order to provide the strong physiological response of saliva gland stimulation.
With respect to claim 30, the combination teaches or suggests a method comprising:
(A) providing a device comprising:
(i) a hollow mouthpiece (the rubber intra oral member 11 of Karlsson) comprising an opening (the opening 13 of Karlsson) communicating with an internal space (the internal space inside the member 11of Karlsson), the mouthpiece comprising a pliable material (the rubber intra oral member 11 of Karlsson), and configured to receive saliva through the opening such that the saliva can drop downwards through the opening and into the internal space; and
(ii) an elongate member positioned below and axially aligned with the mouthpiece comprising a proximal portion (the element D in the above annotated FIG. 2 of Spiteri; the element D is aligned with (the rubber intra oral member 11 of Karlsson) positioned proximal to the mouthpiece and radially within a larger diameter distal portion (the element E in the above annotated FIG. 2 of Spiteri) such that a space (the element F in the above annotated FIG. 2 of Spiteri) exists between an outer wall of the proximal portion and an inner wall of the distal portion, and further comprising one or more vents (the ventilation openings 32 of Spiteri), wherein:
(a) the proximal portion of the elongate member comprises a lumen (the element G in the above annotated FIG. 2 of Spiteri) communicating with the internal space and configured to receive the saliva from the internal space such that salivary bubbles burst as the saliva flows down through the lumen (the filter element 21 is capable of bursting salivary bubbles);
(b) the distal portion of the elongate member comprises a collection portion comprising a collection space (the collection space 40 of Spiteri) configured to collect the saliva received into the lumen and a mating element distal to the mouthpiece comprising a sealed opening (the opening having the sealing element 52; paragraphs 0063, 0069, 0091, 0136-0137 of Spiteri) that can retain the saliva in the collection space until the device is mated with a processor (the assay unit 60 of Spiteri); and
(c) the one or more vents comprise one or more apertures (the ventilation openings 32 of Spiteri) in fluid communication with the lumen (the element G in the above annotated FIG. 2 of Spiteri) and configured to allow air to pass therethrough and out of the device, wherein, during collection, the device is configured so that saliva can flow from the mouthpiece to the collection portion without application of vacuum or suction to the saliva (no application of vacuum or suction is used); wherein the opening on the mouthpiece can be inserted into a user's mouth, and the device has dimensions configured to allow the user to chew the mouthpiece when the mouthpiece inserted into the user's mouth (the rubber intra oral member 11 of Karlsson has such dimensions);
(B) chewing on the mouthpiece of the device to stimulate saliva production (the chewing suggested by Baldwin); and
(C) collecting the saliva in the collection space of the collection portion (the collecting of Spiteri).
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Spiteri, in view of Karlsson, and further in view Baldwin, and further in view of Skakoon.
With respect to claim 32, Spiteri teaches that the samples are analyzed (paragraphs 0115 and 0147 of Spiteri). Skakoon teaches that saliva samples are analyzed for drugs of abuse (paragraphs 0003-0006 and 0082-0083 of Skakoon). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the collected saliva of the combination to detect for drugs of abuse, as suggested by Skakoon, since it provide useful information of a person’s condition to health professionals, law enforcement personnel, and government or private employers, among others (paragraph 0005 of Skakoon). Thus, the combination teaches or suggests (D) mating the device with the processor (see FIG. 2 of Spiteri); and (E) detecting a presence of a drug in the collected saliva (the drug analysis suggested by Skakoon).
With respect to claim 33, the combination teaches the step of detecting the presence of a drug in the collected saliva (the drug analysis suggested by Skakoon). Baldwin teaches that cannabinoids is one such drug (paragraph 0003 of Baldwin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the collected saliva of the combination to detect for cannabinoids, as suggested by Baldwin, since drugs are analyzed and Baldwin teaches one such drug and/or it provide useful information to police officers which may wish to conduct roadside tests to determine whether a motorist has taken an illegal substance that will affect his driving capabilities or to the criminal justice system who conducts random drug tests on prison inmates, detainees or individuals on probation in order to monitor the presence of illegal drugs (paragraph 0003 of Baldwin). Thus, the combination teaches or suggest that the drug comprises a cannabinoid (the cannabinoid drug testing of Baldwin).
Response to Arguments
The Applicant’s arguments filed 10/10/2025 have been fully considered.
Claim objections
In view of the claim amendments filed on 10/10/2025, the previous claim objections have been withdrawn.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 10/10/2025.
Also, the Applicant’s amendments and arguments did not address the indefiniteness issue with respect to “a mating element of the device comprises a breakable seal which, when broken, allows collection of the saliva from the collection portion” in claim 22, lines 1-3. It is not clear what relation, if any, this recitation has with any of the recitations that have come before it. How is the mating element and breakable seal physically incorporated into the claimed device?
Further, the Applicant’s amendments and arguments did not address the indefiniteness issue with respect to “the processor” in claim 36, line 3 lacking sufficient antecedent basis.
Prior art rejections
The Applicant’s arguments with respect to claims 1-7, 9-11, 13-16, 18-22, 27, 30, 32-33, 36, and 47-48 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 prior art rejections.
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.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 U.S. Patent No. 8,329,437 (Ayliffe)(previously cited) teaches this as well (col. 8, lines 20-36 of Ayliffe).