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 .
Claims Pending
Applicant's arguments, filed 12/10/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicant’s previous cancellation of claims 2 and 4 is acknowledged.
Claims 1, 3, and 5-7 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, and 5-7 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “a linear length from the front end to the rear end of the connection flow path part is longer than a linear length from the front end to the rear end of the collection space”, which is considered to be new matter, as the applicant did not previously make any indication as to any specific relationship between the linear lengths of the connection flow path part and collection space. The specification does state “The connection flow path part 13 may be configured such that an area of a section perpendicular to a direction from the front end to the rear end gradually decreases from the front end to the rear end.” (Page 9, lines 2-5 of applicant’s spec.). However, this does not make any indication as to a difference in the linear lengths. As such, the claim is rejected.
Claims 3 and 5-7 are dependent on claim 1, and as such are also rejected.
Claim Rejections - 35 USC § 101 – Previously Withdrawn
Applicant's amendments to the claims, filed 11/25/2024, have been fully considered, and the previous 101 rejection withdrawn as a result of the applicant’s removal of the claim language directed towards a human organism.
Claim Rejections - 35 USC § 102 – Previously Withdrawn
Applicant's amendments to the claims, filed 1/19/2024, have been fully considered, and the previous 102 rejection withdrawn.
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 claims are generally directed towards a saliva collection device with a collector part having one side that is opened and a saliva movement part connected to a collection space that stores the collected saliva of the user. The front end of the saliva collector part is configured to be fixed to a salivary gland by an attachment part structure.
Claim(s) 1, 3, and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhan (US Pub. No. 20190200966) hereinafter Zhan, and further in view of Richard (US Pat. No. 4834110) hereinafter Richard, Hobbs (US Pat. No. 6341631) hereinafter Hobbs, and Theis (US Pat. No. 7308920) hereinafter Theis.
(Examiner's Note: The examiner previously referred to the “Hobbs” reference under the assignee “Platt” rather than the inventor of “Hobbs”. As such, each instance of “Platt” has been changed to “Hobbs”)
Regarding claim 1, Zhan discloses A saliva collection device (Par. 86) comprising:
a saliva collector part (Fig. 1, collection body - 11) having a container shape having one side that is opened (Par. 91, Fig. 2, funnel – 111), and formed therein with a collection space having one side that is opened (Fig. 2, collection cavity – 1112 (observable that one side is opened));
a saliva movement part (Fig. 2, pre-storage tube – 12a) having a preset length, having one end connected to the saliva collector part (Par. 92, Fig. 2, (observable contact between the collection member and pre-storage tube)), and having a pipe structure (pre-storage tube – 12a (a tube is a pipe structure)) having a saliva movement passage connected to the collection space (Par. 93, Fig. 2 (pre-storage tube 12a connects the collection cavity 1112 to the storage chamber 21)); and
a saliva collection part connected to an opposite end of the saliva movement part (Par. 66, Fig. 2, storage chamber – 21 (observable that the storage chamber is on the opposite end of pre-storage tube 12a), and formed therein with a space in which saliva is stored (Par. 66, 87 (“saliva can enter the storage chamber 21 from the upper opening of the storage chamber 21 for storage”)),
wherein an opening connected to the saliva movement part (Fig. 2, pre-storage tube – 12a) is provided on one side of the saliva collection part (Par. 91, “the collection body 11 of this embodiment comprises a funnel 111. The funnel 111 has a collection cavity 1112 that is open both at the top and the bottom”) (Par. 93, “Since the saliva needs to enter the storage chamber 21 through the collection cavity 1112 in the collection process…” “…such that the outflow port may communicates with the storage chamber 21 and the collection port 1111 (i.e. the upper end of the collection member 1) so that the saliva may flow”, (saliva flows from collection cavity 1112 all the way to storage chamber 21, with an opening at collection port 1111), so that the space of the saliva collection part (Fig. 1, Collection body – 11) communicates with the collection space (Fig. 2, collection cavity – 1112 (observable that one side is opened)),
wherein the space (Fig. 2, collection cavity 1112 comprises collection body 11) in communication with the collection space maintains the same normal pressure as the collection space (Par. 91, “a collection cavity 1112 that is open both at the top and the bottom” (the bottom and top are open))(Examiner’s Note: the applicant does not define normal pressure),
wherein the saliva collected from the saliva collector part (collection body -11) (Par. 90, “The collection body 11 is configured to collect the saliva.”) is coagulated with each other due to surface tension to form droplets (Par. 2 (collection of saliva includes that of droplets)), passes through the saliva movement part (pre-storage tube -12a), and is stored in the space of the saliva collection part (storage chamber – 21) (Par. 91, “The upper end of the collection cavity 1112 is the upper end of the collection member 1, which is open to form a collection port 1111 for receiving the saliva to be detected, so that the collection cavity 1112 can collect the saliva”) (Par. 92-93 (saliva flows from collection body 11, through pre-storage tube – 12a, and then to storage chamber -21)),
wherein the saliva collector part (collection body – 11) includes a connection flow path part (Fig. 2, funnel – 111) formed at a portion of the saliva collector part (collection body - 11) connected to the saliva movement part (Fig. 2, pre-storage tube – 12a (funnel 111 is observably connected to the tube)),
wherein the connection flow path part (Fig. 2, funnel – 111) has a front end connected to the collection space (Fig. 2, collection cavity – 1112) and a rear end connected to the saliva movement passage (Fig. 2, funnel – 111, pre-storage tube – 12a (funnel is observably connected to the tube)),
wherein a cross-sectional area of the collection space perpendicular to a direction from a front end to a rear end of the collection space decreases at a first rate (Fig. 2, collection cavity – 1112, funnel - 111 (the structure is a funnel directed downwards, and as such the cross-sectional area decreases moving downwards)).
Zhan fails to explicitly disclose wherein the saliva collector part includes an attachment part having adhesiveness and provided at inside of a front end of the saliva collector part opened toward an outside.
However, Richard teaches wherein the saliva collector part (Fig. 1, cup -10) includes an attachment part (Fig. 3, soft foam rim - 24) having adhesiveness and provided at inside of a front end of the saliva collector part opened toward an outside (Fig. 3, Col. 4, lines 37 – 42 (suction is the adhesiveness)).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zhan with that of Richard to include the saliva collector part includes an attachment part having adhesiveness and provided at inside of a front end of the saliva collector part opened toward an outside as this combination would have yielded the predictable result of allowing the cup to remain in the desired location through suction (Richard (Col. 4, lines 34 – 42)).
Modified Zhan fails to explicitly disclose wherein the front end of the saliva collector part is configured to be fixed to a circumference of a specific salivary gland by the attachment part, and
wherein the collection space is shielded from the outside so that only saliva secreted from the specific salivary gland is collected.
However, Richard further teaches wherein the front end of the saliva collector part is configured to be fixed to a circumference of a specific salivary gland by the attachment part (Fig. 1-2, (observable that the cup -10 surrounds the outlet 17 of the parotid duct)) (Col. 4 lines 9-18), and
wherein the collection space is shielded from the outside (Fig. 3, Col. 4, lines 37 – 42 (suction is the adhesiveness)) so that only saliva secreted from the specific salivary gland is collected (Col. 4, lines 9-18, Fig. 1-2 (observable that the cup – 10 with interior cavity 12 is covering saliva from the single parotid salivary duct)) .
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zhan and Richard with that of Richard to include wherein the front end of the saliva collector part is configured to be fixed to a circumference of a specific salivary gland by the attachment part, and wherein the collection space is shielded from the outside so that only saliva secreted from the specific salivary gland is collected through the combination of references as it would have yielded the predictable result of isolating saliva from the parotid duct (Richard (Col. 4, lines 9-18)) and allowing the cup to remain in the desired location through suction (Richard (Col. 4, lines 34 – 42)).
Modified Zhan fails to explicitly disclose wherein a cross-sectional area of the connection flow path part perpendicular to the direction from the front end to the rear end of the connection flow path part decreases at a second rate that is less than the first rate.
However, Hobbs teaches wherein a cross-sectional area of the connection flow path part (Fig. 1, spout – 102) perpendicular to the direction from the front end to the rear end of the connection flow path part decreases at a second rate (Fig. 1, (spout 102 is observably decreasing)) (Col. 3-4, lines 64-1) (Col. 2, lines 23-25 (the angle at which the final taper decreases is 10 degrees)) that is less than the first rate (Fig. 1, Col. 2, lines 26-28 (the first rate is the section of the funnel above the spout, which is at 25 degrees)) (Fig. 1, Col. 2, lines 23-28 ( the first cross sectional area is in the funnel section angled at 25 degrees from the centerline, and the second cross-sectional area corresponds to the tapered part of the funnel at an angle of 10 degrees from the centerline (corresponding to the steeper section of the funnel of Fig. 1), the cross sectional area decreases at a higher rate in the section angled at 25 degrees from the centerline, which is the first area)).
Zhan, Richard, and Hobbs are considered to be analogous art to the claimed invention as they are involved with funnel shaped devices.
Therefore, it would have been further obvious to modify the device of Zhan and Richard with that of Hobbs to include wherein a cross-sectional area of the connection flow path part perpendicular to the direction from the front end to the rear end of the connection flow path part decreases at a second rate that is less than the first rate from the front end to the rear end of the connection flow path part through the substitution of the funnel of Zhan for the funnel Hobbs as differing funnel angles are known in the art (Hobbs (Col. 2, lines 23-28)) and it would have yielded the same result as Zhan of allowing for the passage of fluid.
Modified Zhan fails to explicitly disclose a linear length from the front end to the rear end of the connection flow path part is longer than a linear length from the front end to the rear end of the collection space, such that formation of air bubbles inside the saliva is minimized during a process in which the saliva is introduced into the saliva movement passage and agglomerates to a droplet.
However, Theis teaches a linear length from the front end to the rear end of the connection flow path part (Claim 1 (spout)) is longer than a linear length from the front end to the rear end of the collection space (Claim 1 (main body)) (Claim 1, “the length dimension of the spout being greater than the height dimension of the main body”).
Hobbs does teach such that formation of air bubbles inside the saliva is minimized during a process in which the saliva is introduced into the saliva movement passage and agglomerates to a droplet (Fig. 1, (spout 102 is observably decreasing)) (Col. 3-4, lines 64-1) (Col. 2, lines 23-25 (the angle at which the final taper decreases is 10 degrees)) (Examiner's Note: spout 102 of Hobbs is capable of the indicated function).
Zhan, Richard, Hobbs, and Theis are considered to be analogous art to the claimed invention as they are involved with funnel shaped devices
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhan, Richard, and Hobbs with that of Theis and Hobbs to include a linear length from the front end to the rear end of the connection flow path part is longer than a linear length from the front end to the rear end of the collection space, such that formation of air bubbles inside the saliva is minimized during a process in which the saliva is introduced into the saliva movement passage and agglomerates to a droplet through the substitution of heights of the differing sections of the funnel as varying heights of different sections of a funnel are known in the art (Hobbs (Col. 2, (lines 23-31))) and it would have yielded the same or similar results as Zhan of allowing for the passage of fluid.
Regarding claim 3, modified Zhan fails to explicitly disclose the limitations of the claim.
However, Hobbs further teaches wherein an area of a section in the collection space perpendicular to a front-rear direction is smaller at the rear end of the collection space than at the front end of the collection space opened toward an outside (Hobbs (Fig. 1, Col. 2, lines 26-28 (the first rate is the section of the funnel above the spout, which is at 25 degrees)) (Fig. 1 (observable that the cross sectional area of the reservoir portion 101 of funnel 100 decreases going downwards))).
Therefore, it would have been further obvious to modify the device of Zhan, Richard, Hobbs, and Theis with that of Hobbs to include further discloses wherein an area of a section in the collection space perpendicular to a front-rear direction is smaller at the rear end of the collection space connected to the saliva movement part of Zhan than at the front end of the collection space opened toward an outside through the substitution of the funnel of Zhan for the funnel Hobbs as differing funnel angles are known in the art (Hobbs (Col. 2, lines 23-28)) and it would have yielded the same result as Zhan of allowing for the passage of fluid.
Regarding claim 5, modified Zhan fails to explicitly disclose the limitations of the claim.
However, Richard further teaches wherein the attachment part is located at the front end of the saliva collector part in a ring shape (Richard (Fig. 4, soft foam suction rim – 24 (observable that the rim is in a circular shape))(Col. 4, lines 16-17)).
It would have been further obvious to modify the device of Zhan, Richard, Hobbs, and Theis with that of Richard to include the attachment part is located at the front end of the saliva collector part in a ring shape as this is a design choice and would have yielded the predictable result of allowing the cup to remain in the desired location through suction (Richard (Col. 4, lines 34 – 42)).
Regarding claim 6, modified Zhan fails to explicitly disclose the limitations of the claim.
However, Richard further teaches further comprising an attachment part (Richard (Fig. 3, soft foam rim - 24)) located on an outer surface of the front end of the saliva collector part that is opened toward an outside (Richard (Fig. 3, Col. 4, lines 37 – 42 (suction is the adhesiveness))), having a ring shape (Richard (Fig. 4, soft foam suction rim – 24 (observable that the rim is in a circular shape))(Col. 4, lines 16-17)), and having a structure for covering the front end of the saliva collector part (Richard (Fig. 4, cup – 10)) shape (Richard (Fig. 4, soft foam suction rim – 24 (observable that the rim is on the front end of the cup))).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zhan, Richard, Hobbs, and Theis with that of Richard to include further comprising an attachment part located on an outer surface of the front end of the saliva collector part that is opened toward an outside, having a ring shape, and having a structure for covering the front end of the saliva collector part as this combination would have yielded the predictable result of allowing the cup to remain in the desired location through suction (Richard (Col. 4, lines 34 – 42)).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhan in view of Richard, Hobbs, and Theis as applied to claim 1 above, and further in view of Schlesinger (US Pat. No. 4283498) hereinafter Schlesinger.
Zhan, Richard, Hobbs, and Theis teach the device of claim 1 above.
Regarding claim 7, modified Zhan fails to explicitly disclose the limitations of the claim.
However, Schlesinger teaches wherein the saliva movement part includes a plurality of flow amount measurement markings formed in a length direction thereof (Fig. 1, graduated scale – 18, Col. 3, lines 33-40).
Zhan, Richard, Hobbs, Theis, and Schlesinger are considered to be analogous art to the claimed invention as they are involved with funnel shaped devices.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Zhan, Richard, Hobbs, and Theis with that of Schlesinger to include wherein the saliva movement part includes a plurality of flow amount measurement markings formed in a length direction through combination as it would have yielded the predictable result of enabling the determination of the amount of the specimen in the tube at a given time and aid in the analysis (Schlesinger (Col. 3, lines 33-40)).
Response to Arguments
Applicant's arguments filed 12/10/2025, regarding the 112(a) rejection have been fully considered and deemed as not persuasive.
The applicant’s argument, that the claim 1 limitation “a linear length from the front end to the rear end of the connection flow path part is longer than a linear length from the front end to the rear end of the collection space” is not new matter, has been fully considered and deemed as not persuasive.
The applicant specifically states “FIG. 2 of the present application clearly illustrates that a linear length (d2) from the front end to the rear end of the connection flow path part (13) is longer than a linear length (dl) from the front end to the rear end of the collection space (11).”, and further emphasizes that support was provided within the drawings. Firstly, “When the reference does not disclose that the drawings are to scale and is silent as to dimensions, arguments based on measurement of the drawing features are of little value. See Hockerson-Halberstadt, Inc. v. Avia Group Int’l, 222 F.3d 951, 956, 55 USPQ2d 1487, 1491 (Fed. Cir. 2000) (The disclosure gave no indication that the drawings were drawn to scale. "[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.")” (see MPEP 2125.II).
The annotated figure provided by the applicant within page 3 of the applicant’s arguments, is NOT the figure provided within the applicant’s original disclosure, both of which have been attached and labeled below. As seen below, “d1 < d2” was not present within the applicant’s original drawing filed 02/03/2021, there was no indication of “d1” or “d2” provided in the drawings, there was no statement regarding the length provided as part of the drawings, no indication regarding scale, and no corresponding statement of scale provided within the applicant’s specification. As indicated in the 112(a) rejection above, the applicant’s specification does not make any indication as to a difference in the linear lengths. Additionally, there was no previous indication within the applicant’s drawings or specification regarding the claim limitation “a linear length from the front end to the rear end of the connection flow path part is longer than a linear length from the front end to the rear end of the collection space”. As such, the limitation is considered to be new matter and the rejection is maintained.
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Applicant's original Fig. 2 (in drawings filed 02/03/2021)
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Applicant's annotated version of Fig. 2, (provided in applicant’s arguments, filed 12/10/2025)
Applicant's arguments filed 12/10/2025, regarding the 103 rejection have been fully considered, but are deemed as not persuasive.
The applicant's argument, on Pages 4-6, that Theis and Hobbs do not teach the limitation “a linear length from the front end to the rear end of the connection flow path part is longer than a linear length from the front end to the rear end of the collection space, such that formation of air bubbles inside the saliva is minimized during a process in which the saliva is introduced into the saliva movement passage and agglomerates to a droplet”, has been fully considered and deemed as not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The applicant applicant’s argument, “Theis is directed to a tree watering funnel and one end of the spout 14 is a watering end 30” (Page 5 of applicant’s arguments), has been fully considered and deemed as not persuasive. As indicated in the 103 rejection above, Theis teaches a linear length from the front end to the rear end of the connection flow path part (Claim 1 (spout)) is longer than a linear length from the front end to the rear end of the collection space (Claim 1 (main body)) (Claim 1, “the length dimension of the spout being greater than the height dimension of the main body”). As such, Theis reads on the indicated limitation of the claim.
In response to applicant's argument that Hobbs is silent to minimizing air bubbles inside the saliva based on a difference in lengths of the collection space and a connection flow path part, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As indicated in the 103 rejection above, Hobbs does teach such that formation of air bubbles inside the saliva is minimized during a process in which the saliva is introduced into the saliva movement passage and agglomerates to a droplet (Fig. 1, (spout 102 is observably decreasing)) (Col. 3-4, lines 64-1) (Col. 2, lines 23-25 (the angle at which the final taper decreases is 10 degrees)) (Examiner's Note: spout 102 of Hobbs is capable of the indicated function). As such, the applicant’s arguments are deemed as not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to a person of ordinary skill in the art to modify the device of Zhan, Richard, and Hobbs with that of Theis and Hobbs to include a linear length from the front end to the rear end of the connection flow path part is longer than a linear length from the front end to the rear end of the collection space, such that formation of air bubbles inside the saliva is minimized during a process in which the saliva is introduced into the saliva movement passage and agglomerates to a droplet through the substitution of heights of the differing sections of the funnel as varying heights of different sections of a funnel are known in the art (Hobbs (Col. 2, (lines 23-31))) and it would have yielded the same or similar results as Zhan of allowing for the passage of fluid.
The applicant’s arguments regarding the dependent claims, rely on the arguments related to the independent claim, and as such are also deemed as not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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, Jason Sims can be reached at (571) 272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARI S PADDA/ Examiner, Art Unit 3791
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791
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