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 Objections
Claims 15 and 24 are objected to because of the following informalities:
in claim 15, lines 1-2: “a use indication region” should be “the use indication region”;
in claim 15, line 2: “a distal end” should be “the distal end”;
in claim 15, line 2: “a reaction” should be “the reaction”; and
in claim 24, line 2: “a” should be inserted before “Yankauer”.
Appropriate correction is required.
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.
Claim 27 is 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 27 recites “the Yankauer suction tip” in line 2 in which there is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 only recites “wherein the distal end is configured to interact with the human or animal subject” in lines 1-2. This recitation is already present in the claim. In particular, claim 1 from which claim 13 depends recites “a distal end configured to interact with a human or animal subject” in line 3. Since claim 13 has no other recitation, it does not further limit the scope of claim 1. Such a claim is improper.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6-7, and 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2004/0022687 (Wuske)(previously cited).
First Interpretation
With respect to claim 1, Wuske teaches a device, comprising:
a proximal end (the puncturing cylinder 9 of Wuske); and
a distal end (the window 6 of Wuske) configured to interact with a human or animal subject, the distal end comprising a use indication portion (the indicator zone 5 of Wuske);
wherein the use indication portion comprises a reactive agent to react with a foreign substance (the saliva of a patient; paragraph 0024 of Wuske) to exhibit a visible change in appearance of the reactive agent (a color change; paragraph 0024 of Wuske).
With respect to claim 6, Wuske teaches that the reactive agent comprises a pH indicator (the pH indicator of Wuske; paragraph 0024 of Wuske).
With respect to claim 7, Wuske teaches that the reactive agent is configured to react with a range of pH representative of saliva (the pH indicator of Wuske; paragraph 0024 of Wuske).
With respect to claim 11, Wuske teaches that the device is a medical device (the device is for collecting saliva for medical analysis and evaluation; paragraphs 0012 and 0024 of Wuske).
With respect to claim 12, Wuske teaches a selectively detachable use indication region (the hemispherical mouthpiece 4 of Wuske) on the distal end (the window 6 of Wuske).
With respect to claim 13, Wuske teaches that the distal end (the window 6 of Wuske) is configured to interact with the human or animal subject (the human use is disclosed in paragraph 0007 of Wuske).
With respect to claim 14, Wuske teaches a method for identifying whether a medical device has been used on a patient, the method comprising:
identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change an appearance of the use indication region (identifying a color change of the indicator zone 5; paragraph 0024 of Wuske);
wherein the reaction comprises exposing a reagent from the use indication region to body fluid (exposing the pH indicator to saliva; paragraph 0024 of Wuske).
With respect to claim 15, Wuske teaches that identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change the appearance of the use indication region further comprises determining that the use indication region has changed color from the reaction (identifying a color change of the indicator zone 5; paragraph 0024 of Wuske).
With respect to claim 16, Wuske teaches that the reagent comprises a pH indicator (the pH indicator of Wuske; paragraph 0024 of Wuske).
Second Interpretation
With respect to claim 1, Wuske teaches a device, comprising:
a proximal end (the puncturing cylinder 9 of Wuske); and
a distal end (the hemispherical mouthpiece 4 of Wuske) configured to interact with a human or animal subject, the distal end comprising a use indication portion (the indicator zone 5 of Wuske);
wherein the use indication portion comprises a reactive agent to react with a foreign substance (the saliva of a patient; paragraph 0024 of Wuske) to exhibit a visible change in appearance of the reactive agent (a color change; paragraph 0024 of Wuske).
With respect to claim 6, Wuske teaches that the reactive agent comprises a pH indicator (the pH indicator of Wuske; paragraph 0024 of Wuske).
With respect to claim 7, Wuske teaches that the reactive agent is configured to react with a range of pH representative of saliva (the pH indicator of Wuske; paragraph 0024 of Wuske).
With respect to claim 11, Wuske teaches that the device is a medical device (the device is for collecting saliva for medical analysis and evaluation; paragraphs 0012 and 0024 of Wuske).
With respect to claim 13, Wuske teaches that the distal end (the hemispherical mouthpiece 4 of Wuske) is configured to interact with the human or animal subject (human use is disclosed in paragraph 0007 of Wuske).
With respect to claim 14, Wuske teaches a method for identifying whether a medical device has been used on a patient, the method comprising:
identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change an appearance of the use indication region (identifying a color change of the indicator zone 5; paragraph 0024 of Wuske);
wherein the reaction comprises exposing a reagent from the use indication region to body fluid (exposing the pH indicator to saliva; paragraph 0024 of Wuske).
With respect to claim 15, Wuske teaches that identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change the appearance of the use indication region further comprises the use indication region has changed color from the reaction (identifying a color change of the indicator zone 5; paragraph 0024 of Wuske).
With respect to claim 16, Wuske teaches that the reagent comprises a pH indicator (the pH indicator of Wuske; paragraph 0024 of Wuske).
Claims 1, 6-7, and 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2009/068864 (Campbell)(previously cited).
With respect to claim 1, Campbell teaches a device, comprising:
a proximal end (the observational surface 6 of Campbell); and
a distal end (the wider stem 16 of Campbell) configured to interact with a human or animal subject, the distal end comprising a use indication portion (the reaction pad 36 of Campbell);
wherein the use indication portion comprises a reactive agent (the oral fluid indicator; page 8 of Campbell) to react with a foreign substance (the saliva of a patient; page 1 of Campbell) to exhibit a visible change in appearance of the reactive agent (a color change; page 8 of Campbell).
With respect to claim 6, Campbell teaches that the reactive agent comprises a pH indicator (the pH indicator of Campbell; pages 6 and 11 of Campbell).
With respect to claim 7, Campbell teaches that the reactive agent is configured to react with a range of pH representative of saliva (the pH indicator of Campbell; pages 6 and 11 of Campbell).
With respect to claim 11, Campbell teaches that the device is a medical device (the device is for collecting saliva for medical testing; page 1 of Campbell).
With respect to claim 12, Campbell teaches a selectively detachable use indication region (the sponge 12 of Campbell) on the distal end (the wider stem 16 of Campbell).
With respect to claim 13, Campbell teaches that the distal end (the wider stem 16 of Campbell) is configured to interact with the human or animal subject (human use is disclosed in page 1 of Campbell).
With respect to claim 14, Campbell teaches a method for identifying whether a medical device has been used on a patient, the method comprising:
identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change an appearance of the use indication region (identifying a color change of the oral fluid indicator on the reaction pad 36 of Campbell);
wherein the reaction comprises exposing a reagent from the use indication region to body fluid (exposing the oral fluid indicator to saliva; pages 1 and 8 of Campbell).
With respect to claim 15, Campbell teaches that identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change the appearance of the use indication region further comprises the use indication region has changed color from the reaction (identifying a color change of the oral fluid indicator on the reaction pad 36 of Campbell).
With respect to claim 16, Campbell teaches that the reagent comprises a pH indicator (the pH indicator of Campbell; pages 6 and 11 of Campbell).
With respect to claim 17, Campbell teaches that when the reaction has occurred to change the appearance of the use indication region. disposing the medical device (the device is disposable after use; page 14 of Campbell).
Claims 1, 6-7, 9, 11, and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 5,645,824 (Lim).
With respect to claim 1, Lim teaches a device, comprising:
a proximal end (the proximal end of the syringe needle of Lim; abstract of Lim); and
a distal end (the distal end of the syringe needle of Lim; abstract of Lim) configured to interact with a human or animal subject, the distal end comprising a use indication portion (the color changing reagent composition coating of Lim; abstract of Lim);
wherein the use indication portion comprises a reactive agent (the color changing reagent composition coating of Lim; abstract of Lim) to react with a foreign substance (the blood, mucous, saliva, and semen of a patient; abstract of Lim) to exhibit a visible change in appearance of the reactive agent (a color change; abstract of Lim).
With respect to claim 6, Lim teaches that the reactive agent comprises a pH indicator (the chemicals and reagents listed in col. 3, line 40 to col. 6, line 40 of Lim).
With respect to claim 7, Lim teaches that the reactive agent is configured to react with a range of pH representative of saliva (the chemicals and reagents listed in col. 3, line 40 to col. 6, line 40 of Lim).
With respect to claim 9, Lim teaches that the reactive agent comprises a moisture or humidity (the water; col. 4, lines 50-60 of Lim).
With respect to claim 11, Lim teaches that the device is a medical device (the syringe needle of Lim; abstract of Lim).
With respect to claim 13, Lim teaches that the distal end (the distal end of the syringe needle of Lim; abstract of Lim) is configured to interact with the human or animal subject (human use is disclosed in col. 3, lines 5-40 of Lim).
With respect to claim 14, Lim teaches a method for identifying whether a medical device has been used on a patient, the method comprising:
identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change an appearance of the use indication region (identifying a color change of the indicator on the distal end of the syringe needle of Lim);
wherein the reaction comprises exposing a reagent from the use indication region to body fluid (exposing the indicator to the blood, mucous, saliva, and semen of a patient; abstract of Lim).
With respect to claim 15, Lim teaches that identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change the appearance of the use indication region further comprises determining that the use indication region has changed color from the reaction (identifying a color change of the indicator; abstract of Lim).
With respect to claim 16, Lim teaches that the reagent comprises a pH indicator (the chemicals and reagents listed in col. 3, line 40 to col. 6, line 40 of Lim).
With respect to claim 17, Lim teaches that when the reaction has occurred to change the appearance of the use indication region. disposing the medical device (col. 2, line 18 to col. 3, line 54 of Lim).
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 21-23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Lim, in view of U.S. Patent Application Publication No. 2015/0112248 (Helliwell)(previously cited).
Lim teaches a syringe needle (abstract of Lim). Helliwell teaches such medical devices are stored in a sterile package before use (claims 32-35 of Helliwell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to put the syringe needle of Lim in a sterile package before use and take it out for use since it prevents contamination of the device.
With respect to claim 21, the combination teaches or suggests a system, comprising:
a disposable medical device comprising a proximal end (the proximal end of the syringe needle of Lim; abstract of Lim) and a distal end (the distal end of the syringe needle of Lim; abstract of Lim) configured to interact with a human or animal subject, the distal end comprising a use indication region (the color changing reagent composition coating of Lim; abstract of Lim) that comprises a reactive agent (the color changing reagent composition coating of Lim; abstract of Lim) configured to react with a foreign substance (the blood, mucous, saliva, and semen of a patient; abstract of Lim) to exhibit a visible change in appearance (a color change; abstract of Lim); and
a sterile package (the sterile package suggested by Helliwell) configured to enclose the disposable medical device in an unused configuration (the storage of the device) and to be opened to permit removal of the disposable medical device for use (the use of the device), the sterile package being separate from the disposable medical device.
With respect to claim 22, the combination teaches or suggests that the reactive agent comprises a pH indicator configured to react within a range of pH representative of saliva (the chemicals and reagents listed in col. 3, line 40 to col. 6, line 40 of Lim).
With respect to claim 23, the combination teaches or suggests that the reactive agent comprises a moisture- or humidity-responsive indicator (the chemicals and reagents listed in col. 3, line 40 to col. 6, line 40 of Lim).
With respect to claim 26, the combination teaches or suggests that the visible change in appearance comprises a color change (the color changing reagent composition coating of Lim; abstract of Lim).
Claims 1-2, 6, 9, 11, 13-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2009/0202960 (White)(previously cited), in view of U.S. Patent Application Publication No. 2009/0198182 (Fujishima)(previously cited)).
White teaches the use of Yankauer suction tubes (paragraphs 0002, 0037, and 0061-0062 of White; FIG. 3 of White) that are used for sucking fluids from a patient’s mouth, throat, stomach (paragraph 0063 of White). Fujishima teaches a color change indicator 91 on an end of a member 9 located at a distal end of a catheter 3 near a distal opening 5 (paragraphs 0028-0029 of Fujishima; FIG. 3 of Fujishima). The indicator 91 is used to verify the position of the catheter (paragraphs 0028-0029 of Fujishima). 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 color change indicator 91 on the end of a member 9 located at the distal end of suction tube of White near the distal opening since it assists in verifying that the location of the catheter is at the correct location.
With respect to claim 1, the combination teaches or suggest a device, comprising:
a proximal end (the proximal end of the suction tube of White); and
a distal end (the distal end of the suction tube of White) configured to interact with a human or animal subject, the distal end comprising a use indication portion (the color change indicator 91 on the member 9 of Fujishima);
wherein the use indication portion comprises a reactive agent to react with a foreign substance to exhibit a visible change in appearance of the reactive agent (paragraphs 0013-0022 of Fujishima).
With respect to claim 2, the combination teaches or suggests a disposable Yankauer suction tip at the distal end of the device (the Yankauer nozzle of White; paragraphs 0002, 0037, and 0061-0062 of White).
With respect to claim 6, the combination teaches or suggests that the reactive agent comprises a pH indicator (paragraphs 0013-0022 of Fujishima).
With respect to claim 9, the combination teaches or suggests that the reactive agent comprises a moisture or humidity (paragraphs 0013-0022 of Fujishima; paragraph 0019 teaches that the pigment can be in a solution state).
With respect to claim 11, the combination teaches or suggests that the device is a medical device (the use of Yankauer suction tubes).
With respect to claim 13, the combination teaches or suggests that the distal end is configured to interact with the human or animal subject (paragraph 0063 of White; claim 1 of Fujishima).
With respect to claim 14, the combination teaches or suggests a method for identifying whether a medical device has been used on a patient, the method comprising:
identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change an appearance of the use indication region (identifying, on the indicator 91 on the member 9 at the distal end of the suction tube, whether a reaction has occurred so as to change the color of the indicator 91; paragraphs 0013-0022 of Fujishima; paragraphs 0028-0029 of Fujishima);
wherein the reaction comprises exposing a reagent from the use indication region to body fluid (paragraphs 0013-0022 of Fujishima; paragraphs 0028-0029 of Fujishima).
With respect to claim 15, the combination teaches or suggests that identifying, on a use indication region of a distal end of the medical device, whether a reaction has occurred to change the appearance of the use indication region further comprises determining that the use indication region has changed color from the reaction (paragraphs 0013-0022 of Fujishima; paragraphs 0028-0029 of Fujishima).
With respect to claim 16, the combination teaches or suggests that the reagent comprises a pH indicator (paragraphs 0013-0022 of Fujishima).
With respect to claim 19, the combination teaches or suggests that the medical device comprises a Yankauer suction tip at the distal end of the medical device (the Yankauer nozzle of White; paragraphs 0002, 0037, and 0061-0062 of White).
Claims 21-22, 24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over White, in view of Fujishima, and further in view of U.S. Patent No. 6,221,622 (Love).
White teaches the use of Yankauer suction tubes (paragraphs 0002, 0037, and 0061-0062 of White; FIG. 3 of White) that are used for sucking fluids from a patient’s mouth, throat, stomach (paragraph 0063 of White). Fujishima teaches a color change indicator 91 on an end of a member 9 located at a distal end of a catheter 3 near a distal opening 5 (paragraphs 0028-0029 of Fujishima; FIG. 3 of Fujishima). The indicator 91 is used to verify the position of the catheter (paragraphs 0028-0029 of Fujishima). 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 color change indicator 91 on the end of a member 9 located at the distal end of suction tube of White near the distal opening since it assists in verifying that the location of the catheter is at the correct location.
The combination teaches an assembly comprising the suction tube of White and a color change indicator 91 on the end of the member 9 of Fujishima. Love teaches such medical assemblies are stored in a sterile package before use (col. 4, lines 10-25 and col. 7, lines 15-40 of Love). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to put the device components of the combination in a sterile package before use and take it out for use since it prevents contamination of the device.
With respect to claim 21, the combination teaches or suggest a system, comprising:
a disposable medical device comprising a proximal end (the proximal end of the suction tube of White) and a distal end (the distal end of the suction tube of White and the member 9 of Fujishima) configured to interact with a human or animal subject, the distal end comprising a use indication region (the color change indicator 91 on the member 9 of Fujishima) that comprises a reactive agent configured to react with a foreign substance to exhibit a visible change in appearance (paragraphs 0013-0022 of Fujishima); and
a sterile package (the sterile package suggested by Love; col. 4, lines 10-25 and col. 7, lines 15-40 of Love) configured to enclose the disposable medical device in an unused configuration (the storage of the device) and to be opened to permit removal of the disposable medical device for use (the use of the device), the sterile package being separate from the disposable medical device.
With respect to claim 22, the combination teaches or suggests that the reactive agent comprises a pH indicator configured to react within a range of pH representative of saliva (paragraphs 0013-0022 of Fujishima).
With respect to claim 24, the combination teaches or suggests that the disposable medical device comprises Yankauer suction tip at the distal end (the Yankauer nozzle of White; paragraphs 0002, 0037, and 0061-0062 of White).
With respect to claim 26, the combination teaches or suggests that the visible change in appearance comprises a color change (paragraphs 0013-0022 of Fujishima).
With respect to claim 27, the combination teaches or suggests that the use indication region is positioned adjacent a distal opening of the Yankauer suction tip (the color change indicator 91 on the member 9 of Fujishima is adjacent to the distal opening of the Yankauer nozzle of White during insertion into the stomach).
Claims 21-23 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell, in view of U.S. Patent Application Publication No. 2005/0096563 (Liang).
Campbell teaches the use of a device for sampling salvia (abstract and pages 1 and 8 of Campbell). Liang teaches such medical assemblies are stored in a sterile package before use (paragraph 0039 of Liang). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to put the device components of the combination in a sterile package before use and take it out for use since it prevents contamination of the device.
With respect to claim 21, the combination teaches or suggest system, comprising:
disposable medical device comprising a proximal end (the observational surface 6 of Campbell) and a distal end (the wider stem 16 of Campbell) configured to interact with a human or animal subject, the distal end comprising a use indication region (the reaction pad 36 of Campbell) that comprises a reactive agent (the oral fluid indicator; page 8 of Campbell) configured to react with a foreign substance (the saliva of a patient; page 1 of Campbell) to exhibit a visible change in appearance (a color change; page 8 of Campbell); and
a sterile package (the sterile package suggested by Liang; paragraph 0039 of Liang) configured to enclose the disposable medical device in an unused configuration (the storage of the device) and to be opened to permit removal of the disposable medical device for use (the use of the device), the sterile package being separate from the disposable medical device.
With respect to claim 22, the combination teaches or suggests that the reactive agent comprises a pH indicator configured to react within a range of pH representative of saliva (the pH indicator of Campbell; pages 6 and 11 of Campbell).
With respect to claim 23, the combination teaches or suggests that the reactive agent comprises a moisture- or humidity-responsive indicator (the reaction pad 36 of Campbell is responsive to saliva; pages 1 and 8 of Campbell).
With respect to claim 25, the combination teaches or suggests that the use indication region is selectively detachable from the distal end (the reaction pad 36 of Campbell is detachable from the wider stem 16 of Campbell).
With respect to claim 26, the combination teaches or suggests that the visible change in appearance comprises a color change (a color change; page 8 of Campbell).
Response to Arguments
The Applicant’s arguments filed on 9/16/2025 have been fully considered.
Claim objections
In view of the claim amendments filed on 9/16/2025, the previous claim objections have been withdrawn.
There are new grounds of claim objections that were necessitated by the claim amendments filed on 9/16/2025.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 9/16/2025, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn.
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 9/16/2025.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, that were necessitated by the claim amendments filed on 9/16/2025.
Prior art rejection based on Wuske
With respect to the rejections of claim 1, the Applicant asserts:
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These arguments are not persuasive. First, claim 1 does not require that the user indication portion be accessible to the mouth. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the first interpretation, the window 6 of Wuske (which is considered to be the distal end) contains the indicator zone 5 of Wuske (which is considered to be the use indication portion). Thus, the window 6 of Wuske is considered to comprise the indicator zone 5 of Wuske. Both the window 6 and the indicator zone 5 are configured to indirectly or directly interact with a human or animal subject since they are operatively connected to the mouthpiece 4 as part of their function to assist in collecting and analyzing of saliva from the patient. Indeed, mouthpiece 4 and the indicator zone 5 are simply different portions of the sampling tip 2.
With respect to the second interpretation, the mouthpiece 4 of Wuske (which is considered to be the distal end) is considered to comprise the indicator zone 5 of Wuske (which is considered to be the use indication portion) since they are extensions of each other because they are integral pieces of the same material making up the sampling tip 2 (see the same cross-sectional hatching in FIG. 1B of Wuske).
Further, the indicator zone 5 of Wuske is a use indication portion since its changing of color indicates that adequate collection (or adequate use) had occurred.
Thus, the rejections of claim 1 based on Wuske are proper.
With respect to the rejections of claim 14, the Applicant asserts:
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These arguments are not persuasive. First, claim 14 does not require that the distal end be a patient-interfacing distal end. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, with respect to the first interpretation, the window 6 of Wuske (which is considered to be the distal end) contains the indicator zone 5 of Wuske (which is considered to be the use indication portion). Thus, the window 6 of Wuske is considered to comprise the indicator zone 5 of Wuske.
Third, with respect to the second interpretation, the mouthpiece 4 of Wuske (which is considered to be the distal end) is considered to comprise the indicator zone 5 of Wuske (which is considered to be the use indication portion) since they are extensions of each other because they are integral pieces of the same material making up the sampling tip 2 (see the same cross-sectional hatching in FIG. 1B of Wuske).
Fourth, the indicator zone 5 of Wuske is a use indication portion since its changing of color indicates that adequate collection (or adequate use) had occurred.
Thus, the rejections of claim 14 based on Wuske are proper.
Prior art rejection based on Campbell
With respect to the rejection of claim 1, the Applicant asserts:
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These arguments are not persuasive. The reaction pad 36 of Campbell is a use indication portion since its changing of color indicates that adequate collection (or adequate use) had occurred. Also, the wider stem 16 of Campbell contains the reaction pad 36 of Campbell such that the wider stem 16 of Campbell is considered to comprise the reaction pad 36 of Campbell.
Thus, the rejection of claim 1 based on Campbell is proper.
With respect to the rejection of claim 14, the Applicant asserts:
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These arguments are not persuasive. First, the identification on the reaction pad 36 of whether a reaction has occurred to change the appearance of the use indication region does occur since the color change on the reaction pad is identified via transmission of the color change to the observation surface 6 of Campbell. There is no requirement that the identification of the color change must be viewed directly. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Also, the reaction pad 36 of Campbell is a use indication portion since its changing of color indicates that adequate collection (or adequate use) had occurred.
Thus, the rejection of claim 14 based on Campbell is proper.
Prior art rejection based on Lim
With respect to the rejection of claim 1, the Applicant asserts:
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Similarly, with respect to the rejection of claim 14, the Applicant asserts:
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These arguments are not persuasive. The terms proximal and distal end are broad terms of relative position. Also, the claim language does not confine the use indication portion to just the distal end. Even if the coating is applied to the entire working needle surface, the distal end of the working needle surface can be considered the distal end relative to the proximal end of the working needle surface regardless of whether the coating extends to the proximal end of the working needle surface. The claim language does not preclude such an interpretation.
Also, terms like “region” or “portion” do not necessarily convey separate and distinct elements with defined boundaries but can also convey sub-regions or sub-portions of a greater whole. In this case, the use indication portion or the use indication region is simply that portion or region of the coating that comes into contact with the body fluid (i.e., at the distal end of the working needle surface). The claim language does not require anything more.
Thus, the rejections of claims 1 and 14 based on Lim are proper.
Prior art rejection based on White and Fujishima
With respect to the rejection of claim 1, the Applicant asserts:
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Similarly, with respect to the rejection of claim 14, the Applicant asserts:
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These arguments are not persuasive. The assertion that While does not teach the reactive indicator is not persuasive since Fujishima is used to teach this feature. 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 assertion that Fujishima’s indicator is not on the distal end of a suction tube is not persuasive since the claim does not require that the indicator 91 be on the distal end of the suction tube but only on the distal end of the device. The distal end of the device comprises the distal end of the Yankauer suction tube and the indicator 91 is on the distal end of the member 9. The claim does not require that these elements be physically and permanently affixed to each other, but that they merely exist.
The assertion that placing of the indicator on the end of the suction tube is a redesign of the Yankauer tip of White that neither reference teaches or suggests is not persuasive since it is not commensurate with the rejection. Fujishima teaches a color change indicator 91 on the end of the member 9, which is also part of the distal end of the device. The distal end of the Yankauer suction tube of White is also part of the distal end of the device. The claim (and thus the rejection) does not require the indicator be on the suction tube or even be physically and permanently affixed to each other.
The indicator 91 is used to verify the position of the catheter in the stomach (paragraphs 0028-0029 of Fujishima). 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 color change indicator 91 on the end of the member 9 located at the distal end of suction tube of White near the distal opening since it assists in verifying that the location of the catheter is at the correct location in the stomach. There is a cogent rationale for placing the indicator at the distal end of suction tube of White. Further, the placement of such an indicator is a mere improvement to an existing design rather than redesigning the whole suction tube of White. There is an expectation of success since the indicator is being used for the same purpose in the combination as it is in Fujishima, i.e., verifying the placement of the distal end of the device in the stomach. Thus, the proposed combination does not change the location, the structure, or the function of Fujishima’s indicator.
Also, the identification of the color changes occurs at the distal end since the identification of the color change occurs directly from viewing the indicator 91 on the end of the member 9, which is part of the distal end (see paragraph 0029 of Fujishima).
Thus, the rejections of claims 1 and 14 based on White and Fujishima are proper.
Prior art rejections of claims 21-27
There are new grounds of claim rejections for claims 21-27 that were necessitated by the claim amendments filed on 9/16/2025.
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.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791