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 .
Election/Restrictions
Claims 11-15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/23/2026.
Applicant’s election without traverse of claims 1-10 in the reply filed on 02/23/2026 is acknowledged.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Thorens (US 2018/0140016).
Regarding claim 1, Thorens teaches aerosol-generating article comprising an aerosol-forming substrate, the aerosol-generating article (smoking article 100) comprising:
a mouth end 125 and a distal end (opposite distal end of the smoking article 100; fig. 2),
and a biomarker sensor (nicotine metabolite sensor 10), wherein the biomarker sensor is provided to the aerosol-generating article (fig. 2; ¶ [0060]).
Thorens does not explicitly state that the biomarker is positioned at least 1 centimeter distant from the mouth end.
However, Thorens teaches the biomarker sensor 10 is provided to the smoking article and is positioned in proximity to the mouth end 125 within the mouthpiece 120 ¶ [0061], thereby indicating that the distance of the sensor from the mouth end is variable parameter and at some distance away from the mouth end.
The positioning of the sensor affects its ability to detect saliva and its exposure to direct contact, such that the distance of the sensor from the mouth end end constitutes a result-effective variable.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to position the sensor at a distance of at least 1 centimeter from the mouth end through because it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (See MPEP § 2144.05II (B)).
One would be motivated to make the modification to achieve predictable results such as improving durability of the sensor and maintain reliable detection of saliva.
Regarding claim 2, Thorens teaches the sensor 10 is positioned in proximity to the mouth end 125 and within the mouthpiece 120, but not at the mouth end itself ¶¶ [0061]. Thereby reading on the limitation of “a mouthpiece at the mouth end and wherein the biomarker sensor is provided distant from the mouthpiece”.
Regarding claim 3, Thorens teaches an aerosol-generating article (100) comprising an aerosol-forming substrate (150) provided in a portion (110) of the article, and a biomarker sensor (10) (see e.g., Thorens Fig. 2; ¶¶ [0004], [0011]).
Thorens further teaches that the biomarker sensor (10) is positioned at a mouth end (125) of the article, which is adjacent to the portion (110) in which the aerosol-forming substrate (150) is provided (see Fig. 2).
Thorens does not disclose that the biomarker sensor is positioned at the portion (110) in which the aerosol-forming substrate (150) is provided, as required by the claim.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position the biomarker sensor at the portion (110) in which the aerosol-forming substrate (150) is provided, since Thorens already teaches the sensor in close proximity to that portion, and positioning the sensor directly at the substrate portion would have predictably improved interaction between the sensor and constituents of the aerosol-forming substrate, thereby improving detection accuracy.
This modification represents the use of a known technique to improve similar devices in the same way, in accordance with MPEP § 2143(I)(B).
Regarding claim 6, Thorens teaches wherein the biomarker sensor comprises a substance having a characteristic that changes upon contact with corresponding biomarkers in the user's saliva (¶¶ [0060]).
Regarding claim 7, the limitation of wherein the substrate in the biomarker sensor is a colorimetric substance configured to change its color upon contact with nicotine or nicotine metabolites present in the user's saliva, is met by Thorens teaching the biomarker sensor may employ colorimetric detection techniques for detecting nicotine metabolites (¶¶ [0015]). Thorens further teaches that detection of nicotine metabolites in saliva produces a detectable change indicative of the presence or concentration of the metabolite (¶¶ [0004], [0067]), which in the case of colorimetric detection corresponds to a change in color of the sensing material.
Regarding claim 8, Thorens teaches a biomarker sensor 10 configured to detect nicotine metabolites and produce a detectable response (¶¶ [0004], [0067]) including colorimetric detection technique (¶¶ [0015]). The recitation that “the biomarker sensor is positioned such that it can be visually inspected by a user” is a functional language that does not impose a structural limitation on the claimed article. If the prior art structure is capable of performing the claimed use then it meets the claim. A sensor configured to produce a detectable response including a visual response such as a color change is capable of being visually inspected by a user thereby meeting the limitation of the claim.
Regarding claim 9, Thorens teaches an aerosol-generating article (100) comprising a biomarker sensor (10) positioned at a mouth end (125) of the article, where the sensor is configured to contact a user’s saliva during use (see e.g., Thorens ¶¶ [0004], [0011]; Fig. 2). The mouth end (125) constitutes an external portion of the article that interfaces with the user.
However, Thorens does not explicitly disclose that the biomarker sensor is positioned at an outer surface of the aerosol-generating article, as required by the claim.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Thorens to position the biomarker sensor at the outer surface of the aerosol-generating article. This modification represents the use of a known technique (placing a sensor at an exposed surface for improved interaction with a target substance) to improve similar devices in the same way, in accordance with MPEP § 2143(I)(B).
One would be motivated to make the modification, since such placement would facilitate direct exposure of the sensor to saliva and improve detection accuracy and responsiveness of the biomarker sensor.
Claim(s) 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Thorens (US 2018/0140016) as applied to claim 1 above, and further in view of Besso et al. (US 2014/0290678).
Regarding claim 4, Thorens teaches an aerosol-generating article (100) comprising a biomarker sensor (10) positioned at a mouth end (125) of the article (see, e.g., Thorens ¶¶ [0004], [0011]; Fig. 2).
Thorens does not disclose that the article comprises a perforation, nor that the biomarker sensor is positioned upstream from the perforation.
However, Besso discloses an aerosol-generating article comprising one or more circumferential rows of perforations provided along a mouthpiece to allow ventilation and mixing of ambient air with mainstream aerosol (see Besso ¶ [0079]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Thorens in view of Besso to include the perforations as taught by Besso in order to regulate airflow and mix ambient air with mainstream aerosol, as expressly taught by Besso (MPEP § 2143(I)(A)). Further, it would have been obvious to position the biomarker sensor upstream of the perforation so that the sensor interacts with saliva or aerosol constituents prior to dilution by incoming air through the perforations, thereby ensuring more accurate detection.
Regarding claim 10, Thorens teaches an aerosol-generating article (100) comprising a biomarker sensor (10) positioned at a mouth end (125) (see, e.g., Thorens ¶¶ [0004], [0011]; Fig. 2).
Thorens does not teach that the biomarker sensor is covered by one or more layers of transparent, semi-transparent, or perforated material.
However, Besso discloses covering portions of an aerosol-generating article with one or more layers of material, including transparent outer wrappers and layered wrapper structures, such that a color change or indicator within the article can be visually observed through the covering (see, e.g., Besso ¶¶ [0045]–[0047]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Thorens in view of Besso to arrive at the claimed invention to include such a covering as taught by Besso in order to protect the biomarker sensor while permitting visual inspection and interaction with surrounding substances, as taught by Besso (MPEP § 2143(I)(B)).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Thorens (US 2018/0140016) as applied to claims 1 above, and further in view of Aller et al. (US 2020/0113239).
Regarding claim 5, Thorens teaches an aerosol-generating article comprising a biomarker sensor positioned on the article (see, e.g., Thorens Fig. 2).
Thorens does not teach that the biomarker sensor is provided in the form of a band around the outer circumference of the aerosol-generating article.
However, Aller discloses an article comprising an indicator band (band 360) disposed circumferentially around an outer surface of the article (Aller ¶[0065]–[0066]; Fig. 3).
Although Aller describes the band as an indicator rather than a biomarker sensor, Aller is relied upon solely for teaching the structural configuration of a band extending around the outer circumference of a cylindrical article, and not for the sensing function.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the biomarker sensor of Thorens in the form of a circumferential band as taught by Aller because modifying the shape and placement of a known element to conform to a known configuration on a similar article is a predictable variation that would provide uniform circumferential coverage and improved visibility/accessibility of the sensor (MPEP § 2143(I)(B); known technique applied to a known device).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER KESSIE whose telephone number is (571)272-7739. The examiner can normally be reached Monday - Thursday 7:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at (571) 270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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