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Claims 11-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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.
Response to Arguments
Applicant’s arguments filed 07/08/2026 have been fully considered but are not persuasive.
Regarding claim 1, Applicant argues that Thorens’ smoking article 100 corresponds to an aerosol-generating device rather than the claimed aerosol-generating article. This argument is not persuasive. Thorens expressly defines a “smoking article” as an article configured to receive a nicotine-containing aerosol-generating substrate and explains that the smoking article may heat, directly or indirectly, the nicotine-containing aerosol-generating substrate to produce an aerosol. (Thorens ¶ [0008]). Thorens further discloses smoking article 100 including housing 110, mouthpiece 120, aerosol-generating substrate 150, and nicotine metabolite sensor 10. (Thorens, Fig. 2; ¶¶ [0060]-[0063]). Accordingly, Thorens’ smoking article 100 reasonably corresponds to the broadly recited aerosol-generating article of claim 1. Applicant’s reliance on terminology used in the present specification to distinguish an “article” from a “device” does not impose additional structural limitations that are not recited in claim 1.
Applicant further argues that Thorens does not disclose the biomarker sensor positioned “at least 1 centimeter distant from the mouth end.” Applicant is correct that Thorens does not expressly disclose the particular numerical distance of at least 1 centimeter. However, the absence of an express numerical value does not, by itself, establish patentability. Thorens expressly teaches that the position of nicotine metabolite sensor 10 relative to mouthpiece 120 and mouth end 125 is functionally significant because the sensor is positioned so that saliva from the user can interact with the sensor and permit detection of nicotine metabolites. (Thorens ¶¶ [0011], [0027], [0061]). Thus, Thorens recognizes that sensor position relative to the mouth end is a design consideration affecting operation of the sensor.
Applicant additionally relies on the present application’s explanation that the claimed distance prevents the biomarker sensor from being covered or obstructed by the user’s mouth and argues that Thorens does not recognize that problem. This argument is not persuasive. As explained in MPEP § 2144 (IV), the reason for modifying the prior art need not be the same reason relied upon by Applicant, and the prior art need not recognize the identical problem addressed by Applicant. Accordingly, the fact that Thorens does not expressly identify sensor obstruction by the user’s mouth as a problem does not, by itself, establish that the claimed positioning would have been nonobvious.
Applicant next argues that Thorens does not teach or suggest positioning the biomarker sensor at the portion in which the aerosol-forming substrate is provided because Thorens instead positions sensor 10 at mouthpiece 120. This argument is not persuasive because the rejection expressly acknowledged that Thorens does not disclose sensor 10 at the substrate-containing portion and relied upon an obvious modification of Thorens. Thus, Applicant’s showing that Thorens expressly illustrates sensor 10 at the mouthpiece merely identifies the difference already addressed by the § 103 rejection and does not, by itself, establish that the claimed alternative positioning would have been nonobvious.
Applicant further argues that Thorens teaches away from the proposed modification because Thorens positions sensor 10 at the mouthpiece for detecting nicotine metabolites in saliva. This argument is not persuasive. As explained in MPEP § 2145, a reference teaches away when it criticizes, discredits, or otherwise discourages the claimed solution. The mere disclosure of a particular or preferred arrangement does not constitute a teaching away from alternative arrangements. Thorens teaches a mouthpiece location for sensor 10, but Applicant has not identified any disclosure in Thorens criticizing, discrediting, or otherwise discouraging positioning the biomarker sensor elsewhere on the smoking article.
Applicant also argues that positioning Thorens’ sensor at the substrate-containing portion would undermine Thorens’ intended purpose because Thorens relies upon saliva reaching sensor 10 to detect a nicotine metabolite. This argument is not persuasive. Applicant assumes that positioning the sensor at the substrate-containing portion necessarily requires moving the sensor to a location at which saliva cannot reach the sensor. Claim 1 imposes no such requirement. Claim 1 recites where the biomarker sensor is positioned relative to the substrate-containing portion, but does not require that the sensor be inaccessible to saliva or otherwise incapable of performing the biomarker-detection function taught by Thorens. Applicant therefore has not established that the claimed positioning would render Thorens unsatisfactory for its intended purpose. See MPEP § 2145, (X)(D), regarding arguments that a proposed modification would render the prior art unsatisfactory for its intended purpose.
Applicant further argues that Thorens does not recognize the problem of obstruction of the biomarker sensor by the user’s mouth and therefore provides no reason to arrive at Applicant’s claimed arrangement. Again, this argument improperly requires the prior art to recognize Applicant’s particular problem and motivation. Under MPEP § 2144IV, the motivation supporting an obviousness determination may differ from Applicant’s own reason for making the modification. The relevant inquiry is whether the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art, not whether Thorens articulated Applicant’s particular design objective.
Accordingly, Applicant’s arguments establish that Thorens does not expressly disclose the particular numerical distance and sensor location recited in amended claim 1. However, those differences do not, by themselves, establish nonobviousness. Applicant has not shown that Thorens teaches away from the claimed positioning, that the claimed positioning necessarily renders Thorens unsuitable for its intended purpose, or that Thorens was required to recognize Applicant’s particular problem or rationale. Applicant’s arguments are therefore not persuasive.
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, 2, 6-9, and 19—20 are rejected under 35 U.S.C. 103 as being unpatentable over Thorens (US 2018/0140016).
Regarding claim 1, Thorens teaches an aerosol-generating article comprising an aerosol-forming substrate (smoking article 100 configured to receive nicotine-containing aerosol-generating substrate 150; Thorens ¶ [0008]),
the aerosol-generating article comprising a mouth end and a distal end (mouthpiece 120 defining mouth end 125 and an opposite distal end of smoking article 100; Thorens, Fig. 2),
and a biomarker sensor, wherein the biomarker sensor is provided to the aerosol-generating article (nicotine metabolite sensor 10 provided to smoking article 100; Thorens ¶ [0060]).
Thorens further teaches a portion in which the aerosol-forming substrate is provided (housing 110 configured to receive nicotine-containing aerosol-generating substrate 150; Thorens ¶ [0060]).
Thorens does not expressly disclose that the biomarker sensor is positioned at least 1 centimeter distant from the mouth end and at the portion in which the aerosol-forming substrate is provided.
However, Thorens teaches that sensor 10 is positioned relative to mouthpiece 120 so that, when a smoker places his or her lips against the mouthpiece, the sensor can detect nicotine metabolite in the smoker’s saliva. Thorens ¶ [0060]. Thus, Thorens recognizes that the position of sensor 10 on the smoking article relative to the user-contacting mouth end affects operation of the sensor.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position Thorens’ biomarker sensor farther from mouth end 125, including at least 1 centimeter therefrom, and at the substrate-containing portion of smoking article 100, so as to maintain the biomarker sensor on the article while reducing direct placement of the sensor at the user-contacting mouth end. Such modification would have involved selection of an operative sensor position based upon the known relationship between sensor location and user contact and would have yielded the predictable result of retaining the biomarker-sensing function at a location less directly contacted by the user. See MPEP § 2143(I)(B) and MPEP § 2144.05(II)(B).
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 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.
Regarding claim 19, Thorens teaches the aerosol-generating article of claim 2 as discussed above, wherein the portion in which the aerosol-forming substrate is provided is arranged upstream of the mouthpiece (substrate 150 is positioned upstream of mouthpiece 120 such that aerosol generated from substrate 150 is transported through a pathway toward mouth end 125; Thorens ¶ [0062]).
Regarding claim 20, Thorens teaches the aerosol-generating article of claim 2 as discussed above, wherein the mouthpiece is separate from the portion in which the aerosol-forming substrate is provided (mouthpiece 120 is a distinct portion of smoking article 100 from the portion of housing 110 configured to receive aerosol-generating substrate 150; Thorens, Fig. 2).
Claim(s) 4, 10, 16-18 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)).
Regarding claim 16, Thorens teaches the aerosol-generating article of claim 1 as discussed above, but does not expressly disclose that the aerosol-generating article is wrapped by a wrapper.
Besso teaches a smoking article comprising a wrapper that circumscribes at least a portion of the smoking article/mouthpiece (Besso ¶ [0033]).
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’ smoking article to include the wrapper taught by Besso, since wrappers were known for surrounding and retaining components of smoking articles and would have predictably provided structural support and containment of the article components. Such modification would have been the predictable use of a known smoking-article wrapper for its known purpose. See MPEP § 2143(I)(B).
Regarding claim 17, Thorens in view of Besso teaches the aerosol-generating article of claim 16 as discussed above. Thorens further teaches a biomarker sensor 10 provided to the smoking article (Thorens ¶ [0060]).
Thorens does not expressly disclose that the wrapper comprises the biomarker sensor.
Besso teaches incorporating a functional responsive segment into a wrapper of a smoking article, wherein the color-change segment may be provided on a wrapper that circumscribes at least a portion of the article (Besso ¶ [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Thorens’ biomarker sensor into the wrapper taught by Besso, since Besso demonstrates that a responsive indicator component may be carried by the wrapper of a smoking article. Such modification would have predictably provided the biomarker sensor as part of the wrapper while retaining its sensing function and represents the use of a known technique for incorporating a functional sensing or indicating component into a smoking-article wrapper. See MPEP § 2143(I)(B).
Regarding claim 18, Thorens teaches the aerosol-generating article of claim 2 as discussed above, including mouthpiece 120 and the portion in which aerosol-forming substrate 150 is provided (Thorens, Fig. 2).
Thorens does not expressly disclose that the aerosol-generating article is wrapped by a wrapper and the wrapper connects the mouthpiece and the portion in which the aerosol-forming substrate is provided.
Besso teaches a smoking article in which an outer wrapper is wrapped around adjoining portions of the article, thereby connecting the wrapped portions together (Besso ¶ [0054]).
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’ smoking article to include the wrapper arrangement taught by Besso, with the wrapper extending between and connecting the mouthpiece and the substrate-containing portion, since Besso teaches using a common wrapper to surround and retain adjoining portions of a smoking article. Such modification would have predictably provided structural connection and retention of the adjacent article portions and represents the use of a known smoking-article wrapping technique for its known purpose. See 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).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Thorens (US 2018/0140016) as applied to claims 1 above, in view of Batista et al. (US 2017/0143042 A1)
Regarding claim 21, Thorens teaches the aerosol-generating article of claim 1 as discussed above, but does not expressly disclose that the aerosol-generating article is configured to be inserted into a heating chamber of an aerosol-generating device.
Batista teaches an aerosol-forming heater assembly 40 comprising an aerosol-forming cartridge and a removable heater, wherein the aerosol-forming heater assembly 40 is inserted into main cavity 51 of aerosol-generating device 50 for operation of the aerosol-generating system (¶ [0090]).
Batista further teaches that the aerosol-forming cartridge and heater may be removably connected to form a single aerosol-forming heater assembly that is received by the aerosol-generating device, thereby providing a modular arrangement in which the aerosol-forming portion and associated heating functionality may be inserted into and removed from the device as a unit (¶ [0015]).
Thorens likewise provides an aerosol-generating article containing aerosol-forming substrate and associated functional components for generating aerosol. Accordingly, the removable assembly configuration taught by Batista would have been compatible with Thorens’ article and would have provided the known benefits of modular insertion and removal of the aerosol-generating assembly from a separate device, including facilitating replacement, servicing, and reuse of the surrounding aerosol-generating device.
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 Thorens’ aerosol-generating article as a removable assembly configured for insertion into a heating chamber of an aerosol-generating device, as taught by Batista, in order to provide a modular aerosol-generating system in which the aerosol-forming substrate and associated functional components are received and operated within a separate aerosol-generating device while permitting the assembly to be readily inserted and removed. Such modification would have been the predictable use of a known removable aerosol-generating assembly configuration for its known purpose. See MPEP § 2143(I)(B).
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 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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