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 .
Receipt is acknowledged of IDS filed on 11/13/2023, 02/07/2024, 03/30/2026, and 04/17/2026.
Claims 1-16 are pending.
Claims 5-14 are withdrawn.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 05/06/2026 is acknowledged. The traversal is on the ground(s) that a search and examination of the full set of claims can be made with occasioning a serous search burden on the Examiner. This is not found persuasive because the restriction requirement is set forth on unity of invention and as discussed in the rejection KILCULLEN (US 6436371 B2) teaches the overlapping special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 15-16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 18/555,705 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application recites:
A method of assessing the ability of a test oral care flavour ingredient or a test oral care flavour composition to improve the relaxation state of a human subject, comprising the steps of:
a) measuring a base relaxation state of a human test by an optical neuroimaging via functional Near Infrared Spectroscopy (fNIRS) of (i) the left brain hemisphere of the human test subject, (ii) the right brain hemisphere of the human test subject, and (iii) the full brain of the human test subject;
b) providing the test oral care flavour ingredient or the test oral care flavour composition to the human test subject for oral application wherein the human test subject orally applies the test oral care flavour ingredient or the test oral care flavour composition;
c) measuring a resulting relaxation state of the human test subject subjected to the test oral care flavour ingredient or the test oral care flavour composition by an optical neuroimaging via fNIRS of (i) the left brain hemisphere of the human test subject, (ii) the right brain hemisphere of the human test subject, and (iii) the full brain of the human test subject; and
d) determining an improved relaxation state difference between the measured resulting relaxation state and the measured base relaxation state for the human test subject (claim 1)
wherein Channels 1 to 8 and 11 are located in the left brain hemisphere of the human test subject, Channels 9 and 12 are located on the midline of the human test subject, and Channels 10 and 13 to 20 are located in the right brain hemisphere of the human test subject (claim 1).
Channel 4 shows a statistically significant difference of measured Oxy HB 0-30 seconds after the oral application (claim 4), wherein OxyHb is an amount of oxygenated hemoglobin measured by fNIRS (claim 4).
The copending application differs from the instant application in the recitation of “relaxation state” instead of “invigoration state”. However, according to MPEP 2112.02, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. Thus the copending application teaches the same device, fNIRS, with the same method steps (a, b, c and d) would inherently be able of the function of assessing the invigoration state of a human subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MINEMATSU (Activity of frontal pole cortex reflecting hedonic tone of food and drink: fNIRS study in humans. Scientific Reports. 2018.).
Regarding claim 1, MINEMATSU teaches using optical neuroimaging via functional near-infrared spectroscopy (fNIRS) to measure the effect of food and drink on patients (abstract), specifically flavors, such as sweet or bitter (figure 4) and page 1 paragraph 2). Note “oral care flavor” is an intended use of flavor and since MINEMATSU teaches testing flavors, they could be used as “oral care flavors”. The method comprising:
a) a base measurement of the brain was taken, where values were examined on the left hemisphere, right hemisphere and midline of the brain (figure 7), which would be the full brain. Note Applicant’s specification states that measurement from the right and left hemisphere and midline were used for full brain analysis (Applicant’s specification, page 6, paragraph 1).
b) the patient then eats or drinks (figure 7), such as chewing then swallowing (page 9, paragraph 9), which reads on the test subject orally applies the test oral care flavor ingredient.
c) after administration the resultant brain activity was measured (figure 7) on the left hemisphere, right hemisphere and midline of the brain (figure 7), which would be the full brain.
d) the pre-stimulus baseline and taste condition measurements were compared to determine the difference (page 11, paragraph 3). Note, “determining an improved invigoration state difference” appears to be a mental state since one could simply look at the results and mentally determine if there is a difference or not.
The channels are located on the left and right hemispheres, as well as the midline (figure 7).
Oxygenated hemoglobin (oxyHb) and deoxygenated hemoglobin (deoxyHb) levels were measured (figure 7). OxyHb in particular showed significant changes between the baseline and after administration (page 11, paragraph 1 and figure 7). OxyHb changes were seen 15s after the patient swallowed the test substance in both hemispheres and midline (figure 6).
Channel 10, located on the left hemisphere, showed a statistically significant difference in measured oxyHb (figure 7 and figure 3), which would read on the instant limitation of channel 1, shows a statistically significant difference in measured oxyHB since the channel names are arbitrary and the channels are located in the same position and measuring the same thing.
Regarding claim 3 and 4, MINEMATSU teaches measurements were taken continuously during and after administration, measurements were taken and differences of deoxyHb and the sum of both oxyHb and deoxy Hb (totalHb) were seen 0-5 seconds after application (figure 7 and figure 1). Specifically totalHb and Oxyhb, showed a substantial difference (figure 1 and 2). Differences in measurement were seen in the hemispheres and midline (figure 2).
Note, MINEMATSU teaches the results allowed for determination of measured values that corelated to like and dislike of test substances, which is useful for objective evaluation of pleasantness of food and drink (abstract). A subjects feeling of “pleasantness”, reads on an invigoration state. Note, Applicant’s specification states "improving the invigoration state" is meant to express that a certain item has a positive, activating mood enhancing effect on a human subject. In other words, they induce positive activated moods and emotions, such as invigoration (page 9, paragraph 1).
Furthermore, according to MPEP 2112.02, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. Thus the prior art teaches the same device, fNIRS, with the same method steps (a, b, c and d) would inherently be able of the function of assessing the invigoration state of a human subject.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over MINEMATSU (Activity of frontal pole cortex reflecting hedonic tone of food and drink: fNIRS study in humans. Scientific Reports. 2018.) in view of STOVELL (Important considerations in the development of toothpaste formulations for children. International Dental Journal. 2013.).
MINEMATSU teaches Applicant’s invention as discussed above.
MINEMATSU does not teach that the test substance is an oral care flavor ingredient, such as toothpaste and using those results to design a toothpaste flavor.
Regarding claims 2, STOVELL teaches that flavors in perceived as pleasant during brushing studies have been linked to increased brushing time, which, in turn, can increase the delivery and efficacy of fluoride from toothpastes (abstract). Therefore, manufacturers select tested, child-friendly flavors to maximize compliance, providing a more pleasurable brushing experience and oral health benefits (abstract).
Regarding claim 15, STOVELL teaches flavor development for children’s toothpaste should take flavor type, flavor intensity, level of sweetness and masking of any bitter tastes in the formulation into consideration (page 59, paragraph 6), which reads on developing guidelines for creatin an oral care flavor composition.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having toothpaste be the test substance and in turn using those results to develop guidelines for making toothpaste flavors. The person of ordinary skill in the art would have been motivated to make those modifications, because toothpaste flavors are important to be determined if they will be liked or not, especially in regards to children. Since if children do not like the taste of toothpaste it can lead to poor oral hygiene. If children like the taste it can maximize compliance, providing a more pleasurable brushing experience and oral health benefits and reasonably would have expected success because the method taught in MINEMATSU teaches the results allowed for determination of measured values that corelated to like and dislike of test substances, which is useful for objective evaluation of pleasantness of a test substance and the method described in STOVELL is towards determining the pleasantness of a test substance for future use.
Claims 1-4 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over MINEMATSU (Activity of frontal pole cortex reflecting hedonic tone of food and drink: fNIRS study in humans. Scientific Reports. 2018.) and STOVELL (Important considerations in the development of toothpaste formulations for children. International Dental Journal. 2013.) in view of PINTI (The present and future use of functional near-infrared spectroscopy (fNIRS) for cognitive neuroscience. Annals of the New York Academy of Sciences. 2018.).
MINEMATSU, CHOUDHARI and STOVELL teach Applicant’s invention as discussed above. Including, MINEMATSU teaching using fNIRS to measure OxyHb and deoxyHB.
Regarding claim 16, MINEMATSU, CHOUDHARI and STOVELL do not specifically state that fNIRS is based on brain tissue concentrations.
Regarding claim 16, PINTI teaches that NIRS is an optical, noninvasive neuroimaging technique that allows the measurement of brain tissue concentration changes of oxygenated (HbO2) and deoxygenated (HbR) hemoglobin following neuronal activation. (page 6, paragraph 5).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate basing the fNIRS on brain tissue concentrations. The person of ordinary skill in the art would have been motivated to make those modifications, and reasonably would have expected success because MINEMATSU teaches using fNIRS and PINTI teaches that fNIRS is always based on brain tissue concentrations.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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, MICHAEL HARTLEY can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
Prosecution Insights