DETAILED CORRESPONDENCE
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The claim set and remarks filed on 9/16/2025 are acknowledged.
Claims 3, 16, 18, and 20 are cancelled.
Claims 21-23 are newly added.
Claims 1, 5, 7, 9, 11, and 19 are amended.
Claims 1, 2, 4-15, 17, 19, and 21-23 are pending.
Response to Arguments/Amendments
The claims and remarks filed 9/16/2025 have been fully considered. Examiner has identified claim 1 is drawn to a composition comprising naturally occurring products and makes a 35 USC 101 rejection. In a telephonic interview with Attorney Jinggao Li on 12/23/2025, examiner proposed amendments that can expedite prosecution for example one proposal was bringing the combination of the limitations of claim 2 with claim 21 or claim 22 into claim 1 as well as addressing the 35 USC 101 rejection.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21 recites “02-0.4 wt%” which should read as “0.2-0.4 wt%”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 4-15, 17, 19, and 21-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is drawn to a composition comprising lavender oil as an active ingredient for medicinal use in a treatment of a concentration disorder, and a gum base, wherein the composition comprises the gum base, and lavender oil as an active ingredient is in a concentration of 0.1 to 1 wt% and wherein the gum base has a tensile strength between 0.25 N/mm2 and 4 N/mm2 for engaging the facial muscles.
The broadest reasonable interpretation of the claimed compositions would be the material that is named, that is: lavender oil and a gum base. Lavender oil is a naturally occurring product, and the gum base can comprise naturally occurring gum bases that are naturally occurring unless otherwise specified.
Thus, the compositions claimed in claim 1 is not markedly different from how the individual components in nature. It is not integrated into a practical application because nothing in claim 1 relies on or uses the exception. There is nothing significantly more than the judicial exception because there are no additional elements in the claim. With regard to claims 2, 4-15, 17, 19, and 21-23 the enumeration of the amounts or additional products of nature do not make the combination of the products of nature markedly different from how they occur in nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the formulation at the broadest interpretation of the claim language is a mixture of products of nature comprising: lavender oil and a gum base, which does not appear to change the biological/pharmacological functions, chemical/physical properties, or the structure/form of said ingredients. Because the claimed formulation does not have markedly different characteristics, it is a product of nature.
Claim Interpretation
Regarding claims 1, 2, 4-15, 17, 19, and 21-23, the claimed formulation is drawn to product claims and therefore the intended use of the formulation, “lavender oil as an active ingredient for medicinal use in a treatment of a concentration disorder,” does not carry patentable weight over the teachings of the prior art.
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 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 4-15, 17, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Leveille et al. (US20080008663A1) hereinafter Leveille in view of Pischel et al. (EP1623716A1 Machine Translation, See 1/2/2023 IDS) hereinafter Pischel.
Regarding claims 1, 2, 4-15, 17, 19, and 21-23, Leveille discloses in an embodiment, the chewing gum includes a flavor selected from the group consisting of an herbal flavor. The flavor is present in an amount of about 0.2% to about 5% by weight of the chewing gum. The herbal flavor includes an herbal extract selected from lavender [0013-0015].
Leveille discloses the chewing gum may also include at least one flavorant or flavoring agent. The flavor may be used in amounts of approximately 0.1 to about 15 weight percent of the gum, and in an embodiment, about 0.2 to about 5%. The flavorant or flavor may include any natural or synthetic oil and/or flavor as is commonly known in the art. The chewing gum may also include herbal flavors such as herbal extracts. Herbal extracts may include lavender [0054].
Leveille discloses the gum may comprise synthetic elastomer or natural elastomer [0039]. Leveille discloses sugarless sweeteners may include, but are not limited to, sorbitol, mannitol, xylitol, [0049]. Leveille discloses zinc salts [0006]. Leveille discloses the chewing gum may or may not include an active ingredient or medicament. As used herein, “medicament” may include a pharmacologic or therapeutic agent or component or metabolite thereof that demonstrates pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a condition, or disease [0055]. One of ordinary skill in the art would reasonably expect success in formulating the chewing gum wherein lavender is the only active ingredient as well as in combination with other pharmacologic agents as disclose by Leveille, such as niacin, pantothenic acid, and biotin.
Leveille does not explicitly disclose wherein the lavender in the gum is lavender oil.
However, Pischel discloses a chewing gum formulation wherein 100 g of chicle are powdered, mixed with 300 g of sugar or sugar substitute and heated in an evaporating dish until the mass softens. It is then worked well with the addition of 60 g of dry extract mixture of lemon balm, hops and oats and 2 g of lavender oil and placed on a sugar-sprinkled plate and kneaded to homogeneity. Finally, the mixture is rolled out into thin sheets and cut into flat slices while still warm, preventing the mass from sticking to the plate with some sugar powder. The chewing gum portions thus obtained should be 2 to 3 grams (Example 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings as previously disclosed by Leveille, wherein the lavender in the gum is lavender oil, as previously disclosed by Pischel, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Leveille and Pischel are both in the field of gum formulations that comprise lavender, and Pischel discloses lavender oil in a chewing gum formulation (Example 4), thus combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615