DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 08/20/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments with respect to the instant claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103 - Obviousness
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-3, 11, 13-17 and 19-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonda et al (WO 2008/069970 A2), in view of Gin et al (US 2004/0151771 A1) and further in view of Johnson et al (USP 6,627,234 B1).
Gonda taught oral (e.g., lozenge, at 0022-0023]; pouches at [00194 and Tables 5-8]; chewing gum at [00139]; spray at [0079]) products [0022, 00139, 00157] comprising nicotine [claim 1]; and, vegetable or mineral oil carriers (e.g., reads on liquid hydrophobic carrier) [00118]. Alcohols were also taught, generally, as carriers [00123].
Although Gonda generally taught alcohols, Gonda did not teach borneol, as recited in claim 2.
Gin taught oral products (e.g., chewing gum, at [claim 31]) comprising nicotine as a beneficial agent [abstract], and further comprising borneol as an alcohol [0046], and as a flavoring agent [claim 22]. Flavoring agents provided for extremely effective taste-masking [0016; see also claim 58], where an effective amount may be determined by one of ordinary skill in the art using routing experimentation [0026].
Since Gonda generally taught alcohol, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Gonda, borneol, as taught by Gin. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, it is prima facie obvious to select borneol for incorporation into an oral product, based on its recognized suitability for its intended use as an alcohol, as taught by Gin et al. Furthermore, the ordinarily skilled artisan would have been motivated, in including borneol within the teachings of Gonda, to provide for extremely effective taste-masking, as taught by Gin et al.
Although the combined teachings of Gonda and Gin generally taught flavoring agents, the combined teachings of the prior art did not teach camphor, as instantly recited.
Nevertheless, Johnson taught oral products (e.g., chewing gum at the abstract) comprising nicotine [claim 1], and further comprising camphor as a flavor component [col 10, lines 35-40].
Since the combined teachings of Gonda and Gin generally taught flavoring agents, it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of Gonda and Gin, camphor, as taught by Johnson. It is prima facie obvious to select camphor for incorporation into an oral product, based on its recognized suitability for its intended use as a flavoring agent, as taught by Johnson et al.
The instant claim 2 recites “the compound is dissolved in the liquid hydrophobic carrier.” The limitation of dissolving the compound in the liquid hydrophobic carrier is a product-by-process limitation. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Even though product-by-process claims are limited by and defined by the process, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as, or obvious from, a product of the prior art, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the oral product of the combined teachings of Gonda (nicotine, liquid hydrophobic carrier), Gin (nicotine, borneol) and Johnson (nicotine, camphor) read on the claimed oral product. As such, the patentability of the instant product does not depend on its method of production, and the Applicant’s limitation regarding the process of dissolving the compound in the liquid hydrophobic carrier is not patentable, in view of the combined teachings of Gonda, Gin and Johnson. MPEP 2113.
Further regarding claim 2, the claim recites that “the compound is present in an effective amount to have a non-detectable taste during use”. Gin taught flavoring agents (borneol) provided for extremely effective taste-masking, where an effective amount may be determined by one of ordinary skill in the art using routing experimentation. It appears that the product of the instant claims and that of the combined teachings of the prior art would reasonably be expected to have substantially the same physical and chemical properties (non-detectable taste).
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition (borneol and amounts thereof) and its properties (non-detectable taste) are inseparable. If the prior art teaches the identical chemical compounds, then the properties that the Applicant discloses and/or claims are necessarily present (see MPEP 2112).
Gonda, in view of Gin and Johnson, reads on claims 2-3, 11, 13-14, 16 and 19-20.
Claim 17 is rendered prima facie obvious because Gonda taught encapsulation of ingredients [claim 3, ¶s [0020-0021, 0069, 0080, 0083, 0087].
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonda et al (WO 2008/069970 A2), in view of Gin et al (US 2004/0151771 A1) and further in view of Johnson et al (USP 6,627,234 B1) and further in view of Meyer et al (US 2010/0063110 A1).
The pre-AIA 35 U.S.C. 103(a) rejection over Gonda, Gin and Johnson was previously discussed.
Additionally, Gonda taught pouches, as previously discussed.
Although Gonda generally taught pouches, Gonda was not specific dimensions, as recited in claim 15.
Nevertheless, Meyer taught oral products, comprising nicotine, and formulated as pouches, where the product was cut into rectangles with side lengths of 0.5-3 cm (5-30 mm) and 2-20 cm (20-200 mm) [0034], in order to pack individually in pouches [Example 1, 0040, 0045-0046].
Since Gonda generally taught pouches, it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of Gonda, Gin and Johnson, rectangular dimensions with side lengths of 0.5-3 cm (5-30 mm) and 2-20 cm (20-200 mm), as taught by Meyer. The ordinarily skilled artisan would have been motivated to pack the oral products individually in pouches, as taught by Meyer [Examples throughout, and at [0040 and 0045-0046].
The instant claim 15 recites dimensions ranging from 20-35 mm, 10-20 mm and 3-6 mm.
Meyer taught dimensions, with four sides (e.g., rectangle), with sides of dimensions 5-30 mm and 2-20 mm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gonda et al (WO 2008/069970 A2), in view of Gin et al (US 2004/0151771 A1) and further in view of Johnson et al (USP 6,627,234 B1) and further in view of Mishra et al (US 2008/0202533 A1).
The pre-AIA 35 U.S.C. 103(a) rejection over Gonda, Gin and Johnson was previously described.
The combined teachings of the prior art did not teach a coating, as recited in claim 18.
Mishra taught tobacco products contained within a coating, where the coating comprised a soluble component and an insoluble component, to both dissolve upon placement in the mouth, and maintain the tobacco for the duration of use of the product [abstract, 0007]. The coating facilitated placement of the tobacco product in the mouth, enhanced cohesiveness of the tobacco product when inserted in the mouth, and provided additional flavor carrying moisture upon dissolution [0016-0017]. Finally, the coating was aesthetically pleasing, non-tacky, and pleasant to touch, while being strong enough to maintain the integrity of the material contained inside the coating during insertion and placement in the mouth [0018].
Since the combined teachings of Gonda, Gin and Johnson taught oral products, it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of the prior art, a coating, as taught by Mishra. The ordinarily skilled artisan would have been motivated to facilitate placement of the contained ingredients in the mouth, enhance cohesiveness of the contained product when inserted in the mouth, provide additional flavor, and provide a product that was aesthetically pleasing, non-tacky, and pleasant to touch, while being strong enough to maintain the integrity of the material contained inside the coating during insertion and placement in the mouth, as taught by Mishra et al [abstract, 0007 and 0019-0018].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELESTE A RONEY whose telephone number is (571)272-5192. The examiner can normally be reached Monday-Friday; 8 AM-6 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, Frederick Krass can be reached at 571-272-0580. 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.
/CELESTE A RONEY/Primary Examiner, Art Unit 1612