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 .
This office action is in response to preliminary amendment filed on 5/23/24. Claims 1-144 are cancelled and claims 145-164 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 164 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 164 is not totally supported. The claim recites “ a water activity of less than .7”. This range encompasses any water activity below .7 which is not disclosed in the specification. Original claim 89 recites about.45 to about .6 and claim 90 recites about .5. Paragraph 0075 discloses about .45-.7. There is no disclosure that applicant is in possession of formulation having water activity below .45.
Claims 147-149,157-161 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 147 is vague and indefinite because it’s not clear what is being claimed. The claim recites “ polyphenols are present in a concentration at least 3X that of bee made honey. However, the amount of polyphenols in bee made honey is not recited in the claim. Thus, it’s not clear what 3 times that amount encompasses and if the amount exceeds the range of .001 to about 5% cited in claim 145. Therefore, it’s unclear how the claim further limits claim 145.
Claim 148 is vague and indefinite because it’s unclear how the concentration is related to the range recited in claim 145. It’s unclear if the concentration is within the range claimed in claim 145. The recitation of “ the total polyphenols” does not have antecedent basis.
Claim 149 has the same problem as claim 148.
Claim 157 is vague and indefinite because it is not clear what is being claimed. The claim recites “ substantially similar to bee made honey” but it’s unclear what this encompasses. What does substantially similar denote, the taste,flavor, viscosity, etcc or what. There are also different kinds of honey; thus, it not clear what the comparison is being made against.
Claims 158-161 have the same problem as claim 157. The ground of comparison is unclear because there are many different kinds of honey. It’s not clear what honey the claims are targeting. It’s unclear what would constitute as “ substantially similar”. It is unclear how characteristics like mouthfeel, taste, aroma are being measured to determine that they are substantially similar to bee made honey and what bee made honey are they closed to.
Claim Rejections - 35 USC § 103
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) 145-164 is/are rejected under 35 U.S.C. 103 as being unpatentable over An et al “ Efficiency of Polyphenol Extraction from Artificial Honey Using C18 Cartridges and Amberlite XAD-2 Resin: A Comparative study” in view of Carlos “ Role of honey polyphenols in health”, Han ( KR 1021848823) and Eisele ( 11744272).
For claims 145,146, 152. An discloses an artificial honey comprising 38.5% fructose and 31% glucose. Phenolic acids and flavornoids are added to achieve 50microgram/mL of each polyphenol standard. The flavonoids include quercetin ( 50 microgram/mL of quercetin equals to .005%). Flavonoids are polyphenols. An does not disclose adding protein. The claimed amount of less than .17% includes 0 amount. ( see page 2, the materials and method section)
An does not disclose adding one or more organic acid in the claimed amount and sea buckthorn extract as in claim 145, the amounts as in claims 147-149, the ingredient as in claim 150, the amount as in claim 151, the amount as in claims 153-156, the properties as in claims 157-161, the pH as in claim 162, the antioxidant capacity as in claim 163 and the water activity as in claim 164.
Han discloses an antioxidant composition comprising sea buckthorn extract. Han teaches that sea buckthorn extract contains vitamins, flavonoids, essential amino acids and fatty acids thereby exhibiting a high antioxidant and anti-inflammatory effect, a female disease prevent effect and diet effect. ( see page 4)
Carlos discusses the role of honey polyphenols in health. Carlos teaches that honey is mainly composed of water and sugar with the remainder being substances such as amino acids, enzymes, flavonoids, phenolic acids, proanthocyanidin, ascorbic acid, citric acid, gluconic acid et.. Polyphenols, especially flavonoids and phenolic acids are known to play an important role as antioxidant. Honey has benefits and therapeutic properties due to the presence of polyphenols. ( see pages 141-144)
Eisele discloses honey compositions. Eisele teaches gluconic acid, other acids are present in honey and honey is mildly acidic having a pH about 3.9 such as from 3.1-6.1. Honey has a low moisture content of 13-26% and a low water activity of .562-.62. ( see col. 3 lines 22-35)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to add organic acid to the artificial honey disclosed in An because organic acid is known to be present in natural honey as taught in Carlos and Eisele. One skilled in the art would have been motivated to add organic acids to make the artificial honey to resemble natural honey. Eisele discloses that natural honey has a pH of from 3.1-6.1. It would have been obvious to one of ordinary skill in the art to determine amounts of organic acid to add to achieve such pH so that the artificial would be closed to natural honey. The claimed formulation has the same pH range as disclosed in Carlos. Thus, when organic acids are added to achieve such pH, it’s obviously inherent the amount would be within the range claimed. It would have been obvious to add gluconic acid because it’s an acid known to be present in natural honey as shown in Eisele and Carlos. It would have been obvious to one of ordinary skill in the art to add sea buckthorn extract as disclosed in Han to the artificial honey in An to further enhance the nutritive value of the artificial honey. Han teaches that buckthorn extract has high antioxidant and anti-inflammatory effect. An artificial honey will not have all the components of natural honey and thus the benefits of natural honey. Thus, one of ordinary skill in the art would have been motivated to add ingredient that is known to enhance the composition to resemble its natural counterpart. It would have been obvious to one of skilled in the art to determine the amount depending on the extent of health effect desired. Such parameter can be determined through routine experimentation. The amounts claimed in claims 147-149 are indefinite as explained in the 112 rejection above. The amount of polyphenols disclosed in An fall within the range recited in claim 145. Thus, it’s expected the concentration in claims 147-149 is met. In any event, polyphenols are the components that give honey its many health benefits as discussed in Carlos. Thus, it would have been obvious to one skilled in the art to determine the amount depending on the extent of health benefits desired. It would have been obvious to proanthocyanidins to make the artificial honey to resemble natural honey because Carlos shows that proanthocyanidins are present in natural honey. It would have been obvious to determine the amount depending on the extent of antioxidant effect desired. It would have been obvious to one of ordinary skill in the art to make the artificial honey to resemble natural honey in all properties to obtain the most optimum product. It would have been obvious to one of ordinary skill in the art to form the artificial honey to have the water activity that is found in natural honey as taught in Eisele. It would have been obvious to one of ordinary skill in the art to determine the antioxidant capacity that would give the most optimum health benefits to the artificial honey that is closely correlated to natural honey.
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 145-164 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5,12-17, 29-41,77 of copending Application No. 19/012569 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to non-bee made honey comprising similar ingredients. The co-pending does not recite adding gluconic acid and the percent of polyphenols as in the instant application. However, the difference is not patentably distinct as it would have been obvious to add any known organic acid. It would have been obvious to add polyphenols in amounts that would give optimum health benefits to the honey formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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November 5, 2025
/LIEN T TRAN/Primary Examiner, Art Unit 1793