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 .
DETAILED ACTION
The Amendments filed on 2/13/2026 has been received and entered.
Claims 1-20 are pending. Claims 1-3 and 8-14 are examined on the merits. Claims 4-7 and 15-20 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-14), the species honey, sodium gluconate, a preservative, benzoic acid, eye drop, aqueous carrier, in the reply filed on 2/13/2026 is acknowledged.
Claims 4-7 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/13/2026. Claims that are dependent on non-elected species claims are also withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-3 and 11-14 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(s) 1 is directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims honey, which is a product from honey bees. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, in claim 1, the honey as an eye drop would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition contains a mixture of products that are found in nature (the individual natural molecules) and thus must be evaluated as per the described analysis. As for Claim 14 with aqueous carrier, this ingredient can derive from product of nature, such as water. Mixing together various natural molecules doesn’t change those molecules per se; they are simply mixed together and thus would have the same characteristics as the same molecules prior to being mixed together.
In this case, claims 11-12, the pH from about 3.5-4.5 does not make the product have markedly different characteristic. Honey inherently has a pH of about 3.5-4.5.
Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application.
The composition of honey and an aqueous carrier together are naturally found. However, a composition can be used in many different ways and thus not integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” The mixing of honey with water are well understood, routine, and conventional method of making a product for supplementing nutrition such as a tea or beverage (see 2025, https://draxe.com/nutrition/honey-water-benefits/ Honey Water Benefits and How to Make It - Dr. Axe). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 8-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moloney (WO 2016/011498).
Moloney teaches a composition comprising honey, a preservative, and an aqueous carrier for the treatment of ophthalmic condition (Abstract). A preservative includes benzoic acid or sodium benzoate (page 8, lines 20-30), which meet the limitations of Claims 9 and 10). Honey property acid pH is 3.8-4.6 (page 1, lines 22-23), which meets the limitation of Claims 11-12. The composition can be in the form of an eye drop, eye spray, eye wash (page 13, lines 29-30), which meets the limitation of Claims 13. The amounts of honey ranges from 2-50% w/w/ (Claim 1), from 2-45% w/w (Claim 2), from 7-18% w/w (Claim 3), in an amount of about 16.5% w/w (Claim 4), which meet the limitations of Claims 2-3).
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moloney (US 2004/0121020 A1).
Moloney teaches a composition of honey in the amount of at least 50%, in the range of 70-90% [0014] and a surfactant (Claim 1), which is a pharmaceutically acceptable carrier.
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 1-3 and 8-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, and 12 of U.S. Patent No. 11154578 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amount ranges are not the same.
U.S. Patent No. 11154578 B2 teaches
1. A composition comprising honey, a preservative, and an aqueous carrier, wherein, by weight of the composition, the honey is present in a therapeutically effective amount in the range of from 2% (w/w) to less than 25% (w/w), wherein the preservative is selected from the group consisting of benzoic acid, sorbic acid, a flavonoid, a phenolic acid, abscisic acid, ascorbic acid, pharmaceutically acceptable salts and combinations thereof; and wherein the composition is in the form of a nasal lavage, nasal spray, eye drop, eye spray, eye wash, ear wash, ear drop, throat spray, douche, wound dressing hydrator, wound cleansing solution, or lung aspirant.
2. The composition according to claim 1, wherein the honey is present in an amount in the range of from 7 to 18% w/w.
3. The composition according to claim 1, wherein the honey is present in an amount of about 16.5% w/w.
4. The composition according to claim 1, wherein the preservative is benzoic acid or a pharmaceutically acceptable salts thereof.
5. The composition according to claim 4, wherein the salt of benzoic acid is sodium benzoate.
6. The composition according to claim 1, wherein the aqueous carrier is saline.
9. The composition according to claim 1, wherein the pH of the composition is in the range of from 3.8 to 4.2.
12. The composition according to claim 1, which is in the form of a nasal lavage, eye drop, eye spray, eye wash, ear wash, ear drop, throat spray, douche, wound dressing hydrator, wound cleansing solution or lung aspirant.
However, the honey amount ranges from about 2-98% w/w is not taught.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising ranges from about 2-98% w/w of the active agent combination for the following reasons. The reference does teach the composition for treating eye. U.S. Patent No. 11154578 B2 teaches a composition comprising honey, a preservative, and an aqueous carrier, wherein, by weight of the composition, the honey is present in a therapeutically effective amount in the range of from 2% (w/w) to less than 25% (w/w) (Claim 1). Thus, it would have been obvious to make a concentrated composition containing honey for use as composition for eye. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655