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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 10-20 in the reply filed on 08/26/2026 is acknowledged. The traversal is on the ground(s) that the holding of a restriction does not account for the method as actually claimed. More specifically, Applicant argues that antibiotics are not the claimed phytogenic essential oil composition and do not show that the claimed process can be practiced as claimed using a materially different product. This is not found persuasive because the inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the claimed method comprises the following active steps: providing a drinking water supplemented with phytogenic composition to post-weaning (PW) piglets. And, antibiotics can be provided, instead of a drinking water supplemented with phytogenic composition, to post-weaning (PW) piglets.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-20 are pending. Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/26/2026. Claims 10-20 are under examination.
Claim Objections
Claim 10 is objected to because of the following informalities: The use of the abbreviation “PW” without first providing the non-abbreviated form. To overcome the objection, insert “post-weaning” at the first instance of “PW”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-14 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 13, which depends on claim 10, recites “the eugenol”. There is insufficient antecedent basis for “the eugenol”.
Claim 14, which depends on claim 10, recites “the tea tree oil”. There is insufficient antecedent basis for “the tea tree oil”.
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)(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.
(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) 10-11 is/are rejected under 35 U.S.C. 102 (a)(1) or (2) as being anticipated by Sojourner’s Sojourns, as evidenced by Cleveland Clinic.
Sojourner’s Sojourns. Make Your Own Mouthwash! https://sojournersojourns.com/sojourners-sojourns-travel-and-wellness-blog/tag/Clove+and+Tea-Tree+Oil+Mouthwash. Published June 2014.
Cleveland Clinic. Do Cloves Have Any Health Benefits? https://health.clevelandclinic.org/benefits-of-cloves. Published September 8, 2023.
Claims 10 is directed toward a composition comprising water and a phytogenic composition comprising essential oils. Sojourner’s Sojourns teaches adding clove and tea tree oil to water. [Directions section] Sojourner’s Sojourns does not establish that clove contain eugenol. However, Cleveland Clinic establishes that clove contains eugenol, which is an essential oil. In the instant case, Sojourner’s Sojourns teaches a composition comprising water and a phytogenic composition comprising eugenol and tea tree oils, both are essential oils.
The recitation “wherein PW piglets in a nursery provided drinking water with the phytogenic composition have a reduced mortality rate relative to PW piglets provide drinking water without the phytogenic composition” has been considered. However, MPEP 2111.04 states, “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.”
In the instant case, said wherein clause is directed toward the intended effect of the claimed composition when it is being used. Given this, the wherein clause does not limit the scope of the claim nor does it limit the claim to a particular structure.
Claim 11, which depends on claim 10, requires the essential oils to comprise eugenol and tea tree oil. As noted above, Sojourner’s Sojourns teaches a composition comprising of water and a phytogenic composition comprising eugenol and tea tree oils, both are essential oils.
Claim(s) 10-11 and 15-17 is/are rejected under 35 U.S.C. 102 (a)(1) or (2) as being anticipated by Markus, as evidenced by Cleveland Clinic.
Markus. USPGPub 20160050914, published Feb 25, 2016
Cleveland Clinic. Do Cloves Have Any Health Benefits? https://health.clevelandclinic.org/benefits-of-cloves. Published September 8, 2023.
Regarding claim 10, Markus teaches a composition comprising at least one microencapsulated essential oil. [Claim 1] Markus teaches that the at least one essential oil may be selected from a group of essential oils that includes clove and tea tree oil. [Claim 2] Markus teaches that a combination of essential oils may be used. [Claim 2] In the instant case, Markus teaches the claimed phytogenic composition comprising essential oils.
Markus also teaches a liquid formulation comprising the composition of at least one microencapsulated essential oils, wherein the formulation is a liquid. [Claim 8] Markus teaches that formulation can consist of the composition suspended in carriers, such as water. [0058]
The recitation “wherein PW piglets in a nursery provided drinking water with the phytogenic composition have a reduced mortality rate relative to PW piglets provide drinking water without the phytogenic composition” has been considered. However, MPEP 2111.04 states, “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.”
In the instant case, said wherein clause is directed toward the intended effect of the claimed composition when it is being used. Given this, the wherein clause does not limit the scope of the claim nor does it limit the claim to a particular structure.
Regarding claim 11, as noted above, the essential oils that Markus teaches include clove oil and tea tree oil. However, Cleveland Clinic establishes that clove contains eugenol, which is an essential oil. In the instant case, Markus teaches the claimed phytogenic composition comprising eugenol and tea tree oil.
Regarding claim 15, as noted above, Markus teaches the claimed phytogenic composition comprising eugenol and tea tree oil. [Claim 2] Markus also teaches that the concentration of the oils within a formulation may vary between 0.1% to 90%. [0406] The noted 0.1 wt% endpoint is within the claimed wt% of about 0.005-0.1.
Regarding claim 16, as noted above, Markus teaches the claimed phytogenic composition comprising eugenol and tea tree oil. [Claim 2] Markus also teaches that the concentration of the oils within a formulation may vary between 0.1% to 90%. [0406] The noted 0.1 wt% endpoint is the same as the claimed 0.1.
Regarding claim 17, Markus teaches that the formulation may have composition comprising the same microcapsules, wherein the microcapsules comprise the same mixture of essential oils. [0099]
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 12-14 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markus, as evidenced by Cleveland Clinic.
Markus. USPGPub 20160050914, published Feb 25, 2016
Cleveland Clinic. Do Cloves Have Any Health Benefits? https://health.clevelandclinic.org/benefits-of-cloves. Published September 8, 2023.
Regarding claim 12, Markus teaches that the concentration of the oils within a formulation may vary between 0.1% to 90%. [0406] The noted wt% overlaps with claimed wt% of 5-40. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 13, as noted above, Markus teaches the claimed phytogenic composition comprising eugenol and tea tree oil. [Claim 2] Markus also teaches that the concentration of the oils within a formulation may vary between 0.1% to 90%. [0406] The noted wt% overlaps with claimed wt% of 3-20. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 14, as noted above, Markus teaches the claimed phytogenic composition comprising eugenol and tea tree oil. [Claim 2] Markus also teaches that the concentration of the oils within a formulation may vary between 0.1% to 90%. [0406] The noted wt% overlaps with claimed wt% of 3-20. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 18, Markus teaches a composition comprising at least one microencapsulated essential oil. [Claim 1] Markus teaches that the at least one essential oil may be selected from a group of essential oils that includes clove and tea tree oil. [Claim 2] Markus teaches that a combination of essential oils may be used. [Claim 2] In the instant case, Markus teaches the claimed phytogenic composition comprising essential oils.
The essential oils that Markus teaches include clove oil and tea tree oil. However, Cleveland Clinic establishes that clove contains eugenol, which is an essential oil. In the instant case, Markus teaches the claimed phytogenic composition comprising eugenol and tea tree oil.
Markus teaches that the concentration of the oils within a formulation may vary between 0.1% to 90%. [0406] The noted wt% overlaps with claimed wt% of 5-15. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 19, Markus teaches that the concentration of the oils within a formulation may vary between 0.1% to 90%. [0406] The noted wt% overlaps with claimed wt% of 7.5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 20, as noted above, Markus teaches microencapsulation of the essential oils.
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 10-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 24, 28, 31 , 37-39of copending Application No. 19/523981(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are directed toward a composition comprising at least 2 microencapsulated essential oils. It is noted that claims of the copending application do not require the presence of tea tree oil; however, Markus teaches a formulation that comprises a composition comprising at least 2 microencapsulated essential oils, wherein the oils include tea tree oil.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
