DETAILED ACTION
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 .
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.
DETAILED ACTION
Election/Restrictions - Groups
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-8, drawn to an intramammary teat sealant composition, wherein said composition is injectable and comprises organic salt of glyceryl monostearate or calcium stearate, with particle size between 30 and 100 µm, in addition to mineral oil, titanium dioxide and stabilizer.
Group II, claims 9-12, drawn to a method of preparing an intramammary teat sealing composition.
As set for the in Rule 13.1 of the Patent Cooperation Treaty (PCT), “the international application shall relate to one invention only or to a group of inventions so linked as to from a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, “where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines “special technical features” as “those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.”
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The special technical feature of Group I is a composition comprising an organic compound containing a planar ring and a heat-stable solubilizing compound. This composition is not novel in view of Razzak (US 2010/0143510 A1; cited in IDS dated 8/21/2024), in further view of Mattei (US 4,439,420). Razzak teaches formulations useful as a teat sealant to prevent or treat mastitis in an animal (Abstract). Razzak teaches the compositions may comprise calcium stearate (pg 4, [0033]); titanium dioxide (pg 5, [0037], [0039]); mineral oil (pg 5, 0036]); and a stabilizer such as zinc oxide or titanium dioxide ([0037]).
Razzak dose not teach the particle size of calcium stearate.
Mattei teaches the missing element of Razzak.
Mattei teaches a medical sealant composition which is extrudable from a syringe comprising a biocompatible fatty acid salt in a biocompatible base such as a synthetic or natural oil (col 3: 43-47), the composition (Abstract; col 3: 15-20). Mattei teaches the fatty acid salt is calcium stearate (col 3: 61), preferably in a particle size of less than 100 microns (col 4: 45-51), overlapping the claimed range.
As such, Group I does not share a special technical feature with the instant claims of Group II. Therefore, the claims are not so linked within the meaning of PCT Rule 13.2 so as to form a single inventive concept, and unity between Groups I-II is broken.
Inventorship
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Rejoinder
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Telephonic Election
During a telephone conversation with attorney Christian Ehret on April 2, 2026. a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-12 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Status
Claims 1-12 are pending.
Claims 9-12 are withdrawn.
Claims 1-8 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Indefiniteness Rejection
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.
Claims 1-8 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 pre-AIA the applicant regards as the invention.
Claims 1 and 2 recites the limitation of an “organic salt of glyceryl monostearate or calcium stearate.” This limitation is considered indefinite since glyceryl monostearate is a neutral (uncharged) compound and is not capable of forming a salt. It is also unclear what is meant by an “organic salt” of calcium stearate since the compound is, in fact, a salt.
Claim 6 recites the limitation "the preservatives" in the second line. There is insufficient antecedent basis for this limitation in the claim.
Obviousness Rejection
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.
1) Claims 1-2 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Razzak (US 2010/0143510 A1; cited in IDS dated 8/21/2024), in view of Mattei (US 4,439,420).
Razzak teaches formulations useful as a teat sealant to prevent or treat mastitis in an animal (Abstract). Razzak teaches the compositions may comprise calcium stearate (pg 4, [0033]); titanium dioxide (pg 5, [0037], [0039]); mineral oil (pg 5, 0036]); and a stabilizer such as zinc oxide or titanium dioxide ([0037]).
For claim 6, Razzak teaches BHA (butylated hydroxy anisole) as a preservative (pg 5, [0038]).
Razzak dose not teach the particle size of calcium stearate, or the amount of calcium stearate in the sealant composition.
Mattei teaches the missing elements of Razzak.
Mattei teaches a medical sealant composition which is extrudable from a syringe comprising a biocompatible fatty acid salt in a biocompatible base such as a synthetic or natural oil (col 3: 43-47), the composition (Abstract; col 3: 15-20). Mattei teaches the fatty acid salt is calcium stearate (col 3: 61), preferably in a particle size of less than 100 microns (col 4: 45-51), overlapping the ranges claimed in claims 1 and 2. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 4, Mattei teaches the calcium fatty acid salt comprises 45-80% of the sealant composition (col 2: 61-64), overlapping the claimed range
For claim 5, Razzak teaches a formulation comprising mineral oil (“liquid paraffin”) in an amount of about 5% to about 50% w/w (pg 4, [0032]). Razzak teaches an amount of calcium stearate of up to about 10% (pg 5, [0033]), but Mattei teaches an amount of 45-80% (col 11, claim 1). Razzak teaches titanium dioxide in an amount of 0.5% to 25% as a colorant (pg 5, [0039]) or 0.5% to 2.5% as an opacifier (pg 5, [0037]), in each case overlapping the claimed range. Regarding the claim 5 limitation of preservatives in an amount of 0.05% to 0.60%, Razzak teaches BHA or BHT is present in an amount of from 0.01% to 2.0% ([0038]), overlapping the claimed range.
As for claims 6 and 7, the teachings of Razzak and Mattei set forth above for claim 5 also overlap the claimed ingredients and ranges.
The skilled artisan would have expected success in substituting Mattei’s calcium stearate comprising a particle size of less than 100 microns for the generic calcium stearate taught by Razzak, as well as utilizing the claimed amount of calcium stearate and oil, because Mattei teaches that calcium stearate in the range below 100 micron, and in the claimed ratio, create a safe and effective in vivo sealant.
2) Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Razzak (cited above), in view of Mattei (cited above) and Priyanka (“Microbicidal activity of TiO2 nanoparticles synthesised by sol-gel method,” IET Nanobiotechnol., 2016, Vol. 10, lss. 2, pp. 81-86).
The teachings of Razzak and Mattei are discussed above.
The combination of Razzak and Mattei does not teach anatase titanium dioxide.
Priyanka teaches the missing element of the combination of Razzak and Mattei.
Priyanka teaches: “It can be seen from Table 1 and Figs. 4-6 that the sample S1, (anatase TiO2), shows significant antimicrobial activity compared with samples S2 (TiO2-600) and S3 (rutile TiO2). Similar results are reported in literature.” See pg 84, left column, top. Table 1 (pg 83), is reproduced below.
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Greyscale
The skilled artisan would have expected success in substituting Priyanka's anatase titanium oxide for the titanium oxide taught by Razzak since Priyanka teaches both forms of titanium dioxide are effective antimicrobials. The skilled artisan could have been motivated to utilize anatase titanium dioxide since Priyanka demonstrates that the anatase titanium dioxide is a more potent antimicrobial than rutile or TiO2-600.
3) Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Razzak (cited above), in view of Mattei (cited above) and Li (“Insight into synergistic antioxidation mechanisms of butyl hydroxyanisole with common synthetic antioxidants,” Grain & Oil Science and Technology 5 (2022) 114–130).
The teachings of Razzak and Mattei are discussed above. It is noted that Razzak teaches antioxidants including BHT and BHA are “generally added to the formulation in amounts of from about 0.01% to about 2.0%, based upon total weight of the formulation, with about 0.05% to about 1.0% being especially preferred ([0038]).
The combination of Razzak and Mattei does not teach a combination of BHA and BHT antioxidants.
Li teaches the missing element of the combination of Razzak and Mattei.
Li teaches butyl hydroxyanisole (BHA) is usually blended with other synthetic antioxidants such as BHT to improve the antioxidative property due to synergistic antioxidation (Abstract). Li teaches a 1:1 wt/wt ratio of BHA to BHT (pg 115, section 2.2.; see also Fig. 1, chromatogram A).
The claimed composition requires an amount of butylhydroxytoluene of between 0.05% and 0.3% and an amount of butylhydroxyanisole of between 0.05% and 0.3%. Since Razzak teaches or suggests an amount of BHA and BHT of from 0.01% to about 2.0%, and Li teaches a 1:1 weight ratio of BHA to BHT in the composition has synergistic antioxidant properties, the amounts taught by Razzak, as modified by Li, overlaps with the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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