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 .
Status of Claims
The amendments to the claims filed March 25, 2026 are acknowledged and entered. Claims 2, 12, 14 and 17 are pending.
Priority
This application is a 371 of PCT/EP2022/060700, filed April 22, 2022, which claims priority of NL2028053, filed April 23, 2021.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on October 19, 2023 and February 19, 2026. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Election/Restriction
Applicant’s election without traverse of Group 2 (claims 2, 12, 14 and 17) and election with traverse of the species corresponding to lauroyl lactylate in the reply filed March 25, 2026 is acknowledged. Applicant’s argument regarding the species election requirement is found persuasive. The election of species requirement set forth in the office action mailed February 3, 2026 is hereby withdrawn. The full scope of the claims is presently under examination.
Claim Rejections - 35 USC § 112b
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 12 is 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 12 recites the limitation "infection" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 12 depends from claim 2 which does not recite an infection.
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) 2, 14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cazemier (WO2009/092787 A1, cited by Applicant in IDS filed October 19, 2023)(hereinafter “Cazemier”) in view of Abril et al. (Toxins 2020, 12, 537, pages 1-18)(hereinafter “Abril”).
The instant claims are drawn to a method of preventing or treating mastitis in a ruminant animal, the method comprising: administering a lactylate to the animal, wherein the lactylate is selected from one or more of lauroyl lactylate, myristoyl lactylate, cetyl lactylate, palmitoyl lactylate or oleic lactylate and the sodium salts thereof.
Regarding claims 2, 14 and 17, Cazemier teaches a method of treating or preventing an infection caused by gram-positive bacterial in a ruminant animal comprising administering an antimicrobial compound to the animal wherein the compound is a lactylate (claim 1, claim 8; page 2, lines 10-20, method and composition for animal feed…including ruminants). Cazemier teaches lauroyl lactylate, myristoyl lactylate and their sodium salts are particularly preferred (page 6, lines 1-5)
Further regarding claim 14, Cazemier teaches the antimicrobial compound is comprised in a ruminant nutrition composition for preventing or treating the infection (claim 7).
Further regarding claim 17, Cazemier teaches wherein the animal is a ruminant including cattle or goat, (page 2, lines 10-20).
Cazemier is silent regarding wherein the method is for treating mastitis. However, Abril teaches staphylococcus aureus (a bacteria) is one of the major causes of bovine (cow), ovine (sheep) and caprine (goat) mastitis, resulting in substantial reduction in both milk production and quality, generating considerable economic losses in the dairy industry (page 2 of 18, Introduction: Staphylococcus aureus is a frequent food contaminant…it is one of the major causes of bovine, ovine and caprine mastitis… This bacterial pathogen can produce… ). Cazemier teaches staphylococcus aureus is a gram-positive organism (page 2 of 18, introduction: S aureus is a Gram-positive…organism).
The difference between the prior art and the instant claims is that the instant claims recite a method of treating mastitis in a ruminant animal comprising administering a lactylate to the animal. However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to use the method of treating infection caused by gram-positive bacteria that was disclosed by Cazemier to treat mastitis as required by the claims because at the time it was known, as taught by Abril, that mastitis was caused by a gram-positive bacteria.
One would have been motivated as a matter of treating mastitis in a ruminant animal which was known to result in substantial reduction in both milk production and quality and generate considerable economic losses in the dairy industry (Abril). One would have been especially motivated to use the method of Cazemier to treat mastitis because the method treated infections caused by gram-positive bacteria, mastitis was known to be caused by a gram-positive bacteria, and treating the causative agent of mastitis would have been viewed as a possible therapy for treating or preventing the condition.
One would have had a reasonable expectation of success because the method of Cazemier treated infections caused by gram-positive bacteria and mastitis was known to be caused by a gram-positive organism. One of ordinary skill in the art therefore would have reasonably expected that the method of Cazemier would treat the causative agent of mastitis and thus have the effect of treating or preventing mastitis.
Claim(s) 2, 12, 14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Songlin (CN102948652, cited by Applicant in IDS filed October 19, 2023 )(hereinafter “Songlin”) in view of Cosmetic Ingredient Review (Safety Assessment of Alkyl Lactyl Lactate Salts as Used in Cosmetics, 2018, pages 1-102) (hereinafter “CIR”).
Regarding claim 2, 12, 14 and 17, Songlin teaches a method of treating mastitis in a cow comprising administration of a composition comprising sodium stearoyl lactylate, wherein the method has the effect of increasing milk production (see page 2 of English translation, lines 15-20: a ruminant fat powder comprising sodium stearoyl lactylate; see page 8 of translation, lines 5-6: the diet is to add ruminant fat powder to the basic diet; and lines 15-20, it can be seen that milk production increased by a large amount…so it has an effect on the improvement of dairy cow mastitis).
Further regarding claim 14, Songlin teaches the ruminant fat powder is easily digest, absorbed, and utilized by the rumen digestive system (page 1 of translation, lines 25-30). The powder as disclosed by Songlin is a ruminant nutrition composition.
Further regarding claim 12, Songlin does not teach the ruminant fat powder is for preventing or treating infection.
Further regarding claim 17, Songlin teaches cows (cattle) were fed the ruminant fat powder ( see page 8 of translation, Test example, the concentrate is supplied…after milking and calving of milk cows).
Songlin is silent regarding the lactylate required by the instant claims. However, CIR teaches lactylates are a class of compounds with related structure and properties that include sodium stearoyl lactylate as well as sodium lauroyl lactylate and oleic lactylate of the claims (see page 10, Definition and General Characterization; see Table 1, chemical structures of sodium lauroyl lactylate, sodium oleoyl lactylate and sodium stearoyl lactylate; see Table 2. Chemical and Physical Properties of Alkyl Lactyl Lactate Salts).
The difference between the prior art and the claimed invention is that the claimed invention requires administration of lauroyl lactylate or oleic lactylate or sodium salts thereof. However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the method of Songlin to treat mastitis comprising administration of lauroyl lactylate or oleic lactylate or sodium salts thereof as required by the claims because lactylates were a known class of compounds with similar structure and properties.
One would have been motivated as a matter of determining if feeding other lactylates, including lauroyl lactylate or oleic lactylate or sodium salts thereof, were more effective than sodium stearoyl lactylate in treating mastitis and resulted in a greater production of milk which would have been desirable.
One would have had a reasonable expectation of success because Songlin had already shown a composition comprising a lactylate treated mastitis and lactylates, including those claimed, were known to have similar structure and chemical properties. One skilled in the art therefore could have reasonably expected that the claimed lactylates may also have the effect of treating mastitis.
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 2, 14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-9 of copending Application No. 18/013,791 (reference application) in view of Abril et al. (Toxins 2020, 12, 537, pages 1-18)(hereinafter “Abril”).
The instant claims are drawn to a method of preventing or treating mastitis in a ruminant animal, the method comprising: administering a lactylate to the animal, wherein the lactylate is selected from one or more of lauroyl lactylate, myristoyl lactylate, cetyl lactylate, palmitoyl lactylate or oleic lactylate and the sodium salts thereof.
It is noted that the instant claims are drawn to a method “comprising” and therefore administration of additional elements are not excluded from the method. See MPEP 2111.03 Transitional Phrases for further detail.
Claim 1 of the reference application is drawn to a stable liquid ingredient composition comprising: oleyl lactylate and/or salts thereof (OL); a further lactylate selected from lauroyl lactylate and/or salts thereof (LL) or a mixture of lauroyl lactylate and myristoyl lactylate and/or their salts (LL/ML-blend); and a diluent, wherein the diluent comprises monopropylene glycol (MPG). Claims 2-5 and 7-9 of the reference application depend from claim 1 and recite additional limitations to the composition.
The reference claims are thus drawn to a composition comprising a lactylate, including lauroyl lactylate or myristoyl lactylate as recited in the instant claims.
The specification of the reference application teaches the composition is useful as a food for preventing or reducing bacterial infections in animals (see Field, lines 5-9). In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008);Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The reference claims are silent regarding administering the composition to treat mastitis in a ruminant animal. However, Abril teaches staphylococcus aureus (a bacteria) is one of the major causes of bovine (cow), ovine (sheep) and caprine (goat) mastitis, resulting in substantial reduction in both milk production and quality, generating considerable economic losses in the dairy industry (page 2 of 18, introduction).
The difference between the reference claims, prior art and the instant claims is that the instant claims recite a method of treating mastitis in a ruminant animal comprising administering a lactylate to the animal. However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to use the composition of the reference application to treat mastitis because at the time it was known, as taught by Abril, that mastitis was caused by a bacterial infection.
One would have been motivated as a matter of treating mastitis in a ruminant animal which was known to result in substantial reduction in both milk production and quality, and generate considerable economic losses in the dairy industry. One would have been especially motivated to use the composition of the reference application because it was disclosed to be useful for preventing or reducing infections in animals and treating the causative agent of mastitis would have been viewed as a possible therapy for treating or preventing the condition.
One would have had a reasonable expectation of success because the composition of the reference application was disclosed to be useful for treating infections caused by bacteria and mastitis was known to be caused by a bacterial infection. One of ordinary skill in the art therefore would have reasonably expected that the composition of the reference application would have the effect of treating or preventing mastitis.
This is a provisional nonstatutory double patenting rejection.
Claim 2, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,329,638 B2 or claims 1-10 of U.S. Patent No. 7,973,006 B2 in view of Hogan et al. (Vet. Res. 34 (2003) 507-519)(hereinafter “Hogan”).
U.S. Patent No. 8,329,638 B2
Patent claim 1 is drawn to an antibacterial composition comprising a combination of
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Patent claim 2 depends from patent claim 1 and recites the lactylate is selected from…oleic-lactylate, which is a lactylate of the instant claims.
Patent claims 3-6 depend from patent claim 1 and recite additional limitations to the composition.
Patent claim 7 depends from patent claim 1 and recites a method for reduction or prevention of the presence, growth or activity of gram-negative bacteria into, or on, a product, the method comprising applying the antibacterial composition of claim 1 into the product or the surface.
Patent claim 8 depends from patent claim 7 and recites wherein the gram-negative bacteria is a bacterium from the family of Escherichia coli.
The patent claims are thus drawn to a composition comprising a lactylate, including oleic-lactylate as recited in the instant claims, which is useful for reducing or preventing the growth of gram-negative bacteria.
U.S. Patent No. 7,973,006 B2
Patent claim 1 is drawn to an antibacterial composition comprising a combination of
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Patent claim 2 depends from patent claim 1 and recites the lactylate is selected from…oleic-lactylate, which is a lactylate of the instant claims.
Patent claims 3-7 depend from patent claim 1 and recite additional limitations to the composition.
Patent claim 8 depends from patent claim 1 and recites a method for reduction or prevention of the presence, growth or activity of gram-negative bacteria into, or on, a product, the method comprising applying the antibacterial composition of claim 1 into the product, or on the surface.
Patent claim 9 depends from patent claim 8 and recites wherein the gram-negative bacteria is a bacterium from the family of Escherichia coli.
Patent claim 10 depends from patent claim 1 and recites a food product or a feed or drink product for animals comprising the antibacterial composition of claim 1.
The patent claims are thus drawn to a composition comprising a lactylate, including oleic-lactylate as recited in the instant claims, which is useful for reducing or preventing the growth of gram-negative bacteria, including wherein the composition is used in a feed product for animals.
The abovementioned patent claims do not recite a method of preventing or treating mastitis in a ruminant animal as required by the claims; however, Hogan teaches gram-negative bacteria, including Escherichia coli, are a cause of mastitis in cows (Abstract: Gram-negative bacteria that commonly cause bovine mastitis; see also page 508, introduction, col 1: Gram-negative bacteria are the etiological agents most often isolated…Genera classified are Escherichia…; see page 508, Etiology: Diagnoses of intramammary infections caused by Gram-negative bacteria…).
The difference between the patent claims, prior art and the instant claims is that the instant claims recite a method of treating mastitis in a ruminant animal comprising administering oleic lactylate to the animal. However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to use the composition of the reference application to treat mastitis because at the time it was known, as taught by Hogan, that mastitis was caused by a gram-negative bacteria including Escherichia coli.
One would have been motivated as a matter of treating mastitis in a cow. One would have been especially motivated to use the compositions of the patent claims because they were useful in a method for preventing or reducing gram-negative infections and mastitis was caused by gram-negative bacteria. Moreover, claim 10 of U.S. Patent No. 7,973,006 was explicitly drawn to a food product for animals. Treating the causative agent of mastitis with an animal food comprising an antibacterial agent would have been viewed as a possible therapy for treating or preventing the condition.
One would have had a reasonable expectation of success because the composition of the reference application was disclosed to be useful for treating infections caused by gram-negative bacteria, including E. coli, and mastitis was known to be caused by such a bacterial infection. One of ordinary skill in the art therefore would have reasonably expected that the compositions of the patent claims would have the effect of treating or preventing mastitis.
Conclusion
No claim is allowed.
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April 16, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
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