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 and Response to Amendments
The amendments filed September 9, 2026 have been acknowledged and entered. Claims 2, 12, 14 and 17 are pending.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Claim Objections and Allowable Subject Matter
Claim 12 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Applicant remarks regarding the obviousness rejection based on Songlin in view of CIR were found persuasive.
Rejections Necessitated by Applicant Amendment
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.
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”) and Lam et al. (Journal of Dairy Science Vol. 96, No. 2, 2013).
Regarding claims 2, 14 and 17, Cazemier teaches a method of treating or preventing an infection caused by gram-positive bacteria 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 improves udder health. 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).
Taken together neither reference recites improving udder health; however, Lam teaches improving udder health is the result of treating mastitis (Title; Abstract; Materials and Methods at page 1302: This strategy focused on improving udder health by educating farmers using comprehensive science-based and rational argumentation about mastitis prevention and treatment; Conclusion: In a 5-yr mastitis control program in the Netherlands… udder health seemed to have improved during the course of the program with a significant decrease in IRCM… The results of this program may inspire other countries to invest in udder health, not only for economic reasons, but also for animal welfare, reduction of antibiotic resistance, and total image of the dairy industry).
The difference between the prior art and the instant claims is that the instant claims recite a method of improving udder health 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 because at the time it was known, as taught by Abril, that mastitis was caused by a gram-positive bacteria. Furthermore, as indicated by Lam, treating mastitis was known to have the effect of improving udder health.
One would have been motivated as a matter of improving udder health and because treating mastitis was associated with improvements in udder health. One would have been especially motivated to use the method of Cazemier to treat mastitis because the method treated infections in ruminants 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 in ruminants 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. In view of Lam, improvement in udder health would have been no more than the expected consequence of treating mastitis.
Response to Arguments
Applicant’s arguments filed September 9, 2026 have been fully considered but they are not persuasive.
Applicant states Cazemier teaches the administration of lactylates for their antibacterial activity in preventing or treating infection, particularly intestinal infection. Cazemier does not teach or suggest administering the recited lactylates for improving udder health of a ruminant animal. Abril does not cure this deficiency. Abril discusses Staphylococcus aureus, a Gram positive bacterium, as one of the major causes of bovine, ovine, and caprine mastitis. Abril's discussion of prevention and treatment is directed to controlling S. aureus infection, including through antibiotic and vaccine approaches. Abril does not teach or suggest administering lactylates to a ruminant animal, much less administering lactylates as a
feed supplement for improving udder health (page 5 of remarks).
These arguments are not found persuasive because the rejection is over Cazemier in view of Abril. Cazemier clearly teaches treating or preventing an infection caused by gram-positive bacteria in a ruminant animal. Cazemier does not teach wherein the infection is in the udder; however, Abril provides staphylococcus aureus is a causative agent of mastitis in ruminant animals. One skilled in the art could have reasonable expected that the method of treating infection in a ruminant animal that was disclosed by Cazemier would also apply to other infections in ruminant animals. Moreover, an improvement to udder health, as taught by Lam, would have been an expected consequence 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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,727,608 B2 (previously copending Application No. 18/013,791) in view of Abril et al. (Toxins 2020, 12, 537, pages 1-18)(hereinafter “Abril”) and Lam et al. (Journal of Dairy Science Vol. 96, No. 2, 2013).
The instant claims are drawn to a method of improving udder health of 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.
The patents claims are 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).
The patent 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 patent teaches the composition is useful as a food for preventing or reducing bacterial infections in animals (see col 1, Field). 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 patent claims are silent regarding administering the composition to improve udder health 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) and Lam provides that the result of treating mastitis is an improvement in udder health. The teachings of Lam were discussed above and are incorporated herein by reference.
The difference between the patent claims, prior art and the instant claims is that the instant claims recite a method of improving udder health 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 patent to treat mastitis because at the time it was known, as taught by Abril, that mastitis was caused by a bacterial infection. Furthermore, as indicated by Lam, treating mastitis was known to have the effect of improving udder health.
One would have been motivated as a matter of improving udder health and because treating mastitis was associated with improvements in udder health. One would have been especially motivated to use the composition of the patent 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 patent 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 patent claims would have the effect of treating or preventing mastitis. Improvement in udder health would have been no more than the expected consequence of treating mastitis.
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”) and Lam et al. (Journal of Dairy Science Vol. 96, No. 2, 2013).
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 improving udder health 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…) and Lam provides that the result of treating mastitis is an improvement in udder health. The teachings of Lam were discussed above and are incorporated herein by reference.
The difference between the patent claims, prior art and the instant claims is that the instant claims recite a method of improving udder health 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. Furthermore, as indicated by Lam, treating mastitis was known to have the effect of improving udder health.
One would have been motivated as a matter of improving udder health and because treating mastitis was associated with improvements in udder health. 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. Improvement in udder health would have been no more than the expected consequence of treating mastitis.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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October 7, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
