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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 24, 2026 has been entered.
Detailed Action
This office action is a response to applicant’s communication submitted March 24, 2026, wherein claim 8 is amended, claims 17 and 18 are canceled, and new claim 22 is introduced. This application is a continuation of US application 16/289288, now US patent 11234992, filed February 28, 2019, which claims benefit of provisional application 62/636708, filed February 28, 2018.
Claims 1, 4-6, 8-16, and 20-22 are pending in this application.
Claims 1, 4-6, 8-16, and 20-22 as amended are examined on the merits herein.
Response to Arguments
Applicant’s arguments, submitted March 24, 2026, with respect to the rejection of claims 1, 4, 6, 8-16, and 19-21 under 35 USC 103 for being obvious over Ben Labri in view of Kang in view of Wang, have been fully considered and found to be persuasive to remove the rejection as Ben Labri does not particularly suggest the two claimed oligosaccharides 3’-SL and 6’-SL as being useful on their own. Therefore the rejection is withdrawn.
Applicant’s arguments, submitted March 24, 2026, with respect to the rejection of claims 1, 4, 6, 8-16, and 19-21 under 35 USC 103 for being obvious over Ben Labri in view of Kang in view of Reiche, have been fully considered and found to be persuasive to remove the rejection as Ben Labri does not particularly suggest the two claimed oligosaccharides 3’-SL and 6’-SL as being useful on their own. Therefore the rejection is withdrawn.
The following new grounds of rejection are introduced:
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.
Claims 1, 4, 6, 8-13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vigsnaes et al. (PCT international publication WO2019/106620, Reference included with PTO-892) as evidenced by Li et al. (Reference included with PTO-892)
Independent claims 1 and 8 are directed to a method comprising administering two or three oligosaccharides to a subject, wherein these oligosaccharides are described as being selected from a group including a first listing of neutral oligosaccharides including 2’-fucosyllactose and a second group which is 6’- sialyllactose. Furthermore claim 1 describes the method as a method of treating or attenuating atherosclerosis while claim 8 describes the method as a method of treating or attenuating complications associated with atherosclerosis. Still further the claims require that the effective amount of the active ingredients significantly reduces inflammation caused by macrophages.
Vigsnaes et al. discloses a human milk oligosaccharide for use in increasing the abundance of Akkermansia in the gastrointestinal tract of a human, preferably for treating or preventing one of a number of conditions including metabolic disorders associated with obesity, diabetes, and liver disease. (p. 4 lines 9-14) Human milk oligosaccharides include, for example, a combination of 2’-fucosyllactose and 6’-sialyllactose. (p. 5 lines 8-9) Specific conditions treatable by this method include atherosclerosis. (p. 13 lines 3-16) While Vigsnaes et al. does not specifically state that the therapeutic benefits described in the reference are accomplished by a mechanism involving suppressing inflammation caused by macrophages, Li et al. discloses a study of the effects of Akkermansia muciniphila in a mouse model of atherosclerosis. (p. 2435 left column last paragraph – right column third paragraph) A. muciniphila is specifically mentioned as a beneficial species of Akkermansia in the disclosure of Vigsnaes et al. (p. 2 lines 8-23) Treatment with A. muciniphila probiotic reduced atherosclerotic lesion size. (p. 2436 left column last paragraph – right column third paragraph) Li further discloses that the progression of atherosclerosis is promoted by macrophage-induced inflammation, and that this macrophage induced inflammation was reduced by treatment with A. muciniphila. (p. 2437 right column last paragraph – p. 2438 right column first paragraph) Therefore based on the disclosure of Li et al., it can reasonably be concluded that the beneficial effect of the human milk oligosaccharides described by Vigsnaes et al. for treating atherosclerosis is inherently produced at least in part by the reduction of inflammation caused by macrophages, in view of the fact that Li indicates that the effect of Akkermansia on atherosclerotic lesions is driven at least in part by suppression of macrophage inflammation.
Regarding claims 4 and 16, Vigsnaes et al. discloses that the composition can be a nutritional product. (p. 5 line 3) Regarding claim 9, p. 13 lines 3-16 of Vigsnaes further describes treating complications such as stroke and cardiac pathology. Regarding claim 10, as discussed previously, Li indicates that increasing the population of Akkermansia in a subject suffering from atherosclerosis would reasonably be expected to reduce the size of aortic plaques. Regarding claim 11, Vigsnaes describes a pharmaceutical composition comprising one or more excipients. (p. 17 lines 19-22) Regarding claims 12 and 13, Vigsnaes describes orally administering the composition, for example as a tablet. (p. 17 line 29)
For these reasons Vigsnaes et al. anticipates the present claims.
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.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Vigsnaes et al. (PCT international publication WO2019/016620, Reference included with PTO-892) as evidenced by Li et al. (Reference included with PTO-892)
The disclosure of Vigsnaes et al. is discussed above. Vigsnaes et al. does not specifically disclose the exact dosage of 2g/day recited in present claims 20 and 21. However, Vigsnaes et al. does disclose administering the composition in an amount of about 1-15 g/day, (p. 5 lines 11-19) or 2-5g/day. (p. 6 lines 10-11) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer the human milk oligosaccharide compositions described by Vigsnaes et al. in an amount of 2g/day, as this amount overlaps with the dosage ranges suggested by the reference.
Therefore the invention taken as a whole is prima facie obvious.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Vigsnaes et al. as applied to claims 1, 4, 6, 8-13, 16, 20, and 21 above, and further in view of Reiche et al. (US pre-grant publication 2015/0164856, of record in previous action)
The disclosure of Vigsnaes is discussed above. Vigsnaes does not describe a method wherein the subject is a non-human companion animal. However, Reiche et al. discloses methods of treating metabolic disorders in a feline animal, which is a companion animal or pet according to claim 1. Atherosclerosis is recited as part of a list of metabolic disorders that feline animals can suffer from. (p. 1 paragraph 2, p. 8 paragraph 103) It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the therapeutic method described by Vigsnaes et al. to a feline animal suffering from atherosclerosis, in view of the fact that Reiche et al. suggests that feline animals can suffer from this condition and therefore be in need of treatment.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1, 4, 8, 10-16, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (US pre-grant publication 2019/0030053, of record in previous action) in view of Wang et al. (Reference of record in previous action)
Independent claims 1, 8, and 22 are directed to a method comprising administering two or three oligosaccharides to a subject, wherein these oligosaccharides are described as being selected from a group including a first listing of neutral oligosaccharides including 3’-sialyllactose and a second group which is 6’- sialyllactose. Furthermore claim 1 describes the method as a method of treating or attenuating atherosclerosis while claim 8 describes the method as a method of treating or attenuating complications associated with atherosclerosis. Still further the claims require that the effective amount of the active ingredients significantly reduces inflammation caused by macrophages.
Kang discloses a composition comprising a sialic acid containing oligosaccharide which can be used for treating ore preventing various diseases caused by mitochondrial dysfunction associated with a decrease in PGC-1α (peroxisome proliferator-activated receptor coactivator 1-alpha) expression. (p. 3 paragraphs 23-25) Preferred oligosaccharides include 3’- sialyllactose or 6’- sialyllactose. (p. 4 paragraph 41) In one example administration of 3’-SL or 6’-SL was to treat vascular aging, and atherosclerosis. (p. 20 paragraph 273 – p. 21 paragraph 285) The treatment was described as reducing mitochondrial superoxide production. Kang does not specifically disclose treating or attenuating atherosclerosis. Kang additionally does not specifically disclose administering a combination of both 3’-SL and 6’-SL.
Wang et al. discloses that oxidative DNA damage in atherosclerotic lesions correlates with lesion progression. (p. 423 left column) Furthermore suppression of mitochondrial oxidative stress was seen to protect against atherosclerosis, and decrease inflammation in atherosclerotic lesions. (p. 423 left column last paragraph – p. 425 right column last paragraph) These findings are interpreted as suggesting that treatments to reduce mitochondrial oxidative stress would be useful for treating atherosclerosis. (p. 431 right column third paragraph)
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer a combination of 3’-SL or 6’-SL to a subject in need of treatment for atherosclerosis. One of ordinary skill in the art would have been motivated to do so because Wang indicates that reducing oxidative stress in a subject suffering from atherosclerosis, as would be expected from inducing PGC-1α as described by Kang, would lead to treatment of the condition. Furthermore regarding the combination of two of these active agents, one of ordinary skill in the art would have found it to be obvious to combine two therapeutic agents known to be useful for treating the same patient population. As described in MPEP 2144.06(I), combining equivalents usable for the same purpose, such as the two structurally and functionally similar oligosaccharides described by Kang, is prima facie obvious. Furthermore, the effects of co-administering these oligosaccharides would be expected to be predictable as they work by the same mechanism.
Additionally, while the disclosures of Kang and Wang do not specifically describe their therapeutic method as functioning by suppressing inflammation caused by macrophages, it is reasonably concluded from the art that such an effect is part of the mechanism by which treating atherosclerosis by PGC-1α induction would work. In particular, Kadlec et al. (Reference included with PTO-892) describes the role of PGC-1α in vascular biology. (p. 1468 left column second and third paragraph) Kadlec et al. Specifically describes PGC-1α as seen as reducing inflammation and atherosclerotic disease burden. (p. 1470 left column second paragraph) This effect is mediated by macrophages. (p. 1470 left column) Therefore it is reasonably expected that the inflammation being decreased by treatment with 3’-SL and 6’-SL is at least in part caused by macrophages, thereby infringing the present claims.
Regarding claims 4 and 16, Kang describes preparing the composition as a food composition. (p. 8 paragraph 96) Regarding claim 6, Wang describes the therapeutic methods being studied as relevant for human disease. (p. 421 right column last paragraph) Regarding claim 10, this claim recites decreasing incidence or severity of the disease, which would be expected to be an effect of any successful treatment of atherosclerosis. Regarding claim 11, Kang describes pharmaceutical compositions comprising a carrier or excipient. (p. 5 paragraph 61) Regarding claims 12-14, Kang describes oral and parenteral administration, as well as dosage forms such as powders, tablets, and capsules. (p. 5 paragraphs 52-54)
Regarding claims 20 and 21, Kang discloses that the dose of the pharmaceutical composition can be a broad range of 0.001-600 mg/kg. (p. 5 paragraph 60) This range indicates that the dose administered is a result-effective variable and thereby suggests determining the appropriate dosage to administer. Since a total dosage of 2g in an adult human would fall within this range, the specific dosages recited in claims 20 and 21 are prima facie obvious.
Therefore the invention taken as a whole is prima facie obvious.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. in view of Wang et al. as applied to claims 1, 4, 8, 10-16, and 20-22 above, and further in view of Reiche et al. (US pre-grant publication 2015/0164856, of record in previous action)
The disclosure of Vigsnaes is discussed above. Kang et al. in view of Wang et al. does not describe a method wherein the subject is a non-human companion animal. However, Reiche et al. discloses methods of treating metabolic disorders in a feline animal, which is a companion animal or pet according to claim 1. Atherosclerosis is recited as part of a list of metabolic disorders that feline animals can suffer from. (p. 1 paragraph 2, p. 8 paragraph 103) It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the therapeutic method described by Kang et al. to a feline animal suffering from atherosclerosis, in view of the fact that Reiche et al. suggests that feline animals can suffer from this condition and therefore be in need of treatment.
Therefore the invention taken as a whole is prima facie obvious.
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, 8-10, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11234992. (of record in previous action, herein referred to as ‘992) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘992 anticipate the present claims.
Independent claim 1 of ‘992 claims a method of decreasing the size of aortic plaques or atherosclerotic lesions in a subject comprising administering to the subject a composition comprising 3’ – sialyllactose and 6’-sialyllactose, and furthermore indicate that the therapeutic method works by suppressing inflammation caused by macrophages. Dependent claim 3 specifies that the subject suffers from one or more complications which are the same as those recited in present claim 9. Therefore the claims of ‘992 anticipate the present claims.
Claims 4, 6, 11-16, 18, 20, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11234992. (of record in previous action, herein referred to as ‘992) in view of Kang et al. 2019. (US pre-grant publication 2019/0030053, of record in previous action)
Claims 1 and 3 of ‘992 are as discussed previously. While the claims of ‘992 do not describe the specific dosage forms recited in present claims 11-16, as discussed previously under 35 USC 103, Kang et al. ‘2019 describes these dosage forms as appropriate for administering sialyllactose and similar oligosaccharides for the treatment of atherosclerosis. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the oligosaccharides recited in the claims of ‘992 as one of these pharmaceutical compositions. Furthermore as discussed previously Kang et al. 2019 also describes these compositions as useful for administering to a human, as recited in present claims 6 and 18, and provides a rationale for considering the dosage of oligosaccharide to be a result-effective variable.
Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the therapy claims by ‘992 in the manner defined by the present claims.
Claim 5 is are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11234992. (of record in previous action, herein referred to as ‘992) in view of Reiche et al. (US pre-grant publication 2015/0164856, of record in previous action)
Claims 1 and 3 of ‘992 are as discussed previously. While the claims of ‘992 do not describe administration specifically to a non-human companion animal, for example a cat, Reiche et al. discloses that cats can suffer from metabolic disorders including atherosclerosis, as well as hepatic lipidosis and hyperlipidemia. (p. 1 paragraph 2) Furthermore Reiche et al. discloses pharmacological therapy with a SGLT2 inhibitor for treating metabolic disorders in feline animals. (p. 2 paragraph 20, p. 8 paragraph 103) It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the human milk oligosaccharides described by the claims of ‘992 to a feline subject suffering from hyperlipidemia, atherosclerosis and/or fatty liver. One of ordinary skill in the art would have been motivated to treat a feline subject because Reiche et al. discloses that cats also suffer from these conditions and are furthermore in need of therapeutic agents for treating said conditions, suggesting to one of ordinary skill in the art to use available therapeutic compounds to treat these disorders, such as the oligosaccharides claimed by ‘992.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 4/1/2026