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 .
Priority
The present application, filed June 2, 2023, is a national stage application of PCT/IB2021/061287, filed December 3, 2021, and claims priority to foreign priority application DKPA202001371, filed December 4, 2020.
Status of the Application
Applicant’s communication, received April 28, 2026, wherein claims 1-7, 21-24, and 28-29 are amended, claims 8-20 and 25-27 are canceled, and new claims 30-33 are added, is acknowledged.
Claims 1-7, 21-24, and 28-33 are pending and examined on the merits herein.
Withdrawn Objections
Applicant’s amendment, received April 28, 2026, with respect to the objections to claims 6-7 and 13-14 for minor informalities, has been fully considered and found to be persuasive to remove the objections because claims 13-14 are canceled and claims 6-7 are amended to remove these informalities. Therefore the objection is withdrawn.
Withdrawn Rejections
Applicant’s amendment, received April 28, 2026, with respect to the rejection of claims 1-14 and 18 under 35 USC § 101, has been fully considered and found to be persuasive to remove the rejection because claims 1-7 are amended to recite a method for improving sleep maturation of a non-infant human, which is not patent ineligible subject matter, and because claims 8-14 and 18 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 28, 2026, with respect to the rejection of claims 1, 8, 15-18, 20-24, and 26-29 under 35 USC § 112(b), has been fully considered and found to be persuasive to remove the rejection as it applies to claims 8, 15-18, 20, and 26-27, because claims 8, 15-18, 20, and 26-27 are canceled. Therefore the rejection is withdrawn.
Claims 21-24 and 28-29 are now amended to remove exemplary language and/or to depend from claim 1. However, the rejection of claim 1 under 112(b) still applies, as described in the rejection below. Because claims 21-24 and 28-29 now depend from claim 1, claims 21-24 and 28-29 are still indefinite.
Applicant’s amendment, received April 28, 2026, with respect to the rejection of claims 26-27 and 29 under 35 USC § 112(d), has been fully considered and found to be persuasive to remove the rejection because claims 26-27 are canceled, and because independent claim 1 is amended to recite a method for improving sleep maturation of a non-infant human, and thus the previous rejection of claim 29 as failing to further limit the composition of claim 1 no longer applies. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 28, 2026, with respect to the rejection of claims 1-17, 19, 26-27, and 29 under 35 USC § 102 as anticipated by McConnell, has been fully considered and found to be persuasive to remove the rejection because claims 8-17, 19, and 26-27 are canceled, and because independent claim 1 is amended to recite a method for improving sleep maturation of a non-infant human, which is not anticipated by McConnell. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 28, 2026, with respect to the rejection of claims 20-25 and 28 under 35 USC § 103 as unpatentable over McConnell, has been fully considered and found to be persuasive to remove the rejection because claims 20-25 and 28 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 28, 2026, with respect to the rejection of claim 18 under 35 USC § 103 as unpatentable over McConnell in view of Williams, has been fully considered and found to be persuasive to remove the rejection because claim 18 is canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 28, 2026, with respect to the nonstatutory double patenting rejections over the claims of U.S. patent nos. 11,026,959, 11,833,165, 11,890,293, 10,835,544, 10,946,032, 10,588,917, 11,173,171, 11,040,049, 11,896,604, 11,040,050, 11,896,605, 11,142,541, 9,382,564, 9,963,729, 9,234,225, 9,896,470, 10,987,368, 10,881,674, 10,314,852, 10,946,032, 10,695,359, 10,751,354, 11,696,921, 10,780,103, 11,491,171, 11,998,558, 10,835,545, 11,684,630, 11,432,578, 10,857,168, 11,529,365, 11,312,741, 11,384,110, 11,278,558, 11,541,068, 11,505,567, 11,939,351, 12,054,513, 11,541,067, 11,291,677, 11,524,019, 11,224,605, 11,541,069, 11,602,545, 11,304,966, 11,452,736, 11,986,487, 11,554,131, 12,233,079, 11,541,069, 11,224,605, and 12,458,052, and over the claims of co-pending U.S. patent applications 17/798270, 17/780390, 17/756832, and 18/808271, in some instances with secondary references, has been fully considered and found to be persuasive to remove the rejections because claim 1 is amended to recite a method for improving sleep maturation of a non-infant human, which the above patents and patent applications do not claim. Therefore the rejection is withdrawn.
The following is a new rejection, necessitated by Applicant’s amendment received April 28, 2026.
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.
Claim 29 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 29 recites: “The method according to claim, wherein the non-infant human is a patient with irritable bowel syndrome (IBS)” (emphasis added). Because claim 29 does not depend from another claim, there is insufficient antecedent basis for “the method” and “the non-infant human” limitations in claim 29.
For the purposes of expedited prosecution, claim 29 is interpreted herein as depending from claim 1.
The following rejection is maintained from the previous office action, updated herein to reflect Applicant’s amendment received April 28, 2026.
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 1, 21-24, 28-31, and 33 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.
Claims 1 recites the term “preferably”. This term renders claim 1 indefinite because it is unclear whether the limitation(s) following these phrases are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of expedited prosecution, claim 1 is examined without the narrower limitation following “preferably.”
Because claims 21-24, 28-31, and 33 depend from claim 1 and fail to cure this deficiency, claims 21-24 and 28-33 are also indefinite.
Claims 2-7 depend from claim 1 and further limit the synthetic fucosylated HMO. Because these claims require the synthetic fucosylated HMO is selected from a group of defined compounds, these claims are not indefinite.
In addition, claim 32 requires the synthetic fucosylated HMO is a synthetic fucosylated neutral HMO. Therefore, claim 32 requires the narrower limitation of claim 1 and thus is not indefinite.
The following are new and/or modified grounds of rejection, necessitated by Applicant’s amendment received April 28, 2026.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claims 1-7, 21-24, and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over McConnell (Publication No. WO 2019087140 A1; cited in IDS received June 2, 2023) in view of Williams (Williams, G.; et al. European Journal of Clinical Investigation 2002, vol. 32, pp. 831-837; cited in previous office action) and Fossey (Fossey, M.; et al. Journal of Behavioral Medicine 2004, vol. 27, pp. 581-605; cited in PTO-892).
McConnell was published May 9, 2019, and thus qualifies as prior art under 35 U.S.C. 102(a)(1).
Claim 1 claims a method for improving sleep maturation of a non-infant human, wherein sleep maturation involves development of a night and day sleep pattern from a more fragmented sleep composed of frequent short bouts of sleep and absence of circadian cycle to a pattern with long uninterrupted night sleep, limited day sleep and presence of circadian cycle, wherein the method comprises administering to the non-infant human an effective amount of a synthetic fucosylated human milk oligosaccharide (HMO). Claims 2-7 and 32 further limit the HMO, claims 21-24 and 33 further limit the dose and dosing schedule, claims 28-29 further limit the non-infant human, claim 30 requires the HMO is part of a nutritional composition, and claim 31 claims the improved sleep maturation improves trouble sleeping.
McConnell teaches and claims a human milk oligosaccharide for use in reducing or preventing fatigue and/or improving focus or concentration on a mental or physical activity in a human (p. 15, claim 1), and a synthetic composition for use in reducing or preventing fatigue and/or improving focus or concentration on a mental or physical activity in a human, the composition comprising at least one human milk oligosaccharide (p. 15, claim 2). McConnell further teaches and claims the human milk oligosaccharide of claim 1 or the synthetic composition of claim 2, in which the human milk oligosaccharide is selected from 2'-FL, 3-FL, DFL, LNT, LNnT, 3'-SL, 6'-SL, LNFP-I or a mixture thereof (p. 15, claim 4). In addition, McConnell, teaches and claims human milk oligosaccharide or the synthetic composition comprising or consisting of i) 2'-FL and/or DFL and ii) LNnT and/or LNT (p. 15, claim 5).
McConnell teaches that a synthetic composition means a composition which is artificially prepared and preferably means a composition containing at least one compound that is produced ex vivo chemically and/or biologically, for example, by means of chemical reaction, enzymatic reaction or recombinantly (p. 5, lines 7-9). Therefore, a synthetic composition taught by McConnell would include compositions in which at least one compound is produced ex vivo chemically or biologically, which is interpreted as equivalent to the synthetic HMO recited in claim 1.
Moreover, McConnell teaches and claims a method for reducing or preventing fatigue and/or improving focus or concentration on a mental or physical activity in a human, the method comprising administering to the human an effective amount of at least one human milk oligosaccharide (p. 15, claim 9), claims the human is administered the human milk oligosaccharide for a period of at least 1 to 2 weeks (p. 15, claim 11) (emphasis added), claims the human has a disease or condition that includes prolonged fatigue as a co-morbidity (p. 15, claim 12), and specifies the disease may be selected from the group that includes chronic fatigue syndrome, sleep deprivation, a sleep disorder, and irritable bowel syndrome (p. 16, claim 13). Therefore, one of ordinary skill in the art would have contemplated the method of McConnell for the purposes of treating, for example, chronic fatigue syndrome, sleep deprivation, or a sleep disorder.
McConnell teaches and claims the HMO is administered to a human in an amount of 1 g to 15 g per day of the human milk oligosaccharide, preferably 2 g to 10 g per day, and more preferably 3 g to 7 g per day (p. 15, claim 10), that the HMO is selected from 2'-FL, 3-FL, DFL, LNT, LNnT, 3'-SL, 6'-SL, LNFP-I (p. 16, claim 14), and further that the HMO comprises or consists of i) 2'-FL and/or DFL and ii) LNnT and/or LNT (p. 16, claim 15). Finally, McConnell claims the human is non-infant (p. 16, claim 16). McConnell teaches that "non-infant human" or "non-infant" means a human of 3 years of age and older, and can be a child, a teenager, an adult or an elderly (p. 4, lines 21-22). McConnell also teaches that examples of neutral fucosylated
HMOs include 2'-fucosyllactose (2'-FL) and 3-fucosyllactose (3-FL) (p. 4, lines 33-35). McConnell teaches the synthetic composition can be in the form of a nutritional composition, such as a food composition (p. 8, lines 10-11).
McConnell teaches that during an initial treatment phase, the human may be administered a higher amount of the HMO, for example 3 g to 15 g per day, preferably 3 g to 10 g per day, and during a subsequent maintenance phase, the human may be administered a lower amount of the HMO, for example, 1 g to 10 g per day, preferably 2 g to 7.5 g per day.
McConnell teaches that fatigue is a subjective feeling of tiredness that can have many possible causes and accompanies many different conditions (p. 1, lines 7-8). As one example, McConnell teaches that one example of prolonged fatigue is Chronic Fatigue Syndrome (CFS), a multisystem illness, associated with disabling fatigue, cognitive dysfunction and sleeping disturbances (p. 2, lines 7-8) (emphasis added). McConnell teaches that CFS is characterized by persistent and relapsing fatigue, post exertional malaise (both physical and mental), cognitive and mood changes, and gastrointestinal disturbance and food intolerances. In addition, sleep disturbances and unrefreshing sleep are commonly reported by these patients (p. 2, lines 10-13) (emphasis added).
McConnell teaches that prolonged fatigue is a persistent state of fatigue lasting for a period of time such as at least one month, and that prolonged or chronic fatigue is a symptom of many diseases and conditions (p. 1, lines 36-37).
McConnell does not teach sleep maturation as involving development of a night and day sleep pattern from a more fragmented sleep composed of frequent short bouts of sleep
and absence of circadian cycle to a pattern with long uninterrupted night sleep, limited day sleep and presence of circadian cycle, as required by claim 1.
Williams teaches that patients with chronic fatigue syndrome (CFS) show evidence of circadian rhythm disturbances (p. 831, Abstract, Background section, lines 1-2). Williams teaches CFS symptoms closely resemble those of jet-lag and shift-work maladjustment, in which circadian rhythms are disrupted, and that the peak of the circadian temperature rhythm and the onset of melatonin secretion are significantly correlated in healthy subjects, but that this relationship has been shown to be absent in patients with CFS (p. 831, right column, lines 3-10). Circadian rhythm is interpreted herein as equivalent to circadian cycle.
Fossey teaches sleep quality in chronic fatigue syndrome (p. 581, title). Fossey teaches there is a growing body of research suggesting chronic fatigue (abbreviated by Fossey as CFS) may be caused or maintained by desynchronization or dysregulation of neuroendocrine functions which drive the sleep/wake cycle. Fossey teaches it is notable that some of the major presenting complaints of persons with CFS, including daytime fatigue, difficulty with memory and concentration, insomnia, and nonrestorative sleep are related to the sleep disruption and problems with daytime functioning common to individuals with primary sleep disorder and insomnia (p. 583, second paragraph, lines 1-8). Fossey teaches that a sample of individuals with CFS was included as part of a larger investigation in their laboratory where the focus was on distinguishing sleepiness from fatigue, and a serendipitous finding of this study was the high rate of sleep disorder such as sleep apnea/hypopnea syndrome, restless legs syndrome/periodic
limb movement disorder (RLS/PLMD ), and insomnia in the CFS sample. Fossey teaches a subsequent study confirmed these results and corroborated findings of relatively high rates of sleep disruption in CFS (p. 583, first paragraph, lines 1-8). Moreover, Fossey teaches that in their present study scores on daytime sleepiness for patients in their CFS sample were significantly elevated compared to the control group, and that the results show that daytime functioning in the
CFS sample is seriously compromised (p. 599, Daytime Functioning section, lines 7-11).
Therefore, in view of Williams and Fossey, one of ordinary skill in the art would have recognized that subjects with CFS are known to have disrupted circadian rhythm, experience insomnia and nonrestorative sleep due to sleep disruption, and to experience daytime sleepiness.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to administer one or more fucosylated HMOs to a non-infant human with CFS and experiencing short bout of sleeps and absence of circadian cycle for the purposes of treating CFS and improving sleep maturation. One of ordinary skill in the art would have been motivated to administer one or more fucosylated HMOs to a non-infant human with CFS and experiencing short bout of sleeps and absence of circadian cycle for the purposes of treating CFS and improving sleep maturation because McConnell teaches fucosylated HMOs for treating CFS and sleep disorders, Williams teaches patients with chronic fatigue syndrome show evidence of circadian rhythm disturbances, and Fossey teaches that CFS may be caused or maintained by desynchronization or dysregulation of neuroendocrine functions which drive the sleep/wake cycle, and that subjects with CFS have symptoms of daytime sleepiness. Accordingly, in view of the cited art above, one of ordinary skill in the art would have recognized that a subject suffering from CFS having fragmented sleep composed of frequent short bout of sleeps and absence of circadian cycle may be provided a treatment for CFS and sleep disorders with a reasonable expectation that such a treatment would improve in the subject a sleep pattern with a pattern with long uninterrupted night sleep, limited day sleep and presence of circadian cycle as required by the present claims.
One of ordinary skill in the art would have had a reasonable expectation of success administering one or more fucosylated HMOs to a non-infant human with CFS and experiencing short bout of sleeps and absence of circadian cycle for the purposes of treating CFS and improving sleep maturation because McConnell teaches administering HMOs for treating CFS and sleep disorders, and because Williams and Fossey teach subjects with CFS as having sleep disturbances and disrupted circadian cycle. Accordingly, by administering to a patient with CFS a treatment recognized for treating CFS and sleep disorders, one of ordinary skill in the art would have had a reasonable expectation of improving sleep patterns, including the specific symptoms of long uninterrupted night sleep, limited day sleep and presence of circadian cycle.
Regarding the specific combination of HMOs required by claims 4-7, given the small number of HMOs taught by McConnell and the suggestion of using HMO mixtures, one of ordinary skill in the art would have contemplated practicing the method of improving sleep maturation obvious over McConnell, Williams, and Fossey using the combinations of HMO recited in claims 4-7.
Regarding the requirement that the non-infant human is administered a higher dose initially followed by a lower dose, as recited in claims 23 and 24, because McConnell teaches an initial treatment phase with a higher dose of HMO and a subsequent maintenance phase with a lower dose of HMO, one of ordinary skill in the art would have contemplated said treatment options when practicing the method on a human experiencing CFS.
Regarding the specific dose of HMO required by claim 24, McConnell suggests a range of higher dose and lower dose (initial treatment phase and maintenance phase) that overlaps with the range recited in claim 24. Therefore, doses required in claim 24 are obvious in view of McConnell. MPEP 2144.05 at I states: “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).” Similarly, because the preferred dose of 3 g to 7 g taught by McConnell overlaps with the daily dose range recited claim 33, the dose of claim 33 is also obvious in view of McConnell.
Regarding the requirement that the non-infant is an IBS patient as recited in claim 29, because McConnell teaches and claims IBS as a co-morbidity associated with prolonged fatigue, one of ordinary skill in the art would have contemplated administering the claimed HMOs to a human suffering from CFS associated with prolonged fatigue that also suffering from IBS, because IBS is a co-morbidity associated with such fatigue.
Regarding the requirements of claim 31 wherein the improved sleep maturation
improves trouble sleeping, because McConnell expressly teaches sleeping disturbances as one symptom of CFS and that their method may be used for treating CFS, sleep disorders, and sleep deprivation, one of ordinary skill in the art would have had a reasonable expectation that said method of treating CFS would also treat sleep disturbances and sleep deprivation, which is reasonably considered as improving trouble sleeping.
Therefore the invention taken as a whole is prima facie obvious.
Response to Applicant’s arguments: In response to the previous rejection over McConnell and Williams, Applicant argues that the mere mentioning of sleep deprivation or sleep disorders in the passages of McConnell noted above is taken out of context. Specifically, the HMOs disclosed by McConnell are used in a method for reducing or preventing fatigue and/or improving focus or concentration on a mental or physical activity in a human and is therefore not as such directed to sleep deprivation or a sleep disorder. Applicant further argues that Chronic Fatigue Syndrome (CFS) is a neurological disease, and sleep disturbances and unrefreshing sleep is mentioned among a number of challenges associated with this disease, such as cognitive and mood changes, and gastrointestinal disturbance and food intolerances. Applicant further argues that CFS is only mentioned by way of background in McConnell, it can be stated that McConnell does not even teach that HMOs generally may be effective against CFS. Note here that that McConnell does not contain any examples illustrating that the HMOs actually have an effect on types of sleep disorders.
Applicant argues that in Example 1 of McConnell, the table on page 13, participants with a number of conditions are enrolled into a study (sleep deprivation is not listed). The participants are administered with HMOs and asked to score the reduction in fatigue, not in any other symptoms associated with the listed disorders. The Applicant therefore submits that the ordinarily skilled person reading McConnell is taught that fatigue can arise from many different disorders. There is however nothing in McConnell that teaches the skilled person that the causes of the fatigue can be treated with the HMOs, and therefore the pending claims are not unpatentably obvious over McConnell.
Applicant’s arguments regarding McConnell have been fully considered but they are not found persuasive. McConnell both teaches and claims treating chronic fatigue syndrome, sleep deprivation, and a sleep disorder by administering at least one human milk oligosaccharide (p. 16, claim 13). Therefore, arguments that CFS, sleep deprivation, and sleep disorders is only mentioned by way of background in McConnell, and that McConnell does not teach that HMOs generally may be effective against these diseases are not persuasive. Although McConnell teaches HMOs as effective for treating other diseases as well, as Applicant notes, does not take away from using HMOs for treating chronic fatigue syndrome, sleep deprivation, and a sleep disorder. One of ordinary skill in the art would have still considered administering HMOs as a potential treatment for treating said diseases.
Regarding Example 1 of McConnell, although McConnell embodies treating fatigue with HMOs, as stated, that does not take away from McConnell teaching treating CFS, sleep deprivation, or sleep disorders with HMOs. One of ordinary skill in the art, in view of McConnell, would have contemplated administering HMOs as a potential treatment for treating CFS, sleep deprivation, or sleep disorders. Moreover, because subjects with chronic fatigue syndrome experience the same sleep challenges associated with subjects in need of improved sleep maturation, as defined in claim 1, one of ordinary skill in the art would have recognized that treatments for fatigue, including CFS, may reasonably provide the required sleep maturation of the method of claim 1.
Applicant further argues that Williams specifically shows that the circadian rhythm disturbance in CFS (which McConnell describe as a neurological disease) cannot be regulated by melatonin and bright-light phototherapy which are known to affect circadian rhythms in healthy individuals. Applicant argues that Williams therefore basically teaches away from using other dietary supplements, such as HMOs, to alleviate circadian rhythm disturbances in CFS patients.
Applicant’s arguments regarding Williams have been fully considered but they are not found persuasive. Williams teaches symptoms associated with chronic fatigue syndrome, including disturbances of circadian rhythm. Although Williams attempts at treating CFS by alleviating circadian rhythm disturbances did not show an effect, this is not relevant to the presently claimed method.
Sleep maturation as defined in the present application is extremely broad, and subjects experiencing CFS also show the symptoms associated with subjects in need of sleep maturation improvement. Accordingly, one of ordinary skill in the art would have recognized that a treatment for CFS also recognized for treating sleep deprivation and sleep disorders would reasonably be expected to provide the effects associated with improved sleep maturation recited in claim 1. A teaching by Williams that different therapies directed towards alleviating circadian rhythm disturbances in CFS patients were not effective does not teach away from practicing the method of McConnell, because the method of McConnell is taught for the purposes of treating CFS, and by treating CFS, one of ordinary skill in the art would have had a reasonable expectation of improving sleep disorder symptoms associated with CFS, including improvement in the presence of a circadian rhythm.
Therefore, for the reasons stated above, the present rejection is maintained.
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 1-7, 21-24, and 28-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. patent no. 12,628,857 (reference patent, hereinafter ‘857; cited in PTO-892) in view of McConnell (Publication No. WO2019087140A1; cited in IDS received June 2, 2023), Williams (Williams, G.; et al. European Journal of Clinical Investigation 2002, vol. 32, pp. 831-837; cited in previous office action), and Fossey (Fossey, M.; et al. Journal of Behavioral Medicine 2004, vol. 27, pp. 581-605; cited in PTO-892).
Both the present application and ‘857 include Clara Lucia Garcia-Rodenas and Jonas Hauser as inventors.
Claim 1 of ‘857 claims a method for improving total night sleep duration or sleep quality in a subject in need thereof, the method comprising administering to the subject a nutritional composition comprising at least one human milk oligosaccharide, wherein the at least one human milk oligosaccharide is present in a total amount of 50 mg to 2500 mg/L of the nutritional composition, and the total sleep night duration or sleep quality is assessed on the basis of a questionnaire to quantify quantity and quality of sleep (BISQ), the subject is an infant or young child that is small for gestational age (SGA) or was born preterm, and the at least one human milk oligosaccharide comprises one of (i) a mixture of lacto-N-neotetraose (LNnT), lacto-N-tetraose (LNT), and para-lacto-N-neohexaose; (ii) a combination of 3′ sialyllactose (3-SL) and lacto-N-tetraose (LNT); or (iii) a combination of 3′ sialyllactose (3-SL) and a mixture of lacto-N-neotetraose (LNnT), lacto-N-tetraose (LNT), and para-lacto-N-neohexaose. Claim 7 of ‘857 claims the nutritional composition is a supplement.
The claims of ‘857 do not claim a method for improving sleep maturation as involving development of a night and day sleep pattern that includes an absence of circadian cycle to a pattern that includes the presence of circadian cycle, as required by claim 1.
McConnell teaches as described in the above rejections under 35 U.S.C. § 103.
Williams and Fossey teach as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to administer an HMO, such as the HMOs claimed by ‘857 and taught by McConnell, for the purposes of improving sleep maturation, because the claims of ‘857 claim improving total night sleep duration in an infant or young child, and because McConnell teaches administering HMOs to a patient, including adults, for the purposes of treating CFS, which includes sleep disturbances as one side effect. Moreover, in view of Williams and Fossey, one of ordinary skill in the art would have recognized a subject with CFS may experience a more fragmented sleep composed of frequent short bouts of sleep
and absence of circadian cycle.
Accordingly, in view of McConnell, Williams, and Fossey, one of ordinary skill in the art would have recognized the method claimed by ‘857 may be practiced on a non-infant human suffering from CFS having fragmented sleep composed of frequent short bout of sleeps and absence of circadian cycle with a reasonable expectation that such a treatment would treat CFS and improve in the subject a sleep pattern with a pattern with long uninterrupted night sleep, limited day sleep and presence of circadian cycle as required by the present claims.
In addition, the specific combinations of HMOs, the dose and dosing schedule, the non-infant person as an adult or elderly person or as a patient with IBS, and the improved sleep maturation as improving trouble sleeping, would also have been obvious over the claims of ‘857 in view of McConnell, Williams, and Fossey.
Response to Applicant’s arguments: With respect to the previous provisional nonstatutory double patenting rejection over the claims of co-pending U.S. patent application 18/255768 in view of McConnell, Applicant argues that the present claims are patentable over 18/255768 and McConnell for the same reasons described in the above arguments relating to McConnell.
Applicant’s arguments have been fully considered but they are not found persuasive. Insofar as these arguments apply to the present rejection, because ‘857 claims a method of improving total night sleep duration or sleep quality by administering human milk oligosaccharides, and the combination of McConnell, Williams, and Fossey render obvious a method of improving sleep maturation, which includes improving uninterrupted night sleep, by administering human milk oligosaccharides, one of ordinary skill in the art would have contemplated applying the method of ‘857 to an adult with a reasonable expectation that such a method would be effective for improving sleep maturation.
Accordingly, for the reasons described above, the present nonstatutory double patenting rejection is maintained.
Claims 1-7, 21-24, and 28-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, and 7 of co-pending U.S. patent application 18/255774 (reference application, hereinafter ‘774; U.S. pre-grant publication no. US 20240000818 A1 cited in PTO-892) in view of McConnell (Publication No. WO2019087140A1; cited in IDS received June 2, 2023).
Both the present application and ‘774 include Clara Lucia Garcia-Rodenas and Jonas Hauser as inventors.
The amended claims of ‘774 received January 9, 2026 are cited in this provisional nonstatutory double patenting rejection.
Claim 1 of ‘774 claims a method for improving sleep maturation in an infant or a
young child in need thereof, the method comprising administering to the infant or young child a nutritional composition comprising fucosylated human milk oligosaccharides, wherein the nutritional composition does not comprise probiotics.
Claim 2 of ‘774 claims the fucosylated human milk oligosaccharides are selected from the group recited therein, and claim 7 claims the lacto-N-fucopentaose is selected from the group consisting of lacto-N-fucopentaose I, lacto-N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V and any combination thereof.
Claim 3 of ‘774 claims the fucosylated human milk oligosaccharides are present in a total amount of from 50mg to 5000mg/L of the nutritional composition.
Claim 5 of ‘774 claims sleep maturation is associated to a reduced number of episodes of night awakenings.
The specification of ‘774 defines sleep maturation as referring to the development of night and day sleep pattern from a more fragmented sleep composed of frequent short bouts of sleeps and absence of circadian cycle immediately after birth, to a more adult-like sleep pattern, with long uninterrupted night sleep, limited day sleep and presence of circadian cycle (p. 4, last paragraph, lines 4-7). Therefore, the method of sleep maturation claimed by ‘774 satisfies the sleep maturation requirements of present claim 1.
MPEP 804 at II states: “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.").” Therefore, use of the specification as a dictionary to determine the meaning of the term “sleep maturation” is proper.
The claims of ‘774 do not claim the method of claim 1 as practiced on a non-infant human. In addition, the claims of ‘774 do not claim administration of a synthetic HMO, as recited in claim 1.
McConnell teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to administer an HMO, such as an HMO claimed by ‘774 or a combination of HMOs taught by McConnell, for the purposes of improving sleep maturation in a non-infant human, because the claims of ‘774 claim improving sleep maturation by administering an HMO, and because McConnell teaches administering HMOs to subjects, including adults, for the purposes of treating sleep disorders and reducing fatigue, which includes sleep disturbances as one side effect. Accordingly, one of ordinary skill in the art would have recognized the method claimed by ‘774 for improving sleep maturation, may be administered to a non-infant for the purposes of also improving sleep maturation with a reasonable expectation that such a method would be effective for improving sleep maturation in an adult. In addition, the synthetic HMO, the specific combinations of HMOs, the dose and dosing schedule, and the improvement in trouble sleeping would have been obvious over ‘774 in view of McConnell.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not been patented. However, a notice of allowance has been mailed in ‘774, and upon issue of the corresponding patent, this provisional non-statutory double patenting rejection will become a non-statutory double patenting rejection.
Response to Applicant’s arguments: With respect to the previous provisional nonstatutory double patenting rejection over the claims of co-pending U.S. patent application 18/255774 in view of McConnell, Applicant argues that the present claims are patentable over 18/255774 and McConnell for the same reasons described in the above arguments relating to McConnell.
Applicant’s arguments have been fully considered but they are not found persuasive. In this instance, the claims of ‘774 claim a method of improving sleep maturation in an infant or young child by administering a nutritional composition comprising fucosylated human milk
Oligosaccharides. The difference between the method claimed by ‘774 and the presently claimed method is the subject upon which the method is practiced. In this instance, because McConnell teaches administration of human milk oligosaccharides, including those recited in the claims of ‘774, for treating sleep disorders, and further teaches that their method as being practiced on other subjects, including adults, one of ordinary skill in the art would have contemplated practicing the method claimed by ‘774 on populations other than infants and young children, such as adults, with a reasonable expectation that such a method would also improve sleep maturation in adults.
Accordingly, for the reasons described above, the present provisional nonstatutory double patenting rejection is maintained.
Conclusion
No claims are allowed.
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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/B.M.B./ Examiner, Art Unit 1693
/ANDREA OLSON/ Primary Examiner, Art Unit 1693
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