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
Claims 1-29 are pending and examined on the merits herein.
Claim Objections
Claims 6-7 and 13-14 are objected to because of the following informalities:
These claims recite the parenthetical: (LNT and/or LNnT). It is believed that this parenthetical requires the HMO of composition comprise LNT and/or LNnT, in addition to the other components of the claim. Please amend these claims to recite, for example: “i) 2’-FL and ii) LNT and/or LNnT” (as recited in claims 6 and 13).
Appropriate correction is required.
Claim Interpretation
Claim 1 recites: “A fucosylated human milk oligosaccharide (HMO), preferably a fucosylated neutral HMO, for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant. The limitation “for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant” is interpreted as an intended use of the HMO of claim 1.
Claim 8 recites: “A synthetic composition for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant wherein the composition comprises, consists of or consists essentially of an effective amount of one or more fucosylated human milk oligosaccharides (HMOs), preferably fucosylated neutral HMOs. The limitation “for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant” is interpreted as an intended use of the synthetic composition of claim 8.
Claim 15 recites: “A pack for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant, the pack comprising at least 14 individual daily doses of an effective amount of one or more fucosylated human milk oligosaccharides (HMOs), preferably fucosylated neutral HMOs.” The limitation “for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant” is interpreted as an intended use of the pack recited in claim 15.
MPEP 2111.02 (at II) states: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. …To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim.” In this instance, claims 1, 8, and 15, as well as claims depending from claims 1, 8, and 15, are considered to be satisfied by an HMO, a synthetic composition, or a pack that satisfies the HMO, synthetic composition, or pack limitations of claims 1, 8, and 15, even if the HMO, composition, or pack is not used in improving sleep maturation in a non-infant.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. These claims are drawn to a fucosylated human milk oligosaccharide for use in improving sleep maturation in a non-infant, and to a synthetic composition that comprises, consists of or consists essentially of an effective amount of one or more fucosylated human milk oligosaccharides for use in improving sleep maturation in a non-infant.
These claim do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Subject matter that is not patent eligible is determined by evaluating a claim for patentability based on the eligibility test set forth below:
(1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter? For the instant claims, the answer is “Yes” because the claim is directed to a composition of matter.
(2a) Prong 1: Does the claim recite or involve a judicial exception? The answer is “Yes” because the HMO and the composition comprise a fucosylated human milk oligosaccharide (HMO), such as 2′-FL or combinations of HMOs, such as 2′-FL and DFL, LNFP-1, LNT, or LNnT, which are from natural sources, human milk.
As evidence, Castanys-Muñoz (Castanys-Muñoz, E.; et al. Nutrition Reviews 2013, vol. 71, pp. 773-789; cited in PTO-892) teaches that lactose is the preeminent soluble glycan in milk, and that elongation of lactose with additional monosaccharides gives rise to a varied repertoire of free soluble glycans (p. 773, Abstract, lines 1-3). These glycans include 2′-FL, DFL, LNFP-1, LNT, and LNnT (p. 776, Table 1). Therefore, fucosylated human milk oligosaccharides (HMOs), such as 2′-FL, DFL, LNFP-1, LNT, and LNnT, are naturally occurring compound from human milk. In addition, combinations of these HMOs are naturally occurring compounds present together in human milk.
(2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is “No”. The claim recites that the composition is “for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant,” but this is interpreted as an intended use of the composition and does not limit the structure of the HMO or of the synthetic composition.
(2b) Does the claim as a whole recite additional elements that amount to something significantly more than the judicial exception(s)? The answer is “No.”
The claims are drawn to a fucosylated HMO or combinations of fucosylated HMOs for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant, as well as to a synthetic composition comprising, consisting of, or consisting essentially of a fucosylated HMO or combinations of fucosylated HMOs for use in improving sleep maturation.
The closest counterpart to the claimed mixture is the naturally occurring human milk from which it is derived. The claims require that this nature-based compound or these nature-based compounds may be used for improving sleep maturation, for example improving trouble sleeping, in a non-infant. However, there is nothing to suggest that the compound having this intended use has any particular change in structure or function or any other characteristic resulting in something markedly different than as it exists in human milk. In addition, claims 8-14 require the composition is a synthetic composition, defined by the specification 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. However, the mere requirement that a composition be artificially prepared would not result in any particular change in structure, function, or any other characteristic of an HMO that would result in something markedly different than the HMO as it exists in human milk.
In view of the foregoing, there is no indication that the fucosylated HMO or synthetic composition comprising, consisting of, or consisting essentially of a fucosylated HMO for use in improving sleep maturation in a non-infant changes the structure, function, or other properties in any marked way that would confer eligibility on the naturally fucosylated HMO compounds.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are drawn to a use without setting forward a positive method step to qualify as a process. See MPEP 2173.05(q).
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, 8, 15-18, 20-24, and 26-29 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, 8, 15-18, 20-22, and 24 recite the terms "preferably" and “for example” renders these claims indefinite because it is unclear whether the limitation(s) following these phrases are part of the claimed invention. See MPEP § 2173.05(d).
Because claims 26, and 29 depend from claim 1 and fail to cure the above deficiencies, claims 26 and 29 are also indefinite.
Because claim 27 depends from claim 8 and fail to cure the above deficiencies, claims 9-14 are also indefinite.
Because claims 16-17 depend from claim 15 and fail to cure the above deficiencies, claims 16-17 are also indefinite.
Because claims 21-24 and 28 depend from claim 20 and fail to cure the above deficiencies, claims 21-24 and 28 are also indefinite.
For the purposes of expedited prosecution, these claim are examined without narrower limitations following the terms “preferably” and “for example”.
Claims 2-7, 9-14, 19, and 25 require specific fucosylated HMOs, and thus the scope of these claims is definite.
Claim 29 depends from claim 26 and recites: "The HMO for the use, the synthetic composition for the use, the pack for the use, the use or the method" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 26 depends from claim 1 and is drawn to the HMO according to claim 1. Therefore, the limitations “the synthetic composition for the use, the pack for the use, the use or the method” lack antecedent basis.
Claims 18 is a “use” claim. This claim is indefinite because it is not known what process steps are intended to be covered by the recitation of the use. See MPEP 2173.05(q).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 26-27 and 29 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 26 depends from claim 1 and requires the non-infant is a child, a teenager, an adult or an elderly person. Claim 29 depends from claim 26 and requires the non-infant is an IBS patient. As described in the above Claim Interpretation section, the limitation ‘for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant” is interpreted as an intended use of the HMO recited in claim 1. Because this intended use does not limit the structure of the HMO recited in the claim, and because claims 26 and 29 further limit the non-infant that is recited as part of the intended use of the HMO, claims 26 and 29 fail to further limit the subject matter of the claim upon which the depend.
Claim 27 depends from claim 8 and requires the non-infant is a child, a teenager, an adult or an elderly person. As described in the above Claim Interpretation section, the limitation “for use in improving sleep maturation, for example, improving trouble sleeping, in a non-infant” is interpreted as an intended use of the composition recited in claim 8. Because this intended use does not limit the structure of the composition recited in the claim, and because claim 27 further limits the non-infant that is recited as part of the intended use of the composition, claim 27 fails to further limit the subject matter of the claim upon which it depends.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-17, 19, 26-27, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McConnell (Publication No. WO 2019087140 A1; cited in IDS received June 2, 2023).
McConnell was published May 9, 2019, and thus qualifies as prior art under 35 U.S.C. 102(a)(1).
Claim 1 is drawn to a fucosylated human milk oligosaccharide (HMO), for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant. Claims 2-7 further limit the fucosylated HMO, claim 26 requires the non-infant is a child, a teenager, an adult or an elderly person, and claim 29 requires the non-infant is an IBS patient.
Claim 8 is drawn to a synthetic composition for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant wherein the composition comprises, consists of or consists essentially of an effective amount of one or more fucosylated HMOs. Claims 9-14 further limit the fucosylated HMO used in the synthetic composition of claim 8. Claim 27 requires the non-infant is a teenager, an adult or an elderly person.
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.
As described in the above Claim Interpretation section, the limitation “for use in improving sleep maturation, for example, improving trouble sleeping, in a non-infant” is interpreted as an intended use of the HMO of claim 1 and the composition of claim 8. Because this intended use does not limit the structure of the HMO or the structure of the composition recited in the claim, these claims are anticipated by a reference that teaches the HMO and the synthetic composition comprising said HMO.
Regarding the specific combination of HMOs required by claims 4-7 and 11-14, MPEP 2131.02 III at A states: “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).” In this instance, given the small number of HMOs taught by McConnell and its suggestion of HMO mixtures thereof, one of ordinary skill in the art would have at once envisaged the claimed combination of HMOs.
Thus McConnell anticipates claims 1-14, 26-27, and 29.
Claim 15 claims a pack for use in improving sleep maturation, for example improving trouble sleeping, in a non-infant, the pack comprising at least 14 individual daily doses of an effective amount of one or more fucosylated human milk oligosaccharides (HMOs), preferably fucosylated neutral HMOs. Claim 16 requires the pack comprises at least 21 individual daily doses, claim 17 requires each daily dose contains 0.1 to 10 g of HMO, and claim 19 requires the HMO is one of those recited in the claim.
McConnell teaches a study with various conditions in which each participant is provided with an amount of HMO sufficient for 3 weeks of a daily dose of about 4 g of HMO, and wherein the HMO provided is either 2'-FL alone or a 4:1 mix of 2'-FL and LNnT (by weight) (p. 13, lines 1-9). In this instance, the sum of daily doses provided to each participant is reasonably considered as a pack. In addition, the daily dose of HMO, the number of daily doses, and the specific HMO provided in the pack anticipates present claims 15-17 and 19.
As described in the above Claim Interpretation section, the limitation “for use in improving sleep maturation, for example, improving trouble sleeping, in a non-infant” is interpreted as an intended use of the pack of claim 15. Because this intended use does not limit the structure of the pack recited in these claims, these claims are anticipated by a reference that teaches the pack comprising an HMO as required by claim 15.
Thus McConnell anticipates claims 15-17 and 19.
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.
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 20-25 and 28 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).
Claim 20 claims a method for improving sleep maturation, for example improving trouble sleeping, in a non-infant, the method comprising administering to the non-infant human an effective amount of one or more fucosylated human milk oligosaccharides (HMOs), preferably fucosylated neutral HMOs. Claim 21 requires the non-infant human is administered the HMO for a period of at least 1 week, claim 22 requires a daily dose of 0.1 to 10 g, claim 23 requires the non-infant human is administered a higher dose initially followed by a lower dose, claim 24 requires the higher dose is about 0.5 g to about 10 g per day and the lower dose is about 0.1 to about 5 g per day, and claim 25 requires the HMO is an HMO recited in the claim. Claim 28 requires the non-infant is an adult or an elderly person.
McConnell teaches as described in the above rejection under 35 U.S.C. 102. In addition, McConnell teaches a method for reducing or preventing fatigue and/or improving focus or concentration on a mental or physical activity by administering at least one HMO and the use of said one or more HMOs in a dietary management of a human (cover page, Abstract, lines 3-5).
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).
Finally, 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), 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).
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 defines "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).
Finally, 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.
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 HMOs to a non-infant human for the purposes of improving sleep maturation. One of ordinary skill in the art would have been motivated to administer one or more HMOs to a non-infant human for the purposes of improving sleep maturation because 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, and further teaches that prolonged fatigue includes Chronic Fatigue Syndrome (CFS), which includes as a side effect sleeping disturbances and unrefreshing sleep. In addition, McConnell teaches their method may be applied to a human with a prolonged morbidity that includes sleep deprivation or a sleep disorder. Accordingly, one of ordinary skill in the art would have recognized that administration of an HMO, including the HMOs and combinations of HMOs taught by McConnell, may reasonably improve sleep maturation, such as trouble sleeping.
Regarding the requirement that the human is administered a higher dose initially followed by a lower dose as recited in claims 23 and 24, because McConnell expressly 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 prolonged fatigue with a sleep disorder or sleep deprivation.
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 sleep disturbances due to prolonged fatigue that is also suffering from IBS.
Therefore the invention taken as a whole is prima facie obvious.
Claim 18 is 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 PTO-892).
Claim 18 claims use of one or more fucosylated human milk oligosaccharides (HMOs), preferably fucosylated neutral HMOs, a synthetic composition comprising, consisting of or consisting essentially of one or more fucosylated human milk oligosaccharides (HMOs), preferably fucosylated neutral HMOs, or a pack comprising at least 14 individual daily doses of an effective amount of one or more fucosylated human milk oligosaccharides (HMOs), preferably fucosylated neutral HMOs, in the dietary management of a non-infant human having fragmented sleep composed of frequent short bout of sleeps and absence of circadian cycle.
McConnell teaches as described in the above rejections under 35 U.S.C. 102 and 35 U.S.C. 103.
McConnell does not teach use of the claimed HMOs in the dietary management of a non-infant human having fragmented sleep composed of frequent short bout of sleeps and absence of circadian cycle, as recited in claim 18.
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.
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 use one or more fucosylated HMOs in the dietary management of a non-infant human having fragmented sleep composed of frequent short bout of sleeps and absence of circadian cycle. One of ordinary skill in the art would have been motivated to use one or more fucosylated HMOs in the dietary management of a non-infant human having fragmented sleep composed of frequent short bout of sleeps and absence of circadian cycle because McConnell teaches administration of fucosylated HMOs for the purposes of treating fatigue, including chronic fatigue syndrome which includes sleep disturbances as a symptom, and because Williams teaches patients with chronic fatigue syndrome show evidence of circadian rhythm disturbances. Accordingly, one of ordinary skill in the art would have been motivated to administer the HMOs taught by McConnell to a non-infant human having fragmented sleep composed of frequent short bout of sleeps and absence of circadian cycle, because this administration of HMOs may treat CFS, as taught by McConnell, which may improve sleep quality and restore a predictable circadian cycle.
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 1-2, 8-9, 26, 27, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 12 of U.S. patent application 18/255768 (reference application, herein referred to as ‘768). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘768 anticipate the claimed invention.
Both the present application and ‘768 include Clara Lucia Garcia-Rodenas and Jonas Hauser as inventors.
The amended claims of ‘768 received June 2, 2025 are cited in this provisional nonstatutory double patenting rejection.
Claim 1 of ‘768 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 selected from the
group consisting of (i) 3' sialyllactose (3-SL), (ii) lacto-N-tetraose (LNT), (iii) a mixture of lacto-N-neotetraose (LNnT), lacto-N-tetraose (LNT), and para-lacto-N-neohexaose and (iv) any
combination thereof, wherein the at least one human milk oligosaccharide is present in a total amount of 50 mg to 5000 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) wherein the subject is an infant or young child.
Claims 3 and 4 of ‘768 claim the at least one human milk oligosaccharide comprises 3' sialyllactose (3-SL) or lacto-N-tetraose (LNT).
Claim 12 claims the nutritional composition is in a form selected from the group consisting of an infant formula, a starter infant formula, a follow-on or follow-up infant formula, a baby food, an infant cereal composition, a fortifier and a supplement. These are interpreted herein as synthetic compositions.
As stated above, the intended use of the present claims does not limit the structure of the product or composition recited in these claims. Therefore, the structural limitations of the HMO and synthetic composition recited in claims 1-2, 8-9, 26, 27, and 29 are satisfied by the HMO and synthetic compositions comprising said HMOs required by these claims.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 12 of U.S. patent application 18/255768 (reference application, herein referred to as ‘768) in view of McConnell (Publication No. WO2019087140A1; cited in IDS received June 2, 2023).
Both the present application and ‘768 include Clara Lucia Garcia-Rodenas and Jonas Hauser as inventors.
The amended claims of ‘768 received June 2, 2025 are cited in this provisional nonstatutory double patenting rejection.
The claims of ‘768 claim as described in the above provisional non-statutory double patenting rejection.
The claims of ‘768 do not claim the additional HMOs and combinations of HMOs of claims 1-14, the pack of claims 15-17 and 19, the use of claim 18, or the method of claims 20-25 and 28.
McConnell teaches as described in the above rejections under 35 U.S.C. 102 and 35 U.S.C. 103.
It would therefore have been prima facie obvious to administer an HMO, such as the HMOs claimed by ‘768 or taught by McConnell, for the purposes of improving sleep maturation, because the claims of ‘768 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 reducing fatigue, which includes sleep disturbances as one side effect. Accordingly, one of ordinary skill in the art would have recognized the HMOs claimed by ‘768 and taught by McConnell may be administered for the purposes improving sleep maturation in a non-infant human. In addition, the specific combinations of HMOs, the dose and dosing schedule, and the pack of HMOs would also have been obvious over the claims of ‘768 in view of McConnell.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 1-3, 8-10, 26, 27, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 6 of U.S. patent application 18/255774 (reference application, herein referred to as ‘774). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘774 anticipate the claimed invention.
Both the present application and ‘774 include Clara Lucia Garcia-Rodenas and Jonas Hauser as inventors.
The amended claims of ‘774 received June 2, 2023 are cited in this provisional nonstatutory double patenting rejection.
Claim 1 of ‘774 claims a method for improving sleep maturation in a subject
comprising administering to a subject in need of same a nutritional composition comprising fucosylated human milk oligosaccharides. Claim 2 requires the fucosylated human milk oligosaccharides is selected from the group listed, including 2’-fucosyllactose, 3-fucosyllactose, difucosyllactose, lacto-N-fucopentaose and combinations thereof.
Claim 6 of ‘774 claims said nutritional composition is in a form selected from the group consisting of an infant formula, a starter infant formula, a follow-on or follow-up infant formula, a baby food, an infant cereal composition, a fortifier or a supplement. The nutritional composition is interpreted herein as a synthetic composition.
As stated above, the intended use of the present claims does not limit the structure of the product or composition recited in these claims. Therefore, the structural limitations of the HMO and synthetic composition recited in claims 1-3, 8-10, 26, 27, and 29 are satisfied by the HMO and synthetic compositions comprising said HMOs that are required by the claims of ‘774.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 6 of U.S. patent application 18/255774 (reference application, herein referred to as ‘774) 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 June 2, 2023 are cited in this provisional nonstatutory double patenting rejection.
The claims of ‘774 claim as described in the above provisional nonstatutory double patenting rejection.
The claims of ‘774 do not recite method of claim 20 in a non-infant human or the additional limitations regarding dose and dosing schedule. In addition, the claims of ‘774 do not claim the specific combinations of HMOs or the pack of HMOs required by the present claims.
McConnell teaches as described in the above rejections under 35 U.S.C. 102 and 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 a patient, including adults, for the purposes of reducing fatigue, which includes sleep disturbances as one side effect. Accordingly, one of ordinary skill in the art would have recognized the HMOs claimed by ‘774 and taught by McConnell may be administered for the purposes improving sleep maturation in a non-infant human. In addition, the specific combinations of HMOs, the dose and dosing schedule, and the pack of HMOs would also have been obvious over the claims of ‘774 in view of McConnell.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 1-14, 26, 27, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,026,959 (reference patent, herein referred to as ‘959) in view of McConnell (Publication No. WO2019087140A1; cited in IDS received June 2, 2023).
The present application and ‘959 are each assigned to Glycom A/S.
Claim 1 of ‘959 claims a method comprising: selecting an adult human patient with irritable bowel syndrome (IBS) experiencing one or more IBS symptoms; selecting an amount of a mixture of 2′-fucosyllactose (2′-FL) and lacto-N-neotetraose (LNnT) effective for increasing a relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the adult human patient; and increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the adult human patient and reducing the likelihood of the adult human patient experiencing the one or more IBS symptoms by administering a daily dose of the selected effective amount of the mixture of 2′-FL and LNnT to the adult human patient.
Claim 6 of ‘959 depends from claim 1 and claims further comprising administering with the selected effective amount of the mixture of 2′-FL and LNnT, one or more neutral HMOs selected from 3-fucosyllactose (3-FL), lacto-N-fucopentaose I (LNFP-I), and difucosyllactose (DFL).
McConnell teaches as described in the above rejections under 35 U.S.C. 102 and 35 U.S.C. 103.
As stated above, the intended use of the present claims does not limit the structure of the product or composition recited in these claims. Therefore, the structural limitations of the HMO and synthetic composition recited in claims 1-14, 26, 27, and 29 are satisfied by the HMO and synthetic compositions comprising said HMOs required by these claims.
Regarding the synthetic composition recited in the present claims, if the mixtures of specific HMOs required by the claims are not reasonably considered as synthetic mixtures, these synthetic mixtures would have been obvious over McConnell teaching synthetic compositions comprising HMOs that may be used for reducing fatigue in a human (cover page, Abstract, lines 1-3), because one of ordinary skill in the art would have recognized a synthetic compositions as a viable method of delivery for HMOs.
Therefore, claims 1-14, 26, 27, and 29 are anticipated by the claims of ‘959 and/or obvious over the claims of ‘959 in view of McConnell.
Claims 1-14, 26, 27, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 11,833,165 (reference patent, herein referred to as ‘165) in view of McConnell (Publication No. WO2019087140A1; cited in IDS received June 2, 2023).
The present application and ‘165 are each assigned to Glycom A/S.
Claim 1 of ‘165 claims a method comprising: selecting a non-infant human patient with irritable bowel syndrome (IBS) experiencing one or more IBS symptoms; selecting an amount of one or more neutral human milk oligosaccharides (HMOs) selected from the group consisting of 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), lacto-N-fucopentaose I (LNFP-I), lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and combinations thereof, the amount effective for increasing a relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human patient; and increasing the relative abundance of Bifidobacterium adolescentis in the gastrointestinal microbiota of the non-infant human patient and reducing the likelihood of the non-infant human patient experiencing the one or more IBS symptoms by administering a daily dose of the selected amount of the one or more neutral HMOs to the non-infant human patient, wherein the daily dose is from about 2.5 g to about 10 g.
Claim 6 of ‘165 depends from claim 1 and claims administering the one or more neutral HMOs comprises administering a mixture of: one or more fucosylated neutral HMOs selected from the group consisting of 2′-FL, 3-FL, DFL, and LNFP-I; and one or more non-fucosylated neutral HMOs selected from the group consisting of LNT and LNnT.
McConnell teaches as described in the above rejections under 35 U.S.C. 102 and 35 U.S.C. 103.
As stated above, the intended use recited in claims does not limit the structure of the product or composition recited in the claims. Therefore, the structural limitations of the HMO and synthetic composition recited in claims 1-14, 26, 27, and 29 are satisfied by the HMO and synthetic compositions comprising said HMOs required by these claims.
Regarding the synthetic composition recited in the present claims, if the mixtures of specific HMOs required by the claims are not reasonably considered as synthetic mixtures, the synthetic mixtures would have been obvious over McConnell teaching synthetic compositions comprising HMOs that may be used for reducing fatigue in a human (cover page, Abstract, lines 1-3) because one of ordinary skill in the art would have recognized a synthetic compositions as a viable method of delivery for HMOs.
Regarding the specific mixtures of HMOs required by the present claims, if the mixtures of HMOs claimed by ‘165 are not sufficiently specific to anticipate the present claims, then the claimed combinations of HMOs would have been obvious over the claims of ‘165 in view of McConnell.
Therefore, claims 1-14, 26, 27, and 29 are anticipated by the claims of ‘165 and/or obvious over the claims of ‘165 in view of McConnell.
Claims 1-14, 26, 27, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,890,293 (reference patent, herein referred to as ‘293) in view of McConnell (Publication No. WO2019087140A1; cited in IDS received June 2, 2023).
The present application and ‘293 are each assigned to Glycom A/S.
Claim 1 of ‘293 claims a method comprising: selecting an effective amount of one or more human milk oligosaccharides (HMOs) selected from: fucosylated HMOs 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), difucosyllactose (DFL), and lacto-N-fucopentaose I (LNFP-I);
non-fucosylated HMOs lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), 3′,6-disialyllacto-N-tetraose (DSLNT), 6′-sialyllactose (6′-SL), and 3′-sialyllactose (3′-SL); and mixtures thereof, in a total daily dosage of HMOs from about 3 g to about 10 g that is effective to increase Bifidobacterium adolescentis in the gut microbiota of a non-infant human during an initial treatment period; selecting a non-infant patient having an obesity-related metabolic disorder and being diagnosable with one or more of obesity, obesity-induced pre-diabetes, and obesity-induced type 2 diabetes; and increasing the relative abundance of Bifidobacterium adolescentis in the non-infant patient and improving in the non-infant patient at least one condition selected from increased insulin sensitivity, reduced insulin resistance, improved gut barrier function, and reduction of metabolic inflammation by providing the total daily dosage of the selected one or more HMOs for consumption by the non-infant patient during the initial treatment period.
Claim 2 of ‘293 depends from claim 1 and requires the one or more HMOs are synthetic HMOs.
McConnell teaches as described in the above rejections under 35 U.S.C. 102 and 35 U.S.C. 103.
As stated above, the intended use recited in claims does not limit the structure of the product or composition recited in the claims. Therefore, the structural limitations of the HMO and synthetic composition recited in the present claims are satisfied by the HMO and synthetic compositions comprising said HMOs required by these claims.
Regarding the synthetic composition recited in the present claims, if the synthetic HMOs required by the claims are not reasonably considered as synthetic mixtures, the synthetic mixtures would have been obvious over McConnell teaching synthetic compositions comprising HMOs that may be used for reducing fatigue in a human (cover page, Abstract, lines 1-3), because one of ordinary skill in the art would have recognized a synthetic compositions as a viable method of delivery for HMOs.
Regarding the specific m