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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 08/26/2026 has been entered.
Priority
The instant application is a 371 of PCT/US2021/058321 filed on 11/05/2021, which claims
domestic benefit to US provisional application no. 63/110,736 filed on 11/06/2020.
Status of the Claims
The claim amendments and remarks filed on 08/26/2026 is acknowledged. Claims 1 and 18 are amended. Claims 7-8 and 11 are cancelled.
Accordingly, claims 1-6, 9-10, and 12-23 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(b) rejection for claims 1-6, 9-10, and 12-23 is withdrawn because the claims have been amended to not recite “Prolectin”.
The 35 USC 112(a) enablement rejection for claims 1-6, 9-10, and 12-23 is withdrawn because the claims now recite administering a pectin polysaccharide that comprises the newly recited glycosyl residues and wherein the most abundant glycosyl residues are GalpA residues, which were not previously considered in this rejection.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 9-10, and 12-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Formal, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) The breadth of the claims,
2) The nature of the invention,
3) The state of the prior art,
4) The level of one of ordinary skill,
5) The level of predictability in the art,
6) The amount of direction provided by the inventor,
7) The existence of working examples, and
8) The quantity of experimentation necessary
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, the breadth of the claims, and relative skill level
The nature of the invention and breadth of the claims relates to a method of treating a SARS-CoV-2 infection in a subject, the method comprising administering to the subject an effective amount of pectin polysaccharides, wherein the pectin polysaccharides comprise glycosyl residues t-Araf, t-Arap, 2-Rhap, t-Galp, t-GalpA, either 4-Arap or 5-Araf, 2-Xylp, 4-Xylp, 2,4-Rhap, 3-Galp, 4-Galp, 4-GalpA, 4-Glcp, 3,4-GalpA, and 3,6-Galp, wherein the most abundant glycosyl residues are GalpA residues.
The relative skill of those in the art is high, that of an MD or PHD, someone with experience in the recited disease and administered compound.
The amount of direction or guidance provided and the presence or absence of working examples
Applicant demonstrates in Example 1 (pages 12-14) the inhibition of a patient sample derived strain of SARS-CoV-2 virus by administering a type of pectin polysaccharide called Prolectin-l at a dosage as disclosed in Table 1 (page 13).
Applicant provides in Example 2 (pages 14-16) a NMR analysis of Prolectin-l and identified the percentages of specific residues and glycosidic linkage present in the Prolectin-l as seen in Table 5 (page 15), which contained all of the recited glycosyl residues and where GalpA was the most abundant as recited in the instant claims.
While Applicant has demonstrated sufficient support to use the claimed invention, Applicant has not provided enough guidance on how to make the claimed invention. Applicant has only provided a general disclosure on how to make pectin polysaccharides in page 7 lines 9-17, in which Applicant states the pectin polysaccharides may be obtained via processing of a variety of crude fruit pectins and can be obtained by chemical, enzymatic, physical treatment, and purification.
Even though Applicant has provided a NMR analysis of Prolectin-l, Applicant has not provided enough guidance or suggestions for which types of starting materials and processing conditions/parameters are necessary in order to make this recited pectin polysaccharide comprising the recited glycosyl residues and wherein GalpA is the most abundant. Therefore, an ordinary skilled artisan would not be able to predictably determine whether or not the recited pectin polysaccharide is formed.
The state and predictability of the art
The state of the prior art suggests that it would not be predictable to make the claimed pectin polysaccharide. For example, Gawkowska (in PTO-892) discloses that due to the variability of plant pectin sources, controlling the pectin structure extracted from plants for the particular purpose of various experiments is extremely difficult and that the comparison of results of different experiments on different plants and different maturity stage is often ambiguous (first paragraph page 2).
Gawkowska discloses that pectins are mainly composed of GalA residues and contain different pectin domains such as homogalacturonan (HG), rhamnogalacturonan I (RGI), rhamnogalacturonan II (RGII), xylogalacturonan (XGA), apiogalacturonan (AGA), arabinan, galactan, arabinogalactan I (AGI) and arabinogalactan II (AGII) (first paragraph under section 2.1 page 2).
Gawkowska discloses the structure of these different domains and shows that the glycosyl residue present within these domain structures can vary depending on the plant source and processing conditions (section 2.1 pages 2-3). For example, the RG-1 domain is composed of repeating residues of galacturonic acid and rhamnose, and the C-4 of the rhamnose residue can contain side chains composed of a single sugar residue or combined chains of arabinans, galactans, or arabinogalactans depending on the origin of the polysaccharide (third paragraph under section 2.1 page 2). These polysaccharides cannot be separated without a chain-cleavage using for example, enzymes such as endopolygalacturonase or chromatographic fractionation methods (third paragraph under section 2.1 page 2).
Furthermore, Gawkowska discloses that different extraction methods of the pectin will result in varying amounts of galacturonic acid content (GalA), which further varies by plant species and physiological development of the plant (second paragraph under section 2.3 page 5). Gawkowska discloses that different extraction methods such as using water, a chelating agent such as CDTA or EDTA, and sodium carbonate along with the pectin source such as carrot, plum fruit, and others contained significantly different GalA content (second paragraph under section 2.3 page 5).
The teachings of Gawkowska disclose that pectin structures are highly diverse and contain different glycosyl residues and amounts of these residues depending on the source of the pectin and how it is extracted. Therefore, it is not predictable in the state of the prior art on how to make pectin polysaccharides comprising the recited glycosyl residues and wherein GalA is the most abundant.
The quantity of experimentation necessary
Because of the unpredictability of the art, and in the absence of a disclosed method to make the claimed recited pectin polysaccharides, one of ordinary skilled in the art would not be able to predictably make the claimed invention. Furthermore, the quantity of experimentation required to make the recited pectin polysaccharides is undue because Applicant has only provided a general disclosure for making pectins. Furthermore, the NMR data provided by Applicant only identifies what monomers and/or linkages are present in the compound but does not provide reasonable guidance for how this data can then be used to determine which starting material and processing methods can be used, especially in light of the diverse nature of the pectin source and processing methods as described above. Therefore, an ordinary skilled artisan would not be able to determine without undue experimentation if the recited pectin polysaccharide is made.
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claims 1-6, 9-10, and 12-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims recite a method of treating a SARS-CoV-2 infection in a subject, the method comprising administering to the subject an effective amount of pectin polysaccharides, wherein the pectin polysaccharides comprise glycosyl residues t-Araf, t-Arap, 2-Rhap, t-Galp, t-GalpA, either 4-Arap or 5-Araf, 2-Xylp, 4-Xylp, 2,4-Rhap, 3-Galp, 4-Galp, 4-GalpA, 4-Glcp, 3,4-GalpA, and 3,6-Galp, wherein the most abundant glycosyl residues are GalpA residues.
MPEP 2163 II.A.3.(a).ii. states that “[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention”, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus … Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus”, and “The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." … The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species”.
In this case, the disclosure does not provide sufficient description such that the ordinary skilled artisan would have understood the Applicant had possession of the recited method because the disclosure does not provide a structure-function relationship or a representative number of species for the recited pectin polysaccharides comprising any amounts of the recited glycosyl residues and wherein GalpA is the most abundant to treat the SARS-CoV-2 infection.
Applicant demonstrates in Example 1 (pages 12-14) the inhibition of a patient sample derived strain of SARS-CoV-2 virus by administering a type of pectin polysaccharide called Prolectin-l at a dosage as disclosed in Table 1 (page 13).
Applicant discloses that the N-terminal domain (NTD) of the SARS-CoV-2 spike protein is essential for viral entry into human cells and that portions of the SARS-CoV-2 spike protein resemble human galectins, which contain a highly conserved carbohydrate-binding domain that binds a variety of pectin polysaccharides (lines 32-34 page 8). Applicant discloses that their pectin polysaccharides bind to either the NTD of the galectins of the SARS-CoV-2 spike protein (lines 35-40 page 8).
Applicant provides in Example 2 (pages 14-16) a NMR analysis of Prolectin-l and identified the percentages of specific residues and glycosidic linkage present in the Prolectin-l as seen in Table 5 (page 15), which contained all of the recited glycosyl residues and where GalpA was the most abundant as recited in the instant claims.
Applicant has only demonstrated in the disclosure the use of a specific type of pectin polysaccharide (Prolectin-l) that contains certain percentage amounts for each of the recited glycosyl residues. Applicant has not provided further guidance for additional species of pectin polysaccharides comprising any other amounts of the recited glycosyl residues and wherein GalpA is the most abundant that can also inhibit the SARS-CoV-2 virus. Furthermore, while Applicant generally discloses that the pectin may bind to either the NTD or galectins of the SARS-CoV-2 spike protein, Applicant has not provided guidance of a structure-function relationship to determine whether any amount of each of the recited glycosyl residue and wherein GalA is the most abundant will perform the function of treating the SARS-CoV-2 infection.
The state of the art also does not provide guidance to predictably determine what amounts of the recited glycosyl residues are required in order to treat the SARS-CoV-2 infection.
Prado (in PTO-892) discloses that pectin is comprised of two types of polysaccharides – homogalacturonan (HG) and rhamnogalacturonan-I (RG-I), and that the molecular size, monosaccharide composition, and linkage pattern of HG and RG-I vary substantially during the development of any plant species and organ, which results in a large degree of pectin heterogeneity in fruits and vegetables (right column paragraph page 141). Prado discloses that this structural diversity within a single pectin fraction makes it challenging to establish a structure-function relationship between pectin and intestinal cells (right column paragraph page 141 through first line left column page 142).
Prado discloses that even though modified citrus pectins fractions are known to bind galectin-3, there is a need to elucidate the structural modifications and the explanation of a possible structure-function relationship. (first paragraph left column page 142).
Furthermore, as described above in Gawkowska (in PTO-892), due to the variability of plant pectin sources, controlling the pectin structure extracted from plants for the particular purpose of various experiments is extremely difficult and that the comparison of results of different experiments on different plants and different maturity stage is often ambiguous (first paragraph page 2).
The teachings of Prado and Gawkowska establish that pectin polysaccharides have diverse structures which makes it difficult to establish structure-function relationships for these pectins and suggests that it would not be predictable to determine what amounts of the recited glycosyl residues are required in order to treat the SARS-CoV-2 infection.
Therefore, it is not evident by the disclosure or the prior art, that the Applicant was in possession of the recited method of treating SARS-CoV-2 infection comprising administering pectin polysaccharides comprising any amount of the recited glycosyl residues and wherein GalAp is the most abundant. Furthermore, as described above, there is no disclosed and/or art recognized guidance of a structure-function relationship to determine what amounts of the recited glycosyl residues in the pectin are required in order to treat the SARS-CoV-2 infection, and Applicant has only demonstrated inhibiting the SARS-CoV-2 virus using a specific type of pectin (Prolectin-l) which contains a certain amount of the recited glycosyl residues as seen in the NMR data described above.
Therefore, instant claims 1-6, 9-10, and 12-23 do not meet the written description requirement under 35 USC 112(a).
Claims 1-6, 9-10, and 12-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains new subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims recite a new limitation “wherein the pectin polysaccharides comprise glycosyl residues t-Araf, t-Arap, 2-Rhap, t-Galp, t-GalpA, either 4-Arap or 5-Araf, 2-Xylp, 4-Xylp, 2,4-Rhap, 3-Galp, 4-Galp, 4-GalpA, 4-Glcp, 3,4-GalpA, and 3,6-Galp, wherein the most abundant glycosyl residues are GalpA residues”.
Applicant has demonstrated the use of a specific type of pectin polysaccharide (Prolectin-l) in Example 1 (pages 12-14), and provides a NMR analysis of this Prolectin-l (Example 2 pages 14-16), which showed that the compound contained all of the recited glycosyl residues and where GalpA was the most abundant as recited in the instant claims.
Furthermore, Applicant has generally disclosed that pectins can include several types of glycosyl residues in varying amounts (lines 1-8 page 7 and lines 39-40 page 7 through lines 1-10 page 8).
However, as discussed above in Gawkowska, pectin structures are highly diverse and contain different glycosyl residues and amounts of these residues depending on the source of the pectin and how it is extracted, and Applicant has not provided further disclosure for other species within the claimed genus of the pectin polysaccharides comprising any amount of the recited glycosyl residues and wherein GalpA is the most abundant.
Therefore, a showing of one specific type of pectin is not sufficient support for the newly claimed genus and introduces new matter that does not have support in the specification. One of ordinary skill in the art would not recognize in the Applicant’s disclosure a description of the invention as presently claimed.
Response to Arguments
Applicant' s arguments filed on 08/26/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states in regards to being enabled for how to make the claimed invention that enablement does not require disclosure of a single starting material or a single set of processing parameters, and rather enablement requires that the specification describes the invention in such terms that one skilled in the art can make and use the claimed invention.
Applicant points to Example 2 which discloses the structural features of Prolectin-l and an analytical framework for determining whether a pectin polysaccharide has the claimed residue profile. Applicant states that the specification teaches that pectin may be obtained from crude fruit pectin and processed by chemical, enzymatic physical treatment, and purification. Therefore, Applicant states that an ordinary skilled artisan would understand that pectins are composed mainly of HG with short RG-l fragments and thus the skilled artisan would be guided to routinely elect a source accordingly. Applicant further states that any routine selection or adjustment of known pectin sources and processing conditions would be guided by the disclosed structural endpoint and confirmed by conventional analysis such as GC or NMR.
Applicant’s arguments described above were not found persuasive because MPEP 2164.01 states that “the specification does not always need to "describe with particularity how to make and use every single embodiment within a claimed class … However, "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class….The more one claims, the more one must enable … The specification may require a reasonable amount of experimentation to make and use the invention and what is reasonable will depend on the nature of the invention and the underlying art.”
In this case, the quantity of experimentation needed to make the claimed invention would be undue because as discussed above, Applicant has only provided a general disclosure for making pectins, and while the NMR data provided by Applicant identifies what monomers and/or linkages are present in the compound, the specification does not provide further reasonable guidance for how this information can then be used to determine which types of starting materials and processing methods can be used to make the claimed pectin polysaccharides, especially in light of the known diverse nature of the pectin source and processing methods. As discussed above in Gawkowska, pectin structures are highly diverse and contain different glycosyl residues and amounts of these residues depending on the source of the pectin and how it is extracted. Therefore, the disclosure does not provide enablement for how to make the claimed pectin polysaccharides comprising the recited glycosyl residues and wherein GalpA is the most abundant.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6, 9-10, 12-16, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Eliaz et al. (US20220072031A1 in PTO-892 dated 10/20/2025, this application was filed on 10/05/2020 and has an effective filing date of 09/10/2020) in view of Prado et al. (Carbohydrate Polymers, 2019 in PTO-892), Raz et al. (Nutrients, 2019 in PTO-892), and Pettolino et al. (Nature Protocols, 2012 in PTO-892).
Eliaz discloses the treatment of COVID-19 patients by administering modified citrus pectin to patients either infected by SARS-CoV-2 or presymptomatic for COVID-19 but at risk of severe morbidity and mortality due to potential COVID-19 infection (see Abstract).
Eliaz discloses that the striking parallel between gal-3 expression in the body, and COVID-19-induced gal-3 mediated events including inflammation, fibrosis, acute kidney injury and the like have led researchers to call for immediate exploration of gal-3 inhibitors as a possible treatment for COVID-19 (paragraph 0003). Eliaz discloses that inhibiting gal-3 activity could be a path to a COVID-19 solution by a dual mechanism of reducing the host inflammatory immune response, T-cell activation, and interrupting viral attachment to host cells (paragraph 0004).
Therefore, Eliaz discloses that the administered modified pectin may play an essential role by lowering SARS-CoV-2 levels and gal-3 levels (see paragraph 0007).
Such patients are given preferably modified citrus pectin in an amount that may range from 2.5 or 5 on up to 10-25 grams per day and divided into two or three doses per day (see Abstract). Eliaz discloses that their modified citrus pectin can be prepared by enzymatic processes or related processes or of similar character and effect (paragraph 0005) and are reduced to a molecular weight of 40,000 daltons or less (see paragraph 0006). Eliaz discloses that the administration may be oral, by inhalation, intrabuccal, or IV (intravenous) (see Abstract). Eliaz discloses that dosages of the modified pectin for COVID-19 patients can be advantageously distributed in two or three dosages per day, for example, 7-8 grams per day three times a day (see paragraph 0014).
Eliaz discloses that the administration of modified pectins can begin prior to detection of COVID-19, and that the administration of a preventative dosage of modified pectin is on the order of 12-18 grams per day (see paragraph 0013).
Even though Eliaz teaches a method of treating SARS-CoV-2 infection in a patient by administering a pectin polysaccharide, Eliaz does not teach the pectin polysaccharide comprises glycosyl residues t-Araf, t-Arap, 2-Rhap, t-Galp, t-GalpA, either 4-Arap or 5-Araf, 2-Xylp, 4-Xylp, 2,4-Rhap, 3-Galp, 4-Galp, 4-GalpA, 4-Glcp, 3,4-GalpA, and 3,6-Galp, wherein the most abundant glycosyl residues are GalpA residues.
Prado teaches the effects of molecular size of modified citrus pectins on cancer cell migration and proliferation (Abstract).
Prado teaches that galectin-3 is a member of the carbohydrate-binding protein family that exhibits an affinity for β-galactoside sugars in a conserved sequence of the carbohydrate-binding site and that overexpression of galectin-3 might induce cancer cells to become more aggressive by increasing their proliferation and metastasis (paragraph under section 3.3 right column page 149). Therefore, Prado teaches that the interaction of pectin fractions with galectin-3 could prevent this increased activity in cancer cells (paragraph under section 3.3 right column page 149).
Prado teaches that citrus pectins inhibit cancer cell aggregation through interaction with galectin-3, where galectin-3-mediated interactions are reduced between cells and between cells and the extracellular matrix (left column first paragraph page 142). Prado teaches that the enhanced anticancer effects of citrus pectin that has been thermally modified have mostly been attributed to a reduction in molecular size, which allows the modified citrus pectin to access and bind galectin-3 (left column first paragraph page 142). Prado demonstrates in their studies that thermally modified citrus pectins fractionated by size showed different galectin-3 binding powers, with the smaller sizes resulting in more inhibition, probably enhancing the observed anticancer activity due to a better penetration in cancer cells because of their smaller molecular sizes (first paragraph left column page 150).
Prado discloses and shows in Fig. 1 (page 145) the linkage analysis of their modified citrus pectins and modified citrus pectin fractions. Prado discloses that galacturonic acid GalA was the most abundant monosaccharide in all the modified citrus pectin fractions (second paragraph under section 3.1 left column page 144). Prado also shows in Fig. 1 and discloses (second paragraph under section 3.1 left through right column page 144) that their modified citrus pectin fractions had several glycosyl residues including t-Araf, t-Arap, 2-Rha, t-Gal, t-GalA, 5-Ara(f), 2-Xyl, 4-Xyl, 2,4-Rha, 3-Gal, 4-Gal, 4-GalA, 4-Glc, 3,4GalA, and 3,6-Gal. It is noted that glycosyl residues 2-Rha, t-Gal, t-Gal, 2-Xyl, 4-Xyl, 2,4-Rha, 3-Gal, 4-GalA, 4-Glc, 3,4-GalA, and 3,6-Gal disclosed in Prado do not specify that these residues are in the “p” form (6 carbon sugar ring) as recited in the instant claims.
Raz discloses citrus pectin contains the following sugar structure in Fig. 1 (page 2) shown below:
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Raz shows that the GalA, Gal, Rha, and Xyl residues exist in the “p” form (6-membered sugar ring) in citrus pectin.
Furthermore, Pettolino discloses polysaccharide compositions within plant cell walls (Abstract), and further discloses that 4-Glc (p) is common to cellulose, xyloglucan, galacto(glucomannan), (1,3:1,4)-beta-glucan, and starch (last paragraph right column page 1595).
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the modified citrus pectins of Eliaz with the thermally modified citrus pectin fractions of Prado to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this modification because Prado discloses that their smaller sized thermally modified citrus pectin fractions resulted in increased galectin-3 inhibition due to better penetration and access to bind to galectin-3.
One of ordinary skill in the art would have a reasonable expectation of success because both Eliaz and Prado teach therapeutic methods that involves inhibiting galectin-3 by administering modified citrus pectins that have lower molecular weights that the starting citrus pectin.
Furthermore, an ordinary skilled artisan would have understood that the 2-Rha, t-Gal, t-Gal, 2-Xyl, 4-Xyl, 2,4-Rha, 3-Gal, 4-GalA, 4-Glc, 3,4-GalA, and 3,6-Gal disclosed in Prado would exist in the “p” form (6-membered sugar ring) because Raz shows that the GalA, Gal, Rha, and Xyl residues exist in the “p” form in pectin. Furthermore, Pettolino discloses that 4-Glc (p) is common to xyloglucans, and Prado discloses their modified citrus pectin fractions contained 4-glc within xyloglucan (first paragraph right column page 144 in Prado).
In regards to instant claims 2-6, 9-10, and 12, these recited limitations are a result of when an effective amount of the recited pectin polysaccharide is administered to a patient with SARS-CoV-2 infection. Therefore, these recited results would necessarily flow for the COVID-19 treatment as disclosed by the combined teachings of Eliaz and Prado described above because as evidenced by the instant specification, the administered pectin polysaccharides in the instant invention can be a pectin polysaccharide derived from citrus and further modified to reduce the natural molecular weight of 40,000-1,000,000 to a desired range (see page 7 lines 9-17 and lines 23-32 in instant specification), and the combined teachings of Eliaz and Prado described above disclose administering in an effective amount the same reduced molecular weight modified citrus pectin comprising the same glycosyl residues with GalA being the most abundant to treat the same patient population with SARS-CoV-2 infection and reduce SARS-CoV-2 levels. Furthermore, both the combined teachings of Eliaz and Prado described above and the instant specification disclose that the administered pectin inhibits gal-3 (see paragraph 0007 in Eliaz et al. and page 8 lines 38-40 through page 9 lines 1-9 in instant specification).
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claims 18-23, the limitations of instant claims 22-23 are disclosed in Eliaz as described above. Furthermore, under broadest reasonable interpretation, the recited sample of cells encompasses those in the body. Therefore, the treatment method as disclosed by the combined teachings of Eliaz and Prado described above meet this limitation, and the recited result of reducing the number of SARS-CoV-2 virons would necessarily flow because the combined teachings of Eliaz and Prado described above disclose the same pectin polysaccharides being administered at an effective amount to treat the same patient population with SARS-CoV-2 infection as discussed above. Furthermore, the combined teachings of Eliaz and Prado described above discloses an effective amount of 2.5 – 25 grams of pectin, and the instant specification discloses an effective amount of 80 mg for a 70 kg adult (see page 12 lines 25-27). Therefore, an ordinary skilled artisan would reasonably expect that the amount administered in the combined teachings described above would necessarily provide a viron reduction percentage greater than the recited 50%, 80%, or 95% due to providing a higher dosage amount.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Eliaz et al. (US20220072031A1 in PTO-892 dated 10/20/2025, this application was filed on 10/05/2020 and has an effective filing date of 09/10/2020) in view of Prado et al. (Carbohydrate Polymers, 2019 in PTO-892), Raz et al. (Nutrients, 2019 in PTO-892), and Pettolino et al. (Nature Protocols, 2012 in PTO-892), as applied to claims 1 and 14-15 above, and further in view of Muntendam et al. (US20230107479A1 in PTO-892 dated 10/20/2025, this application was filed 03/23/2021 and has an effective filing date of 03/23/2020).
The combined teachings of Eliaz, Prado, Raz, and Pettolino are as described above and teach the method of instant claims 1 and 14-15 as discussed above.
The combined teachings, however, do not disclose the pectin polysaccharides are administered to the subject one time per hour during each hour that the subject is awake.
Muntendam discloses methods, compositions, and kits using a galectin-3 inhibitor to treat fibrosis resulting from a coronavirus infection, such as fibrosis in a subject's lung resulting from a coronavirus 2 infection (see Abstract). Muntendam discloses that the galectin-3 inhibitor may be a pectin (see paragraph 0006) such as modified citrus pectin (MCP) (see paragraph 0069). Muntendam discloses that a suitable effective daily dose of the active compound may be administered as two, three, four, five, six or more sub-doses administered separately at appropriate intervals throughout the day, optionally, in unit dosage forms (see paragraph 0162).
An ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosing time interval in the treatment method as disclosed by the combined teachings of Eliaz and Prado described above and arrive at the recited dosing time interval based on guidance from Muntendam disclosing administering the same modified citrus pectin to the same SARS-CoV-2 patients at two, three, four, five, six or more sub-doses per day in appropriate intervals throughout the day. See MPEP 2144.05 II
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 1-6, 9-10, 12-16, and 18-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-7, 9, 11-12, 14-16, and 22-23 of copending Application No. 18/847,466 (‘466) in view of Prado et al. (Carbohydrate Polymers, 2019 in PTO-892), Eliaz et al. (US20220072031A1 in PTO-892 dated 10/20/2025, this application was filed on 10/05/2020 and has an effective filing date of 09/10/2020), Raz et al. (Nutrients, 2019 in PTO-892), and Pettolino et al. (Nature Protocols, 2012 in PTO-892).
Claim 1 of ‘466 recites a method of treating a viral infection in a subject in need thereof, the method comprising administering to the subject an effective amount of lectin-binding carbohydrates. Claim 2 of ‘466 recites the lectin-binding carbohydrates are pectin polysaccharides. Claim 23 of ‘466 recites the viral infection is caused by SARS-CoV-2.
Even though the claims of ‘466 recite a method of treating SARS-CoV-2 infection in a subject comprising administering an effective amount of pectin polysaccharides, the claims of ‘466 do not recite the pectin polysaccharide comprises glycosyl residues t-Araf, t-Arap, 2-Rhap, t-Galp, t-GalpA, either 4-Arap or 5-Araf, 2-Xylp, 4-Xylp, 2,4-Rhap, 3-Galp, 4-Galp, 4-GalpA, 4-Glcp, 3,4-GalpA, and 3,6-Galp, wherein the most abundant glycosyl residues are GalpA residues.
The independent teachings of Prado, Eliaz, Raz, and Pettolino are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the pectin recited in ‘466 with the thermally modified citrus pectin fractions of Prado and further guidance from Eliaz to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this modification because Prado discloses that their smaller sized thermally modified citrus pectin fractions resulted in increased galectin-3 inhibition due to better penetration and access to bind to galectin-3.
One of ordinary skill in the art would have a reasonable expectation of success because Eliaz provides guidance that inhibiting gal-3 activity using a modified citrus pectin could be a path to a COVID-19 solution by a dual mechanism of reducing the host inflammatory immune response, T-cell activation, and interrupting viral attachment to host cells, and Prado also teaches a therapeutic method that involves inhibiting galectin-3 by administering modified citrus pectins that have lower molecular weights than the starting citrus pectin.
Furthermore, an ordinary skilled artisan would have understood that the 2-Rha, t-Gal, t-Gal, 2-Xyl, 4-Xyl, 2,4-Rha, 3-Gal, 4-GalA, 4-Glc, 3,4-GalA, and 3,6-Gal disclosed in Prado would exist in the “p” form (6-membered sugar ring) because Raz shows that the GalA, Gal, Rha, and Xyl residues exist in the “p” form in pectin. Furthermore, Pettolino discloses that 4-Glc (p) is common to xyloglucans, and Prado discloses their modified citrus pectin fractions contained 4-glc within xyloglucan (first paragraph right column page 144 in Prado).
In regards to instant claims 2-6, 9-10, and 12, these recited limitations are a result of when an effective amount of the recited pectin polysaccharide is administered to a patient with SARS-CoV-2 infection. Therefore, these recited results would necessarily flow for the COVID-19 treatment as disclosed by the combined references described above because as evidenced by the instant specification, the administered pectin polysaccharides in the instant invention can be a pectin polysaccharide derived from citrus and further modified to reduce the natural molecular weight of 40,000-1,000,000 to a desired range (see page 7 lines 9-17 and lines 23-32 in instant specification), and the combined references described above disclose administering in an effective amount the same reduced molecular weight modified citrus pectin comprising the same glycosyl residues with GalA being the most abundant to treat the same patient population with SARS-CoV-2 infection and reduce SARS-CoV-2 levels. Furthermore, both the combined references described above and the instant specification disclose that the administered pectin inhibits gal-3 (see paragraph 0007 in Eliaz et al. and page 8 lines 38-40 through page 9 lines 1-9 in instant specification).
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claims 13-16, it would have been prima facie obvious before the effective filing date of the claimed invention to have modified the treatment method as disclosed by the combined references described above by administering the modified citrus pectin intravenously three times a day as disclosed in Eliaz to arrive at the claimed invention.
One of ordinary skill in the art would made these modifications with a reasonable expectation of success because Eliaz provides guidance that this mode of administration and dosing regimen is effective for treating SARS-CoV-2 infection using a pectin compound.
In regards to instant claims 18-23, the limitations of instant claims 22-23 are disclosed in Eliaz as described above. Furthermore, under broadest reasonable interpretation, the recited sample of cells encompasses those in the body. Therefore, the treatment method as disclosed by the combined references described above meet this limitation, and the recited result of reducing the number of SARS-CoV-2 virons would necessarily flow because the combined references described above disclose the same pectin polysaccharides being administered at an effective amount to treat the same patient population with SARS-CoV-2 infection as discussed above. Furthermore, the combined references described above discloses an effective amount of 2.5 – 25 grams of pectin, and the instant specification discloses an effective amount of 80 mg for a 70 kg adult (see page 12 lines 25-27). Therefore, an ordinary skilled artisan would reasonably expect that the amount administered in the combined references described above would necessarily provide a viron reduction percentage greater than the recited 50%, 80%, or 95% due to providing a higher dosage amount.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 14-15,and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-7, 9, 11-12, 14-16, and 22-23 of copending Application No. 18/847,466 (‘466) in view of Prado et al. (Carbohydrate Polymers, 2019 in PTO-892), Eliaz et al. (US20220072031A1 in PTO-892 dated 10/20/2025, this application was filed on 10/05/2020 and has an effective filing date of 09/10/2020), Raz et al. (Nutrients, 2019 in PTO-892), Pettolino et al. (Nature Protocols, 2012 in PTO-892), and Muntendam et al. (US20230107479A1 in PTO-892 dated 10/20/2025, this application was filed 03/23/2021 and has an effective filing date of 03/23/2020).
The combination of the claims of ‘466 and the teachings of Prado, Eliaz, Raz, and Pettolino are described above and recite the method of instant claims 1 and 14-15 as discussed above.
The combined references, however, do not recite the pectin polysaccharides are administered to the subject one time per hour during each hour that the subject is awake.
The teachings of Muntendam are as described above.
An ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosing time interval in the treatment method as disclosed by the combined references described above and arrive at the recited dosing time interval based on guidance from Muntendam disclosing administering the same modified citrus pectin to the same SARS-CoV-2 patients at two, three, four, five, six or more sub-doses per day in appropriate intervals throughout the day. See MPEP 2144.05 II.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
