DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Preliminary Amendment filed 06 November 2023, Applicant amended claims 3, 5-6, 9-10, 12-13, 16, 20, and 22-23. Additionally, Applicant cancelled claims 4, 7-8, 11, 21, and 26-29. Claims 1-3, 5-6, 9-10, 12-20, and 22-25 are pending.
Claim Objections
Claims 24-25 are objected to because of the following informality: the word “virons” is misspelled. Appropriate corrected is required. Applicant is advised that the correct spelling is “virions.”
Claim Rejections - 35 U.S.C. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-3, 5-6, 9-10, 12-14, 20, 22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Caniglia (“A potential role for Galectin-3 inhibitors in the treatment of COVID-19.” PeerJ 8 (2020 June): e9392) in view of Blanchard (“Galectin-3 inhibitors: a patent review (2008–present).” Expert Opinion on Therapeutic Patents 24.10 (2014): 1053-1065), Traber (US 2013/0259870 A1), and Platt (US 7,893,252 B2).
Caniglia is directed to “[a] potential role for Galectin-3 inhibitors in the treatment of COVID-19.” Title.
Caniglia discloses: “Galectins, a structurally similar family of animal lectins with chemokinetic properties, have been implicated extensively in the immune response. Gal-3, arguably the most well studied of the galectins, has been shown to activate the pro-inflammatory transcription factor NF-kB and induce the release of both IL-6 and TNF-α. Additionally, data obtained from The Human Protein Atlas shows baseline Gal-3 protein expression in healthy tissues is highest in the lungs, followed by the gastrointestinal tract (stomach, duodenum, small intestine, colon and rectum) and brain (cortex and hippocampus). This is particularly noteworthy as an increasing number of patients infected with SARS-CoV2 have reported gastrointestinal symptoms such as diarrhea, nausea, vomiting and abdominal pain.” Pages 2-3 (internal citations omitted).
Caniglia discloses: “The spike proteins found in the β-genus of coronaviridae share unique structural similarities with human Gal-3. Structural analysis of the N-terminal domain (NTD) of the spike protein subunit S1 in murine hepatitis virus (MHV) showed a nearly identical topology to human Gal-3, with the only difference being two additional β-strands in one of the β-sheet layers of MHV S1-NTD. Additionally, a study of bovine coronavirus (BCoV) found significant overlap between the virus’s S1-NTD receptor binding domain and the galactose-binding domain of human galectins, strongly supporting a functional similarity. Pertinent to these findings is the high degree of structural conservation in the S1-NTD observed amongst the β-genus of coronaviridae, which now includes SARS-CoV2. Given this structural similarity, it may be possible that inhibitors against human galectins also have the capability to bind the S1-NTD of β-coronaviridae.” Page 3 (internal citations omitted).
Caniglia discloses: “The recognition and binding of membrane-bound cell receptors is the first step in viral infection and a necessary event prior to cell invasion. In β-coronaviridae such as SARS-CoV2, this function is mediated entirely by the S1 subunit of the spike protein. The S1 subunit can be further divided into two distinct domains: the NTD and the C-terminal domain (CTD). Though both domains play a role in the adhesion process, the receptor binding mechanisms amongst these viruses can be thought of as predominantly CTD or NTD mediated. A general rule is that the CTD mainly binds peptides while the NTD mainly binds extracellular sugars, though there are exceptions such as that seen in the entry mechanism of MHV via carcinoembryonic antigen cell adhesion molecule 1 (CEACAM1).” Page 3 (internal citations omitted).
Caniglia discloses (emphasis added): “More pertinent than these findings, however, is the evidence that coronaviruses which bind receptors in a CTD-mediated fashion still are reliant upon their galectin-like NTD for functioning. In a study by Li et al. (2017) it was shown that MERS-CoV, in addition to binding dipeptidyl peptidase 4 (DPP4) through its CTD domain, selectively binds to sialic acids at the NTD domain. Additionally, the depletion of sialic acids through treatment with neuraminidase inhibitors inhibited MERS-CoV entry into Calu-3 human airway cells, demonstrating that sialoconjugate binding by the galectin-like NTD is an essential component of MERS-CoV infection (Li et al., 2017).” (Emphasis added) Page 4.
Caniglia discloses (emphasis added): “To date, there are no studies investigating whether sialic acid binding is an essential component of SARS-CoV2 infection. However, a recent study has elucidated the crystalline structure of the SARS-CoV2 S1-NTD. Molecular dynamic simulations of the tip of the S1-NTD (amino acids 100–175) reveal a strong interaction with GM1 ganglioside, a molecule commonly found on cell surfaces. This data strongly supports a dual attachment model for SARS-CoV2 similar to the mechanism observed in MERS-CoV, where the CTD domain is involved in ACE-2 receptor recognition and the NTD region binds gangliosides on the cell surface to stabilize viral adhesion.” Pages 4-5 (internal citations omitted); see also page 5 at Figure 2 (showing how Gal-3 inhibition may disrupt the attachment of SARS-CoV2 S1-NTD to GM1 gangliosides on the cell surface).
Caniglia discloses (emphasis added): “In addition to Gal-3 inhibition potentially being able to bind and disrupt the NTD of β-coronaviridae, inhibiting Gal-3 has shown numerous anti-inflammatory effects that may be beneficial in the treatment of COVID-19. Retrospective studies of the MERS-CoV and SARS-CoV outbreaks have provided evidence that cytokine release syndrome (CRS)-induced pneumonia was the major cause of fatality in affected patients.” Page 5 (internal citations omitted).
Caniglia discloses (emphasis added): “Treatment with Gal-3 inhibitors shows promise in reducing the incidence of CRS in SARS-CoV2 patients through directly suppressing the release of pro-inflammatory cytokines by dendritic cells.” Page 6.
Caniglia discloses (emphasis added): “There are several Gal-3 inhibitors that have been developed to date, with some currently in clinical trials (Blanchard et al., 2014).” Page 6.
Caniglia concludes: “Taken together, the strong correlation of organs showing high Gal-3 expression and symptoms of SARS-CoV2, anti-inflammatory effects of Gal-3 inhibition, and theorized ability of galectin inhibitors to impair NTD-mediated viral attachment make Gal-3 an attractive potential target in the treatment of COVID-19. This treatment may exhibit a dual benefit in both inhibiting viral attachment and reducing the host inflammatory response.” Page 7 (emphasis added and internal citations omitted).
Although Caniglia provides strong motivation to treat a SARS-CoV2 infection by administering a Gal-3 inhibitor, Caniglia is silent as to whether galactomannans inhibit Gal-3 or would otherwise be suitable for treating an infection of that type. Consequently, Caniglia does not satisfy claim 1 of the present application. As explained below, the following three references compensate for this deficiency: Blanchard, Traber, and Platt.
Blanchard, which is directed to a review of patents issued for Gal-3 inhibitors, is cited on page 6 of Caniglia.
Blanchard teaches: “Two polysaccharide-based multivalent Gal-3 inhibitors, GR-MD-02 and GM-CT-01 (Davanat), that show low micromolar binding affinity to Gal-3 of 2.9 µM and 2.8 µM respectively (data unpublished as stated by authors/patent inventors), have been tested in clinical trials and were invented by Galectin Therapeutics, previously known as Pro-Pharmaceuticals, Inc. (US7893252 B2; US20130259870 A1; US20130261078 A1). The water-soluble Davanat of an average molecular weight of up to 60 kDa has a backbone of galactomannan composed of (1→4)-linked β-D-mannopyranosyl units decorated with α-D-galactopyranosyl via a (1→6)-linkage.” Page 1058, right column.
In Table 1 (page 1056), Blanchard teaches that (i) US Publication No. 2013/0259870 A1 (Traber) is directed to the formulation for Davanat and (ii) US Patent No. 7,893,252 B2 (Platt) identifies the following as a Gal-3 inhibitor: “a homogenous galactomannan oligosaccharide is (((1,4)-linked β-D-mannopyranose)17-((1,6)-linked-β-D-galactopyranose)10)12).”
Traber is directed to a therapeutic formulation comprising a galactomannan polysaccharide compound. Abstract.
Traber teaches how to manufacture the galactomannan polysaccharide compound. Paras. [0120]-[0122] at Example 1; see also para. [0075].
Traber teaches various routes of administration, various effective dosage amounts (mg/kg), and various dosing frequencies (e.g., three times per week) for the galactomannan polysaccharide compound. Paras. [0108]-[0112].
Platt is directed to selectively depolymerized galactomannan polysaccharide. Title.
Platt teaches how to manufacture and purify the selectively depolymerized galactomannan polysaccharide. Columns 18-19 at Example 2.
Platt teaches how to formulate the selectively depolymerized galactomannan polysaccharide. Column 13, lines 32-67; column 14, lines 1-21.
Before the effective filing date of the claimed invention, the foregoing teachings would have motivated a person having ordinary skill in the art to modify Caniglia by (A) selecting, as the Gal-3 inhibitor, either (i) the galactomannan polysaccharide compound of Traber or (ii) the selectively depolymerized galactomannan polysaccharide of Platt and, thereafter, (B) administering an effective amount of the selected galactomannan polysaccharide to a subject in need of treatment for a SARS-CoV-2 infection. This modification would have been made in an effort to develop a treatment option that provides a dual benefit of inhibiting SARS-CoV-2 viral attachment, while simultaneously reducing the inflammatory response of the subject. Therefore, claim 1 is prima facie obvious.
Regarding claims 2-3, 5-6, 9-10, and 12, the language recited in each of these claims merely directly concerns, or indirectly relates, to various intended results of engaging in the active (manipulative) step recited in claim 1, i.e., “administering to the subject an effective amount of galactomannans,” and, therefore, is not afforded patentable weight. MPEP § 2111.04(I) (a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited’”), quoting Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003)).
Regarding claim 13, Platt teaches: “Pharmaceutical compositions for use in accordance with the present invention thus can be formulated in conventional manner using one or more physiologically acceptable carriers comprising excipients and auxiliaries that facilitate process ing of the active compounds into preparations which can be used pharmaceutically.” (Emphasis added) Column 13, lines 32-38.
Regarding claim 14, Platt teaches: “Pharmaceutical preparations for oral use can be obtained solid excipient, optionally grinding a resulting mixture, and processing the mixture of granules, after adding suitable auxiliaries, if desired, to obtain tablets or dragee cores.” (Emphasis added) Column 13, lines 52-56.
Regarding claims 20 and 22, Platt teaches: “For buccal administration, the compositions can take the form of tablets or lozenges formulated in conventional manner.” (Emphasis added) Column 14, lines 18-20. A person having ordinary skill in the art would have readily inferred that lozenges and other buccal dosage forms typically remain in the mouth for at least about one to about five minutes. MPEP § 2144.01 (“‘[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.’”), quoting In re Preda, 401 F.2d825, 826 (CCPA 1968).
Regarding claims 24-25, given that Caniglia discloses that Gal-3 protein expression in humans is highest in the lungs, which is a primary locus of infection by SARS-CoV-2, a person having ordinary skill in the art would have been especially motivated to test the galactomannan polysaccharide of Traber or Platt on a sample of human lung tissue while exposing that tissue to the SARS-CoV-2 virus, in the course of routine experimentation to obtain in vitro data concerning effectiveness, toxicity, etc. MPEP § 2144.01 (quoted above). The preamble of claim 24, which merely recites the purpose of engaging in the active step of “contacting the cell with an effective amount of galactomannans” and does not result in a manipulative difference, is not considered limiting. MPEP § 2111.02(II). Similarly, the intended result recited in claim 25 (i.e., “wherein the number of virons in the sample of cells is reduced by at least 50%”) is not afforded patentable weight. MPEP § 2111.04(I) (quoted above).
Claims 15-19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Caniglia (“A potential role for Galectin-3 inhibitors in the treatment of COVID-19.” PeerJ 8 (2020 June): e9392) in view of Blanchard (“Galectin-3 inhibitors: a patent review (2008–present).” Expert Opinion on Therapeutic Patents 24.10 (2014): 1053-1065), Traber (US 2013/0259870 A1) and Platt (US 7,893,252 B2), as applied above to claims 1-3, 5-6, 9-10, 12-14, 20, 22 and 24-25, and further in view of Rausch (US 2019/0230969 A1).
Caniglia and the secondary references (Blanchard, Traber, Platt) are silent as to whether the galactomannan polysaccharide can be formulated as a chewable tablet. Consequently, they do not satisfy claim 15. As explained below, Rausch compensates for this deficiency.
Rausch is directed to a “composition of purified soluble mannans for dietary supplements and methods of use thereof.” Title.
In paragraphs [0103]-[0109] and Tables 1-2 therein, Rausch teaches an exemplary formulation for a chewable tablet comprising galactomannan polysaccharides.
Before the effective filing date of the claimed invention, the foregoing teachings would have motivated a person having ordinary skill in the art to modify Caniglia and the secondary references (Blanchard, Traber, Platt) by selecting the chewable tablet formulation taught in Rausch and, thereafter, administering that formulation to a subject in need of treatment for a SARS-CoV-2 infection. This modification would have been made in an effort to test an oral unit dosage form (the chewable tablet) that is widely considered especially convenient to carry and administer on the go, even when water or another beverage is unavailable. Therefore, claim 15 is prima facie obvious.
Regarding claims 16-19, Rausch teaches that the chewable tablet formulation is “safe up to 20 tablets a day.” Para. [0124] at Table 3; see also MPEP § 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”). In further regard to claim 19, the examiner notes that a patient must be awake to chew/swallow a chewable tablet.
Regarding claim 23, although Rausch teaches “two tablets before a meal” (para. [0124] at Table 3), it is well established that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP § 2144.04(IV)(C), citing In re Burhans, 154 F.2d 690 (CCPA 1946).
Claim Rejections - Double Patenting (Non-Statutory)
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 obviousness-type 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR1.321(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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 eTerminalDisclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/ eTD-info-I.jsp.
Claims 1-3, 5-6, 9-10, 12-20, and 22-25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 4, 6, 16, 22-23, 37, and 39 of co-pending Application No. 18/847,466 (as preliminarily amended on 19 May 2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following: Conflicting claim 1 of the ’466 Application is directed to “[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.” Conflicting claim 4, which depends on conflicting claim 1, recites that “the lectin-binding carbohydrates are galactomannans” (emphasis added). Conflicting claim 23, which depends indirectly on conflicting claim 1, recites that “the viral infection is caused by SARS-CoV-2” (emphasis added). Thus, scope of those three conflicting claims collectively overlaps the scope of claim 1 of the present application. The remaining conflicting claims (e.g., claim 39) recite limitations that satisfy or overlap the corresponding formulation limitations (e.g., chewable tablet) recited in present dependent claims. Therefore, the present claims are not patentably distinguishable over conflicting claims 1, 4, 6, 16, 22-23, 37, and 39 of the ’466 Application.
This is a provisional rejection because the conflicting claims have not been patented.
Conclusion
Claims 1-3, 5-6, 9-10, 12-20, and 22-25 are rejected.
Claims 24-25 are also objected to.
No claim is allowed.
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/P.A./
10 January 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611