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 .
DETAILED ACTION
Pursuant to the amendment dated 06/02/2025, claims 1, 15 and 16 are amended and claims 3 and 19 are cancelled. Claims 1, 2, 4-18, and 20-30 are pending in the instant application and are examined on the merits herein.
Priority
This application is a continuation of National Stage Application of PCT/US2022/044032 filed on 09/19/2022 and claims benefit provisional application 63/245,716 filed on 09/17/2021.
Withdrawn Objections
Applicant’s amendment, filed on 06/02/2025, with respect to the objection of claim 1s as being in improper form because “Cu” was listed twice is noted. The applicant amended claim 15 to eliminate the second “Cu”. The objection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) necessitated by Applicants' amendment, filed on 06/02/2025, wherein instant independent claims 1 and 16 are amended to alter the breadth and scope of the claims, wherein the remaining pending claims 2, 4-15, 17-18, and 20-30 depend from said independent claims.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4, 10, 11, 13, 14, 16-18, 20, 26, 27, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Izraeli et al. (WO 2006/092799 A1, published 08/09/2006, see PTO-892 dated 12/03/2024), Larm et al (US 6,207,653 B1, published 03/27/2001, see PTO-892 dated 12/03/2024) and as evidenced by Li et al. (Appl. Sci., published 04/02/2021, see PTO-892 dated 12/03/2024)
Izraeli teaches the use of a polysaccharide mucoadhesive backbone and ligand composition capable of binding and preventing toxins from the mucosal membrane (page 3, line 1-4). The reference teaches that the nasal cavity is covered by mucous membranes (page 18, line 20). The mucoadhesive backbone may be one or more polysaccharides with mucoadhesive properties including heparin and chitosan derived from the exoskeletons of crustaceans (page 7, line 17) or a combination of both heparin and chitosan (Page 3, line 11). As evidenced by Li, chitosan derived from exoskeletons of crustaceans are alpha-chitosan (page 1). The ligand may be a functional group or a side group, which is chemically substituted onto the mucoadhesive backbone and is capable of interacting with a toxin to which it is exposed (page 5, lines 15-20). The ligand is capable of interacting with a toxin by formation of a bond or interaction that is strong enough so as to not allow release of the toxin, once captured, back into the mucosal membrane (page 5, lines 15-27). The ligand functional group may be a sulfonate (page 6, lines 12-14). Izraeli teaches that heparin is a sulfated polysaccharide (page 4, lines 16-17). Izraeli teaches that the polysaccharide composition can complex with particulate toxins including industrial, medicinal, or other environmental sources such as metal ions and biological toxins (page 8, line 5-13). The toxins may enter the body of the subject through the opening of a body cavity such as the nose by inhalation or by contamination by other air-borne particulates or by other particulate contaminants (page 7, line 29). The polysaccharide composition may be used for the preparation of a composition suitable for therapeutic purposes such as to prevent or reduce the concentration of a certain toxin in a mucosal membrane. Izraeli teaches that the composition may be sprayed intranasally and may be in either spray or dry powder form (page 13, lines 20-25). Izraeli teaches that the composition frequency of application can vary considerably, from once to several times per day, or over days, depending on the condition (page13, lines 23-24). One of ordinary skill in the art could envision that the administration could extend beyond two weeks depending on the condition. Regarding claims 1 and 16, Izraeli is silent on the specific phrase “reducing infiltration into the brain”. However, Izraeli does point out that the purpose of the invention is to reduce the toxins in the mucous membranes which would necessarily reduce those said toxins from infiltrating into any part of the body, which includes the brain. Regarding instant claim 14, by binding the metal atoms, thereby reducing the amount of metal atoms that infiltrate the brain, the composition would necessarily reduce the inflammation caused by the metal atom. Regarding instant claim 30, by binding the particulate matter, thereby reducing the amount of particulate matter that infiltrates the brain, the composition would necessarily reduce the inflammation caused by the particulate matter.
Regarding claim 17, Izraeli teaches that composition may remove particulate contaminants (page 7, line 29), but is silent to a specific number by which the particulate matter is reduced. However, one of ordinary skill in the art would understand that the total percent reduction would be dependent on many factors such as the starting concentration of the particulate and the total amount of the composition present in the nasal cavity and it would be reasonable to adjust the composition amount to remove the desired amount of particulate matter.
Izraeli does not teach the ratio of the alpha-chitosan and polyanionic polysaccharide in the complex. Izraeli does not teach the degree of deacetylation of the chitosan .
Larm is drawn to the use of sulfated polyanionic glucoseaminoglycans for the manufacture of medicaments that can be used for preventing or treating infections (column1, lines 10-14). Larm teaches the preparation of ionic complexes comprising chitosan and heparin. The product provides a matrix preventing deactivation by enzymes, such as heparinase (column 4, lines 49-52). The suggested degree of acetylation is about 25% (column 2, lines 10-26). That translates to a degree of deacetylation of about 75%. The reference suggests a product wherein chitosan is present in the range of about 0.5% to about 5% of the product as a whole (claim 12). The suggested range for heparin in the product is 0.1% to about 2% (claim 13).
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Izraeli and Larm before the effective filing date of the claimed invention to optimize the ratio of the polysaccharides as taught by Larm in the composition comprising chitosan and heparin as taught by Izraeli to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to optimize the ratio of the polysaccharides because Larm teaches that the composition should be about 0.5 to 5% by weight of the chitosan and about 0.1 to 2.0% by weight heparin. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Izraeli and Larm before the effective filing date of the claimed invention to select the polysaccharides in the composition to be chitosan and heparin as taught by both Izraeli and Larm to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to select heparin and chitosan because Izraeli teaches that the composition for binding to and removing toxins may contain both chitosan and heparin and Larm teaches that chitosan and heparin produce an ionically complexed matrix that enhances the stability of heparin with respect to enzymic degradation. One of ordinary skill in the art would have a reasonable expectation of success because both Izraeli and Larm teach the composition comprising both chitosan and heparin and Larm teaches that the combined complex enhances the stability of heparin with respect to enzymatic degradation.
Regarding claims 2 and 18, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Izraeli and Larm before the effective filing date of the claimed invention to optimize the amount of the deacetylation of the chitosan as taught by Larm in the composition comprising chitosan and heparin as taught by Izraeli to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to optimize the ratio of the polysaccharides because Larm teaches that the chitosan should be about 25% acetylated which would be about 75% deacetylated. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Regarding claims 10, 11, 26, and 27, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Izraeli and Larm before the effective filing date by applying the composition taught by the combined teachings of Izraeli and Larm to the olfactory support structure either as a spray or a dry powder and to bind to metals to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to apply the composition to the olfactory support structure as a spray or dry powder and to bind to metals, because Izraeli teaches that the composition is mucoadhesive and may be applied intranasally via spray or as a dry powder and that it binds to metals. One of ordinary skill in the art would have a reasonable expectation of success because Izraeli teaches that the composition is mucoadhesive and may be applied intranasally via spray or as a dry powder and that it binds to metals.
Regarding claims 13 and 29, it would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Izraeli and Larm before the effective filing date of the claimed invention to administer the chitosan and heparin composition taught by both Izraeli and Larm for at least two weeks to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to administer the composition taught by both Izraeli and Larm because Izraeli teaches that the frequency of application can vary considerably depending on condition and that it can be administered over days. One of ordinary skill in the art would have a reasonable expectation of success because Izraeli teaches that the frequency of application varies considerably depending on condition and that it can be administered over days.
Claims 5, 6, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Izraeli et al. (WO 2006/092799 A1, published 08/09/2006, see PTO-892 dated 12/03/2024), and Larm et al (US 6,207,653 B1, published 03/27/2001, see PTO-892 dated 12/03/2024) as applied to claims 1 and 16 above, and further in view of Kaminski et al. (J. of Med. Chem, published 04/27/2010, see PTO-892).
Claims 1 and 16 are rejected as discussed above.
The combined teachings of Izraeli and Larm are discussed above.
The combined teachings of Izraeli and Larm do not teach the form of heparin, anticoagulant or non-anticoagulant, used in the chitosan and heparin composition.
Kaminski is drawn to the study of chitosan derivatives as novel potential heparin reversal agents (title). Kaminski teaches that heparin has complex pharmacokinetics and its anticoagulant effect cannot be precisely predicted and differs considerable among patients (column 1, page 4141). Kaminski teaches that chitosan can bind to heparin (column 1, page 4142) and suggests that chitosan can act as a reversal to the anticoagulant behavior of heparin, making it difficult in clinical practice to attain therapeutic anticoagulation which is why heparin overdoses are not rare (column 2, paragraph 4145).
It would have been prima facie obvious to one of ordinary skill in the art to combine the combined teachings of Izraeli and Larm with the teachings of Kaminski by selecting either the anticoagulant or the non-anticoagulant forms of heparin in the composition comprising chitosan and heparin to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select either form of heparin because Kaminski teaches that chitosan can act as a reversal to the anticoagulant behavior and therefore, the chitosan would minimize the risk of adverse effects from the anticoagulation of heparin. One of ordinary skill in the art would have a reasonable expectation of success of using either anticoagulant or non-anticoagulant heparin because Kaminski shows that chitosan binds to heparin and teaches that it should inhibit the anticoagulant effects of heparin.
Claims 7 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Izraeli et al. (WO 2006/092799 A1, published 08/09/2006, see PTO-892 dated 12/03/2024), and Larm et al (US 6,207,653 B1, published 03/27/2001, see PTO-892 dated 12/03/2024) as applied to claims 1 and 16 above, and further in view of Saladini et al. (Journal of Inorganic Biochemistry, published 07/11/2001, see PTO-892).
Claims 1 and 16 are rejected as discussed above.
The combined teachings of Izraeli and Larm are discussed above.
Izraeli further teaches that polysaccharides may be synthetically modified in order to obtain the desired ligand-toxin specificity (Page 7, line 20).
The combined teachings of Izraeli and Larm do not teach a product further comprising sialic acid.
Saladini is drawn to the study of the binding ability of sialic acid towards biological and toxic metal ions (title). Saladini teaches that sialic acid forms complexes with biological meal ions such as Co(II) and Cu(II) and toxic metal ions such as Cd(II) and Pb(II) (abstract).
It would have been prima facie obvious to one of ordinary skill in the art to combine the combined teachings of Izraeli and Larm with the teachings of Saladini before the effective filing date by modifying the heparin and chitosan composition taught by the combined teachings of Izraeli and Larm to include sialic acid as taught by Saladini to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to modify the composition to include sialic acid because Saladini teaches that sialic acid can be used to bind to toxic metals and Izraeli teaches that the polysaccharides may be modified in order to obtain the desired ligand-toxin specificity. One of ordinary skill in the art would have a reasonable expectation of success because Saladini shows that sialic acid can be used to bind to toxic metals.
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Izraeli et al. (WO 2006/092799 A1, published 08/09/2006, see PTO-892 dated 12/03/2024), and Larm et al (US 6,207,653 B1, published 03/27/2001, see PTO-892 dated 12/03/2024) as applied to claims 1 and 16 above, and further in view of Stevic et al. (Cell. Biochem. Biophys., published 10/28/2010, see PTO-892 dated 12/03/2024).
Claims 1 and 16 are rejected as discussed above.
The combined teachings of Izraeli and Larm are discussed above.
Izraeli further teaches that the toxins may enter the body of the subject through the opening of a body cavity such as the nose by inhalation (page 7, lines 28-29).
The combined teachings of Izraeli and Larm do not teach the composition binding to specific metal ions or metal atoms.
Stevic is drawn to the study of the binding of heparin to metals (title). Stevic teaches that heparin has a high affinity for a wide variety metal ions with varying oxidation states including Mn2+, Cu2+, Zn2+, Mg2+, Fe3+, Ni2+, Al3+(abstract).
It would have been prima facie obvious to one of ordinary skill in the art to combine the combined teachings of Izraeli and Larm with the teachings of Stevic before the effective filing date by binding the metal ions taught by Stevic using the composition comprising chitosan and heparin taught by Izraeli to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to bind the metal ions including Mn2+ as taught by Stevic using the composition comprising chitosan and heparin because Stevic teaches that heparin can bind the metal ions including Mn2+ and Izraeli teaches that the toxins may enter through the nose and that the composition may be used to bind to toxic metals. One of ordinary skill in the art would have a reasonable expectation of success because Stevic teaches that heparin binds to metals including Mn2+.
Claims 9, 12, 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Izraeli et al. (WO 2006/092799 A1, published 08/09/2006, see PTO-892 dated 12/03/2024), and Larm et al (US 6,207,653 B1, published 03/27/2001, see PTO-892 dated 12/03/2024) as applied to claims 1 and 16 above, and further in view of Alt et al. (US 2020/0353183, published 11/12/2020, see PTO-892 dated 12/03/2024).
Claims 1 and 16 are rejected as discussed above.
The combined teachings of Izraeli and Larm are discussed above.
The combined teachings of Izraeli and Larm do not teach administering a composition in atomized form or the use of a device configured to apply substances to olfactory epithelium.
Alt is drawn to an intranasal drug delivery device (abstract). Alt teaches a device that delivers a substance specifically to the olfactory region in atomized form (paragraphs 0011 and 0074).
It would have been prima facie obvious to one of ordinary skill in the art to combine the combined teachings of Izraeli and Larm with the teachings of Alt before the effective filing date by administering the composition taught by Izraeli and Larm with the device taught by Alt to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to administered the composition taught by Izraeli and Larm with the device taught by Alt because Izraeli teaches intranasal administration. One would look to the art for a device that would administer the composition intranasally and Alt teaches a device that may administer a substance to the olfactory region in atomized form. One of ordinary skill in the art would have a reasonable expectation of success because Alt teaches the device may administered a substance to the olfactory region in atomized form.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Izraeli et al. (WO 2006/092799 A1, published 08/09/2006, see PTO-892 dated 12/03/2024), and Larm et al (US 6,207,653 B1, published 03/27/2001, see PTO-892 dated 12/03/2024) as applied to claim 16 above, and further in view of Calderon-Garciduenas et al (J. Alzheim. Dis., published 08/28/2020, see PTO-892 dated 12/03/2024).
Claim 16 is are rejected as discussed above.
The combined teachings of Izraeli and Larm are discussed above.
The combined teachings of Izraeli and Larm do not teach that the particulate matter is PM2.5 or smaller.
Calderon-Garciduenas is drawn to the study of environmental nanoparticles on the acceleration of Alzheimer’s and Parkinson’s diseases in young urbanites exposed to air pollution (title). Calderon-Garciduenas teaches that the nasal pathway is an effect and direct pathway to the brain through the olfactory bulb. Particulate matter, (PM) such as PM2.5 or smaller, has the potential of carrying toxic metals, spores, viruses and bacteria. Calderon-Garciduenas further teaches that PM and viruses share ports of entry to systemic circulation, including the olfactory epithelium (page 481-482).
It would have been prima facie obvious to one of ordinary skill in the art to combine the combined teachings of Izraeli and Larm with the teachings of Calderon-Garciduenas before the effective filing date by removing particulate PM2.5 or smaller as taught by Calderon-Garciduenas using the composition comprising chitosan and heparin as taught by Izraeli and Larm to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to utilize the composition comprising chitosan and heparin as taught by Izraeli and Larm to bind and remove particulate matter that is PM2.5 or smaller because Calderon-Garciduenas teaches that particulate matter that is PM2.5 or smaller has the potential to carry toxic metals via the olfactory epithelium. One of ordinary skill in the art would have a reasonable expectation of success because Izraeli teaches that the composition comprising heparin and chitosan may bind to particulate toxins and metals and Calderon-Garciduenas teaches that the particulate matter that is PM2.5 or smaller may carry toxic metals.
Response to Arguments
Applicant argues that Izraeli fails to teach or suggest alpha-chitosan complexed with a polyanionic polysaccharide. Applicant’s argument is not found persuasive. Izraeli teaches the use of a polysaccharide mucoadhesive backbone and ligand composition capable of binding and preventing toxins from the mucosal membrane (page 3, line 1-4). The ligand of the complex may be a functional group such as sulfate found on heparin. The reference teaches that the nasal cavity is covered by mucous membranes (page 18, line 20). The mucoadhesive backbone may be one or more polysaccharides with mucoadhesive properties including heparin and chitosan derived from the exoskeletons of crustaceans (page 7, line 17) or a combination of both heparin and chitosan (Page 3, line 11). As evidenced by Li, chitosan derived from exoskeletons of crustaceans are alpha-chitosan (page 1). Izraeli does not teach the ratio of the chitosan and heparin. However, Larm also teaches a composition of chitosan and heparin and teaches wherein chitosan is present in the range of about 0.5% to about 5% of the product as a whole (claim 12 and the suggested range for heparin in the product is 0.1% to about 2% (claim 13). It would be obvious to one of ordinary skill that one could optimize the ratio of the chitosan and heparin using the numbers provided by Larm.
Applicant also argues that Izraeli teaches that ligands are responsible for capturing toxins, and not the polysaccharide complex. Applicant’s argument is not found persuasive. Izraeli teaches the use of a polysaccharide mucoadhesive backbone and ligand composition capable of binding and preventing toxins from the mucosal membrane (page 3, line 1-4). The ligand of the complex may be a functional group such as sulfate found on heparin. In this case, the polysaccharide complex contains the ligand and is also responsible for capturing toxins.
Applicant argues that Izraeli fails to teach that the composition reduces the amount of a metal atom or ion or any other particulate matter from infiltrating the brain. Applicant’s argument is not found persuasive. Izraeli teaches that the composition binds to mucosal linings in the nasal passage way (page 18, line16-20). The bond between the ligand and the toxin is strong enough so as to not allow release of the toxin, once captured, backing into the mucosal membrane (page 5, lines 15-27). By binding to the toxin, the composition is reducing how much of the toxin can infiltrate the brain.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The MPEP also states that “the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves” (see MPEP 2411 II). The cited references Izraeli and Larm both teach a composition comprising heparin and chitosan and Larm teaches a range of the heparin and chitosan to be used. Applicant further argues that Larm teaches the composition in a gel formulation. Applicant’s argument is not found persuasive. Larm also teaches that the composition may be in a different physical forms such as powders and may be adapted to the nature of the disorder to be treated (column 2, lines 1-4).
Conclusion
No claims are allowed.
This Office Action is non-final because it contains new grounds of rejection, to which Applicant has not previously had the opportunity to respond.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693