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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 has been entered.
This Office Action is in response to Applicant’s response filed on 6/11/2026, where no claim amendments accompany the response. The request is proper and the accompanying amendment to the claims is entered on the record.
Claims 1, 2, 4-21 and 23 are pending in the instant application and are examined on the merits herein.
Priority
The application is a National Stage entry of PCT/US2021/051628 filed on 9/23/2021, which claims priority to provisional application 63/082236 filed on 9/23/2020.
Maintained Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 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 1, 2, 4-9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al. (US 5,476,844; 1995, reference of record), in view of Buddington et al. (US 7,431,939B1; 2008, reference of record).
Cooper discloses a composition comprising gamma-inulin within an aluminum hydroxide gel, co-administered with an immunomodulator or immunotherapeutic agent, in a method for enhancing an immune response, or treating an infection, in a human subject, where the inulin has a molecular weight of 3000-16000 Da (equivalent to a degree of polymerization of 16-88, given the molecular weight of fructose monomer at 180 Da). (Claims 8, 14, 25-31; Col. 2, Ln. 40-45) Cooper also discloses that the composition may comprise a chitin polysaccharide as a component of the carrier material. (Claim 10) Cooper discloses that the immunomodulator may be an antigen or combination of antigens, such as one or more vital, bacterial, fungal or protozoal proteins. (Col. 3, Ln. 1-8)
With respect to claim 2, the claim recites that “wherein associated with comprises”. (emphasis added) The use of comprises includes the recited elements as well as any unrecited elements relevant to how one would interpret an “association” between two elements of a composition. The breadth of associations encompassed by the claim is considered to be met by Cooper, regardless of Cooper specifically disclosing “complexed, conjugated, encapsulated, absorbed, adsorbed and admixed”.
With respect to claim 7, it is noted that the prior art does not teach that the composition can be used in the manner instantly claimed, regarding the effect on an allergic response. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Cooper does not disclose a DP of 20-47, preferably 26. Cooper does not teach oral administration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the DP range of Cooper overlaps that claimed. 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).
Buddington et al. discloses oral administration…of dietary fibers, in particular inulin and oligofructose, does not only effect the gastro-intestinal flora by stimulating the growth of beneficial bacteria and by improving the ratio of beneficial/pathogenic bacteria, but, surprisingly, also has beneficial effects on the host's response to systemic infections by pathogenic bacteria. (Col. 4, Ln. 9-24)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the inulin immunomodulating composition of Cooper, for treating and infection, could be administered via an oral route, as per the teachings of Buddington that orally administered inulin is known to be effective for treating infection.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Cooper/Buddington, has been fully considered but is not persuasive.
Applicant argues that Cooper/Buddington does not teach a self-supporting gel. Applicants’ argument is not persuasive because the specification has no discussion of what is meant by “self-supporting”, so the term will be defined by what is known in the art as per Berzon et al. (US 2007/0202265, PTO-892), which states, “By formation of a hard gel, one means that the resulting polymerized composition is self-supporting, i.e. is able to withstand its own shape without deformation.” (¶0033) Considering the spherical gel shape captured in the images of Figure 1 of Cooper, the gel of Cooper meets the definition of “self-supporting”. Applicant further argues that Cooper does not teach the claimed limitation of, “the gel-based inulin formulation comprises a self-supporting gel matrix formed by inulin itself” because the gel of Cooper is composed of inulin within a aluminum hydroxide gel matrix. Applicants argument is not persuasive because there is no description within the specification of what is meant by “formed by inulin itself” and there is no description of a process for making the claimed gel, to direct one of ordinary skill how to interpret “formed by inulin itself”. Thus, the claimed limitation of “the gel-based inulin formulation comprises a self-supporting gel matrix formed by inulin itself” is interpreted to include any gel that is self-supporting where inulin is a component of the gel matrix. As such the gels of Cooper meet this limitation because, in one embodiment, Cooper teaches that the gel can be formed by co-crystalizing inulin and aluminum hydroxide where “Preferably, the particles are prepared by co-crystallization of the gamma inulin and the antigen-binding carrier material so that both of these components are contained in the same particles”. (Col. 1, Ln. 28-31 and Claims 5, 20, 22)
The rejection is still deemed proper and is maintained.
Claim 1, 2, 4-9, 11-19 and 23 is rejected under 35 U.S.C. 103 as being unpatentable over Petrovsky et al. (WO 2011/032229A1, reference of record).
Petrovsky discloses a composition comprising epsilon-inulin within a carrier gel, co-administered with an immunomodulator, in a method for stimulating an immune response in a subject, for the purposes of preventing or treating an infectious disease, autoimmune disease, immunodeficiency disorder, neoplastic disease, degenerative or ageing disease, where the carrier gel is aluminium hydroxide gel, aluminium phosphate gel or calcium phosphate gel, further where the molecular weight of the inulin is 5-50 kDa (equivalent to a degree of polymerization of 27-278, given the molecular weight of fructose monomer at 180 Da). (Claims 4-8) Petrovsky also discloses that the composition may comprise a chitin polysaccharide as a component of the carrier material. (p. 10) The composition of Petrovsky may be formulated in a pharmaceutically acceptable carrier, diluent or excipient in a form suitable for injection, or a form suitable for oral, rectal, vaginal, topical, nasal or ocular administration…the active component may be a lymphokine or cytokine, a thymocyte stimulator, a macrophage stimulator, an endotoxin, a polynucleotide molecule, or recombinant viral vector, a whole microorganism, or even a whole virus. (p. 9) Petrovsky discloses that antigens that are suitable for inclusion in the composition of the present invention include all or antigenic portions of bacteria, viruses, yeasts, fungi, protozoa and other microorganisms or pathogens of human, animal or plant origin and pollens and other allergens, especially venoms (e.g. bee and wasp venoms), and asthma-inducing allergens such as house dust mite, cat or dog dander. (p. 10) Petrovsky further discloses that the method may stimulate/enhance an immune response by activation or modulation of mononuclear immune cell (e.g. monocytes, macrophages, and dendritic cells) function and/or the complement pathway in a human or non-human animal subject, for the purposes of inducing or modulating an immune response for, for example: the treatment or prevention of an infection by a bacterium, mycoplasma, fungus, virus, protozoan or other microorganism, or of an infestation by a worm or parasite or to treat or prevent immuno-pathology induced by such an infection; the treatment of an immune disorder such as an allergic or rheumatic disease, an autoimmune disease, an immunodeficiency disease, or neurological, dermatological, renal, respiratory or gastrointestinal disorders relating to dysfunction of the immune system; or the treatment of a tumour or cancer.(p. 12)
With respect to claim 2, the claim recites that “wherein associated with comprises”. (emphasis added) The use of comprises includes the recited elements as well as any unrecited elements relevant to how one would interpret an “association” between two elements of a composition. The breadth of associations encompassed by the claim is considered to be met by Petrovsky, regardless of Petrovsky specifically disclosing “complexed, conjugated, encapsulated, absorbed, adsorbed and admixed”.
With respect to claim 7, it is noted that the prior art does not teach that the composition can be used in the manner instantly claimed, regarding the effect on an allergic response. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
With respect to claims 17-19 and the recitations regarding suppression of an immune response, suppression of IgE antibodies or suppression of Th2 response, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. The active method step in the instant claim is administering the inulin-based composition to treat an autoimmune disorder, whereas the suppressive effects will necessarily occur and do not delineate a manipulative difference between the instant method and the method of the prior art. Therefore, because the combined prior art teaches the same active step to administer the same composition, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
Petrovsky does not disclose a DP of 20-47, preferably 26.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the DP range of Petrovsky overlaps that of claim 1 and lies close enough to that of claim 4.
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).
With respect to claim 4, it would have been prima facie obvious to one of ordinary skill in the art that the disclosure of Petrovsky having a value of 27 DP, while not explicitly overlapping the instant claim at a DP of 26, is considered sufficiently close to the instantly claimed DP such that absent evidence to the contrary, one of ordinary skill in the art would reasonably expect the composition of Petrovsky to have similar properties to the instant composition. It is held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (MPEP § 2144.05)
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Petrovsky, has been fully considered but is not persuasive.
Applicant argues that Petrovsky does not teach a self-supporting gel. Applicants’ argument is not persuasive because the specification has no discussion of what is meant by “self-supporting”, so the term will be defined by what is known in the art as per Berzon et al. (US 2007/0202265, PTO-892), which states, “By formation of a hard gel, one means that the resulting polymerized composition is self-supporting, i.e. is able to withstand its own shape without deformation.” (¶0033) Considering that Petrovsky teaches the gel in particulate form, the gel of Petrovsky meets the definition of “self-supporting”. Applicant further argues that Petrovsky does not teach the claimed limitation of, “the gel-based inulin formulation comprises a self-supporting gel matrix formed by inulin itself” because the gel of Petrovsky is composed of inulin within a aluminum hydroxide gel matrix. Applicants argument is not persuasive because there is no description within the specification of what is meant by “formed by inulin itself” and there is no description of a process for making the claimed gel, to direct one of ordinary skill how to interpret “formed by inulin itself”. Thus, the claimed limitation of “the gel-based inulin formulation comprises a self-supporting gel matrix formed by inulin itself” is interpreted to include any gel that is self-supporting where inulin is a component of the gel matrix. As such the gels of Petrovsky meet this limitation because, in one embodiment, Petrovsky teaches that the gel can be formed by co-crystalizing inulin and aluminum hydroxide where “Preferably, where an antigen-binding carrier material is present, it is present in a form that is intrinsically associated with the eIN (a.k.a. epsilon inulin), such as, for example, co-crystals with the eIN. Co-crystals of a particulate form of inulin and an antigen-binding carrier material such as a metal salt may be prepared by, for example, a method comprising: (a) preparing an inulin solution or partial inulin solution by heating an aqueous suspension of eIN particles; (b) adding to said solution an amount of one or more metal phosphate compounds; (c) recrystallizing the inulin from said solution; (d) transforming the recrystallized inulin back to the eIN form; and (e) isolating formed co-crystals of the eIN and one or more metal phosphate compounds.”. (p. 11, Ln. 5-14)
The rejection is still deemed proper and is maintained.
Claims 10, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Petrovsky et al. (WO 2011/032229A1, reference of record), in view of Singh et al. (US 2020/0246454A1, pub 8-2020, reference of record).
The disclosure of Petrovsky is referenced as discussed above. Petrovsky does not disclose treating a food allergy, specifically a peanut allergy.
Singh discloses method of treating allergies by administering a composition comprising prebiotics, including inulin, where the allergies include those to peanuts, wheat, soy, fish, shellfish, tree nuts, dairy and eggs. (Claims 4, 5; ¶0015, 0081, 0129; Example 2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of Petrovsky for treating an allergic disorder in general could be modified to specifically treat a food allergy, particularly a peanut allergy, thereby arriving at the instant invention. One would be motivated to modify Petrovsky in this manner because Singh teaches that anti-allergy compositions comprising inulin as a prebiotic are effective for treating food allergies, particularly peanut allergies.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that the combined prior art does not render the independent claims prima facie obvious for the reasons outlined above, thus the rejection of dependent claims that reply on the teachings of said combined prior art, should be withdrawn. Applicants' arguments are not persuasive because the rejection of the independent claims is maintained as prima facie obvious over said combined prior art, as per the response to arguments above.
The rejection is still deemed proper and is maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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