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 .
Claim Status
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-5, 7-12 and new claim 21 are under consideration in this office action.
Terminal Disclaimer
The terminal disclaimer filed on March 13, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application 17/413468 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Rejections
Any objection or rejection of record pertaining to cancelled claim 6 is rendered moot by applicant’s cancellation of said claim.
The rejection of claim 4 under 35 U.S.C. 112(b) for indefiniteness is withdrawn in view of applicant’s amendment to remove the parentheses.
The rejection of claims 1-5 and 7-12 on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 17/413468 is withdrawn. A terminal disclaimer was filed.
New Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-12 and new claim 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims are directed to a naturally occurring barn dust product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they claim dust and fractions of dust, which is a product produced by nature; the applicant has merely isolated it.
Under Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance the claimed product is found to be drawn to one of the four statutory categories of inventions, a composition of matter.
Under Step 2A, prong 1, the claims have been determined to recite a natural product, a barn dust extract that is isolated from dust collected from a barn. This nature-based product does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state (STEP 2A, Prong One: YES). The invention as a whole is directed to a judicial exception and thus required further analysis at Step 2B to determine if the claims amount to significantly more than the exception itself.
Under Step 2A, prong 2, the claims have been determined to not integrate the recited judicial exception into a practical application. In the absence of the hand of man, naturally occurring products are considered nonstatutory subject matter. Specifically, the claims, as written, do not sufficiently distinguish over the dust that exists naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed products and the naturally occurring products. The instant claims require that the barn dust fractions comprise specific protein and fatty acids, but there is no evidence that the unfractionated barn dust sample extract exhibits properties that are distinct from the claimed barn dust fractions. The barn dust fractions are a natural product because the intervention is only isolation, which does not significantly change or manipulate the naturally occurring product.
The instant claims only require the naturally occurring dust have characteristics, which do not further limit or distinguish the dust from those found in nature. The intended use of this composition does not further limit or change the basic structure of these naturally occurring products. They serve the ends nature originally provided and act quite independently of any effort of the patentee (STEP 2A, Prong 2: NO).
Under final Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception encompassed by the composition of matter of the instant claims, i.e. the claims do not recite elements beyond the well-understood, routine, or conventional activities previously known in the field. The extra-solution activity of collecting the barn dust and fractionating the barn dust do not provide the required meaningful limit. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, and the claims fail to include any limitations that would distinguish the claimed extract from that which occur in nature.
Therefore, claims 1-5, 7-12, and 21 are not patent eligible.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 contains percentages with no basis for the percent, which is improper. Applicant is required to amend the claim to limit clearly the term percentage. In the interest of compact prosecution, the percentage will be interpreted to be percentage by weight.
Claim 11 recites the composition of claim 1, “wherein the barn dust composition is a pharmaceutical composition, wherein the pharmaceutical composition is administered orally, conjunctivally, subcutaneously, intraarticularly, intraperitoneally, rectally, or vaginally, or via nasal inhalation.” The limitation “is administered. . .” introduces a method-type limitation into a composition claim without clarifying the role that limitation plays in defining the claimed composition. For example, it is unclear whether the “administered” language is intended to describe (i) a structural or functional characteristic of the composition (e.g., suitability for administration) or (ii) an actual step of use. Both interpretations are reasonable and materially different.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 8, 10-12, and new claim 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2008/0112983, published May 15, 2008 (“Bufe”; see IDS from 10/20/2022).
Bufe teaches an extract for the treatment of disease prepared from barn dust from farms that can be used for the prevention and treatment of allergic diseases (abstract; [0010]; [0018]), which reads on the barn dust extract with asthma-protective properties of instant claim 1 and the farm dust limitation of instant claim 5. Composition analysis of the barn dust extract identified proteins [0030] and fatty acids [0034], which reads on instant claims 1 and 21. Bufe teaches that the size of proteins in the extracts range from 30 kDa to 100 kDa ([0030], figure 2), which reads on the size limitation of the bioactive fraction of claims 1 and 21.
Regarding the limitation of instant claim 5 directed to preventing, suppressing, and/or abrogating airway hyperresponsiveness of a barn dust composition comprising farm dust and the limitation of instant claim 10 directed to proteolytic activity, because Bufe teaches the claimed barn dust composition, the barn dust composition of Bufe inherently possesses the properties related to preventing or treating disease and proteolytic activity. See MPEP 2112.01.II: “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Bufe teaches that after the dust is taken up in an aqueous solution or water, the suspension is mixed and left to stand, so that water-soluble substances may enter aqueous phase [0015], which reads on the limitation of claim 8 directed to a solubilized composition.
The extract of Bufe can be used for the prevention and treatment of allergic disease, as a medicament for the treatment of diseases caused by allergies [0018], which reads on the pharmaceutical composition and compositions of instant claims 11-12 and 21. Bufe teaches that the compound is administered via inhalation [0021], which reads on instant claim 11.
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 1-3, 5, 8, 10-12 and new claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0112983, published May 15, 2008 (“Bufe”) in view of Williams et al, published online August 20, 2014 (see PTO-892 from 11/13/2025).
The teachings of Bufe are discussed above. Bufe does not teach a farm dust composition comprising Bos d2.
Williams et al teaches that the settled dust from homes proximate to dairy farms comprise cow allergen Bos d2, which is a member of the lipocalin family of allergens (see abstract). As evidenced by Jappe et al, published February 14, 2019 (instant PTO-892), lipocalins are a family of proteins involved in the transport of small hydrophobic molecules (pg 7, column 1). Mammalian lipocalin allergens, including Bos d2, are distantly related to cytoplastic fatty acid binding proteins (pg 7, column 2); establishing that Bos d2 is a transport protein for carrying fatty acids, as in instant claim 3.
As Bufe teaches a barn dust composition with asthma-protective properties comprising proteins and Williams et al teaches that cow dust comprises the fatty acid carrier Bos d2, the ordinary artisan would expect to find Bos d2 in the barn dust composition of Bufe, because the dust of Bufe is collected from cow and calf houses [0024]. The composition of cow dust with Bos d2 with fatty acid transport properties of instant claims 2-3 is obvious over Bufe in view of Williams et al.
Claims 1, 4-5, 8, 10-12 and new claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0112983, published May 15, 2008 (“Bufe”) in view of US 2008/0112966, published May 15, 2008 (“Gow”; see PTO-892 from 11/13/2025).
The teachings of Bufe are discussed above. In addition, Bufe teaches that barn dust is comprised of a number of different substances, including fungi [0004]. Although Bufe teaches that the farm dust composition is comprised of C18 unsaturated fatty acids (see Table 2 and [0034]), Bufe does not teach a farm dust composition comprising polyunsaturated fatty acids, wherein the polyunsaturated fatty acid is selected from 11-HpOME, 9,12-dihydroxy stearic acid, 12-oxo-10E-octadecenoic acid, 9-hydroperoxy-10E,12,15Z- octadecatrienoic acid, 9,10,1 3-trihydroxy-1 1 -octadecenoic acid, 9-hydroxy-1 0-oxo-1 2- octadecenoic acid, 9R,10S,18-trihydroxy-stearic acid, a-12(13)-EpODE, 3-keto palmitic acid, 6E,8E, 1 4E-Hexadecatriene-1 0,1 2-diynoic acid, 9,12-Octadecadiynoic acid, 8-Octadecenoic acid, 10-hydroxy- 12-oxo, 1 3-hydroxy-9Z-octadecenoic acid, 6-ethyl-tetradecanoic acid, 11,1 5-dimethyl-hexadecanoic acid, and 11-hydroperoxy-1 2,13-epoxy-9-octadecenoic acid, as required by instant claim 4.
Gow teaches biological compositions that include bioactive fractions extracted from fungus species of Ganoderma (see abstract). In the Ganoderma essential oil fraction, major compounds identified were C11-C20 fatty acids [0082]. The most abundant being C18 fatty acid and 9,12-octadecadienoic acid (Z,Z) [0082], as in instant claim 4.
As Bufe teaches a barn dust composition with asthma-protective properties comprising unsaturated fatty acids, and Gow teaches biological compositions from a fungus that include C18 polyunsaturated fatty acids, the ordinary artisan would expect to identify the polyunsaturated fatty acids of Gow in the barn dust composition of Bufe, because the barn dust of Bufe is comprised of fungi. The composition of instant claim 2 is obvious over Bufe in view of Gow.
Claims 1, 5, 7-8, 10-12 and new claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0112983, published May 15, 2008 (“Bufe”) in view of Stein et al, published August 4, 2016 (see IDS from 10/20/2022).
The teachings of Bufe are discussed above. Although Bufe teaches the farm dust composition comprised of proteins and fatty acids for the treatment of asthma, Bufe does not teach wherein the barn dust comprises Amish farm barn dust, as required by instant claim 7.
Stein et al teaches that dust extracts obtained from Amish homes provides protection against asthma (abstract). Therefore, it would have been obvious to one of ordinary skill in the art to obtain barn dust from an Amish farm barn for the barn dust composition of Bufe comprised of fatty acids and proteins with asthma-protective properties. One looking for a type of barn with anti-allergenic dust would have selected an Amish barn; such amounts to combining prior art elements (i.e. the barn dust extraction method of Bufe and the dust of the Amish barn of Stein et al) to achieve predictable outcomes (i.e. barn dust composition from Amish farm dust with anti-allergenic properties).
Claims 1, 5, 8, 9-12 and new claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0112983, published May 15, 2008 (“Bufe”) in view of US 5,589,591, published December 31, 1996 (“Lewis”; see IDS from 10/20/2022).
The teachings of Bufe are discussed above. In addition, Bufe teaches that barn dust is comprised of a number of different substances, including bacteria [0004]. Although Bufe teaches the farm dust composition comprised of proteins and fatty acids for the treatment of asthma, Bufe does not teach wherein the barn dust comprises less than 2.0% total organic carbon content, less than 0.2% endotoxins, less than 0.2% lipopolysaccharide, or a combination thereof, as required by instant claim 9.
Lewis teaches obtaining arabinogalactan from Larix occidentalis by an aqueous extraction of wood chips (Column 3, ln 26-28); this extract is substantially endotoxin free (Column 2, ln 26-27), as in the limitation of claim 9 directed to less than 0.2% endotoxin.
Given that Bufe teaches farm dust compositions comprised of fatty acids and proteins and further given that Lewis teaches that compositions from extracted samples have less than 0.2% endotoxins, it would have bene obvious to the ordinary artisan to provide the composition of Bufe, which is made from barn dust comprised of bacteria, with a minimal amount of endotoxin. The motivation to do so comes from Lewis, which teaches that parenterally administered products must be free of bacterial endotoxins because endotoxins can cause fever, vasodilation, and even endotoxic shock (Col 2, ln 1-59). One of ordinary skill would appreciate the necessity to limit the amount of endotoxin in a therapeutic product and would modify the product of Bufe to limit the amount of endotoxin present in the composition.
Response to Arguments
Applicant's arguments filed March 13, 2026 have been fully considered.
Regarding the rejection of claim 9 under 35 U.S.C. 112(b) for being indefinite for containing percentages with no basis for the percent is maintained because applicant did not address this rejection in the remarks or amend the claim.
With respect to the rejection of claims 1, 5, 8, 10-12 and new claim 21 under 35 U.S.C. 102(a) as being anticipated by Bufe, applicant asserts that Bufe does not teach all the elements of the claims (remarks, pg 5). Applicant argues that the Bufe prior art fails to disclose or suggest a barn dust comprising one or more bioactive fractions, each having a molecular weight of about 30 kDa to about 100 kDa (remarks, pg 7). These arguments are not persuasive because, as detailed above in the rejection under 35 U.S.C. 102(a)(1) and 102(a)(2), each limitation of claims 1, 5, 8, 10-12, and new claim 21 is taught by Bufe. Bufe teaches a barn dust extract for the treatment of asthma that is comprised of proteins and fatty acids of the same molecular weight. The new limitation directed to the molecular weight of the composition is also taught by Bufe. Bufe teaches that the size of proteins in the extracts range from 30 kDa to 100 kDa ([0030], figure 2), which reads on the size limitation of the bioactive fraction of claim 1.
Applicant asserts that Bufe does not teach fractionating the barn dust extract to isolate compositions within any defined molecular weight range (remarks, pg 7). Arguments related to differences in the methods of preparing dust extracts are not persuasive because applicant is not claiming the method of making, but the final product. As claimed, the barn dust composition product of claim 1 is anticipated by Bufe. There is no evidence that the barn dust composition claimed is distinct from the barn dust compositions taught by Bufe.
Regarding other limitations of claims 2-4, 7, and 9 that are taught by Williams et al, Gow, Stein et al, and Lewis for the obviousness type rejections, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses combining prior art elements according to known methods to yield predictable results. Applicant argues that the secondary references do not teach a barn dust composition comprising one or more bioactive fractions and that there is no motivation to combine the references. The motivation statements to combine the references are provided in the rejections. While Williams et al, Gow, Stein et al, and Lewis do not disclose all the features of the presently claimed aptamer, it is not necessary for these secondary references to do so, because Bufe already teaches the barn dust composition. These references are used to establish that Bos d2 and polyunsaturated fatty acids would be identified in barn dust and that Amish barn was recognized as a source of hypoallergenic dust. Moreover, one of ordinary skill in the art would recognize that limiting endotoxin to less than 0.2% in a therapeutic composition is a necessary property to avoid adverse responses. Applicant is reminded that the test for obviousness is not whether the features of the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claim is allowed.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
Prosecution Insights