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Claims 19, 25, 29, and 37-40 remain withdrawn.
Claims 1-2, 4, 6-8, 10, 12-14, 43, and new claims 44-45 are under consideration in this office action.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 102/103
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.
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.
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.
Claims 1-2, 4, 6-7, 10, 12-13, 43, and new claim 44 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by or, in the alternative, under U.S.C. 103 as obvious over US 2008/0112983, published May 15, 2008 (“Bufe”; see IDS from 4/13/22).
The claims are directed to a method of preparing a barn dust extract, wherein the barn dust is from a cow barn. Bufe teaches a method for the extraction of barn dust comprising collecting barn dust, homogenizing barn dust, and digesting the barn dust [0011-0013], as in claims 1 and 12-13. The dust collection is preferably made in cow and calf houses [0024], as in the cow barn limitation of instant claim 1. The extract prepared by Bufe has a markedly higher protein content than extracts prepared by traditional extractions method [0017], as in the enrichment of instant claims 6-7.
The barn dust extract taught by Bufe is prepared with barn dust from farms [0010], as in claim 2. The extraction of dust is accomplished with the aid of water or an aqueous solution [0013], as in claim 4. The dust extract is dried by lyophilization, as in the drying step of claim 10.
The dust extract can be subjected to a dialysis step, wherein the preferred exclusion limit for the dialysis is approximately 3 kDa, thereby removing smaller molecules from the extract [0016], as in the limitation wherein the barn dust extract consists of molecules having a molecular weight of at least 10 kDa of claims 1, 7, 43 and new claim 44. As recited in MPEP 2131.03.II, when a prior art teaches a range that touches or overlaps the claimed range, the prior art may anticipate the claimed range, if the prior art range discloses the claimed range with “sufficient specificity”. In the instant case, the Bufe teaches a preferred size of at least 3 kDa, whereas the claims are directed to a size of at least 10 kDa. Given the broad size range of Bufe, any evidence of unexpected results within the narrower range may render the claims nonobvious. However, there is no evidence of criticality of the range from 3-10 kDa in the specification over the prior art. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960); see MPEP716.02(d).II. In the absence of any criticality regarding a size exclusion at 10 kDa, the instant claims are obvious over the teachings of Bufe.
Limitations directed to depleting the fraction of molecules having a molecular weight of less than 10 kDa by a factor of at least 10, 20, or 100, of claims 1, 7, and 43 and enriching by a factor of at least 5, at least 10, at least 20, or at least 100 compared to the mixture in the step of providing of claim 6 are obvious over the teachings of Bufe because any enrichment or depletion is an inherent property of the referenced barn dust extract. Also, the limitation directed to the obtained extract having a greater anti-allergenic potential than the extract in the step of providing of claim 43 are obvious over Bufe, as this limitation is an inherent property of the same product that is generated by the same method.
Overall, the instant claims are anticipated or obvious over the method taught Bufe, because the methods are both directed to the same barn dust and the same active steps to achieve the same intended properties.
Claims 1-2, 4, 6-7, 10, 12-14, 43, and new claim 44 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0112983, published May 15, 2008 (“Bufe”), as applied to claims 1-2, 4, 6-7, 10, 12-13, and 43-44 above, and further in view of Mathisen et al published January 16, 2004 (“Mathisen”; PTO-892 from 10/8/2024).
The teachings of Bufe are discussed above. Bufe does not teach a filter sterilization step in the preparation of a barn dust extract as in instant claim 14.
Mathisen teaches a method for the preparation of hog barn dust extract, wherein the final supernatant is filter sterilized with a 0.22 um pore size [pg 1739, column 1, para 4), as in claim 14.
As Bufe teaches a method to prepare a barn dust extract from a cow barn and Mathisen teaches a similar method with an additional step comprising filter sterilization of the extract, it would have been obvious to one of ordinary skill in the art to modify the method of Bufe with the filter sterilization step of Bufe to remove cells (e.g., bacteria). One would be motivated to do so in order to ensure a therapeutic composition is sterile for delivery to subjects in need. The instant method comprises steps that are known in the art, and one would have a reasonable expectation of successfully preparing the barn dust extract after filter sterilization.
Claims 1-2, 4, 6-8, 10, 12-13, 43, and new claims 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0112983, published May 15, 2008 (“Bufe”), as applied to claims 1-2, 4, 6-7, 10, 12-13, and 43-44 above, further in view of WO 9600579 published January 11, 1996 published January 16, 2004 (“Laves”; PTO-892 from 10/8/2024; machine translation retrieved from Patentscope on 1/26/24).
The teachings of Bufe are discussed above. Bufe does not teach a heat treatment step of at least about 110 °C and/or a pressure of at least about 1.5 bar for at least about 3 min in the preparation of a barn dust extract.
Laves teaches a method for preparing aqueous extracts from myobacteria for increasing activation of the immune system (pg 2, ln 3-13). The extracts are heated for 20 min at 121 °C (pg 3, example 1), as in claim 8 and new claim 45. Heat sterilization in an autoclave is a routine laboratory practice, and, in the instant method, heating the dust extract does not appear to offer any unique advantages. As the heat treatment does not alter the therapeutic potency of the barn dust extract (specification pg 13), the heating step yields no advantage apart from standard sterilization. Therefore, it would be obvious to one of ordinary skill in the art to sterilize the dust extract of Bufe, which could be comprised of various microbes, by heating prior to the administration to subjects in need.
Response to Amendment
The declaration under 37 CFR 1.132 filed October 7, 2025 is insufficient to overcome the rejection of claims 1-2, 4, 6-8, 10, 12-14, and 43 based upon the combined teachings of US 2008/0112983 in view of Mathisen et al and WO 9600579 as set forth in the last Office action; reasons are addressed below in the response to arguments.
Response to Arguments
Applicant's arguments filed October 7, 2025 have been fully considered but they are not persuasive. Regarding the rejection of the claims under 35 U.S.C. 102/103, applicant asserts that Bufe does not inherently disclose the enrichment of a >10 kDa fraction, because the cutoff of Bufe is 3 kDa (remarks, pg 7). It is the Examiner’s position that the claimed molecular weight fraction completely overlaps completely with the molecular weight fraction of Bufe, and, thus, the fraction of Bufe anticipates/makes obvious the claimed fraction. Applicant is directed to MPEP 2131.03.II, which states that when a prior art teaches a range that touches or overlaps the claimed range, the prior art may anticipate the claimed range, if the prior art range discloses the claimed range with sufficient specificity. However, given the broad range of Bufe, any evidence of unexpected results within the narrower range may render the claims nonobvious. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP 716.02(c).II). It is the examiner’s position that the favorable results exhibited by a >10 kDa fraction over the whole barn dust extract and 10-100 kDa fractions (see Figure 16 of the specification) are not sufficient to overcome a conclusion of obviousness, because all three extract fractions appear to function similarly (e.g., decrease Ova-induced increase in eosinophils and increase in macrophages). The differences among the three groups are not statistically significant and the difference seems to be one of degree rather than in kind.
Case law holds that although the record may establish evidence of secondary consideration which are indicia of nonobviousness, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. Newell Cos. V. Kenney Mfg. Co., 864 F.2d 757, 769, 9 USPQ2d 1417, 1427 (Fed. Cir. 1988), cert. denied, 493 U.S. 814 (1989). Such is the case here. Without any evidence of unexpected results, the claimed method is anticipated/obvious over Bufe because the recited steps are the same and the size range of the molecules of the fractions overlap.
Regarding the rejections under 35 U.S.C. 103, Applicant is incorrect that the rejection over Bufe in view of Mathisen is being applied by the examiner only for the rejection of claim 14 (remarks, pg 11). As claims 1-2, 4, 6-7, 10, 12-14, and 43 are rejected under Bufe alone, these claims are by extension also rejected under Bufe in view of Mathisen. Similarly, Bufe in view of Laves is used to reject claims 1-2, 4, 6-8, 10, 12-13, and 43.
Applicant maintains their position that the interpretation of the combined teachings of Bufe in view of Laves is improper for establishing the claimed heat treatment as obvious (remarks, pg 11). Applicant argues that the additional heat treatment step of claim 8 is not obvious over the prior art because Bufe does not teach heat treatment (remarks, pg 11). Although applicant is correct that Bufe does not teach a heat treatment step, the rejection of claim 8 was made over Bufe and Laves, which does teach a heat treatment step. In the von Mutius Declaration, applicant asserts, as one of the inventors of Bufe, that it was believed at the time Bufe was filed that heat treatment should be avoided throughout the entire process (Declaration, pg 4). Bufe, however, offers no motivation to not use heat. As stated in the office action mailed May 7, 2025, applicant has provided no data or indication that a heat-treated barn dust extract would have altered therapeutic potency. In response, Applicant has provided new evidence (see Appendix B of von Mutius Declaration) that the claimed autoclaved >10 kDa fraction more efficiently decreased eosinophils (BAL cell count) and ratio of Goblet to non-Goblet cells than the non-autoclaved >3 kDa fraction. The effects of the two fractions, however, do not appear to be significantly different from each other; rather the difference is a matter of degree. Regarding the volume of mucus, mucus volume appears to be significantly greater in the nonautoclaved >3 kDa fraction than the autoclaved >10 kDa fraction. This evidence, however, is not persuasive for nonobviousness, as the other metrics for assessing efficacy are not significantly different between the two fractions. These data indicate that neither the heating step nor the elimination of molecules <10 kDa are critical for the method of preparing a barn dust extract. Applicant is reminded, for product-by-process claims, if the product is obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Furthermore, heating of antigens was routine in the art prior to the filing date of the application; applicant is directed again to WO 01/49319, published July 12, 2001 (seePTO-892 from 5/7/2025; machine translation retrieved from Patentscope on 4/23/2025). WO ’319 teaches compositions comprising air-borne microbial antigens of stables (abstract). These microbial antigens are found in combination with carrier particles, like dust, and microorganisms of the barn dust composition can be killed by a sterilization step comprising heat (pg 2, para 14). Laves teaches concepts with respect to heat treatment, and in combination with the primary reference, disclose the presently claimed invention. Applicant’s assertion that the individual references do not teach the claimed method does not address the fact that the combination of references provided good reason to select the steps of the method and the references cited teach the product.
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). Applicant’s arguments do not show how the combined teachings of the cited references and the knowledge/skills contained therein cannot render the rejected claims obvious. Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. “Good science and useful contributions do not necessarily result in patentability.” PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675