DETATILED 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 filed on May 4, 2026 has been entered.
Claim Status
Claims 29, 25, 37-38, and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 19, 2023.
Claims 1-2, 4, 6-8, 10, 39, 43-45, and new claims 46-51 are under consideration in this office action.
Withdrawn Rejections
Any rejection of record pertaining to cancelled claims 12-14 is rendered moot by applicant’s cancellation of said claims.
The rejection of claims 1-2, 3, 6-7, 10, and 43-44 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bufe is withdrawn in view of applicant’s amendment of the method to include a heat treatment step.
New Rejections Necessitated by Amendment
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 50-51 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 50 contains the trademark/trade name Agilent. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe chromatography system and associated columns and, accordingly, the identification/description is indefinite.
Claim 51 is included in this rejection for being dependent on a rejected base claim and for failing to cure the indefiniteness.
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, 6-7, 10, 43-44 and new claims 46-51 are rejected under 35 U.S.C. under U.S.C. 103 as obvious over US 2008/0112983, published May 15, 2008 (“Bufe”; see IDS from 4/13/22), 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) and WO 01/49319, published July 12, 2001 (see PTO-892 from 5/7/2025; machine translation retrieved from Patentscope on 4/23/2025).
The claims are directed to a method of preparing a cow barn dust extract, wherein the method is comprised of fractionating and heating steps. The extract consists essentially of molecules having a molecular weight of at least about 10 kDa. Bufe teaches a method for the extraction of barn dust comprising collecting barn dust, homogenizing barn dust, and digesting the barn dust [0011-0013]. 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, 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 addition of the 3-10 kDa proteins 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.
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, as required in claim 1 and new claims 46-47.
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 in an autoclave(pg 3, example 1), as in claims 1, 8 and new claim 45.
As taught by Mutius, heating of antigens was routine in the art prior to the filing date of the application. Mutius teaches compositions comprising air-borne microbial antigen in the air 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; page 4, para 1).
Based on the teachings of Laves and Mutius, 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 unexpectedly alter the therapeutic efficacy 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. 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 heat treatment.
New limitation of claim 1 is drawn to a dust extract, when analyzed by SEC, has two distinct peaks. If the two peak profile of the composition merely results from the application of heat, this two peak profile would be an inherent result of the obvious process taught by Bufe in view of Laves and Mutius, as heating could denature proteins, dissociate complexes, or precipitate proteins. For this limitation to be nonobvious, applicant would need to show that the two-peak profile was unexpected and that this two peak profile is associated with a meaningful advantage.
New limitations of claim 1 and new claims 48-51 directed to analysis of the barn dust extract by size exclusion chromatography (SEC) for separating and detecting protein based on size are obvious over Bufe, which teaches methods for characterizing the extracts using HPLC [0029]. Since the claimed method of making the barn dust extract is obvious over the teachings of Bufe in view of Laves and Mutius, it follows that the composition would be comprised of the same peaks, as detected using related analytical chemistry methods known in the art.
Limitations drawn 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.
Response to Arguments
Applicant's arguments filed May 4, 2026 have been fully considered but they are not persuasive.
Applicant argues that the rejection of Bufe in view of Laves is improper because the Bufe reference teaches away from the use of heat. The examiner does not deny that Bufe teaches a method that does not use heat. However, the rejections of the claims were made over the combined teachings of Bufe and Laves in the Final office action mailed 11/4/2025 and over Bufe in view of Laves and Mutius in the new 103 rejection set forth above. Laves and Mutius teaches concepts with respect to heat treatment of extracts from biomaterials, and in combination with Bufe, disclose the presently claimed invention. Applicant’s assertion that it is unreasonable to conclude that Bufe has to provide a motivation for such teaching in order for it to be considered as teaching away from the use of heat (remarks, pg 15) cannot be accepted since the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Bufe offers no rationale why not to use heat. Because other references teach the heat treatment step in method of making an extract from biological samples found in barn dust and because there is no demonstrated technical reason to avoid heat, the results appear generally predictable rather than surprising. As the prior art teaches all the process steps, there would have been a reason for a skilled artisan to add the heating step to improve extraction. The Federal Circuit has repeatedly upheld that a reference does not teach away simply because it discloses a preferred embodiment that excludes the claimed feature; a true teaching away generally requires discouraging the modification or suggesting that it would be unsuccessful, undesirable, or inferior. Citing In re Gurley and In re Fulton, the Federal Circuit reiterated the proper standard for teaching away as follows: a reference will teach away when it suggests that the developments flowing from its disclosures are unlikely, reasonably, to produce the objective of the applicant’s invention. A statement that a particular combination is not a preferred embodiment does not teach away absent clear discouragement of that combination. See Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005).
The applicant point to improvement in efficacy using the heat-treated samples. The improvements in efficacy are modest, however, as the resulting extract from the claimed method retains essentially the same properties as the extract of Bufe. "[A] modification of a process parameter may be patentable if it ‘produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art." (citing Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 693, 2023 USPQ2d 448 (Fed. Cir. 2023). Overall, the difference in the efficacy of the two fractions, appear to a matter of degree not kind. 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 mentions that Bufe relies entirely on dialysis, whereas claims 1 and 8 require the combination of heat treatment and fractionation (remarks, pg 15). Because dialysis is a type of method to fractionate proteins based on size, it is unclear what applicant’s point is regarding the dialysis step of Bufe not reading on the size limitations of claims 1 and 8. The fraction of Bufe would comprise all proteins greater than 10 kDa in size, as required by claim 1. Given that fraction is defined (specification, pg 11) as that obtained by fractioning mixture according to the molecular weight or size of the molecules comprising the mixture, the dialysis step of Bufe reads on the claimed method. It is noted that the specification include an ultracentrifugation step for the fractionation (pg 20), but this limitation is not included in the claim. Mutius does teach a centrifugation step in the preparation of the extract (pg 2, last para): “the composition can consist mainly of isolated fragment of the microorganisms… the fragments can also be wholly or partially purified by known biochemical methods, i.e. centrifugation” (pg 2, last para).
Without any strong evidence of unexpected results, the claimed method is obvious over Bufe in view of Laves and Mutius because the recited steps are the same and the size range of the molecules of the fractions overlap and the unexpected results are not actually unexpected. 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).
New limitations of claim 1 are drawn to alterations SEC profile, demonstrating that the composition is analytically different than that of Bufe. This finding, however, is not persuasive for nonobviousness, because heating biological materials will yield predictable changes to the composition (e.g., denaturation of proteins, degradation of some component or enrichment of others). Thus, the fact that the SEC profile is different is not unexpected, the product is merely the results of the addition of the heating step made obvious over the teachings of Laves and Mutius.
In the von Mutius Declaration filed 11/4/2025, 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). The declaration does not, however, provide sufficient evidence that Bufe is a teaching away reference. Although the statement indicating that an inventor of Bufe did not believe that heating would work is evidence, it is not dispositive, given that lack of objective evidence. Was this belief held extensively in the field at the time the application was filed? Without objective evidence, the declaration merely reflects a subjective concern rather than a true teaching away, especially since no reason was given in Bufe to not use heat. Laves and Mutius teach that heat treatment was a known processing technique and, thus, it would have been an obvious modification of the prior-art method to add this step to the method of Bufe. Because the record does not establish that heat is harmful and that lack of heat is technically justified or widely accepted in the art to be disadvantageous, the rejection under 35 U.S.C. 103 is maintained.
Conclusion
No claim is allowed.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
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