DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The examiner of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Joseph Spangler in Art Unit 1656.
Claims 1-20 are pending.
Election
Applicant’s election with traverse of
Group I, corresponding to claims 1-16, drawn to the technical feature of a method for making a concentrated allergen,
elected in the reply filed 10/15/2025 is acknowledged. The traversal is on the grounds examination of all claims would be no undue search and examination burden.
Applicant’s arguments are considered and not found convincing because this application is filed under 35 U.S.C. 371 and the “unity of invention” standard applies, not the “independent and distinct” standard for non-provisional applications filed under 35 U.S.C. 111(a). See MPEP 1893.03(d). As such, whether or not a serious burden is required is not a proper basis of traversal in a national stage application filed under 35 U.S.C. 371. The inventions of Groups I, II and III as set forth in the Requirement for Restriction mailed 07/14/2025 lack unity of invention because even though the inventions of these groups require the technical feature of an allergenic intermediate, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 2020/0147208 (cited on the IDS filed May 10, 2023), which teaches allergenic intermediates, methods of making the allergens and a diluent [paras 0033 and 0099], as well as US 2,316,311 (cited on the IDS filed 05/10/2023) which teaches a method
comprising the purification of a product with high allergic activity [p 1, col 2, para 6].
At least because the applicant does not dispute the examiner's asserted lack of unity of invention, the requirement is still deemed proper and is therefore made FINAL.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 10/15/2025.
Claims 1-16 are being examined on the merits.
Priority
The instant application is a national stage filing under 35 U.S.C. 371 of international application PCT/US2021/059013 filed on 11/11/2021, which claims domestic priority to U.S. Provisional Application No. 63/113052 filed on 11/12/2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 05/10/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Objections to Specification
The disclosure is objected to because of the following informalities.
The use of the terms WHATMAN, PALL, and 3M, which are trade names or marks used in commerce, have been noted in this application in paragraphs 0098-0099. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claims 2 and 8 are objected to for the phrase “allergenic source” in line 4 of claim 2 and line 1 of claim 8. In the interest of improving claim form, Applicant should consider an amendment to recite “allergenic source material”.
Claim 8 is objected to for the phrase “wherein said allergenic source is contacted with said extraction fluid at a concentration ratio of 1:6-7”. In the interest of improving claim form and for the sake of consistency, Applicant should consider an amendment to recite “wherein said allergenic source is contacted with said extraction fluid at a concentration ratio of 1:6 to 1:7” in the style of claim 4.
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.
Claims 1-16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 (claims 2-16 dependent therefrom) is indefinite for the limitation “adjusting the concentrated extract with a ketonic solvent” in line 7. As the claim previously recites a “concentrated crude extract”, it is unclear whether this limitation is directed to the same “concentrated crude extract”, or the “concentrated extract” in the phrase is the distinct from the “concentrated crude extract”.
Claim 13 is rejected for the phrase “wherein said concentrating is carried out to a concentration equal to or less than 20% of the original volume”. The recitation of a volume to define a concentration renders the scope of the limitation indefinite, as concentration is understood to be a ratio of mass to volume. Additionally, it is unclear what component of the crude extract is being concentrated in order to determine the degree of concentration. Finally, it is unclear what the intended final concentration of the crude extract should be, whether the phrase above is intending to limit the final concentration to be equal to or less than 20% compared to the original concentration, or if it is intending to limit the final concentration as being equal to or less than the concentration of 20% of the volume of the original crude extract.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 1-8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2,316,311 (cited on the IDS filed 05/10/2023; herein Boatner), in view of Vane et al. (J Chem Technol Biotechnol, 2005, 80:603; cited on the attached Form PTO-892; herein Vane) and U.S. 7,887,821 (cited on the IDS filed 05/10/2023; herein Jacobi).
Claim 1 is drawn to a process for preparing a highly concentrated allergenic intermediate from a dilute allergen extract, said process comprising:
providing a crude extract comprising biological material from an allergenic source, wherein the biological material comprises a solid phase portion and a liquid phase portion;
concentrating the crude extract using pervaporation;
adjusting the pH of the concentrated crude extract to 4.0 - 5.0;
treating the concentrated extract with a ketonic solvent to form a precipitate; and
recovering the precipitate by filtration to obtain a highly concentrated allergenic intermediate.
Boatner relates to the production of allergic extracts [title] and discusses that various materials such as animal hairs and danders contain certain factors to which some people are hypersensitive, and extracts from said materials can be used for immunization [p 1, col 1, paras 2-3].
Regarding claim 1 and the limitation of providing a crude extract comprising biological material from an allergenic source, Boatner teaches that house dust collected by means of a vacuum cleaner is treated with solvents to remove fats, and the fat-free house dust is contacted with an extraction fluid for 48 hours to separate the liquid from the undissolved material [p 2, col 1, para 4].
Regarding claim 1 and the limitation of treating the concentrated extract with a ketonic solvent to form a precipitate, Boatner teaches the treatment of an aqueous allergen extract with a suitable ketone to produce a precipitate [p 1, col 1, final paragraph].
Regarding claim 1 and the limitation of recovering the precipitate by filtration to obtain a highly concentrated allergenic intermediate, Boatner teaches the house dust extract after being mixed with water/acetone for 2 h at 3 °C is subjected to filtration to remove the solids [p 2, col 1, final paragraph].
Regarding claim 1 and the production of a highly allergic intermediate, Boatner teaches further purification of the concentrated product to produce a product with high allergic activity [p 1, col 2, para 6].
Boatner does not teach concentrating the crude extract using pervaporation and adjusting the pH of the concentrated crude extract to 4.0 - 5.0.
Vane reviews pervaporation for product recovery from biomass fermentation processes [title].
Regarding claim 1 and the limitation of concentrating the crude extract using pervaporation, Vane teaches the use of pervaporation to separate different components in a mixture fed to membrane based on permeation and diffusion rates that is capable of highly enriching a target component in the permeate, even if that target component was originally at a low concentration in the mixture [p 605, col 1, para 2]. As Boatner describes that an initial purification can result in a product with little allergic activity as a result of the loss of allergen material [p 3, col 2, para 2], that said activity can improve upon subsequent extractions [p 1, col 2, para 6], and that aqueous extracts of allergen can be used as allergic extracts after concentration of the aqueous solution [p 1, col 1, para 4], one of skill in the art would be motivated to concentrate the crude extract by pervaporation, as taught by Vane, to increase the allergen content material of the starting material, in order to increase the yield of material with high allergic activity.
Jacobi relates a process for producing an allergen extract [title], and discusses that conventional specific allergy vaccination is a causal treatment for allergic disease [1], and require allergen extracts purified from grass pollen, tree pollen and house dust mites that do not have the risk of allergic side reactions [col 2, para 5; col 3 para 6; and col 4, para 3].
Regarding claim 1 and the limitation of adjusting the pH of the concentrated crude extract to 4.0-5.0, Jacobi teaches the steps of allergen extraction from a biological source depend on the type or source material, and typically include extraction, separation and purification steps [col 5, final para], wherein an initial liquid extraction in water for 1-24 h from 2-25 °C and a pH of 5-9 produces an allergen mixture that is subsequently subjected to a separation step [col 6, para 2], wherein the separation step of Jacobi is considered to correspond to the treatment of the allergen extract with ketones as taught by Boatner. According to MPEP 2144.05.I, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. As such, the pH taught by Jacobi is considered to correspond to the pH recited in the claim.
In view of Boatner, Vane and Jacobi, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Boatner by concentrating the extract via pervaporation, as taught by Vane, and adjusting the pH of the extract before separation, as taught by Jacobi, to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to modify the method of Boatner by concentrating the extract via pervaporation because Boatner teaches method optimizations to concentrate the allergenic material in a product, and Vane teaches pervaporation is a method capable of highly enriching a target component from a mixture even if that target component was originally at a low concentration in the mixture.
One of ordinary skill in the art would have been motivated to modify the method of Boatner by adjusting the pH of the extract before separation because Jacobi teaches the treatment for allergic disease requires purified allergen extracts which are typically carried produced by methods comprising extraction at a pH of 5-9 from a biological source before separation and purification of the allergenic material.
One of ordinary skill in the art would have had a reasonable expectation of success because Boatner, Vane and Jacobi relate to methods of purifying target components from complex mixtures, and Boatner and Jacobi relate to methods of purifying allergen extracts.
Regarding claims 2-3 and 5, Boatner teaches that house dust collected by means of a vacuum cleaner is treated with solvents to remove fats, and the fat-free house dust is contacted with an extraction fluid for 48 hours to separate the liquid from the undissolved material [p 2, col 1, para 4], wherein said extraction involves no recited adjustment to pH.
Regarding claim 4, Boatner teaches the production of extract from house dust involving 50 g of house dust mixed with 200 mL of an acetone-water mixture [p 4, col 2, para 4], which corresponds to a 25% (w/v) solution, or a 1:4 ratio of allergen source material to extraction fluid.
Regarding claims 6 and 10, Jacobi teaches an initial liquid extraction in water from 2-25 °C and a pH of 5-9 produces an allergen mixture that is subsequently subjected to a separation step [col 6, para 2].
Regarding claim 7, Boatner teaches the production of allergenic extracts from biological sources as described in the rejection of claim 1 above that can be obtained from various materials such as animal hairs and danders to be used for immunization [p 1, col 1, paras 2-3].
Regarding claim 8, Boatner teaches the production of extract from house dust involving 50 g of house dust mixed with 200 mL of a 1:1 acetone-water mixture corresponding to a 1:4 ratio of allergenic source to extraction fluid in order to combine the steps of extraction and addition of acetone to precipitate insoluble constituents, producing an equivalent result through a fractional extraction [p 4, col 2, para 4]. Boatner additionally teaches said fractional extraction can be further treated by increasing acetone content to 80% in the mixture in order to produce precipitates that would contain the valuable allergenic factors or constituents [p 4, col 2, para 5]. According to MPEP 2144.05.II.A, where 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. While Boatner does not teach the 1:6 or 1:7 ratio of allergenic source to extraction fluid recited in the claim, Boatner teaches a 1:4 ratio as stated above, and teaches the increase in acetone content produces further precipitates containing the target allergen, therefore identifying increased acetone content in the fractional extraction to be a result effective variable, according to MPEP 2144.05.II.B, that effects the yield of allergen through fractional extraction. In view of the teachings of Boatner, it would have been obvious for one of skill in the art before the effective filing date to achieve the claimed ratio of 1:6-1:7 of allergenic source to extraction fluid by adding acetone to the 1:4 solution of allergenic source to extraction fluid of Boatner, as Boatner teaches the result effective variable of acetone content that effects the yield of extracted allergen.
Regarding claim 11, Boatner teaches the aqueous liquid of the extract is separated from the undissolved material by squeezing in a filter cloth [p 2, col 1, para 4], which corresponds to filtration as recited in the claim.
Regarding claim 12, Vane teaches the use of pervaporation to enriching or concentrate a target component from a mixture [p 605, col 1, para 2], and Boatner teaches the activity of allergenic extracts improve upon subsequent extractions that increase yield [p 1, col 2, para 6], therefore one of skill in the art would be motivated to concentrate the crude extract by pervaporation, as taught by Vane, to increase the allergen content material of the starting material, in order to increase the yield of material with high allergic activity. As Boatner and Vane do not disclose steps of performing conductivity tests in their concentration methods, the teachings of Boatner and Vane are considered to correspond to the limitation of concentrating the extract in the absence of a conductivity test recited in the claim.
Regarding claim 13, in view of the indefiniteness of the phrase “concentrating is carried out to a concentration equal to or less than 20% of the original volume”, and for the sake of compact prosecution, the phrase is being interpreted to mean the concentrated sample has a concentration equal to or less than the concentration of 20% of the volume of the original sample. Put another way, the claim is being interpreted such that the concentration of extract after the concentration step is being compared to the concentration of 20% of the volume of the original extract before the concentration step. Boatner teaches the activity of allergenic extracts improve upon subsequent extractions that increase yield [p 1, col 2, para 6], and describes a method of subsequent extractions in different solvents to effectively concentrate the allergenic material of a crude extract [beginning p 2, col 2, final paragraph to p 3, col 1, para 3 concluding with the separation of a readily soluble syrup of a high allergic activity in line 24], but does not disclose a final concentration of the crude extract. In view of the claim interpretation set forth above, while the concentrating method of Boatner does not describe a final concentration of extract, the concentrated extract of Boatner is considered to be encompassed by the limitation of “a concentration equal to or less than 20% of the original volume”. As 20% of the volume of the original extract would have the same concentration as 100% of the volume of the original extract, and the method of Boatner removes components from the original extract, the final extract of Boatner would be expected to have a concentration equal to or less than the concentration of 20% of the volume of the original extract.
Regarding claim 14, Boatner teaches the repeating of steps to increase yield of allergenic intermediate, wherein the addition of acetone results in the separation of a precipitate which is for the most part inactive or inert, while the removal of the precipitate and further addition of acetone to the filtrate results in a precipitate of high allergic activity [p 1, col 2, para 6].
Therefore, the invention of claims 1-8 and 10-14 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Boatner, Vane and Jacobi as applied to claims 1-8 and 10-14 above, and further in view of Portnoy et al. (J Allergy Clin Meth, 1993, 91:930; cited on the attached Form PTO-892; herein Portnoy).
Claim 9 is drawn to the method of claim 7, wherein said extracting is carried out for 3-5 days.
The teachings of Boatner, Vane and Jacobi as applied to claims 1-8 and 10-14 are discussed above. These references do not teach an extraction of 3-5 days.
Portnoy describes the effect of time and extraction buffers on residual protein and allergen content of Alternaria extracts [title].
Regarding claim 9, Portnoy teaches that the amount of protein and carbohydrate released during extraction vary with time, wherein longer extractions tend to contain more carbohydrate, and that certain allergens can be released at specific times during extraction occurring at a final tested time of 24 h compared with other allergens that are prevalent at an earliest tested time of 1 h [p 930, Results Summary]. Portnoy further teaches screening identified specific optimal times of extraction for each tested allergen, but could not determine a single best time for all allergens or for whole biologic activity [p 936, col 1, para 1]. While Portnoy teaches extraction times from 1-24 h, and Boatner teaches an extraction time of 48 h, Portnoy and Boatner do not teach the extraction time of 3-5 days as recited in the claim. However, according to MPEP 2144.05.II.A, where 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. As Portnoy teaches that certain allergens can be released at certain times during extraction that is specific per target allergen, Portnoy identifies extraction time as a result effective variable, according to MPEP 2144.05.II.B, that effects the extraction yield of allergen. In view of the teachings of Portnoy, it would have been obvious for one of skill in the art before the effective filing date to achieve the claimed extraction time of 3-5 days through routine experimentation, as Boatner describes a general method of producing allergen extracts applicable to house dust, animal hairs and danders, feathers, cotton, wool [p 1, col 1, paras 2-3], timothy grass pollen [p 4, col 1, para 4] and orris root [p 4, col 1, para 6], and Portnoy suggests optimizing extraction times to effect the extraction yield of a target allergen.
In view of Portnoy, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined method of Boatner, Vane and Jacobi by carrying out extraction for 3-5 days through routine experimentation to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined method of Boatner, Vane and Jacobi by extracting for 3-5 days because Portnoy identifies extraction time as a result effective variable that effects the extraction yield of allergen and teaches that different extraction times produce different yields dependent on the specific target allergen, therefore suggesting the optimization of extraction time suitable to the target allergen. One of ordinary skill in the art would have had a reasonable expectation of success because Boatner and Portnoy relate to the extraction of allergens from biological sources.
Regarding claim 15, Boatner teaches that allergenic products of the method can be preserved in a dry condition [p 3, col 1, para 1], and Portnoy teaches lyophilizing extracts for storage until use [p 931, col 2, para 1].
Regarding claim 16, Boatner teaches methods of production of allergenic extracts and concentrates of increase allergenic activity [p 1, col 1, para 5], and that the allergenic products of the method can be preserved in a dry condition, and can be prepared in solution of regulated strength [p 3, col 2, para 1], which is considered to correspond to subjecting a lyophilized or vacuum-dried precipitate to reconstitution to form a highly concentrated extract. Additionally, Portnoy teaches lyophilized samples are reconstituted to a target solution in aqueous buffer for use [p 931, col 2, para 3].
Therefore, the invention of claims 9 and 15-16 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 1-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0147208 (cited on the IDS filed 05/10/2023; herein Jubilant) in view of Vane.
Jubilant relates to a process for the preparation of allergenic extracts [title].
Regarding claim 1, Jubilant teaches a process for the preparation of an allergenic intermediate comprising extracting biological material from the allergenic source into the extraction fluid; separating the biological material into a solid phase portion and a liquid phase portion to obtain a crude extract; concentrating the crude extract using ultrafiltration to extract and to partially remove low molecular weight molecules of less than 5 kDa; subjecting the concentrated extract to continuous diafiltration to remove remaining lower molecular weight molecules from the concentrated extract; and lyophilizing the ultrafiltered and diafiltered extract to obtain the allergenic intermediate [claim 1].
Regarding claim 1 and the limitation of pH recited in the claim, Jubilant teaches extractions can involve the adjusting of pH from 5 to 9 [para 0018].
Regarding claim 1 and the limitation of treating the concentrated extract with ketonic solvent to form a precipitate, Jubilant teaches extractions can involve fractional precipitation by the addition of ketone [para 0011]. Jubilant does not teach the use of pervaporation to concentrate the extract.
Vane reviews pervaporation for product recovery from biomass fermentation processes [title].
Regarding claim 1 and the limitation of concentrating the crude extract using pervaporation, Vane teaches the use of pervaporation to separate different components in a mixture fed to membrane based on permeation and diffusion rates that is capable of highly enriching a target component in the permeate, even if that target component was originally at a low concentration in the mixture [p 605, col 1, para 2].
In view of Jubilant and Vane, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jubilant by replacing the ultrafiltration in the concentrating step with pervaporation as taught by Vane, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that the ultrafiltration of Jubilant and the pervaporation of Vane are both techniques for concentrating a target molecule, and as such both are capable of being incorporated into such methods as described by Jubilant. Thus it would have been obvious to one of ordinary skill in the art to replace the ultrafiltration of Jubilant with the pervaporation of Vane, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both Jubilant and Vane relate to methods of product recovery comprising steps for concentration of a target substance.
Regarding claims 2 and 12, Jubilant teaches the process for allergenic intermediate as described above, comprising extracting biological material from the allergenic source into the extraction fluid; separating the biological material into a solid phase portion and a liquid phase portion to obtain a crude extract; wherein said process is carried out without adjusting pH of the extraction fluid during said extracting or without requiring conductivity testing to determine the endpoint of ultrafiltration [claim 1].
Regarding claims 3 and 7, Jubilant teaches the allergenic source material is selected from allergens that include animal hair and dander [claim 3].
Regarding claims 4 and 8, Jubilant teaches said allergenic source is contacted with said extraction fluid at a concentration ratio of about 1:6-7 [claim 12].
Regarding claims 5 and 9, Jubilant teaches said extracting is carried out for about 3-5 days [claim 13].
Regarding claims 6 and 10, said extracting is carried out at 0 °C – 5 °C [claim 14].
Regarding claim 11, Jubilant teaches said separating is carried out using centrifugation and dead end filtration [claim 17].
Regarding claim 13, in view of the indefiniteness of the phrase “concentrating is carried out to a concentration equal to or less than 20% of the original volume”, and for the sake of compact prosecution, the phrase is being interpreted to mean the concentrated sample has a concentration equal to or less than the concentration of 20% of the volume of the original sample. Put another way, the claim is being interpreted such that the concentration of extract after the concentration step is being compared to the concentration of 20% of the volume of the original extract before the concentration step. Jubilant teaches the concentration of extract until the concentration target of 10% of the starting extract is achieved [para 0085], which is considered to correspond to an extract having a concentration equal to or less than the concentration of 20% of the volume of the original extract.
Regarding claim 15, Jubilant teaches lyophilizing extract [claim 1].
Regarding claim 16, Jubilant teaches the reconstitution of the lyophilized extract [paras 0060-0061].
Therefore, the invention of claims 1-13 and 15-16 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jubilant in view of Vane as applied to claims 1-13 and 15-16 above, and further in view of Boatner.
Claim 14 is drawn to the method of claim 1, further comprising repeating said treatment step with ketonic solvent to form a precipitate.
The teachings of Jubilant and Vane as applied to claims 1-13 and 15-16 are described above. These references do not teach repeating said treatment step.
Boatner relates to the production of allergic extracts [title] and discusses that various materials such as animal hairs and danders contain certain factors to which some people are hypersensitive, and extracts from said materials can be used for immunization [p 1, col 1, paras 2-3].
Regarding claim 14, Jubilant references the method of Boatner (US 2,316,311 cited in the rejection above) as subjecting extract to fractional precipitation by addition of a suitable ketone such as acetone [para 0011 of Jubilant], and Boatner teaches the repeating of steps to increase yield of allergenic intermediate, wherein the addition of acetone results in the separation of a precipitate which is for the most part inactive or inert, while the removal of the precipitate and further addition of acetone to the filtrate results in a precipitate of high allergic activity [p 1, col 2, para 6 of Boatner].
In view of Boatner, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined method of Jubilant and Vane by repeating the treatment step as taught by Boatner to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined method of Jubilant and Vane by repeating the treatment step because Boatner teaches the repeat treatment of extract with acetone markedly increases the allergic activity of the resulting precipitate. One of ordinary skill in the art would have had a reasonable expectation of success because Jubilant and Boatner relate to methods of purifying allergen extracts.
Therefore, the invention of claim 14 would have been obvious to one of ordinary skill in the art before the effective filing date.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 10-12 and 15 of U.S. Patent No. 11,617,789 (cited on the attached Form PTO-892; herein patent) in view of Boatner, Jacobi and Vane.
Regarding instant claim 1, claim 1 of the patent recites a process for production of an allergenic intermediate comprising extracting biological material from the allergenic source into the extraction fluid; separating the biological material into a solid phase portion and a liquid phase portion to obtain a crude extract; concentrating the crude extract using ultrafiltration to extract and to partially remove low molecular weight molecules of less than 5 kDa; subjecting the concentrated extract to continuous diafiltration to remove remaining lower molecular weight molecules from the concentrated extract; and lyophilizing the ultrafiltered and diafiltered extract to obtain the allergenic intermediate.
The claims of the patent do not recite the adjustment of pH of the extract, the treatment of the extract with a ketonic solvent, and the use of pervaporation to concentrate the extract.
Boatner relates to the production of allergic extracts [title] and discusses that various materials such as animal hairs and danders contain certain factors to which some people are hypersensitive, and extracts from said materials can be used for immunization [p 1, col 1, paras 2-3].
Regarding instant claim 1 and the limitation of treating the concentrated extract with a ketonic solvent to form a precipitate, Boatner discloses the treatment of an aqueous allergen extract with a suitable ketone to produce a precipitate which is then desiccated and ground to a powder [p 1, col 1, final paragraph], wherein said acetone treatment can be repeated to increase the yield of allergenic material as needed [p 1, col 2, para 6].
Jacobi relates a process for producing an allergen extract [title], and discusses that conventional specific allergy vaccination is a causal treatment for allergic disease [1], and require allergen extracts purified from grass pollen, tree pollen and house dust mites that do not have the risk of allergic side reactions [col 2, para 5; col 3 para 6; and col 4, para 3].
Regarding instant claim 1 and the limitation of adjusting the pH of the concentrated crude extract to 4.0-5.0, Jacobi discloses the steps of allergen extraction from a biological source depend on the type or source material, and typically include extraction, separation and purification steps [col 5, final para], wherein an initial liquid extraction in water for 1-24 h from 2-25 °C and a pH of 5-9 produces an allergen mixture that is subsequently subjected to a separation step [col 6, para 2]. According to MPEP 2144.05.I, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. As such, the pH disclosed by Jacobi is considered to correspond to the pH recited in the instant claim.
Vane reviews pervaporation for product recovery from biomass fermentation processes [title].
Regarding instant claim 1 and the limitation of concentrating the crude extract using pervaporation, Vane discloses the use of pervaporation to separate different components in a mixture fed to membrane based on permeation and diffusion rates that is capable of highly enriching a target component in the permeate, even if that target component was originally at a low concentration in the mixture [p 605, col 1, para 2].
In view of Boatner and Jacobi, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by treating the extract with ketonic solvent as disclosed by Boatner and adjusting the pH of the extract before separation as disclosed by Jacobi to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to modify the claims of the patent by treating the extract with ketonic solvent Boatner discloses a method of producing allergic extracts wherein extract can be precipitated with ketones to successively increase the yield of precipitate having high allergic activity.
One of ordinary skill in the art would have been motivated to modify the claims of the patent by adjusting the pH of the extract before separation because Jacobi discloses the treatment for allergic disease requires purified allergen extracts which are typically carried produced by methods comprising extraction at a pH of 5-9 from a biological source before separation and purification of the allergenic material.
One of ordinary skill in the art would have had a reasonable expectation of success because the claims of the patent, Boatner, and Jacobi relate to methods of purifying allergen extracts.
In view of Vane, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by replacing the ultrafiltration in the concentrating step with the pervaporation of Vane, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that the ultrafiltration of the patent and the pervaporation of Vane are both techniques for concentrating a target molecule, and as such both are capable of being incorporated into such methods as described by the patent. Thus it would have been obvious to one of ordinary skill in the art to replace the ultrafiltration of the patent with the pervaporation of Vane, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both the patent and Vane relate to methods of product recovery comprising steps for concentration of a target substance.
Regarding instant claims 2 and 12, claim 1 of the patent recites the process for allergenic intermediate as described above, comprising extracting biological material from the allergenic source into the extraction fluid; separating the biological material into a solid phase portion and a liquid phase portion to obtain a crude extract; wherein said process is carried out without adjusting pH of the extraction fluid during said extracting or without requiring conductivity testing to determine the endpoint of ultrafiltration.
Regarding instant claims 3 and 7, claim 3 of the patent recites the allergenic source material is selected from allergens that include animal hair and dander.
Regarding instant claims 4 and 8, claim 10 of the patent recites said allergenic source is contacted with said extraction fluid at a concentration ratio of about 1:6-7.
Regarding instant claims 5 and 9, claim 11 of the patent recites said extracting is carried out for 3-5 days.
Regarding instant claims 6 and 10, claim 12 of the patent recites said extracting is carried out at 0 °C – 5 °C.
Regarding instant claim 11, claim 15 of the patent recites said separating is carried out using centrifugation and dead end filtration.
Regarding instant claim 13, in view of the indefiniteness of the phrase “concentrating is carried out to a concentration equal to or less than 20% of the original volume”, and for the sake of compact prosecution, the phrase is being interpreted to mean the concentrated sample has a concentration equal to or less than the concentration of 20% of the volume of the original sample. Put another way, the instant claim is being interpreted such that the concentration of extract after the concentration step is being compared to the concentration of 20% of the volume of the original extract before the concentration step. Boatner discloses the activity of allergenic extracts improve upon subsequent extractions that increase yield [p 1, col 2, para 6], and describes a method of subsequent extractions in different solvents to effectively concentrate the allergenic material of a crude extract [beginning p 2, col 2, final paragraph to p 3, col 1, para 3 concluding with the separation of a readily soluble syrup of a high allergic activity in line 24], but does not disclose a final concentration of the crude extract. In view of the claim interpretation set forth above, while the concentrating method of Boatner does not describe a final concentration of extract, the concentrated extract of Boatner is considered to be encompassed by the limitation of “a concentration equal to or less than 20% of the original volume”. As 20% of the volume of the original extract would have the same concentration as 100% of the volume of the original extract, and the method of Boatner removes components from the original extract, the final extract of Boatner would be expected to have a concentration equal to or less than the concentration of 20% of the volume of the original extract.
Regarding instant claim 14, Boatner discloses the repeating of steps to increase yield of allergenic intermediate, wherein the addition of acetone results in the separation of a precipitate which is for the most part inactive or inert, while the removal of the precipitate and further addition of acetone to the filtrate results in a precipitate of high allergic activity [p 1, col 2, para 6].
Regarding instant claim 15, claim 1 of the patent recites lyophilizing extract.
Regarding instant claim 16, claim 1 of the patent recites lyophilizing the extract, and Boatner discloses the allergenic products of the method can be preserved in a dry condition, and can be prepared in solution of regulated strength [p 3, col 2, para 1], wherein the dry condition is considered to correspond to the lyophilized extract of the patent, and wherein the preparation of dry product in solution of regulated strength is considered to correspond to the reconstitution of lyophilized extract to form a highly concentrated extract.
Conclusion
Status of the Application:
Claims 1-20 are pending.
Claims 17-20 are withdrawn.
Claims 1-16 are rejected.
No claim is in condition for allowance.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656