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 .
Status of Application
The Amendments and Remarks filed on 11/17/25 are acknowledged.
Claims 1, 7-8, and 15-16 were amended.
Claims 1-27 are pending and included in the prosecution.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 08/29/25; 09/22/25; 10/24/25; 11/14/25; 01/15/26; and 02/05/26 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Response to Amendments/Arguments
Claim Objections
In light of the amendment of claim 7, and the explanation and justified alignment of the claim set filed on 11/17/25, the claim objections of 08/15/25 are withdrawn.
Rejection of claims under 35 USC § 112(b)
Applicant’s arguments (Page 6, filed 11/17/25) with respect to the rejection of claims 3 and 11 under 35 USC § 112(b) have been fully considered and are persuasive. Therefore, the rejection under 35 USC § 112(b) is withdrawn.
Notice for all US Patent Applications filed on or after March 16, 2013
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Maintained Rejections
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 1-4, 7-11, 15-18, and 20 are again rejected under 35 U.S.C. 103 as being unpatentable over Bafundo et al. (WO 2015/179840 A1 – “Bafundo”) in view of Marker et al. (J Am Chem Soc. 1943, 65, 6, 1199-1209 – “Marker ‘43”) and Marker et al. (J Am Chem Soc. 1947 69, 10, 2403-2404 – “Marker ’47”).
Instant claim 1 is drawn to a method of enhancing an immune response in a non-human animal comprising the steps of administering to a non-human animal an immunogenically effective amount of an extract from a non-woody plant of the genus Hesperaloe comprising at least one saponin.
Bafundo discloses a method of treating coccidiosis and enhancing the immune response in chickens by using a basal animal feed, yucca extract which contains saponins, and quillaja extract which contains saponins, wherein the chicken are challenged by adding coccidian E. acervulina, E. maxima or E. tenella to the feed (Page 40, lines 4-10, Examples 2-8 – Page 22, line 18 to Page 36, line 6). Bafundo also discloses the use of the composition comprising the yucca extract and quillaja extract in combination of a coccidiosis vaccine in treating coccidiosis and enhancing the immune response (Example 3 and Example 7). The coccidiosis vaccine disclosed by Bafundo comprises oocysts derived from Eimeria, and the yucca extract and quillaja extract, along with the composition of the coccidiosis vaccine, are admixed with a feedstuff to form an admixed composition (Page 37, lines 16-20 and 29-34).
Bafundo does not expressly teach that the extract comprising saponins is extracted from Hesperaloe rather than Yucca or Quillaja.
Marker ’43 teaches that the sapogenins gitogenin and tigogenin exist in both Hesperaloe and Yucca (Pages 1207-1208, sections 3 and 4).
Marker ’47 teaches that the sapogenins manogenin, hecogenin, gitogenin, and tigogenin exist in Hesperaloe (Page 2403, formulae and Page 2404 - Summary).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of treating coccidiosis and enhancing the immune response in chickens by using a basal animal feed, yucca extract which contains saponins, and quillaja extract which contains saponins, wherein the chicken are challenged by adding coccidian E. acervulina, E. maxima or E. tenella to the feed, as taught by Bafundo, in view of the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43, and the sapogenins manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do this because both Hesperaloe and Yucca contain the same sapogenins, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4). One of ordinary skill in the art would have found it obvious to use various sources of the saponins, including both Hesperaloe and Yucca, in the method of Bafundo with a reasonable expectation of success in effectively enhancing the immune response of the chickens.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 1, 9, 17, and 18, the limitations of a method of enhancing the immune response in a non-human animal comprising the steps of administering to a non-human animal an immunogenically effective amount of an extract from a non-woody plant of the genus Hesperaloe comprising at least one saponin would have been obvious over the method of treating coccidiosis and enhancing the immune response in chickens by using a basal animal feed, yucca extract which contains saponins, and quillaja extract which contains saponins, wherein the chicken are challenged by adding coccidian E. acervulina, E. maxima or E. tenella to the feed, as taught by Bafundo (Page 40, lines 4-10, Examples 2-8 – Page 22, line 18 to Page 36, line 6), in view of the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4), and the sapogenins manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47 (Page 2403, formulae and Page 2404 - Summary).
Regarding instant claims 2 and 10, the limitations of the extract further comprising saccharides, proteins, and lipids would have been obvious over the extracts containing the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4), and the sapogenins manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47 (Page 2403, formulae and Page 2404 - Summary) since these saponins intrinsically contain sugar chains and a steroidal molecule. One of ordinary skill in the art would have found it obvious to include the coccidiosis vaccine disclosed by Bafundo which comprises oocysts derived from Eimeria, which contain protein, and the yucca extract and quillaja extract, along with the composition of the coccidiosis vaccine, are admixed with a feedstuff to form an admixed composition (Page 37, lines 16-20 and 29-34).
Regarding instant claims 3 and 11, the limitation of the extract being substantially free from saccharides, proteins, and lipids would have been obvious over the yucca extract which contains saponins, and quillaja extract which contains saponins, (Page 40, lines 4-10, Examples 2-8 – Page 22, line 18 to Page 36, line 6), as taught by Bafundo since this reference does not disclose saccharides, proteins, or lipids in the yucca and quillaja extracts.
Regarding instant claims 4, 12, and 20, the limitations of the saponin and the glycosidic moiety would have been obvious over the yucca extract which contains saponins, and quillaja extract which contains saponins (Page 40, lines 4-10, Examples 2-8 – Page 22, line 18 to Page 36, line 6), as taught by Bafundo, in view of the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4), and the sapogenins manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47 (Page 2403, formulae and Page 2404 - Summary), which intrinsically contain the glycosidic moiety glucose.
Regarding instant claims 7 and 15, the limitations of the Hesperaloe species would have been obvious over Hesperaloe funifera as a source of hecogenin (Pages 1200 - Table) and Hesperaloe parviflora as a source of tigogenin (Pages 1208 – under “4. Tigogenin”), as taught by Marker ’43.
Regarding instant claims 8 and 16, the limitations of the saponin in the extract ranging from about 10 to about 25%, by weight of the extract would have been obvious over the manogenin saponin which accounted for 22% of the total crystalline sapogenin fraction (Page 1202 – under “6. Agavogenin”), as taught by Marker ’43. One of ordinary skill in the art would have found it obvious to use various concentrations of saponins in the extract based on the desired therapeutic efficacy. The recited range would have been an obvious variant over the concentration taught by Marker ’43 unless there is evidence of criticality or unexpected results.
Response to Arguments
Applicant’s arguments (Pages 6-8, filed 11/17/25) with respect to the rejection of claims 1-4, 7-11, 15-18, and 20 under 35 U.S.C. 103 as being unpatentable over Bafundo in view of Marker ’43 and Marker ’47 have been fully considered but are not persuasive.
Please note that in the previous Office Action (mailed 08/15/25) there was an inadvertent typo regarding the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4), and the sapogenins manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47 (Page 2403, formulae and Page 2404 - Summary). The Office Action inadvertently identified the sapogenins as saponins.
Applicant argues that there is nothing in Bafundo to suggest that Hesperaloe would be a suitable candidate to replace Yucca or Quillaja without the use of hindsight. Applicant argues that there is nothing in Bafundo to suggest that Hesperaloe would be a suitable candidate for a high yield saponin extract.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the rationale to combine the teachings of Bafundo with those of Marker ’43 and Marker ’47 is based on the fact that both Hesperaloe and Yucca contain the same sapogenins, which are taught by Marker ’43 (Pages 1207-1208, sections 3 and 4). One of ordinary skill in the art would have found it obvious to use various sources of the saponins, including both Hesperaloe and Yucca, in the method of Bafundo with a reasonable expectation of success in effectively enhancing the immune response of the chickens.
Applicant argues that “Marker '43 and Maker '47 disclose steroidal sapogenins from Yucca and Agave. In contrast, the present claims are directed to a composition comprising saponins. Saponins and sapogenins are different things … for clarity the structures of an example sapogenin (in this case manogenin) is shown together with an example saponin (Figure 2C from the present application)” (emphasis original).
The Examiner acknowledges that saponins and sapogenins are different. As noted above, there was an inadvertent typo regarding saponins and sapogenins in the last Office Action. One of ordinary skill in the art would have found it obvious to substitute the yucca extract which contains saponins, and quillaja extract which contains saponins (Page 40, lines 4-10, Examples 2-8 – Page 22, line 18 to Page 36, line 6), as taught by Bafundo, in view of the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4), and the sapogenins manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47 (Page 2403, formulae and Page 2404 - Summary). One of ordinary skill in the art would have known that the sapogenins taught by Marker ’43 and Marker ’47 are from the saponins in both Hesperaloe and Yucca, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4), and from Hesperaloe, as taught by Marker ’47 (Page 2403, formulae and Page 2404 - Summary). Furthermore, instant claim 4 also recites that the at least one saponin comprises the sapogenins which are disclosed by Marker ’43 and Marker ’47. Since the same sapogenins from the same source plant, i.e., Hesperaloe, are taught, the same saponins are naturally also taught by the art.
Regarding instant claims 9 and 18, Applicant argues that Bafundo, Marker '43, and Marker '47 do not teach or suggest a composition or an immunomodulator comprising at least one saponin extracted from a non-woody plant of the genus Hesperaloe and thus, do not teach or suggest each and every limitation of claims 9 or 18.
This is not persuasive because Bafundo teaches the method of treating coccidiosis and enhancing the immune response in chickens by using a basal animal feed, the plant extracts which contain saponins, i.e., yucca extract and quillaja extract which contain saponins, wherein the chicken are challenged by adding coccidian E. acervulina, E. maxima or E. tenella to the feed (Page 40, lines 4-10, Examples 2-8 – Page 22, line 18 to Page 36, line 6). One of ordinary skill in the art would have found it obvious to use various plant sources of saponins in the method taught by Bafundo. One of ordinary skill in the art would have found it obvious to use saponins which contain gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4), and the saponins which contain manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47 (Page 2403, formulae and Page 2404 - Summary), and have a reasonable expectation of success in following the method of treating coccidiosis and enhancing the immune response in chickens of Bafundo.
Therefore, the rejection of 08/15/25 is maintained.
Claim Rejections - 35 USC § 103
Claims 5, 13, 19, and 21 are again rejected under 35 U.S.C. 103 as being unpatentable over Bafundo et al. (WO 2015/179840 A1 – “Bafundo”) in view of Marker et al. (J Am Chem Soc. 1943, 65, 6, 1199-1209 – “Marker ‘43”) and Marker et al. (J Am Chem Soc. 1947 69, 10, 2403-2404 – “Marker ‘47”), as applied to claims 1-4, 7-11, 15-18, and 20 above, in view of Simmons-Boyce et al. (Natural Product Communications Vol. 2 (1) 2007, pages 99-114 – “Simmons-Boyce”).
Instant claim 5 is drawn to the method of claim 1 wherein the at least one saponin is 25(27)-dehydrofucreastatin, 5(6),25(27)-disdehydroyuccaloiside, 5(6)-disdehydroyuccaloiside, furcreastatin or yuccaloiside.
Bafundo, Marker ’43, and Marker ’47 do not expressly teach the saponins recited in instant claim 5.
Simmons-Boyce teaches that yucca contains yuccaloeside C (Pages 110-112 – under the section “Yucca”), and both yuccaloeside C and furcreastatin isolated from F. selloa cv marginata and F. foetida (Page 103, under “Furcraea”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of treating coccidiosis and enhancing the immune response in chickens by using a basal animal feed, yucca extract which contains saponins, and quillaja extract which contains saponins, wherein the chicken are challenged by adding coccidian E. acervulina, E. maxima or E. tenella to the feed, as taught by Bafundo, in view of the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43, the sapogenins manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47, and further in view of the yuccaloiside and furcreastatin, as taught by Simmons-Boyce, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do this because Bafundo, Marker ’43, and Marker ’47 teach the extracts of yucca and Simmons-Boyce teaches that extracts of yucca contain yuccaloiside. One of ordinary skill in the art would have found it obvious to combine the yucca extracts with other extracts such as the furcreastatin since F. selloa contains both yuccaloeside C and furcreastatin, as taught by Simmons-Boyce (Page 103, under “Furcraea”).
Regarding instant claims 5, 13, 19, and 21, the limitations of the saponins would have been obvious over the yuccaloeside C (Pages 110-112 – under the section “Yucca”), and both yuccaloeside C and furcreastatin isolated from F. selloa cv marginata and F. foetida (Page 103, under “Furcraea”), as taught by Simmons-Boyce. One of ordinary skill in the art would have found it obvious to include various saponins contained in the extracts taught by Bafundo, Marker ’43, Marker ’47, and Simmons-Boyce.
Response to Arguments
Applicant’s arguments (Pages 8-9, filed 11/17/25) with respect to the rejection of claims 5, 13, 19, and 21 under 35 U.S.C. 103 as being unpatentable over Bafundo in view of Marker ’43, Marker ’47, and Simmons-Boyce have been fully considered but are not persuasive.
Applicant argues that Simmons-Boyce fails to disclose or suggest an extract from a non-woody plant of the genus Hesperaloe comprising at least one saponin as recited in claims 1, 9, and 18.
This is not persuasive because both Hesperaloe and Yucca contain the same sapogenins, which are taught by Marker ’43 (Pages 1207-1208, sections 3 and 4). One of ordinary skill in the art would have found it obvious to use various sources of the saponins, including Hesperaloe, in the method of Bafundo with a reasonable expectation of success in effectively enhancing the immune response of the chickens.
Simmons-Boyce is relied upon to cure the deficiency regarding the specific saponins recited in instant claim 5. One of ordinary skill in the art would have found it obvious to combine the teachings of Bafundo, Marker ’43, Marker ’47, and Simmons-Boyce since all the references teach extracts of yucca and Simmons-Boyce teaches that extracts of yucca contain yuccaloiside. One of ordinary skill in the art would have found it obvious to combine the yucca extracts with other extracts such as the furcreastatin since F. selloa contains both yuccaloeside C and furcreastatin, as taught by Simmons-Boyce (Page 103, under “Furcraea”).
Therefore, the rejection of 08/15/25 is maintained.
Claim Rejections - 35 USC § 103
Claims 23-27 are again rejected under 35 U.S.C. 103 as being unpatentable over Bagi et al. (EP 3 056 214 B1 – “Bagi”) in view of Bafundo et al. (WO 2015/179840 A1 – “Bafundo”) and Marker et al. (J Am Chem Soc. 1943, 65, 6, 1199-1209 – “Marker ‘43”).
Instant claim 23 is drawn to an immunogenic or a vaccine composition against coccidiosis, infectious bronchitis, infectious bursal disease, laryngotracheitis, Marek's disease or Newcastle disease in a chicken comprising: at least one parasite, microorganism, antigen, immunogen, epitope, or vaccine; and an adjuvant comprising from 1 to about 50 μg of total saponin extracted from Hesperaloe.
Bagi discloses a vaccine composition comprising E. maxima protein (as antigen), Quil A (saponin fraction from Quillaja saponaria molina) and PBS (phosphate buffered saline ([0116]) (pharmaceutically effective carrier), wherein each 1 ml of the composition comprises 20 μg of saponins ([0187]), and a method of treating coccidiosis in chickens by using the same (Example 16). Bagi also discloses a method of enhancing an adaptive immune response by using a vaccine composition comprising Quil A (Examples 14-16 and 22).
Bagi does not expressly teach that the saponin fraction is extracted from Hesperaloe rather than Quillaja.
Bafundo discloses a method of treating coccidiosis and enhancing the immune response in chickens by using a basal animal feed, yucca extract which contains saponins, and quillaja extract which contains saponins, wherein the chicken are challenged by adding coccidian E. acervulina, E. maxima or E. tenella to the feed (Page 40, lines 4-10, Examples 2-8 – Page 22, line 18 to Page 36, line 6). Bafundo also discloses the use of the composition comprising the yucca extract and quillaja extract in combination of a coccidiosis vaccine in treating coccidiosis and enhancing the immune response (Example 3 and Example 7). The coccidiosis vaccine disclosed by Bafundo comprises oocysts derived from Eimeria, and the yucca extract and quillaja extract, along with the composition of the coccidiosis vaccine, are admixed with a feedstuff to form an admixed composition (Page 37, lines 16-20 and 29-34).
Marker ’43 teaches that the saponins gitogenin and tigogenin exist in both Hesperaloe and Yucca (Pages 1207-1208, sections 3 and 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a vaccine composition comprising E. maxima protein (as antigen), Quil A (saponin fraction from Quillaja saponaria molina) and PBS (pharmaceutically effective carrier), wherein each 1 ml of the composition comprises 20 μg of saponins, and a method of treating coccidiosis in chickens by using the same, as taught by Bagi, in view of the method of treating coccidiosis and enhancing the immune response in chickens by using a basal animal feed, yucca extract which contains saponins, and quillaja extract which contains saponins, wherein the chicken are challenged by adding coccidian such as E. maxima to the feed, as taught by Bafundo, further in view of the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do this because both Hesperaloe and Yucca contain the same saponins and sapogenins, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4). One of ordinary skill in the art would have found it obvious to use various sources of the saponins, including Hesperaloe, Yucca, and Quillaja, as taught by Bagi and Bafundo, in the vaccine composition of Bagi with a reasonable expectation of success in effectively enhancing the immune response of the chickens.
Regarding instant claim 23, the limitation of an immunogenic or a vaccine composition against coccidiosis, infectious bronchitis, infectious bursal disease, laryngotracheitis, Marek's disease or Newcastle disease in a chicken comprising: at least one parasite, microorganism, antigen, immunogen, epitope, or vaccine; and an adjuvant comprising from 1 to about 50 μg of total saponin extracted from Hesperaloe would have been obvious over the vaccine composition comprising E. maxima protein (as antigen), Quil A (saponin fraction from Quillaja saponaria molina) and PBS (pharmaceutically effective carrier), wherein each 1 ml of the composition comprises 20 μg of saponins ([0187]), a method of treating coccidiosis in chickens by using the same (Example 16), and a method of enhancing an adaptive immune response by using a vaccine composition comprising Quil A (Examples 14-16 and 22), as taught by Bagi, in view of the method of treating coccidiosis and enhancing the immune response in chickens by using a basal animal feed, yucca extract which contains saponins, and quillaja extract which contains saponins, wherein the chicken are challenged by adding coccidian E. acervulina, E. maxima or E. tenella to the feed (Page 40, lines 4-10, Examples 2-8 – Page 22, line 18 to Page 36, line 6), and the use of the composition comprising the yucca extract and quillaja extract in combination of a coccidiosis vaccine in treating coccidiosis and enhancing the immune response (Example 3 and Example 7), as taught by Bafundo, further in view of the same saponins, gitogenin and tigogenin extracted from both Hesperaloe and Yucca (Pages 1207-1208, sections 3 and 4), as taught by Marker ’43.
Regarding instant claim 24, the limitation of a pharmaceutically effective carrier would have been obvious over the PBS ([0116] and [0187]), as taught by Bagi.
Regarding instant claim 25, the limitation of a coccidiosis vaccine would have been obvious over the vaccine composition for treating avian coccidiosis (Example 16), as taught by Bagi, and by the coccidiosis vaccine (Example 3 and Example 7), as taught by Bafundo.
Regarding instant claim 26, the limitation of the coccidiosis vaccine comprising one or more strains of E. acervulina, E. maxima, E. mitis, and E. tenella would have been obvious over the vaccine composition comprising E. acervulina, E. maxima, E. mitis, and E. tenella ([0181]), as taught by Bagi.
Regarding instant claim 27, the limitation of Marek’s disease vaccine would have been obvious over the vaccine composition comprising Marek’s disease virus and Newcastle disease virus ([0087]), as taught by Bagi.
Response to Arguments
Applicant’s arguments (Page 9, filed 11/17/25) with respect to the rejection of claims 23-27 under 35 U.S.C. 103 as being unpatentable over Bagi in view of Bafundo and Marker ’43 have been fully considered but are not persuasive.
Applicant argues that Bagi fails to disclose or suggest an immunogenic or a vaccine composition comprising an adjuvant comprising from 1 to about 50 μg of total saponin extracted from Hesperaloe as recited in claim 23; and Bagi fails to disclose or suggest an extract from a non-woody plant of the genus Hesperaloe, but rather teaches a composition extracted from Quillaja. Applicant argues that Bafundo and Marker '43 both fail to disclose or suggest an extract from a non-woody plant of the genus Hesperaloe and thus, do not teach or suggest each and every limitation of claim 23.
This is not persuasive because although Bagi teaches a saponin fraction from Quillaja and does not expressly teach that the saponin fraction is extracted from Hesperaloe, both Hesperaloe and Yucca contain the same saponins and sapogenins, as taught by Marker ’43 (Pages 1207-1208, sections 3 and 4). One of ordinary skill in the art would have found it obvious to use various sources of the saponins, including Hesperaloe, Yucca, and Quillaja, as taught by Bagi and Bafundo, in the vaccine composition of Bagi with a reasonable expectation of success in effectively enhancing the immune response of the chickens.
Therefore, the rejection of 08/15/25 is maintained.
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 1-26 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 5, 6, 8-14, and 18-21 of U.S. Patent No. 12,576,098 B2 (“the ‘098 Patent”).
Please note that this rejection is updated since Application No. 18/011,326 (the ‘326 Application) issued as US Patent No. 12,576,098 B2 on 03/17/26.
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of enhancing the immune response in a non-human animal, a method of treating coccidiosis in poultry, a method of enhancing an adaptive immune response in a non-human animal, and immunogenic or a vaccine composition against coccidiosis, comprising the steps of administering to a non-human animal an immunogenically effective amount of an extract from a non-woody plant of the genus Hesperaloe comprising at least one saponin, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘098 Patent recites an immunological composition whereas instant claim 23 recites an immunogenic composition. However, one of ordinary skill in the art would have known that the compositions recited in both instant claims and claims of the ‘098 Patent comprise the same antigens and the same saponins extracted from Hesperaloe, and therefore both compositions would elicit immunological responses.
Another difference is that claim 1 of the ‘098 Patent recites that water soluble solids (in the extract) comprise at least 5 wt.% saponin, whereas instant claims don’t recite this limitation. However, instant claims recite the transitional phrase “comprising” which is considered open language and allows the inclusion of components and their corresponding concentrations, such as the water soluble solids comprising at least 5 wt.% saponin.
Therefore, instant claims are obvious over claims of the ‘098 Patent, and they are not patentably distinct over each other.
Response to Arguments
Applicant’s arguments (Page 10, filed 11/17/25) with respect to the provisional rejection of claims 1-26 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3, 5, 6, 8-14, 17, and 23-29 of copending Application No. 18/011,326 (the ‘326 Application) have been fully considered but are not persuasive.
Applicant’s statement regarding the Notice of Allowance for the ‘326 Application is acknowledged. However, as noted above, this rejection was updated since Application No. 18/011,326 (the ‘326 Application) issued as US Patent No. 12,576,098 B2 on 03/17/26.
Applicant’s statement that they are prepared to file a terminal disclaimer (TD) upon indication of allowable subject matter in the present application is also acknowledged.
However, since Applicant did not point out any deficiencies and since a terminal disclaimer has not yet been filed, the provisional double patenting rejection of 08/15/25 is maintained for the reasons explained above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on 571-272-6023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARADHANA SASAN/Primary Examiner, Art Unit 1615
Prosecution Insights