DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s amendment submitted on 5/13/2026 is acknowledged.
Applicant’s election of Invention I, which encompasses claims 1-7 and 15-17, without traverse in the reply filed on 10/23/2023 is acknowledged.
Claims 8-14 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 without traverse in the reply filed on 10/23/2023.
Claims 1-7 and 15-17 are under examination on the merits.
Rejections Removed
The following rejections and objections are withdrawn due to amendment or a granted terminal disclaimer:
35 U.S.C. §103: The previous rejection of Claims 1-7 and 15-17 under 35 U.S.C. 103 as being unpatentable over Starzl (US PGPub 20120141458 A1, filed 11/22/2011, published 6/7/2012; hereinafter referred to as “Starzl”) in view of Sharma, et al. (Journal of Applied Microbiology, Volume 121, Issue 2, 1 August 2016, Pages 309–319; hereinafter referred to as “Sharma, et al.”), Yonezawa, et al. (Biomed Res Int. 2015;2015:914791. PMID: 26078970; hereinafter referred to as “Yonezawa”), Zhang, et al. (Infect Immun. 2019 Feb 21;87(3):e00619-18. doi: 10.1128/IAI.00619-18. PMID: 30559219; hereinafter referred to as “Zhang”) and Elemental Impurities Analysis (ThermoFisher Scientific, 4-page printout, published 3/10/2019, https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pharma-biopharma-learning-center/pharmaceutical-qa-qc-information/elemental-impurities-information.html, retrieved from WayBack machine; hereinafter referred to as “ThermoFisher”) is withdrawn due to the amendment of the claims.
Double Patenting: The previous rejection of Claims 1-7 and 15-17 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 15, and 17 of copending Application No. 19/341,976 (PGPub US20260021179, filed 9/26/2025, claimed priority date 10/3/2018; hereinafter referred to as “’976”) in view of Starzl (supra) as evidenced by Sharma (supra) and Yonezawa (supra), Zhang (supra) and ThermoFisher (supra) is withdrawn due to the amendment of the claims.
Claim Interpretation
The disclosure does not define “treating”, so in applying the broadest reasonable interpretation to the term, “treating” is being interpreted as only treating infection, and not preventing infection.
New Objections
Claim Objections
Claims 1 and 15 are objected to because of the following informalities: the claims contain a typographical mistake “less than 0.001ppm” on lines 7. Instead, the claims should recite “less than 0.001 ppm”. Appropriate correction is required.
New Rejections
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.
(New Rejection Necessitated by Amendment) Claims 1-7 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Starzl (US PGPub 20120141458 A1, filed 11/22/2011, published 6/7/2012; hereinafter referred to as “Starzl”) in view of Sharma, et al. (Journal of Applied Microbiology, Volume 121, Issue 2, 1 August 2016, Pages 309–319; hereinafter referred to as “Sharma, et al.”), Yonezawa, et al. (Biomed Res Int. 2015;2015:914791. PMID: 26078970; hereinafter referred to as “Yonezawa”), Zhang, et al. (Infect Immun. 2019 Feb 21;87(3):e00619-18. doi: 10.1128/IAI.00619-18. PMID: 30559219; hereinafter referred to as “Zhang”), Elemental Impurities Analysis (ThermoFisher Scientific, 4-page printout, published 3/10/2019, https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pharma-biopharma-learning-center/pharmaceutical-qa-qc-information/elemental-impurities-information.html, retrieved from WayBack machine; hereinafter referred to as “ThermoFisher”), Hashemi, et al. (Environ Monit Assess. 2018. 190:540. https://doi.org/10.1007/s10661-018-6811-3), and Tammam, et al. (J. Food and Dairy Sci. Vol. 3 (12):715-723, 2012).
The claimed invention encompasses a composition for treatment of mucosal infection in an animal by application to a mucous membrane, the composition comprising, a mixture of IgY antibodies specific for a plurality of antigens obtained from a plurality of organisms, wherein the plurality of organisms can cause infection of the mucous membrane, and wherein the mixture is tested to be safe for ingestion by the animal, with a tested mercury content of less than 0.001 ppm; and a protective matrix comprising non-hyperimmune colostrum combined with the mixture of IgY antibodies, wherein the protective matrix comprises at least 20% by weight of the composition.
Starzl teaches compositions and methods for immunizations, wherein a specific binding molecule, such as a specific immunoglobulin, is combined with a carrier matrix to provide a composition for oral or mucosal administration for management of microorganisms, including treatment or prophylaxis of a pathogenic infection (Abstract; para. [0013]). These infections may be pathogenic infections of mucosal membranes (para. [0194]). Starzl also teaches that the specific binding molecule can be IgY antibodies, and an example of the matrix that can harbor the antibodies can be bovine colostrum (paras. [0014]-[0015] and [0027]), or specifically non-hyperimmune colostrum (paras. [0155] and [0160]). Starzl further teaches that the specific molecules bind to a pathogen, or pathogen’s toxin, adhesion element, or combination thereof, and the pathogen may be an enteric or gastrointestinal pathogen that causes gastroenteritis (para. [0018]). The pathogen may be one or a combination of human or veterinary pathogens, including adenovirus, parasitic organisms, fungal organisms, Escherichia coli, Candida albicans, Yersinia enterocolitica, Salmonella typhimurium, Clostridium difficile, Mycoplasma spp., Streptococcus spp., Clostridium perfringens, and Helicobacter pylori (paras. [0019], [0128], [0130] & [0142]; claim 6). Additionally, the pathogen may be one or a combination of human or veterinary pathogens that cause gastroenteritis (claim 5; para. [0130]). Starzl also teaches immunization of chickens with mixed antigens preparations to obtain mixed antigen-specific IgY from their eggs (paras. [0106]-[0112]). Further, Starzl teaches its composition may comprise equivalent weight amount of dried immune egg product co-packaged with specific weight amount of commercial dried non-hyperimmune bovine colostrum, such as 0.5 to 3g of dried immune egg product to a single dose packet with 1 to 5g of dried colostrum added to the same packet (para. [0197]). Starzl teaches that its compositions may be administered in solid form, as a powder in suspension, as a liquid, a spray, an or an aerosol (paras. [0169], [0170], [0182], [0183] & [0185]). Starzl indicates its compositions may provide safe and effective treatments (para. [0245]). Sharma, et al. provides evidence that Escherichia coli forms biofilms (Sharma, generally), and Starzl teaches that its compositions can be directed against Escherichia coli. Yonezawa provides evidence that Helicobacter pylori forms biofilms (Yonezawa, generally), and Starzl teaches that its compositions can be directed against Helicobacter pylori. Therefore, a mixture of IgY antibodies specific for a plurality of antigens obtained from a plurality of organisms that cause infection of a mucous membrane or form biofilms, and a protective matrix comprising non-hyperimmune colostrum combined with the mixture of IgY antibodies, wherein the protective matrix comprises at least 20% by weight of the composition would have been obvious before filing.
However, Starzl does not teach testing of the mixture to be safe for ingestion by the animal, with a tested mercury content of less than 0.001 ppm, as required by the instant claims.
Zhang discloses that IgY has attracted much attention as a strategy to prevent and control infectious diseases, and that passive immunity using specific IgY is an effective protective approach against bacterial infections in poultry (p. 9, para. 1). Additionally, Zhang discloses that IgY has been administered by the intravenous, intramuscular, and oral (in the feed) routes (p. 9, para. 1). Zhang teaches IgY from vaccinated chicken egg yolks protected chickens against Gallibacterium anatis infection (Abstract; Fig. 5). Zhang also specifically discloses that prior to application, sterility testing of IgY antibody is performed to confirm there is no bacterial growth on lysogeny broth (LB) agar, to ensure safe IgY application without any bacterial contamination (p. 5, para. 2).
ThermoFisher teaches that for over 100 years, regulators have demanded the testing of heavy metal impurities in pharmaceutical products, monitoring a range of metal elemental pharmaceutical materials, including Cd, Pb, As, Hg, Co, V, Ni, Ti, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt, Li, Sb, Ba, Mo, Cu, Sn, and Cr (p. 1, para. 2; p. 1, para. 7; p. 2, table). ThermoFisher also explains that elemental impurities in pharmaceutical formulations can interfere with drug efficacy or even elicit a direct toxic effect on the patient (p. 1, para. 1). ThermoFisher further discloses that elemental impurities in pharmaceutical formulations can come from catalysts, formulation ingredients, and process vessels (p. 1, para. 1).
Hashemi discloses the assessment of both strain and feed intake on trace element depositions in eggs, including toxic heavy metal concentration (Abstract). Hashemi also discloses that trace elements may be classified into different groups, and mercury is among the non-essential, toxic trace elements (p. 2, col. 1). Additionally, Hashemi discloses that researchers have focused on the trace element assessment of egg (p. 2, col. 2). Hashemi teaches testing for detection of toxic trace elements: lead (Pb), chromium (Cr), arsenic (As), cadmium (cd), nickel (Ni), and mercury (Hg) in eggs using Inductively Coupled Plasma Mass Spectrometry (ICP-OES; p. 3, col. 1), and that Mercury concentration in all samples was below the instrument detection limit (p. 9, col. 1). Hashemi performed the detection assay on egg white, yolk, and whole eggs of a number of strains of chickens (Tables 3-5).
Tammam discloses testing of heavy metals in colostrum and dairy products, and found that cows colostrum had a mercury level of 0.0003 ppm of mercury (Abstract). Tammam also discloses that heavy metals are recognized as cumulative toxic substances due to low elimination rates from the body and not being able to be metabolized, thus they persist in the body and exert toxic effects, resulting in serious health hazards, depending on their levels of contamination.
It would have been obvious to one of ordinary skill in the art to test the IgY and colostrum compositions taught by Starzl for safety by the methods disclosed by ThermoFisher, Zhang, Hashem, and Tammam. Starzl discloses combination of IgY antibodies, which can be specific for a plurality of antigens from a plurality of organisms that can cause infection of a mucous membrane. Starzl also discloses testing the mixture for safety, and the combination of IgY with bovine colostrum at certain proportions, including 0.5 to 3g of dried immune egg product combined with 1 to 5g of dried colostrum, which would result in at least 20% colostrum by weight. Zhang teaches testing of IgY compositions prior to use, to ensure safety. ThermoFisher discloses that for over 100 years regulators have demanded the testing of heavy metal impurities in pharmaceutical products, monitoring a range of metal elemental pharmaceutical materials, including Cd, Pb, As, Hg, Co, V, Ni, Ti, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt, Li, Sb, Ba, Mo, Cu, Sn, and Cr. ThermoFisher also explains that elemental impurities in pharmaceutical formulations can interfere with drug efficacy or even elicit a direct toxic effect on the patient. Hashemi discloses that eggs can contain toxic trace elements and testing therefore, including for Mercury. Tammam discloses testing of cow colostrum for mercury levels, and found a level of 0.0003 ppm mercury.
The determination of whether a preamble limits a claim is made on a case-by-case basis in light of the facts in each case; there is no litmus test defining when a preamble limits the scope of a claim. Catalina Mktg. Int’l v. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (Fed. Cir. 2002). MPEP §2111.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). "[W]here a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation." Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). MPEP §2111.02(II). In the instant case, the preambles of claims 1 and 15 are merely intended uses of the compositions, for treatment of mucosal infection in an animal by application to a mucous membrane and for therapeutic treatment of biofilms, respectively. The preambles are not given patentable weight; however, even if they were, since all structural feature of the claimed composition are in the obvious composition here, the intended uses would be doable as they flow inherently from the composition structure. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, the treatment requirements of claims 15 and 1 will necessarily occur.
As demonstrated by ThermoFisher, Hashemi, and Tammam, mercury levels in pharmaceuticals, eggs, and cow colostrum specifically are result effective variables. It would have been obvious to one of ordinary skill in the art to optimize the testing to reach a safe level of harmful substances like mercury. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
One of ordinary skill in the art would have been motivated to provide IgY and non-hyperimmune colostrum compositions effective for treating mucosal infections in an animal by application to a mucous membrane and biofilms. Additionally, it would have been obvious to ensure that the mercury content is less than 0.001 ppm, because Hashemi and Tammam report lower levels than that in chicken eggs and bovine colostrum, respectively. It is equally obvious to test the colostrum, the IgY, and the combination thereof for mercury contamination, due to the negative health effects associated with mercury. There would be a reasonable expectation of success because testing for heavy metals, and mercury specifically below a threshold of 0.001 ppm, in pharmaceuticals, is known in the prior art, as disclosed by ThermoFisher and Tammam, and Starzl indicates its compositions may provide safe and effective treatments. Therefore, claims 1-7 and 15-17 were prima facie obvious before the priority date of the instant invention.
Although Applicant’s arguments were directed to the prior rejection under 35 U.S.C. §103, the arguments relevant to the new rejection are not persuasive and will be addressed below.
Applicant presents the following arguments:
Applicant describes the teachings of the cited references Starzl, Sharma, Yonezawa, Zhang, and ThermoFisher.
Claims 1 and 15 have been amended to address these rejections. Specifically, the amendments to claims 1 and 15 specify that a tested mercury content in the composition is less than 0.001 ppm. This limitation is not disclosed by any of the references, either alone or in combination. For example, while Zhang discloses testing for harmful microbial contents and ThermoFisher discloses testing for heavy metals, both references are silent with respect to a tested mercury content range.
Applicant’s arguments are unpersuasive because:
The new references Hashemi and Tammam disclose testing for mercury in eggs and cow colostrum and other dairy products, respectively which demonstrates that persons of ordinary skill in the art are concerned with mercury content in eggs and colostrum. As described in the rejection under 35 U.S.C. §103 above, mercury levels in a pharmaceutical composition is a result effective variable, and it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable.
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.
(New Rejection Necessitated by Amendment) Claims 1-7 and 15-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 15, and 17 of copending Application No. 19/341,976 (PGPub US20260021179, filed 9/26/2025, claimed priority date 10/3/2018; hereinafter referred to as “’976”) in view of Starzl (US PGPub 20120141458 A1, filed 11/22/2011, published 6/7/2012; hereinafter referred to as “Starzl”) in view of Sharma, et al. (Journal of Applied Microbiology, Volume 121, Issue 2, 1 August 2016, Pages 309–319; hereinafter referred to as “Sharma, et al.”), Yonezawa, et al. (Biomed Res Int. 2015;2015:914791. PMID: 26078970; hereinafter referred to as “Yonezawa”), Zhang, et al. (Infect Immun. 2019 Feb 21;87(3):e00619-18. doi: 10.1128/IAI.00619-18. PMID: 30559219; hereinafter referred to as “Zhang”), Elemental Impurities Analysis (ThermoFisher Scientific, 4-page printout, published 3/10/2019, https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pharma-biopharma-learning-center/pharmaceutical-qa-qc-information/elemental-impurities-information.html, retrieved from WayBack machine; hereinafter referred to as “ThermoFisher”), Hashemi, et al. (Environ Monit Assess. 2018. 190:540. https://doi.org/10.1007/s10661-018-6811-3), and Tammam, et al. (J. Food and Dairy Sci. Vol. 3 (12):715-723, 2012). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant set of claims is drawn to a composition for treatment of an infected animal, comprising a mixture of IgY antibodies specific for a plurality of antigens obtained from a plurality of organisms, wherein the mixture is tested to be safe for animal ingestion, with a tested mercury content of less than 0.001 ppm, and a protective matrix that comprises at least 20% by weight of the composition. The claims differ in that the instant application is drawn to a composition with the intended use of treating a mucosal infection, and is applied to a mucous membrane (claims 1-7) or a composition for therapeutic treatment of biofilms (claims 15-17), whereas the copending Application has the intended use of treatment or prevention of diarrhea or enteric infection in animals (copending claims 1-7, 15, and 17). The claimed invention (see claim 1 of the instant invention) recites an intended use of "for treatment of mucosal infection in an animal by application to a mucous membrane", or “for therapeutic treatment of biofilms” (see claim 15 of the instant invention). The MPEP § 2111.02 (II) recites, "If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction." Therefore, if the other claimed invention (‘976) in view of secondary references teaches the structural requirements of the claimed composition of the instant invention, it is interpreted to render obvious said composition.
The claims also differ in that the protective matrix of the instant application comprises non-hyperimmune colostrum, whereas the copending Application's protective matrix is more generic, being a protein derived from a non-hyperimmune animal source, and does not specifically include a colostrum limitation. Additionally, the claim sets differ in that the instant application has embodiments related to the administration form of the composition (e.g., solid, powder suspended liquid, etc.; claim 5), whereas the copending Application does not.
Starzl teaches compositions and methods for immunizations, wherein a specific binding molecule, such as a specific immunoglobulin, is combined with a carrier matrix to provide a composition for oral or mucosal administration for management of microorganisms, including treatment or prophylaxis of a pathogenic infection (Abstract; para. [0013]). These infections may be pathogenic infections of mucosal membranes (para. [0194]). Starzl also teaches that the specific binding molecule can be IgY antibodies, and an example of the matrix that can harbor the antibodies can be bovine colostrum (paras. [0014]-[0015] and [0027]), or specifically non-hyperimmune colostrum (para. [0160]). Starzl further teaches that the specific molecules bind to a pathogen, or pathogen's toxin, adhesion element, or combination thereof, and the pathogen may be an enteric or gastrointestinal pathogen that causes gastroenteritis (para. [0018]). The pathogen may be one or a combination of human or veterinary pathogens, including adenovirus, parasitic organisms, fungal organisms, Escherichia coli, Candida albicans, Yersinia enterocolitica, Salmonella typhimurium, Clostridium difficile, Mycoplasma spp., Streptococcus spp., Clostridium perfringens, and Helicobacter pylori (paras. [0019], [0128], [0130] & [0142]; claim 6). Additionally, the pathogen may be one or a combination of human or veterinary pathogens that cause gastroenteritis (claim 5; para. [0130]). Starzl also teaches immunization of chickens with mixed antigens preparations to obtain mixed antigen-specific IgY from their eggs (paras. [0106]-[0112]). Starzl teaches that its compositions may be administered in solid form, as a powder in suspension, as a liquid, a spray, an or an aerosol (paras. [0169], [0170], [0182], [0183] & [0185]). Starzl indicates its compositions may provide safe and effective treatments (para. [0245]). Sharma, et al. provides evidence that Escherichia coli forms biofilms (Sharma, generally), and Starzl teaches that its compositions can be directed against Escherichia coli. Yonezawa provides evidence that Helicobacter pylori forms biofilms (Yonezawa, generally), and Starzl teaches that its compositions can be directed against Helicobacter pylori.
Another difference in the instant and copending claims is that the instant claims require the mixture is tested to be safe for ingestion by the animal with a tested mercury content of less than 0.001 ppm, whereas the copending application merely requires the mixture is tested to be safe for animal ingestion.
Zhang discloses that IgY has attracted much attention as a strategy to prevent and control infectious diseases, and that passive immunity using specific IgY is an effective protective approach against bacterial infections in poultry (p. 9, para. 1). Additionally, Zhang discloses that IgY has been administered by the intravenous, intramuscular, and oral (in the feed) routes (p. 9, para. 1). Zhang teaches IgY from vaccinated chicken egg yolks protected chickens against Gallibacterium anatis infection (Abstract; Fig. 5). Zhang also specifically discloses that prior to application, sterility testing of IgY antibody is performed to confirm there is no bacterial growth on lysogeny broth (LB) agar, to ensure safe IgY application without any bacterial contamination (p. 5, para. 2).
ThermoFisher teaches that for over 100 years, regulators have demanded the testing of heavy metal impurities in pharmaceutical products, monitoring a range of metal elemental pharmaceutical materials, including Cd, Pb, As, Hg, Co, V, Ni, Ti, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt, Li, Sb, Ba, Mo, Cu, Sn, and Cr (p. 1, para. 2; p. 1, para. 7; p. 2, table). ThermoFisher also explains that elemental impurities in pharmaceutical formulations can interfere with drug efficacy or even elicit a direct toxic effect on the patient (p. 1, para. 1). ThermoFisher further discloses that elemental impurities in pharmaceutical formulations can come from catalysts, formulation ingredients, and process vessels (p. 1, para. 1).
Hashemi discloses the assessment of both strain and feed intake on trace element depositions in eggs, including toxic heavy metal concentration (Abstract). Hashemi also discloses that trace elements may be classified into different groups, and mercury is among the non-essential, toxic trace elements (p. 2, col. 1). Additionally, Hashemi discloses that researchers have focused on the trace element assessment of egg (p. 2, col. 2). Hashemi teaches testing for detection of toxic trace elements: lead (Pb), chromium (Cr), arsenic (As), cadmium (cd), nickel (Ni), and mercury (Hg) in eggs using Inductively Coupled Plasma Mass Spectrometry (ICP-OES; p. 3, col. 1), and that Mercury concentration in all samples was below the instrument detection limit (p. 9, col. 1). Hashemi performed the detection assay on egg white, yolk, and whole eggs of a number of strains of chickens (Tables 3-5).
Tammam discloses testing of heavy metals in colostrum and dairy products, and found that cows colostrum had a mercury level of 0.0003 ppm of mercury (Abstract).
It would have been obvious to one of ordinary skill in the art that colostrum could be used as the protective protein matrix in the copending Application, because the colostrum of Starzl is an example of a protective matrix comprising protein that is derived from a non-hyperimmune animal source. Instant claim 5 would also have been obvious to one of ordinary skill in the art in view of Starzl because Starzl teaches that the compositions may be administered in solid form, as a powder in suspension, as a liquid, a spray, an or an aerosol. Further, the mixture being tested to be safe for ingestion by the animal with a tested mercury content of less than 0.001 ppm, because ‘976 requires the mixture is tested to be safe for animal ingestion, Zhang teaches testing of IgY compositions for safety, ThermoFisher teaches that regulators have demanded testing of heavy metal impurities in pharmaceutical products for 100 years, due to elemental impurities interfering with drug efficacy or eliciting a direct toxic effect, Hashemi teaches testing of toxic trace elements, including mercury, in chicken eggs at an undetectable level, and Tammam discloses testing of heavy metals in colostrum and dairy products, and found that cows colostrum had a mercury level of 0.0003 ppm of mercury (Abstract).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey Sifford whose telephone number is 571-272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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, Michael Allen can be reached on 571-270-3497. 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.
/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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