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 .
Applicants arguments filed 10/21/2025 has been entered. Claims 37, 56, 65, 66, 72 and 73 were amended. Claims 37, 39, 56, 57, 59, 60 and 62-75 are pending.
Withdrawn rejections
Applicant's amendments and arguments filed 10/21/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn.
Applicants amendment has necessitated new rejections.
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 37, 39, 56, 57 and 62-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 9, 12-15 and 21-28 of copending Application No. 17/524,709 (herein ‘709). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to a method of improving growth performance by orally administering a feed composition comprising an antimicrobial clay whereas the copending application ‘709 teaches a method of improving performance comprising orally administering a therapeutic clay to improve efficiency of nutrient utilization which include improving average daily gain (claim 21). The therapeutic clay is mined in the Crater Lake region of the Cascade Mountains of Oregon (claim 2). Therefore, the present claims are prima facie obvious in view of the teachings of ‘709.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 59 and 60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 9, 12-15 and 21-28 of copending Application No. 17/524,709 (herein ‘709) in view of Metge et al. (WO 2010/141070; publication date December 9, 2010). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to a method of improving growth performance by orally administering a feed composition comprising an antimicrobial clay whereas the copending application ‘709 teaches a method of improving performance comprising orally administering a therapeutic clay it does not specify the clay comprises 3-10% pyrite, 1-5% Fe 3+ and about 15% aluminum. It is for this reason that Metge et al. is joined.
Metge et al. teaches antibacterial compositions comprising pyrite and natural clay which have antibacterial properties suitable to topically treat infections and skin diseases [0002]. Domestic clay from Oregon was found to be bactericidal and contain 3-10% pyrite naturally which was found to give the clay its antibacterial properties [0021, 0023, 0061-0062; Table 1]. Figure 6 shows the effect on Escherichia coli when pyrite is removed from Blue clay and suggests that pyrite is necessary for bactericidal effects [0041]. Table 3 details the makeup of pure smectites which comprise aluminum, Fe3+, silicon and magnesium (Table 3).
With respect to claims 59 and 60, Metge et al. teach that domestic clay from Oregon was found to be bactericidal and contain 3-10% pyrite naturally. Metge et al. teach that smectite clays inherently comprise aluminum and Fe 3+ in these amounts in naturally mined clays. Therefore, it would have been prima facie obvious to combine the teachings of ‘709 in view of Metge et al. because Metge et al. teach natural clays from Oregon inherently comprise 3-10% pyrite, about 15% aluminum and 1-5% Fe 3+ since they are known to naturally possess this amounts in their natural mined state.
Claims 37, 39, 56, 57, 59, 60 and 62-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,738,045 (herein ‘045) in view of Metge et al. (WO 2010/141070; publication date December 9, 2010). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to a method of improving growth performance by orally administering a feed composition comprising an antimicrobial clay whereas ‘045 teaches a method of improving litter performance comprising orally administering a therapeutic clay it does not specify the clay is from the Crater Lake regio of the Cascade Mountains of Oregon. It is for this reason that Metge et al. is joined.
Metge et al. teaches antibacterial compositions comprising pyrite and natural clay which have antibacterial properties suitable to topically treat infections and skin diseases [0002]. Domestic clay from Oregon was found to be bactericidal and contain 3-10% pyrite naturally which was found to give the clay its antibacterial properties [0021, 0023, 0061-0062; Table 1]. Figure 6 shows the effect on Escherichia coli when pyrite is removed from Blue clay and suggests that pyrite is necessary for bactericidal effects [0041]. Table 3 details the makeup of pure smectites which comprise aluminum, Fe3+, silicon and magnesium (Table 3).
With respect to claims 59 and 60, Metge et al. teach that domestic clay from Oregon was found to be bactericidal and contain 3-10% pyrite naturally. Metge et al. teach that smectite clays inherently comprise aluminum and Fe 3+ in these amounts in naturally mined clays. Therefore, it would have been prima facie obvious to combine the teachings of ‘045 in view of Metge et al. because Metge et al. teach natural clays from Oregon inherently comprise 3-10% pyrite, about 15% aluminum and 1-5% Fe 3+ since they are known to naturally possess this amounts in their natural mined state.
Maintained 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 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.
Claim 37, 39, 56, 57, 59, 60 and 62-75 are rejected under 35 U.S.C. 103(a) as being unpatentable over Almeida et al. (Effects if dietary clays on performance and intestinal mucus barrier of broiler chicks challenged with Salmonella enterica serovar Typhimurium and on goblet cell function in vitro, Poultry Science, 93:839-847, 2014) in view of Subramaniam et al. (Clays as dietary supplements for swine: A review, Journal of Animal Science and Biotechnology, 6:38, pages 1-9; published August 22, 2015) and Metge et al. (WO 2010/141070; publication date December 9, 2010).
Applicant’s Invention
Applicant claims a method of improving growth performance of an animal comprising orally administering a feed composition comprising an antimicrobial effective amount of an antimicrobial clay, wherein the amount in the feed ranges from about 0.1% to about 0.5%, and wherein the clay is mined in the Crater Lake region of the Cascade Mountains of Oregon wherein the improved growth performance is selected from increasing gastrointestinal tract weight, small intestine weight or large intestine weight and any combination thereof. (Claim 37).
Applicant claims a method of improving growth performance of an animal comprising
a. providing an antimicrobial mined clay,
b. combining an antimicrobial effective amount of the clay with an animal feed to prepare an antimicrobial feed composition wherein the amount antimicrobial clay is combined with the feed at a rate of about 0.1% to about 0.5% wt./wt. of the feed composition, and
c. feeding said composition to the animal to improve growth performance. (Claim 56)
Determination of the scope and the content of the prior art
(MPEP 2141.01)
With respect to claims 37, 39, 56 and 62-75, Almeida et al. teach the use of dietary clays to treat growth depression caused by Salmonella in chicks (abstract). Feeding a low dietary concentration of specific clays to pigs challenged with Escherichia coli was known to reduce diarrhea and clays in feed were also known to be used in diets for poultry and pigs for absorption of mycotoxins (page 839, paragraph 1). Almeida et al. examines further beneficial effects of clays on enteric health (page 839, paragraph 2). Almeida et al. examined different clays on their ability to maintain integrity of the gastrointestinal mucosal surface of the small and large intestine (page 840, paragraph 1). In an in vivo experiment with 230 broiler chickens the chicks were assigned 1 of 4 dietary treatments: basal diet, smectite A, smectite B and zeolite (at 0.3% wt. inclusion in the basal diet) (page 840, paragraph 5; limitation of claim 37 and 56). The clays were obtained from Milwhite, Inc. (Brownsville, TX) (page 840, paragraph 7). The pens of chicks and feeders were weighed on day 0 (inoculation day), 3, 7, and 10 post infection to determine ADG, ADFI and G:F and circumstances were maintained so that all chicks were able to access feed daily (page 840, paragraph 8; limitation of claims 39 and 62-75). Results showed that growth performance was reduced in Salmonella challenged chicks fed the basal diet, however, chicks fed feed with the clays had similar growth to chicks not infected with Salmonella (page 842, paragraph 6). The conclusion is that clays in poultry diets alleviate detrimental effects of enteric disease and that clays used in dietary supplements for pigs and children have a positive effect (page 844, paragraph 3). One clay showed strengthening of the intestinal mucus barrier which implies that different clays produce benefits through different mechanisms (page 846, paragraph 1).
With respect claims 62-64 and 69-71, an increase in gastrointestinal tract weight for small and large intestine would inherently follow from administering the clay since growth of the challenged chicks increased to weights of unchallenged chicks when clays are added to their feed. Likewise, with respect to claims 65-68 and 72-75, an increase in feed efficiency, ADG, ADFI and body weight was observed when challenged chicks were treated with clays in their feed. Therefore, improved growth performance is taught by Almeida et al.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
With respect to claims 37, 39, 56 and 62-75, Almeida et al. teach an increase in gastrointestinal tract weight, feed efficiency ADG, ADFI and body weight is implied but not clearly specified. Almeida et al. do not specify the improved growth performance selected from increasing small intestine weight or large intestine weight. It is for this reason that Subramaniam et al. is joined.
Subramaniam et al. teach clays selected from montmorillonite, smectite, illite, kaolinite, biotite and clinoptilolite have been shown to improve weight gain and feed conversion in pigs (abstract). Clays added to the diet can bind and immobilize toxic materials in the gastrointestinal tract and have significant influence on growth, nutrient digestibility and the reproductive performance of swine (page 1, paragraph 3). Clays are composed mainly of phyllosilicates which commonly include Al3+ and Fe3+ (page 2, paragraph 1). Table 1 details the effect of clay supplementation on the performance of weanling pigs by analyzing the average daily weight gain and average daily intake over a period of 35 days (Table 1). The weight gain increased by 8.5% and feed conversion improved by 5.4% (page 2, paragraph 6). Table 2 details the effect of clinoptilolite on the performance of growing and finishing pigs by analyzing the average daily weight gain and average daily intake from day 25 to 161 (Table 2). The report shows an improvement in weight gain by 14.3% and feed conversion by 2.9% when feeding pigs 2% clinoptilolite (page 4, paragraph 1). Additionally, feeding clay minerals can cause changes to the intestinal mucosa by increasing villus height in pigs fed diets supplemented with 0.2% montmorillonite (page 5, paragraph 1 and Table 5). Clays detailed comprise 8.18-23.19% Al2O3 and 3.97-9.42% Fe2O3 (page 2, paragraph 6; page 4, paragraph 3; Table 1, footnote). Subramaniam et al. also teaches supplementation with 0.2% montmorillonite significantly reduced the viable counts of E.coli in weaning pigs (page 5, paragraph 9).
With respect to claims 37, 56 and 57, Almeida et al. does not specify that the clays used are antimicrobial or preferably mined in the Crater lake region of the Cascade Mountains of Oregon. It is for this reason that Metge et al. is joined.
Metge et al. teaches antibacterial compositions comprising pyrite and natural clay which have antibacterial properties suitable to topically treat infections and skin diseases [0002]. Domestic clay from Oregon was found to be bactericidal and contain 3-10% pyrite naturally which was found to give the clay its antibacterial properties [0021, 0023, 0061-0062; Table 1]. Weathered blue clay which has been oxidized naturally by weather was found not to contain pyrite and lacked bactericidal effects [0021]. Figure 6 shows the effect on Escherichia coli when pyrite is removed from Blue clay and suggests that pyrite is necessary for bactericidal effects [0041]. Table 3 details the makeup of pure smectites which comprise aluminum, Fe3+, silicon and magnesium (Table 3).
With respect to claims 59 and 60, Metge et al. teach that domestic clay from Oregon was found to be bactericidal and contain 3-10% pyrite naturally. Almeida et al. and Metge et al. are silent to the clay comprising 1-5% Fe 3+ or about 15% aluminum, however, Metge et al. teach that smectite clays inherently comprise aluminum and Fe 3+ in these amounts in naturally mined clays. Subramaniam teaches that clays are known to comprise 8.18-23.19% Al2O3 and 3.97-9.42% Fe2O3 Therefore, it would have been inherent that the natural clays from Oregon would inherently comprise 3-10% pyrite in mixture with about 15% aluminum and 1-5% Fe 3+ since they are known to naturally possess this amounts in their natural mined state.
Metge et al. teach that domestic clay from Oregon was found to be bactericidal and contain 3-10% pyrite naturally. Therefore, one of ordinary skill would have inherently expect the clays in the same region to have similar properties since they Oregon clay possess the claimed amount of pyrite naturally. Almeida et al. teach that clays in feed are known to improve the health of animals affected by Escherichia coli. Subramaniam teaches that clays added to feed were known to increase in gastrointestinal tract weight, feed efficiency ADG, ADFI and body weight and Metge et al. teach blue antibacterial clays from Oregon are known to be effective against Escherichia coli. Therefore, one of ordinary skill would have been motivated to combine the teachings of Almeida et al., Subramaniam et al. and Metge et al. to use mined blue clays from Oregon which naturally have antibacterial properties.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Almeida et al., Subramaniam et al. and Metge et al. teach treatment of Escherichia coli with clays. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Almeida et al., Subramaniam et al. and Metge et al. an select antibacterial mined clay from Oregon and use it in methods of increasing growth performance of the gastrointestinal tract with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to combine the teachings Almeida et al. Subramaniam et al. and Metge et al. and use mined clay from Oregon because Subramaniam teaches that clays were known to increase in gastrointestinal tract weight, feed efficiency ADG, ADFI and body weight in pigs and Metge et al. teach that blue clay is was known to be bactericidal and naturally contains 3-10% pyrite.
Response to Arguments
Applicant's arguments filed 10/21/2025 have been fully considered but they are not persuasive.
Applicant argues Almeida and Subramaniam and Metge do not teach increased gastrointestinal weight. The Examiner is not persuaded by this argument because Subramaniam teach feeding clay minerals to pigs can cause changes to the intestinal mucosa by increasing villus height (page 5, paragraph 1 and Table 5). Therefore, adding clay to feeds to increase gastrointestinal weight was known before the time of filing.
Applicant next argues that the claimed antimicrobial clay has enhanced growth performance when fed to animals challenged with enterotoxigenic Escherichia coli K88+ and draws attention to Example 1, FIG. 3, FIG. 7. The data is not convincing for several reasons. First, The claims are not commensurate in scope with the data detailed in the Examples. Example 1 details oral administration of an antimicrobial clay in combination with a basal diet (PV). The claims do not include these limitations. Furthermore, the improved body weight has not been shown to be unexpected.
Applicant argues pigs fed the antimicrobial clay had about 25% more follicles which were about 36% larger in size which demonstrates growth performance benefits outside of infection prevention. The data is not presented in a proper side by side comparison because clays were known to increase gastrointestinal weight and there is not data that suggest and unexpected improvement when clay mined in the Crater Lake region are used.
Applicant argues that even though Subramanian teaching an increase in villus height that does not mean that the gastrointestinal tract is inherently increase weight. The Examiner is not persuaded by this argument because the specification specifies that the follicles in pig ileum is used to correlate to the increase in the gastrointestinal tract [0031-37]. These are related to the follicles (villus) of the gastrointestinal tract displayed in figures 5B, 5C and 5D. Subramanian shows an improvement in weight gain by 14.3% when clay is added to the diet of pigs (page 4, paragraph 1). Additionally, feeding clay changes the intestinal mucosa by increasing villus height in pigs fed diets supplemented with 0.2% montmorillonite (page 5, paragraph 1 and Table 5). Subramaniam et al. also teaches supplementation with 0.2% montmorillonite significantly reduced the viable counts of E.coli in weaning pigs (page 5, paragraph 9).
Finally, Applicant argue that although Metge teach clays from the region claimed inhibit E.coli the use of the clay to improve growth performance is variable and unpredictable and depend on a variety of factors. The Examiner is not persuaded by this argument because the rejection is based on the teachings of Almeida et al., Subramaniam et al. and Metge et al. which all teach treatment of Escherichia coli with clays and Subramanian teaches feeding clay changes the intestinal mucosa by increasing villus height in pigs fed diets supplemented with 0.2% montmorillonite (page 5, paragraph 1 and Table 5). Therefore, adding any antimicrobial clay to feed would be expected to result in an increase in gastrointestinal tract weight.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached on Monday-Friday 9:00 am-5:30 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, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617