DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendments
1) Acknowledgment is made of Applicants’ preliminary amendments filed 12/09/25, 08/18/25, 04/14/25, 07/12/23 and 04/26/23.
Election
2) Acknowledgment is made of Applicants’ election filed 12/09/25 in response to the restriction and the species election requirement mailed 10/09/25. Applicants have elected invention II without traverse.
Status of Claims
3) Claims 1-20 are canceled.
Claims 21-43 are pending.
Claims 21-32 and 36-40 have been withdrawn from consideration as being directed to a non-elected invention or species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 33-35 and 41-43 are examined on the merits.
Substitute Specification
4) Acknowledgment is made of Applicants’ substitute specification filed 07/12/2023.
Drawings
5) Acknowledgment is made of Applicants’ drawings filed 02/01/2022.
Information Disclosure Statements
6) Acknowledgment is made of Applicants’ information disclosure statements each filed 09/20/23 and the one filed 04/24/24. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Priority
7) The instant AIA application, filed 04/26/2023, is a continuation-in-part of U.S. application 17/320,706 filed 05/14/2021, now abandoned, which claims priority to the provisional application 63/024,886 filed 05/14/2020.
The prior applications to which priority is claimed lack support for the limitations in claim 33 “administering a biomass composition ..... the composition being deposited under ATCC Item No. SD-8636”. Furthermore, the disclosure therein is not sufficient to comply with the requirements of 35 U.S.C § 112(a) or 35 U.S.C § 112, (pre-AIA ) first paragraph because these applications fail to provide adequate support or enablement in the manner provided by 35 U.S.C § 112(a) or 35 U.S.C § 112, (pre-AIA ) first paragraph for one or more of the instant CIP application, for example, for the claimed method of administering a biomass-based composition including a generic compound derived from generic Gram-negative bacteria at amounts efficacious for the treatment of clinical or subclinical coccidiosis, “the composition being deposited under ATCC Item No. SD-8636”. Accordingly, the effective filing date of claims 33-35 and 41-43 is 04/26/2023.
Objection(s) to Specification
8) The specification is objected to for the following reason(s):
(a) The paragraph [0001] of the substitute specification filed 07/12/23 does not reflect the abandoned status of the prior U.S. application 17320706, as indicated above in italicized letters under ‘Priority’. Appropriate correction is needed.
(b) The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). The limitation “being deposited” under ATCC Item No. SD-8636 in claim 33 lacks antecedent basis in the specification.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ) First Paragraph
9) The following is a quotation of 35 U.S.C § 112(a):
(a) IN GENERAL. - The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out the invention.
10) Claim 33 and the dependent claims 34, 35 and 41-43 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention, because the specification does not provide evidence that the claimed biological material is (1) known and readily available to the public; (2) reproducible, e.g. sequenced; or (3) deposited.
Claim 33 is drawn to a method for treating a broiler chicken for clinical or subclinical coccidiosis comprising administering a biomass composition ‘being deposited under ATCC Item No. SD-8636’. It is apparent that the recited ATCC Item No. SD-8636 that is being deposited is required to practice the claimed invention and therefore must be known and readily available to the public, or obtainable by a reproducible method set forth in the specification. If not so obtainable or available, the enablement requirements of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph may be satisfied by a deposit of the recited deposited biological material at an acceptable depository such as ATCC. From the instant specification, it appears that said biological material has not been deposited in an acceptable depository. For example, parts of section [0001] added in the instant CIP application only recite that SD-8636 was “received by the ATCC on or about August 25, 2022” after referring to it at one paragraph therein as “Gram-negative bacteria” and at another paragraph therein as “specific bacteria”. Claim 33 identifies the recited ‘SD-8636’ as ‘the composition being deposited under ATCC Item No. SD-8636’. If the deposit has been made under the provisions of the Budapest Treaty, then a statement, an affidavit or declaration by Applicants or assignees having the authority and control over the conditions of the deposit, or a statement by an attorney of record who has a registration number over his or her signature, is required. The statement should state that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced, if viable samples cannot be dispensed by the depository. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each state. The statement should identify the deposited biological material by its depository accession number, establish that the deposited biological material is the same as the one described in the specification/claim, and establish that the deposited biological material was in Applicants’ possession at the time of filing. As a means of satisfying the necessary criteria of the deposit rules, for completing the record, and to show that the claimed biological material is the same as the one deposited, Applicants may submit a copy of the contract or the notice of acceptance of the strain by the depository.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicants, by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depositary for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application. The application must contain: 1) The name and address of the depository; 2) The name and address of the depositor; 3) The date of deposit; 4) The identity of the deposit and the accession number given by the depository; 5) The date of the viability test; 6) The procedures used to obtain a sample if the test is not done by the depository; and 7) A statement that the deposit is capable of reproduction. If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from Applicants to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the Applicants’ possession at the time the application was filed.
Applicants’ attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 C.F.R § 1.801-1.809 for further information concerning deposit practice.
Rejection(s) under 35 U.S.C § 112(b) or (pre-AIA ), Second Paragraph
11) The following is a quotation of 35 U.S.C § 112(b):
(B) CONCLUSION --The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
12) Claims 33-35 and 41-43 are rejected under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
(a) Claim 33 is ambiguous and indefinite in the use of the abbreviated limitation ‘TLR’ in the claim language. It is unclear what does this abbreviation represent or stand for. The abbreviated limitation fails to specifically and unambiguously set forth the metes and bounds of the claim such that a skilled artisan would be readily apprised of that which is claimed.
(b) Claim 33 is ambiguous and indefinite in the limitations “a biomass-based composition including a compound derived from Gram negative bacteria ....., the composition being deposited under ATCC Item No. SD-8636”. It is unclear what does the recited biomass-based composition include or encompass with regard to its ingredients or contents and/or the structure of the biomass. What exactly “a compound derived from Gram negative bacteria” represents or encompasses structure-wise and scope-wise is unclear. In the absence of a precise or distinct definition in the as-filed specification as to its ingredients, one of skill in the art cannot understand in an unambiguous way that which is being claimed and the scope of the claim.
(c) Claim 33 is further ambiguous and indefinite in the limitations: biomass-based composition including a compound derived from Gram negative bacteria ....., “the composition being deposited under ATCC Item No. SD-8636”. It is unclear what precisely is the ATCC-deposited “SD-8636”. Given that ATCC is generally and mostly a depository of microorganisms, it is unclear how a biomass-based composition that includes a compound derived from Gram negative bacteria can be deposited at the ATCC. Furthermore, a biomass-based “composition” being deposited under ATCC Item No. SD-8636 as claimed is inconsistent with the two different descriptions provided under section [0001] of the substitute specification filed 07/12/23, wherein ‘ATCC Item No. SD-8636’ is described as (a) Gram-negative bacteria of ATCC Item No. SD-8636; and (b) Specific bacteria of ATCC Item No. SD-8636. One of skill in the art cannot understand in an unambiguous way that which is being claimed and the scope of the claim.
(d) Claim 34 is ambiguous and indefinite in the limitations ‘about .... and about ... lbs’ because these are relative terms. The term ‘about’ is not specifically defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. What precise range of lbs is encompassed within the terms ‘about ... and .... about ... lbs’ is unclear.
(e) Analogous rejection applies to claim 35 with regard to the relative limitation “about ... lbs”.
(f) The dependent claims 34, 35 and 41-43 are indefinite for lacking sufficient antecedence in the limitation “a broiler chicken of Claim ...”. For proper antecedence, it is suggested Applicants replace the above-identified limitation with --the broiler chicken of claim ...--.
(g) The dependent claim 43 is indefinite for having improper antecedence in the limitation “said Gram-negative bacteria-derived lipopolysaccharide ...”. Claim 43 depends from claim 33 which does not include any recitation of Gram-negative bacteria-derived “lipopolysaccharide”. One of skill in the art cannot understand in an unambiguous way that which is being claimed and the scope of the claim.
(h) Claims 34-35 and 41-43, which depend directly or indirectly from claim 33, are also rejected as being indefinite because of the indefiniteness identified supra in the base claim(s).
Notice Re Prior Art Available under Both Pre-AIA and AIA
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.
Rejection(s) under 35 U.S.C § 102
13) The following is a quotation of the appropriate paragraphs of 35 U.S.C § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
14) Claims 33-35 and 41-43 are rejected under 35 U.S.C § 102(a)(1) and 35 U.S.C § 102(a)(2) as being anticipated by WO 2021/231869 A1 published 18 November 2021 (Applicants’ IDS).
WO 2021/231869 A1 disclosed a method for treating broiler chicks or birds, poultry or an animal for clinical or subclinical coccidiosis through modulation of the TLR pathway, the method comprising administering a biomass-based composition including a compound such as the LPS/lipid A compounds or a purified lipopolysaccharide derived from Gram-negative bacteria such as Variovorax paradoxus at amounts efficacious for the treatment of the clinical or subclinical coccidiosis. The biomass-based composition is administered at the concentration range of between about 0.5 lbs per ton and about 11.0 lbs per ton or about 3.5 lbs per ton of finished feed. The biomass composition used was ZIVO A Treatment Compound that comprised a fresh water algal biomass with the compound(s). The broiler birds administered with the composition showed significantly reduced mortality and the coccidia lesion score following the cocci-challenge. See claims 13-15, 12, 11, 8, 7, 6, 5, 4 and 16; sections [0051], [0050], [0063] to [0066], [0080] to [0082], [0088], [0076], [0079], [0055], and [0054]; and Treatment Group 4 in section [0078]. The prior art biomass-based composition is the same as the instantly recited biomass-based composition merely being deposited under ATCC Item No. SD-8636 absent evidence to the contrary. Since the Office does not have the facilities for examining and comparing Applicants’ biomass-based composition with that of the prior art, the burden is on Applicants to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the biomass-based composition of the prior art does not possess the same characteristics of the claimed biomass-based composition). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claims 33-35 and 41-43 are anticipated by WO 2021/231869 A1.
Double Patenting Rejection(s)
15) 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); and 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 §§ 706.02(1)(1) - 706.02(1)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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.aspto.gov/paients/process/fIle/efs/giiidance/eTD-mfo-I.jsp.
16) Claims 33-35 and 41-43 are provisionally rejected on the ground of non-statutory obviousness double patenting as being unpatentable over claims 9, 8, 1-6, 10, 16, 15, 11-13 and 17 of the co-pending application 17/358,953. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim a method of treating a broiler against coccidiosis comprising administering a biomass containing a lipopolysaccharide compound of the Gram-negative Variovorax paradoxus in an amount effective for said treatment. The prior art biomass-based composition is the same as the instantly recited biomass-based composition merely being deposited under ATCC Item No. SD-8636 absent evidence to the contrary.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) Objection
17) Claim 41 is objected to for reciting the plural limitation “bacteria” in association with the linking verb “is”.
Conclusion
18) No claims are allowed.
Correspondence
19) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Acting Supervisor of AU 1645, Vanessa Ford, can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
20) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
January, 2026