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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 1/28/26. Claims 1-5, 7, 8, 10-32 are pending. Claims 27, 28, and 31-32 are withdrawn. Claims 1-5, 7, 8, 10-26 and 29-30 are considered on the merits.
Response to Restriction Requirement
Applicant's response, with traverse, to the Restriction/Election requirement filed on 2/27/26 is acknowledged. The applicant elected Group I which includes claims 1-5, 7, 8, 10-26 and 29-30. The required species elected is a hematopoietic factor.
The Applicant argues that since Group II ( claims 27-28) and Group III (claims 31-32) make or use the composition of Group I, they represent overlapping subject matter and should be rejoined.
As mentioned in the restriction requirement the method of group II does not limit that the yeast is pre-coated with the same long chain fatty acids of Group I. Furthermore the bolus in Group II is made by extrusion while those in Group I can be made by an alternative process including pressing. The Applicant is reminded that Group II may be rejoined if Group I is found allowable.
Group I and III differ because the composition of Group I can be used a manner other than claimed, as in a starter culture for yeast rather than administered to a ruminant animal. Group III can also be rejoined if the composition of Group I is found allowable and all of those allowable limitations are incorporated into Group III.
Therefore, the Restriction/Election requirement is therefore made FINAL and the elected species and the claims they include will now be examined on the merits.
Priority
The current application is listed as a CIP of 18/080371 with a filing date of 12/13/22 and 15/670284 with a filing date of 8/7/2028. However it is not afforded the filing date of either of these applications because they do not disclose a) using calcium propionate and b) precoating the yeast with one or more the long chain fatty acids selected from the group consisting of oleic acid, olenic acid, palmitic acid, stearic acid,
linoleic acid, and linolenic acid. These limitations are disclosed in 18/536601 so the effective filing date of this application is 12/13/2023.
Claim Interpretation
Claim 29 and 30 limit the ruminant animals to administer this composition. However compositions are limited by their structure and not their intended uses. Art reading on the structure of the composition will also read on these claims.
Claim 26 has many product by process limitations. M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)
The use of 35 U.S.C. §§ 102 and 103 rejections for product-by-process claims has been approved by the courts. “[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claim Objections
Claims 1-32 are objected to for their form. The claims are identified by their number twice. For example, claim 1 reads:
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The extra “1.” is unnecessary and should be written as:
Claim 1. (Currently Amended) A ruminant dietary supplement in the form of a pressed shelf-stable solid pill or bolus administered into the reticulo-rumen of a ruminant animal, comprising:
Repeating these changes to all claims will remove this objection
Claims 6 and 9 are further objected to because they are listed as cancelled yet retain their text. 37 CRF 1.121 (c)(4) (i) state “No claim text shall be presented for any claim in the claim listing with the status of "canceled" or "not entered."” Simply delete the lined through text to claims 6 and 9 to remove this part of the objection.
Claim Rejections - 35 USC § 112
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.
Claims 1-5, 7, 8, 10-26 and 29-30 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 limits the long chain fatty acid to “olenic acid”. This does not appear to be a common fatty acid since a typical internet search did not provide any structure. It is believed this is a typo for ‘oleanolic acid’.
Claim 26 is confusing because it is not clear what structural components these product-by-process limitations are imparting to the composition. It is understood that the fatty acids are sprayed around the live active yeast however this limitation is unclear:
The coating of the hydrophobic fat or fatty acid material separate from the dried live active yeast particles prior to and during the material being sprayed around the exterior of the dried live active yeast particles
It is unclear how this further limits the hydrophobic coating of the yeast in the composition. If the fat or fatty acid material is separate from the yeast prior to and during the spraying, how does that limit this material when it contacts the yeast. More importantly, how does this limit the final form of the composition. In the interest of compact prosecution, any coating around a particle of yeast(s) will read on this claim.
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, 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(s) 1, 2, 4, 5, 7, 8, 10-15, 17-26, 29 and 30, is/are rejected under 35 U.S.C. 103 as being unpatentable over Franz et al. (US 2019/0037884, in IDS 6/27/24) in view of Durand et al. (US 7157258, published 2007, in IDS 3/22/24) in light of support by MCC Organic Chemistry (2022);
Franz et al. teach a ruminant dietary supplement as a pressed shelf-stable solid pill or bolus (Franz, [0003]). This composition comprises the following:
Calcium chloride from 30-70 wt% (Franz [0012-0014]); and
microgranules of live dehydrated (i.e. dried) yeast coated with a hydrophilic substance including fat or fatty acids and may be obtained from Lallemand (Franz [0010]).
The composition further comprises:
2-3 wt% live yeast (Franz [0012-0014]);
5-25 wt% calcium carbonate (Franz, 0012) as a base constituent;
citric acid, formic acid, or sorbic acid at 5 wt% (Franz, 0012-0013) as an acid constituent;
The sugar alcohols selected from sorbitol, maltitol, erythritol, and mannitol at 10-30 wt% (Franz, 0012-0013);
Magnesium stearate at 0.5-2 wt% (Franz, 0012);
Minerals including zinc, potassium, and magnesium (Franz, 0012); and
Vitamins including E and Niacin (B3) (Franz, 0012);
One of ordinary skill would recognize that cations such as Ca2+ are considered Lewis Acids as supported by MCC Organic Chemistry (Chapter 2, pg. 6). Therefore calcium chloride (CaCl2) represents an acid component of 30-70wt% since it dissociates to Ca2+ and 2 Cl-. Calcium carbonate dissociates to carbonate which is a base component comprising 5-25 wt% of the composition. Also the composition comprises magnesium sulfate at 5 wt% which dissociates to the base component sulfate. It would be obvious to one of ordinary skill that 25 wt% carbonate and 5 wt% sulfate would represent a base component of 30 wt% of the composition.
While Franz et al. teach microgranules of live dehydrated (dried) yeast coated with a hydrophilic substance including fat or fatty acids and may be obtained from Lallemand, they do not teach the yeast is precoated with stearic and/or palmitic acid. Nor do they teach the identity of the yeast. This would be obvious in view of Durand et al. who lists Lallemand S.A as their Assignee.
Durand teach coating dehydrated living microorganism with a hydrophobic coating (Durand, col 3, lines 28-31). This coating can include stearic acid and palmitic acid as well as animal fat and vegetable waxes (Durand, col 3, lines 35-40). The microorganisms include Saccharomyces cerevisiae (Durand, col 4, lines 10-15). In Example 2, Durand et al. teach coating with equal parts (i.e. 50:50) stearic acid and palmitic acid. This coating is applied around the lyophilized yeast in a layer that is separate from the yeast (Durand, col 3, lines 45-55).
It would be obvious to use the particles of Durand et al. in the composition of Franz et al. since:
a) Franz et al. desires yeast coated in a hydrophobic material such as fat or fatty acids and may be obtained by Lallemand and
b) Durand et al. is assigned to Lallemand and teaches a yeast coated in a hydrophobic fatty acid.
Therefore one of ordinary skill would recognize the coated yeast of Durand et al. as a suitable substitute for those used by Franz et al. (MPEP 2141 III B).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franz et al. (US 2019/0037884) and Durand et al. (US 7157258, published 2007) as applied to claims above, and further in view of EJ (EFSA Journal, 2017).
Franz et al. and Durand et al. teach ruminant feed composition of claim 1 with precoated Saccharomyces cerevisiae. They do not teach the specific strain of Saccharomyces cerevisiae CNCM I-1077. However this would be obvious in view of EJ who teach S. cerevisiae CNCM I-1077 is a commercially available yeast used in ruminant animal feeds (EJ, see Title and pg. 5 top lines). Therefore it would be obvious to substitute S. cerevisiae CNCM I-1077 for the yeast in Franz et al. and Durand et al. since it is known to be a suitable additive to ruminant feeds MPEP 2141 III B and 2144.06 II).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franz et al. (US 2019/0037884) and Durand et al. (US 7157258, published 2007) as applied to claims above, and further in view of CN107988089 (IDS 6/27/24). An English-language translation is provide for CN’089. All citations to CN’089 will be to the translation.
Franz et al. and Durand et al. teach ruminant feed composition of claim 1 with precoated Saccharomyces cerevisiae. They do not teach adding starch to their composition. However this would be obvious in view of CN’089 who teach an animal feed with yeast and starch coated in steric acid. One of ordinary skill would recognize that adding starch to the composition of Franz et al. and Durand et al. would be obvious since it is a known ingredient for animal feeds (MPEP 2144.06 I). While CN’089 is not specific if the starch is from potatoes or corn, this reads as a product by process of the origin of the starch and does not appear to provide a structural differences between the starches.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-5, 7, 8, 10-26 and 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11523625. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets disclose
A ruminant dietary supplement in the form of a pressed shelf-stable solid pill or bolus administered into the reticulo-rumen of a ruminant animal, comprising;
(a) at least 30% wt of an acidogenic source of calcium; and
(b) particles of dried live active yeast coated with a hydrophobic fat or fatty acid substance with the coating of the hydrophobic fat or fatty acid material separate from the dried live active yeast particles prior to and during the material being sprayed around the exterior of the dried live active yeast particles;
(c) wherein the hydrophobic fat or fatty acid coating contributes to a reduction in the degradation of cells in the yeast particles and enables them to remain viable when the yeast particles are homogeneously incorporated into the pressed solid pill or bolus.
The difference between the current claims and US’625 is the option to use calcium propionate and long change fatty acids oleic acid, olenic acid., palmitic acid ... stearic acid, linoleic acid, and linolenic acid. However this are more specific fatty acids that fall under those generically disclosed in US’625.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.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.
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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