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 Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 12/15/23.
Election
2) Acknowledgment is made of Applicants’ election filed 12/17/25 in response to the species election requirement mailed 12/02/25. Applicants have elected the Enterococcus and E. faecium. Because Applicants did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse. M.P.E.P § 818.03(a).
Status of Claims
3) Claims 1-15 have been amended via the preliminary amendment filed 12/15/23.
New claim 16 has been added via the preliminary amendment filed 12/15/23.
Claims 1-16 are pending.
Claims 5-7 and 16 have been withdrawn from consideration as being directed to a non-elected species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 1-4 and 8-15 are examined on the merits.
Drawings
4) Acknowledgment is made of Applicants’ drawings filed 12/15/2023.
Sequence Listing
5) Acknowledgment is made of Applicants’ sequence listing which has been entered on 12/19/23.
Information Disclosure Statement
6) Acknowledgment is made of Applicants’ information disclosure statements each filed 02/08/24. 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 12/15/2023, is the national stage 371 application of PCT/EP2022/066487 filed 06/16/2022, which claims priority to the European application 21180190.7 filed 06/18/2021.
Rejection(s) under 35 U.S.C § 112(b) or (pre-AIA ), Second Paragraph
8) 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.
9) Claims 1-4 and 8-15 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) Claims 1, 12 and 15 are vague, ambiguous and indefinite in the limitations “increasing resilience against infection” because the disease against which resilience is increased is not clear. Furthermore, ‘increasing’ is a relative term which renders the claim indefinite. The term 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 degree or level of ‘increase’ is encompassed and ‘increase’ compared to what is unclear.
(b) The dependent claim 12 is indefinite and appears to lack sufficient antecedence in the limitation “a pathogenic bacterium”. It is unclear whether or not this “pathogenic bacterium” is different from the one recited in the base claim 1. If not, it is suggested that Applicants provide sufficient antecedence by replacing said limitation with --the pathogenic bacterium--.
(c) Claim 12 is further ambiguous, indefinite and has an indefiniteness issue in the limitation “.... a post-weaned mammalian subject”. Claim 12 depends from claim 1, wherein the mammalian subject is administered with a probiotic composition in a pre-weaning period to increase the subject’s resilience against a pathogenic bacterium. Does the method of claim 12 increase resilience in any generic ‘a post-weaned mammalian subject’ against infection by any generic ‘a pathogenic bacterium’, or does the method increase resilience in –the-- mammalian subject from claim 1 --post-weaning--?
(d) Analogous rejection applies to the dependent claim 15 with regard to the limitation “.... a post-weaned mammalian subject”.
(e) Claims 2-4 and 8-15, which depend directly or indirectly from claim 1, are also rejected as being indefinite because of the indefiniteness identified supra in the base claim.
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
10) 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.
11) Claims 1-4, 8 and 10-15 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by Scharek et al. (Vet. Immunol. Immunopathol. 105: 151-161, 2005).
Scharek et al. taught a method of administering to suckling piglets a feed composition comprising a probiotic strain of Enterococcus faecium. The prior art method resulted in up to 50% reduction in the frequency or isolation rate of beta-hemolytic and enterotoxigenic E. coli O141 in suckling piglets of the probiotic group that had free access to a feed supplemented with 1.7 x 108 CFU of a probiotic strain of E. faecium per kg feed. See Figure 8B; the sentence bridging pages 157 and 158; section 2.1 including the 4th full sentence therein; 2nd and 3rd full sentences under section ‘5. Conclusions’. Along with the teaching that the O141 serovar group of E. coli is associated with post-weaning diarrhoea and edema disease in piglets, Scharek et al. taught that the observed reduction in the isolation frequency of E. coli O141 is regarded as a major change in the immunological challenge of the animals. Scharek et al. further taught that the reduction in beta-hemolytic E. coli isolates in the probiotic-treated group is suggestive of a reduced pathogenic load in the probiotic group. See 6th to 8th sentences of paragraph 5 under the section ‘4. Discussion’. Accordingly, the prior art method is expected to necessarily increase the piglets’ resilience against infection by a pathogenic bacterium such as enterotoxigenic E. coli at post-weaning 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 method and the method of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claims 1-4, 8 and 10-15 are anticipated by Scharek et al.
12) Claims 1-4, 8, 10-13 and 15 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by Zayner et al. (J. Anim. Physiol. Anim. Nutr. (Berl) 90 (1-2): 25-31, 2006, Abstract).
Zayner et al. taught a method of administering orally to piglets from birth to weaning (i.e., pre-weaning period) an Enterococcus faecium composition. Said piglets suffered from diarrhoea less frequently and showed a lower diarrhoea score. Zayner et al. taught that these results suggest that the daily oral supplementation of Enterococcus faecium from birth to weaning reduces the portion of piglets suffering from diarrhoea. See Abstract. Accordingly, the prior art method is expected to necessarily increase the pre-weaning piglets’ resilience against infection by a pathogenic bacterium.
Claims 1-4, 8, 10-13 and 15 are anticipated by Zayner et al.
13) Claims 1, 2, 8-10 and 12-15 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by Venkatachalapathy et al. (Probiotics in Sustainable Food Production: Current Status and Future Prospects- Probiotics in Food Production, ISBN 978-93-82338-50-5, pages 281-283, Bonfring 2013).
Along with the teaching that Escherichia coli that produce enterotoxins (enterotoxigenic E. coli) have been identified as one of the main causes of infectious diarrhoea which is one of the major causes for the mortality in neonatal pigs, Venkatachalapathy et al. taught that oral administration of probiotic bacteria helps to maintain microbiota balance preventing or remedying the appearance of gastrointestinal infections. Venkatachalapathy et al. taught a method of administering to suckling or preweaned piglets a probiotic composition comprising no more than two bacterial species, i.e., Propionibacterium frendenreichii and Lactgobacillus acidophilus. The prior art method resulted in 5% reduction in pre-weaning mortality with low incidence of diarrhoea and a positive effect on growth performance of pre-weaned piglets. See sections ‘I. INTRODUCTION’; ‘II. MATERIALS AND METHODS’; the full paragraph below Table 1 on page 2; and 1st full paragraph on page 283.
Claims 1, 2, 8-10 and 12-15 are anticipated by Venkatachalapathy et al.
Double Patenting Rejection(s)
14) 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.
15) Claims 1, 2 and 8-15 are rejected on the ground of non-statutory obviousness double patenting as being unpatentable over claims 1-11 of US 9844573 B2 in view of US 20150079058 A1.
Although the claims at issue are not identical, they are not patentably distinct from each other because the method of the ‘573 patent comprising administering to pigs a composition comprising or consisting of at least two probiotic Bacillus species that inhibit growth of E. coli and Clostridium perfringens pathogenic bacteria render obvious instant claims. As in In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008), that part of the ‘953 patent’s specification that defines or covers the pigs included piglets and nursery pigs (see 4th full paragraph of column 12) indicating that these subjects were intended to fall within the coverage and/or meaning of the claims. Note that ‘[The specification] may be used to learn the meaning of terms and in interpreting the coverage of a claim’ [Emphasis added]. In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
The claims of the ‘573 patent are silent on the piglets being in a pre-weaning period.
However, that piglets suffer from diarrhea caused by pathogenic bacteria such as E. coli and Clostridium perfringens types A and C resulting in death and severe production losses and that enteric infections including Clostridium perfringens infections occur predominantly in swine with increasing frequency in preweaning pigs was known in the art at the time of the invention. For example, see last three full paragraphs of column 1 of US 20150079058 A1.
. Given the increased frequency in preweaning piglets of infections by pathogenic bacteria such as E. coli and Clostridium perfringens infections as disclosed by US 20150079058 A1, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to extend the method of the ‘573 patent of administering the composition to pre-weaning piglets to produce the instant invention with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to produce the instant invention for the expected benefit of reducing the increased frequency of infections due to said pathogenic bacteria. The resultant method is expected to result in the same effects as the instantly administered composition including increasing resilience against infection by a pathogenic bacterium such as enterotoxigenic E. coli absent evidence to the contrary.
Conclusion
16) No claims are allowed.
Correspondence
17) 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.
18) 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