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 .
Applicant’s response filed 6/18/2025 has been received and entered into the case. Claims 8, 12-17, 20, 21, 24, 25 are pending. Claims 8, 14-17, 20, 24 are withdrawn. Claims 12, 13, 21, 25 have been considered on the merits. All arguments and amendments have been considered.
The previous rejection of Claims 18 and 22 rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement is withdrawn in light of applicants statement by an attorney of record over his or her signature and registration number, stating that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent filed on 6/18/2025. It should be noted that a new enablement rejection is applied below over newly added strains to claims 12 and 13.
The following rejection is withdrawn in light of applicants claim amendments; Claim(s) 12, 13, 21, 25 rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wittke et al. (US20120171176) (IDS).
-Note-Applicant’s specification discloses that B. breve NITE BP-02622 is the same bacterium as B. breve M-16V.
Maintained rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
Claims 12, 13, 21, 25 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating or suppressing norovirus, the specification does not reasonably provide enablement for preventing or inhibiting norovirus from infecting a human or norovirus infection according the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Specifically, when looking to applicants’ specification and Drawings there is no teachings or data showing that the administration of the claimed strains would inhibit or prevent norovirus infection from infecting a human (or preventing infection) when administered to a human. When looking to the Figures, applicants demonstrate rather a suppression of plaque formation of murine norovirus-1 CW1 (MNV) in RAW264.7 cells, but not inhibition or prevention of plaque formation in the assay. The Figures demonstrate a reduction in plaque formation.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The claims are drawn to a method of inhibiting and preventing norovirus infection. While the person of ordinary skill in the art would have a reasonable expectation of successfully treating norovirus infections by administering the strains disclosed in the present application, he or she would not have such an expectation for preventing the actual viral infection. An infection is simply an invasion by pathogenic microorganisms (See Dictionary.com). Norovirus causes the majority of acute infectious nonbacterial gastroenteritis in human worldwide, and easily spreads from person to person (See Ishikawa et al. (IDS)), therefore, it is impossible to ensure that the virus would not enter the body and multiply even once, which would constitute “infection.” Rather, it would be more appropriate to limit the claims to method of treating norovirus and symptoms thereof.
Additionally, the applicants have provided no direction for the claimed method to prevent norovirus. The Figures demonstrate a decrease in plaque formation of murine norovirus-1 CW1 (MNV) in RAW264.7 cells compared to controls; however, inhibition is not demonstrated and no long-term results are provided showing human administration and that patients never acquire norovirus, as would be required to support the “prevention” claim. While lack of a working embodiment cannot be a sole factor in determining enablement, the absence of substantial evidence, in light of the unpredictable nature of the art and the direction applicants present, provides additional weight to the lack of enablement in consideration of the Wands factors as a whole. Thus, one of ordinary skill in the art would not have a reasonable expectation of successfully inhibiting and preventing norovirus by performing the claimed method.
New rejection necessitated by amendment
Claims 12 and 13 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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. Since the microorganisms, Bifidobacterium longum subsp. infantis NITE BP-02623, Bifidobacterium bifidum NITE BP-02429, Bifidobacterium bifidum NITE BP-02431, Bifidobacterium bifidum NITE BP-02432, Bifidobacterium bifidum NITE BP- 02433, and Lactobacillus helveticus NITE BP- 01671 are recited in the claims, it is essential to the invention recited in those claims. It must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the microorganism. The specification does not disclose a repeatable process to obtain the microorganism and it is not apparent if the microorganism is readily available to the public.
It is noted that applicants have deposited the organism but there is no indication in the specification as to public availability.
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
See MPEP2409 “Under the Budapest Treaty, there is a requirement that the deposit be tested for viability before it is accepted. Thus, a mere statement by an applicant, an authorized representative of applicant or the assignee that the deposit has been accepted under the Budapest Treaty would satisfy 37 CFR 1.807. The examiner should note the clear distinction between a statement by the applicant that the deposit has been made under the Budapest Treaty and one in which the deposit has been made and accepted under the Budapest Treaty. Where a statement is merely an indication that a deposit has been made (with no indication as to whether it has been accepted), there is no assurance that the requirements under 35 U.S.C. 112 have been satisfied.”
In addition, applicant have not provided an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited and accepted under the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, to satisfy the deposit requirement made herein. See 37 C.F.R. 1.808.
Maintained rejection
Claim Rejections - 35 USC § 102
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 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 an 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.
Claim(s) 12, 13, 21, 25 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO2016/139333 (IDS).
Regarding claims 12, 13, 21, 25, WO’333 teaches a method of treating gastrointestinal infections/inflammations in young children or infants and relieving symptoms thereof (p. 1, lines 5-10, 24-35, p. 6, lines 30-35, p. 11, lines 16-26, p. 12, lines 21-35) including treating viral enteritis caused by Norwalk virus (norovirus)(p. 2, lines 28-35) comprising administering a composition comprising Bifidobacterium breve (M-16V/NITE BP-02622)(p. 25, lines 31-p. 26, lines 1-25, specifically line 16) and lactoferrin (p. 29, line 35) and which may additionally comprise stabilizers, excipients, diluents, binders, flavoring agents, for example (p. 29, lines 30-32, p. 31, lines 18-29).
Thus, the reference anticipates the claimed subject matter.
New rejection necessitated by amendment
Claim Rejections - 35 USC § 102/ 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 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 an 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.
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) 12, 13 is/are rejected under 35 U.S.C. 102((a)(1) and (a)(2)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO2015/021530 (IDS).
WO2015/021530 teaches a method of inhibiting and treating symptoms of norovirus in a human (p. 12, lines 16) comprising administering a composition comprising probiotic bacteria selected from Bifidobacterium infantis, B. bifidum, L. helveticus (p. 1, whole page, p. 3, lines 14-33, p, 4, lines 24-p.6, lines 1-16, 22-27, p.9, lines 23-33, p. 10, lines 34-p. 11, lines 1-2, p. 11, lines 20-32, p. 14, lines 1-9).
While the claimed B. infantis NITE BP-02623, B. bifidum NITE BP-02431, 02432, or 02433, L. helveticus NITE BP-01671 (of claim 12 and 13) is not taught, the art teaches that Bifidobacterium infantis, B. bifidum, L. helveticus are used in methods of treating norovirus.
The reference microorganisms Bifidobacterium infantis, B. bifidum, L. helveticus appearsto be identical to the presently claimed strains since the microorganism is disclosed in a composition for treating norovirus and is considered to anticipated the claimed microorganisms.
In the alternative, even if the claimed microorganisms are not identical to the referenced strains with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the referenced microorganisms are likely inherently possess the same characteristics of the claimed microorganisms particularly in view of the similar characteristics which they have been shown to share, i.e. treatment of the same illnesses and symptoms thereof and assignment to the same genus or species. Thus, the claimed strain would have been obvious to those of ordinary skill in the art within the meaning of USC 103.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of evidence to the contrary.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicant’s strains differ and, if so, to what extent, from the strains discussed in the references. Accordingly, it has been established that the prior art strains, which are of the same species as that claimed, likewise share the property of treating mental illness and symptoms thereof, and thus demonstrate a reasonable possibility that the compared strains are either identical or sufficiently similar; and therefore, whatever differences exist, are not patentably significant. Therefore, the burden of establishing non-obviousness by objective evidence is shifted to Applicants.
Thus, a POSITA would have had a reasonable expectation that the claimed strain and that of the prior art would exhibit the same characteristics and functions when substituted for each other, therefore, one could have substituted one known strain for another and the results of the substitution would have been predictable.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2015/021530 (IDS) as applied to claims 12 and 13 above, and further in view of WO2016/139333 (IDS) and Wakabayashi et al. (J. Infect. Chemother., 2014, IDS).
WO2015/021530 teaches a method of inhibiting and treating symptoms of norovirus in a human (p. 12, lines 16) comprising administering a composition comprising probiotic bacteria selected from Bifidobacterium infantis, B. bifidum, L. helveticus (p. 1, whole page, p. 3, lines 14-33, p, 4, lines 24-p.6, lines 1-16, 22-27, p.9, lines 23-33, p. 10, lines 34-p. 11, lines 1-2, p. 11, lines 20-32, p. 14, lines 1-9).
While the claimed B. infantis NITE BP-02623, B. bifidum NITE BP-02431, 02432, or 02433, L. helveticus NITE BP-01671 (of claim 12 and 13) is not taught, the art teaches that Bifidobacterium infantis, B. bifidum, L. helveticus are used in methods of treating norovirus.
The reference microorganisms Bifidobacterium infantis, B. bifidum, L. helveticus appearsto be identical to the presently claimed strains since the microorganism is disclosed in a composition for treating norovirus and is considered to anticipated the claimed microorganisms.
In the alternative, even if the claimed microorganisms are not identical to the referenced strains with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the referenced microorganisms are likely inherently possess the same characteristics of the claimed microorganisms particularly in view of the similar characteristics which they have been shown to share, i.e. treatment of the same illnesses and symptoms thereof and assignment to the same genus or species. Thus, the claimed strain would have been obvious to those of ordinary skill in the art within the meaning of USC 103.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of evidence to the contrary.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicant’s strains differ and, if so, to what extent, from the strains discussed in the references. Accordingly, it has been established that the prior art strains, which are of the same species as that claimed, likewise share the property of treating mental illness and symptoms thereof, and thus demonstrate a reasonable possibility that the compared strains are either identical or sufficiently similar; and therefore, whatever differences exist, are not patentably significant. Therefore, the burden of establishing non-obviousness by objective evidence is shifted to Applicants.
Thus, a POSITA would have had a reasonable expectation that the claimed strain and that of the prior art would exhibit the same characteristics and functions when substituted for each other, therefore, one could have substituted one known strain for another and the results of the substitution would have been predictable.
WO530 does not teach administering lactoferrin with the probiotic bacteria.
WO’333 teaches a method of treating norovirus in a human comprising administering the claimed bacteria with lactoferrin.
Further, Wakabayashi teaches lactoferrin to decrease murine norovirus infection to murine macrophage cell line Raw264.7 through inhibition of the norovirus attachment to cells and interference with norovirus replication. Lactoferrin induces the antiviral cytokine, interferon α/β (IFN α/β), which inhibits viral replication in the infected cells. Wakabayahi also teaches that the oral administration of lactoferrin to children reduced noroviral gastroenteritis (p. 667, section 3. Viral gastroenteritis).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use lactoferrin with the claimed bacterial strains to treat/inhibit norovirus infection and replication, in light of the teachings of the prior art references.
Response to Arguments
Applicant's arguments filed 6/18/2025 have been fully considered but they are not persuasive.
Regarding the 112(a)-enablement rejection over preventing or inhibiting a norovirus infection, applicant argues that they teach a plaque formation assay which is well-known in the art for teaching measuring and quantifying infectious particles in a sample. Applicant argues that the data clearly shows prevention or inhibition of plaque, directly correlated with infection prevention and further argues that the claims do not require 100% prevention of infection but prevention or inhibition which could be measure relative to a control, and thus prevention/inhibition would be attained.
It is the Examiners position that the claims are drawn to inhibiting norovirus from infecting a human (claim 12) and preventing syndromes or a symptom by inhibiting norovirus infection, and the data only demonstrates a reduction in plaque formation but does not demonstrate preventing or inhibiting norovirus in a human. In Fig. 1-4, it can be seen that there is only a reduction in plaque formation compared to control but not inhibition or prevention of infection as the claimed strains demonstrate between 20-60% plaque formation compared to control (100%). Thus, the strains would not prevent or inhibit the virus from infecting a human. The rejection is maintained.
Regaridng the WO’333 reference applicants argue that the reference only teaches the M-16 (NITE BP-02622) strain and does not disclose any other bacterial species. Applicants further argue the reference does not teach administering with lactoferrin.
It is the Examiners position that the reference teaches a claimed strain from the Markush group of claims 12 and 13 and the reference teaches that the composition comprising the probiotic strains are formulated with lactoferrin (p. 29, line 35) and which may additionally comprise stabilizers, excipients, diluents, binders, flavoring agents, for example (p. 29, lines 30-32, p. 31, lines 18-29).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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, Adam Weidner can be reached at 571-272-3045. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/Adam Weidner/SPE, Art Unit 1651