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 .
Applicants’ Amendment
1) Acknowledgment is made of Applicants’ amendment filed 11/04/25 in response to the non-final Office Action mailed 08/06/25. Said amendment is non-complaint under 37 CFR 1.121 in that claims previously withdrawn from consideration as being directed to non-elected species have incorrect status identifiers. Appropriate correction is needed.
Status of Claims
2) Claims 1 and 12 have been amended via the amendment filed 11/04/25.
Claims 1-17 are pending.
Claims 1-6 and 12-15 are under examination.
Information Disclosure Statement
3) Acknowledgment is made of Applicants’ Information Disclosure Statement filed 08/15/25. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Prior Citation of Title 35 Sections
4) The text of those sections of Title 35 U.S. code not included in this action can be found in a prior Office Action.
Prior Citation of References
5) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Rejection(s) Maintained
6) The provisional rejection of claims 1-7, 11, 14 and 15 set forth in paragraph 8 Office Action mailed 08/06/25 on the ground of non-statutory obviousness double patenting as being unpatentable over claims 1-6 and 13-15 of the co-pending application 18257603 (reference application) is maintained.
Applicants request that this rejection be held in abeyance until allowable subject matter is found.
Rejection(s) Withdrawn
7) The rejection of claim 12 set forth in paragraph 10 Office Action mailed 08/07/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ claim amendments.
8) The rejection of claims 1-6 and 13-15 set forth in paragraph 12 Office Action mailed 08/07/25 under 35 U.S.C § 102(a)(1) as being anticipated by Biffi (US 2019192590 A1 (of record, ‘590) as evidenced by the Wikipedia document entitled ‘Lactocaseibacillus rhamnosus’ (pages 1-8, No publication date, of record) is withdrawn in light of Applicants’ amendments to the base claim narrowing the scope of the claim.
Rejection(s) under 35 U.S.C § 112(d) or (Pre-AIA ), Fourth Paragraph
9) The following is a quotation of 35 U.S.C § 112(d):
(d) REFERENCE IN DEPENDENT FORMS. - Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. § 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
10) Claim 6 is rejected under 35 U.S.C § 112(d) or pre-AIA 35 U.S.C § 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6, dependent from the amended claim 1, reciting: wherein “the one or more bacterial strains are probiotic bacterial strains” is improperly broadening in scope. Claim 1, as amended, is limited in scope to the specifically recited bacterial strain species, for example, Lactobacillus rhamnosus strain HN001 deposited under registration number DSM22876. The dependent claim 6 fails to further limit the subject matter of claim 1 from which it depends with regard to the above-identified limitations, because it encompasses any generic probiotic bacterial strains, i.e., other than the bacterial strain species specifically recited in claim 1.
Applicants may cancel the claim, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Rejection(s) under 35 U.S.C § 102
11) 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.
12) Claims 1-6 and 12-15 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by EP 2525811 B2 published 02/27/2019 as evidenced by the Document entitled “Lacticaseibacillus rhamnosus”, USP, The United States Pharmacopeial Convention, page 1/1, DOI: https://doi.org/10.31003/USPNF M10467 05 01.html.
EP 2525811 B2 disclosed a method of enterally administering to an individual in need such as a human infant an effective amount of a composition comprising the Lactobacillus rhamnosus HN001 (DR20) probiotic and a prebiotic. The composition is in a powder form. The effective amount administered is a dose of about 106 to about 1012 CFU, the same dosage as recited in the amended claim 1. The composition is a nutritional formula or infant formula comprising sufficient nutrients including proteins, or nutritional formulas comprising non-hydrolyzed or partially hydrolyzed proteins or protein sources including vegetable/plant proteins from soy, a legume. See sections [0007], [0016], [0012], [0048], [0024] to [0028], [0040], and [0041]. EP 2525811 B2 disclosed a method of administering via feeding (i.e., orally) to pigs a chow composition comprising 1010 CFU (i.e., a dosage falling within the dosage range recited in the amend ed claim 1) daily of Lactobacillus rhamnosus HN001 supplemented with a prebiotic. See section [0093], [0091], [0009], [0001], [0005], [0006], [0099] and [0100]; and claims. The prior art nutritional formula, infant formula, and chow composition comprising therein the disclosed CFU dosage of the Lactobacillus rhamnosus HN001 (DR20) probiotic qualifies at least as a food product or as a pharmaceutically acceptable formulation as claimed in instant claim 13. That the prior art Lactobacillus rhamnosus HN001 is the instantly recited Lacticaseibacillus rhamnosus HN001 is inherent from the teachings of EP 2525811 B2 in light of what is well known in the art. For instance, with the disclosure that Lacticaseibacillus rhamnosus was formerly known as Lactobacillus rhamnosus, the Document entitled “Lacticaseibacillus rhamnosus” (USP, The United States Pharmacopeial Convention, DOI: https://doi.org/10.31003/USPNF M10467 05 01.html) refers to strain HN001 as a specific strain of Lactobacillus rhamnosus. See page 1/1 of said document. The administration to a subject in the prior art method of a dosage ranging from about 106 to about 1012 CFU, or 1010 CFU of the Lactobacillus rhamnosus HN001, the same HN001 strain of Lacticaseibacillus rhamnosus as recited in instant claim 1, is expected to necessarily result in the same effects as the instantly administered HN0001 strain. Two identical strains administered in a dose falling within the recited dose range cannot have mutually exclusive effects. Clearly, the prior art method meets the administering step of instant claims. Furthermore, the preamble claim limitations “for improving protein digestion ....... or both” represent an intended use of the claimed method. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3 d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473,478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
Claims 1-6 and 12-15 are anticipated by EP 2525811 B2. The Document entitled “Lacticaseibacillus rhamnosus” (USP, The United States Pharmacopeial Convention, DOI: https://doi.org/10.31003/USPNF M10467 05 01.html) is not used as a secondary reference in combination with EP 2525811 B2, but rather is used to show that every element of the claimed subject matter is disclosed by EP 2525811 B2 with the unrecited limitation(s) being inherent as evidenced by the state of the art. See In re Samour 197 USPQ (CCPA 1978).
Claim(s) Objection(s) - Suggestion(s)
13) (a) Each the limitations “Colony-Forming Units ...” in claim 1, as amended, is objected to since it is inconsistent with the limitation in the as-filed specification --colony forming units ....--. See for example, line 17 on page 7 of the as-filed specification.
(b) For clarity, it is suggested that Applicants insert the limitation --the-- prior to the limitation “registration number ....” in claims 1 and 12 each as amended.
Conclusion
14) No claims are allowed.
15) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37 C.F.R 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 extension fee pursuant to 37 C.F.R 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.
Conclusion
16) No claims are allowed.
17) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R 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 extension fee pursuant to 37 C.F.R 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.
Correspondence
18) 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 Supervisor of AU 1645, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
19) 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
March, 2026