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 11/05/25 in response to the non-final Office Action mailed 08/07/25.
Status of Claims
2) Claims 1, 2, 11 and 14 have been amended via the amendment filed 11/05/25.
Claims 1-17 are pending.
Claims 8-10, 12, 13, 16 and 17 have been withdrawn from consideration as being directed to a non-elected species.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 1-7, 11, 14 and 15 are under examination.
Prior Citation of Title 35 Sections
3) 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
4) 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
5) The provisional rejection of claims 1-7, 11, 14 and 15 set forth in paragraph 8 Office Action mailed 08/07/25 on the ground of non-statutory obviousness double patenting as being unpatentable over claims 1-6, 10 and 13-15 of the co-pending application 18257612 (reference application) is maintained.
Applicants request that this rejection be held in abeyance until allowable subject matter is found.
Rejection(s) Withdrawn
6) The rejection of claims 1-7, 11, 14 and 15 set forth in paragraph 10 Office Action mailed 08/07/25 under 35 U.S.C § 101 as being directed to a judicial exception without significantly more is withdrawn in light of Applicants’ claim amendments to the base claim.
7) The rejection of claim 11 set forth in paragraph 12(a) Office Action mailed 08/07/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ claim amendments.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 claim 14 set forth in paragraph 12(b) Office Action mailed 08/07/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ claim amendments
9) The rejection of claim 15 set forth in paragraph 12(c) Office Action mailed 08/07/25 under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, is withdrawn in light of Applicants’ amendments to claim 14.
10) The rejection of claims 1-7, 14 and 15 set forth in paragraph 14 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) is withdrawn in light of Applicants’ amendments to the base claim narrowing the scope of the claim.
11) The rejection of claims 1 and 3-7 set forth in paragraph 14 Office Action mailed 08/07/25 under 35 U.S.C § 102(a)(1) as being anticipated by Edwards et al. (J. Food Sci. 85: 3543-3551, 31 August 2020, of record) is withdrawn in light of Applicants’ amendments to the base claim narrowing the scope of the base claim.
12) The rejection of claims 1, 3-5 and 7 set forth in paragraph 16 Office Action mailed 08/07/25 under 35 U.S.C § 102(a)(1) as being anticipated by Valdez et al. (J. Food Protection 56: 320-322, 1993, of record) is withdrawn in light of Applicants’ amendments to the base claim narrowing the scope of the base claim.
13) The rejection of claim 11 set forth in paragraph 18 Office Action mailed 08/07/25 under 35 U.S.C § 103 as being unpatentable over Biffi (US 2019192590 A1 (Applicants’ IDS) (‘590) as applied to claim 1 above and further in view of Aljewicz et al. (Food Technol. Biotechnol. 52: 439-447, 2014, of record) is withdrawn in light of Applicants’ amendments to claims 11 and the base claim 1. Applicants are referred to the new art rejection set forth in this Office Action to address the claims as amended. Applicants’ arguments that are still relevant to the claims as amended are addressed below.
Applicants in essence argue that the NCFM is not the instantly recited NCFM having the registration number DSM 33840. Applicants assert that Aljewicz et al. teach that Lactobacillus acidophilus NCFM can be viable in Edam cheese and may enhance peptidolytic activity, but fails to teach the specific strain as claimed, i.e., Lactobacillus acidophilus strain NCFM deposited under registration number DSM33840.
However, contrary to Applicants’ assertion and as set forth below in this Office Action, Aljewicz et al. taught the Lactobacillus acidophilus NCFM strain and its proteolysis-intensifying and peptidolysis-intensifying proteolysis pattern in a cheese, i.e., a food product. Note that the composition recited in instant claim 14 is a food product. Aljewicz et al. taught that the high activity of cell wall proteinases and peptidases synthesized by the L. acidophilus contribute significantly to the release of amino acids. Aljewicz et al. also demonstrated that the Lactobacillus acidophilus NCFM strain retained significant viability in cheese. The maintenance of viability is an important feature of the probiotic bacteria as recited at lines 30-32 of page 6 of Applicants’ specification. See last full paragraph on page 440; and 1st and 2nd sentences of 2nd full paragraph in left column of page 446; the last full sentence in left column of page 446; and the last half of Summary on page 439 of Aljewicz et al. Applicants’ statement that NCFM is not the instantly recited NCFM having the registration number DSM 33840 is a mere attorney argument unsupported by evidence. The Office notes that no reasoning or evidence is provided in support of the mere assertion that the specific strain as claimed, i.e., Lactobacillus acidophilus strain NCFM deposited under registration number DSM33840, is not taught by Aljewicz et al. "An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness." In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). No specific distinguishing genetic and/or structural characteristics, for example, different 16S rRNA profiles, that differentiate the instantly claimed Lactobacillus acidophilus from that of the prior art, are of record. No part of the as-filed specification indicates that the Lactobacillus acidophilus strain NCFM administered in the claimed method is modified in any way either genetically or in any other way that alters its structure.
Most importantly, with regard to Applicants’ statement that NCFM is not the instantly recited NCFM having the registration number DSM 33840, the Office notes a publication in the art which reports on the NCFM strain of Lactobacillus acidophilus as being equivalent to, synonymous with, or the same as the DSM 33840. For example, Marttinen et al. (Nutrients 15(18), 3905, pages 1 of 17 to 17 of 17, 07 September 2023) identify the strain by referring to it as “NCFM (DSM 33840)”. See line 3 of Abstract; and line 2 of section ‘2.1 Cultivation of Probiotic Bacteria’ of Marttinen et al. The Office further notes that the reference of Marttinen et al. is co-authored by Maija Marttinen, Markku T. Saarinen, Arja Laitila, Paivi Nurminen, Markus J. Lehtinen, and Mehreen Anjum, all of whom appear to be the inventors of the instant application 18257603.
Applicants’ arguments have been considered, but are not persuasive.
Rejection(s) under 35 U.S.C § 112(d) or (Pre-AIA ), Fourth Paragraph
14) 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.
15) Claim 7 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 7, 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 acidophilus strain NCFM deposited under registration number DSM33840. The dependent claim 7 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 § 103
16) 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 of this title, 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, that are applied for establishing a background for determining obviousness under 35 U.S.C § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or unobviousness.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
17) Claims 1-7, 11, 14 and 15 are rejected under 35 U.S.C § 103 as being unpatentable over Biffi (US 2019192590 A1, of record) (‘590) in view of Altermann et al. (PNAS 102: 39-6-3912, 2005) and Aljewicz et al. (Food Technol. Biotechnol. 52: 439-447, 2014, of record).
Biffi (‘590) disclosed a method of increasing the absorption and/or the bioavailability of proteins such as soy protein in an individual with increased protein and/or energy requirements comprising orally administering a composition comprising the Lactobacillus acidophilus probiotic bacteria to the individual in an amount sufficient to allow gut colonization, for example, at least 109 units per day. The probiotic bacteria are more preferably Lactobacillus acidophilus. The composition is in the form of a granular powder, lozenges, a beverage or syrup, a food product such as cheese, fruit juice or yogurt, and further comprises prebiotics such as inulin, guar gum, fructooligosaccharides and galactooligosaccharides. The individuals administered with the composition are preferably those having a need for an increased protein and/or energy requirements, an increased protein absorption and/or bioavailability such as elderly persons, children, pregnant women, or athletes. See claims, claims 12-14, 3, 6, 7, 8, 10 and 1 in particular; Abstract; and sections [0047], [0058], [0055], [0056], [0060], [0041], [0035], [0066] and [0001].
The teachings of ‘590 are set forth supra, which are silent on the L. acidophilus being the L. acidophilus strain NCFM as recited in instant claims.
However, Altermann et al. taught the Lactobacillus acidophilus NCFM strain and showed that it produces proteases that digest proteins extracellularly and generate small peptides and essential amino acids. See section “Proteolytic System” on page 3910, the last full sentence of said section in particular. Altermann et al. expressly taught that the probiotic Lactobacillus acidophilus NCFM organism encodes 20 putative peptidases and homologs for PrtP and PrtM, and two complete oligopeptide transport systems. See 1st full paragraph in bold on page 3906, 1st and 12th sentences therein in particular; and proteases and peptidases shown in green in Figure 1.
Aljewicz et al. also taught the Lactobacillus acidophilus NCFM strain and its proteolysis-intensifying and peptidolysis-intensifying proteolysis pattern in a cheese, i.e., a food product. Aljewicz et al. taught that the high activity of cell wall proteinases and peptidases synthesized by the L. acidophilus contribute significantly to the release of amino acids. Aljewicz et al. also demonstrated that the Lactobacillus acidophilus NCFM strain retained significant viability in cheese. See last full paragraph on page 440; and 1st and 2nd sentences of 2nd full paragraph in left column of page 446; the last full sentence in left column of page 446; and the last half of Summary on page 439.
Given the express teachings of Altermann et al. and Aljewicz et al. as set forth supra, 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 add Altermann’s or Aljewicz’s Lactobacillus acidophilus NCFM strain, an art-known producer of proteases that digest proteins extracellularly and generate small peptides and essential amino acids, to ‘590’s composition in the disclosed gut-colonizing amount of at least 109 units to produce the instant invention. Since both the prior art strain and the instantly recited strain are the specific “NCFM” strain, they cannot have mutually exclusive effects or functions. All the recited characteristics, functions, and effects are specific to and are the intrinsic features inseparable from the prior art NCFM strain. One of ordinary skill in the art would have been motivated to produce the instant invention for the expected benefit of supplementing, strengthening, or adding to the effects of protein absorption effects and/or increasing the bioavailability of proteins such as soy protein in ‘590’s method. The resultant method meets the administering step of the instantly claimed method. Since the same Lactobacillus acidophilus NCFM is administered in the prior art method, it is expected to elicit the same effects as recited in instant claims. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Furthermore, the preamble claim limitations “for breaking down and increasing amino acid and peptide availability delaying skin aging” 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"). Furthermore, MPEP 2144.06 states: ‘It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition to be used for the very same purpose …. [T]he idea of combining them flows logically from them having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quandranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (A mixture of two known herbicides held prima facie obvious).
Claims 1-7, 11, 14 and 15 are prima facie obvious over the prior art of record.
Claim(s) Objection - Suggestion
18) 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 24 on page 7 of the as-filed specification.
Conclusion
19) No claims are allowed.
20) 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
21) 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.
22) 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