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) Applicant’s preliminary amendment filed 04/23/24 and the claim set filed 05/20/26 are acknowledged.
Election
2) Applicant’s election filed 05/20/2026 in response to the restriction and the species election requirement mailed 02/20/2026 is acknowledged. Applicant has elected, without traverse, invention I; and the Faecalibacterium altered salivary microbiota genera species.
Status of Claims
3) Claims 1-20 are pending.
Claims 8-20 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 1-7 are examined on the merits.
Drawings
4) Applicant’s drawings filed 04/23/24 are acknowledged. Figure 3A drawings flow into multiple next pages, each as “Fig. 3A (continued)” without proper labeling as required under 37 CFR 1.84(u)(1). Appropriate corrections to the drawings and to their corresponding description throughout the specification are needed.
Objection(s) to Specification
5) The specification is objected to for the following reason(s):
The instant specification incorporates subject matter into the patent application by reference to a hyperlink “https”. For example, see section [0102]. However, attempts to incorporate subject matter into the patent application by reference to an active hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01. Such embedded active hyperlinks and/or other forms of browser-executable code therefore require deletion or replacement with the phrase --hypertext transfer protocol secure--. It is suggested that Applicant examine the whole specification for similar recitations and make necessary correction.
Information Disclosure Statement
6) Acknowledgment is made of Applicant’s Information Disclosure Statement filed 02/14/25. 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 04/23/2024, is the national stage application filed under 35 U.S.C § 371 of PCT/US2022/078622 filed 10/25/2022, which claims priority to the US provisional application 63/271,957 filed 10/26/2021.
Objection(s) to Specification
8) Instant specification is objected to for the following reason(s):
The instant specification incorporates subject matter into the patent application by reference to a hyperlink “https”. For example, see section [0102]. However, attempts to incorporate subject matter into the patent application by reference to an active hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01. Such embedded active hyperlinks and/or other forms of browser-executable code therefore require deletion or replacement with the phrase --hypertext transfer protocol secure--. It is suggested that Applicants examine the whole specification for similar recitations and make necessary correction.
Rejection(s) under 35 U.S.C § 112(a) or Pre-AIA , First Paragraph
9) The following is a quotation 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.
The following is a quotation of 35 U.S.C § 112 (pre-AIA ), first paragraph:
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 of carrying out the invention.
10) Claim 3 is rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing 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, because the specification does not provide evidence that the claimed biological material is (1) known and readily available to the public; (2) reproducible, e.g., sequenced; or (3) deposited.
Claim 3 is drawn to the method of claim 1 comprising oral administration of a probiotic composition to a subject, wherein the probiotic composition comprises “BL-11”. It is apparent that this BL-11 is required to practice the claimed invention. As a required element, the specifically claimed BL-11 must be known and be readily available to the public, or obtainable by a reproducible method set forth in the specification. If not so obtainable or available, the enablement requirements of 35 U.S.C § 112(a) may be satisfied by a deposit of the claimed BL-11 at an acceptable depository. The as-filed specification has conflicting descriptions of what precisely “BL-11” represents. For example, sections [0026] and [0071] of as-filed specification refer to BL-11 as ‘the BL-11 probiotic’, whereas section [0027] refers to it as pleural “probiotics BL-11”. The last two lines of section [0032] of the as-filed specification recites “ the Bifidobacterium lactis BL-11 (e.g., a subspecies of Bifidobacterium animalis”). Per section [0033] of the specification, BL-11 is a strain. From the instant specification, it appears that this strain, i.e., a biological material, has not been deposited at an acceptable depository as required under 37 C.F.R § 1.801-1.809. If the deposit has been made under the provisions of the Budapest Treaty, then a statement, an affidavit or declaration by Applicant or assignees having the authority and control over the conditions of the deposit, or a statement by an attorney of record who has a registration number over his or her signature, is required. The statement should state that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced, if viable samples cannot be dispensed by the depository. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each state. The statement should identify the deposited strain by its depository accession number, establish that the deposited strain is the same as the one described in the specification/claim, and establish that the deposited strain was in Applicant’s possession at the time of filing.
If the deposit has been made as a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant, by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depositary for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application. The application must contain: 1) The name and address of the depository; 2) The name and address of the depositor; 3) The date of deposit; 4) The identity of the deposit and the accession number given by the depository; 5) The date of the viability test; 6) The procedures used to obtain a sample if the test is not done by the depository; and 7) A statement that the deposit is capable of reproduction. If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the strain described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from Applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the Applicant’s possession at the time the application was filed.
Applicant’s attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 C.F.R § 1.801-1.809 for further information concerning deposit practice.
Rejection(s) under 35 U.S.C § 112(b) or Pre-AIA , Second Paragraph
11) 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.
12) Claims 3, 4, 6 and 7 are 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 inventor or a joint inventor regards as the invention.
(a) Claim 3 is vague, ambiguous and indefinite in the limitation “BL-11”. It is unclear what does BL-11 represent structure-wise, scope-wise and/or source-wise.
(b) Claim 4 is vague, ambiguous and indefinite in the abbreviated limitation “PWS” because it is unclear what does it represent or encompass. It is suggested that Applicant recite the specific full terminology with the abbreviation retained within parentheses.
(c) The dependent claim 6 is indefinite in having an insufficient antecedence issue with regard to the limitations “probiotic administration” in line 2 and “treatment” in line 3. For proper antecedence, it is suggested that Applicant insert the limitation --the-- prior to said limitations.
(d) Analogous rejection applies to the dependent claim 7 with regard to the limitations “probiotic administration” in lines 3 and 4 and “treatment” in line 5.
(e) Claim 4 is ambiguous and indefinite in the phrase “subject ...... comprises a subject diagnosed with ....”. It is unclear how a subject diagnosed with PWS can be comprised within a subject. For the purpose of distinctly claiming the subject matter, it is suggested that Applicant replace the above-identified phrase with --subject ..... is a subject diagnosed with ....--.
Rejection(s) under 35 U.S.C § 102
13) 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.
14) Claims 1-7 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by Kong et al. (Frontiers in Nutrition Nutrients 8: Article 587974, pages 1-14, 19 February 2021 - Applicant’s IDS) (Kong et al., February, 2021).
Kong et al. (February, 2021) taught a method comprising orally administering daily to patients with Prader-Willi Syndrome (PWS) a probiotics supplement comprising 6 x 1010 CFU or 3 x 1010 CFU of Bifidobacterium animalis subsp. lactis, B. lactis-11 (i.e., BL-11) probiotics for 12 weeks. The prior art method altered the gut microbiota at the overall phylum and genus level and significantly increased alpha diversity. The altered microbiota in the prior art method included an increase in or the presence of Faecalibacterium. See page 1; MATERIALS AND METHODS; the paragraph bridging the two columns on page 3; RESULTS; and Figures 5 and 6. The prior art method meets the structural requirements of the instantly claimed method in that the very same Bifidobacterium animalis subsp. lactis, BL-11 is administered orally to the very same PWS patient population as claimed, and therefore, the prior art method necessarily results in the same biological effects as the instantly claimed method, i.e., an altered salivary microbiota in the PWS patient with an increase in alpha diversity. Furthermore, the claim limitations “to alter the salivary microbiota of a subject .....” represent the 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 1-7 are anticipated by Kong et al. (February, 2021).
15) Claims 1 and 4-7 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by Kong et al. (Probiotics and Antimicrobial Proteins 13: 1508-1520, 11 June 2021 - Applicant’s IDS) (Kong et al., June, 2021).
Kong et al. (June, 2021) taught a treatment method comprising orally administering daily to patients with Prader-Willi Syndrome (PWS) a probiotic supplement comprising 6 x 1010 CFUs of the Limisilactobacillus reuteri LR-99 probiotic for 12 weeks or 6 weeks. Said treatment increased the abundance of Faecalibacterium. See Abstract; 1st sentence of the paragraph bridging pages 1516 and 1517; the last but one row of Table 5; section ‘Study Design’ on page 1509; and the last full paragraph on page 1500. The prior art method meets the structural requirements of the instantly claimed method in that a probiotic composition is administered orally to the PWS patient population as claimed, and therefore, the prior art method necessarily results in the same biological effects as the instantly claimed method, i.e., an altered salivary microbiota in the PWS patient with an increase in alpha diversity. Furthermore, the claim limitations “to alter the salivary microbiota of a subject .....” represent the 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 and 4-7 are anticipated by Kong et al. (June, 2021).
16) Claim 1 is rejected under 35 U.S.C § 102(a)(1) as being anticipated by Park H-R (Res. J. Pharm. Technol. 10: 2984-2988, 2017 - Abstract).
Park H-R taught a treatment method wherein test subjects ingested (orally consumed) probiotics once a day. Said prior art method decreased or suppressed salivary S. mutans counts and increased salivary Lactobacilli counts, i.e., altered the salivary microbiota. See Abstract.
Claim 1 is anticipated by Park H-R.
Double Patenting Rejection(s)
17) 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 claims at issue 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://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.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
18) Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 9, 13-15, 17-19 and 21 of the co-pending application 18267969 (‘969).
Although the conflicting claims are not identical, they are not patentably distinct from each other. The claims of the co-pending ‘969 application, drawn to a method of treating a pediatric subject diagnosed with or at risk of Prader-Willi syndrome, the method comprising administering to the subject an effective amount of a probiotic comprising Bifidobacterium animalis subsp. lactis BL-11 (BL-11) for at least about 3 weeks or 12 weeks, wherein the method resulted in an increase in Faecalibacteria in the microbiome, read on instant claims drawn to a method comprising administering orally a probiotic composition comprising Bifidobacterium animalis subsp. lactis or BL-11. The method of the co-pending ‘969 application meets the structural requirements of the instantly claimed method in that the very same Bifidobacterium animalis subsp. lactis, BL-11 is administered to the very same PWS patient population as claimed, and therefore, the method of the co-pending ‘969 application necessarily results in the same biological effects as the instantly claimed method, i.e., an altered salivary microbiota in the PWS patient with an increase in alpha diversity. Furthermore, the claim limitations “to alter the salivary microbiota of a subject .....” represent the 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").
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19) Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21of the co-pending application 18794131 (‘131).
Although the conflicting claims are not identical, they are not patentably distinct from each other. The claims of the co-pending ‘131 application, drawn to a method of treating a pediatric subject diagnosed with or at risk of Prader-Willi syndrome, the method comprising administering to the subject an effective amount of a probiotic comprising Bifidobacterium animalis subsp. lactis (B. lactis) for at least about 12 weeks, wherein the method resulted in an increase in Faecalibacteria in the microbiome, read on instant claims drawn a method comprising administering orally a probiotic composition comprising Bifidobacterium animalis subsp. lactis or BL-11. As in In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008), the specification of the co-pending ‘131 application, for example at sections [0208] and [0161], defines the Bifidobacterium animalis subsp. lactis by identifying it as Bifidobacterium animalis subsp. lactis BL-11 probiotic indicating that the BL-11 Bifidobacterium animalis subsp. lactis is 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 method of the co-pending ‘131 application meets the structural requirements of the instantly claimed method in that the very same Bifidobacterium animalis subsp. lactis, BL-11 is administered to the very same PWS patient population as claimed, and therefore, the method of the co-pending ‘131 application necessarily results in the same biological effects as the instantly claimed method, i.e., an altered salivary microbiota in the PWS patient with an increase in alpha diversity. Furthermore, the claim limitations “to alter the salivary microbiota of a subject .....” represent the 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").
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
20) Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8, 10, 11, 13-15, 17-19 and 20 of the co-pending application 18972671 (‘671).
Although the conflicting claims are not identical, they are not patentably distinct from each other. The claims of the co-pending ‘671 application, drawn to a method of treating a pediatric subject diagnosed with or at risk of Prader-Willi syndrome, the method comprising administering to the subject an effective amount of a probiotic comprising Bifidobacterium animalis subsp. lactis BL-11 (BL-11) for at least about 3 weeks or 12 weeks, wherein the method resulted in an increase in Faecalibacteria in the microbiome, read on instant claims drawn a method comprising administering a probiotic composition comprising Bifidobacterium animalis subsp. lactis or BL-11. The method of the co-pending ‘671 application meets the structural requirements of the instantly claimed method in that the very same Bifidobacterium animalis subsp. lactis, BL-11 is administered to the very same PWS patient population as claimed, and therefore, the method of the co-pending ‘671 application necessarily results in the same biological effects as the instantly claimed method, i.e., an altered salivary microbiota in the PWS patient with an increase in alpha diversity. Furthermore, the claim limitations “to alter the salivary microbiota of a subject .....” represent the 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").
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Objection(s) to Claim(s) - Suggestion(s)
21) Claim 1 is objected to for the following reason(s):
(a) The notation “:” in line 1 of claim 1 within the limitation “thereof:” is unnecessary and should be replaced with a comma.
(b) The notation “:” in line 2 of claim 1 within the limitation “comprising:” is unnecessary and should be deleted.
Conclusion
22) No claims are allowed.
Correspondence
23) 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, her supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
24) 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
June, 2026
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