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 .
Claim Status
Claims 8-10, 14, 16-17, 19-21, 23, 25-28, 30-32, 34-39 and 41-60 were canceled.
Claims 1-7, 11-13, 15, 18, 22, 24, 29, 33 and 40 are pending.
Claims 33 and 40 were withdrawn from further consideration (see below).
Claims 1-7, 11-13, 15, 18, 22, 24, and 29 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 7/2/2026 is acknowledged.
Claim(s) 33 and 40 were/was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/2/2026.
Applicant’s election without traverse of species Example Group D (Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, Gardnerella spp., Atopobium spp., and Prevotella spp.) in the reply filed on 7/2/2026 is acknowledged.
For compact prosecution, species are rejoined.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at page 116 at paragraph [0550], [0551], [0552] and [0553]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: conjunction “and” must be inserted between Lactobacillus jensenii and Lactobacillus gasseri in line 2-3 of subpart (i) because proper Markush group requires format “selected from A, B, C and D”. Appropriate correction is required. “a material selected from the group consisting of A, B, and C” or “wherein the material is A, B, or C”) MPEP 2117 Markush Claims [R-01.2024]
Claim Rejections - 35 USC § 112
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.
Claims 1-7, 11-13, 15, 18, 22, 24, and 29 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “said method comprising administering to the subject an effective amount of the pharmaceutical composition” in line 3-4 which recites active process step for process claim. However, because the preamble of claim 1 is “a pharmaceutical composition” and therefore it is unclear if Applicant intends to claim composition claim or process claim. Hereinafter, claim 1 will be treated as if claim 1 does not recite “said method comprising administering to the subject an effective amount of the pharmaceutical composition” and claim 1 will be treated as composition claim.
Claim 1 recites “said method” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite “method” before “said method” recited in line 3.
Claims 1, 7, 18, 24 and 29 recite “substantially complete vaginal microbiota preparation” which is a relative term which renders the claim indefinite. The term “substantially complete” is not 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 invention.
In addition, it is unclear what Applicant intends to mean by “complete vaginal microbiota preparation”. Does “complete vaginal microbiota preparation” mean vaginal microbiota preparation comprising all possible microorganisms recited by instant claims? If so, is the preparation comprising only one bacterial species recited by claim 1(i) not a “complete vaginal microbiota preparation”?
It is suggested that Applicant delete “substantially complete” from instant claims.
Claim 1(ii) and claim 18(ii) recite “comprises less than 5% of Gardnerella spp.”. It is unclear what Applicant intends to recite by “comprises less than 5% of Gardnerella spp.”. The concentration unit “%” requires the reference point to determine percentage of what total amount.
It is suggested that Applicant amend
“comprises less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; wherein” to
“comprises Gardnerella spp., Atopobium spp., and Prevotella spp., which comprise less than 5% of all detectable bacterial species of the preparation; wherein” to be consistent with subpart (i).
Wherein-clause of claims 2-5 recites active process steps, and therefore it is unclear if Applicant intends to claim process claim or composition claim for claims 2-5 because claims 2-5 depend from composition claim of claim 1. Claims 2-5 will not be further treated hereinafter.
Claim 13 does not recite any conjunction between Lactobacillus jensenii and Lactobacillus gasseri in line 2. Therefore, it is not clear if claim 13 requires all four species (in case of conjunction “and”) or any one of them (in case of conjunction “or”).
Claim 13 recites “may be present” in line 3 and therefore the recited species may be present or may not be present in greater relative quantity than one or more of the other vaginal lactobacilli present in the preparation. Therefore, it is unclear if these species are present or not present in greater relative quantity than one or more of the other vaginal lactobacilli present in the preparation.
It is suggested that Applicant amend “may be present” to “are present”.
Claim 22 recites “claim 18 one of claims 18 to 21” in line 1-2. Therefore, the dependency of claim 22 is unclear. Hereinafter, claim 22 will be treated as if it depends only from claim 18.
Dependent claims are also rejected because they depend from claim 1 and 18 and do not cure the deficiency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18, 22, 24, and 29 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to a judicial exception (natural phenomenon), specifically, the claims are drawn to a substantially complete vaginal microbiota preparation or pharmaceutical composition comprising the same, wherein said preparation (i) comprises one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) comprises less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; wherein the preparation and/or the pharmaceutical composition comprises a pharmaceutically acceptable carrier or diluent. Furthermore, the claims do not integrate said judicial exception into practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The MPEP Section 2103 through 2106 provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101.
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a composition, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to a natural product, specifically, the claims are drawn to a pharmaceutical composition comprising Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, Gardnerella spp., Atopobium spp., and Prevotella spp. As evidenced by instant Figure 3 and instant specification at page 15, paragraph 0077, this combination of microorganisms is from 96 female donors, and therefore the combination of bacterial species recited by instant claim 18 is natural product.
With respect to prong two of Step 2A, the claim does not recite additional elements that integrate the judicial exception into a practical application. In contrast to instant claim 1 reciting “for use in treating inflammation in the female genitourinary tract of a human subject”, instant claims 18, 22, 24 and 29 do not recite any limitation that integrates the recited judicial exception, for example, by applying or using said judicial exception to effect a particular treatment for a disease or medical condition. Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, in addition to the recited judicial exception, instant claim 18 recites “wherein the preparation and/or the pharmaceutical composition comprises a pharmaceutically acceptable carrier or diluent.” However, this limitation is well-understood, routine, and conventional adjuvant known in the art. This limitation is not additional element that amounts to significantly more than the recited judicial exception. Furthermore, instant claim 24 recites additional limitation “wherein the dosage form is solid, semi-solid, a liquid formulation, or a film-forming formulation”. However, pharmaceutical composition is administered in a dosage form of solid, semi-solid, a liquid formulation, or a film-forming formulation and this limitation is well-understood, routine, and conventional dosage form known in the art. This limitation is not additional element that amounts to significantly more than the recited judicial exception. Instant claim 29 further recites “vaginal delivery system for administration to the vaginal cavity”. However, pharmaceutical composition is administered by a delivery system and instant claim 29 does not recite specific structure of the recited delivery system. In fact, this limitation is recited at such a high level of generality and this limitation’s inclusion in the claim is at best nominal. These limitations are not additional element that amounts to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
A claim that focuses on use of a natural product must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
Claim Rejections - 35 USC § 102
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) 1, 6, 11-12, 15, 18, 24 and 29 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Parks et al (US2020/0171107; published 6/4/2020; 9/5/2023 IDS).
Regarding claims 1 and 18, Parks teaches “An aqueous bacterial suspension (corresponds to “pharmaceutical composition and vaginal microbiota preparation” of instant claim 1) of vaginal Lactobacillus species, having no animal-derived excipients, where the suspension results from a combination of a cell pellet of vaginal Lactobacillus species with an aqueous preservation medium (corresponds to “pharmaceutically acceptable carrier or diluent” of instant claim 1) consisting essentially of: (i) trehalose at between 5-20%, w/v; (ii) xylitol at between 2-9%, w/v; (iii) sodium ascorbate 0.5-1.5%, w/v; and (iv) sodium phosphate at between 10-50 mM.” (claim 1). The limitation “for use in treating inflammation in the female genitourinary tract of a human subject, wherein the female subject exhibits a dysbiotic microbiota in the genitourinary tract” of instant claim 1 is intended use and does not change the claimed composition. Parks teaches “The bacterial suspension of claim 1, wherein the vaginal Lactobacillus species is selected from the species consisting of Lactobacillus crispatus, Lactobacillus jensenii and Lactobacillus gasseri.” (claim 4). Because Parks does not teach that the bacterial suspension further comprises other bacterial species, it is considered that the bacterial suspension of Parks comprises 100% of Lactobacillus crispatus, Lactobacillus jensenii and/or Lactobacillus gasseri. which corresponds to “about 99.9% of all detectable bacterial species of the preparation” of instant claim 1(i).
Parks does not expressly teach that the bacterial suspension comprises less than 5 % of Gardnerella spp., Atopobium spp., and Prevotella spp. as recited by instant claim 1(ii). Therefore, it seems that the bacterial suspension of Parks does not comprise these species and because 0% is less than 5%, the bacterial suspension of Parks is encompassed by instant claims 1 and 18.
Regarding claim 6 and 15, wherein-clause of claim 6 and 15 describes the status of the patient to whom the pharmaceutical composition is intended to be administered and therefore claim 6 and 15 do not change the composition of the claimed pharmaceutical composition of claim 1. Therefore, claim 6 and 15 are also anticipated by Parks.
Regarding claim 11-12, as discussed above, claim 4 of Parks recites “wherein the vaginal Lactobacillus species is selected from the species consisting of Lactobacillus crispatus, Lactobacillus jensenii and Lactobacillus gasseri.” Therefore, the bacterial suspension of Parks encompasses (a) suspension comprising Lactobacillus crispatus only, (b) suspension comprising Lactobacillus jensenii only and (c) suspension comprising Lactobacillus gasseri only. Therefore, claim 11 is anticipated by Parks. By same reasoning, Parks anticipates subpart (a), (d), and (f) of claim 12.
Regarding claims 24 and 29, Parks teaches “A 200-mg dose of the SJ-3C drug product having an activity of 2×109 CFU per dose is administered to the patient vaginally using the packaged medical powder applicator.” [0108]. The limitation “medical powder” corresponds to dosage form of solid as recited by instant claim 24. The limitation “applicator” corresponds to a vaginal delivery system recited by instant claim 29.
Double Patenting
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); 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 § 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
NSDP 1
Claims 1, 6, 11-13 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/108696 (hereinafter application’696; US2026/0207684; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 1, and 18, application’696 claims a method of treating an infertile female subject, said method comprising administering to the subject vaginal microbiota preparation comprising:
PNG
media_image1.png
285
1197
media_image1.png
Greyscale
Therefore, application’696 claims same pharmaceutical composition as instant invention.
Regarding claim 6, application’696 does not claim that the subject has been diagnosed with bacterial vaginosis. Therefore, there is no evidence that the subject of application’696 has been diagnosed with bacterial vaginosis. Thus, it must be that the subject of application’696 has not been diagnosed with bacterial vaginosis.
Regarding claim 11-13, claim 8 of application’696 claims
PNG
media_image2.png
172
1285
media_image2.png
Greyscale
Therefore, claim 8 of application’696 claims subpart (a), (d), and (f) of instant claim 12. Due to conjunction “or” in claim 8 of application’696, claim 8 of application’696 encompasses instant claim 11.
Because at least 90% of all detectable bacterial species of the preparation of application’696 are Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri, these Lactobacillus species are present in greater relative quantity than one or more of the other vaginal lactobacilli present in the preparation as claimed by instant claim 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
NSDP 2
Claims 1 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 43 of copending Application No. 18/863199 (hereinafter application’199; US2025/0382676; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 1 and 18, claim 43 of application’199 claims sample comprising about 80-99.9%: Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, and Lactobacillus gasseri. Because instant claims 1(ii) and 18(ii) recites “comprises less than 5%”, instant claims encompass 0% because 0% is less than 5%. Therefore, composition claimed by instant claims 1 and 18 do not necessarily comprise Gardnerella spp., Atopobium spp., and Prevotella spp. Therefore, instant claims 1 and 18 encompasses claim 43 of application’199.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
Prosecution Insights