The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-10 are pending and currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 3-27-2024 has been considered. An initialed copy is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 7 is objected to for containing an obvious typographical error. The phrase “and or” in line 2 should read “and/or”.
Claim 9 is objected to for containing an obvious grammatical error. The phrase “wherein Lactobacillus gasseri is…” in lines 1-2 should read “…wherein the Lactobacillus gasseri is…”.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 his invention.
Biological Deposit
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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.
It is apparent that the Lacticaseibacillus rhamnosus strain HN001 is required in order to practice the invention. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of organisms with the DSMZ under the accession number DSM22876 in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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.
It is apparent that the Lactobacillus acidophilus strain La-14 is required in order to practice the invention. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of organisms with the DSMZ under the accession number DSM33880 in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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.
It is apparent that the Lactobacillus crispatus strain 13331 (Lc-22) and strain 13348 are required in order to practice the invention. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of organisms with the DSMZ under the accession numbers DSM33966 and 33968, respectively, in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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.
It is apparent that the Lactobacillus gasseri strain 13224 is required in order to practice the invention. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of organisms with the DSMZ under the accession number DSM33965 in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
Written Description
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification discloses in vitro growth experiments utilizing the use of supernatants from cultures of Lacticaseibacillus rhamnosus HN001 and Lactobacillus acidophilus La-14. However, the rejected claims are drawn to in vivo methods of promoting the growth and metabolism of vaginal Lactobacillus species utilizing a composition comprising bacterial strains of the genera Lacticaseibacillus and Lactobacillus. The rejected claims optionally require:
the bacterial strain of the genus Lacticaseibacillus is of the species Lacticaseibacillus rhamnosus (claim 2);
the bacterial strain of the genus Lactobacillus is of the species Lactobacillus acidophilus (claim 3);
the strain of Lacticaseibacillus rhamnosus is HN001 (claim 4);
the strain of Lactobacillus acidophilus is La-14;
the vaginal Lactobacillus species is Lactobacillus crispatus and/or Lactobacillus gasseri (claim 7);
the vaginal Lactobacillus crispatus is strain 13331 (LC-122) and/or strain 13348 (claim 8);
the vaginal Lactobacillus gasseri is strain 13224 (claim 9).
With the exception of the oral administration of Lacticaseibacillus rhamnosus HN001 and Lactobacillus acidophilus La-14, none of these treatment methods meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, since the specification is silent as to which bacterial strains of the genera Lacticaseibacillus and Lactobacillus (other than the combination of Lacticaseibacillus rhamnosus HN001 and Lactobacillus acidophilus La-14) have efficacy in promoting the growth and metabolism of vaginal Lactobacillus species generally or Lactobacillus crispatus and/or Lactobacillus gasseri, specifically; or what “phenotype” is required for a given Lacticaseibacillus or Lactobacillus species to have the claimed biological activity when administered in vivo.
To fulfill the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the claimed genus therapeutic methods, Applicant must adequately describe the bacterial phenotype(s) (i.e. Lacticaseibacillus and Lactobacillus species) that correlate with the ability to promote the growth and metabolism of vaginal Lactobacillus species generally or Lactobacillus crispatus and/or Lactobacillus gasseri, specifically. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of Lacticaseibacillus and Lactobacillus species to which the claims are drawn, such as a correlation between the structure (phenotype/species) of the bacteria its recited function (promoting the growth and metabolism of vaginal Lactobacillus species generally or Lactobacillus crispatus and/or Lactobacillus gasseri, specifically), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of treatment methods. The specification is silent with regard to what bacterial species, if any, (other than the combination of Lacticaseibacillus rhamnosus HN001 and Lactobacillus acidophilus La-14) have the claimed biological activity when administered in vivo. The specification is limited to utilizing the use of supernatants from cultures of Lacticaseibacillus rhamnosus HN001 and Lactobacillus acidophilus La-14 to determine specific mechanisms of action. The specification fails to disclose the efficacy of any other Lacticaseibacillus and Lactobacillus species which have the claimed biological activity when administered in vivo and is equally silent with regard to routes of administration and concentrations that need to be employed. Therefore, since the specification fails to adequately describe at least a substantial number of members of the genus of Lacticaseibacillus and Lactobacillus species to which the claims refer it fails to adequately describe at least a substantial number of members of the claimed genus therapeutic treatment methods.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Therefore, because the art is unpredictable, in accordance with the MPEP and current case law, the description of the bacterial species/phenotypes is not deemed representative of the genus of vaginal therapeutics and therefore fail to fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Consequently, only the oral administration of a composition comprising Lacticaseibacillus rhamnosus HN001 and Lactobacillus acidophilus La-14 meets the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
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 1-10 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 is rendered vague and indefinite by the use of the phrase “…metabolism of vaginal Lactobacillus species…”. It is unclear what constitutes “metabolism” or to which Lactobacillus species said term is meant to encompass. Does the method have to affect all Lactobacillus species or some species? If the latter is the case which species? As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 3 is rendered vague and indefinite by the use of the phrase “…wherein the bacterial strain of the genus Lactobacillus is of the species Lactobacillus acidophilus.”. It is unclear whether said phrase is referring to the vaginal Lactobacillus species or the Lactobacillus in the composition to be administered. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 6 is rendered vague and indefinite by the use of the phrase “…wherein the bacteria Lacticaseibacillus:Lactobacillus are present…”. It is unclear what is meant to be engendered by said term as there is no bacterial species identified as Lacticaseibacillus:Lactobacillus. If said phrase is meant to refer to the relative abundance of the Lacticaseibacillus and Lactobacillus species it is suggested that the phrase “… wherein the Lacticaseibacillus and Lactobacillus species are present…”.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alberti et al. (Archives of Gynecology and Obstetrics Vol. 292, pages 861-867 – IDS filed on 3-27-2024) as evidenced by Jang et al. (Nutrients Vol. 9 No. 6, pages 1-14 – IDS filed on 3-27-2024).
Alberti et al. disclose the oral consumption of a composition (Respecta) comprising Lacticaseibacillus rhamnosus HN001 and Lactobacillus acidophilus La-14 (see abstract. Alberti et al. further disclose that a healthy human vagina is characterized by its colonization with members of the genus Lactobacillus. The predominance of lactobacilli in the healthy vaginal microbiota forms are Lactobacillus crispatus, Lactobacillus jensenii and Lactobacillus gasseri, and to a lesser extent Lactobacillus inners. As a reduced proportion of lactobacilli in the vaginal microbiota is associated with disease or increased disease risk; attempts have therefore been made to increase the levels of vaginal lactobacilli through the use of probiotics (see page 861). Finally, Alberti et al. disclose that women who received the aforementioned composition had increased vaginal levels of Lacticaseibacillus rhamnosus and Lactobacillus acidophilus (see page 866). While Alberti et al. does not specifically disclose that that the oral administration of their composition results in an increase in vaginal Lactobacillus crispatus and/or Lactobacillus gasseri, the mere recognition of inherent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Thus, although the prior art does not specifically anticipate the claimed functional interactions, it is the combination of the references that would inherently lead to the modification of the immunological properties. Moreover, the mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. 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. Given, that both Alberti et al. and the rejected claims utilize compositions comprising the same bacterial strains, they would necessarily have the same biological activities. Finally, while Alberti et al. do not explicitly disclose that the Lacticaseibacillus rhamnosus and Lactobacillus acidophilus are present in a ratio of 1:4 (v/v), Jang et al. clearly demonstrates that the Respecta composition contains Lacticaseibacillus rhamnosus and Lactobacillus acidophilus in that ration (see section 2.1 of Jang et al.). Consequently, Alberti et al. anticipates all the limitations of the rejected claims.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 February 7, 2026