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 .
Election/Restrictions
Applicant’s election without traverse of Group II, species Prevotella, primers, probe, antisense oligonucleotides, and 16S rRNA in the reply filed on 10/10/25 is acknowledged.
Claim Objections
Claim 9 is objected to because of the following informalities: there should be an “of” between the word “quantity” and “microorganisms” in the “analyzing” step. Appropriate correction is required.
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 9 is 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 9 is indefinite because when it recites “to determine presence” it is not clear if this means to determine whether or not the microbes are present or if the claim is meant to be limited to analyzing only samples where all five microbes are present. For the purposes of compact prosecution and in light of the specification the claims are interpreted to mean the first option.
Claim 9 is indefinite because the claim requires “categorizing the pregnant woman into a clinical profile” followed by the two “wherein” clauses. The criteria in the two wherein clauses are quite narrow and cannot be reasonably expected to cover the results from every analysis of vaginal fluid in a pregnant woman. It is indefinite what should occur in the instance when the patient does not have one of these profiles. It is clear that the claim requires “categorizing” every woman, but unclear how to categorize a woman, for example who has a ratio of Lactobacillus that is 90% or who has no Ureaplasma, for example. The claim has been interpreted to require a step of categorizing a woman, and “when” the woman has a profile as recited assigning as stated, but “when” the woman does not meet that profile assigning is interpreted broadly to encompass any assignment.
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 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and an abstract idea without significantly more.
The method claim(s) recite(s) an association between preterm birth and level of bacterial genera present in a vaginal fluid sample isolated from a pregnant woman. This is a law of nature judicial exception because the relationship between the levels microorganisms and preterm labor exists regardless of any human activity. Further, the claim recites calculating a ratio which is a mathematical concept abstract idea. Catagorizing a pregnant woman requires comparing the ratios to the standard, which is a mathematical concept abstract idea, and assigning a class is a mental process abstract idea. Thus, the determining and categorizing steps of the claim recite steps that are only judicial exceptions.
This judicial exception(s) is/are not integrated into a practical application because the claims to not apply or use the judicial exceptions in any way.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because in addition to the judicial exceptions the claims only require analyzing a vaginal fluid sample to determine the presence and quantity of microorganisms of a plurality of genera. This step is recited at an extremely high level of generality and invite the practitioner to gather the data necessary to practice the judicial exceptions using any possible technique. Further, the techniques to determine α-diversity and microbiome constituents were well established at the time of the invention. For example, Koedooder et al. teach that reproductive microbiomes can be determined using 16S ribosomal sequencing techniques and that α-diversity is a measure of diversity within a sample (see p. 299, 301-302; Koedooder et al. Human Reproduction Update, Vol.25, No.3 pp. 298–325, 2019). See also, Park and Callahan, cited previously, and Hocevar cited in this Office action.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hocevar et al. (Front. Med. 6:201. doi: 10.3389/fmed.2019.00201. 2019, including supplemental figures).
The reference teaches a method that comprises analyzing a vaginal fluid sample obtained from a pregnant woman to determine the presence and quantity of microorganisms of a plurality of genera, wherein the plurality of genera comprise Lactobacillus, Prevotella, Ureaplasma, Staphylococcus, and Escherichia. See supplementary Figure S4 for evidence that each of these 5 genera were analyzed. The reference teaches determining the relative abundance of each genus, see Figure S4.
Regarding the “wherein” clause the reference does not teach any woman who has the exact profile of either option in the claim.
The profiles assigned to women categorized as term birth where the at least 99% of observed bacteria are Lactobacillus of the bacteria, see for example patient MCBX016 profile illustrated in Supplemental figure S4. The reference teaches that51% of term births had lactobacillus above 98% (p. 6). Thus, these women are assigned a term birth profile as required by the claim based on their Lactobacillus level, and they do not fit into either of the conditional “when” clauses set forth in the claim. The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does no include steps that are not required to be performed because the condition(s) precedent are not met. See MPEP 2111.04(II).
Response to Remarks
All previously set forth rejections were overcome by amendment. Newly formulated rejections are set forth to address the amended claims. Applicant argues that the claim does not preempt the law of nature because the specific composition ratios do not exist as “facts of nature” in a vacuum. However, the examiner cannot agree following the analysis set forth in the new rejection.
The prior 102 rejections were overcome and a new rejection was set forth.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682