DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/25/26 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 4/24/25 is acknowledged.
Priority
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: “wherein the isolated nucleic acid sample is obtained from at least one selected from stool, excreta, dejecta, stercus, feces and gut mucosa of the subject”. See claim 11. While the parent application, as originally filed teaches DNA isolation from fecal samples (Example 1) it does not teach excreta, dejecta, or gut mucosa. Excreta and dejecta are broader than fecal samples as they encompass urine and the gut mucosa is distinct from feces as it is the specialized lining of the digestive tract, not feces. As such, the effective filing date of this claim, which has basis in the originally filed claims of the instant specification, is the actual filing date of this application: 2/18/2022.
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 6, 11, 12, 13 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural law without significantly more.
The method claim(s) recite(s) the relationship between the relative of certain subspecies F06 of F. prausnitzii in a sample and that the subject has atopic dermatitis or is in a high-risk group for atopic dermatitis. This correlation is a natural correlation.
The claims sets forth “determining a relative abundance” which describes a mathematical process abstract idea because determining a relative abundance is determining a ratio.
The claims also recite “determining” that the subject as atopic dermatitis or is in a high risk group which is a mental process abstract idea, because the determining could be accomplished in the mind.
The claims also recite “when the relative abundance of the subspecies…is higher than that of a normal group” which sets forth a comparing of an obtained value and that of a “normal group” which is a mathematical concept abstract idea as well as a mental process abstract idea since the process is simple enough that it could be carried out in the mind.
These judicial exceptions are not integrated into a practical application because the claims do not apply or use the judicial exceptions in any way. The only steps in the claims in addition to the judicial exceptions are pre-solution data gathering steps.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to the judicial exceptions (providing an isolated nucleic acid sample and detecting) are pre-solution data gathering recited at a high level of generality. The claims do not require particular probes or primers provided that they “hybridize” to the region that distinguishes F06. The steps are necessary to apply the judicial exceptions. Furthermore, recognizing a species of bacteria by recognizing a nucleotide sequence in a sample could be accomplished by PCR amplification and detection in a sample, a method was well established, routine, and conventional at the time of the invention, as evidenced by Thomas et al. (Thomas et al. (2015). Future Microbiology, 10(9), 1485–1504. https://doi.org/10.2217/fmb.15.87) and Karch et al. (Journal of Microbiological Methods Volume 23, Issue 1, July 1995, Pages 55-73). Additionally sequencing the V1-V2 regions of 16S rRNA genes in an isolated nucleic acid sample was also routine, as evidenced by Thomas which teaches sequence the 16S gene see p. 1492 and following. See Also MPEP 2106.05(d)II which discusses laboratory techniques the courts have recognized as well-understood, routine, and conventional.
Claim Rejections - 35 USC § 112
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.
Claims 12 and 13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th 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 6 clearly requires “recognizing a nucleotide sequence including SEQ ID NO: 1 or SEQ ID NO: 2 in the isolated sample.” This means that SEQ ID NO: 1 or SEQ ID NO: 2 must be “recognized” or detected in the isolated nucleic acid sample. However, claims 12 and 13 set forth that the recognized sequence is different from SEQ ID NO: 1 or SEQ ID NO: 2 which is not within the scope of claim 1 and therefore not properly dependent from claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 12 and 13 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.
It is unclear how the requirement in claim 6 of “recognizing a nucleotide sequence including SEQ ID NO: 1 or SEQ ID NO: 2” is compatible with the claim limitation in claim 12 that “the sequence recognized” comprises “a sequence of SEQ ID NO: 1” in which there are changes, or similar for SEQ ID NO: 2 in claim 13. How can the recognized sequence be both a a sequence including SEQ ID NO: 1 and a sequence that is different from SEQ ID NO: 1 at the same time?
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) 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (J Allergy Clin Immunol, Vol 137; Number 3; pages 852-860; available online 10/1/2015).
Song et al. teach the claimed methods. See Abstract, methods and materials, and results. Figure 2B and C.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Response to Remarks
Previously set forth rejections were overcome by amendment to the claims.
Remarks are addressed insofar as they are relevant to the currently set forth complete set of rejections.
First, explain basis for the claims, the response refers to numbered paragraphs. However, the specification in this application does not have numbered paragraphs, and the numbering convention used in the remarks is not consistent with the numbering in the related PGPUB. The examiner was able to identify basis for the claims by careful review of the specification and original claims, but future correspondence should be clearer as to what numbering convention is being used or refer to page and line number of the specification.
The rejection under 101 is traversed because applicant argues that the claim as a whole integrates the judicial exception because it is a multi-step workflow that applies a correlation to produce a defined clinical output, namely determination of atopic dermatitis status. The examiner does not agree- the “determining” step in the claim is itself an abstract idea that sets forth a mental process as well as a mathematical concept. It is itself a judicial exception and does not integrate the natural correlation that is set forth in the claims.
Applicant further argues that the specific ordered combination provides an inventive concept because the specific ordered combination was not conventional at the time of filing. However, the step 2B consideration asks whether the claim elements “in addition” to the judicial exceptions amount to significantly more. In the claims, the steps “in addition” to the judicial exceptions are providing an isolated nucleic acid an detecting the subspecies by recognizing SEQ ID NO: 1 or SEQ ID NO: 2 using any possible technique in a technology area where there were many known techniques for detecting a target sequence, including sequencing which is set forth in dependent claim 14. These data gathering steps recite at high level of generality are essential for applying the judicial exception and do not amount to significantly more.
Claims which have basis to the parent application are free of the prior art. Regarding Claim 6, the prior art does not teach determining the relative abundance of subspecies F06 which includes SEQ ID NO: 1 or SEQ ID NO: 2 in a sample, and determining that a subject has atopic dermatitis or is in a high-risk group.
Claim 11 is rejected here because it does enjoy the benefit of priority to the 9/21/16 filing date, as discussed previously in this Office 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