DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1-19 are pending.
Election/Restrictions
Applicants' election with traverse of Group I, claims 1-3 and 13, drawn to a combination of biomarkers comprising COL1A1 and CCN5, in the reply filed on 1/26/26 is acknowledged. The traversal is on the ground(s) that “when the claims are considered as a whole, the common technical feature is not merely the recitation of COLA1A1 and CCN5 in biological samples, but their use in combination as biomarkers for assessing risk of preterm delivery” (pages 1-2) and that “no lack of unity objection was raised during the international (PCT) phase for a substantially similar set of claims”, which “supports that the claims are properly unified” (page 2).
These arguments have been fully considered but are not found persuasive for the following reasons. First, the elected invention is directed to product, the recited use for this product is an intended use that does not distinguish the claimed product from a prior art reference teaching the same product. See the rejection of the claims under 35 U.S.C. 102(a)(1) set forth below. Thus, as set forth previously, the technical feature linking the inventions of Groups I and II does not constitute a special technical feature as defined by PCT rule 13.2, as it does not define a contribution over natural products that inherently express both proteins, which constitutes prior art. Second, consideration of lack of unity in a 371 (National Phase) application by the USPTO is not bound by determination during the International Phase. Claims 4-12 and 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The elections without traverse of (1) “protein biomarkers/antibodies” as the species of “biomarker structure/means of detection”, and (2) CCL2 as the species of first additional markers, in the reply filed on 1/26/26 are also acknowledged.
Claims 1-3 and 13 are under consideration, as they read on the elected species.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive because it is directed broadly to any combination of biomarkers for preterm delivery, but the claimed biomarkers are limited to combinations including COL1A1 and CCN5. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Combination of COLA1A and CCN5 Biomarkers of Preterm Delivery”.
---On page 69, line 10, “24 et” should be “24 and”.
Appropriate correction is required.
Claim Objections
Claims 1-3 and 13 are objected to because of the following informalities:
In claim 1, the acronyms “COL1A1” and “CCN5” should be accompanied by the full terminology the first time each is used in a series of claims; e.g., “COL1A1 (collagen type I alpha 1)” and “CCN5 (cellular communication network factor 5)”. See pages 11-12 of the specification.
In claim 13, line 3, “is pregnant individual” should be “is a pregnant individual”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 13 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 pre-AIA the applicant regards as the invention.
Claim 13 recites the limitation “the individual” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Specifically, there is no recitation of an individual in parent claim 1 to provide antecedent basis for the recitation in claim 13.
Claim Rejections - 35 USC § 112(d)
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
Claim 13 is 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.
Per MPEP 608.01(n).III, “If the dependent claim does not comply with the requirements of 35 U.S.C. 112(d), the examiner should reject the dependent claim under 35 U.S.C. 112(d) rather than objecting to the claim” and “a dependent claim must be rejected under 35 U.S.C. 112(d) if it omits an element from the claim upon which it depends or it fails to add a limitation to the claim upon which it depends”.
Specifically, dependent claim 13 further limits the combination of biomarkers of claim 1 to a combination “wherein the individual is [sic] pregnant individual”. As set forth above, this recitation lacks antecedent basis because the parent claim does not recite an individual. However, assuming that the further limitation of claim 1 is directed to the intended use recited in parent claim 1, which is “for use as biomarkers for preterm delivery, wherein the preterm delivery is a preterm delivery before 32 weeks of gestation”, claim 13 does not further limit the parent claim because the use of claim 1 that is directed to 32 weeks of gestation is, by definition, already directed to a pregnant individual. Therefore, dependent claim 13 is of improper dependent form because it fails to further limit the subject matter of parent 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 § 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 1-3 and 13 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 abstract ideas) without significantly more.
Per the “2019 Revised Patent Subject Matter Eligibility Guidance" (available at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf), subject matter eligibility under 35 U.S.C. 101 involves two considerations, termed "steps". The first consideration, "Step 1", is whether the claimed invention is directed to one of the four statutory patent-eligible subject matter categories that are listed in 35 U.S.C. 101 (see MPEP 2106.03). The second consideration, "Step 2", is divided into two parts, "Step 2A" and "Step 2B". Step 2A includes evaluating whether the claim recites a judicial exception ("Prong One"), and if so, whether the judicial exception is integrated into a practical application ("Prong Two"). Step 2B involves evaluating whether the claim provides an element, or combination of such, sufficient to ensure the claim as a whole amounts to significantly more than the judicial exception.
With respect to Step 1, independent claim 1, from which each of the other claims depends, is directed to a combination of biomarkers comprising COL1A1 and CCN5, and is therefore a composition of matter, which is one of the four categories of subject matter. Thus, the claims are directed to patent-eligible subject matter.
With respect to Step 2A, Prong One, claim 1 is directed to a product (composition of matter) that is a combination of biomarkers comprising COL1A1 and CCN5. The specification teaches that COL1A1 is “collagen type I alpha 1” (page 11, lines 28-29), and that CCN5 is “cellular communication network factor 5”, also known as WISP2 (page 12, lines 1-2). The specification teaches that with respect to the term “biomarkers”, this term “may be used to refer to a naturally-occurring biological molecule present in a sample obtained from pregnant individual at varying concentrations and that may be isolated from, or measured in the sample, and which is particularly useful in prognosis and/or diagnosis the risk of preterm delivery, advantageously useful in prognosis and/or diagnosis the risk of preterm delivery before 32 weeks of gestation” (page 10, lines 4-9). The specification further indicates that the biomarkers can be proteins or nucleic acids (page 10, lines 9-12). As such, the biomarkers of the invention include DNA, RNA and proteins. Therefore the combination of claim 1 encompasses any of COL1A1 DNA (i.e., the gene itself), COL1A1 mRNA, or COL1A1 protein in combination with any of CCN5 DNA, CCN5 mRNA, or CCN5 protein. The working examples in the specification provides evidence that the combination of COL1A1 protein and CCN5 protein naturally occurs in vaginal samples from “women with symptomatic preterm labor” between 24 and 32 weeks of gestation (Example 1; see pages 61-63). Accordingly, claim 1 encompasses a combination of biomarkers comprising COL1A1 and CCN5 from a natural source. Per MPEP 2106.04(b), “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.” In the instant case, the combination of COL1A1 protein and CCN5 protein encompassed by claim 1 has the same structural characteristics as the naturally-occurring combination. Accordingly, this limitation is directed to a ‘product of nature’, which is a type of natural phenomenon judicial exception (MPEP 2106.04.II), and the claims are held to recite a judicial exception according to Step 2A, Prong One.
With respect to Step 2A, Prong Two, this is evaluated by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (b) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. Furthermore, the “[f]or a claim reciting a judicial exception to be eligible, the additional elements (if any) must “transform the nature of the claim” into a patent-eligible application of the judicial exception”. In the instant case, the only additional limitations recited in claim 1 are that the combination is “for use as biomarkers for preterm delivery, wherein the preterm delivery is a preterm delivery before 32 weeks of gestation. This merely indicates an intended use for the product, and in accord with MPEP 2106.04(d)(2), an intended use is not sufficient to integrate a judicial exception into a practical application. Accordingly, the combination of claim 1 does not integrate the judicial exception into a practical application.
Claims 2 and 3 each depend from claim 1 and require that the combination of biomarkers include one further biomarker selected from a group (claim 2) or all of the biomarkers recited in a group (claim 3). The specification provides further evidence that each of the further biomarkers, including ALDH1A1, CCL18, CCL13, IL1RL1, CD14, CD!63 and TNFRSF8 are also present in protein form in the vaginal samples (Example 2, pages 63-65). As such, the combinations of claims 2 and 3 are also directed to products of nature that are not markedly different from the natural phenomenon. Furthermore, there are no additional limitations that would integrate the judicial exception into a practical application.
Claim 13 depends from claim 1 and presents a further limitation that is directed solely to the intended use of the parent claim; specifically, it further limits that the individual is pregnant. As this is directed solely to the intended use, it is not sufficient to integrate the judicial exception into a practical application for the same reasons as for the intended use of parent claim 1.
Note on Prior Art Rejection(s)
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 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.
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.
Claims 1-3 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldenberg et al. 1996. Obstet Gynecol. 87:656-60. The earliest date to which the instant application claims priority is 10/26/20.
Claim 1 is directed to a product that is a combination of biomarkers comprising COL1A1 and CCN5. The recitation that the biomarkers are “for use as biomarkers for preterm delivery, wherein the preterm delivery is a preterm delivery before 32 weeks of gestation” has been considered in the context of the entire claim, and is interpreted as an intended use for the method because it does not result in any structural difference between the claimed product and a prior art reference teachings the same product. See MPEP 2111.02. Thus, claim 1 encompasses a combination of biomarkers comprising COL1A1 and CCN5. As set forth the elected species of “biomarker structure/means of detection” is “protein biomarkers/antibodies”. The specification teaches that with respect to the term “biomarkers”, this term “may be used to refer to a naturally-occurring biological molecule present in a sample obtained from pregnant individual at varying concentrations and that may be isolated from, or measured in the sample, and which is particularly useful in prognosis and/or diagnosis the risk of preterm delivery, advantageously useful in prognosis and/or diagnosis the risk of preterm delivery before 32 weeks of gestation” (page 10, lines 4-9). As such, the “biomarkers” of the claim is interpreted broadly as encompassing a biological sample that includes a combination of naturally-occurring COL1A1 and CCN5 proteins.
Goldenberg teaches vaginal samples from women from 23-24 to 30 weeks gestation (see Abstract), which were collected for analysis of fetal fibronectin (see Abstract), a known biomarker for preterm delivery (page 656). The instant specification provides evidence that vaginal samples collected from “women with symptomatic preterm labor” between 24 and 32 weeks of gestation inherently include the COLA1A1 and CCN5 protein (Example 1; see pages 61-63). Thus, the samples taught by Goldenberg inherently comprise the COL1A1 and CCN5 proteins, even if not recognized as such by Goldenberg. Thus, the samples taught by Goldenberg meet the limitations of the combination of claim 1, as such samples inherently represent a combination of biomarkers comprising COL1A1 and CCN5 proteins. As such, the teachings of Goldenberg anticipate claim 1.
Claims 2 and 3 each depend from claim 1 and require that the combination of biomarkers include one further biomarker selected from a group (claim 2) or all of the biomarkers recited in a group (claim 3). The specification provides further evidence that each of the further biomarkers, including ALDH1A1, CCL18, CCL13, IL1RL1, CD14, CD!63 and TNFRSF8 are also present in protein form in the same vaginal samples (Example 2, pages 63-65). As such, the samples taught by Goldenberg meet the limitations of the combination of claims 2 and 3, as such samples inherently represent a combination of biomarkers comprising COL1A1, CCN5, ALDH1A1, CCL18, CCL13, IL1RL1, CD14, CD!63 and TNFRSF8 proteins. As such, the teachings of Goldenberg also anticipate claims 2 and 3.
Claim 13 depends from claim 1 but fails to further limit the claim for the reasons set forth above in the section titled, “Claim Rejections – 35 U.S.C. 112(d)”. As such, the teachings of Goldenberg that anticipate claim 1 also anticipate claim 13.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674