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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 of RCE on 8/7/25 and the amendment of claims has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I, claimed in claims 1-19 and 22 in the reply filed on 4/17/23 was previously acknowledged. Election was made without traverse of a combination of plasma, MNCs and MSCs and FGF-4.
In the reply filed 7/12/23, Applicants amended claims 1, 16,18 and added NEW claims 24-35. Claims 2-15 and 23 were canceled.
In the reply filed 6/9/25, Applicants amended 1, 25-26, 33 and added new claims 36-38. Claim 16 and 18 were canceled.
Claims 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1, 17-22 and 24-35 are pending
Claims 1, 17, 19, 22 and 24-38 read on elected Group I and elected species and are under consideration.
Claim Objections-Withdrawn
The objection to claims 25, 26 and 33 is withdrawn due to amendment of the claims.
Claim Rejections-Withdrawn
The rejection of claims 1, 17, 19 and 22 under 35 U.S.C. 102(a)(1) as being anticipated by Silini et al. (Frontiers in Bioengineering and Biotechnology Review, Oct 2015; Vol. 3 Article 162) as evidenced by The Human Protein Atlas, BDNF (Tissue expression of BDNF - Summary - The Human Protein Atlas, accessed 5/4/23), FGF-7 (Tissue expression of FGF7 - Summary - The Human Protein Atlas, accessed 5/4/23), GDF-11 (Tissue expression of GDF11 - Summary - The Human Protein Atlas, accessed 5/4/23) and IL-10 (Tissue expression of GDF11 - Summary - The Human Protein Atlas, accessed 5/4/23) (<Tissue expression of BMP2 - Summary - The Human Protein Atlas, accessed 5/5/23), Siddesh et al. (“Stem Cell Investig, 2021;8:3;2021) and Ziganshina et al. (Aca Naturae, 2016 Jul-Sep; 8(3):59-71) is withdrawn due to amendment of the claims.
The rejection of claims 25 and 26 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) is withdrawn due to amendment of the claims.
Claim Rejections - 35 USC § 101-Maintained
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.
The rejection of claims 1, 17, 19, 22 and 24-35 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter is maintained and extended to new claims 36-38. Based upon an analysis with respect to the claim as a whole, claims 1, 17, 19, 22 and 24-38 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s 2019 Revised Patent subject matter Eligibility Guidance (referred to as 2019 PEG) published January 2019 and the “PEG update” in October 2019. This rejection has been modified necessitated by amendment of the claims.
Claim Interpretation
Claims 1, 17, 19, 22 and 24-38 are drawn to a sterilized liquid therapeutic formulation comprising plasma, a plurality of MNCs, a plurality of MSCs, BDNF, FGF-7, GDF-11 and IL-10, BPC-157 and a pharmaceutically acceptable carrier wherein the plurality of isolated MNCs and MSCs have been isolated and expanded in culture from an umbilical cord and/or placental tissue.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see, e.g., 79 FR 74621)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a composition of matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (see, e.g., 79 FR 74621)?
Yes, the claims are directed to a natural phenomenon. The components of claim 1 are naturally found in the placenta. As evidenced by The Human Protein Atlas, BDNF (Tissue expression of BDNF - Summary - The Human Protein Atlas, accessed 5/4/23), FGF-7 (Tissue expression of FGF7 - Summary - The Human Protein Atlas, accessed 5/4/23), GDF-11 (Tissue expression of GDF11 - Summary - The Human Protein Atlas, accessed 5/4/23) and IL-10 (Tissue expression of IL10 - Summary - The Human Protein Atlas, accessed 5/4/23) are naturally found in the placenta. As evidenced by Siddesh et al. (“Stem Cell Investig, 2021;8:3;2021) placenta possesses various compartments of stem cells (Fig. 1) including mesenchymal stem cells. Mesenchymal stem cells are the same as Mesenchymal signaling cells (please see [0037] of the instant specification). MNCs and plasma are also obtained from placenta (please see [0035, 0039] of instant specification). Therefore, the placenta includes plasma, MNCs, MSCs, BDNF, FGF-7, GDF-11 and IL-10. As evidenced by McPhee (Molecules. 2014 Nov. 19; 19(11): 19066-19077), BPC-157 is a peptide derived from human gastric juice and is naturally occurring. A combination of naturally occurring components that is not found in nature but does not have markedly different characteristics is not patent eligible.
Accordingly, the pending claims are directed to a naturally occurring product.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application?
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see, e.g., 79 FR 74621)?
No, the claims do not recite additional elements that amount to significantly more than the judicial exception. With respect to limitation “wherein the plurality of isolated MNCs and/or the plurality of isolated MSCs have been isolated and expanded in culture from an umbilical and/or placental tissue”, there is no indication that isolated MNCs and/or MSCs isolated and expanded in culture have characteristics (structural, functional, or otherwise) that are different from naturally occurring MSCs and MNCs found in the placenta. With respect to claim 17, hyaluronic acid is naturally found in the placenta as well. As evidenced by Ziganshina et al. (Aca Naturae, 2016 Jul-Sep; 8(3):59-71) discloses that hyaluronic acid is found in the placenta (p. 13, 2nd col.). With respect to claim 19, BMP-2 is naturally expressed in the placenta (<Tissue expression of BMP2 - Summary - The Human Protein Atlas, accessed 5/5/23). With respect to claim 22, dosage units of the naturally occurring combination does not amount to significantly more. Claims 24-38 do not add significantly more than the judicial exception.
Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in the Guidance (74623; see esp. 79 FR 74623 at §I.A.3.b). see also, 79 FR.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 1, 17, 19, 22 and 24-38 do not qualify as eligible subject matter.
Response to Arguments
Applicant's arguments filed 6/8/25 have been fully considered but they are not persuasive. Applicants argue the rejection should be withdrawn because the combination is not found in nature together. Applicants argue that none of the references cited even mentions the application of these components to the eye and it is nonsensical to consider adding placental components in their natural states to the eye. Applicants argue Example 1 of the 2014 Interim Eligibility Guidance. Example 1 was directed to gunpowder comprising an intimate finely ground mixture of 75% potassium nitrate, 15% charcoal and 10% sulfur. This claim was found to patent eligible even though all of the components are naturally occurring substances since the explosive property of the claimed composition is markedly different from the non-explosive properties of the substances by themselves in nature. Applicants argue that the formulations of the instant claims synergistically provide therapeutic efficacy against various disorders and diseases of the eye which is not achieved by any one of the individual components of the claimed composition. Applicants further argue that Mayo Collaborative Servs. V. Prometheus Labs, Inc.,566 U.S. 66 (2012) confirms that the limited purpose for the exceptions is to protect the basic tools of scientific and technological work. The Supreme court in Mayo emphasized that there must be some balance in the application of the exclusionary ruling. Applicants argue that Diamond v. Chakrabarty, the Court stated that congress intended statutory subject matter to include anything under the sun that is made by man. Applicants argue that it is evident from the specification that the applicant is not claiming a naturally occurring product.
These arguments were considered but are not persuasive because there is no indication that the composition has characteristics (structural, functional, or otherwise) that are different from naturally occurring components. There is also no indication that the concentration amounts to significantly more or provided significantly different characteristics. The argument that the references cited do not teach or suggest application to the eye is not persuasive because the claims are composition claims, not methods of use. Claim 1 does not require application to the eye for treatment of an eye disorder. With respect to the gunpowder example 1, the claim was found eligible because the combination was found markedly different due to the non-explosive properties when found by themselves in nature vs explosive when combined. In the instant case, there is no naturally occurring counterpart to the claimed combination (the components do not occur together in nature), so the combination is compared to the individual components as they occur in nature. There was no evidence found that the components together had markedly different characteristic compared to each component alone. The specification does not show that the combination of ingredients would treat an eye disorder or condition. Example 1 from the instant specification does disclose results. Under MPEP 2106.04, a composition comprising naturally occurring materials is patent eligible only if the claimed composition exhibits markedly different characteristics from its naturally occurring counterparts. The present specification does not demonstrate that the claimed composition results in structural, functional or property based differences from the natural occurring materials. Therefore, the claim recites a product of nature exception.
For the reasons presented above, the rejection is maintained.
Conclusion
No claims are allowed.
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/TARA L MARTINEZ/Examiner, Art Unit 1654