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 .
Status of Claims
Examined Herein: 1-20
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 63/340,828 on 5/11/2022.
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 3-20 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 3 recites the limitation “…said stem cells.” It is unclear if this phrase refers to the stem cell procedure or the stem cell therapy described in claim 1 and the specification does not provide clarity. As a result, one of ordinary skill in the art would not be reasonably apprised of the scope of the claims. Dependent claims fall therewith.
Claim 15 recites the limitation "said bone marrow nuclear cells" in line 1. There is insufficient antecedent basis for this limitation in the claim, as claim 3 only describes cells derived from a bone marrow source of origin, not bone marrow nuclear cells specifically. Dependent claims fall therewith.
Claim 17 recites the limitation “…wherein said exosomes possess an increased affinity to a solid surface as compared to other materials.” This language creates ambiguity because “a solid surface” can refer to a physical form or boundary of a surface and is not limited to the description of a material. As written, this limitation seemingly compares the exosomes affinity for a solid surface to an undefined “other material.” Comparing a physical surface (a form) to an unspecified material seems ill suited for meaningful comparison and the phrases “a solid surface” and “others material” cast a broad scope. Moreover, this language is also ambiguous because exosomes do not have an affinity to a solid surface; rather, they have an affinity to a functionalized solid surface conferred for binding. The specification describes an embodiment wherein exosomes are bound to a solid substrate with immobilized lectins binding high mannose structures. Thus, the exosomes possess an increased affinity for a functionalized substrate, not a solid surface; and the two are not synonymous. Still, the specification does not provide clarity on what constitutes “other materials.” Applicant may consider amending the claim to resolve these ambiguities.
Claims 18 and 19 recite the limitation “…wherein exosomes expression of [miRNA]…” There is insufficient antecedent basis for this limitation in the claim, as claim 1 describes the exosomes are collected and assessed but do not describe measuring or assessing the expression thereof.
Claim 20 recites the limitation “wherein exosomes are concentrated based on their affinity to a lectin.” It is unclear whether this limitation recites an additional step that must be performed (i.e., a step of concentrating exosomes based on their affinity to a lectin) or merely characterizes the collected exosomes and the specification does not provide clarity. If the limitation is intended to recite an additional step, it is unclear at what point the step is performed (i.e., before or after the exosomes are collected and assessed). Applicant may consider amending the claim to resolve these ambiguities.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter.
"Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection." MPEP 2106.04(I) Abstract ideas include procedures for evaluating, analyzing or organizing information, which are a type of mental process. MPEP 2106.04(a)(2) The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than the abstract idea of assessing exosomes and their possibility of success in a stem cell procedure.
Step 1: The Four Categories of Statutory Subject Matter - MPEP 2106.03
The claims are directed to a process (method), which is one of the categories of statutory subject matter.
Step 2A, Prong One: Whether the Claims Set Forth or Describe a Judicial Exception - MPEP 2106.04(II)(A)(1)
Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim as a whole is directed to a judicial exception. The judicial exceptions recited in the claims include the following abstract ideas/mental processes:
“selecting a patient”
“assessing possibility of success”
“assessing said exosomes for molecules associated with resistance to stem cell therapy”
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
As a result, the claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application.
Step 2A, Prong Two: Whether the Claims Contain Additional Elements that Integrate the Judicial Exception(s) into a Practical Application - MPEP 2106.04(II)(A)(2) and MPEP 2106.04(d)
Prong Two asks 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. Claim 1 recite the following additional elements that are not abstract ideas:
“obtaining a fluid from said patient”
“collecting exosomes from said fluid”
These additional elements do not integrate the exception into a practical application because they constitute insignificant extrasolution activity. Factors that indicate that claim elements are insignificant extrasolution activity include whether the extra-solution limitation is well known, whether the limitation is significant & it imposes meaningful limitations on the claim, and whether the limitation amounts to necessary data gathering and outputting. MPEP 2106.05(g) The limitations “obtaining a fluid from said patient” and “collecting exosomes from said fluid” do not meaningfully limit the claim because they constitute mere data gathering. Furthermore, none of the dependent claims recite any additional non-abstract elements; they are all directed to limitations that recite further aspects of the information being assessed, the manner in which that assessment is performed and/or other limitations that fail to impose meaningful limits on the claim.
Because the claims recite an abstract idea and do not integrate that abstract idea into a practical application, the claims are directed to that abstract idea.
Claims that are directed to abstract ideas must be examined further to determine whether the additional elements besides the abstract idea render the claims significantly more than the abstract idea. Claims that are directed to abstract ideas and that raise a concern of preemption of those abstract ideas must be examined to determine what elements, if any, they recite besides the abstract idea, and whether these additional elements constitute inventive concepts that are sufficient to render the claims significantly more than the abstract idea MPEP 2106.05.
Step 2B: Whether the Claims Contain Additional Elements that Amount to an Inventive Concept - MPEP 2106.05
The courts have found adding insignificant extra-solution activity to the judicial exception are not enough to qualify as "significantly more" when recited in a claim with a judicial exception.
As explained above, the limitations selecting a patient, assessing possibility of success, and assessing the exosomes are directed to a judicial exception. The additional limitations including the steps of obtaining a fluid from said patient and collecting exosomes from said fluid constitute insignificant extra-solution activity. Thus, claim 1 is drawn to a judicial exception that adds insignificant extra-solution activity. Furthermore, none of the dependent claims recite any additional non-abstract elements. Therefore, when considered as a whole, the claims do not constitute inventive concepts that would render the claims significantly more than an abstract idea MPEP 2106.05(g).
To that end, the claims also do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. 2106.05(a) and 2106.05(h).
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not
constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Peng (US 2022/0154279 A1, Published 5/19/2022).
With respect to claim 1, Peng discloses a method comprising the steps of:
a) selecting a patient suffering from a degenerative disease, Alzheimer’s disease;
b) obtaining a fluid, blood, from said patient;
c) collecting exosomes from said fluid. [Peng, 0027]
The limitation “…of assessing possibility of success in a stem cell procedure” recites an intended use. The body of the claim, steps a-d, fully and intrinsically sets forth all of the limitations of the claimed invention. The preamble merely states the intended use, which does not result in a structural or manipulative difference between the claimed invention and the prior art. As a result, this limitation is of no significance to claim construction and is not given patentable weight.
The limitation “…d) assessing said exosomes for molecules associated with resistance to stem cell therapy” recites a mental process. A mental process is an abstract idea and is not eligible for patent protection. As a result, this limitation is not given patentable weight.
Therefore, since Peng discloses all the limitations of claim 1 that are owed patentable weight, the limitations of claim 1 have been met.
Claims 2-16 further limit the stem cells described in either the preamble or step d) of claim 1. For the reasons described above, the preamble and step d) of claim 1 are not accorded patentable weight. As a result, claims 2-16 fall therewith. Accordingly, since the limitations of claim 1 have been met, the limitations of claims 2-16 have also been met.
Claims 18, 19, and 20 recite non-limiting descriptions of the exosomes described in claim 1. These claims do not require steps to be performed, limit claim 1 to a particular structure, or give meaning and purpose to the manipulative steps of claim 1. As a result, these claims are not given patentable weight. Accordingly, since the limitations of claim 1 have been met, the limitations of claims 18-20 have also been met.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Peng as applied to claim 1-16 and 18-20 above, and further in view of Zayas (US 2023/0026916 A1, Filed 7/5/2019).
With respect to claim 1, Peng discloses the teachings above.
Peng does not disclose the exosomes are collected by an affinity selection means, wherein said exosomes possess an increased affinity to a solid surface as compared to other materials.
However, with respect to claim 17, Zayas discloses exosomes may be isolated from blood samples using affinity bead capture. [Zayas, 0031, 0032, 0102] Affinity bead capture is an affinity selection means wherein exosomes possess an increased affinity to a solid surface functionalized with antibodies as compared to other materials.
Modifying the method disclosed by Peng by collecting the exosomes using affinity bead capture results in the method of claim 17, as affinity bead capture is an affinity selection means wherein exosomes possess an increased affinity to a solid surface functionalized with antibodies as compared to other materials.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Peng by collecting the exosomes using affinity bead capture and have a reasonable expectation of success because Peng discloses a method comprising the step of collecting exosomes from a blood sample of a patient. Zayas discloses exosomes may be collected from a blood sample of patient using affinity bead capture. So, Peng discloses a method comprising the step of collecting exosomes from a blood sample of a patient and Zayas discloses this step may be carried out using affinity bead capture. Thus, the combined teachings of Peng and Zayas suggest affinity bead capture may be used to collect exosomes from a blood sample of a patient in the method disclosed by Peng. Therefore, it is reasonable to expect the method disclosed by Peng may be modified by collecting the exosomes using affinity bead capture. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. In the instant case, Zayas discloses a method for analyzing single cell interactions, wherein peripheral blood cells are obtained from the patient, then exosomes are isolated using affinity bead capture microfluidics to target surface markers on the outside of hepatocyte derived exosomes. The cell surface markers are used to target markers that can capture both healthy and diseased hepatocyte tissue and identify tissue source rather than a state of the cell. [Zayas, 0102] Therefore, one would have been motivated by the expectation that the aforementioned modification could enable the method disclosed by Peng to target surface markers on the outside of exosomes, capture both healthy and diseased tissue and identify the tissue source.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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