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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20 January 2026 has been entered.
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 20 January 2026.
CLAIMS UNDER EXAMINATION
Claims 1-5, 7-8, 10-17 and 21 have been examined on their merits.
PRIORITY
EP16173465.2, filed on 08 June 2016, is acknowledged. The Foreign priority document does not provide support for incubating pooled donor-donated platelets within a temperature range from “at least about” 20 °C to at most “about 24°C”. The document discloses “During the storage time of nearly one week “at 20-24°C”, cells continue secreting their specific EVs into the surrounding plasma” (page 11,lines 15-17). The document discloses “Another point is that hPL contains EVs that were released from living thrombocytes during the period of storage of thrombocyte-concentrates (20-24 °C) before reaching the expiry date after 4-6 days” (page 12, lines 14-16). The document does not provide support for at least about 20 °C to at most about 24°C.
PCT/EP2017/063868, filed on 07 June 2017, is acknowledged. The document discloses “During the storage time of nearly one week at 20-24°C, cells continue secreting their specific EVs into the surrounding plasma” (page 11,lines 16-17). The document discloses “Another point is that hPL contains EVs that were released from living thrombocytes during the period of storage of thrombocyte-concentrates (20-24 °C) before reaching the expiry date after 4-6 days” (page 12, lines 14-15). The document does not provide support for at least about 20 °C to at most about 24°C.
The specification filed on 21 September 2021 does not provide support for at least about 20 °C to at most about 24°C. The earliest support for this limitation is the claims filed on 20 January 2026.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
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 1-5, 7-8, 10-17 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
Based on the claims as a whole, claims 1-5, 7-8, 10-17 and 21 are determined to be directed to a law of nature/natural principle. The rationale for the determination is explained below.
Claim 1 is directed to a method processing human platelets.
Question 1: Is the claim to a process, machine manufacture or composition of matter? Yes, the invention recited in claim 1 is a process.
Question 2A Prong 1: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes, claim 1 is directed to a law of nature.
(a) The limitations in the claim that set forth the law of nature is:
The 2019 PEG explains that the abstract idea exception includes the following groupings of subject matter:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Step c of claim 1 recites determining an in vitro immune suppressive effect. The specification does not explicitly define a determination. [0103] of the PG Pub identifies reduced IL-Iβ, TNF-a, T-cell proliferation as examples of said effect. Therefore visually observing and/or analyzing reduced data points reads on the claim limitation. Such mental observations and evaluations fall within the “mental processes” grouping of abstract idea set forth in the 2019 PEG. 2019 PEG Section I, 84 Fed. Reg. at 52. observations and evaluations that can be performed in the human mind (hence within the “mental processes” grouping of abstract ideas).
Step d recites “selecting” the enriched fraction of human platelet derived extracellular vesicles if the enriched fraction exhibits the in vitro effect. The specification does not recite a definition for the term “selecting”. Therefore visually identifying extracellular vesicles is interpreted to read on the claim limitation. Such mental observations and evaluations fall within the “mental processes” grouping of abstract idea set forth in the 2019 PEG. 2019 PEG Section I, 84 Fed. Reg. at 52. observations and evaluations that can be performed in the human mind (hence within the “mental processes” grouping of abstract ideas).
Question 2A Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? No.
Claim 1 has been amended to recite incubating pooled donor-donated platelets at the claimed temperature. This is considered insignificant extra-solution activity that is required to make the determination and selection required by steps c-d.
Steps a-b recite steps for obtaining extracellular vesicles. These are considered insignificant extra-solution activities that are required to make the determination and selection required by steps c-d. The claim recites the selection in step d is not required. Therefore this step does not add more to the judicial exception.
Question 2B: Do the claims recite any additional elements? Yes.
With respect to Step 2B, limitations that were found to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2B, limitations that were found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Do the additional elements result in the claim amounting to significantly more?
No.
Regarding claim 1: As set forth above, pooling donating platelets, step a and step b are interpreted to be insignificant extra-solution activities that are required in order to make the determination and selection recites in steps c-d.
Regarding claims 2-5, 8, 10-14 and 16-17: The claims further limits step b. Step b is considered to be an insignificant extra-solution activity required in order to make the determination and selection recites in steps c-d.
Regarding claims 7 and 15: The claims further limit the lysate recited in step a. As set forth above, step a is interpreted to be an insignificant extra-solution activity that is required in order to make the determination and selection recites in steps c-d.
Regarding claim 21: the claim recites the donor platelets are non-activated. This limitation does not add significantly more to the judicial exception. The claim further limits the pooling step of claim 1, which is an insignificant extra-solution activity required in order to make the determination and selection recites in steps c-d.
Therefore claims 1-5, 7-8, 10-17 and 21 are not eligible subject matter under 35 USC 101.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 20 January 2026 are acknowledged.
Argument 1: The Applicant argues the claimed determination step requires sophisticated, quantitative laboratory assays (e.g., ELISA and flow cytometry) that are not mental steps, but technical procedures.
Response to Argument 1: The specification does not define “determining” or “selecting”. The claims do not require the assays argued by the Applicant. Even arguendo the claims recited the cited assays for measurement, determining whether the results are “immune suppressive” encompasses a mental process of deciding (a mental process) whether the results are immune suppressive. The claims do not require selection of a fraction. Therefore the arguments are not persuasive.
Argument 1: The Applicant argues the process transforms platelets to a highly purified, functionally defined therapeutic substance.
Response to Argument 2: The claims are not directed to a product. Therefore, the rejection is not based on a product of nature exception. The judicial exceptions are the determination and selection steps (mental processes). Isolation of the extracellular vesicles is required to perform the judicial exceptions: determining an immune suppressive effect and selection based on said effect. Therefore the arguments are not persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1-5, 7-8, 10-17 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite incubating pooled donor-donated platelets within a temperature range from at least about 20 °C to at most about 24°C. The specification defines the term “about” as “within a statistically meaningful range of a value or values such as a stated concentration, length, molecular weight, pH, time frame, temperature, pressure or volume”. Therefore the term “about” includes temperatures below 20 °C and above 24 °C. The specification provides support for “20- 24 °C” (see [0033] [0038]). It does not provide support for all the temperatures below at least about 20 °C and above about 24°C encompassed by the term “about”. This is new matter. All dependent claims are included in this rejection.
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Applicant is required to cancel the new matter in the reply to this Office Action.
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 21 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 21 recites “..before the human platelet lysate derived extracellular vesicles are provided in step a”. There is a lack of antecedent basis because the base claim does not recite providing human platelet lysate derived extracellular vesicles in step a. It is unclear what the Applicant is referring. Appropriate correction is required. For the purpose of examination, a teaching of a thrombocyte activator is interpreted to read on the claim limitation.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-5, 7-8, 10-17 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demiroschedji et al. (Human platelet lysate derived extracellular vesicles for use in medicine. EP3468568B1 published 09 February 2020) as evidenced by Merriam Webster Dictionary (definition of “room temperature”).
Demiroschedji et al. teach a pharmaceutical preparation comprising an enriched fraction of human platelet-derived extracellular vesicles obtainable by a method comprising the steps (see [0096]):
a) providing human platelet lysate from single donor donated platelets or from pooled donor-donated platelets of at least 15 donors, preferably of at least 20 or of at least 30 or of at least 40 donors.
b) enriching extracellular vesicles originating from human platelet lysate
c) optionally, determining an in vitro effect such as an immunomodulatory effect, in particular an anti-inflammatory effect and/or immune suppressive effect, of said enriched extracellular vesicles by, for example, a reduced IL-Iβ, TNF-a, T-cell proliferation, and
d) optionally, selecting those enriched extracellular vesicle fractions that exhibit the in vitro effect such as an immunomodulatory effect, in particular an anti-inflammatory effect and/or immune suppressive effect,
e) optionally, selecting those enriched extracellular vesicles of step b) that exhibit extracellular vesicles negative for the EV/exosome marker CD81 and positive for the EV/exosome marker CD9, and
f) optionally, admixing said enriched extracellular vesicles of step b), d) or e) with at least one suitable pharmaceutical excipient and/or carrier
The art teaches platelet concentrate is left at room temperature for 1 hour ([0124] [0127]). As evidenced by Merriam Webster, room temperature is defined as a temperature of 15° to 25°C. This reads on at least “at least about 20 °C to at most about 24°C”.
The fraction is enriched for human platelet lysate derived extracellular vesicles (exosomes) have a size of between about 70 to 200 nm, preferably between about 70 to 140 nm ([0068]). Filtration is used for enrichment ([0104]).
The art teaches EVs such as exosomes present a common set of generally expected markers that can be used for their characterization. Most commonly used markers are tetraspanins (CD9, CD63, CD81) and HSP90 (a heat shock protein) ([0075]).
PL-EV fractions should not contain Grp94, calnexin, GM130 or prohibin ([0075]). These are used as negative markers ([0075]).
Therefore claim 1 is anticipated.
Regarding claim 2: Lysed cells, cellular fragments and other debris is/are depleted by centrifugation ([0128]). Therefore claim 2 is included in this rejection.
Regarding claim 3: the extracellular vesicles are positive for at least one of the EV- or exosome-markers consisting of the group: CD9, CD41a, CD41b, CD42b, CD61, CD62P and CD63. Preferably the extracellular vesicles are positive for 2, 3, 4, 5, 6 or 7 of the above mentioned EV- or exosome-markers ([0070]). Therefore claim 3 is included in this rejection.
Regarding claim 4: the extracellular vesicles are negative for at least one of the surface-markers consisting of the group CD81, CD3, CD4, CD19, CD20, CD2, CD8, CD11a and CD25. Preferably the extracellular vesicles are negative for 2, 3, 4, 5, 6, 7, 8 or 9 of the above mentioned cellular exosome markers ([073]). Therefore claim 4 is included in this rejection.
The art teaches tangential flow filtration ([0104]). Therefore claim 5 is included in this rejection.
Regarding claim 7: The art teaches at least 40 donors ([0096]). Therefore claim 7 is included in this rejection.
The preparation is cell-free ([0027]. Therefore claim 8 is included in this rejection.
The vesicles are preferably between about 70 to 140 nm (supra). Therefore claims 10-12 are included in this rejection.
hPLEV markers comprise tetraspanins (e.g., CD9, CD10, CD26, CD53, CD63, CD82) ([0069]). Therefore claim 13 is included in this rejection.
The protein content of the pharmaceutical preparation is higher than 0.5 mg/ml ([0108]). Therefore claim 14 is included in this rejection.
The human platelet lysate is provided from platelet apheresis or from buffy coat platelets, more preferred from platelet apheresis ([0101]). Therefore claim 15 is rejected.
The preparation is enriched for EVs that comprise miRNAs ([0112]). Therefore claims 16 and 17 are included in this rejection.
Human platelet lysate or a fraction that is enriched for human platelet lysate can be obtained from platelets that have been incubated before the lysis with one or more compounds known as thrombocyte activators that activate the platelets and thus improve the quality of the inventive preparation ([0048]). Therefore claim 21 is included in this rejection.
Therefore Applicant’s Invention is anticipated as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 20 January 2026 are acknowledged. New rejections have been necessitated by claim amendment.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653