747
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 .
DETAILED ACTION
Applicant’s election of claims 1-22 and 49-54 in the reply filed on 03/09/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Further, applicant elected the method of administration as oral administration and the cargo as a nucleic acid molecule or polypeptide. As such, claims 11, 15-17, and 20 are also withdrawn as claiming non-elected cargo. Claims 11, 14-17, 20-22, and 25-48 are withdrawn; claims 23-24 are cancelled. Claims 1-10, 12-13, 18-19, and 49-54 are currently under examination and the subject of the present Office Action.
As such, the restriction is made final.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 03/09/2026, 07/18/2025, 11/13/2024, and 04/17/2024 have been considered here.
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 1-10, 12-13, 18-19, and 49-54 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.
Claims 1 and 4 recite that the composition is formulated for administration to a subject that is an animal however the method of administration is not limited. The specification only teaches examples of in vitro treatment, not being administered to a subject that is an animal. One with ordinary skill in the art would not understand the metes and bounds of the claims as written and as such are indefinite. It is noted that the applicant elected oral administration as the method of administration, however the independent claims do not limit the method of administration to just oral administration.
Claims 2-3, 5-10, 12-13, 18-19, and 49-54 are indefinite as they depend from an indefinite claim.
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 1-10, 12-13, 18-19, and 49-54 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to laws of nature and natural phenomena without significantly more.
The claims recite natural phenomena. These judicial exceptions are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP §2106:
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Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an
abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP §2106.05(a)
Applying the judicial exception with, or by use of, a particular machine. See MPEP §2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP §2106.05(c)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP §2106.05(d)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP §2106.05(e)
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1): The answer to this step is yes since claims 1-10, 12-13, 18-19, and 49-54 are directed to a composition of matter, which is a statutory category.
Step (2A): The answer to this step is yes because the claimed compositions are directed to laws of nature and natural phenomena, specifically a composition comprising isolated microalgae extracellular vesicles (MEVs) comprising cargo that is a biomolecule that is formulated for administration to a subject.
Prong 1:
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
Claim Analysis
Independent claim 1 recites a composition comprising isolated MEVs, wherein the microalgae is a species of the family Chlorellaceae; the MEVs comprise exogenously-loaded cargo that is a biomolecule for treating or preventing a disease, disorder, or condition in a subject; the composition is formulated for administration to a subject; and the subject is an animal. Independent claim 4 recites a similar composition, with the distinction that the cargo is heterologous.
In the instant case, the scope of the positively recited elements of the composition defines it in terms of naturally-occurring compounds, and as such the composition is defined as consisting of naturally-occurring compounds. The composition of the claims is merely taking naturally occurring materials and combining them, which does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product of nature a particular technological environment. While the claim does recite that the cargo is exogenously loaded, it is noted that the cargo is also taught to be naturally occurring compound, such as a nucleic acid or polypeptide, and is not a significant addition to the limitations of the claim. Therefore, the instant claim recites a product of nature. Further, it is noted that the composition claimed would be no different as orally administering a microalgae of the family Chlorellaceae as a whole, for the microalgae would have MEVs and nucleic acid within it. In regards to claim 4, heterologous cargo, such as nucleic acids and polypeptides, are also known and found in nature (e.g., mitochondrial DNA).
The dependent claims simply recite more specific combinations of composition, such as the form or method administration, of the independent claims, however there is no significant addition to the limitations of the claims. Therefore, the instant claims recite a product of nature.
There is no evidence within the specification that the compositions recited in claims 1-10, 12-13, 18-19, and 49-54 contain markedly different characteristics from their naturally-occurring counterparts.
Therefore, the answer to step 2A prong 1 is yes.
Prong 2:
The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application.
Here, the instantly amended claims do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claim 1 and do not do anything beyond generally linking the use of the judicial exception to a particular technological environment.
Therefore, the answer to step 2A prong 2 is no.
Step (2B):
Claims 1-10, 12-13, 18-19, and 49-54 do not recite additional elements which require analysis under step 2B.
Therefore, the answer to step (2B) is no.
Conclusion
Claims 1-10, 12-13, 18-19, and 49-54 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. §101.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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