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
1. Applicant's amendment, filed 08/19/26 is acknowledged.
2. Claims 1,2,11,19,20,31,42,53,59,108,111-113, 148-159 are pending.
3. Applicant’s election without traverse of Group I, claims 1,2,11,19,20,31,42,53,59,108,111-113, 148-159 in the reply filed on08/19/26 is acknowledged.
Claims 1,2,11,19,20,31,42,53,59,108,111-113, 148-159 read on an isolated extracellular vesicles derived from ex-vivo-expanded human suppressive immune cells are under consideration in the instant application.
4. The following is a quotation of the appropriate paragraphs of AIA U.S.C. §101 that form the basis for the rejections under this section made in this Office action:
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.
5. The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1,2,11,19,20,31,42,53,59,108,111-113, 148-159 do not recite something significantly different than a judicial exception.
Claim 1 as written, do not sufficiently distinguish over extracellular vesicles (EV) as they exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed products and the naturally occurring products. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements Thus, the claimed EVs population derived from Treg not markedly different from what exists in nature.
The fact that Applicant substantially isolated and purified said EVs does not add “enough” to make the claims as a whole patent-eligible and thus does not result in an inventive concept that transforms the natural phenomenon of EVs population derived from Treg into a patentable invention. See MPEP 2106.04(c)(II), subsections (A) and (B), as well as Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) and University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. 2014) cited therein and 2106.04(c)(II)(C)(2). As both sets of cells are not markedly different from what occurs in nature, the claims recite a natural product judicial exception.
Mayo made clear that transformation into a patent eligible application requires “more than simply stat[ing] the law of nature while adding the words ‘apply it.’” Id. At 1294. A claim that recites an abstract idea, law of nature, or natural phenomenon must include “additional features”
to ensure “that the [claim] is more than a drafting effort designed to monopolize the [abstract idea, law of nature, or natural phenomenon].” Id. at 1297. For process claims that encompass natural phenomenon, the process steps are the additional features that must be
new and useful. See Parker v. Flook, 437 U.S. 584, 591 (1978) (“The process itself, not merely the mathematical algorithm, must be new and useful.”).
See “Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc.”
Inc., 569 , 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013) (Myriad) on the Supreme Court’s long-standing “rule against patents on naturally occurring things”, as expressed in its earlier precedent including Diamond Chakrabarty, 447 U.S. 303 (1980) (Chakrabarty), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (Mayo). See Myriad, 133 S. Ct. at 2116. Myriad relied on Chakrabarty as “central” to the eligibility inquiry, and re-affirmed the Office’s reliance on Chakrabarty’s criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products). Id. at 2116-17. Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman’s art”). Thus, while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.
The Supreme Court instructs that “[g]round breaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Myriad Genetics, Inc., 133 S. Ct. at 2117. The discovery of the BRCA1 and BRCA2 genes was a significant contribution to the medical field, but it was not patentable. Id. at 2117.
The Supreme Court has recently articulated a two part test for distinguishing patents that claim one of the patent-ineligible exceptions from those that claim patenteligible applications of those concepts. Id. (citing Mayo, 132 S. Ct. at 1294, 1296-97). Step one asks whether the claim is “directed to one of [the] patent-ineligible concepts.” Id. If the answer is no, the inquiry is over: the claim falls within the ambit of § 101. If the answer is yes, the inquiry moves to step two, which asks whether, considered both individually and as an ordered combination,
“the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo, 132 S. Ct. at 1297). Step two is described “as a search for an ‘inventive concept.’” Id. (quoting Mayo, 132 S. Ct. at 1294). At step two, more is required than “wellunderstood, routine, conventional activity already engaged in by the scientific community,” which fails to transform the claim into “significantly more than a patent
upon the” ineligible concept itself. Mayo, 132 S. Ct. at 1298, 1294.
Based on the analysis of factors in the Myriard-Mayo, the Examiner determiners that factors against eligibility are satisfied.
See MPEP § 2106.03. The Manual contains instructions to examiners, as well as other material in the nature of information and interpretation, and outlines the current procedures which the examiners are required or authorized to follow in appropriate cases in the normal examination of a patent application. The Manual does not have the force of law or the force of the rules in Title 37 of the Code of Federal Regulations.
For these reasons the claims are rejected under section 101 as being directed tonon-statutory subject matter.
6. 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.
5. Claims 1,2,11,19,20,31,42,53,59,108,111-113, 148-159 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Yu et al ( Cellular Immunology,2013,v.285,pages 62-68) and Tung et al ( Frontiers in Cell and Develop Biology, 2020,v.317, pages 1014, IDS).
Yu et al., teach an isolated cell-free population of anti-inflammatory exosomes ( extracellular vesicles) derived from ex vivo expanded population of human Treg. Yu et al., teach that said exosomes expressing CD25 on the surface ( see entire document, Abstarct and Material and Method in particular).
Tung et al., teach an isolated cell-free population of anti-inflammatory extracellular vesicles derived from ex vivo expanded population of human Treg. Tung et al., teach that said extracellular vesicle expressing CD2 and CD25 on their surface. ( see entire document, Abstarct and Material and Method in particular).
Claims 2,11,19,20,31,42,53,59,108,111-113, 148-159 are included because the claimed functional/structural properties would be inherent properties of the referenced extracellular vesical because the claimed and the reference EVs are essentially the same, obtained from the same Treg and thus would inherently have the same structural/functional properties. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. “ The Court further held that “this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art”. See MPEP 2112.02. Also, see Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc. 58 USPQ2d 1508 (CA FC 2001); Ex parte Novitski 26 USPQ 1389 (BPAI 1993); Mehl/Biophile International Corp. V. Milgraum, 52 USPQ2d 1303 (Fed. Cir. 1999); Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999).
Since the office does not have a laboratory to test the reference EVs it is applicant’s burden to show that the reference EVs do not have the same structural/functional properties as recited in the claims. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
The reference teaching anticipates the claimed invention.
7. No claim is allowed.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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