DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 07/03/2024.
Election
2) Acknowledgment is made of Applicants’ election filed 06/25/2026 in response to the restriction and species election requirement mailed 03/25/2026. Applicants have elected invention VII with traverse. Applicants assert that inventions I, VI and VII should be rejoined since the method of the elected invention VII uses the extracellular vesicles produced by the method of invention VI, which comprises the composition of invention I. Applicants opine that rejoinder of inventions I, VI and VII would not pose an undue search burden since the composition of invention I must be searched in order to search the methods of inventions VI and VII.
Applicants’ arguments have been carefully considered, bur are not persuasive. New claim 27 of the elected invention VII is drawn to a method of preventing or treating an autoimmune or inflammatory disease comprising administering ‘the extracellular vesicles of claim 26’ to a subject, the remaining features in the claim being optional. Claim 26 of invention VI, however is drawn to a method, not to a product, i.e., extracellular vesicles (see indefiniteness rejection under 35 U.S.C § 112(b) set forth in this Office Action). Furthermore, the method of claim 27 does not require the use of the composition of invention I. Also, the extracellular vesicles comprised in the composition of claim 1 are not required to be produced by the method steps of claim 26. Additionally, there is an examination burden since, for example, the composition of invention I requires analysis and examination under subject matter eligibility statute. As set forth previously, inventions VI and VII are drawn to different methods which differ from one another in method objectives, method steps and parameters, elements or reagents used and/or the ultimate goals accomplished. Therefore, the restriction requirement as set forth previously is proper, is maintained and is hereby made FINAL.
Status of Claims
3) Claims 2, 5, 9, 21, 22, 24 and 25 have been canceled via the preliminary amendment filed 07/03/24.
Claims 1, 3, 4, 6, 8, 11, 12, 14, 16, 17, 19, 20, 23 and 26 have been amended via the preliminary amendment filed 07/03/24.
New claim 27 has been added via the preliminary amendment filed 07/03/24.
Claims 1, 3, 4, 6-8, 10-20, 23, 26 and 27 are pending.
Claims 1, 3, 4, 6-8, 10-20, 23 and 26 are withdrawn from consideration as being directed to a non-elected species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claim 27 is examined on the merits.
Drawings
4) Applicants’ drawings filed 04/19/2024 are acknowledged.
Information Disclosure Statements
5) Two of Applicants information disclosure statements each filed 07/23/24 are acknowledged. The information referred to therein has been considered and a signed copy of the same is attached to this Office Action.
Priority
6) The instant AIA application, filed 04/19/202, claims priority to the U.S. provisional application 63/460,768 filed 04/20/23.
Objection(s) to Specification
7) The specification is objected to for the following reason(s):
(a) The instant specification incorporates subject matter into the patent application by reference to a hyperlink “https”. For example, see at least sections [00122], [0137] and [0141] However, attempts to incorporate subject matter into the patent application by reference to an active hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01. Such embedded active hyperlinks and/or other forms of browser-executable code therefore require deletion or replacement with the phrase --hypertext transfer protocol secure--. It is suggested that Applicants examine the whole specification for similar recitations and make necessary correction.
(b) The use of trademark recitations in the instant specification has been noted. For example, see ‘Superdex 200’ at least at section [00125]. All trademark recitations should be CAPITALIZED wherever they appear, or where appropriate, should include a proper symbol indicating use in commerce such as TM, SM, or ® following the term. See M.P.E.P 608.01(v) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks. It is suggested that Applicants examine the whole specification to make similar corrections to trademark recitations, wherever such recitations appear.
Rejection(s) under 35 U.S.C § 112(a) or (pre-AIA ), First Paragraph
8) The following is a quotation 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 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
9) Claim 27 is 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 the (pre-AIA ), the Applicant. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an analysis of the scope of the claims and of the variable genus encompassed therein indicates the following.
Claim 27 is drawn to a method of preventing or treating an autoimmune or inflammatory disease comprising administering ‘the extracellular vesicles (EVs) of claim 26’ to a subject. Claim 26 is not directed to extracellular vesicles, but to a method of producing extracellular vesicles from Parabacteroides goldsteinii. The claim limitation ‘an autoimmune or inflammatory disease’ broadly represents a huge genus encompassing large numbers of autoimmune or inflammatory disease species of diverse causes and etiology including bacterial, fungal, parasitic and viral infectious etiology, non-infection autoimmune etiology, due to adverse reactions to various therapeutic drugs etc all potentially needing diverse therapeutic interventions. For example, the art documents that there are over 100 autoimmune conditions and inflammatory diseases affecting different systems and tissues of the body. See Balingit A. Medical News Today, pages 1-11, 29 November 2023; and Wikipedia, List of inflammatory disorders, pages 1-5. The administering encompasses administering by any route including oral, rectal, subcutaneous, intramuscular, intravenous, intrathecal, intratracheal, intraperitoneal, mucosal, vaginal, intranasal etc. The claimed method is required to ‘prevent’ or treat’ said genus of diverse autoimmune or inflammatory diseases and produce a) increased IL-10 and/or adenosine production, b) activation of adenosine receptor A2a, c) increased autophagy and/or d) reduced TNF-alpha, IL-4 and/or IL-5 production in one or more cells of the subject. However, a review of the instant specification indicates that at the time of the invention, Applicants were not in possession of the full scope of the method as claimed broadly. There is a lack of showing of possession of a method of preventing or treating a representative number and variety of autoimmune or inflammatory disease species of divergent causes and etiology upon administration to a subject by any route an unspecified amount or dose of extracellular vesicles from Parabacteroides goldsteinii, wherein said administration results in the recited effects a), b), c) and/or d) and elicits autoimmune disease-treating or inflammatory disease-treating therapeutic functions and autoimmune disease-preventing or inflammatory disease-preventing prophylactic functions. Applicants should note that written description requires more than a mere statement that something is a part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. A mere statement that the invention includes the element(s) and step(s) recited in the claims is insufficient to meet the adequate written description requirement of the claimed invention. A convincing structure-function relationship must exist between the administered product and the autoimmune disease-treating or inflammatory disease-treating therapeutic function and autoimmune disease-preventing or inflammatory disease-preventing prophylactic function in a representative number and variety of autoimmune diseases or inflammatory diseases of diverse causes and etiology.
A review of the as-filed specification indicates that Applicants were in possession of purified extracellular vesicles (EVs) of Parabacteroides goldsteinii ASF519 which was orally administered to mice in a specific amount 3 times a week from one week before the subcutaneous collagen immunization; and the mice were then monitored for arthritis severity and body weight. See Example 8. Example 3 shows that colonization by Parabacteroides goldsteinii ASF519 bacteria is needed to induce tolerogenic phenotypes and adenosine accumulation following oral introduction of ASF519 in mice, but Example 3 is not of the use of EVs of Parabacteroides goldsteinii ASF519. Results in Figures 5J-5L are stated as showing efficacy of EVs prepared from ASF519 in a collagen-induced arthritis model. However, collagen-induced arthritis is not representative of the incredibly huge autoimmune disease genus and inflammatory disease genus as claimed. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated”).
The written description inquiry is case-specific and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372 [Emphasis added]. According to MPEP 2163 [Emphasis added]:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts, as in instant case, are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. Clearly, at the time of the invention, Applicants were not in possession of the method of preventing or treating an autoimmune or inflammatory disease in a subject as claimed broadly, the method comprising administering EVs of claim 26 as claimed. A mere idea is insufficient for written description. Clearly, the specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the claimed invention at the time of filing.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown in a variety of ways including by showing that the invention was “ready for patenting”. MPEP 2163. MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph is severable from its enablement provision. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph. Clearly, Applicants did not describe the invention of the instant claims sufficiently to show that he/she had possession of the claimed broad method. Instant claims do not meet the provision of 35 U.S.C § 112 (pre-AIA ), first paragraph or 35 U.S.C § 112(a).
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), Second Paragraph
10) 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.
11) Claim 27 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 inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
Claim 27 is ambiguous and indefinite in the limitation “the extracellular vesicles of claim 26” (see line 2). Claim 26, a non-elected claim, from which claim 27 depends, is not drawn to ‘extracellular vesicles’ product, but to a method.
Claim(s) Interpretation
12) Due to the ambiguity and indefiniteness identified supra, new claim 27 is interpreted as a method of preventing or treating an autoimmune or inflammatory disease comprising administering to a subject, extracellular vesicles of Parabacteroides goldsteinii, parts a, b, c and d of the claim being optional.
Notice Re Prior Art Available under Both Pre-AIA and AIA
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 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.
Rejection(s) under 35 U.S.C § 102
13) 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 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.
14) Claim 27 is rejected under 35 U.S.C § 102(a)(1) and 35 U.S.C § 102(a)(2) as being anticipated by US 20200101121 A1.
US 20200101121 A1 disclosed a method of treating a bone disease comprising administering to a mammalian subject having rheumatoid arthritis a pharmaceutical composition comprising secreted extracellular vesicles from Parabacterioides goldsteinii. See claims 30, 4 and 1; lines 1, 2 and 4 of section [0008]; lines 4, 6, 7 and 11 of section [0049]; 3rd and 4th full sentences of section [0005]; and sections [0026] to [0032]. The prior art method meets the structural requirement of the claimed method since it treats rheumatoid arthritis, which qualifies as a representative autoimmune or inflammatory disease as expressly defined via the last sentence of section [0055] of Applicants’ as-filed specification.
Claim 27 is anticipated by US 20200101121 A1.
Claim Objection(s)
15) Claim 27 is objected to for being dependent from a withdrawn claim.
Conclusion
16) No claims are allowed.
Correspondence
17) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Supervisor of AU 1645, Jeffrey Stucker, can be reached at (571) 272-0811. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
18) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.DPrimary Examiner
Art Unit 1645
September, 2026
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