DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Preliminary Amendments and Remarks, filed 6 May 2024, in the matter of Application N° 18/284,812. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been canceled. Claims 11-20 have been added and are supported by the originally-filed disclosure.
Original claims 3-10 have been amended. The amendments made include the removal of improper multiple dependencies, indefinite language (e.g., “preferably”), and changing claim 8 from an improper “use” claim to a method claim.
No new matter has been added.
Thus, claims 1-20 now represent all claims currently under consideration.
Information Disclosure Statement
Two Information Disclosure Statements (IDS) filed 28 September 2023 and 18 December 2024 are acknowledged and have been considered.
Specification - Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
The Examiner objects to the presence of Figure 1 in the Abstract. Should the application result in an allowance, the Examiner may then select a Figure to appear on the cover of the patent. However, for the filed application, the Examiner submits that Figures are not part of an Abstract. See MPEP §608.01(b) for guidelines for the preparation of patent abstracts.
Claim Rejections - 35 USC §112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 5, 17, and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The limitations of instant claim 1 are directed to an immune adjuvant wherein the immune adjuvant is an erythrocyte-derived vesicle, and the vesicle comprises an erythrocyte content and a biomembrane structure encapsulating the erythrocyte content. [emphasis added]
Here, the term “is” is considered by the Examiner as being synonymous with the transitional phrase “consisting of”. See MPEP §2111.03(II).
The limitations of claim 4 recite: “The immune adjuvant according to claim 1 wherein the immune adjuvant further comprises…”
The limitations of claim 5 recite “The immune adjuvant according to claim 1 wherein the immune adjuvant is a tablet, a capsule, an injection, a spray, a granule, a pulvis, a suppository, a pill, a cream, a paste, a gel, a powder, an oral solution, an inhalant, a suspension, or a dry suspension.”
Owing to the interpretation of the immune adjuvant in claim 1, wherein “is” is synonymous with “consisting of,” neither claim is considered to properly further limit claim 1. Claim 4 adds limitations to a closed group of limitations; by definition “‘consisting of’ excludes any element, step, or ingredient not specified in the claim”. As such, the immune adjuvant of claim 1 cannot further comprise any other elements.
Claim 5 is also considered to fail to further define the immune adjuvant of claim 1 as its define the immune adjuvant as compositions that are neither the same as or even the same scope as presented in claim 1.
Instant claims 17 and 18 depend directly from independent method claim 8. The method of claim 8 recites administering the composition of claim 1. As such, claims 17 and 18, which respectively recite the same compositional limitations as claims 4 and 5, are rejected for the reasons discussed above.
Applicants may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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, 2, 4, 6, 7, 11, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jung (Methods in Enzymology; 1987).
The limitations of instant claim 1 are directed to an immune adjuvant wherein the immune adjuvant is an erythrocyte-derived vesicle, and the vesicle comprises an erythrocyte content and a biomembrane structure encapsulating the erythrocyte content.
Claim 2 recites that the vesicle is an extracellular vesicle released by an erythrocyte.
The limitations of claim 4 are discussed above and are also recited in claim 7.
Claim 6 recites a composition comprising the immune adjuvant according to claim 1.
The scope of the limitations recited by claim 6, while broader than claim 1, will broadly and reasonably be considered to be met by any showing over claim 1. The Examiner broadly and reasonably considers the limitations of claims 11 and 13 to be met by any showing over claims 2 and 4, respectively.
Jung defines erythrosomes as being “a modified version of the liposome system in which chemically cross-linked human erythrocyte cytoskeletons are used as a support upon which a lipid bilayer is coated” (see pg. 217; second paragraph; Title).
The reference additionally discloses trapping macromolecules in erythrosomes and further discloses that drugs may be entrapped within (see pg. 219; first full paragraph).
The foregoing is considered to teach the limitations of the instantly claimed compositions.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gaudreault et al. (USPN 5,653,999; IDS reference).
The limitations of claims 1, 2, 4, 6, 7, 11, 13, and 14 are discussed above.
Gaudreault discloses nanoerythrosomes having an average vesicle diameter of 0.1 micron (or 100 nm) as carriers for pharmacologic agents (see e.g., Abstract; claims 1 and 2).
As established by the state of the art, “erythrosomes” are “a modified version of the liposome system in which chemically cross-linked human erythrocyte cytoskeletons are used as a support upon which a lipid bilayer is coated” (see Jung, Methods in Enz.; 1987; pg. 217; second paragraph; Title). Thus, Gaudreault’s disclosure of nanoerythrosomes is considered to expressly meet the limitations of claims 1-3, 6, 11, and 12.
The reference additionally discloses complexes comprising a bioactive agent coupled or conjugated to nanoerythrocytes wherein the bioactive agent is a pharmacological agent (see e.g., claims 3-5). Claim 21 discloses that the such an agent is an antineoplastic agent and that it may be conjugated to or entrapped within the vesicle. Daunorubicin is specifically disclosed (see e.g., Abstract, claim 23, col. 6, lines 35-39).
Oral and injection routes of administration are disclosed for the prepared compositions, with injection being a preferred route (see col. 5, line 43 to col. 6, line 5).
The foregoing is considered to teach the limitations recited by claims 1-7 and 11-14.
The limitations of instant claims 8, 19, and 20 are considered to be expressly met owing the administration of daunorubicin-loaded nanoerythrosomes to treat tumors (see e.g., Abstract). The practiced nanoerythrosomes are further disclosed as being used a diagnostic tool in order to target tumoral antigens (see e.g., col. 5, lines 23-27).
The limitations of instant claims 15-18 recites the same compositional and structural limitations as are recited by instant claims 2-5, respectively.
The limitations recited by claim 9 are directed to the method by which the immune adjuvants are prepared, wherein the steps comprise culturing erythrocytes in a culture environment, and then collecting the erythrocytes.
Claims 7-9 of the reference disclose a method for preparing the practiced nanoerythrocytes which concludes with a step of collecting those nanoerythrocytes having a mean diameter of about 100 nm. Though the claims do not disclose a culturing step, the instantly claimed culturing step is taught by the reference (see e.g., Fig. 2 discussion at col. 7, lines 35-41; and col. 7, line 62 to col. 9, line 22). Therein, the “culturing” or growth of the erythrocytes is considered to be carried out in the mice from which they are harvested. The method further discloses centrifuging acquired erythrocytes at 27000xg for 20 minutes (see col. 8, lines 43-44).
Thus, the reference is considered to teach each of the instantly claimed limitations.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615