Applicant is requested to note that the Examiner for this application has changed. Future correspondence should be directed to Joseph (Paul) Miano, Art Unit 1631, whose contact information can be found below.
DETAILED ACTION
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 .
Election/Restrictions
Claims 1-7 and 9-21 are pending.
Applicant’s election without traverse of Group I, claims 1-3, 7, and 9-15 and the species of a lung cancer cell the reply filed on 04/13/2026 is acknowledged.
In regards to the species, in view of the prior art, upon reconsideration, the section requirement has been withdrawn.
Claims 4-6 and 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/13/2026.
Claims 1-3, 7, and 9-15 have been examined on their merits.
Specification
The disclosure is objected to because of the following informalities: the specification references color in the figures (see paragraph [0058], in refence to Fig. 4). However, no request for color drawings has been submitted and approved. Simply crossing out the references to color in paragraph [0058] would be ameliorative. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7, and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over El Andaloussi et al. (US20160137716A1) in view of Cocozza et al. (Journal of Extracellular Vesicles, 2020) as evidenced by Battistelli et al. (Biology, 2020).
In regards to claims 1-2 and 10-14, El Andaloussi teaches a therapeutic delivery extracellular vesicle (an extracellular decoy as commonly referred to in the art) which can be a microparticle or apoptotic body specifically (claims 1 and 5). El Andaloussi teaches that these vesicles express receptors on their surfaces (claim 1).
While El Andaloussi does not explicitly teach that the vesicles express a spike binding receptor, Cocozza teaches an extracellular vesicle that expresses ACE2 (a spike (S) binding protein) on its surface (Title, Abstract, p1; Fig. 1, p3; Fig. 2, p5; Introduction, p1-2).
A person of ordinary skill in the art would have been motivated to use a spike binding receptor such as ACE2 because Cocozza teaches that vesicles containing ACE2 block SARS-CoV-2 Spike-dependent infection (SAR-COV-2 is a known pneumonia virus, and thus, a pneumonia spike protein) in a much more efficient manner than soluble ACE2, and therefore, is a potential versatile therapeutic tool for blocking not only SARS-CoV-2 infection but also other coronavirus infections that use the ACE2 receptor for host cell entry (Discussion, p4).
Furthermore, because Cocozza teaches that extracellular vesicles can express ACE2 and because El Andaloussi and Cocozza are in the same technical field of producing exosome decoys, it could have been done with predictable results and a reasonable expectation of success.
Additionally, while El Andaloussi is silent as to the specific cell, a person of ordinary skill in the art would have been motivated to derive microparticles from Calu-3 cells or Caco-2 cells (both well-known lung cancer and colon tumor cell lines, respectively) because Cocozza teaches that these cells endogenously express ACE2 and are known targets for SARS-CoV-2 infection (Results, p2). Furthermore, because Cocozza teaches that ACE2 decoy vesicles can be derived from Calu-3 cells or Caco-2 cells (Results, p2; Fig. 1, p3), it could have been done with predictable results and a reasonable expectation of success.
In regards to claims 3 and 15, El Andaloussi teaches that microparticles have diameters ranging from 150 to 1000 nm (paragraph [0003], which overlaps with the claimed ranges 200 to 800 nm (as in claim 3) or 300 to 700 nm (as in claim 17). Additionally, as evidenced by Battistelli, it is known in the art that apoptotic bodies specifically also have size ranges between 500 nm to 2.5 µm (Fig. 1, p2).
In regards to claim 7, the claim is a product-by-process claim because it defines the claimed product in terms of the process by which it is made (see MPEP 2173.05(p)).
In regards to product by process claims, according to MPEP 2113(I), “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”.
Additionally, MPEP 2113(I) continues, “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)”.
Furthermore, according to MPEP 2113(III), “A rejection based alternatively on 35 U.S.C. 102 or 103 for product-by-process claims have been approved by the courts”, continuing, “[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972)”.
In regards to the process steps, the composition of claim 7 is made by a process of providing a tumor cell expressing a spike protein binding receptor, subjecting the tumor cell to apoptosis, and collecting a cellular vesicle released by the apoptotic tumor, wherein the average size particle size of the cellular vesicle is 200 to 800 nm.
Thus, the only structural element to the process steps is that they result in vesicles with an average size of 200 to 800 nm.
However, as above, El Andaloussi teaches that microparticles have diameters ranging from 150 to 1000 nm (paragraph [0003], which overlaps with the claimed ranges 200 to 800 nm. Additionally, as evidenced by Battistelli, it is known in the art that apoptotic bodies specifically also have size ranges between 500 nm to 2.5 µm (Fig. 1, p2). Therefore, the process steps do not impart distinctive structural characteristics to the final product.
Therefore, the microparticle as taught by El Andaloussi and as modified by Cocozza which comprises ACE2 on its surface derived from either Calu-3 or Caco-2 cells, as discussed above (see specifically, the rejection of claim 1) is identical to the tumor cel-derived microparticle of claim 4.
In regards to claim 9, in regards to a dosage “suitable” for administration, it is noted that this term has been interpreted broadly to refer to any dosage that can be administered.
In this regard, El Andaloussi teaches that the vesicle can be part of a pharmaceutically acceptable carrier (claim 9) for administration to lung (e.g., intrapulmonary) (paragraph [0068]) for the treatment of disease (paragraph [0067]; claim 8). As El Andaloussi teaches that the composition can be administered to the lung for the treatment of disease, a person of ordinary skill in the art would have recognized that this composition must be at a dosage suitable for administration to this tissue and the claim does not define any specific amount.
Therefore, the combined teachings El Andaloussi and Cocozza renders the invention unpatentable as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Inal (Clinical Science, 2020).
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
Prosecution Insights