DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 7, 2025 has been entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 10, 13, and 14 are pending.
Election/Restrictions
4. In the reply filed on September 24, 2024, applicant elected Group II, fibrosis for species A, bronchial epithelial cell for species B, lung for species C, and pulmonary fibrosis for species D without traverse. The claims to Group I have been cancelled.
Claim Rejections - 35 USC § 101
5. Claims 10, 13, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite extracellular vesicles derived from a bronchial epithelial cell in combination with a pharmaceutically acceptable carrier formulated for inhalation or an aerosol where the carriers are a binder, a disintegrant, an emulsifier, a surfactant, a stabilizer, a lubricant, a streaming accelerator, a flavoring agent, a colorant, or a fragrance. Extracellular vesicles are naturally occurring cellular components and pharmaceutically acceptable binders, disintegrants, flavorings, etc. can also be naturally occurring such as gums, pectin, fruit essence. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, there is no indication that mixing an exosome and a carrier together as commensurate in scope with the stated claims changes the structure, function, or other properties of the ingredients in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each ingredient is the ingredient itself. Each ingredient in the composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, a mixture of the naturally occurring ingredients can be administered via inhalation or aerosol. Thus, these formulations are not considered to create a markedly distinct structure to the combination. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use as a pharmaceutical. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application.
In addition, the combination of the two ingredients is also not considered to show significantly more because MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element is the intended uses. However, applicant’s intended uses are not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional element is not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicant's arguments filed August 7, 2025 have been fully considered but they are not persuasive. Applicant argues:
Not in acquiescence to the rejection, and merely to expedite prosecution, claim 10 has
been amended to recite "wherein the pharmaceutically acceptable carrier is one or more of a binder, a disintegrant, an emulsifier, a surfactant, a stabilizer, a lubricant, a streaming
accelerator, a flavoring agent, a colorant, and a fragrance."
However, as discussed above, these additional ingredient can also be naturally occurring substances. Thus, applicant’s claims are still considered to read on a combination of natural products without a markedly distinct characteristics.
In addition, applicant argues that the specifically claimed forms, i.e. “formulated for inhalation or aerosol” are directed to a particular physical form rather than an intended use. However, as discussed above, a mixture of naturally occurring ingredients can be administered via inhalation or aerosol. Thus, these formulations are not considered to create a markedly distinct structure to the combination. Therefore, applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 102
6. Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Motamedi (WO 2017/165800) with Samuel (WO 2018/023170) providing evidence to inherent characteristics of Motamedi.
Motamedi teaches a composition comprising exosomes derived from bronchial epithelial cell in combination with PBS (phosphate buffered saline) (see pages 10, 11, 47, and 48). PBS is considered to be a stabilizer because it maintains the pH of a composition.
The reference does not specifically teach that the composition is for treating or preventing fibrosis or that it is formulated for inhalation or aerosol. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Samuel teaches that PBS is suitable for intranasal administration (see pages 36 and 37). Thus, the composition of exosomes and PBS taught by Motamedi would be capable of performing the intended administration route. Therefore, the reference composition is structurally the same as the claimed composition and would be capable of performing the intended uses claimed.
Response to Arguments
Applicant's arguments filed August 7, 2025 have been fully considered but they are not persuasive. Applicant argues “Motamedi et al. does not teach the utilization of exosomes in the form of a pharmaceutical composition. Rather, Motamedi et al. teaches nanosensors which detect biological markers, which include exosomes… Furthermore, Motamedi et al. does not disclose the use of a pharmaceutically acceptable carrier as required by the pending claims with exosomes…”. However, as discussed above PBS is considered to be a stabilizer ingredient and Samuel teaches that PBS is suitable for intranasal administration. Thus, the composition of exosomes and PBS taught by Motamedi would be capable of performing the intended administration route. Therefore, the reference composition is structurally the same as the claimed composition and would be capable of performing the intended uses claimed.
7. Claim(s) 10, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kesimer (The FASEB Journal (2009), vol. 23, pp. 1858-1868) with Samuel (WO 2018/023170) providing evidence to inherent characteristics of Kesimer.
Kesimer teaches a composition comprising exosomes derived from healthy bronchial epithelial cells in combination with PBS (phosphate buffered saline) (see abstract and page 1859). PBS is considered to be a stabilizer because it maintains the pH of a composition.
The reference does not specifically teach that the composition is for treating or preventing fibrosis or that it is formulated for inhalation or aerosol. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Samuel teaches that PBS is suitable for intranasal administration (see pages 36 and 37). Thus, the composition of exosomes and PBS taught by Kesimer would be capable of performing the intended administration route. Therefore, the reference composition is structurally the same as the claimed composition and would be capable of performing the intended uses claimed.
Claim Rejections - 35 USC § 103
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.
8. Claim(s) 10, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kesimer (The FASEB Journal (2009), vol. 23, pp. 1858-1868) in view of Paspaliaris (US 2016/0296560).
Kesimer teaches a composition comprising exosomes derived from healthy bronchial epithelial cells. The reference teaches that the exosomes have antiviral properties and can inhibit the ability of a virus to infect a host (see abstract, pages 1859 and 1867).
The reference does not explicitly teach formulating the exosomes for inhalation or as an aerosol using a binder, a disintegrant, an emulsifier, a surfactant, a stabilizer, a lubricant, a streaming accelerator, a flavoring agent, a colorant, and a fragrance. However, an artisan of ordinary skill would reasonably expect that the exosomes taught by Kesimer would have pharmaceutically useful properties in the treatment or inhibition of a viral infection. Given this reasonable expectation of success, an artisan would be motivated to formulate the exosomes into a composition for pharmaceutical use. Paspaliaris teaches formulating exosomes for pharmaceutical use. The reference teaches that the exosomes can be formulated for nasal or aerosol administration using stabilizers, surfactants, flavoring agents, and coloring agents (see paragraph 57). Therefore, an artisan of ordinary skill would have reasonably expected that the exosome taught by Kesimer could be formulated for nasal or aerosol administration using the ingredients as taught by Paspaliaris. This reasonable expectation of success would have motivated the artisan to modify Kesimer in this manner.
9. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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