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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 12/29/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/19/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Election/Restrictions
Applicant's election with traverse of Group I and the species: exosomes derived from mesenchymal stem cells and the therapeutic treatment and/or prevention is of fistulas, in the reply filed on 05/01/2026 is acknowledged. The traversal is on the ground(s) that the applicant believes that searching one invention/species would necessarily cover all inventions/species. This is not found persuasive because the applicant has not articulated any reason why or how one could indeed search all of the species and inventions with one search or how the species or inventions are related. The species are not related and the inventions are not single inventions as described in the election/restriction previously posted.
The requirement is still deemed proper and is therefore made FINAL.
Claims 36-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/01/2026.
Claims 20-35 are being examined on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
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.
Claims 20-35 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising components found within animals, the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products a biological material, Wharton’ jelly, umbilical cord, placenta, connective tissue, proteoglycans, amniotic membrane and exosomes the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within animals. Animal extracts are made by partitioning the starting animal material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that animal versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the animal material. Animal extracts are purified by removing unwanted animal material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the animal in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the animals they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is merely claiming the judicial exceptions which can indeed be found existing together in nature. Exosomes are embedded throughout tissues and can be found in solution (ie water or other biological fluids) and tissues can be found existing frozen in nature, which is essentially what the applicant is broadly claiming.
Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
The only other considerations to take analyze are the impregnating of exosomes into a biological material and the process of lyophilizing which has already been discussed. These biological materials already naturally contain exosomes and these tissues can indeed be found frozen in nature and so the claims as a whole do not amount to significantly more than claiming those judicial exceptions.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
Claim Rejections - 35 USC § 112
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.
Claims 28 and 31-33 are 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 28 is indefinite because the applicant recites “wherein the impregnated biological material comprises a therapeutically effective amount of exosomes according to the invention” and the applicant has not shown or determined any amount to be effective for anything (treatment or otherwise). What is the effective amount? What is the effective amount for?
Claims 31-33 are confusing because they each recite a kit comprising two independent means: and then the claims do not describe any particular function, which normally would invoke U.S.C. 112(f). However the claims are directed to a composition and in this case the claims do not recite a function which is connected to the “means” thus the means cannot be understood making the limitation confusing and indefinite. It is not understood how a kit can have a means wherein the means does not describe any function.
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 20-24, 27 and 28-35 are rejected under 35 U.S.C. 103 as being unpatentable over Zhai Quimei et. al. (CN111407716A) and Zhnag Yu et. al. (CN110607274A).
Regarding claims 20-24, 27, 29-30, Quimei teaches that: “the invention discloses an umbilical cord mesenchymal stem cell exosome mask which comprises the following raw materials: the composition comprises lyophilized powder of a P2 umbilical cord mesenchymal stem cell culture solution, lyophilized powder of umbilical cord mesenchymal stem cell exosomes, sweet almond oil, isopropyl myristate, bletilla striata, ligusticum wallichii, lithospermum, pentapeptide, sodium carboxyethyl cellulose, disodium edetate, dodecamethylcyclohexasiloxane, egg yolk lecithin, cetostearyl alcohol, soybean isoflavone, dipotassium glyceroborate, an antibacterial agent, an emulsifying agent, an active agent and allantoin” (see abstract).
Specifically “the composition comprises lyophilized powder of a P2 umbilical cord mesenchymal stem cell culture solution, lyophilized powder of umbilical cord mesenchymal stem cell exosomes” discloses the instant claims 20-24, as umbilical cord is known to contain proteoglycans and is also a connective tissue. Furthermore the lyophilized powders would be “impregnated” together in solution with the other biological materials like the sweet almond oil and other plant extracts along with emulsifier.
Quimei does not specifically teach the composition to be in a kit comprising at least two independent means: a lyophilized biological material, and a solution comprising exosomes.
Yu teaches of mesenchymal stem cell exosomes and there use in treating anal fistulas (see abstract) and teaches of methods for extracting the mesenchymal stem cell exosomes (see claim 1) and teaches the exosomes to be in a calcium ion and thrombin solution (see claims 7-8).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to create a kit which has two independent means: a lyophilized biological material taught by Quimei and a solution comprising exosomes taught by Yu. It would have also been obvious to optimize the amount of exosomes to be an effective amount for treating fistulas because Yu teaches exosomes from mesenchymal stem cells to be useful for such a purpose and this optimization is well within the purview of any skilled artisan especially given the prior art.
Claim 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Zhai Quimei et. al. (CN111407716A) and Zhnag Yu et. al. (CN110607274A) as applied to claims 20-24 and 27-35 above, and further in view of Scheffer Tseng et. al. (EP2470231B1).
Quimei and Yu teach the instant invention however are silent on the starting biological material being amniotic membrane.
Tseng’s general invention is to umbilical cord amniotic membrane products (see invention).
Tseng teaches “There is a need for a product derived from a natural source (e.g., human, non-human primate, pig or cow) that repairs, reconstructs, replaces or supplements tissue (e.g., tendons or nerves) that has been damaged, compromised, or is even missing” (see 0005).
Tseng teaches “accordingly, the present invention provides a pulverized umbilical cord amniotic membrane (UCAM) product as set forth in any of claims 1 to 7” (see 0006).
Tseng also teaches using Wharton’s jelly (see claims 2 and 7).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use umbilical cord amniotic membrane as the biological material in the invention taught by Quimei and Yu because Tseng teaches it to be useful for repairing, reconstructing or replacing tissues that have been damaged.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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