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
Applicant’s election without traverse of Group I and the species Wnt as the small molecule cell growth signaling pathway activator and H4 as the non-cancerous mammalian cell-secreted protein, in the reply filed on 03/25/2025 is acknowledged.
Claims 15, 17, 20-21, 25-26, 40-46 and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 03/25/2026.
Claims 1, 3, 5, 8-10 and 13 are being examined on the merits.
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 1, 3, 5, 8-10 and 13 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.
Claim 5 recites “a cell-secreted protein” and the applicant elected H4 as the protein to be examined which is not a cell-secreted protein, which makes the limitation confusing and indefinite. Histone 4 is a protein involved with support for chromatin structure and is not secreted outside the cell.
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 1, 3, 5, 8-10 and 13 are rejected under 35 U.S.C. 101 because the claimed invention 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 “a cell-free conditioned medium from non-cancerous mammalian cells” 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 cell-free conditioned medium comprising a cultured substantially homogenous non-cancerous mammalian cell population; wherein at least a portion of the non-cancerous mammalian cell population is contacted by at least one small molecule cell growth signaling pathway activator before being cultured in the cell culture medium, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart. In this case the application is drawn to a cell extract or the secreted components of a cell that has been stimulated by small molecules.
The claim recites the naturally occurring components found within mammalian cells. Cell extracts of mammals are made by partitioning the starting cell 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 cell versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the cell. In other cases the cells can be stimulated to secrete different proteins, cytokines and small molecules as is the case for the instant application. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the mammalian cells 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 cells they are secreted 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 only claims those extracted components broadly with a conditioned medium that is cell-free. There is no integration of the judicial exceptions into any practical application because the applicant is only claiming those judicial exceptions without reciting any specific use or incorporation into any practical application.
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)).
Since the naturally-occurring components as-claimed are not found together in nature, admixing the ingredients into a single formulation is considered an ‘additional element’ which must be analyzed for eligibility. Admixing naturally-occurring cellular components with a conditioned media is well-understood, routine practice in the art because mammalian cells have been grown in medium for the last century in order to keep cells alive, study various aspects of different cell types and for collecting cellular secretions to isolate and determine structures and functions of various proteins, cytokines and small molecules. Also, broadly claiming a container and label do not exclude the claimed judicial exceptions from this rejection.
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 § 102 and/or- 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 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.
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, 8-10 and 13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Brodie Chaya and Brodie Shlomt (CN110402146A) hereinafter Chaya.
Regarding claims 1, 3, 8-9, Chaya teaches of extracellular matrix secreted by chorion placenta derivative mesenchymal stem cell (CH-MSC) (non-cancerous mammalian cells) groups and their conditioned mediums (see page 2, (b) iii) and teaches wherein the modified MSC groups are grown in the presence of a variety of various small molecules one of which is WNT3 agonist CAS 853220-52-7 (also referred to as BML-284) (see first para. page 22).
Furthermore Chaya recites that the pharmaceutical composition for treating disease or situation is provided according to another aspect, and described pharmaceutical composition includes Pharmaceutically acceptable adjuvant, excipient or carrier and following at least one: (c) from CH-MSC groups of conditioned mediums; With (d) extracellular matrix secreted by CH-MSC groups (see page 8). Chaya does not require the cells to be present in the medium and so it can be understood that it is the conditioned medium which is intended for treatment.
Regarding claim 10, Chaya describes wherein the MSC is bone marrow derived MSC’s (see page 2, last para., page 3, last sentence, page 8 first para. etc.) and with the broadest reasonable interpretation bone marrow derived MSC’s are also bone cells.
Regarding claim 13, Chaya describes a kit (see after Summary of the invention, page 7). Chaya does not describe wherein the kit has instructions or a label however these are conventionally done in the art and would have been prima facie obvious to those having ordinary skill in the art.
Chaya does not specifically describe that the medium is cell-free however Chaya describes wherein it is the extracellular components from the modified MSCs and the conditioned medium which are useful for treating diseases. Furthermore Chaya recites that the pharmaceutical composition for treating disease or situation is provided according to another aspect, and described pharmaceutical composition includes Pharmaceutically acceptable adjuvant, excipient or carrier and following at least one: (c) from CH-MSC groups of conditioned mediums；With (d) extracellular matrix secreted by CH-MSC groups (see page 8). Chaya does not require the cells to be present in the medium and so it can be understood that it is the conditioned medium which is intended for treatment.
If Chaya does not indeed anticipate the instant claims, it would have been obvious to persons having ordinary skill in the art to not include cells in the final composition which would comprise of the MSC’s secreted components and the conditioned medium, because cells can cause unwanted immune responses due to interactions with membrane proteins.
Claim 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Brodie Chaya and Brodie Shlomt (CN110402146A) as applied to claims 1, 3, 8-10 above, and further in view of Dong-Young Lee et. al. (Histone H4 Is a Major Component of the Antimicrobial Action of Human Sebocytes, J Invest Dermatol. 2009 October; 129(10): 2489-2496).
Chaya teaches the instant invention however is silent on the media containing the protein H4 as claimed.
Lee teaches that histone 4 (H4) is a major component of antimicrobial action of human sebocytes. Lee teaches that cultured sebocyte fractions contained H4 which exhibited antimicrobial action (see Figure 2).
Therefore it would have been obvious to persons having ordinary skill in the art to include H4 protein in the conditioned medium taught by Chaya because as Lee teaches this protein acts as a natural antimicrobial agent when detected in cultured medium. Furthermore, including a container, label and instructions in a kit is conventional and routine in the art.
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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