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 .
DETAILED ACTION
Claim status
Claims 1-6 are pending
Claims 1-6 are under examination
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/25/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections to the Specification
The disclosure is objected to because of the following informalities: p. 39 [0090] refers to “Table 12”, yet Fig. 12 is not labeled as such. Furthermore, tables are to be presented and numbered in order of appearance and “Table 12” only appears to be preceded by Table 1 and Table 2.
Claim Objections
Claims 1-6 are is objected to because of the following informalities: the preamble of claim 1 introduces the initial phrase “amnion-derived mesenchymal stem cells”, yet subsequent references to these cells use the phrase “mesenchymal stem cells”. Although the antecedence for these cells is clear enough as there are no other cells being claimed, Applicant should be consistent with claim language and use the same initial phrase when referring back to the amnion-derived mesenchymal stem cells.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-6 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 1 recites the limitation that the removing step (3) is performed so as to obtain an enzyme digested fraction having a “reduced proportion” of epithelial cells. A claim may be rendered indefinite by reference to term of an object that is variable (see MPEP 2173.05(b), II). Specifically, the phrase “reduced proportion” is a relative term which renders the claim indefinite. The phrase "reduced proportion" is not defined by the claim, the specification does not provide a comparative standard for ascertaining the requisite degree of reduction, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention as there is no indication of what the “reduced proportion” is relative to. Dependent claims 2-6 do not clarify the scope of what the standard of the reduced proportion is relative to.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yamahara et al., (US2016/0228474, see IDS filed 9/25/2023)
In regard to claim 1, Yamahara teaches methods for producing a population of amnion-derived MSCs comprising the following 9 steps (see p. 5, col 1, [0085-0094]:
Step 1. Aseptically obtaining human fetal appendages (e.g., placenta, umbilical cord, and fetal membrane) from a Caesarean section.
Step 2. Removing the amnion from the fetal appendages.
Step 3. Transferring and washing the amnion with a isotonic solution in order to remove blood and the like.
Step 4. Cutting the amnion into several smaller pieces, and storing the amnion in a medium at 2°C to 8°C for 24 to 48 hours, which would have been an obvious step to include if the Caesarean did not occur at a convenient time or place for tissue processing in a cell culture facility.
Step 5. The amnion is immersed in an enzyme solution comprising collagenase and thermolysin and/or dispase, and then stirred and shaken at 37°C at 60 rpm for 90 min using a thermostatic shaker.
Step 6. The MSCs are suspended in the enzyme solution, while the epithelial cells remain as a monolayer.
Step 7. Filter the enzyme solution only allowing the MSCs to pass through a mesh, while the epithelial cell layers remain. Thus, Yamahara implies the removing of undigested material that did not pass through the mesh, such that the enzyme digested fraction has a reduce proportion of epithelial cells.
Steps 8-9. Centrifuging the MSCs and resuspending in media, followed by seeding for culture.
However, Yamahara is silent to a preferred embodiment of a method for producing amnion MSCs comprising all of the taught steps.
Nevertheless, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to practice said method to produce a amnion MSCs because each of the individual steps of the instant claims are independently presented by Yamahara as embodiments and are taught that they can be combined in various embodiments; therefore a combination of all the steps into a single embodiment would be apparent to an artisan skilled in primary cell culture in light of the Supreme Court’s KSR decision (see MPEP 2143 Exemplary Rationale (A)). Regarding the rationale for combining prior art elements according to known methods to yield predictable results, all of the claimed elements and steps were known in the prior art and one skilled in the art could have combined the element as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of filing of the invention. Each of the elements (storing the amnion in medium, treating amnion in enzymes, filtering and culturing the enriched amnion MSCs) are taught by Yamahara and further they are taught in various combinations and are shown to be used in a method for producing amnion MSCs. It would have been therefore predictably obvious to use a combination of these steps and elements in said method.
In regard to claim 2, as stated supra, Yamahara teaches the amnion is “immersed in a solution” containing the enzymes, which implies the tissue was removed from the media before being placed in the solution. Furthermore, this would have been an obvious step so as to minimize contamination of the enzyme solution by the media.
In regard to claim 3, although Yamahara does not define the phase of the medium, all of the other media used by Yamahara are aqueous solutions, which would have been obvious for the media.
In regard to claim 4, as stated supra, Yamahara teaches the enzymes include collagenase and dispase.
In regard to claim 5, as stated supra, Yamahara teaches the amnion is first cut into several smaller pieces before being stored in the medium. Note that Applicant’s does not have a special definition for “shredded” and only indicates that it may encompass being “cut into small pieces”, wherein the size of “small” is not defined. Thus, the cutting step of Yamahara appears to reasonably suggest being “shredded”.
In regard to claim 6, as stated supra, Yamahara teaches the media is between 2°C to 8°C.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631