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
This application is in response to the papers filed on March 4, 2025. Claims 8-20 are currently pending. Claims 1-7 have been cancelled, and claims 8-20 are newly filed in Applicants amendment filed on March 4, 2025. Therefore, claims 8-20 are currently under examination to which the following grounds of rejection are applicable.
Claim Interpretation
Claims 16 and 17 are directed to “uses”. This claims are indefinite since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. Additionally, because this claim does not to set forth any steps involved in the process, it results in an improper definition of a process, i.e., results in a claim which is not a proper process claim. For the sake of compact prosecution, the Examiner has interpreted claims 16 and 17 as the compositions described in claim 8, particularly a medical product that comprises Wharton’s Jelly. If Applicants do not wish for this claim to be interpreted as a composition Applicants are invited to amend the claims, at which point, the Examiner will determine if the amended claims fall within the elected group.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/CN2022/078588 filed on March 1, 2022.
Thus, the earliest possible priority for the instant application is March 1, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 23, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The Specification incorrectly recites “Wharton’s Jelly” as “Walden’s Jelly” in paragraphs 0024 and 0037.
Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed 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.
Claims 8-20 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Schmid et al. (US 2021/0315199 A1) and Barnouin (WO 2019/038411 A1; Published February 28, 2019; citations made herein are based on the machine translated document).
Claim 8 recites a product-by-process.
"[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) MPEP 2113.
The claims are directed to a “A medical product” that involves Wharton’s Jelly cryopreserved with a cryoprotective agent then thawed or rather lyophilized Wharton’s Jelly. Therefore, Wharton’s Jelly that has been treated in a different manner, yet still has a similar structural composition would still read on the claim so long as the compositions are the same or not patentably distinct from the prior art.
In reference to ‘method (1)’ of claim 8, Schmid teaches treating Wharton's Jelly derived from umbilical cord tissue with a cryoprotective agent, particularly DMSO, followed by cryopreservation, and thawing before use for use as a cellular therapeutic composition (abstract, par 0012, 0025).
In reference to the second alternative, ‘method (2)’ of claim 8, Barnouin teaches the lyophilization/freeze-drying of Wharton’s Jelly as described in Example 1 (par 0312-0344). Moreover, Barnouin describes the composition can be used in cell regeneration in vivo, and more specifically for bone repair (par 0474, 509).
Barnouin and Schmid teach the process for preparing the claimed medical product based on teaching cryopreservation and lyophilization of Wharton’s Jelly, respectively, and therefore anticipate the claimed compositions in view of the product-by-process limitations.
However, even if Barnouin or Schmid’s medical products and the claimed medical products are not one and the same and there is, in fact, no anticipation, the references would, nevertheless, have rendered to one of ordinary skill in the art at the time the invention was made the claimed medical product an obvious design choice based on the claimed cryopreservation techniques being well-known in the art.
Thus, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the references, especially in the absence of evidence to the contrary.
In reference to the recited preamble, “A medical product for promoting bone regeneration,” this is being understood as an intended use. MPEP 2111.02 states, “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.” In the instant case there are no clear manipulative differences nor structural differences between the medical products claimed in view of the intended use than the prior art. Therefore, no weight is being given to “for promoting bone regeneration” due to the expectation that the compositions taught by the prior art would have the same effect due to no structural differences.
Regarding claim 9, dependent on claim 8, Schmid describes the Wharton’s Jelly being derived from a mammal umbilical cord (par 0019), additionally Barnouin teaches the same (par 0006).
Regarding claim 10, dependent on claim 8, Schmid teaches wherein the cryoprotective agent is a 10% dimethyl sulfoxide (DMSO) solution (par 0021, 0027).
Regarding claim 11, dependent on claim 8, Schmid teaches wherein the cryopreservation is performed in liquid nitrogen (par 0028).
Regarding claims 12, and 18-20, dependent on claim 8 and 9, respectively, Schmid teaches wherein the Wharton's Jelly under the cryopreservation contains cell bodies, particularly MSCs (Example 1, par 0029).
Regarding claim 13, Barnouin teaches wherein the lyophilizing comprises taking a piece of fresh Wharton's Jelly from the umbilical cord, followed by direct cryopreservation at -80°C, and then draining moisture from tissues using a freeze dryer (par 0338).
Regarding claim 14, dependent claim 13, Barnouin teaches wherein the Wharton's Jelly contains no cell bodies (“significant decellularization of the biological tissue”, par 00319).
Regarding claim 15, dependent on claim 8, Schmid and Barnouin teach the claimed compositions as described above in the claim 8 rejection. Therefore, the prior art teaches the claimed properties of these compositions as they are inherent. MPEP 2112 states:
“Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.”
Based on the references teaching all the limitations of the claim except the properties pertaining effects on using the composition, these are considered inherent to the composition itself, and therefore it is clear Schmid and Barnouin anticipate or renders obvious the claimed invention.
Claims 16 and 17 are similarly rejected as claims 8 and 15 due to being directed the same compositions. Please note the Claim Interpretation section above regarding “use claims.”
Conclusion
Claims 8-20 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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