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
The instant application is a national stage entry under 35 USC 371 of PCT/KR2022/006238, filed
02 May 2022. Acknowledgement is made of Applicant’s claim for foreign priority under 35 USC 119(a)-(d) to Republic of Korea application KR10-2021-0057205, filed 03 May 2021. Receipt is acknowledged of certified copies of papers, in a non-English language, required by 37 CFR 1.55.
Status of the Claims
Applicant’s preliminary submission filed 03 November 2023 has been entered. Claims 1-18 are pending. Claims 4-8 have been amended, while claims 9-18 have been newly added. Therefore, prosecution on the merits commences for claims 1-18.
Specification
The substitute Specification filed 03 November 2023 is acknowledged and entered into the application file.
Claim Objections
Claims 3-4, 9, and 14 are objected to because of the following informalities:
Regarding claims 3-4, 9, and 14: The instant claims are each objected to for reciting “…are selected from the group consisting of… , or…”. Instead, the claims should utilize “and” as the conjunction between the listed terms, as they are closed lists of terms given the transitional phrase of “consisting of” within the language of each claim. See MPEP § 2117.
Appropriate correction is required.
Claim Interpretation
A preamble is generally not accorded any patentable weight where it merely recites the purpose
of a process or the intended use of a structure or composition, and where the body of the claim does
not depend on the preamble for completeness but, instead, the process steps or structural limitations
are able to stand alone. See MPEP § 2111.02 (II) and In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976); Kropa v. Robie, 88 USPQ 478, 481 (CCPA 1951). Therefore, the pharmaceutical compositions of the instant claims are interpreted as being drawn to the specific structural limitations recited in the claims, wherein the pharmaceutical composition must comprise chorion membrane extract-derived extracellular vesicles as an active ingredient.
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 5, 10, and 15 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.
Regarding claims 5, 10, and 15: The instant claims each recite the limitation "per well" in Line 2. There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of a well or any type of cell culture dish within the instant claims or parent claims 1-3. Therefore, the scope of each claim is rendered indefinite.
Furthermore, the ordinary artisan would not be readily apprised of the well size and it’s corresponding effect on the concentration of the extracellular vesicles. Therefore, the metes and bounds of the claim cannot be readily determined, thus rendering the scope of each claim indefinite.
Appropriate correction is required.
For the sake of compact prosecution, the claims will each be interpreted as if the total amount of extracellular vesicles is between 1 x 1010 to 1 x 1012 particles.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 8-9, 13-14, and 18 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Qin et al (WO 2020/214868 A9).
Qin et al disclose compositions for treating a pathological condition in a body part of a patient in need thereof, comprising an effective amount of a birth tissue elute or birth tissue particulates (Abstract).
As such, Qin et al disclose that the birth tissue particulates comprised within the composition are extracellular vesicles or exosomes that are derived from the chorion membrane of placental tissue (Pages 2, 4-6, 13, 17, 21-25, 31). Qin et al further disclose that the extracellular vesicles or exosomes are lyophilized into a powder and then suspended into an injectable solution (Pages 4-6, 10, 12, 14, 17, 27, 32, 43; Examples 11, 14).
Qin et al further disclose that the pathological condition is osteoarthritis (Pages 1, 7-8, 15-16, 33-34).
Accordingly, Qin et al anticipate the claims as follows:
Regarding claims 1-4, 9, and 14: Qin et al disclose a pharmaceutical composition comprising chorion membrane-derived extracellular vesicles or exosomes (claims 4, 9, and 14) for the treatment of osteoarthritis (claim 3). Given the intended use interpretation of the claims as discussed above, this therefore reads on the pharmaceutical compositions of instant claims 1-2.
Regarding claims 8, 13, and 18: Following the discussion of claims 1-3, Qin et al further disclose that the extracellular vesicles are lyophilized into a powder and then suspended into an injectable solution. This therefore reads on the pharmaceutical compositions of instant claims 8, 13, and 18.
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 1-6, 8-11, 13-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Qin et al (WO 2020/214868 A9).
The discussion of Qin et al regarding claims 1-3 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Qin et al anticipate claims 1-4, 8-9, 13-14, and 18.
Regarding claims 5, 10, and 15: Following the discussion of claims 1-3 above, Qin et al further disclose that the concentration of extracellular vesicles within the pharmaceutical composition is greater than 10,000 extracellular vesicles per mL, and can even be 100,000,000 extracellular vesicles per mL (Pages 6, 21, 25).
Qin et al further disclose – or reasonably suggest – that the pharmaceutical composition can have a volume of 100 mL, as the pharmaceutical composition comprising the extracellular vesicles would be equivalent to the elute of the first birth tissue in the disclosed embodiment (Page 28, Lines 18-30).
Therefore, the final number of extracellular vesicles comprised within the pharmaceutical composition having a volume of 100 mL is 1010. Given the claim interpretation as discussed in the 35 USC 112(b) rejection above, this therefore renders obvious the pharmaceutical compositions of instant claims 5, 10, and 15. See MPEP § 2144.05: In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Regarding claims 6, 11, and 16: Following the discussion of claims 1-3 above, Qin et al further disclose that the particulates of birth tissue – or extracellular vesicles – have an average particle size of 0.1-1 μm (Pages 14, 18, 27). As the range of 0.1-1 μm – or 100-1000 nm – substantially overlaps with the claimed range of 100 nm to 150 nm, this therefore renders obvious the pharmaceutical compositions of instant claims 6, 11, and 16. See MPEP § 2144.05: In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Qin et al (WO 2020/214868 A9) in view of Song et al (WO 2017/222111 A1, as translated by Espacenet).
The discussion of Qin et al regarding claims 1-3 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Qin et al anticipate claims 1-4, 8-9, 13-14, and 18. Qin et al render obvious claims 1-6, 8-11, 13-16, and 18. Song et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 7, 12, and 17: As aforementioned in the discussion of claims 1-3 above, Qin et al disclose a pharmaceutical composition comprising chorion membrane-derived extracellular vesicles for the treatment of osteoarthritis.
Qin et al further disclose that the pharmaceutical composition can be utilized for the regrowth of bone (Pages 8, 36).
Qin et al do not disclose that the pharmaceutical composition is mixed and used with a hydroxyapatite/β-tricalcium phosphate (HA/bTCP) scaffold, as required by claims 7, 12, and 17.
Song et al, however, disclose a pharmaceutical composition for the prevention or treatment of osteoarthritis comprising an extract from postnatal tissue, including from the chorion membrane (Pages 1-3, 7). Song et al further disclose that the pharmaceutical composition can also comprise a HA/bTCP support (Pages 3-4).
Therefore, it would have been prima facie obvious to have modified the pharmaceutical composition of Qin et al such that it further comprises a HA/bTCP scaffold, as detailed in Song et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to include the HA/bTCP scaffold, as it allows for an increased bone regeneration efficiency when combined with the pharmaceutical composition (Song et al: Page 4), and would have had a reasonable expectation of success given that the disclosures of Qin et al and Song et al are both concerned with the treatment of osteoarthritis via the administration of a pharmaceutical composition comprising a chorion membrane extract. See MPEP § 2143(I)(G).
Consequently, Qin et al as modified by Song et al render obvious a pharmaceutical composition comprising chorion membrane-derived extracellular vesicles and a HA/bTCP scaffold. This therefore renders obvious the pharmaceutical compositions of instant claims 7, 12, and 17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633