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 action is in response to the papers filed on July 12, 2023. Claims 1-18 are currently pending. Claims 1 and 10 are independent claims.
Therefore, claims 1-18 are examined on their merits to which the following grounds of rejection are applicable.
Priority
This application is claiming the priority filing date of July 12, 2023.
IDS
The information disclosure statement (IDS) submitted on 07/12/2023 was filed after the mailing date of the non-final office action. 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 objection
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 or an official IDS, they have not been considered.
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 1-18 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 applicant regards as the invention.
Claims 1 and 10 are indefinite in their recitation of “the perivascular space” in line 1 and 2, respectively. There is not proper antecedent basis for the pellet in the claims.
Claims 1 and 2 are indefinite in their recitation of “the umbilical cord blood vessel” in line 2. There is not proper antecedent basis for “the umbilical cord blood vessel” in the claims.
Claims 1 and 2 are indefinite in their recitation of “the umbilical cord blood vessel” in lines 2 and 5. The Specification does not provide a definition of what is meant by “the umbilical cord blood vessel”. However, paragraph [0012] of the published application describes the blood vessels of the umbilical cord having the vein and the two arteries. Thus, it is unclear what the meaning of a single cord blood vessel is. As such the metes and bounds of the claim are indefinite.
Claim 1 and 10 recites the limitation "the pellet" in lines 16 and 18, respectively. There is insufficient antecedent basis for this limitation in the claim. There is no previous mention of what is “the pellet”.
Claims 1 and 10 are indefinite in their recitation of “cutting out a section of umbilical cord” in lines 4, 5, 7 and 10-11. There is not proper antecedent basis for “umbilical cord”. The claims refer in line 2 to “umbilical cord blood vessel”. As such the metes and bounds of the claim are indefinite.
Claims 1 and 10 are indefinite in their recitation of “filling the vessel with a new 0.01-0.5% collagenase solution” in lines 10 and 12, respectively. It is unclear how after the active step of “sealing both ends of the umbilical cord”, the umbilical cord blood vessel is filed. As such the meets and bounds of the claim are indefinite.
Claim 10 is indefinite in its recitation of “the pellet obtained from centrifugation” in line 18. It is unclear whether the term “centrifugation” refers to the first or second centrifugation. As such the metes and bounds of the claim are indefinite.
Claims 2-9 are indefinite insofar as they depend from claim 1. Claims 11-18 are indefinite insofar as they depend from claim 10.
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.
Claims 1 – 18 are rejected under 35 U.S.C 102(a)(1) as being anticipated by Bagaeva Varvara Vladimirovna (RU 2620981, Publication date 30-May-2017– 1p com translated document).
Regarding claims 1 and 10, Vladimirovna teaches in page 4, example 1, a method of obtaining a culture of human mesenchymal stem cells from the perivascular space of the umbilical cord which consists
in cutting out a fragment of the umbilical cord,
filling the vein of the mentioned fragment of the umbilical cord with a 0.2% collagenase solution,
closing both ends of the mentioned fragment of the umbilical cord and keeping it for at least 20 minutes at a temperature of 37 ° C (‘at a temperature of 37 ° C and gentle stirring for 20 minutes”), and said vein is washed with a balanced saline solution, where the “collagenase solution and saline after washing were collected and centrifuged”, falling within the scope of “washing the vessel with a first balanced normal saline solution and harvesting the first balanced salt solution” and “centrifuging the first balanced salt solution” of claim 10,
filling the vessel with a new 0.01-0.5% collagenase solution, “umbilical vein was washed a second time with said collagenase solution using a syringe”, sealing both ends of said umbilical cord and incubated for at least 30 minutes, at 37 °C, (“at a temperature of 37 ° C and gentle stirring for 30 minutes),
after which said vein is washed with a balanced saline solution, the liquid obtained by washing is centrifuged, the resulting precipitate is cultured on selective environments: “The collagenase solution and saline after washing were collected and centrifuged on the centrifuge for 7 minutes at 1100 rpm” page 4, para. 6 and
“The supernatant was removed, the pellet was placed in a 75 cm 2 culture vial, to which 10-15 ml of the complete culture medium was previously added.” Page 4, para 6, falling within the scope of “culturing the pellet obtained from centrifugation on a selective medium” of claim 1 and 10.
Regarding claims 2 and 11, Vladimirovna teaches a 0.2% collagenase solution (Page 4, para 6; also in claims, pg. 9) reading on 0.1-0.3%.
Regarding claims 3 and 12, Vladimirovna teaches a 0.2% collagenase solution (found in Claims, pg. 9) reading on 0.2%.
Regarding claims 4 and 13, Vladimirovna teaches closing both ends of the mentioned fragment of the umbilical cord and keeping it for at least 20 minutes, but not more than 40 minutes at a temperature of 37 ° C for the first incubation (Page 4, para 6; also in claim 1, pg. 9) reading on the first incubation is carried out for 25-45 minutes.
Regarding claims 5 and 14, Vladimirovna teaches closing both ends of the mentioned fragment of the umbilical cord and keeping it for at least 20 minutes, but not more than 40 minutes at a temperature of 37 ° C for the first incubation (found in Claims, pg. 9) reading on the first incubation is carried out for 25-35 minutes.
Regarding claim 6, Vladimirovna teaches closing both ends of the mentioned fragment of the umbilical cord and keeping it for at least 20 minutes, but not more than 40 minutes at a temperature of 37 ° C for the first incubation (Page 4, para 6; also in claim 1, pg. 9) reading on the first incubation is carried out for 30 minutes.
Regarding claims 7 and 16, Vladimirovna teaches filling with a new portion of said collagenase solution, cover both ends of said umbilical cord and incubated for at least 30 minutes, but not more than 60 minutes at 37 °C for the second incubation (Page 4, para 6; also in claim 1, pg. 9) reading on the second incubation is carried out for 40-65 minutes.
Regarding claims 8 and 17, Vladimirovna teaches filling with a new portion of said collagenase solution, cover both ends of said umbilical cord and incubated for at least 30 minutes, but not more than 60 minutes at 37 °C for the second incubation (Page 4, para 6; also in claim 1, pg. 9) reading on the second incubation is carried out for 40-50 minutes.
Regarding claims 9 and 18, Vladimirovna teaches filling with a new portion of said collagenase solution, cover both ends of said umbilical cord and incubated for at least 30 minutes, but not more than 60 minutes at 37 °C for the second incubation (Page 4, para 6; also in claim 1, pg. 9) reading on the second incubation is carried out for 45 minutes.
Thus, by teaching all the claimed limitations, Vladimirovna anticipates the claimed invention.
Conclusion
Claims 1-18 are rejected.
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/JULIANA IRENE CANDELARIA/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634