-13DETAILED 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 .
Status of claims
Claims 1-13 as filed on 12/23/2024 are pending and under examination in the instant office action.
Claim Rejections - 35 USC § 112
Indefinite
Claims 1-13 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 1 is considered indefinite because phrase “system” does not point out whether the claim is drawn to a product or to a method. The body of the claim recite steps of a method but also a group of several labeled/coded containers comprising starting materials and final products.
Claim 1 is rendered indefinite by the phrase “170 (C° x days)”. It is unclear what number 170 stands for and how it is determined. The claimed language appears to recite that this number is equal degree in Celsius multiplied by days (170 = C° x days). However, if a transport period is 1 day, then temperature would be 170 C° to provide the claim-recited number 170. The temperature of 170° C is clearly unreasonable for transportation of biological material as intended for cell culturing. Thus, the meaning of the claim-recited phase is questionable.
Claim 2 recites the limitation drawn to the transport period of about 1-160 hours in the system/method of claim 1, wherein the transport period and temperature are linked by “days” not “hours”. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 is unclear about recited concept of “separating … into respective members one of which is a cell”.
Claim 4 is indefinite with regard what is “a biological raw material” that would “other that the raw materials”.
Claim 11 is unclear about what is sent or arrives in “3 days to 2 weeks”. If interval between sending and arrival materials is 3 days, the, accordingly to the concept of number 170 of claim 1, the transport temperature is above 50°C which is unreasonably high for biological materials intended for culturing.
Claim Rejections - 35 USC § 102
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 1-7, 11, 12 and 13 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Kasai et al (IDS reference; Regenerative Therapy, 2019, Vol. 11, pages 88-94).
The cited reference by Kasai discloses a method for providing a cell product intended for regenerative therapy (see abstract).
In particular, the cited method comprises:
step of collecting (“identification step”) at least two kinds of raw materials including blood and nasal tissue from individual patients (see page 89, sections 2.1 and 2.3), wherein the blood is intended for making a medium based on “autologous” blood (see section 2.2). Term “autologous” means biological material comes from and goes back to the same individual. Thus, the collected materials have been labeled an/or assigned “identification code representing information to each of two kinds of individual raw materials derived from the same patient” within the broadest reasonable meaning of the claims as intended to use for the same individual;
step of transporting (“first transport step”) of the collected materials over 3 hours in ice box to a laboratory or cell processing center (section 2.3, phrase bridging col. 1 and col. 2 of page 89);
step of manufacturing or step of culturing nasal tissue in a medium made from autologous blood to make a cultured product or a cell sheet (section 2.3, page 89, col.2, par. 2); thus, “combining” the two kinds individual raw materials (blood derived materials and nasal cells) into one product after the first transport step within the broadest reasonable meaning of the claims;
step of subsequent transporting (“second transport step”) of the cultured cell product after the manufacturing step (see figure 1, page 90) as intended for examination prior to use in regenerative therapy.
Thus, the cited reference anticipates claims 1, 6 and 7.
As applied to claim 2: in the cited method the collected material is transported for about 3 hours in ice box, thus, at temperate of about 4 C°.
As applied to claim 3: in the cited method blood and nasal tissue sample are handled separately and cells of nasal tissue are cultured at temperature of 37°C (section 2.3).
As applied to claim 4: in the cited method is based on autologous materials; thus, no “other” material is used.
As applied to claim 5: the cited reference clearly teaches the use of specific temperature suitable for handling biological materials. Thus, the temperature have been recorded and traced along to whole process.
As applied to claim 11: claim 11 is unclear.
As applied to claim 13: the cited method is based on the use of “autologous” blood for making medium for culturing cells (see section 2.2). Term “autologous” means biological material comes from and goes back to the same individual. The cells cultured on autologous blood materials are intended for regenerative therapy. Thus, the cultured cells materials have been labeled an/or assigned “second identification code” as representing information associated with patient from which the materials were derived/collected within the broadest reasonable meaning of the claims.
The cited reference anticipates the claimed invention.
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, 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.
Claims 1-7 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kasai et al (IDS reference; Regenerative Therapy, 2019, Vol. 11, pages 88-94) in view of US 2005/0158846 (Hibino et al).
The cited reference by Kasai is relied upon as explained above for the disclosure of a method for providing a cell product intended for regenerative therapy (see abstract).
In particular as applied to claim 12, the cited reference by Kasai discloses temperature for “second transport” (figure 1) being 37°C as intended to transfer the cell product for examination of cell number, purity, etc. However, it would be obvious to ordinary skills in the art that a transport temperature of the cell product to the medical facility would be lower as necessitated by requirement of cell product preservation before actual transplantation for patients of regenerative therapy.
The method of the cited reference by Kasai is based on using autologous materials for providing cell products for the patients in need of regenerative therapy. Term “autologous” means biological material comes from and goes back to the same individual. Thus, the collected and cultured materials have been labeled an/or assigned “identification code representing information to each of two kinds of individual raw materials derived from the same patient” within the broadest reasonable meaning of the claims as intended to use for the same individual.
Although the cited reference by Kasai does not explicitly discloses the use of “identification code representing information” associated with patients, the use of unique identification information codes in the process of collecting, transporting, culturing and outgoing transportation in managing medical databases for regenerative therapy have been used, taught and/or suggested in the prior art as adequately demonstrated by the cited US 2005/0158846 (Hibino et al); for example: see abstract and figure 1.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kasai et al (IDS reference; Regenerative Therapy, 2019, Vol. 11, pages 88-94) in view of US 2005/0158846 (Hibino et al) as applied to claims 1-7 and 11-13 above, and further in view of US 2010/0178274 (Sekiya et al).
The cited reference by Kasai is relied upon as explained above for the disclosure of a method for providing a cell product intended for regenerative therapy (see abstract). In particular, in the method of Kasai the cell product is manufactured from two kinds of individual raw materials including blood and nasal tissue, wherein autologous blood (or serum) is used for making a medium for culturing nasal cells from the same individual.
The reference by Kasai is silent about applications of the synovial tissues. However, the prior art teaches providing a cell product made from synovial tissue cultured on medium made with autologous blood or serum; for example: see US 2010/0178274 par. 0102-0106.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to use synovial tissues instead of nasal tissues the method of Kasai with a reasonable expectation of success in providing a cell product intended for regenerative therapy as depending on needs of the patients to regenerative therapy.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
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Vera Afremova
August 31, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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