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 .
Response to Arguments
The claim amendments have overcome the previously presented Claim Objections.
Regarding the previous rejection of claim 1 under 35 U.S.C. 112(b) directed to the particular limitation “substantially free of neutrophils”, Applicant has argued that the recitation of “the concentration of neutrophils in the wound-healing composition is less than 5% of the separated white blood cells” supplies a guideline for ascertaining the meaning of the noted limitation. The Examiner agrees, and the rejection related to this particular limitation is withdrawn.
The claim amendments have overcome the previous 35 U.S.C.112(b) rejections applied to claims 17-19 and 22.
Regarding the previous rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Smith et al. (US Patent 5,667,963) in view of Turzi et al. (US Patent Application Publication 2018/0110917), Applicant has argued that Smith does not disclose or teach a density separation medium comprising a non-Newtonian gel as required by the amendment to claim 1. The Examiner agrees, and the previous prior art rejection has been withdrawn.
The claim amendments have necessitated a new grounds of rejection.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0094] states “Figure 1 shows free space 20 positioned above anticoagulant solution 16 to provide suitable space for accommodation of a blood sample to be separated.”, and it is believed the numeral 16 should be changed to 18.
Appropriate correction is required.
Election/Restrictions
Claim 1 is allowable. The restriction requirement between Groups I-VI and between Species A and B , as set forth in the Office action mailed on 06/09/2026 , has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 06/09/2026 is partially withdrawn. Claim 6 , directed to a species of the density separation medium, is no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim. However, claims 23-49, directed to system(s), composition(s), and method(s), are withdrawn from consideration because they do not require all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 5 recites wherein the density separation medium is selected from the group consisting of sodium diatrizoate, derivates thereof and combinations thereof. However, claim 1, from which claim 5 ultimately depends, has been amended to recite that the density separation medium must comprise a non-Newtonian gel. The Examiner asserts that Applicant’s disclosure does not contain sufficient information as to enable one of ordinary skill in the art to make and use a density separation medium that is a non-Newtonian gel and a material selected from the group consisting of sodium diatrizoate, derivatives thereof, and combinations thereof. In order to assess whether undue experimentation would be required, the Examiner has considered the Wands factors:
As to Wands factor (C), the prior art discloses that sodium diatrizoate is typically used as a liquid density separation medium (see col. 4 lines 18-43 of US Patent 4,751,001, already of record; see also para. 15 of US Patent Application Publication 2020/0215533; the noted substance is notoriously well known in the art to be used in Ficoll-Paque liquid density gradient materials) and the prior art as a whole does not suggest using sodium diatrizoate or derivatives thereof as a gel density separation medium. Furthermore, one of ordinary skill in the art would not understand sodium diatrizoate or derivatives thereof to be non-Newtonian.
As to Wands factors (F) and (G), the specification as-filed does not direct the artisan as to how a non-Newtonian gel comprising sodium diatrizoate or derivatives thereof could be prepared or used, and the specification contains no working examples involving this particular density separation medium. It is noted that neither of the working examples of Applicant’s specification include use of a density separation medium as a non-Newtonian gel, as Example 1 is directed to a density gradient fluid, and Example 2 is directed to a density gradient liquid.
In view of the forgoing, the Examiner concludes that the subject matter of claim 5 does not comply with the enablement requirement of 35 U.S.C. 112(a).
Claim 6 recites wherein said density separation medium is selected from the group consisting of a polymer of sucrose or epichlorohydrin having a molecular weight of at least 400,000 and derivatives and combinations thereof. However, claim 1, from which claim 6 ultimately depends, has been amended to recite that the density separation medium must comprise a non-Newtonian gel. The Examiner asserts that Applicant’s disclosure does not contain sufficient information as to enable one of ordinary skill in the art to make and use a density separation medium that is a non-Newtonian gel and a material selected from the group consisting of a polymer of sucrose or epichlorohydrin having a molecular weight of at least 400,000 and derivatives and combinations thereof. In order to assess whether undue experimentation would be required, the Examiner has considered the Wands factors:
As to Wands factor (C), the prior art discloses that sucrose and epichlorohydrin are typically used as a liquid density separation medium (see col. 4 lines 18-43 of US Patent 4,751,001, already of record; see also para. 15 of US Patent Application Publication 2020/0215533; the noted substances are notoriously well known in the art to be used in Ficoll-Paque liquid density gradient materials) and the prior art as a whole does not suggest using sucrose and/or epichlorohydrin as a gel density separation medium. Furthermore, one of ordinary skill in the art would not understand sucrose or epichlorohydrin or derivatives thereof to be non-Newtonian.
As to Wands factors (F) and (G), the specification as-filed does not direct the artisan as to how a non-Newtonian gel comprising sucrose or epichlorohydrin or derivatives thereof could be prepared or used, and the specification contains no working examples involving this particular density separation medium. It is noted that neither of the working examples of Applicant’s specification include use of a density separation medium as a non-Newtonian gel, as Example 1 is directed to a density gradient fluid, and Example 2 is directed to a density gradient liquid.
In view of the forgoing, the Examiner concludes that the subject matter of claim 6 does not comply with the enablement requirement of 35 U.S.C. 112(a).
Allowable Subject Matter
Claims 1-2, 4, and 7-22 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 1, the closest prior art is provided by Smith (US Patent 4,957,638) (already of record). Smith discloses a system for preparing a composition comprising at least lymphocytes and monocytes with granulocytes being removed (Abstract), the system comprising a first container having a sealable open end for receipt of a blood sample and a closed end opposite the open end (col. 13 lines 16-30), the first container containing a density separation medium comprising a gel disposed at a first position proximate the closed end (col. 14 line 55-col. 15 line 12) (Fig. 2), and a thixotropic gel having a density of about 1.055 to 1.08 g/cm3 disposed at a second position between the open end and the first position (col. 12 lines 54-57, col. 14 line 55-col. 15 line 12) (Fig. 2), and an anticoagulant solution (col. 12 lines 58-68). However, Smith does not expressly teach wherein the density separation medium comprises a non-Newtonian gel and is silent as to a second container comprising a coagulation-activator. The prior art as a whole does not disclose, teach, or suggest the density separation medium comprising a non-Newtonian gel, within the claim environment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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