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 the Claims
Claims 1, 4, 5 are currently pending in the Application and examined on the merits below.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho et al (WO2010107287). Machine translation are included in this office action.
Claim 1 describes a method of alopecia also known as baldness through administration to a subject an acellular human “amnion-derived” composition which comprises:
a. a plurality of tissue remodeling biomolecules as in claim 1
b. a plurality of tissue proliferation biomolecules as in claim 1
c. a plurality of tissue angiogenic biomolecules as in claim 1
d. a plurality of tissue migration biomolecules as in claim 1
e. a plurality of tissue anti-inflammatory biomolecules as in claim 1, and
f. a plurality of tissue anti-microbial biomolecules as in claim 1.
In the specification applicant indicates methods for making conditioned media derived from human amnion cells (figure 1) and the assessed levels of particular biomolecules of categories (a-f, above) found in acellular conditioned media extracted from the cultured amnion cells compared to control media. Figure 11, A-D particularly indicates that the cells utilized in the culture of the invention are characteristic of “MSC” or mesenchymal stromal cells for example which are found in the cell culture of the invention and thereby describes that the growth factors and cytokines of the claim 1 for example are produced by said MSC in culture. Media utilized in the method to produce the conditioned media of the invention is described as in embodiment “xeno-free media formulated for mesenchymal stem cells” (0048) and cells are indicated as being mesenchymal stromal cells (stem cells) which are characterized as “multipotent progenitor cells used in several cell therapies”. Thus the various bioactive molecule found by the culture are inherent products of the culture of MSC found in the amniotic fluid/membrane cultures.
Regarding claim 1 the disclosure of Cho relates to compositions for promoting hair growth or preventing hair loss in a subject through the creation conditioned media produced by amniotic derived mesenchymal stem cell/stromal cells (“Description”, p2, para 1, 2). The cells utilized in the invention are multipotent and may differentiate into fat, bone and cartilage for instance (figure 4, p3). The disclosure of Cho further indicates that the conditioned media of the invention comprised particular components including matrix metalloproteinases (MMPs) and many growth factors including the MMP1 (figure 6B of original document provided). The conditioned media is centrifuged and filtered thereby removing cells from the conditioned media providing an “acellular” composition (Example 4, p5).
The inventors of Cho utilized conditioned media of the invention in a mouse model of hair regeneration as well as in human bald patients (Cho example 7, example 8, p 6). Thus the disclosure of Cho utilizes amnion derived conditioned media for the purposes of treating alopecia. Therefore while the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). The structure provided by the conditioned media of Cho is significantly identical to that of the instantly claimed conditioned media for example, and thereby is anticipated by the disclosure of Cho which particularly utilizes this conditioned media for the purposes of (successfully) treating baldness as indicated above.
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Cho as applied to claim 1 above, and further in view of Duzer. The disclosure of Cho is described above. The disclosure of Cho does not particularly describe utilizing irradiation of frozen acellular amniotic derived material as a sterilization procedure opting instead for the use of centrifugation and filter sterilization to arrive at a sterile acellular composition. However the disclosure of Duzer relates to methods of destroying microbial contamination in protein material for example serum from animals and humans. The disclosure of Duzer indicates that the material may be reduced to at least the freezing point of the material/solution, and thereafter gamma radiation is applied in an amount to substantially destroy all microbial contamination in the material without reducing the protein efficacy. The disclosure indicates that the method is useful for example in sterilization of in-vitro tissue culture systems in which protein is thereby further lyophilized and then sterilized without the loss of biological efficacy of the protein material (col 30-68, Example VI). It would therefore be obvious to utilize the system of Duzer to sterilize the conditioned in-vitro culture media of Cho for the purposes of providing a previously validated method which removes any contaminating virus particles or microbial contaminant in a formulation while maintaining the bioactivity of protein components to be utilized in human treatment protocols (col10, 44-69).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1, 4-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of copending Application No. 17842156 in view of Cho and Duzer.
The reference claim 1 is concerned with acellular composition with in embodiments identical overlapping components to the instant claim 1 (a-f). Reference claim 1 indicates that the composition may be utilized for the purposes of treating a subject suffering from “hair follicle arrest” for instance. It would therefore be obvious considering the disclosure of the reference claim as well as the disclosure of Cho to treat alopecia with a composition comprising the claimed bioactive molecules. The further disclosure of Duzer makes obvious the additional instant claims 4, 5.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6-9, 12-16 of copending Application No. 17290662 in view Cho and Duzer.
Reference claim 6 describes a method of treating subject with joint disease with a composition which is significantly identical to that of the instant claim 1 for example (a-f). The molecules of the composition utilized for the treatment of the indicated disease are described (reference claim 16) as originating from human amniotic cells (human amnion derived cells). The disclosure of Cho as described above indicates that amnion derived cells (MSC) of the invention may be successfully utilized for the purposes of treating human baldness/alopecia. The disclosure of Duzer further describes sterilization protocols. It would be obvious considering the claims of the reference Application to provide the composition of the instant claim 1 for example as an amenable treatment for baldness as indicated by Cho.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments Claim Rejections - 35 USC § 103 and 35 USC § 102
In reply to previously applied rejection of record Applicant amends instant claim 1 to specify that the acellular human amnion derived composition thereby comprises a “plurality” each of the indicated “tissue remodeling biomolecules”, “proliferation biomolecules”, “angiogenic biomolecules”, “migration biomolecules”, “anti-inflammatory biomolecules” and “one or more anti-microbial biomolecules” comprising B2M. Applicant describes that because the amended claim requires each of the recited biomolecules and the disclosure of Cho does not describe each and every element of the claim 1, the claim is therefore not anticipated or made obvious by the cited references.
In reply it is found that Applicant has not through the changes in terminology of claim 1 provided convincing arguments to allow for removal of the previously applied rejections. In the previously applied rejection the disclosure of Cho indicates that at least a variety of matrix metalloproteases are provided in the amniotic cell derived conditioned media of the invention. The disclosure of Cho further indicates that the derived conditioned medium is utilized for the treatment of Alopecia in mouse models, and human subjects. As described previously the instant specification likewise describes the utilization of amniotic cells cultured ex-vivo to produce conditioned media utilized as described above. The conditioned media was characterized as described in figure 6 of the disclosure of Cho. Therefore as described in the rejection and as outlined in the MPEP 2112.02 the prior art conditioned media anticipates the claimed process.
Response to Arguments-Claim Rejections - 35 USC § 112
Applicant’s amendments to the claims have obviated previously Applied rejections. Therefore the basis of rejection is removed.
Conclusion
Summary: No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/BRIAN HARTNETT/ Examiner, Art Unit 1644
/DANIEL E KOLKER/ Supervisory Patent Examiner, Art Unit 1644