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 .
Applicant’s amendment filed 8/6/2025 is acknowledged. Claims 1-11 are canceled. New claim 12 is added.
Claim 12 is under examination on the merits.
Response to Arguments
Applicant’s arguments, see p. 1, filed 8/6/2025, with respect to the previous claim objections, rejections of claims 1-11 under 35 U.S.C. §§102 and 112 have been fully considered and are persuasive. The claim objections and rejections of claims 1-11 under 35 U.S.C. §§102 and 112 have been withdrawn.
Applicant's arguments filed 8/6/2025, pp. 2-3, regarding the previous rejections under 35 U.S.C. §102 and for Double Patenting have been fully considered but they are not persuasive with regard to new claim 12. Claim 12 has been added to these previous rejections.
Applicant presents the following arguments:
The present invention recited in claim 12 is directed to a novel viral inactivation method for a dried amnion. The claimed method includes irradiating the amnion and simultaneously carrying out drying treatment and viral inactivation. In sharp contrast to the claimed method, Nikaido while describing microwave radiation and far-infrared ray irradiation as a method for drying an amnion, Nikaido does not describe viral inactivation.
Furthermore, the claimed method is novel and distinguishable over Nikaido with regard to the claimed: irradiating the amnion placed in the treatment tank with a microwave with the microwave irradiation device during the pressure recovery step with the pressure recovery means, constantly irradiating with a far-infrared ray with the far-infrared heater during the pressure reduction step and the pressure recovery step which are repeated (see claim 12). A natural consequence of the claimed method is that the claimed method achieves the effect that by controlling the three elements, namely vacuum, far-infrared rays and microwaves, infectivity of viruses can be decreased to 1/200 to 1/1000, which is more advantageous than the effect of Nikaido. Accordingly, the claimed method is novel and in no way obvious from Nikaido.
The double patenting rejection is inappropriate, since U.S. Patent No. 8,932,641 has a different inventorship and a different Applicant. Moreover, claims 1-4 of the ‘641 patent in view of Nikaido fail to render the claimed method obvious.
After careful consideration, Applicant’s arguments are found to be unpersuasive:
As described in the rejection of claim 12 under 35 U.S.C. §102 below, the claimed invention is not novel in view of Nikaido et al. (PGPub US 2009/0258082 A1, published 10/15/2009, filed 2/25/2008; hereinafter referred to as “Nikaido”). Although Nikaido does not specifically teach that its methods inactivate viruses in the amnions, that is an inherent property, because under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. See MPEP §2112.02(I). Otherwise, Nikaido teaches each limitation of the claimed invention.
The examiner is interpreting Applicant’s arguments regarding the claimed method yielding infectivity of viruses to be decreased to 1/200 to 1/1000 to mean an unexpected result. However, unexpected results are to be considered in response to rejections under 35 U.S.C. §103, not rejections under 35 U.S.C. §102. See MPEP §§716.01a and 716.02.
US. Patent No. 8,932,641 shares inventors with the instant application, including Motonori Okabe, Toshiko Yoshida, and Masahiko Arakawa. MPEP §1504.06 states “Double patenting rejections are based on a comparison of the claims in a patent and an application or between two applications which have at least one common inventor [. . .]” [emphasis added]. Thus, the double patenting rejection is proper.
Rejections Removed
The previous rejections are withdrawn due to amendment or cancellation of claims:
Claim objections: claims 2, 4, & 6-11.
35 U.S.C. §102: claims 1-11
35 U.S.C. §112: claims 2-3, 5-8 and 10-11.
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.
(New Rejection Necessitated by Amendment) Claim 12 is 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 12 recites the limitation "the object" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(Previous Rejection Withdrawn in Part, New Claim 12 Added) Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nikaido et al. (PGPub US 2009/0258082 A1, published 10/15/2009, filed 2/25/2008; hereinafter referred to as “Nikaido”). The previous rejection of claims 1-11 is withdrawn due to cancellation of the claims.
The claimed invention encompasses a viral inactivation method for a dried amnion, the inactivation method using a drying apparatus equipped with a treatment tank in which an amnion as the object is placed, pressure reduction means for reducing the pressure in the treatment tank, a microwave irradiation device for heating the amnion placed in the treatment tank under reduced pressure and inactivating a virus, pressure recovery means for recovering the reduced pressure in the treatment tank towards atmospheric pressure and a far-infrared heater and alternately repeating a pressure reduction step of reducing the pressure in the treatment tank with the pressure reduction means and a pressure recovery step of recovering the pressure in the treatment tank with the pressure recovery means multiple times, said method comprising: irradiating the amnion placed in the treatment tank with a microwave with the microwave irradiation device during the pressure recovery step with the pressure recovery means, constantly irradiating with a far-infrared ray with the far-infrared heater during the pressure reduction step and the pressure recovery step which are repeated, and simultaneously carrying out drying treatment and viral inactivation, as recited in claim 12.
The Prior Art
Nikaido teaches compositions and methods related to a dried amnion tissue that can be stored for a prolonged period of time (Abstract; paras. [0001-0002]). Additionally, Nikaido teaches that germfree raw amnions of placentas may be used for eye diseases (para. [0009]). Nikaido produces dried amnion covering a human or animal embryo, wherein the amnion is dehydrated to so as to be stored in a sterilized dry atmosphere, and that epithelial cells, basement membranes, and connective tissues, which are constituents of the raw amnion, are retained when the dried amnion is rehydrated in water or a buffer solution (para. [0020]). The amnion drying is performed in a drying equipment including a means for reducing an inner pressure of a treatment vessel, in which the amnion is placed, means for heating the amnion, which is placed in the treatment vessel whose inner pressure has been reduced, and means for recovering the reduced inner pressure of the treatment vessel to the air pressure, and the method is alternately repeating a pressure-reducing operation and a pressure-recovery operation so as to dehydrate and dry the raw amnion (para. [0021]). Nikaido also specifically indicates that the dried amnion is suitable for use in regenerative medicine (para. [0022]). Additionally, a vacuum pump is a means for reducing an inner pressure of the treatment vessel (paras. [0043], [0078-0080]). In some embodiments, the heating means includes a far-infrared heater and a microwave irradiation apparatus (para. [0025]). Nikaido further teaches that the inner pressure of the treatment vessel is reduced with irradiating far-infrared rays toward the amnion, and the pressure recovery operation, and the pressure-recovery operation, in which the inner pressure of the treatment vessel is recovered with irradiating far-infrared rays and microwaves toward the amnion (para. [0058]). Although Nikaido does not specifically teach that its methods inactivate viruses in the amnions, that is an inherent property, because under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. See MPEP §2112.02(I).
Therefore, Nikaido anticipates claim 12.
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.
(Previous Rejection Withdrawn in Part, New Claim 12 Added) Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 8,932,641 B2 in view of Nikaido et al. (PGPub US 2009/0258082 A1, published 10/15/2009, filed 2/25/2008; hereinafter referred to as “Nikaido”). The previous rejection of claims 1-11 is withdrawn due to cancellation of the claims. Both the instant claim and U.S. Patent No. 8,932,641 B2 are drawn to a dried amnion being produced by a production method wherein an animal, or specifically human, amnion is dried where the cell tissues are not damaged and the epithelium cells, basement membranes, and connective tissues are retained when rehydrated by immersing in water or a buffer solution (instant claim 12 and U.S. Patent No. 8,932,641 B2 claim 1). Additionally, each set of claims require repeating pressure-reducing and pressure-recovery steps that wherein heating occurs. Notably, U.S. Patent No. 8,932,641 B2 teaches that the dried amnion can be used for treating a wound (claim 4) or reconstructing the surface of a surface of an eye (claim 3). The sets of claims differ in that whereas the instant claims encompass methods for viral inactivation and producing a dried amnion, the claims of U.S. Patent No. 8,932,641 B2 do not.
The teachings of Nikaido were described above.
The instant claim would have been obvious to one of ordinary skill in the art because Nikaido teaches that the dried amnion production method can be performed with microwave irradiation under reduced pressure using vacuum pumps. Nikaido also teaches that the inner pressure of the treatment vessel is reduced with irradiating far-infrared rays toward the amnion, and the pressure recovery operation, and the pressure-recovery operation, in which the inner pressure of the treatment vessel is recovered with irradiating far-infrared rays and microwaves toward the amnion. As discussed above, though Nikaido does not specifically teach that its methods inactivate viruses in the amnions, that is an inherent property, because under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. See MPEP §2112.02(I). One of ordinary skill in the art would have been motivated to combine the teachings of U.S. Patent No. 8,932,641 B2 and Nikaido to produce a dried amnion. Therefore, the instant invention was prima facie obvious to one of ordinary skill in the art before the priority date of the instant invention.
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.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671