DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 27-33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rhee WO 2008/016983.
As to claim 27, Rhee teaches a method for treating an injury in a patient, the method comprising:
providing a hemostatic porous composite sponge (Fig. 10; paras. 0028, 0131, 0142),
wherein the hemostatic porous composite sponge comprising a matrix of biomaterial (para. 0142) and a bioadhesive material (para. 0187) stably associated with at least one surface of the hemostatic porous composite sponge (paras. 0028, 0131, 0142).
Rhee does not specifically teach the bioadhesive material is present in a range of 2 to 50 mg/cm² of the biomaterial administering the hemostatic porous composite sponge to a site of the injury. Rhee does teach a small amount of sealant matrix composition is required to create an effective sealant matrix barrier, for example only about 0.5-1.0 g fixed on a surface created a 3cm x 3cm page with very good hemostatic properties (para. 0218). However, one having ordinary skill in the art would be able to determine through routine experimentation the amount of bioadhesive material needed for effective hemostasis.
Rhee further teaches the method includes maintaining the hemostatic porous composite sponge to the site of the injury for a pharmaceutically sufficient amount of time so that the injury is treated (para. 0021, claim 34).
As to claims 28, the injury is selected from the group consisting of a wound, a hemorrhage, a damaged tissue and a bleeding tissue (Rhee paras. 0016-0017).
As to claim 29, the bioadhesive material is capable of covalently reacting with tissue of the patient (para. 0240, 0271, 0277).
As to claim 30, the bioadhesive is selected from the group consisting of polyethylene glycol, derivatives of polyethylene glycol, and combinations thereof (paras. 0187-0190)
As to claim 31, the hemostatic porous composite sponge comprises multiple polymers (para. 0219 )
As to claim 32, Rhee teaches the bioadhesive is in the form of a powder (paras. 0026-0028, 0131).
As to claim 33, Rhee teaches the method according to claim 27, wherein the bioadhesive material comprises a mixture of two pre-polymers comprising a first cross-linkable component and a second cross-linkable component that cross-links with the first cross-linkable component under reaction enabling conditions (para. 0023), and the second cross-linkable component comprises a two or more succinimidyl groups (para. 0019, 0022-0023, 0181-0182,190-193).
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.
Claims 27-30, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, and 13 of U.S. Patent No. 11,071,804. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent contain each and every limitation of the aforementioned claims of the instant application as well as additional features. The claims of the US Patent are narrower than the claims of the instant application, and effectively anticipate the instant claims. Thus, the invention of the patent claims 1 and 7 are in effect a "species" of the "generic" invention of the instant claim 1. It has been held that the generic invention is “anticipated” by the “species". See ln re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 27-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, and 12-13 of U.S. Patent No. 9,872,934. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent contain each and every limitation of the aforementioned claims of the instant application as well as additional features. The claims of the US Patent are narrower than the claims of the instant application, and effectively anticipate the instant claims. Thus, the invention of the patent claims 1 and 7 are in effect a "species" of the "generic" invention of the instant claim 1. It has been held that the generic invention is “anticipated” by the “species". See ln re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. USPN 5874500, USPN 6166130, USPN 6312725, and USPN 6458889 are cited to show biocompatible polymer compositions for use in tissue augmentations and surgical methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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