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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-4 and 10-13 in the reply filed on 05/13/2026 is acknowledged. The traversal is on the ground(s) that the Office is not considering the claims as are currently pending. This is not found persuasive because claims 10-13 are now being included in elected Group I and are examined as set forth below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-9 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/13/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 1-4 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over DeAnglis et al. (US 2021/0213157).
Regarding claim 1, DeAnglis et al. teaches absorbable hemostatic sealant comprising a compressed porous substrate coated with an electrophilic reactive containing polyethylene glycol, preferably PEG-N-hydroxysuccinimide (PEG-NHS) and a nucleophilic reactive containing polyethylene glycol, preferably PEG-Amine (paragraphs [0003] and [0008]-[0009]). Example 1 discloses 1500 mg PEG-SG4 and 400 mg 4-arm PEG-Amine (paragraphs [0030]-[0031]) which corresponds to a ratio of 3.75:1 which falls within the claimed range of 50:1 to 1.1.
Given the overlap between the hemostatic sealant of DeAnglis et al. and that presently claimed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a hemostatic sealant that is both disclosed by DeAnglis et al. and encompassed by the present claims and thereby arrive that the claimed invention.
Regarding claim 2, DeAnglis et al. fails to teach amounts as claimed.
However, DeAnglis et al. does disclose PEG-NHS and PEG-Amine can achieve strong adhesion to tissue thus enabling rapid hemostasis and sealing (paragraph [0002]). Since the instant specification is silent to unexpected results, the specific amount of polyethylene glycol succinimidyl ester and polyethylene glycol amine is not considered to confer patentability to the claims. As the adhesion to tissue is a variable that can be modified, among others, by adjusting the amount of polyethylene glycol succinimidyl ester and polyethylene glycol amine, the precise amount would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the claimed invention. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the claimed invention would have optimized, by routine experimentation, the amount of polyethylene glycol succinimidyl ester and polyethylene glycol amine in DeAnglis et al. to obtain the desired adhesion to tissue (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding claims 3 and 11, DeAnglis et al. fails to teach a plurality of separated layers.
However, DeAnglis et al. does teach use of hemostatic sealants to achieve hemostasis by adhering the hemostatic sealants to a tissue exhibiting severe or oozing bleeding (paragraph [0007]). It would have been obvious to one of ordinary skill in the art to provide an additional hemostatic sealant. The duplication of parts is generally recognized as being within the level of ordinary skill in the art, absent unexpected results. Providing a second hemostatic sealant coating would have achieved expected results such as achieving hemostasis by adhering the hemostatic sealants to a tissue exhibiting severe or oozing bleeding. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP 2144.04 (VI) B. In re Harza, 124 USPQ 378, 380 (CCPA 1960). The resulting hemostatic sealant would result in PEG-NHS in one layer and PEG-Amine in the additional layer.
Regarding claim 4, DeAnglis et al. teaches wherein the compressed porous substrate can be a layer of collagen (paragraph [0003]).
Regarding claim 10, DeAnglis et al. teaches wherein the PEG-N-hydroxysuccinimide (PEG-NHS) has a molecular weight of 10,000 and the polyethylene glycol amine (PEG-Amine) has a molecular weight of 4,000 (paragraphs [0027]-[0028]).
It is noted that although there is no disclosure of whether the molesular weight is weight average or number average, if the molecular weight is number average (Mn), the reference meets the claim. If the molecular weight of DeAnglis et al. is weight average molecular weight (Mw), given the relationship between Mw and Mn, i.e. Mw/Mn>1, it is clear that the molecular weight of DeAnglis et al. would meet that claimed.
Regarding claim 12, DeAnglis et al. teaches wherein the substrate is made from layers of biomaterials selected from the group consisting of a biomaterial, including collagen and gelatin (paragraph [0012]).
Regarding claim 13, DeAnglis et al. teaches wherein the biomatrix substrate is compressed to a thickness of less than 5 millimeters (paragraph [0019]) and may be Woven fabrics, knitted fabrics and open cell foam (paragraph [0016]) which are homogenous.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG HUANG whose telephone number is (571)270-7387. The examiner can normally be reached on Monday-Thursday from 7 AM to 5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Callie Shosho, can be reached at 571-272-1123. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG YUAN HUANG/Primary Examiner, Art Unit 1787
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