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 .
Status of the Application
This Office Action is in response to applicant’s arguments filed on 7/15/26. Claim 8 has been cancelled. Claim 9 has been added. Claims 1-7, 9 are pending. Claims 1, 4, 6 have been amended. Claim 5 has been withdrawn. Claims 1-4, 6-7, 9 are examined herein.
The claim amendments have rendered the 112 rejection of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with regard to the remaining rejections have been fully considered but found not persuasive, therefore maintained for reasons of record and modified below due to the claim amendments.
The following new rejection will also apply.
Claim Rejections - 35 USC § 102
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rothwell et al (US Patent 6,891,077, of record).
Rothwell et al. teach methods of treating wounds, increasing the rate of coagulation of blood from a wound, increasing the amount of or rate of clot formation over a wound, increasing an amount or rate of clot formation over a wound, increasing blood platelet counts, and activating coagulation system by administering a wound dressing comprising fibrinogen and a procoagulant (abstract). A preferred procoagulant is lauryl gallate (col. 2, lines 49-52; col. 3, lines 34-37; and col. 5, lines 20-24). The fibrinogen bandages are useful in the treatment of wounds caused by lacerations, punctures, and surgery, for example deep thoracic surgery (col. 9, lines 15-19).
Response to Arguments
The Hadjkacem Declaration under 37 CFR 1.132 filed 7/15/26 is insufficient to overcome the rejection of claims 1-4 based upon Rothwell et al (US Patent 6,891,077, of record) as set forth in the last Office action because: a 102 anticipatory rejection cannot be overcome by a declaration showing evidence of secondary consideration.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Rothwell et al (US Patent 6,891,077, of record) in view of Carlsson et al. (US Patent Application 2012/0213843, of record).
The instant claims are directed to a method of arresting the flow of blood from a bleeding wound in a patient in need thereof by administering lauryl gallate and ethanol.
Rothwell et al. teach as discussed above, however, fail to disclose ethanol.
Carlsson et al. teach a method of preparing a lipid layer forming wound healing promoting composition or wound dressing comprising volatile silicone oil, polar lipid, alcohol, and a wound healing agent (abstract), wherein the alcohol is ethanol (paragraphs 0031, 0039, and claim 51).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have used fibrinogen and the procoagulant, lauryl gallate, as taught by Rothwell et al., in the wound dressing comprising ethanol, as taught by Carlsson et al.
A person of ordinary skill in the art would have been motivated to use this particular wound dressing comprising ethanol because it is functionally equivalent to the wound dressing taught by Rothwell et al. since both are known for wound healing. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating wounds by applying this wound dressing comprising fibrinogen, lauryl gallate, and ethanol.
Response to Arguments
The Hadjkacem Declaration under 37 CFR 1.132 filed 7/15/26 is insufficient to overcome the rejection of claims 6-7 based upon Rothwell et al (US Patent 6,891,077, of record) in view of Carlsson et al. (US Patent Application 2012/0213843, of record) as set forth in the last Office action because: the 103 obviousness rejection was formulated to address the limitation regarding adding a pharmaceutically acceptable excipient. The declaration does not address this limitation. Instead, the declaration addresses the limitations that have been taught by the Rothwell et al. reference in the 102 anticipatory rejection. As mentioned earlier, a showing of secondary considerations in a declaration cannot overcome a 102 anticipatory rejection.
Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Rothwell et al (US Patent 6,891,077, of record) alone or in view of Speck et al. (US Patent 5,700,634).
The instant claims are directed to a method for inducing platelet aggregation so as to arrest the flow of blood from a bleeding wound in a patient in need thereof by administering lauryl gallate.
Rothwell et al. teach as discussed above, however, fail to disclose wherein no fibrinogen is administered.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have used the procoagulant, lauryl gallate, without fibrinogen in the wound dressing, as taught by Rothwell et al.
A person of ordinary skill in the art would have been motivated to use lauryl gallate without fibrinogen in the particular wound dressing because Rothwell et al. teach that both fibrinogen and lauryl gallate are individually useful for the inducing platelet aggregation, arresting the flow of blood, and treating wounds. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success by applying a wound dressing comprising lauryl gallate without fibrinogen.
Speck et al. teach that bleeding can be stopped six times faster by applying to the site a hemostatic agent comprising a hydroxy-substituted aromatic compound and a metal ion. A preferred hydroxy-substituted aromatic compound is the procoagulant, propyl gallate (abstract).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have substituted the procoagulant, lauryl gallate, as taught by Rothwell et al. for the procoagulant, propyl gallate, in the method of treating bleeding, as taught by Speck et al.
A person of ordinary skill in the art would have been motivated to substitute lauryl gallate for propyl gallate because they are both known in the art as procoagulants. Furthermore, lauryl gallate and propyl gallate both have the same core structure and are considered homologs of one another having the same properties. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating bleeding by administering lauryl gallate and a metal ion.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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