DETAILED ACTION
Claims 21-34 are pending and under consideration on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Rejections
The 103 rejection is maintained.
The112(a) and (b) rejections are withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103
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 negatived 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.
Claims 21-34 are rejected under pre-AIA 35 U.S.C. 103(a) as unpatentable over Rees (US Pat. Pub. 2003/0077655; of record in IDS) in view of Taylor (US Pat. No. 5,405,742; of record) and Benner et al. (US Pat. Pub. 2008/0171094; of record).
As to claims 21-34, Rees discloses a physiological medium for perfusing, preserving, and storing isolated tissue and organ samples, the medium comprising 1-12 mmol of BES, 0.1-2.5 mmol/L calcium ions, 0.4-25 mmol/L magnesium ions, 21-37 mmol/L bicarbonate ions (“hydrogen carbonate”), 100-150 mmol/L sodium ions, 2.5-6.2 mmol/L potassium ions, and 96-126 mmol/L chloride ions (paragraphs 1 and 6 and claim 1 of Rees), wherein the foregoing ranges are the same as, or overlap, the ranges recited by claims 21, 26, and 30.
As to claims 21-34, Rees does not further expressly disclose administering the composition to a human subject (claims 25, 29, and 34) in a method of treating a burn (claims 1, 26, and 30) or treating the loss of interstitial and/or extracellular fluid in a subject suffering from a burn (claims 24, 26, and 33), or that the composition is administered systemically (claims 23, 28, and 32) or topically (claims 22, 27, and 31).
Taylor discloses a blood substitute that is also useful as a solution for the preservation of tissues intended for transplantation in a patient (column 3, lines 22-25), the composition comprising an aqueous solution of electrolytes including potassium, sodium, magnesium and calcium ions, along with a biological pH buffer effective under physiological conditions (column 3, lines 27-36). The composition further preferably comprises hydrogen carbonate ions (column 4, lines 22-28), and the composition also comprises chloride ion (column 9, lines 47-52). Taylor teaches that the blood substitute may be of significant benefit in trauma medicine, for example, in a patient suffering from hemorrhagic shock (paragraph bridging columns 8-9). The composition may be administered systemically when administered to a patient to treat trauma or shock (see, e.g., paragraph bridging columns 15-16), but also may be applied topically to the skin to protect it and extend tissue life (column 8, 1st and 2nd full paragraphs), and the patient may be human (see e.g., column 7, 3rd full paragraph).
Benner is directed to the treatment of burns (Abstract), and teaches that patients suffering from a serious burn injury commonly exhibit a clinical picture produced by systemic inflammatory syndrome, which in severe forms may include shock and multiple organ failure dysfunction (paragraph 14).
As to claims 21-34, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Rees by administering the physiological medium for tissue preservation that is taught therein to a subject suffering from shock due to burns and who is a human, because Taylor teaches that a very similar composition that comprises a medium comprising a physiological buffer and the same electrolytes present in the Rees composition and recited by the present claims is useful not only for preserving tissue but also for treating a patient suffering from hemorrhagic shock, which Benner teaches is a known complication of a severe burn injury, such that the skilled artisan reasonably would have expected that the Rees composition also could be used to treat a subject who is suffering from shock induced by a burn injury, and because Taylor teaches that such compositions are suitable for administration to humans. The resulting method will compensate for the loss of interstitial and/or extracellular fluid resulting from the burn as recited by claims 24, 26, and 33 and treat the loss of interstitial and/or extracellular fluid in the subject as recited by claim 26, and treat the burned tissue as recited by claim 30, because it comprises the same steps of administering the same composition to the same target subject recited by the claims.
Regarding claims 23, 28, and 32, it further would have been prima facie obvious to administer the composition systemically, because Taylor teaches that tissue-preserving compositions should be administered systemically when used to treat a subject for a traumatic injury.
Regarding claims 22, 27, and 31, it further would have been prima facie obvious to administer the composition topically to the skin of the subject in light of Taylor’s teaching that topical administration of a tissue-preserving medium comprising a physiological buffer and the same electrolyte ingredients present in the Rees composition is useful in protecting the skin when applied topically.
Response to Applicant’s Arguments
Applicant argues that Taylor only suggests that its solutions can be used to sustain (not treat) a patient suffering from shock sufficiently long to allow the physician to assess the injury which caused the shock and then treat the injury appropriately with something other than the Taylor solution.
In response, this argument is not persuasive because Taylor expressly suggests administering the Taylor solution to a patient suffering from shock, regardless of whether or not the intent of the treatment is to sustain the patient until another treatment is administered. The administration of the Taylor solution to a patient experiencing shock in order to temporarily sustain the patient provides a motivation to administer the solution to temporarily sustain a patient experiencing shock as a result of a burn injury.
Applicant further argues that there are two types of burn victims: 1) those that do not simultaneously suffer from shock and 2) those that do simultaneously suffer from shock, and that if the skilled artisan wishes to treat a burn victim in the first category, there is nothing in the cited art that would suggest treating such a burn victim with the physiological medium of Rees.
In response, this argument is not persuasive because the language of the claims is not in any way limited to the administration of the medium to burn victims in category 1, but rather encompasses the treatment of burn victims in category 2 as well.
Applicant also argues that even if the skilled artisan wishes to treat a burn victim that is also suffering from shock, the cited art at most might suggest treating the shock symptoms of the burn victim with the Rees medium, but that treating a symptom (i.e., shock) is not the same as treating the underlying cause (i.e., a burn).
In response, this argument is not persuasive because treating a symptom of a burn is a type of treatment of a burn, and the claimed method of treating a burn in a patient in need of treatment does not exclude administering the recited solution to a patient having a burn to treat a symptom of the burn as opposed to directly treating the burn itself. The fact that the cited art does not expressly suggest that administering the solution can directly treat the burn as opposed to a symptom of the burn does not impart a patentable distinction to the claims because the method of the prior art as combined in the rejection would have the effect of directly treating the burn regardless of whether said art expressly teaches this result. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness, however the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).
Conclusion
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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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600