DETAILED ACTION
Summary
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendments filed on 08/03/26 are acknowledged. Claims 1-6, 10, 12-14, and 17-22 are pending.
The examiner appreciates the amendments to the claims to overcome the previous 112 rejections.
Newly submitted claims directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 18 and dependent claims thereon now claim a kit and not a method.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 18 and 21-22 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 18 and 21-22 are withdrawn and claims 1-6, 10, 12-14, 17 and 19-20 are rejected.
Modified REJECTIONS
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.
Claims 1-4, 6, 10, 12-14, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson from the Wayback Machine dated 2022 in view of Scamilla (US 6599525 B2), Horn (US 20200061002 A1), Shinault (US 5407670 A), Isaac from the Wayback Machine dated 2021, and UPMC 2021, as evidenced by Sybridge 2021.
Regarding all the aforementioned claims, Johnson teaches a method to clean, treat and cover wounds (page 2), which reads on the instantly claimed method of treating a wound. Johnson teaches (1) cleaning with an antiseptic to remove dirt and debris, (2) treating with antibiotic ointment to help prevent infection, and (3) protecting to cover and prevent scabs and re-injury (page 1). Regarding step (1), Johnson shows that the antiseptic is applied directly to the wound (Page 1, graphic). Regarding step (2), Johnson teaches the Neosporin + Pain Relief Cream provides dual antibiotic infection protection (page 4, Product Description), so it reads onto the instantly claimed antibiotic formulation. Johnson further teaches the cream contains neomycin, polymyxin B, and pramoxine hydrochloride (page 4, Product Description). Pramoxine hydrochloride reads onto the instantly claimed local anesthetic (according to the limitations of newly added claims 19-22). Regarding step (3), Johnson teaches the affected area may be covered with a sterile bandage (page 5, Directions).
Regarding instant claim 6, Johnson teaches a review by user K. Chan stating that when my son got a nasty cut on his forehead, we cleaned out the wound with soap and water, then with Neosporin Wound Cleanser for kids, then applied the Pain Relief Dual Action Cream twice daily under a bandage (page 8). Cleaning out the wound with soap and water reads on the instantly claimed step of washing the wound with soap and water. The step occurred before cleaning with Neosporin Wound Cleanser for kids, then applying the Pain Relief Dual Action Cream twice daily under a bandage, therefore it reads on the instantly claimed step occurring prior to steps a) through c).
Johnson teaches application to the affected area 1-3 times daily (page 5, Directions) and that one should stop use and ask a doctor if you need to use longer than one 1 week (page 4, Safety Information), which implies repeated use for multiple days.
Johnson does not teach that the antiseptic formulation comprises benzalkonium chloride and lidocaine hydrochloride. Johnson does not teach the specific forms of neomycin and polymyxin that are instantly claimed: neomycin sulfate and polymyxin B sulfate, although it does teach neomycin and polymyxin. Johnson does not clearly teach that the bandage is adhesive and comprises a flexible sheet of material comprising an absorbent pad and an adhesive disposed on a first surface thereof, although it does teach a covering step and a bandage.
Regarding instant claims 1d, 2, 3, 17d, Johnson does not specifically teach repeating steps a-c for at least two, three, or four additional, consecutive days, though it does teach repeated application.
Regarding instant claim 4, Johnson does not teach the antiseptic formulation is a liquid.
Regarding instant claim 6, Johnson does not teach a step of washing the surrounding skin tissue.
Regarding instant claim 14, Johnson does not teach that the antibiotic formulation is applied to the adhesive bandage prior to covering the wound with the adhesive bandage.
Scamilla teaches a bandage which reads on the instantly claimed adhesive bandage. The bandage comprises: a. an absorbent substrate that reads on the instantly claimed absorbent pad, e. a backing material that reads on the instantly claimed flexible sheet of material; and f. a layer of adhesive on one surface of said backing material that reads on the instantly claimed adhesive disposed on a first surface thereof (claim 1). Scamilla teaches backing materials useful in the bandages of the invention include monolithic films, apertured films. In the case of films, the backing may be composed of any of the polymers known to be useful as backing materials. Such polymers include plasticized PVC (column 10, lines 13-18). As evidenced by Sybridge, Scamilla's plasticized PVC reads onto the instantly claimed flexible sheet of material because flexible PVC is created by adding plasticizers, such as phthalates, to the rigid form of PVC (Page 2, What is Polyvinyl Chloride?).
Regarding instant claim 14, Scamilla teaches a coating of an ointment-like composition 115 (Figure 6 and column 11, lines 58-59). The ointment reads on the instantly claimed antibiotic formulation because Scamilla teaches that the coating of a composition having an ointment feel contains d. a second active ingredient (claim 1), and said active ingredients are selected from neomycin sulfate, polymyxin-B sulfate, zinc bacitracin, pramoxine (claim 3). Scamilla teaches that the occlusive composition 115 (ointment) is applied to substrate material 110 (Figure 6 and column 12, lines 41-42), which reads on the instantly claimed antibiotic formulation is applied to the adhesive bandage prior to covering the wound with the adhesive bandage.
Horn teaches a topical composition (claim 1) comprising lidocaine hydrochloride (claim 3) and benzalkonium chloride (claim 12, claim 15) that reads on the instantly claimed antiseptic formulation.
Regarding instant claim 4, Horn teaches its compositions may be used in topical liquids [0182], which reads onto the instantly claimed antiseptic formulation being a liquid.
Shinault teaches an ointment for the topical treatment of wounds comprising a mixture of polymyxin, bacitracin, neomycin (claim 1) wherein said polymyxin is in the form of polymyxin B sulfate (claim 2), said bacitracin is in the form of bacitracin zinc (claim 3), and said neomycin is in the form of neomycin sulfate (claim 4).
Regarding instant claim 6, Isaac teaches washing the surrounding skin with soap and water (page 3, Open Wounds step 1b.). Regarding instant claims 1d, 2, 3, 17d, 18d, UPMC teaches you should keep a wound covered for about five days, change the bandage daily, and reapply petroleum jelly with each change of bandage (Page 1, When to stop covering a wound). These steps read on the instantly claimed repeating steps a-c for at least two, three, or four additional, consecutive days when combined with Johnson. About five days falls within the instantly claimed range of at least two (or three or four) days, and reads on the phrase additional and consecutive with routine optimization.
Therefore, before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to improve the sterile bandage of Johnson with the features of the adhesive bandage of Scamilla and also to apply the ointment (antibiotic formulation) to the bandage first as taught by Scamilla in order to increase the efficiency of wound healing. Johnson teaches covered wounds heal faster than if left uncovered (page 3). Scamilla teaches the use of an ointment in conjunction with a bandage is effective at promoting wound healing (column 1, lines 49-53). Use of Scamilla's teaching to improve Johnson's bandage is an obvious modification and within the purview of the skilled artisan. One of ordinary skill in the art would find the results predictable because as taught by Scamilla, after treatment with an ointment, wounds are typically covered with an adhesive bandage (column 1, lines 48-49), so similar results would be expected.
Before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to improve the antiseptic formulation of Johnson with the specific compounds lidocaine hydrochloride and benzalkonium chloride, and have the formulation be a topical liquid, both as taught by Horn, in order to prevent infection. Johnson teaches treatment is to help prevent infection (page 3). Horn teaches in a preferred embodiment, the present invention is further directed to methods of reducing infections [0087]. Use of Horn's teachings to improve Johnson's antiseptic formulation is an obvious modification and within the purview of the skilled artisan. One of ordinary skill in the art would find the results predictable. Before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to take the neomycin and polymyxin B taught by Johnson, and substitute those antibiotics of Johnson with the neomycin sulfate and polymyxin B sulfate as taught by Shinault. Simple substitution of one known antibiotic for another of Shinault in wound care is an obvious modification and within the purview of the skilled artisan.
Before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to combine the step of washing the wound as taught by Johnson with the step of washing the surrounding skin as taught by Isaac for the advantage of preventing infection. Johnson teaches treatment is to help prevent infection (page 3). Isaac teaches wound cleaning substantially reduces the chance of later infection (page 4, Discussion). Use of Isaac's teachings to improve Johnson's method of treating a wound to prevent infection is an obvious modification and within the purview of the skilled artisan. There would be a reasonable expectation of success given both teachings involve wound cleaning.
Before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to perform Johnson's antiseptic and antibiotic steps, and then repeat application as taught by Johnson for multiple days as taught by UPMC, as well as repeat bandage changes as taught by UPMC, for the advantageof reducing scabs and scarring. Johnson teaches covering wounds helps prevent scabs, which may cause scarring (page 3). UPMC teaches that if you keep the wound covered and moist, you're less likely to end up with a scab. Because scabs can sometimes lead to scars, keeping a wound covered and moist will also reduce your chance of scarring (page 1, Do scabs heal faster when moist or dry?). The use of UPMC's teachings to improve Johnson's repeated applications and method to reduce scabs and scarring are obvious modifications and within the purview of the skilled artisan. There would be a reasonable expectation of success because both teachings are in wound care. At the time of filing, the person of ordinary skill in the art would know that UPMC's range of days is obvious over the instant claims. Therefore, UPMC obviates that presently claimed. "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists" (See MPEP 2144.05 (I) regarding obviousness of ranges).
At the time of filing, the person of ordinary skill in the art would know that UPMC's range of days is obvious over the instant claims. It would be obvious to adjust the about five days taught by UPMC to match that of the claimed invention, and also make the days additional and consecutive as instantly claimed, because it would be considered routine optimization. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson from the Wayback Machine dated 2022 in view of Scamilla (US 6599525 B2), Horn (US 20200061002 A1), Shinault (US 5407670 A), and UPMC 2021, as evidenced by Sybridge 2021, further in view of Dumville 2015.
As applied above, Johnson, Scamilla, Horn, Shinault, and UPMC as evidenced by Sybridge teach the limitations of claim 1.
Horn further teaches its compositions may be used in topical liquids [0182], which reads onto the instantly claimed antiseptic formulation being a liquid.
Johnson, Scamilla, Horn, Shinault, and UPMC as evidenced by Sybridge do not teach that the step of cleansing the wound further comprises applying the liquid antiseptic formulation to a carrier and then cleansing the wound with said antiseptic bearing carrier.
Dumville teaches cleansing the skin at the operation site with an antiseptic and that a dedicated instrument may be used, e.g. a sponge, or X-ray detectable swab, adapted for the purpose. Further, antiseptic agents are referred to as "antiseptics" and can be applied in the form of liquids. The solution should be applied using friction, and extend from the incision site to the periphery (page 3 (using provided page numbers at bottom right corner), Description of the intervention). The dedicated instrument reads on the instantly claimed carrier, and the incision site reads on the instantly claimed wound.
Therefore, before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to modify the method of treating a wound taught by Johnson, Scamilla, Horn, Shinault, and UPMC as evidenced by Sybridge by adding the carrier step as taught by Dumville in order to prevent infection. Johnson teaches treatment is to help prevent infection (page 3). Dumville teaches preoperative skin antisepsis using antisepticsis performed to reduce the risk of SSIs (surgical site infections) by removing soiland transient organisms from the skin (page 1, Background). Use of Dumville's teachings to improve Johnson's method of treating a wound to prevent infectionis an obvious modification and within the purview of the skilled artisan. One of ordinary skill in the art would find the results predictable.
Response to Arguments
Applicant's arguments with respect to instant claims have been considered but are not persuasive. It is noted that the newly added claims 19-22 are rejected as Johnson previously cited teaches the well known topical cream by the tradename of Neosporin+Pain reliefTM with necessarily contains pramoxine hydrochloride in addition to neomycin, polymyxin B and swapping out the specific species of antibiotics to include neomycin sulfate and polymyxin B sulfate would be an obvious simple substitution but this leaves the pramoxine hydrochloride in the composition. Applicants arguments with regards to ‘repeating’ steps of cleansing the wound is not persuasive as all throughout the cited prior art they teach repetition of steps and that cleansing not only with soap and water but also with antiseptic and further in examples cited they state doing this multiple times a day (Johnson page 1, page 5 directions and Review by K. Chan page 8) and UMPC which teaches repeating multiple times (page 1) and further doing so for up to a week and then to seek a Doctor after that (Johnson page 4) and further in conjunction with Scamilla, Horn, Shinault, Isaac and Skybridge which are all addressing reducing infection and promoting wound healing (Scamilla col. 1, lines 48-53; Horn [0087], Issaac pg 4).
Johnson alone states many steps on pgs 1-3 provide infection protection with maximum strength pain relief and wound healing by covering with a bandage:
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Further a reference is analyzed using its broadest teachings. MPEP 2123 [R-5].
“[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Applicants arguments seem to be that rearranging and reapplying multiple times the known steps of cleansing, topically treating and applying a bandage which is well known and documented in the prior art to improve healing and decrease infection is in fact not known. Applicant merely attempting to argue such rearrangement is not disclosed in a single reference and therefore is non-obvious in unpersuasive as this is not an anticipation rejection but an obviousness. It is clear from the record that it is well known to cleanse with soap and water and antiseptic in order to clean the wound and decrease infection and repeat (Johnson, K Chen, Scamilla, UMPC, Isaac, etc.), likewise it is known to apply a topical cream comprising antibiotics and local anesthetic and cover with a bandage to again decrease infection and improve wound healing and then repeat these steps. Applicant bears the burden of establishing the criticality of the steps (i.e. better treating or faster wound healing, etc), but as the prior art lays out that these are common well known steps to treats wounds and that they are commonly repeated for up to week without a seeing doctor then it is obvious and result in less infection and maximum healing then it is obvious.
Conclusions
Applicant's amendment necessitated the modified 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 BETHANY BARHAM whose telephone number is (571)272-6175. The examiner can normally be reached on M-F from 8:30am to 5pm.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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