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 .
In view of the amendment, previous 112(b) rejection on claims 1-3, 5, 7-11 and 13-15, previous 112(b) rejection on claim 2, previous 112(b) rejection on claim 5 and previous 112(b) rejections on claims 14 and 15 are hereby withdrawn.
In view of the amendment, previous 112(d) rejection on claim 5 is hereby withdrawn.
In view of the amendment, previous 112(a) rejection on claims 14 and 15 is hereby withdrawn.
Applicant canceled claim 8. Thus, previous 112(d) rejection on claim 8 and previous 112(a) rejection on claim 8 are now moot.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, from which claim 2 depend, applicant recite that an amylose-containing acrylic polymer is associated with the polymeric sponge substrate. It is the Examiner’s understanding that instant claim 2 explains how the amylose-containing acrylic polymer is associated with the polymeric sponge substrate. That is, after the sponge (substrate) has been rinsed to remove uncomplexed iodine, the amylose-containing acrylic polymer is impregnated as a powder into the sponge. However, the Examiner does not understand what applicant mean by “the non-cellulose polymeric sponge substrate comprises amylose-acrylic starch polymer coating”. First of all, what are applicant referring to by “amylose-acrylic starch polymer coating”? Are they referring to the amylose-containing acrylic polymer associated with the sponge substrate (by being impregnated as a powder into the sponge), or are they referring to something separate from the amylose-containing acrylic polymer associated with the sponge substrate? If applicant meant the former, how can it be an amylose-acrylic starch polymer coating when it is formed by impregnating the amylose-containing acrylic polymer as a powder into the sponge (as opposed to onto the surface of the sponge)? (it is the Examiner’s understanding that “a coating” means a thin layer of material applied to the surface of an object to protect it, improve its appearance or give it special functions). Instant 112(b) rejection on claim 2 can be overcome by deleting the first wherein clause (i.e., “wherein the non-cellulose polymeric sponge substrate comprises an amylose-acrylic starch polymer coating,”) in claim 2.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites that the polymeric sponge substrate of claim 1 (which is a hydroxylated polyvinyl acetal polymeric sponge substrate according to the amended claim 1) comprises a polyvinyl alcohol polymer. Thus, claim 3 is essentially stating that a hydroxylated polyvinyl acetal polymeric sponge substrate comprises a polyvinyl alcohol polymer. Such limitation is confusing, thus rendering the scope of claim 3 indefinite: (i) Are applicant saying that the polymeric sponge substrate of claim 1, which material is already claimed to be a hydroxylated polyvinyl acetal, further contains a polyvinyl alcohol polymer in addition to (or separate from) the hydroxylated polyvinyl acetal? If so, how is that possible? Or, (ii) are applicant merely referring to the fact that the hydroxylated polyvinyl acetal contains residual vinyl-alcohol units (i.e., polyvinyl acetal is formed when the hydroxyl groups (-OH groups) of polyvinyl alcohol is reacted with an aldehyde, and if the reaction is only partial, the resulting polymer retains some residual -OH groups (i.e., residual vinyl-alcohol units), thus yielding a “hydroxylated” polyvinyl acetal)? IF applicant meant the latter (ii) scenario, applicant need to cancel claim 3 since it fails to further limit the subject matter of claim 1 since the phrase “a hydroxylated polyvinyl acetal” (of claim 1) already means that the polymer contains residual vinyl alcohol units in its structure. For the purpose of examining the claim on the merit, the Examiner assumed that applicant meant the latter.
Claims 10-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation "the skin" and “the surface” in line 2. There is insufficient antecedent basis for this limitation in the claim. Instant rejection can be overcome by changing “on the skin or the surface” to --- on skin or a surface --- (see [0013] of present specification for the support).
Claims 14 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In Claim 14, applicant recite “wherein the one or more antimicrobial wipes are stored within the resealable storage pouch after each wipe has been lightly dampened with water and gently squeezed to distribute moisture evenly before being returned to the pouch.” The wherein clause seems to imply that each wipe is first taken out of the storage pouch to be used and then dampened with water and gently squeezed (to distribute moisture evenly) before being returned to (i.e., re-stored within) the pouch. Does this mean that the wipe is in dry state before its first use and is wetted only after being used? If applicant mean that the wipe is in wet state even before its first use as well as after being used, applicant need to change the current wherein clause to state --- wherein the one or more antimicrobial wipes are stored or re-stored within the resealable storage after each wipe has been lightly dampened with water and gently squeezed to distribute moisture evenly --- (i.e., without the phrase “before being returned to the pouch”).
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the iodine content" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5, 7, 9, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt (5,071,648) in view of Rosenblatt et al (US 2013/0171203 A1) and Yang et al (“Research Advances in Superabsorbent Polymers”, Polymers (Basel), vol.16(4) (Feb 12, 2024), obtained from the website: https://pmc.ncbi.nlm.nih.gov/articles/PMC10892691/ ) (with McMillan (4,234,683) or Ju et al (US 2003/0180342 A1), which are being cited here merely to support the Examiner’s assertion that it is well known in the art that starch and iodine form a complex).
Rosenblatt’648 teaches (claims 1, 2 and 4) a composition comprising a hydroxylated polyvinyl acetal sponge (instant hydroxylated polyvinyl acetal non-cellulose polymeric sponge substrate) complexed with iodine (“PVA/I complexed sponge” hereinafter), which is capable of releasing free iodine in the presence of water. Rosenblatt’648 further teaches (abstract) that when topically applied, the PVA/I complexed sponge releases controlled amounts of iodine sufficient to kill germ cells with minimal toxicity to surrounding tissue. Rosenblatt’s PVA/I complexed sponge is a solid iodophor (see col.4, lines 66-68, col.5, lines 1-2, col.8, lines 13-20) (thus, Rosenblatt’648 teaches instant elemental iodine complexed with the polymeric sponge substrate to form a solid iodophor). In an embodiment (col.18, lines 57-66) of its PVA/I complexed sponge, Rosenblatt’648 teaches an experimental product called Merodine sponge, which can be used as (see col.21, lines 10-12, col.22, lines 5, 6, and 18-20) wound cleaning wipes, debridement wipes, hand sanitizing wipes, germicide wipes and face sanitizing wipes. Rosenblatt further teaches (col.21, lines 6-7) that the Merodine sponge can be washed in water without dissipating its bactericidal properties (thus, the sponge is reusable). Rosenbaltt’648 teaches (col.6, lines 66-68, col.7, lines 1-5) that when iodine depletion occurs in its PVA/I complexed sponge, the polymer begins to turn from blue/black (the color of the complex) to lighter shades of blue or purple and eventually completely white, indicating that the iodine is depleted and the sponge needs to be changed. Thus, Rosenblatt’s PVA/I complexed sponge (e.g., Merodine sponge) teaches instant reusable antimicrobial wipe that changes color from black to tan or white upon depletion of its iodine content to indicate a need for replacement or replenishment, comprising a hydroxylated polyvinyl acetal non-cellulose polymeric sponge substrate wherein elemental iodine is complexed with the polymeric sponge substrate to form a solid iodophor.
With respect to instant limitation as to the hydroxylated polyvinyl acetal non-cellulose polymeric sponge substrate having a thickness of about 2 to about 3 millimeters and generally square dimensions of about 6 inched by 6 inches, Rosenblatt’648 teaches (col.13, 25-32) sponges that are 4-15 mm thick, which does not teach instant thickness range of about 2-3 mm. However, Rosenblatt’203 teaches ([0042], claim 1 and claim 7) that the lower density PVA/I sponges used in Rosenblatt’648 are more porous and release complexed iodine at a faster rate than its higher density PVA/I sponge, which not only decreases the duration of the iodine release but also pushes iodine toxicity to undesirable levels (see [0014]). Rosenblatt’203 also teaches ([0039], claim 4 and claim 8) that PVA/I sponges with higher densities allow for sponge thicknesses as low as 2-6 mm which exhibit controlled release of iodine at a much lower rate (50 ppm – 175 ppm in 3 hours vs. 270 ppm in 3 hours as in the lower density PVA/I sponge of Rosenblatt’648). Thus, it would be obvious to one skilled in the art to use a higher density hydroxylated polyvinyl acetal sponge complexed with iodine and having thickness of 2-6 mm in Rosenblatt’648 with a reasonable expectation of achieving controlled release of iodine at a lower rate (to prevent undesirable levels of toxicity) and increasing the duration of the iodine release. The range 2-6 mm overlaps with instant range about 2-3 mm for the thickness of the hydroxylated polyvinyl acetal non-cellulose polymeric sponge substrate, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). As to instant limitation “generally square dimensions of about six(6) inched by six (6) inches”, Rosenblatt’203 uses a 4 x 4 inch PVA/I sponge in its Example 1. Although such size does not each instant size 6 x 6 inch, in Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV). Thus, Rosenblatt’648 in view of Rosenblatt’203 renders obvious instant limitation.
With respect to instant limitation “elemental iodine present in an amount effective to release about 2 to about 3 parts per million upon moistening and contact with organic material”, Rosenblatt’648 teaches (col.6, lines 6-15) that if the PVA/I complexed sponge is placed in an aliquot of saline only, iodine is released. However, the iodine forms an equilibrium with the saline with no loss of iodine from the system. As organic matter is added to the saline which contains the solid complex, then some iodine is released, anywhere from as little as a few PPM to about 100 PPM (see also the Table in col.6). The range of a few PPM to about 100 PPM overlaps with instant range about 2 to about 3 ppm, thus rendering instant ranges prima facie obvious. In re Wertheim, supra. Thus, Rosenblatt’648 teaches or renders obvious instant limitation.
With respect to instant limitation “wherein the wipe lacks typical iodine odor and is non-staining”, Rosenblatt’648 teaches (col.3, lines 20-25 and col.15, lines 62-65) that the iodine complexes in aqueous solutions have the advantage over pure elemental iodine solutions in that because the iodine complexes are present in far less concentration, they greatly reduce irritation to tissue, unpleasant order and staining of tissue. Thus, Rosenblatt’648 teaches instant limitation.
With respect to instant limitation “wherein the solid iodophor is configured to release the elemental iodine in a controlled manner in the presence of water and organic material such that the elemental iodine remains complexed to the polymeric sponge substrate in the absence of the organic material and is released primarily upon contact with the organic material, wherein the organic material comprises microorganisms”, Rosenblatt’648 teaches (col.5, lines 62-68, col.6, lines 6-9) that the PVA/I complex forms less soluble iodine complexes, releasing iodine only when a significant amount of organic matter or microbes are present. Rosenblatt further teaches (col.19, lines 20-22; see also the table in col.22) that its PVA/I complexed sponge (Merodine sponge) has a remarkable ability to kill a wide variety of microorganisms including bacteria, fungi and viruses. As already discussed above, Rosenblatt’648 also teaches in claim 1 that the PVA/I complex releases free iodine in the presence of water and teaches (abstract and col.5, lines 3-7) that its PVA/I complexes release iodine in a sustained and a controlled manner in an amount which will kill germ cells but not damage living tissue. Thus, Rosenblatt’648 teaches instant limitation.
With respect to instant limitation “wherein, because the elemental iodine is chemically complexed with the sponge polymer rather than merely coated or impregnated, the elemental iodine does not leach or wash out in a substantial quantity when the wipe is moistened or rinsed with water.”, as discussed above, Rosenblatt’648 teaches (col.21, lines 6-7) that the Merodine sponge (PVA/I complexed sponge) can be washed in water without dissipating its bactericidal properties, which implies no loss of iodine, i.e., iodine is chemically complexed to the PVA sponge rather than merely coated or impregnated. Thus, Rosenblatt’648 teaches instant limitation.
With respect to instant limitation as to the elemental iodine being complexed with an amylose-containing acrylic polymer associated with the non-cellulose polymeric sponge substrate, Rosenblatt’648 does not teach instant limitation. However, Rosenblatt teaches (col.5, lines 18-21) that its PVA/I complexed sponge can be used in a wound-healing device (Merodine sponge can be used as a wound-cleaning debridement wipe – col.22, lines 5-6). Yang teaches (abstract) that superabsorbent polymers can absorb and retain liquids thousands of times their masses. Yang further teaches (pg.17, last paragraph, pg.18, first paragraph) that one of the advantages of using superabsorbent polymers in wound dressings is their ability to absorb and trap fluids and bacteria in the dressing. Since Rosenblatt’648 contemplates the use of its PVA/I complexed sponge as a wound-cleaning debridement wipe, it would be obvious to one skilled in the art to incorporate superabsorbent polymer in Rosenblatt’s PVA/I complexed sponge with a reasonable expectation of trapping fluids and bacteria in the sponge so that the iodine in the sponge can more effectively kill the bacteria. Yang further teaches (pg.4, first paragraph under 2.1.1 Polyacrylic Acids) that polyacrylic acids (PAA) are the most commonly used superabsorbent. However, Yang also teaches (abstract) that while synthetic superabsorbent polymers like PAA exhibit superior water absorbent properties compared to natural polymers like starch, they do not degrade easily. As concerns about plastic pollution continue to grow worldwide, researchers have begun to focus on a variety of natural superabsorbent polymers that achieve superabsorbent properties by grafting acrylic acid into the (natural) polymer backbone (see pg.1, first paragraph under “Introduction”). Yang taches that by grafting acrylic acid onto starch, its water-absorption capabilities can be enhanced (pg.9, 2nd paragraph under 2.2.2 Modified Natural Superabsorbent Polymer). Yang also teaches (see the last paragraph under section 3.2) that superabsorbent fibers can be produced by adding water-absorbent powder to normal fibers or coating fibers with a solution of superabsorbent polymeric resins so as to increase water absorption of the fibers. Thus, it would be obvious to one skilled in the art to make Rosenblatt’s PVA/I complex sponge superabsorbent by adding an acrylic acid-grafted starch powder (instant amylose-containing acrylic polymer of claims 1 and 2) to the PVA/I complex sponge or coating an acrylic acid-grafted starch polymer (instant amylose-acrylic starch polymer coating of claim 2) onto the PVA/I complex sponge so as to enhance water absorption of Rosenblatt’s PVA/I complex sponge while providing biodegradable properties. Furthermore, as evidenced by McMillan (col.5, lines 3-4) or Ju et al ([0009]), it is well known in the art that starch and iodine form a complex. Thus, when the acrylic acid-grafted starch powder is added to the PVA/I complex sponge or when the acrylic acid-grafted starch polymer is coated onto the PVA/I complex sponge, the iodine would naturally complex with the starch from the acrylic acid-grafted starch polymer. Thus, Rosenblatt’648 in view of Yang renders obvious instant limitation of claim 1 as to the elemental iodine being complexed with an amylose-containing acrylic polymer associated with the non-cellulose polymeric sponge substrate.
Thus, Rosenblatt’648 in view of Rosenblatt’203 and Yang renders obvious instant claim 1.
With respect to instant claim 2, for the reasons discussed above, Rosenblatt’648 in view of Rosenblatt’203 and Yang teaches instant claim 2 except for the amylose-containing acrylic polymer being impregnated as a powder into the sponge after the sponge has been rinsed to remove uncomplexed iodine”. Rosenblatt’648 teaches rinsing the sponge with water and squeezing between rinses to remove free, uncomplexed iodine (col.13, lines 49-51). Since Reosenblatt’648 in view of Yang teaches adding the amylose-containing acrylic polymer powder to Rosenblatt’s PVA/I complex sponge, it would be obvious to one skilled in the art to carry out such step after the sponge has been rinsed with water to remove uncomplexed iodine because if the superabsorbent powder is added before the rinsing step with water, the superabsorbent powder would absorb the water even before the sponge is used in wound-cleaning to trap fluids and bacteria from the wounds. Also, when the amylose-containing acrylic polymer powder is added to Rosenblatt’s PVA/I complex sponge, the powder would naturally be impregnated into the sponge (that has been rinsed with water to remove uncomplexed iodine) since sponges are porous. Thus, Roenblatt’648 in view of Roenblatt’203 and Yang renders obvious instant claim 2.
With respect to instant claim 3, Rosenblatt’s hydroxylated polyvinyl acetal sponge (instant hydroxylated polyvinyl acetal non-cellulose polymeric sponge substrate) contains residual vinyl-alcohol units (as explained above in Paragraph 8, polyvinyl acetal is formed when the hydroxyl groups (-OH groups) of polyvinyl alcohol is reacted with an aldehyde, and if the reaction is only partial, the resulting polymer retains some residual -OH groups (i.e., residual vinyl-alcohol units), thus yielding a “hydroxylated” polyvinyl acetal). Thus, Rosenblatt’648 in view of Rosenblatt’203 and Yang renders obvious instant claim 3.
With respect to instant claim 5, as discussed above, Rosenblatt’648 teaches that in the presence of water and organic matter (or microbes), some iodine is released, anywhere from as little as a few PPM to about 100 PPM, which overlaps with instant range about 2 to about 3 ppm, thus rendering instant range prima facie obvious. In re Wertheim, supra. As to instant limitation “without staining the contacted surface, and wherein the wipe leaves a minute residual amount of iodine on the skin surface that acts as a protective presence of discouraging microbial growth”, as discussed above, Rosenblatt’648 teaches (col.3, lines 18-24, col.5, lines 62-65) that the iodine complexes in aqueous solution have the advantage over pure, elemental iodine solutions, in that because they are present in far less concentration, they greatly reduce irritation to tissue, unpleasant odor, staining of tissue and corrosion of metal surfaces, such as surgical instruments. Since iodine complexes are present in far less concentration (than pure, elemental iodine), the low concentration of iodine released from the PVA/I complex sponge would naturally leave a minute residual amount of iodine on the skin surface that still acts as a protective presence discouraging microbial growth (as discussed above, Rosenblatt’648 teaches (abstract) that when topically applied, the PVA/I complexed sponge releases controlled amounts of iodine sufficient to kill germ cells with minimal toxicity to surrounding tissue). Thus, Rosenblatt’648 in view of Rosenblatt’203 and Yang renders obvious instant claim 5.
With respect to instant claim 7, as already discussed above, Rosenblatt’648 teaches (col.21, lines 6-7) that the Merodine sponge (PVA/I complexed sponge) can be washed in water without dissipating its bactericidal properties (which implies no loss of iodine, i.e., iodine remaining complexed to the PVA sponge). Furthermore, since Rosenblatt’648 also teaches that the iodine releases only when there is water and a significant amount of organic matter or microbes, it is the Examiner’s position that the drying cycles would not affect the release of the iodine, either. Thus, Rosenblatt’648 teaches instant limitation “wherein the elemental iodine remains complexed to the polymer upon repeated wetting and drying cycles”. Therefore, Rosenblatt’648 in view of Rosenblatt’203 and Yang renders obvious instant claim 7.
With respect to instant claim 9, as discussed above, Rosenblatt’648 teaches that a Merodine sponge can be used as wound cleaning wipes, debridement wipes, hand sanitizing wipes, germicide wipes and face sanitizing wipes. Thus, Rosenblatt’s PVA/I complexed sponge provides antiseptic, disinfectant or sterilant activity upon application to a surface or skin. As also discussed above, Rosenblatt’648 teaches that since far less concentration of the iodine complexes are present (when compared to pure elemental iodine), they greatly reduce irritation to tissue, and it is the Examiner’s position that the low concentration of iodine released from the PVA/I complex sponge onto the skin would naturally not dry the skin or leave residues that compromise skin barrier function. Thus, Rosenblatt’648 in view of Rosenblatt’203 and Yang renders obvious instant claim 9.
With respect to instant claim 10, Rosenblatt’648 teaches (col.19, lines 20-22; see also the table in col.22) that its PVA/I complexed sponge (Merodine sponge) has a remarkable ability to kill a wide variety of microorganisms including bacteria, fungi and viruses. Thus, Rosenblatt’648 in view of Rosenblatt’203 and Yang renders obvious instant claim 10.
With respect to instant claim 13, Rosenblatt’648 teaches (col.21, lines 10-15) that its Merodine sponge (PVA/I complexed sponge) is self-sterilizing. Thus, Rosenblatt teaches instant limitation as to the iodine content maintaining the wipe in a self-sterilizing state, thus inactivating microorganisms on the wipe during storage and use. Thus, Rosenblatt’648 in view of Rosenblatt’203 and Yang renders obvious instant claim 13.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt (5,071,648) in view of Rosenblatt et al (US 2013/0171203 A1) and Yang et al (“Research Advances in Superabsorbent Polymers”, Polymers (Basel), vol.16(4) (Feb 12, 2024), obtained from the website: https://pmc.ncbi.nlm.nih.gov/articles/PMC10892691/ ) as applied to claim 10 above, and further in view of Medline (“A review of iodine-based compounds, with a focus on biofilms: results of an expert panel”, Journal of Wound Care, North American Supplement, vol.29 (7), (July 2020), obtained from the website: https://www.medline.com/wp-content/uploads/2020/10/Cover-LetterJournal-of-Wound-Care-Iodine-IoPlex-2020.pdf ).
As already discussed above, Rosenblatt’648 teaches (col.19, lines 20-22; see also the table in col.22) that its PVA/I complexed sponge (Merodine sponge) has a remarkable ability to kill a wide variety of microorganisms including bacteria, fungi and viruses. Rosenblatt does not explicitly teach that its PVA/I complexed sponge is effective to disrupt biofilms on skin. However, Medline teaches (see pg.S3, right-hand column, 1st paragraph under “Biofilms”) that biofilms are omni present in hard to heal wounds, such as non-healing ulcers. Medline further teaches (pg.S4, right-hand column, 1st paragraph under “Clinical implications”) that the presence of biofilm is a major barrier to healing of skin ulcers. Medline then teaches (pg.S4, left-hand column, 1st paragraph under “Biofilms and iodine”) that iodophors have been shown to be able to penetrate and disrupt biofilms. Medline concludes (pg.S5, right-hand column, 1st paragraph under “Conclusions”) that controlled release iodophors are appropriate for aggressively and reliably controlling biofilms and realigning wounds to a positive healing trajectory. Therefore, Rosenblatt’648 in view of and Medline teaches instant limitation “wherein the wipe is effective to disrupt biofilms on the skin or the surface by targeting an extracellular DNA scaffolding matrix, thereby inactivating the microorganisms embedded within the biofilms” (the phrase “by targeting an extracellular DNA scaffolding matrix, thereby inactivating the microorganisms embedded within the biofilms” merely describes the mechanism of how the wipe disrupts biofilms on the skin or the surface. Since Rosenblatt’648 in view of Medline teaches instant wipe, which is effective to disrupt biofilms on the skin or the surface, the cited prior arts inherently teach the mechanism as instantly recited in claim 11). Thus, Rosenblatt’648 in view of Rosenblatt’203, Yang, and further in view of Medline renders obvious instant claim 11.
Claim(s) 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt (5,071,648) in view of Rosenblatt et al (US 2013/0171203 A1) and Yang et al (“Research Advances in Superabsorbent Polymers”, Polymers (Basel), vol.16(4) (Feb 12, 2024), obtained from the website: https://pmc.ncbi.nlm.nih.gov/articles/PMC10892691/ ) as applied to claim 1 above,, and further in view of Rosenblatt (US 6,365,169 B1).
The Examiner already established above that Rosenblatt’648 in view of Rosenblatt’203 and Yang teaches instant reusable antimicrobial wipes. Rosenblatt’648 does not teach instant sealed, substantially airtight resealable storage pouch. As evidenced by Rosenblatt’169 (col. 8, lines 60-66), it is already known in the art that wipes that are used to sanitize surfaces, whether single or multi-use, can come in a resealable poly pouch. It would have been obvious to one skilled in the art to store and carry Rosenblatt’s PVA/I complexed sponge (as discussed above, Rosenblatt’s PVA/I complexed sponge is reusable) in a resealable poly pouch for convenience and also to offer protection for the PVA/I complexed sponge against contaminants. Since such resealable poly pouch would be in a sealed state (during storage and carrying), it would naturally or inherently be configured (due to the impermeable nature of the plastic material and the fact that it is sealed and thus airtight) to retain moisture and maintain the reusable PVA/I complex sponge in a ready-to-use state preserving its antimicrobial effectiveness for subsequent uses. With respect to instant limitation “wherein the one or more antimicrobial wipes are stored within the resalable storage pouch after each wipe has been lightly dampened with water and gently squeezed to distribute moisture evenly before being returned to the pouch”, as already discussed above, Rosenblatt’s PVA/I complexed sponge releases free iodine in the presence of water, and such free iodine maintains the wipe in a self-sterilizing state (thus inactivating microorganisms on the wipe during storage and use). Thus, it would be obvious to one skilled in the art to have Rosenblatt’s sponge wipe wet with water (and remove excess water by squeezing it so that the acrylic acid-grafted starch powder in Rosenblatt’s PVA/I complex sponge would not absorb the excess water) before storing or re-storing the sponge wipe in the resealable storage pouch so that the free iodine (that is released from Rosenblatt’s PVA/I complex sponge in the presence of water) can keep the wipe in a self-sterilizing state during the storage and maintain the wipe in a ready-to-use state for subsequent uses. Thus, Rosenblatt’648 in view of Rosenblatt’203 and Yang, and further in view of Rosenblatt’169 renders obvious instant claims 14-15.
Response to Arguments
Applicant first argue that although the Examiner combines Rosenblatt’648 with Yang by relying on Yang’s teaching of superabsorbent polymers generally and acrylic-acid-grafted starch coatings in wound dressings to enhance water absorption, the Examiner's stated motivation is directed to improving water- absorption and biodegradability, not to complexing elemental iodine with an amylose-containing polymer. Applicant argue that neither Yang nor Rosenblatt teaches, suggests, or provide motivation to use a starch-acrylic polymer as an iodine-complexing agent and that one skilled in the art would not have been directed by Yang's absorption-enhancement rationale to arrive at iodine complexed with an amylose-containing acrylic polymer as claimed. The Examiner disagrees. First of all, MPEP 2144 (IV) states that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). Secondly, the Examiner established above that it would be obvious to one skilled in the art to make Rosenblatt’s PVA/I complex sponge superabsorbent by adding (impregnating) an acrylic acid-grafted starch powder into the PVA/I complex sponge or by coating an acrylic acid-grafted starch polymer onto the PVA/I complex sponge in order to enhance water absorption of Rosenblatt’s PVA/I complex sponge while providing biodegradable properties, and as already discussed above, when the acrylic acid-grafted starch powder is incorporated into the PVA/I complex (or when the acrylic acid-grafted starch polymer is coated onto the PVA/I complex), the starch and the iodine would naturally form a complex (as evidenced by McMillan (col.5, lines 3-4) or Ju et al ([0009]), it is well known in the art that starch and iodine form a complex). Thus, Rosenblatt’648 in view of Yang does teach instant limitation of claim 1 as to the elemental iodine being complexed with an amylose-containing acrylic polymer.
As to instant rejection on claim 5, applicant argue that Rosenblatt’648 does not teach instant residual-protective-iodine function and argue that although Rosenblatt’648 teaches topical germicidal activity it does not describe a wipe configured to leave residual protective iodine on the skin surface as an impediment to microbial colonization. The Examiner disagrees. As discussed above, Rosenblatt’648 teaches (abstract) that when topically applied, the PVA/I complexed sponge releases controlled amounts of iodine (anywhere from as little as a few PPM to about 100 PPM, which overlaps with instant range about 2 to about 3 ppm) sufficient to kill germ cells with minimal toxicity to surrounding tissue. As discussed above, Rosenblatt’648 teaches that much less concentration of the iodine released from the PVA/I complex would greatly reduce staining of tissue and teaches that this low concentration of iodine released on the skin surface would still act as a protective presence discouraging microbial growth (since Rosenblatt’648 clearly states that the PVA/I complex sponge releases controlled amount of iodine (as little as a few PPM to 100 ppm) would be sufficient to kill germ cells with minimal toxicity to surrounding tissue).
With respect to instant rejection on claim 2, applicant state that claim 2 has been amended to recite a polyvinyl alcohol sponge substrate having an amylose-acrylic starch polymer coating, wherein the polymer is impregnated as a powder after rinsing and argue that this amendment distinguishes the prior art by expressly requiring a specific impregnated-powder configuration that is not taught by Yang's general superabsorbent-coating disclosure as Yang teaches coating fiber to increase water absorption, not impregnating a sponge with a powder of amylose-containing polymer following a rinse to remove uncomplexed iodine. However, the Examiner believes that applicant’s such argument is already addressed in Paragraph 13 above. Applicant also argue that the Action's rationale for rejecting instant claim 2 appears to be directed to the concept of adding a superabsorbent polymer to improve the wound-dressing absorbency and biodegradability of a PVA/I composition but claim 2 is not merely about absorbency as it requires the non-cellulose polymeric sponge substrate itself to comprise the recited synthetic carbohydrate-related polymer in the claimed reusable iodophor wipe context. However, the Examiner already established above that it would be obvious to one skilled in the art to make Rosenblatt’s PVA/I complex sponge superabsorbent by adding an acrylic acid-grafted starch powder to the PVA/I complex sponge or coating an acrylic acid-grafted starch polymer onto the PVA/I complex sponge so as to enhance water absorption of Rosenblatt’s PVA/I complex sponge while providing biodegradable properties, and when the amylose-containing acrylic polymer powder is added to Rosenblatt’s PVA/I complex sponge, the powder would be impregnated into the sponge (that has been rinsed with water to remove uncomplexed iodine) since sponges are porous. The result would be Rosenblatt’s PVA/I complexed sponge wipe comprising the amylose-containing acrylic polymer (impregnated as a powder) as instantly required in the amended claim 2. As to applicant’s argument that the Action's proposed mapping to an acrylic-acid grafted starch does not show why a person of skill would specifically modify Rosenblatt's PVA/I sponge in that exact way rather than using many other superabsorbent polymers discussed by Yang, as already discussed above, Yang teaches that polyacrylic acids (PAA) are the most commonly used superabsorbent, but teaches that while synthetic superabsorbent polymers like PAA exhibit superior water absorbent properties compared to natural polymers like starch, they do not degrade easily. Yang teaches that as concerns about plastic pollution continue to grow worldwide, researchers have begun to focus on a variety of natural superabsorbent polymers that achieve superabsorbent properties by grafting acrylic acid into the (natural) polymer backbone. Yang further taches that by grafting acrylic acid onto starch, water-absorption capabilities of the starch can be enhanced. Thus, the Examiner believes that enough motivation has been provided to use the acrylic grafted starch polymer among the superabsorbent polymers taught by Yang. Furthermore, (i) since Yang teaches that by using superabsorbent polymers in wound dressings, one can absorb and trap fluids and bacteria in the dressing, (ii) since Rosenblatt’648 contemplates the use of its PVA/I complexed sponge as a wound-cleaning debridement wipe and (iii) since Yang also teaches that superabsorbent fibers can be produced by adding water-absorbent powder to normal fibers so as to increase water absorption of the fibers, it would be obvious to one skilled in the art to make Rosenblatt’s PVA/I complex sponge superabsorbent by adding an acrylic acid-grafted starch powder to the PVA/I complex sponge (and thus impregnating the powder into the sponge) so as to enhance water absorption of Rosenblatt’s PVA/I complex sponge (while providing biodegradable properties) and effectively trap fluids and bacteria in the sponge so that the iodine in the sponge can more effectively kill the bacteria.
With respect to instant rejection on claims 14-15, applicant argue that the specific rehydration-and-return storage arrangement is not taught by Rosenblatt '169, which discloses only a generic resealable poly pouch for sanitizing wipes. Applicant argue that the Examiner's inherency argument - that a sealed pouch would naturally retain moisture - does not address the claimed step of lightly dampening and squeezing the wipe before return. Applicant also argue that the wipe according to the amended claim 1 changes color from black to tan or white as iodine is depleted and that such feature (which has to be included in claims 14 and 15 as claims 14 and 15 depend from claim 1) is absent from the cited references. Applicant also point out that claim 14 requires a pouch configured to retain moisture and maintain the wipe in a "ready to use" state and argue that the Office Action assumes that once sealed in a pouch, the wipe(s) would inherently retain moisture but fails to identify a teaching or suggestion that Rosenblatt's wipe is packed moist or that the pouch is specifically configured for moisture retention as recited in claim 14. The Examiner disagrees. First of all, the Examiner already established above that Rosenbaltt’648 teaches that when iodine depletion occurs in its PVA/I complexed sponge, the polymer begins to turn from blue/black (the color of the complex) to lighter shades of blue or purple and eventually completely white, indicating that the iodine is depleted and the sponge needs to be changed. Secondly, as already explained above, based on the teaching of Rosenblatt’169, it would have been obvious to one skilled in the art to store and carry Rosenblatt’s PVA/I complexed sponge in a resealable poly pouch for convenience and also to offer protection for the PVA/I complexed sponge against contaminants. Since such resealable poly pouch would be in a sealed state (during storage and carrying), it would naturally or inherently be configured (due to the impermeable nature of the plastic material and the fact that it is sealed and thus airtight) to retain moisture and maintain the reusable PVA/I complex sponge in a ready-to-use state preserving its antimicrobial effectiveness for subsequent uses. With respect to instant limitation “wherein the one or more antimicrobial wipes are stored within the resalable storage pouch after each wipe has been lightly dampened with water and gently squeezed to distribute moisture evenly before being returned to the pouch”, as already discussed above, Rosenblat’648 teaches that its PVA/I complexed sponge releases free iodine in the presence of water, and such free iodine maintains the wipe in a self-sterilizing state (thus inactivating microorganisms on the wipe during storage and use). Thus, it would be obvious to one skilled in the art to wet Rosenblatt’s sponge wipe with water and remove excess water by squeezing it before storing or re-storing the sponge wipe in the resealable storage pouch so that the free iodine will be released from Rosenblatt’s PVA/I complex sponge in the presence of the water to keep the wipe in a self-sterilizing state during the storage and maintain the wipe in a ready-to-use state for subsequent uses. Thus, the Examiner believes that every limitations of claims 14 and 15 have been addressed.
For the reasons stated above, instant 103 rejections over Rosenblatt’648 in view of Rosenblatt’203 and Yang (Polymers (Basel)) still stand.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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.
/SIN J LEE/
Primary Examiner, Art Unit 1613
October 11, 2026
