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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/02/2025 has been entered.
Status of the Claims
Pursuant to the amendment dated 12/02/2025, new claim 24 has been added. Claims 2, 6-9 and 13 have been cancelled in a previous communication. Claims 1, 3-5, 10-12, and 14-24 are pending and under current examination.
All rejections not reiterated have been withdrawn.
Information Disclosure Statement
Citations provided without a publication date were not considered by the examiner as indicated by a line through on the IDS. See MPEP 609.04(a):
37 CFR 1.98(b) requires that each item of information in an IDS be identified properly. U.S. patents must be identified by the inventor, patent number, and issue date. U.S. patent application publications must be identified by the applicant, patent application publication number, and publication date. U.S. applications must be identified by the inventor, the eight digit application number (the two digit series code and the six digit serial number), and the filing date. If a U.S. application being listed in an IDS has been issued as a patent or has been published, the applicant should list the patent or application publication in the IDS instead of the application. Each foreign patent or published foreign patent application must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application. Each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. The place of publication refers to the name of the journal, magazine, or other publication in which the information being submitted was published. See MPEP § 707.05(e), for more information on data that should be used when citing publications and electronic documents. Pending U.S. applications that are being cited can be listed under the non-patent literature section or in a new section appropriately labeled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-5, 10-12, and 14-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, the specification fails to establish that Applicant was in possession of the full scope of the hydrogel biomaterial instantly claimed. The specification only describes one example of the hydrogel biomaterial in which the amount of HEC, allantoin, and sodium lactate are not disclosed. The amount of HEC appears to be important for the performance of the claimed invention (see the response to arguments and declaration section that follows the rejection under 35 USC 103); however, the specification, as filed, does not provide any information as to what amounts of HEC will provide the claimed intended outcomes. Thus the application, as filed does not establish that Applicant was in possession of all methods of treating chronic non-healing wounds with hydrogel biomaterials containing the claimed ingredients that would also result in the claimed outcomes.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the written description concerns outlined above.
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.
Claims 1, 3-5, 10-12, and 14-24 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.
The term “about” in claim 1 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This is particularly the case as the claimed hydrogel biomaterial requires “about 30% v/v” glycerol and “about 70% v/v” purified water but also requires other materials to be present. The amount of hydroxyethyl cellulose, sodium lactate, and allantoin, as components of the hydrogel biomaterial having “about” 70% water and 30% glycerol are implicitly limited by the amount of the water and glycerol; however, the relative term “about” makes the extent of this implicit limitation unclear. This renders the actual amount of each ingredient in the hydrogel biomaterial permitted by the claims wholly unclear.
Each of claims 1 and 3-5 recite a range in percent change in wound area or volume with no upper limit. The percent change in wound area or volume could be greater than 100% if the wound treated with the hydrogel according to the invention is more than 2 times less in area or volume than the wound treated with the hydrogel control, therefore there is also no inherent upper limit on the range in percent required by these claims. As such, the relative performance required by the claim is indefinite.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 fails to incorporate all of the limitations of the claim from which it depends. Claim 1 requires the composition to be administered either directly or as a dressing wherein the surface of the dressing is impregnated with the composition; however, claim 11 requires the composition to be on the surface of the dressing rather than impregnated. Accordingly, claim 11 falls outside the scope of claim 1, from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 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 1, 3-5, 10-12, 15-17, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dentsman (US 2013/0209592; publication date: 08/15/2013; of record) and Serafini et al. (Ciencia Rural, Santa Maria v. 42, n. 12 pp 2213-2218; publication year 2012; citing the English human translation; of record) in view of Junginger (US 2011/0280926; publication date: 11/17/2011; of record) and further in view of Risse et al. (DE 102013018565; publication date: 04/30/2015; citing the English Machine Translation; of record), as evidenced by Kato et al (US 4,780,079; issue date: 10/25/1988; of record).
NOTE: The declaration of Dr. Wetzel, filed 12/02/2025, provides evidence that the amount of sugar in the hydrogel according to the instant claims (claimed as present in a 1:1 v/v ratio with the hydrogel biomaterial) is approximately 38.3% by mass (see table 7 on page 21 of the declaration). As the claims recite a volume/volume ratio of sugar to hydrogel biomaterial whereas all prior art disclosed only weight percentages, it had been impossible to identify with certainty the closest prior art composition in terms of proportion of sugar in the hydrogel wound healing composition in previous Office actions because there was no straightforward means to convert the mass percentage of the prior art to a volume ratio, as claimed, or vice versa. The declaration provides new evidence to support the conclusion that Dentsman’s “second compound”, disclosed in table 2, paragraph 0049, and having 41% by sugarcane block mass, contains the closest amount of sugar to the claimed ratio of 1:1 sugar:hydrogel biomaterial by volume. The obviousness rejection has been adjusted to reflect this new information.
Dentsman discloses a step of formulating (i.e. compounding) example compositions (0036). Dentsman discloses a composition for treating chronic wounds (title) that includes a sugarcane plant extract, water, and a gelling agent that includes at least one of xanthan gum and hydroxyethyl cellulose (HEC; abstract, claim 2). In example I on pages 2-3, discloses a method of treating a wound in patients with compromised wound healing by applying a formulation comprising sugarcane block and hydroxyethyl cellulose (i.e. a method of treating chronic, non-healing wounds by applying a composition comprising sugar and a hydrogel biomaterial comprising water and HEC; para 0035; table I following para 0036). Patients were directed to apply the “healing compound” (i.e. the sugar-containing hydrogel disclosed by Dentsman) to open wounds on a daily basis followed by covering with a moist saline dressing (i.e. the composition is applied to the wound directly; 0038). Example compositions disclosed in tables 1 and 2 contain sugarcane block (i.e. a plant extract wherein the sugar component is crystalized due to boiling away of the water and contains 75-85% crystalized sucrose 6-15% crystalized fructose; 00029). More specifically, the composition disclosed in table 1 following para 0036 contains 75 g sugarcane block in approximately 103 g of the composition, and thus has a sugarcane block percentage of about 73 percent w/w and the composition disclosed in table 2 contains approximately 41% w/w sugarcane block. Noting that the sugarcane block is less than 100% sugar (see above), the content of sugar in Dentsman’s examples would be modestly lower than the percentages above. Dentsman discloses further that the compositions can contain a range of about 35 to 75% wt of sugarcane block (0032). The compositions do not contain iodine. Experiments I and II together show that compositions containing sugarcane extract or sugarcane block (i.e. crystalized sugars from sugarcane; groups B and C, respectively) in amounts close to the endpoints of the range for sugarcane block taught by Dentsman are markedly more effective in promoting wound re-epithelialization relative to a hydrogel only control (group A) or untreated control (group B). Dentsman discloses further that compositions according to their invention containing the sugarcane block are most effective in an experiment analyzing antibacterial efficacy of various wound treatments; see 0058 which states “the wound treatment compound described in Example I had the lowest PA [Pseudomonas aeruginosa] counts”. Dentsman discloses a range in sugar content that embraces the 1:1 vol/vol ratio of sugar to hydrogel biomaterial required by the instant claims, and describes example compositions, both of which are highly effective at promoting wound healing, including wound re-epithelialization (0043) relative to hydrogel controls, and one of which has a percentage of sugar by weight very close to the claimed amount of 38.3% wt, particularly as the percentage of “table sugar” (sucrose) in Dentsman would be modestly lower than the reported value for percentage by weight sugarcane block. The limitation recited in instant claim 1 requiring a ratio “1:1 v/v [i.e. 38.3% by weight, see Wetzel declaration filed 12/02/2025] granulated table sugar … and a hydrogel biomaterial” is rendered obvious by Dentsman who teaches a range in sugar content that embraces the range recited in the instant claims and who discloses an example composition containing sugar in an amount very close to the amount required by the instant claims. In example II, Dentsman discloses that 40% of the wounds were completely re-epithelialized and none of the gel base (control) wounds were re-epithelialized. Thus, Dentsman teaches a method in which application of a sugar-containing hydrogel dressing results in much better wound healing (i.e. percent change in wound area or wound volume).
Moreover, Serafini discloses a method of healing wounds by applying a gel containing 92 g sugar in a hydrogel material formed from 50 mL water and 2 g hydroxyethyl cellulose The composition is free of iodine. The ratio of sugar to water is 92 g to 50 mL. The Wetzel declaration filed 12/02/2025 establishes this hydrogel to be approximately 63.9% by weight sugar. Serafini discloses that the sugar gel is more easily applicable to the wound than granulated sugar because the gel consistency provided to the composition by the hydroxyethyl cellulose allows better adhesion (page 6). Serafini discloses that both granulated sugar and the sugar hydrogel promote wound granulation tissue development, with slight superiority of the sugar gel over the granulated sugar without a hydrogel (page 7) and thus, one of ordinary skill would understand that the additional substances present in “sugarcane block” are not major contributors to the wound healing effect of Dentsman’s composition. Serafini discloses further that in the context of wound treatment, sugar in general was proposed to create an environment with low water and was known to promote concentration in the aqueous wound solution so the water activity in the wound is below the limit needed for bacteria to thrive (i.e. sugar application to a wound draws water out and has antimicrobial effects; page 1).
In summary, Dentsman discloses a method of treating a chronic non-healing wound in a subject, comprising (a) compounding an iodine-free pharmaceutical composition comprising granulated table sugar (i.e. sucrose) and a hydrogel biomaterial comprising a water-swollen polymeric material resulting in a solid, semisolid, pseudoplastic or plastic structure (please refer to page 37 of the instant specification, which indicates that hydroxyethyl cellulose is a “hydrogel biomaterial” that forms the required solid, semisolid, pseudoplastic or plastic structure with water; abstract, page 5), and administering the pharmaceutical composition to the chronic non-healing wound by contacting the non-healing wound topically with the pharmaceutical composition directly. Although neither Dentsman nor Serafini disclose a composition having exactly a 1:1 v/v ratio of granulated table sugar to hydrogel biomaterial, the “1:1 v/v” ratio of sugar to hydrogel biomaterial recited in the instant claims does not patentably define over the cited prior art. This is because in view of Dentsman and Serafini, one of skill in the art would recognize that hydrogel compositions containing sugar and particularly containing a hydrogel biomaterial and sugar at an approximately 1:1 vol/vol ratio (i.e. approximately 38.3% w/w sugar) are effective at promoting healing chronic wounds, are effective at promoting wound re-epithelialization, and have an anti-bacterial effect. One would have attributed the healing benefits mainly to the presence of sugar, as Serafini’s hydrogel that promotes effective wound healing only contains sugar, water, and HEC. One would have attributed ease of handling to the presence of the gel forming material such as HEC, as Serafini recognized combining sugar with a hydrogel improves handling. Moreover, as noted above, one having ordinary skill in the art would recognize that the sugarcane block (i.e. crystalized sugar derived from sugarcane extract) disclosed by Dentsman also causes a marked reduction in bacterial infection in wounds relative to untreated control and to a hydrogel control.
With regard to some additional intended outcomes recited in claims 1, 23, and 24, the examiner notes that the sugar creates an environment with low water and absorbs exudates. The examiner interprets this to indicate that the wound would have been drained. Moreover, the benefits of having sugar present in the hydrogel would inherently provide the benefits described in the instant application to be associated therewith. Finally, the above disclosures teach that the method results in wound closure (i.e. contraction from wound edges), and wound re-epithelialization, thus it would have been obvious to optimize the method within the parameters taught by Dentsman to achieve these goals.
With regard to instant claim 1, as the term “hydrogel biomaterial” is not formally defined in the specification, the examiner interprets “hydrogel biomaterial” to embrace the remainder of the composition other than the granulated sugar. Ranges in amount in terms of percent by weight are disclosed by Dentsman in para 0030-0032. This would give one of ordinary skill a starting point in optimizing the amount of the amount of sugar in the composition required to achieve the desired outcome disclosed by Dentsman of chronic wound healing. Please refer to MPEP 2144.05.
Dentsman discloses compositions comprising water in amounts ranging from 20-60% by weight relative to the total weight of the composition (para 0032). While the numerical range is less than the value recited in instant claim 1 of 70%, the examiner notes that the percentages disclosed by Dentsman include the amount of sugarcane extract in the composition, whereas the instant claims recite a limitation on the amount of water in the hydrogel biomaterial component only. If the percentage of sugarcane extract is excluded from the quantities disclosed by Dentsman at para 0032, it is clear that Dentsman also discloses hydrogels containing water in a range that embraces the amount of water required by instant claim 1. It is noted that Dentsman discloses an embodiment in which glycerin (i.e. glycerol) is contained in amounts lower than required by instant claim 1 (para 0032 discloses using glycerol at about 0-3% by weight relative to the total weight of the composition); however using higher amounts of glycerol in compositions for wound healing was known in the art:
Junginger discloses using glycerol in amounts up to 30% by weight (para 0040) in hydrogel compositions for wound healing (title).
It would have been prima facie obvious to use higher amounts of glycerol than those disclosed by Dentsman in an embodiment, at least up to 30%, because one of ordinary skill in the art would recognize such compositions as suitable for wound treatment. See MPEP 2144.07.
As noted above, Serafini discloses a hydrogel containing hydroxyethyl cellulose and water and Dentsman discloses that the hydrogel may contain hydroxyethyl cellulose and glycerin (i.e. glycerol; para 0032) but is silent with respect to including allantoin or sodium lactate in the composition.
Risse discloses that both allantoin and sodium lactate were known as wound healing agents (para 0027).
It would have been prima facie obvious to add allantoin and sodium lactate to the wound healing hydrogel disclosed by Dentsman because these agents were known at the time the instant invention was filed to serve the same purpose. See MPEP 2144.06.
With regard to instant claims 1 and 10, the composition is applied topically (as noted above, para 0038 discloses cleaning the wounds followed by applying the composition to the wound).
With regard to the intended outcomes recited in instant claims 1 and 3-5, Serafini discloses improved development of granulation tissue and reduced bacterial infection and Dentsman discloses that percent wound closure is greater in the compositions containing sugarcane block than in compositions from which the sugarcane block is absent. Finally, Dentsman discloses effective treatment of the wounds (para 0039) and with regard to claims 1 and 3-5, example II and Fig 4 show re-epithelization in compositions containing sugarcane block and no re-epithelialization in ones from which sugar is absent.
With regard to instant claim 11, Dentsman discloses applying the composition to the wound followed by application of a wound covering (0038). It would have been prima facie obvious to design the treatment protocol such that the composition was applied using a wound dressing that had the composition contained thereon rather than the stepwise protocol disclosed by Dentsman in example 1. The skilled Artisan would have been motivated to do so in order to simplify the application procedure. One of ordinary skill in the art would have had a reasonable expectation of success because this would merely require applying the composition to any wound dressing known in the art. See also para 0032 of Dentsman, which discloses applying the composition with any dressing known in the art.
With regard to instant claim 12, Dentsman discloses using a film dressing (0033).
With regards to instant claims 15-17, Dentsman discloses that the compositions may contain copper (para 0029), therefore it would have been prima facie obvious to include this in the composition used to treat the chronic wound. Kato discloses that copper (Cu) has antibiotic properties (see col 1, line 51-57). Thus, Dentsman discloses including an antibiotic in the composition.
With regard to claim 22, the treated wounds are clearly healing and the presence of pathogenic microorganisms is lowered therefore the examiner considers a method of treating a wound using Serafini’s or Dentsman’s composition to possess this intended outcome, particularly in view of the similarity of the claimed ingredients to those in the prior art as well as the known effect of sugar-containing hydrogels on wound healing and water removal from the wound area. A healed wound would exhibit lesser degree of each of the above properties than an unhealed wound such as those possessed by patients in the control groups of Dentsman’s experiments.
With regard to claims 23 and 24, as noted above, the sugar-hydrogel compositions of Serafini/Dentsman kill microorganisms and accelerate re-epithelialization. The examiner also notes that there is no degree of effect required by claim 23, thus, any amount of killing microorganisms and re-epithelialization falls within the scope of the claims. Further, as noted above, the prior art teaches increased wound healing and draining of the wound. Moreover, as the steps required by the instant claims are rendered obvious by the prior art, the examiner considers the intended outcomes recited in instant claims 23 and 24 to have been inherent in the method disclosed by Dentsman, absent evidence to the contrary.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dentsman (US 2013/0209592; publication date: 08/15/2013; of record) and Serafini et al. (Ciencia Rural, Santa Maria v. 42, n. 12 pp 2213-2218; publication year 2012; citing the English human translation; of record) in view of Junginger (US 2011/0280926; publication date: 11/17/2011; of record) and further in view of Risse et al. (DE 102013018565; publication date: 04/30/2015; citing the English Machine Translation; of record), as evidenced by Kato et al (US 4,780,079; issue date: 10/25/1988; of record), as applied to claims 1, 3-5, 10-12, 15-17, and 21-24 above, and further in view of Taylor et al. (US 5,967,979; issue date: 10/19/1999; of record).
The relevant disclosures of Dentsman, Serafini, Junginger and Risse are set forth above. Dentsman is silent with respect to imaging the wound to measure change in wound area with a 3-dimensional camera system.
Taylor discloses a wound measurement apparatus that can provide three dimensional features of a wound using camera system (abstract and e.g. col 8, lines 25-35).
It would have been prima facie obvious to measure wound healing in the studies disclosed by Dentsman using a 3-dimensional imaging method including a camera such as the method disclosed by Taylor. One of ordinary skill in the art would have been motivated to do so in order to provide improved accuracy for analyzing effectiveness of the treatment. The skilled Artisan would have had a reasonable expectation of success because this would merely require applying Taylor’s method to the wounds treated with Dentsman’s composition.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dentsman (US 2013/0209592; publication date: 08/15/2013; of record) and Serafini et al. (Ciencia Rural, Santa Maria v. 42, n. 12 pp 2213-2218; publication year 2012; citing the English human translation; of record) in view of Junginger (US 2011/0280926; publication date: 11/17/2011; of record) and further in view of Risse et al. (DE 102013018565; publication date: 04/30/2015; citing the English Machine Translation; of record), as evidenced by Kato et al (US 4,780,079; issue date: 10/25/1988; of record), as applied to claims 1, 3-5, 10-12, 15-17, and 21-24 above, and further in view of Gomer et al. (US 2006/0002938; publication date: 01/05/2006; of record).
The relevant disclosures of Dentsman, Serafini, Junginger and Risse are set forth above. Dentsman is silent with respect to including the growth factors recited in instant claim 18.
Gomer discloses that FGF was known as a wound healing factor at the time the instant invention was filed (see clam 22).
It would have been prima facie obvious to add FGF to the wound dressing disclosed by Dentsman because these two agents were known for the same purpose. Please refer to MPEP 2144.06.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dentsman (US 2013/0209592; publication date: 08/15/2013; of record) and Serafini et al. (Ciencia Rural, Santa Maria v. 42, n. 12 pp 2213-2218; publication year 2012; citing the English human translation; of record) in view of Junginger (US 2011/0280926; publication date: 11/17/2011; of record) and further in view of Risse et al. (DE 102013018565; publication date: 04/30/2015; citing the English Machine Translation; of record), as evidenced by Kato et al (US 4,780,079; issue date: 10/25/1988; of record), as applied to claims 1, 3-5, 10-12, 15-17, and 21-24 above, and further in view of Velazquez et al. (US 2010/0272684; publication date: 10/28/2010; of record).
The relevant disclosures of Dentsman, Serafini, Junginger and Risse are set forth above. Dentsman is silent with respect to including adjunct therapy in the method.
Velazquez discloses that hyperbaric oxygen therapy improves chronic dermal ulcers in diabetic patients (abstract, para 0046).
It would have been prima facie obvious to co-treat the patients in the method disclosed by Dentsman with hyperbaric oxygen. One of ordinary skill in the art would have been motivated to do so in order to increase the efficacy of treatment by employing multiple wound healing stimulants. The skilled Artisan would have had a reasonable expectation of success because this would merely require adding in a step of exposing the wound to hyperbaric oxygen as disclosed by Velazquez.
Response to Arguments
Applicant's arguments as well as the Wetzel declaration and the 5th Aslam declaration, each filed 12/02/2025, have been fully considered but they are not persuasive.
Response to Declarations:
Response to Aslam declaration and calculations presented in Wetzel declaration, both filed 12/05/2025:
The 12/02/2025 Aslam declaration provides evidence that the Aslam gel used for experiment 2 of the instant application contained 30 mL glycerin, 0.2 gm allantoin, 2.5 mL of 60% sodium lactate solution, 4 gm HEC, and water to 100mL. This hydrogel was mixed 1:1 by volume with granulated table sugar daily for experiment 2 and there was some undissolved sugar visible in the hydrogel composition. Declarant characterizes the above hydrogel as clear to slightly hazy, easy to apply, not runny during application, and the old gel was easy to wipe off before reapplication of fresh gel in experiment 2.
The declaration establishes further that the “2024 Aslam gel” (i.e. the Aslam gel used for experiments in the 06/21/2024 Aslam declaration) did not have a 1:1 v/v ratio of sugar to hydrogel, but rather had a 1:1 w/w ratio of sugar to hydrogel. This was the sugar-hydrogel composition used for the declaration filed 06/21/2024 in which a comparison was made to the Serafini gel. More specifically the “2024 Aslam gel” contained 67.640 g wound base combined with 67.648 sucrose (confectioner’s sugar), 1.0181 g allantoin, and 0.193 g sodium lactate. [The examiner points out this “2024 Aslam gel” accordingly contained approximately 50% w/w sugar.] The sugar appeared to be completely dissolved. This gel “behaved the same as did the 2015 Aslam gel”. Declarant does not state the amount of HEC present in the “2024 Aslam gel”.
The Serafini gel used in the 06/21/2024 Aslam declaration was prepared as described in Serafini by heating 50 mL distilled water to 80C, adding 92 gm sugar and raising temperature to 90C, at which point the composition was homogenized for 5 min. After lowering the temperature to between 60 – 70C, 2 g HEC was added and the composition was stirred until it cooled.
The 12/02/2025 declaration and the 06/21/2024 declaration, both by Dr. Aslam, characterize the “2024 Aslam gel” as homogeneous in consistency, with no particles or crystals and flows easily without being runny just as it did day 10 after manufacturing, the lid of the jar is clean and the gel is not sticky and is translucent when applied to the wound; whereas, the Serafini gel is difficult to apply, thick, does not spread easily, is harder to clean from the wound, as it was found to be adherent, and clumped and crystallized in the periwound area. The wound healing experiment in the declaration filed by Dr. Aslam on 06/21/2024 is described as showing that the Aslam gel produced earlier and better wound healing (see details in para 23-25 and table on page 7 of the declaration). The “2024 Aslam gel” in this experiment had a markedly greater quantity of sugar than is claimed in the instant claims (50% w/w sugar in the 2024 Aslam gel vs. 38.3% w/w sugar in the claimed gel), see further discussion below.
With regard to the examiner’s request for clarity regarding the amount of each ingredient in the claimed hydrogel, claimed using a v/v ratio vs. the hydrogels taught by the prior art, which are described in % by weight, the Wetzel Declaration filed 12/05/2025 establishes the following: On pages 13-21, Dr. Wetzel performs several calculations to estimate the weight percentages of the components of the Aslam gel used for experiment 2 of the specification, and having a 1:1 v/v ratio of table sugar to hydrogel biomaterial, as claimed; the weight percentages of the components of the Serafini gel, as reproduced for the 06/21/2024 Aslam declaration, and the solubility of sugar in both of these compositions. Dr. Wetzel estimates the “Aslam gel of experiment 2” to have contained 38.3% w/w sugar and 2.19% w/w HEC; and the Serafini gel to have contained 63.9% w/w sugar and 1.39% w/w HEC (see table 7 on page 21 of the Wetzel declaration).
Altogether, the 2024 and 2025 Aslam declarations and the Wetzel declaration establish that the claimed 1:1 v/v ratio of granulated table sugar to hydrogel biomaterial is not critical for the performance of the wound healing composition according to the instant invention, as a 50% by weight hydrogel is described in the declarations as performing comparably to a 38.3% by weight sugar hydrogel. These two compositions are also both shown to be very effective at promoting wound healing in experiment 2 of the specification and in the 06/21/2024 declaration by Dr. Aslam. The examiner points out that these two compositions fall on either side of the Dentsman example cited above as having 41% sugar by weight and both perform well. The record does not support that there is criticality of the claimed range, and also fails to establish a nexus between the difference from the closest prior art (amount of sugar) and any alleged benefit of the composition according to the invention or that the closest prior art differs from the claimed invention in terms of outcome.
Regarding the consistency, handling, and storage stability of the “2024 Aslam gel” (having 50% w/w sugar) relative to the Serafini gel reported in the 06/21/2024 Aslam declaration and previously characterized as unexpectedly superior, the Wetzel declaration establishes the Serafini gel to have been a supersaturated sugar solution having HEC at 1.39% w/w, whereas the Aslam gel contains sugar below its concentration limit. Dr. Wetzel states on page 20 “[i]t is well known that sucrose can form large crystals when recrystallized from water; this is a common elementary school science experiment”. The examiner finds it entirely predictable that a supersaturated solution of sugar in water would have been more difficult to handle and tended to crystalize on the lid of the storage container as well as in the periwound area after application and that a gel having sugar below its saturation concentration would exhibit the better handling described in the 06/21/2024 Aslam declaration. Therefore, these features are not unexpected improvements. The examiner notes that the actual amount of HEC used to form the “2024 Aslam gel” is not reported at this point, and therefore this value has not been clarified for the record. If the gel contained 2.19% HEC, as did the “Aslam gel” used for experiment 2 of the specification, then the Serafini gel had close to half the amount of gelling agent as the “2024 Aslam gel” to which it was compared. HEC is a superabsorbent polymer and would be expected to alter the consistency of the hydrogel. Furthermore, increasing quantity of HEC would increase the amount of wound exudate that the composition could absorb. As noted above, Serafini describes the HEC hydrogel as improving the handling of the sugar composition relative to pure sugar. It would have been a logical extrapolation for one of ordinary skill to adjust the quantity of gelling agent (i.e. superabsorbent polymer) to improve handling and influence the extend of wound exudate that could be absorbed by the dressing. Thus, these supposed improvements due to the instant invention reported in the 06/21/2024 declaration do not appear to have been unexpected improvements.
Regarding the improved wound healing effect compared to the Serafini gel that was reported in the 06/21/2024 Aslam declaration, as noted above, the Wetzel declaration establishes the percentage of sugar in the claimed composition such that a comparison to the prior art formulations can now be made. The declarations of record and the instant specification together establish that the composition according to the invention containing 38.3 % w/w (experiment 2 of the specification) or the composition referred to as the “Aslam gel” and meant to represent the instant invention in the 06/21/2024 declaration, having approximately 50 % w/w sugar both provide the benefits of the instant invention in terms of wound healing and handling and therefore the claimed ratio of sugar to hydrogel biomaterial does not appear to be critical to the performance of the composition. Evidence of record also fails to establish a nexus between any allegedly unexpectedly superior performance and the difference between the claimed invention and the closest prior art. The evidence also has not clearly established that any feature of the claimed invention was unexpectedly superior to the closest prior art. The examiner also points out that now that the record has been clarified as to the quantity of sugar in the instant invention, Dentsman represents closer prior art than Serafini. The Serafini gel contains almost double the sugar of the claimed composition. Dentsman’s example 2 contains 41% sugarcane block (and modestly less sucrose) and is therefore closest to the claimed invention in terms of sugar content but contains a different gelling agent (xanthan gum) and Dentsman’s example 1 contains more sugar (73 %w/w), and the claimed gelling agent (HEC). Both of Dentsman’s compositions are described to be very effective at promoting wound healing relative to their respective hydrogel control composition, and the examiner considers the composition containing 41% w/w sugar to represent the closest prior art.
Regarding the current record and the assertion of unexpected results:
Applicant is referred to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, the record fails to establish an unexpected property over the closest prior art. The prior art teaches sugar-hydrogels improve wound healing when used to treat chronic wounds in patients having compromised wound healing such as individuals suffering from diabetes. As explained above, a beneficial effect is reasonably and unambiguously attributed to the presence of the sugar (Dentsman focuses on the contribution of sugar and Serafini clearly establishes sugar itself is effective at promoting wound healing.) The difference in handling between the “2024 Aslam gel” and the Serafini gel reported in the declaration filed 06/21/2024 can be explained entirely by the composition of the two gels (lower sugar content resulting in less sugar precipitation and better flow, and possibly higher superabsorbent polymer content in the “2024 Aslam gel” affecting flow of the composition and absorption of wound exudate) and this would have been predicted by one of ordinary skill at the time of filing. Importantly, the new evidence provided with the submission filed 12/02/2025 establishes Dentsman as the closest prior art. Although there are some minor differences between example compositions disclosed by Dentsman in terms of (a) amount of sugar, (b) identity of example gelling agents, and (c) possible presence of other factors contributing to the healing effect, no evidence of record establishes a nexus between these minor differences and any unexpected results. Indeed, in view of Dentsman and Serafini, as well as Risse who teaches wound healing properties of allantoin and sodium lactate, one having ordinary skill would have found the ability of the instant invention to promote healing of chronic wounds to have been entirely expected.
Response to Arguments Presented in Wetzel Declaration:
On page 22 of the Wetzel declaration, Declarant argues that Dentsman's described recipes consist of making a solution of sugar cane plant extract at room temperature and converting it at room temperature to the final product. While Dentsman's Description does not exclude the possibility that the compound could contain sugarcane plant extract in solid form, nowhere does it describe such a compound.
As the record makes clear that the instant invention also contains dissolved or almost entirely dissolved sugar, this position is not relevant to the current grounds of rejection. Dentsman teaches sugar-containing hydrogels having HEC are highly effective at promoting healing of chronic non-healing wounds.
On page 23, Declarant argues that the actual amount of sugar in Dentsman’s composition is unknown.
The examiner respectfully disagrees. As noted above, Dentsman discloses that the substance contained in the hydrogel, “sugarcane block” contains 75-85% sucrose. Moreover, Dentsman teaches a range in amount of sugar that renders obvious the instantly claimed invention.
With regard to the argument on page 23 that “Dentsman does not state which, if any, of these may hasten healing or inhibit bacterial growth.”
The examiner points out that the instant invention does not exclude these ingredients as the preamble is open, and that the instant invention embraces compositions containing additional wound healing materials (allantoin and sodium lactate).
On page 23 Declarant argues” Dentsman provides no data to confirm that the sugar plant extract used in Dentsman actually contained copper or, if present, that it served any useful purpose”.
In response, the examiner points out that the prior art is presumed enabling. If Dentsman describes the composition as containing copper, then this is sufficient for a prima facie case of obviousness regarding this limitation. See MPEP 2121(I).
Regarding the “useful purpose” argument, see MPEP2112.01(I): "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Copper may impart more than one benefit to the composition; however, this does not negate the fact that it possesses an antimicrobial effect.
On page 23, Declarant points out The "second compound" described in Dentsman Example II consisted of a solution of sugarcane plant extract prepared at ambient temperature, which was then converted at ambient temperature to a paste by addition of a xanthan gum/glycerol paste. It did not contain HEC.
In response, the examiner points out that Dentsman teaches two choices for required gelling agent (see abstract) and uses HEC in an example. This is sufficient to establish a prima facie case of obviousness for selecting HEC as the gelling agent, as claimed.
On page 23, Applicant points out that glycerin is used by Dentsman’s in lower amounts than claimed.
This point has been recognized by the examiner and addressed in the obviousness rejection. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 23, Declarant asserts that the healing and activity against PA in Dentsman’s example is probably due to the presence of other ingredients.
This statement is not persuasive because it is speculative. The examiner also notes that the instant claims do not exclude other substances.
On page 24, Declarant argues “The antibacterial control for P. aeruginosa was silver sulfadiazine, not mupirocin, which was only for MRSA. While Dentsman may have done some experiments with mupirocin, those are not presented in the application”
This statement is not germane to the issues underlying patentability of the instant application. Dentsman teaches that the sugar-hydrogel can provide antimicrobial benefit, which would also be beneficial for wound healing.
On page 23-26, Declarant describes various features of the instant invention that are not described by Junginger and sections of Junginger that have not been cited in the current grounds of rejection, arguing that the prior art teaches other types of wound dressing compositions.
The existence of alternatives does not negate the obviousness of the instant invention. “Simply because the prior art "discloses a multitude of effective combinations does not render any particular formulation less obvious." Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). "[P]icking and choosing may be entirely proper in the making of a 103, obviousness rejection." In re Arkley, 455 F.2d 586, 587 (CCPA 1972). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 26, regarding Risse, Declarant argues “there are more than 35 exemplary therapeutically active, skin-care or wound-healing components listed in this paragraph, some of which are open-ended classes of compounds, such as "vitamins", "retinoids", "polyhydroxy acids", "hydroxy acids", esters, flavonoids). Risse does not make clear which of these are wound-healing”.
This is not persuasive because it is prima facie obvious to combine two compositions known to serve the same purpose, regardless of how many compositions may have been known to serve that purpose. See MPEP 2144.06 and In re Kerkhoven. The probability of selecting allantoin and sodium lactate from this list is not relevant to the rationale underlying the obviousness conclusion.
Declarant’s comments regarding Kato are not relevant because Kato was merely cited as an evidentiary reference.
Response to Arguments:
On page 23, Applicant argues the Examiner has been describing the actual therapeutic effects of the claimed method as "intended outcomes". the Examiner has been denying Applicant's argument that these limitations are limiting on an incorrect basis of intended use. p 29 “The examiner mischaracterizes the therapeutic effects of the method of treatment as "functional language."” p. 30 “technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy,” On page 24 Applicant provides replication of amended claim 1, and on page 25 Argues that the preamble of the claim is limiting. On page 30 Applicant states “in relying upon a theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy”.
The examiner maintains the opinion that the intended outcome recited in the claims has been addressed in the rejection. The benefits of the sugar containing hydrogel are taught in the prior art (e.g. improved rate of healing, re-epithelialization, antibacterial effect). Additionally, the prior art contains the key ingredients for providing the claimed outcomes, sugar and a hydrogel vehicle. The examiner maintains that the intended outcomes are inherently or expressly taught in the prior art.
On page 29 Applicant states “Applicant directs the Examiner's attention to Table 2 beginning after para. [00244] of the Specification in which the pharmaceutical composition as claimed is compared to other commonly used wound care products in addressing the wound bed preparation processes listed in Table 1 following para. [0055].”
The comparison is noted; however, this does not represent a comparison to the closest prior art, as required to overcome an obviousness rejection with a persuasive showing of unexpected results.
On page 30 Applicant states “the claimed method is a medical treatment, which is, by its very nature, unpredictable. Thus, it was entirely unpredictable that the claimed method comprising administering a therapeutic amount of the claimed composition would increase average percent change in wound closure compared to a hydrogel biomaterial control not containing granulated table sugar (wherein the average percent change in wound closure is average percent change in wound area in a patient population, average percent change in wound volume in a patient population, or a combination thereof), and is at least 50% greater than the hydrogel biomaterial control; that the wound heals with contraction from wound edges, with progressive epithelialization of the wound bed, or both as claimed.”
The examiner acknowledges that medical treatments may be unpredictable, in general; however, in the instant case, the benefits in terms of healing for chronic wounds due to application of a sugar-containing hydrogel had been recognized as of the instant effective filing date, and therefore were predictable. See Dentsman.
On page 30 Applicant argues that cited art does not teach or disclose the claimed method for treating non-healing chronic wounds and on pages 30-31replicates excerpts from the instant specification describing differences between chronic wounds and “normal (acute)” wounds.
This is not persuasive because Dentsman discloses a method of treating chronic (i.e. non-healing) wounds in diabetic patients.
On page 31 Applicant argues that “Only Velazquez, which is cited as prior art only for dependent claims 19 and 20, carried out experiments in a diabetic mouse model to test methods for treating chronic dermal ulcers”.
This is inaccurate: Dentsman discloses a clinical example in which patients suffering from diabetes are treated by application to their wound of a sugar-containing hydrogel (0035-0040).
On page 31-32, Applicant argues that Dentsman’s models are acute wounds not chronic non-healing wounds, as claimed.
As noted above, Dentsman discloses a clinical study in which the sugar-hydrogel was an effective treatment for wounds in a population having compromised healing. Dentsman also discloses model wounds as described in examples II and III. This is similar to the instant specification and declarations. In the instant application one clinical study was also reported an several models in which mice are wounded by punch biopsy. The mouse models in the instant specification are relied upon for analysis compared to various control compositions and also appear to be also be models for acute wounds.
On page 34, Applicant points out “Dr. Rummana Aslam, MD, who is the inventor of the instant application, is an expert in wound healing. Her credentials are provided in the first Declaration under 37 CFR 1.132”.
Dr. Aslam’s credentials are admirable, and the Office holds all Applicants to the same standard regardless.
On page 35, Applicant describes the four already submitted Declarations by Dr. Aslam.
The previously filed declarations have been fully responded to by the examiner in the preceding Office actions.
On page 38, Applicant points out that during an interview Applicant’s representative “pointed out that in the specification as filed, Example 2 defined "the hydrogel biomaterial" and provided two mouse model experiments comparing the Aslam gel, a sugar/iodine gel and the hydrogel biomaterial control. These two experiments have been reported above and are discussed in this response below”.
This argument has been addressed below.
On pages 38-56 Applicant replicates the declaration filed on 12/02/2025 by Dr. Wetzel.
The Wetzel declaration has been addressed above.
On page 57, Applicant argues that “one of ordinary skill would not be motivated by Serafini to make a wound dressing consisting of granulated sugar, water, glycerin, HEC, allantoin and sodium lactate in the amounts specified by the present application” Applicant argues that Serafini did not teach chronic non-healing wounds, describes the Wetzel declaration as quoting the Aslam declaration as stating that “it has other undesirable properties, i.e., it has large crystals in it, is very thick and of a sticky mixed consistency”, and asserts that an adherent dressing such as Serafini’s would disrupt reepithelialization. Applicant argues further that “Wetzel Declaration para. 41 show that the Serafini Gel contains less hydroxyethyl cellulose and more sugar than the Aslam gel tested in Example 2, for a sugar/gel ratio of 2.63: 1 v/v” and that the Serafini gel does not contain glycerin, sodium lactate, and allantoin.
Applicant’s comments regarding Serafini are noted. As explained above, Serafini is no longer considered the closest prior art in view of the most recent filing and Dentsman discloses a method of healing chronic wounds by applying a sugar-containing hydrogel having a HEC gel former; however, the disclosure remains relevant to establish what one of ordinary skill would have understood as of the instant effective filing date. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., amount of HEC) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The examiner notes the difference in HEC in the gel disclosed by Serafini vs. the amount in certain gels used in examples in experiments of record. As explained above, nearly doubling the amount of superabsorbent polymer, the HEC gel former, may explain the differences between the instant invention and the Serafini gel. Although Serafini is no longer considered the closest prior art based on new evidence on the record, the examiner reminds Applicant that any assertion that this amounts to an unexpectedly superior performance must be addressed by establishing the criticality of a claimed range, responsible for imparting any allegedly unexpected property to the claimed invention. Regarding the argument that Serafini does not teach every limitation of the claimed invention, Serafini was not relied upon for the obviousness of glycerin, sodium lactate, and allantoin. Regarding the undesirable properties of the Serafini gel reported in Dr. Aslam’s 06/21/2024 declaration, the crystallization and thickness of the composition are all accounted for by the calculations in the Wetzel declaration which establish Serafini’s gel as having much higher concentrations of sugar, which would make the gel more difficult to handle and prone to precipitation of sugar. Serafini also reports improved wound healing relative to a hydrogel control. The current record is unclear as to why Applicant’s findings reported in the 06/21/2024 declaration are incongruent with Serafini’s results.
On page 57, Applicant argues “one of ordinary skill would not be motivated by the combination of Serafini and Dentsman to make a wound dressing consisting of granulated sugar, water, glycerin, HEC, allantoin and sodium lactate in the amounts specified by the present application. Dentsman does not make up for the deficiencies of Serafini.” On page 58, Applicant supports this statement with the arguments: that [“Dentsman’s] sole experimental model is a partial thickness wound pig model, which is an acute wound”; “Examiner has completely ignored Dentsman's disclosure of collagen, ascorbic acid, vitamin E acetate, polysorbate and/or adjustment of pH, which are likely responsible for the superiority of composition C to composition B in Dentsman”; “Applicant submits that by itself, collagen is capable of accounting for the effect identified in Dentsman. Dentsman makes the point that most known wound healing agents are based on a collagen matrix foundation that provides a strata for fibroblast growth and repair of the injured tissue, and Dentsman's data indicates that Dentsman achieved better results when collagen plus ascorbic acid, vitamin E acetate, polysorbate and/or pH 6 were included”; “Dentsman's therapeutic composition contains a sugar cane plant extract, but because Dentsman never characterizes the extract, a skilled artisan cannot know exactly what Dentsman's extract contains. Dentsman doesn't even indicate where the sugarcane plant extract came from”; “Fourth, when glycerol is used in Dentsman, the gelling agent is xanthan gum”.
The examiner notes that the instant claims do not exclude additional wound healing agents and the record fails to establish any unexpectedly superior performance of the claimed composition over the closest prior art. Regarding the expectations of one of ordinary skill, the combined disclosures of Dentsman and Serafini make clear that one would have expected the sugar and hydrogel components of Dentsman’s invention to be largely responsible for the disclosed improvement in wound healing, as detailed in the rejection above. The argument that “Dentsman's therapeutic composition contains a sugar cane plant extract, but because Dentsman never characterizes the extract, a skilled artisan cannot know exactly what Dentsman's extract contains. Dentsman doesn't even indicate where the sugarcane plant extract came from” has been addressed in the response to declaration above. Regarding the apparent argument that Dentsman only teaches glycerin when xanthan gum is the gelling agent, Dentsman’s broader disclosure teaches a gelling agent selected from only two possible substances, and teaches that glycerin may be present with any of them (see Dentsman’s para 0032 where the gelling agent is described generically and is present in combination with glycerin, and the abstract where the three gelling agents are listed as either xanthan gum and hydroxyethyl cellulose). One of ordinary skill, e.g. an individual with an MD degree or PhD in formulations science would have the background and intelligence to extrapolate that the gelling agent in the example composition containing glycerin could be either xanthan gum or HEC.
On page 58, Applicant describes Kato and “submits that a skilled artisan therefore would have no reason to believe that copper could be safely used in the moist environment found in the wound bed of chronic nonhealing wounds due to its likely oxidation. (Kato Col. 1, 11. 57-65). It is for this reason that Kato teaches to use copper under a layer of cobalt so that the copper is not in direct contact with the moist environment”. “Therefore, based on Kato, a skilled artisan would most likely be motivated to include Co as the most promising mineral for its antibiotic activity in combination with Serafini and Dentsman and not Cu.” On page 59, Applicant argues that the examiner arbitrarily picked out Cu from the list of metals in Kato and on page 60 Applicant argues that Kato teaches cobalt not copper, and that Dentsman does not provide motivation to add copper to the wound dressing.
This argument was addressed in the response to the Wetzel declaration above. Kato is cited as an evidentiary reference.
On page 60, Applicant quotes the Wetzel declaration as stating that "Junginger describes an enormous number of possible wound dressing compositions" and asserts this amounts to infinite possibilities. Applicant describes Junginger’s preferred compositions. Applicant argues that Junginger does not discuss sugar or using HEC and glycerol together.
This argument was addressed in the response to the Wetzel declaration above.
On pages 61-62, Applicant replicates statements from the Wetzel declaration regarding Risse.
This argument was addressed in the response to the Wetzel declaration above.
On pages 62-63, Applicant asserts that “the Examiner homed in on allantoin and sodium lactate because the instant claims and the results reported in Examples 1 and 2 of the present application call them out” and points out some other known wound care agents.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Moreover, the Examiner directs attention to Merck &Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Circ. 1989), which states with regards to its more than 1200 combinations: that the prior art “discloses a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art.” Furthermore, it is noted that Applicants do not identify any secondary consideration demonstrating criticality or anything unexpected about the combination of two known prior art pharmaceutical agents.
See also MPEP 2144.06 and In re Kerkhoven.
On page 64, Applicant argues further that “the combination of ingredients could have been gleaned only from the Applicant's disclosure, because none of the cited references discloses the other necessary ingredient(s) in combination” and on pages 64-65, Applicant lists certain features that were not taught in the various references cited in the 103 rejection.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
On page 65, Applicant asserts that “it would have been unpredictable that the component ingredients of the claimed invention would have been chemically compatible and form a stable composition”; that “[a] skilled artisan would know that the only way to determine chemical compatibility of the claimed ingredients in the ratios as claimed is to make the composition and to test it in order to assess the physical and chemical stability of the compounded composition over time” On page 65 Applicant argues that “the therapeutic superiority of the claimed composition in treating chronic wounds would have been unpredictable” and “even if a skilled artisan were to take the Serafini gel, adjust the amount of sugar and v/v ratio of sugar to gel to match Aslam, and add allantoin and sodium lactate, a skilled artisan would not have been able to predict that the resulting composition would provide the superior performance that Dr. Aslam observed”.
The predictability of the prior art in general and in the instant case has been addressed above in the response to the Wetzel declaration and the assertion of unexpected results has been addressed in the response to declaration section above.
On pages 66-68, Applicant replicates the instant specification’s experiment 2 as “show[ing] that the improved properties of the Aslam gel over the prior art cannot be solely attributable to the predictable effects of allantoin and sodium lactate on wound healing”.
The examiner has reviewed the data presented for experiment 2 of the instant specification. The experiment was not designed to test the effects of sodium lactate and allantoin on wound healing of the claimed composition, and therefore lacks requisite scientific rigor to answer this particular question. Specifically, the experiment does not compare sugar containing hydrogels according to the invention where the only difference between the two compositions is presence or absence of the two known healing agents, allantoin and sodium lactate. However, the experiment suggests that the sodium lactate and allantoin do contribute to the wound healing benefits:
The experiment is described in the specification as follows: “sugar dressing” composition formed by “compounding a 1:1 v/v granulated sugar with wound gel comprising purified water 70%, glycerol 30%, and hydroxyethylcellulose. A small amount of sodium lactate and allantoin were added.” [as in the “wound gel” does not contain sodium lactate and allantoin – this was added only to the “sugar dressing” after combining sugar with the “wound gel”.] Para 00300 states “control dressings were prepared using the wound gel alone” [emphasis added, i.e. only 305 HEC 70% water]. A comparison to a sugar iodine mixture compounded by mixing wound gel [the purified water 70%, glycerol 30%, and hydroxyethylcellulose], granulated sugar, and PVP-I at a ratio of 1:1:0.17. Thus the “control dressing” and “sugar and iodine gel” appear to lack allantoin and sodium lactate, as they are described in the specification. Paragraph 00310 indicates that the “sugar dressing” resulted in better healing relative to the “iodine sugar dressing” or the “control dressing”, both of which lacked sodium lactate and allantoin. If any conclusion can be drawn regarding the effect of sodium lactate and allantoin on the wound healing provided by the claimed hydrogel, one would conclude that these substances do contribute to the healing properties of the composition.
Conclusion
No claims are allowed.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617