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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/23/2026 has been entered.
Status of the Claims
Claims 1-10 are pending and under current examination.
All rejections not reiterated have been withdrawn.
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 (i.e., changing from AIA to pre-AIA ) 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.
back
The factual inquiries 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 1-4, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmed et al. (Journal of Pharmacy Research 3(8):1785-1787; 2010; of record) in view of in view of Teodorescu et al. (Biotechnology advances, 37(1), 109-131. 2019; of record), Munro (US 2002/0026005; publication date: 02/28/2002) and Caldwell et al. (US 8062661 B2; issue date: 11/22/2011; of record).
Ahmed published a study evaluating the effect of the ratio of PVA:PVP on drug release and moisture absorption of PVA/PVP hydrogel (i.e. hydrocolloid) transdermal patches for drug delivery through the skin, using nifedipine as the example drug (abstract). The patches were formed by combining and mixing ingredients followed by pouring on glass and drying at 45-55C in a dryer and stored in a desiccator, therefore they fall within the scope of “dry dressing”. Ahmed tested patches having a 3:2, 1:1, and 2:3 ratio of PVA to PVP and found that while patches containing PVA and PVP at a 3:2 (1.33) ratio were flexible compared to other patches, they found a positive correlation between PVP content and moisture absorption and drug release. Specifically, they found a 2:3, (0.66) ratio of PVA to PVP showed maximal water absorption and drug release (abstract, page 1786, right col). The examiner considers the nifedipine disclosed by Ahmed to fall within the scope of “nutrient” as this term is used in the instant application as it appears to embrace any molecule having any bioactivity (see e.g. page 0024).
Although Ahmed does not disclose an example patch having the claimed PVA:PVP ration, Ahmed tested patches having PVA to PVP ratios surrounding the claimed range. Moreover, PVA/PVP blends were well established for delivery of active substances to the body (Teodorescu: abstract) and the effect of blending these polymers in the art of transdermal patches was very well understood as of the instant effective filing date: Teodorescu et al. also discloses that the applicability of PVA as a wound dressing material is restricted by its limited hydrophilicity, insufficient elasticity, and rigid structure. Teodorescu et al. also discloses that PVA hydrogels also present a mild reaction in contact with body tissues. Teodorescu et al. also discloses that since PVA has regularly arranged hydroxyl groups around the chains that hydrogen bond to form crystalline regions, a good polymer to mix with PVA are those with strong proton acceptor sites, such as PVP. Teodorescu et al. further discloses that PVP is highly hydrophilic and has a strong biocompatibility. Teodorescu et al. further discloses that PVP is therefore well-suited for use with PVA and that PVP used alone gives rise to materials with poor mechanical strength, which is overcome with the addition of PVA (Sections 3 and 3.1).
Moreover, the relationship between water content of a bioadhesive and adherence to skin had been recognized as of the instant effective filing date: Munro discloses “[t]he problem of achieving the desired level of adhesion is exacerbated under wet conditions. Conventional bioadhesives generally provide poor adhesion to wet skin, such adhesion generally reducing as water is absorbed by the bioadhesive” (0015).
It would have been prima facie obvious to optimize the ratio of PVA:PVP to fall within the range of 0.725 to 0.785 for the purposes of optimizing properties such as water absorption and drug release as well as mechanical strength, compatibility with skin, homogeneity and flexibility, depending on the intended end use for the patch. One having ordinary skill would have been further motivated to optimize the water absorption capacity of the patch particularly so as not to impede adherence to skin.
Neither Ahmed nor Teodorescu discuss a “substrate layer” as claimed.
Caldwell discloses that hydrogel patches can be cast onto a backing that provides for protection of the hydrogel composition layer from the environment (col 14, lines 19-20).
It would have been prima facie obvious to cast Ahmed’s patches onto a backing layer. The skilled artisan would have been motivated to do so to provide support and protection for the patch and had reasonable expectation of success because such was routine in the art as of the instant effective filing date.
With regard to the limitation of instant claim 1 requiring the PVPA and PVP to be 96% of the hydrocolloid, as discussed above and in the following paragraphs, it would have been obvious to include active agents as well as other polymers in the hydrogel described by Ahmed. As such, the examiner does not consider the limitation on amount of PVA and PVP in the hydrocolloid instantly claimed to patentably define over the cited art.
With regard to claim 2, product by process language is recited. This language does not add any further structural limitations to the composition of claim 1. The obviousness conclusion regarding claim 2 is therefore the same as for claim 1.
With regard to claim 3 and 4, Caldwell et al. discloses the use of high molecular weight substances, such as polyvinyl alcohol and sodium polyacrylate, in hydrogels. It would have been obvious to combine these two substances because they were known to serve the same purpose (water absorbent polymer for hydrogel formation) as of the instant effective filing date. With regard to the amount required by instant claim 4, Caldwell et al. further discloses that these substances can be used in combination with others or alone and may range in concentration from 0.5 % (w/w) to 20% (w/w) (Column 12 line 41 through Column 13 line 3).
With regard to claims 1 and 7, the hydrogel resulting from incorporating Caldwell’s sodium polyacrylate would contain sodium which is both a metal and a nutrient.
With regard to claim 10, Teodorescu discloses further that patches can be used to deliver drugs or proteins (section 4.1, page 115). It would have been obvious to use as PVA/PVP patch to deliver a protein active because one having ordinary skill would have recognized this as a suitable formulation to do so (see MPEP 2144.07).
Claims 5, 6, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmed et al. (Journal of Pharmacy Research 3(8):1785-1787; 2010; of record), Teodorescu et al. (Biotechnology advances, 37(1), 109-131. 2019; of record), Munro (US 2002/0026005; publication date: 02/28/2002) and Caldwell et al. (US 8062661 B2; issue date: 11/22/2011; of record) as applied to claims 1-4, 7, and 10 above, and further in view of Karandikar (US 9757387; of record).
The relevant disclosures of Ahmed, Teodorescu, Munro, and Caldwell are set forth above. None of these references disclose including xanthan or guaran gum or carboxymethylcellulose in the hydrogel.
Karandikar discloses a hydrogel composition comprising a viscosity enhancing agent between 0.10% (w/w) and 10% (w/w) of the total composition (claim 1). Karandikar discloses natural gums, such as xanthan gum, as hydrogel additives due to their roles as viscosity enhancing agents as is carboxymethyl cellulose (claim 10).
It would have been prima facie obvious to add a viscosity adjusting agent to the hydrogel patch rendered obvious by Ahmed/Teodorescu/Munro/Caldwell above.
The artisan of ordinary skill would have been motivated to do so as an additional means to adjust the mechanical properties of the patch, and had reasonable expectation of success because Karandikar provides guidance for how to do so.
Response to Arguments
Applicant's arguments as well as the declaration, both filed 01/23/2026, have been fully considered but they are not persuasive.
Response to Declaration:
On pages 2-3, Declarant asserts that one of ordinary skill would infer certain specific quantitative values to the qualitative descriptions to the meaning of terms used in the specification (e.g. one of ordinary skill would consider “too heavy” to mean the hydrocolloid absorbs 19.5 to 22.5 g water).
The examiner does not consider these assertions to be sufficient to address the vague and qualitative nature of the data contained in the specification, and maintains the conclusion that these data cannot be relied upon to overcome the obviousness rejection with a persuasive showing of unexpected results. “Too heavy” is totally subjective and would depend upon the end use of the person of ordinary skill as well as their personal preference for the parameter being measured. Additionally, as discussed in more detail below, the relationships between PVA:PVP, water absorption, and adherence to skin were recognized result-effective variables at the time the instant invention was filed (see rejection supra), therefore the examiner does not find any unexpected result has been made of record at this point in prosecution.
On pages 4-9, Declarant reports the results of an experiment evaluating water absorption, “fall distance”, and “dripping behavior”. Declarant describes the experiment as showing that the weight ratio of PVA to PVP has a significant effect on the weight balance of the sample after water absorption, which affects resistance to fall out and dripping behavior under vertical attachment and that PVA to PVP ratios in the range of 0.725 – 0.785 exhibit agreeable weight, no dripping and stable attachment to skin, whereas the formulae having PVA to PVP ratios outside this range do not perform as well.
Insomuch as this may be an assertion of unexpected results, please refer 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, no unexpected property has been made of record. As established in the obviousness rejection above, the relationship between PVA:PVP and water absorption as well as the affect of water absorption on adherence to skin was known as of the instant effective filing date. The data of record appears to be merely optimizing known result-effective variables. As such, the rejection of the claims as obvious under 35 USC 103 is maintained.
Response to Arguments:
Applicant’s comment regarding the scope of the term nutrient on page 5 is noted. The relationship between drug release and PVP content in PVA/PVP hydrogels appears to have been recognized as of the instant effective filing date and the examiner does not consider the identity of the “nutrient” to be critical to the patentability of the claims this point in prosecution as no unexpected result has been made of record to date.
On pages 7-9, Applicant describes the experiment presented in the declaration filed 01/23/2026 and also argues that Oikonomou and Ahmed don’t recognize the property of falling out of a user’s face.
No experiments evaluate the properties of a hydrogel that is inside of a user’s face, and thus the hydrogel appears to be falling off a user’s face due to the weight of water absorbed. The examiner does not find the results presented in the declaration to be unexpectedly superior, in view of the prior art rejection above which establishes that the relationship between water absorption of a PVA/PVP hydrogel was well known as of the instant effective filing date. The examiner does not find it surprising that the pull of gravity on a hydrogel increases as the mass of the hydrogel increases with increasing water content. At some point when the hydrogel has increased in mass due to water absorption, the hydrogen bonding forces holding the hydrogel to skin would be overcome by the force of gravity and the hydrogel would fall off. It also would have been entirely expected that extent of water dripping from a hydrogel would be proportional to the amount of water in the hydrogel. The experiments appear to be optimization of known result-effective variables and to date, the burden on Applicant to overcome an obviousness rejection with a persuasive showing of unexpected results has not been met.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617