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 .
Status of claims
Claims 1-9 as amended on 7/29/2026 are pending and under examination.
Claim Rejections - 35 USC § 112
Indefinite
Claims 1-9 as amended 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 1 as amended is rendered indefinite by the amended phrase “an effective amount of a chia seed composition and a biodegradable substance” because it is unclear whether there are two separate compositions (one is a chia seed composition and the other is a biodegradable substance) or whether there is one therapeutic composition comprising chia seed, PVA, sorbitol and glycerol.
Claims 4-7 are now indefinite because it is unclear to what compositions amounts expressed in w/v% refer since it is unclear if “a biodegradable substance” is a separate composition or not.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over Filho et al (“Plant-based mucilage with healing and anti-inflammatory actions for topical application: A review”. Food Hydrocolloids for Health. 2021, (10), 100012, pages 1-16) in view of US 4,808,353 (Nambu et al).
The cited reference by Filho teaches that plant-based mucilage from Salvia hispanica (chia seed mucilage) has wound healing properties (se abstract) and contributes to the wound healing process (see table 5 on page 5). The cited reference teaches a topical administration of chia seed mucilage in forms of film, dressing or cream (pages 11-12; page 12, col. 2, par. 3).
The cited reference by Filho is silent with regard to additional substances to be incorporated into topical therapeutic wound healing formulations with plant mucilage. The cited reference by Filho does not disclose incorporation of PVA, sorbitol and glycerol as a wound dressing material.
However, US 4,808,353 (Nambu et al) teaches application of a combination of PVA, sorbitol and glycerol in a form of a therapeutic net to cover affected burnt wounds (col. 6, lines 10-16). In particular with regard to PVA, the cited document teaches amount of 6% for providing preparation in a form of hydrogel that is hard and not too soft and not swollen in water (abstract).
Thus, both claim-recited components (chia seed mucilage and combination of PVA, sorbitol and glycerol) have been known and used in the prior art for healing wounds in subjects in need thereof. Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to combine chia seed mucilage with PVA, sorbitol and glycerol a method for wound healing with a reasonable expectation of success in healing wounds because both components were known and used for wound healing effects. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
With regard to specific amounts as recited in the claims: the cited references appear to teach higher amounts for chia seed mucilage and PVA. However, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify amounts depending on a particular application design and/or to reduce amounts of components to provide softer hydrogels. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 7/29/2026 have been fully considered but they are not all found persuasive.
The rejection of claims under 35 U.S.C. 102 (a) (1) as being anticipated by Pintapapung et al (“Effect of chia (Salvia hispanica L.) seed extract on wound healing in mice”. Veterinary Integrative Sciences. 202, 18(2), 103-107) has been withdrawn. because the cited reference does not disclose the use of PVA, sorbitol and glycerol for wound healing.
With regard to claims rejection under 35 U.S.C. 103 Applicant’s main argument is directed to a criticality of proportions of PVA to sorbitol in a biodegradable substance in a wound healing preparation with chia seed in a method of wound healing.
The argument is not found persuasive because the cited document US 4,808,353 (Nambu et al) teaches application of a combination of PVA, sorbitol and glycerol in a form of a therapeutic net to cover affected burnt wounds (col. 6, lines 10-16), wherein PVA is present in amount of 6% for providing hydrogel that is hard and not too soft and not swollen in water (abstract). Nambu clearly teaches that incorporation of additional to PVA materials including glycerol and sorbitol is intended as not to hinder gelation but to improve rigidity (col. 3, lines 32-46; col. 6, lines 10-16). Thus, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to combine PVA, sorbitol and glycerol with a reasonable expectation of success in providing a suitable biological hydrogel material as a dressing for would healing. Although the cited prior art is silent about specific proportions of PVA and additional components (sorbitol and/or glycerol) in a final hydrogel for wound healing, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify and/or to optimize amounts or components depending on a particular application design, wound dressing forms and/or wound conditions of patients in need of wound healing. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
In the instant case, the as-filed specification recites that concentrations of PVA, sorbitol and glycerol are not limited (par. 0047 and 0049 of published application US 2005/0041372). Further, Table 1 and experiments 4-6 do not shown performance of the Applicant’s composition with the same PVA amount (1% PVA as in table 1) but without sorbitol/glycerol to support argument about criticality of sorbitol to PVA proportions/ratios. All compositions lacking sorbitol have different PVA amounts then the compositions with PVA and sorbitol in table 1. Furthermore, the example 6 (par. 0072-0075) for in vivo application does not describe which dressing from table 1 was used and what are components of “DuoDerm” dressing which is compared to the Applicant’s dressing.
Thus, any combination for which critical effects and/or synergism is not clearly established would be properly rejected because non-obviousness would not have been established. The scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Vera Afremova
September 2, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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