DETAILED ACTION
The receipt is acknowledged of applicant’s declaration under 37 C.F.R. § 1.132 by the inventor Dr. Reno filed 02/13/2026.
Claims 26-31 previously presented and subject of this office 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 .
Claim Rejections - 35 USC § 112(a)
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 26-31 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. The new claims 26-31 had introduced new matter not described in the specification as originally filed.
Regarding claim 26, the claim recites the following undisclosed or described elements: “molded to fit the measurements”, “traumatized skin surface”, “with or without an open wound”, “deforms over time by reducing its thickness according to the intensity of the wound’s response to trauma”, “single layer dressing has a scope of application to the entire skin body surface, including articulated parts”, “is not recommended to be used on mucous membranes such as the oral and genital areas”.
Regarding claim 27, the claim recites “elective surgery”, applicants disclosed “surgical wound”, and not wounds due to elective surgery in particular.
Regarding claim 28, the claim recites “…does not absorb blood…”, however, applicant disclosed only “does absorb exudate”, not specifying blood. The claim further recites: “…allowing painless dressing changes and avoiding tissue damage…”, no disclosure for such limitation.
Regarding claim 29, the claim recites: …”the usual time to change the homeostatic single layer dressing is between the fourth and fifth day”, nowhere applicant disclosed this limitation of usual change time.
Regarding claim 31, the claim recites that “…dressing does not stop hemorrhage, but contains bleeding from the microcirculation”, no where applicant disclosed this limitation. To the contrary, applicant disclosed in paragraph [0028] of the published application describing Fig. 7: “FIG. 7 is a close-up view of the homeostatic single layer dressing format E and its application at the end of an eyelid surgery with better control of bleeding and discomfort.”
If applicant contends there is support for this limitation, then applicant is requested to specify the page and line of said support. In accordance to MPEP 714.02, applicant should specifically point out to where in the disclosure a support for any amendment made to the claims can be found.
To satisfy the written description requirement, the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed.Cir.2008) (quoting In re Alton, 76 F.3d 1168, 1172 (Fed.Cir.1996)). In other words, the applicant must `convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and demonstrate that by disclosure in the specification of the patent.
Written description requirement, serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed.Cir. 2005). The requirement serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. (Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed.Cir.2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed.Cir.2002)). A patentee can lawfully claim only what he has invented and described, and if he claims more his patent is void; Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed.Cir.2000). The purpose of the written description requirement] is to ensure that the scope of the right to exclude and does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods,"). Where the specification provides only constructive examples in lieu of working examples, it must still "describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention, including all of the elements and limitations." Id. (citing Hyatt v. Boone, 146 F.3d 1348, 1353 (Fed.Cir. 1998)).
The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to one skilled in the art that the inventor had the possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claimed language. See In re Kaslow, 707 F 2d 1366, 1375 (Fed. Cir. 1983). See MPEP 2163.06.
The written description requirement prevents applications from using the amendment process to update the disclosure in their disclosures (claims or specification) during the pendency before the patent office. Otherwise applicants could add new matter to their disclosures and date them back to their original filing date, thus defeating an accurate accounting of the priority of the invention. See 35 USC 132. The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genetech, 108 F 3d 1361, 1365 (Fed. Cir. at 1366, 78, 1999).
Claim Rejections - 35 USC § 112(b)
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 26-31 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 26 recites the limitation "the traumatized skin surface" in component (b) in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 is confusing as the claim recites “traumatized skin” and also recite “with or without open wound”, while the claim is directed to “.applied to the wound surface…”. These contradicted limitations do not set forth the meets and bounds of the claims
Claim 26 recites “…deforms over time by reducing its thickness…”, does the dressing deform and reduce its thickness by itself or by the attending medical staff?
Claim 26 recites “…the dressing has a scope of application to the entire skin body surface….”, this is confusing because it is not clear if the dressing is applied to the entire body surface, or to the wounded area only?
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 26 recites the broad recitation “entire body surface including articulated parts” “without open wound”, and the claim also recites “applied to wound surface” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 26, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 26 recites the uncertain limitation “not recommended”.
Claims 27-31 recites the limitation "the method of claim 26" in the preamble of each claim. There is insufficient antecedent basis for this limitation in the claims or in claim 26 from which the claims depend because the claims depend on claim 26 that is directed to a product, and does not recite any method.
Regarding claim 31, the claim is confusing as it recites the expression “contains bleeding from microcirculation”, and also recites the expression “does not stop hemorrhage”, which are two contradicting expressions.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 26-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Webster et al. (US 3,662,057, currently cited on PTO 892).
Applicant Claims
Claim 26 is directed to a homeostatic single layer dressing characterized by the fact that it is composed of a single layer of expanded polyethylene applied to the wound surface to exert homeostatic activity on it,
comprising the following characteristics,
(a) the single layer dressing has a thickness ranging from about 2 mm to about 10 mm according to the trauma extent, location and depth,
(b) the single layer dressing is molded to fit the measurements of the traumatized skin surface, with or without an open wound, and” deforms over time by reducing its thickness according to the intensity of the wound’s response to trauma,
(c) the single layer dressing has a scope of application to the entire skin body surface, including articulated parts, but it is not recommended to be used on mucous membranes such as the oral and genital areas.
Note that the limitation of “applied to the wound surface” is directed to the intended use of the dressing claimed by claim 26. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The intended use limitation is not given patentable weight in examining the claim.
Webster discloses sheet of microporous expanded polyethylene glycol, i.e. a single layer, having thickness of about 0.3 cm to 2.5 cm, i.e. 3 mm to 25 mm. The sheet can be molded to the shape of the body with which it is contacted, e.g. injured part of the body, broken limb, or arthritic joint (col.1, lines 15-20, 41, 55-60; col.4, lines 50-51Figure 2). Example 3 discloses polyethylene thickness sheet having thickness of 0.6 cm, i.e. 6 mm, piece of expanded polyethylene to apply to painful heels (col.8, lines 55-60). The sheet is used in surgical field (col.2, lines 22-45). The sheet is non-irritating, inert and nontoxic. The sheet is cut to shape, size and thickness for the part of the patient to be applied to (col.3, lines 45-59).
All the limitations of claim 26 are met by the reference. The reference exemplifies the thickness of the polyethylene sheet of 6 mm that falls within the claimed thickness. The reference disclosed application to articular joints, so it can be used without open wound as claimed by claim 26.
Regarding the limitation “applied to the wound surface” as claimed by claim 26, the reference disclosed surgical use that implies application to wounded area. Claim 26 is directed to product, and all the elements of the claimed product are disclosed by the reference, and its application to the skin is directed to the intended use of the product that impart no patentability to product claim.
Regarding the properties and the functional limitations claimed by claims 26-31, they are inherent properties of the expanded polyethylene sheet disclosed by the prior art and having the same thickness as claimed.
If the prior art meets the structure recited, the properties must be met or Applicant's claim is incomplete. This is in line with In re Spada, 15 USPQ 2d 1655 (1990) which holds that products of identical chemical composition cannot have mutually exclusive properties.
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.
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 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (US 3,662,057, currently cited on PTO 892).
Applicant Claims
Claim 26 is directed to a homeostatic single layer dressing characterized by the fact that it is composed of a single layer of expanded polyethylene applied to the wound surface to exert homeostatic activity on it,
comprising the following characteristics,
(a) the single layer dressing has a thickness ranging from about 2 mm to about 10 mm according to the trauma extent, location and depth,
(b) the single layer dressing is molded to fit the measurements of the traumatized skin surface, with or without an open wound, and” deforms over time by reducing its thickness according to the intensity of the wound’s response to trauma,
(c) the single layer dressing has a scope of application to the entire skin body surface, including articulated parts, but it is not recommended to be used on mucous membranes such as the oral and genital areas.
Note that the limitation of “applied to the wound surface” is directed to the intended use of the dressing claimed by claim 26. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Webster teaches sheet of microporous expanded polyethylene glycol, i.e. a single layer, having thickness of about 0.3 cm to 2.5 cm, i.e. 3 mm to 25 mm. the sheet can be molded to the shape of the body with which it is contacted, e.g. injured part of the body, broken limb, or arthritic joint (col.1, lines 15-20, 41, 55-60; col.4, lines 50-51Figure 2). Example 3 teaches polyethylene thickness sheet having thickness of 0.6 cm, i.e. 6 mm, piece of expanded polyethylene to apply to painful heels (col.8, lines 55-60). The sheet is used in surgical field (col.2, lines 22-45). The sheet is non-irritating, inert and nontoxic. The sheet is cut to shape, size and thickness for the part of the patient to be applied to (col.3, lines 45-59).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012) &
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
While the reference teaches single sheet of expanded polyethylene having thickness of 3-25 mm, and suggests its use for surgery, the reference however does not teach “application to wound surface”. All the elements of the claimed product are taught by the reference, and its application to the skin is directed to the intended use of the product that does not impart patentability to product claim.
The reference teaches the thickness of the polyethylene sheet of 6 mm that falls within the claimed thickness. The reference teaches application to articular joints, so it can be used without open wound as claimed by claim 26.
Regarding the limitation “applied to the wound surface” as claimed by claim 26, the reference teaches surgical use that implies application to wounded area. Claim 26 is directed to product, and all the elements of the claimed product are taught either explicitly or implicitly by the reference, and its application to the skin is directed to the intended use of the product that impart no patentability to product claim.
Regarding the properties and the functional limitations claimed by claims 26-31, they are expected properties of the expanded polyethylene sheet taught by the prior art and having the same thickness as claimed.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments and Declaration under C.F.R. § 1.132
by Dr. Reno filed 02/13/2026
Applicant's declaration including applicant’s arguments filed 02/13/2026 have been fully considered but they are not persuasive.
Applicant did not argue against the 112/a and 112/b rejections. Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Therefore, the rejections are maintained.
Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them. However, Applicant combined the argument against the rejections over Webster’s reference with the declaration filed 02/13/2026. The argument and declaration have been fully considered but they are not persuasive, as will be discussed infra.
Applicant describes the present invention in paragraphs 1-3 of the declaration, and the examiner truly admires the great job done by Dr. Reno using the claimed single layer dressing and its effect on treating wounds by homeostatic activity without using electronic devices. However, applicant’s work does not commensurate in scope with the claimed invention and the results shown by the declaration.
Regarding paragraph 4 and 5 of the declaration, applicants describes what disclosed in the specification and the advantage of present invention as described in paragraphs 14, 16, 17, and 18 of the present specification. The declaration include(s) statements which amount to an affirmation that the claimed subject matter functions as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. See MPEP § 716.
In paragraphs 5 and 8 of the declaration, applicant further argues that Webster is directed to a cast of expanded low density polyethylene to provide a light weight cast, and not for application to a wound. However, it is noted that Webster is also direct to using the cast in surgical field (col.2, lines 22-45). In any event, applicant’s attention is directed to the scope of the present invention that is directed to a composition, and all the elements of the composition are disclosed by the reference. the intended use of the composition does not impart patentability to the composition. If the prior art meets the structure recited, the properties must be met or Applicant's claim is incomplete. This is in line with In re Spada, 15 USPQ 2d 1655 (1990) which holds that products of identical chemical composition cannot have mutually exclusive properties.
In paragraph 5 of the declaration, applicant argues that Webster uses Plastazote that is filled with nitrogen. However, it is noted that the present claims do not exclude the presence of nitrogen. Note that in paragraph 9, page 5 of the declaration, applicant admits using the Plastazote to practice the present invention.
In paragraph 5 of the declaration, applicant argues that the present invention treats the wound through direct contact allowing physiological heating and applies delicate direct pressure. In response to this argument, it is argued that the mechanism of action of the expanded low density polyethylene is inseparable from it since materials and their properties are inseparable, and cannot have mutually exclusive characteristics. Note that in paragraph 9, page 5 of the declaration, applicant admits using the Plastazote to practice the present invention.
In paragraphs 6 and 7 of the declaration, applicant argues that the present dressing is applied directly to the wound to act on the microcirculation and regulate caliber of blood and lymph vessels as shown in paragraph 23 of the present specification. In response to this argument, it is argued that the dressing of Webster is made of the claimed material, and will inevitably perform the same function, absent evidence to the contrary. In addition, regarding applicant's arguments of unexpected results in the instant specification, it is the examiner's position that the data in the specification regarding effect of the expanded low density polyethylene are not unexpected results and therefore cannot rebut prima facie obviousness. The examiner directs applicant's attention to MPEP 716.02 (a). "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness...of the claims at issue." In re Corkhill, 711 F.2d 1496, 266 USPQ 1006 (Fed.Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. Furthermore, the MPEP states, "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
In paragraph 9 of the declaration, applicant provides advantages achieved by the present invention. However, applicant did not compare the prior art invention with the present invention, and did not establish any difference in the current composition over the prior art composition that applicant admits to use the same (Plastazote). The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
In paragraph 12, applicant argues that the current dressing represents a solution of a long felt need to control efficacy in the control of microcirculatory system, while Webster used the same material for orthopedic immobilization. However, there is no showing that others of ordinary skill in the art were working on the problem and if so, for how long. In addition, there is no evidence that if persons skilled in the art who were presumably working on the problem knew of the teachings of the above cited references, they would still be unable to solve the problem. See MPEP § 716.04.
The declaration refers only to the system described in the above referenced application and not to the individual claims of the application. Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Isis A Ghali/Primary Examiner, Art Unit 1611 /I.G./