*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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 30, 2025 has been entered.
Priority
This application is a CON of 16/823,250 filed on 03/18/2020, which is a CON of
15/703,262 filed on 09/13/2017, which claims benefit in provisional application 62/394,700 filed
on 09/14/2016.
Claim Status
Claims 1, 3, 4, 6, 7, and 9-18 are pending and examined. Claims 11-18 were newly added. Claims 2, 5, and 8 were canceled. Claims 1, 4, and 6 were amended.
Claim Objections
Claims 11-18 are objected because the claims do not begin with a capital letter.
Claim Rejections 35 U.S.C. § 112
The following is a quotation of the first paragraph of 35 U.S.C. l 12(a):
(a) INGENERAL.-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, 4, 6, 7, and 9-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (preAIA ), first paragraph, because the specification, while being enabling for "synergistically
enhance adhesion of the polymerized composition to skin and/or tissue at the injury" wherein the
polymerizable compositions are those comprising specific silicone polymers and the first and
second adhesion promoters N-(triethoxvsilylpropyl)-O-polyethylene oxide urethane and
tetrapropoxysilane, does not reasonably provide enablement for synergistically enhance adhesion
of the polymerized composition to skin and/or tissue at the injury with polymerizable
composition comprising components (a) and (b) and the first and second reactive silane adhesion
promoters as claimed. The specification does not enable any person skilled in the art to which it
pertains, or with which it is most nearly connected, to make and/or use the invention
commensurate in scope with these claims.
The instant specification fails to provide information that would allow the skilled artisan
to practice the instant invention without undue experimentation. Attention is directed to In re
Wands, 8 USPQ 2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factor to
consider when assessing if a disclosure would have required undue experimentation, the court
recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence of absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
The nature of the invention: The instant invention pertains to methods of treating an
injury comprising applying a polymerizable composition comprising (a) and (b) wherein the
composition comprises a first and a second reactive silane adhesion promoters that
synergistically enhance adhesion of the polymerized composition to skin and/or tissue at the injury.
The breadth of the claims: The instant claims are deemed very broad since these claims
read on any polymerizable composition comprising components (a) and (b) with any of two so
called reactive silane adhesion promotors, wherein the polymerizable composition polymerizes
in the presence of the at least one of the blood and the tissue to form elastic seal. The claims
broadly define the reactive silane adhesion promoters by their function and defining the first and second reactive silane adhesion promoters as being formed by pairing a hydrophobic network-forming silane with a hydrophilic PEG-urethane silane that co-condenses at the interface. Newly added claims 11-14, each directly depending from claim 1, recite specific hydrophobic network-forming silane, hydrophilic PEG-urethane silane, a concentration of the specific hydrophilic PEG-urethane silane, and a concentration of the specific hydrophobic network-forming silane, respectively. Newly added claims 15-18, each directly depending from claim 6, recite the same subject matter as claims 11-14. While, each of the newly added claims recites a specific component or a specific component and its concentration, the claims are not enabled because the recitation of one specific component while the rest of the components are generic is not sufficient.
Regarding the predictability or unpredictability of the art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually
assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)
indicates that the more unpredictable an area is, the more specific enablement is necessary in
order to satisfy the statute. In the instant case, the instant claimed invention is highly
unpredictable since one skilled in the art would recognize that the recitation encompasses any
polymerizable composition comprising (a) and (b) with two "silane reactive adhesion promoter"
that synergistically enhance adhesion of the polymerized composition to skin and/or tissue at the
injury. Particularly, it is highly unpredictable for two of "reactive silane adhesion promoters"
with any chemical structures to synergistically enhance adhesion (to skin and/or tissue) of a
polymerizable composition comprising (a) and (b), as any variation of any of the components in
the composition would have been expected to affect the chemical, physical and/or biological
properties of the composition and so to affect the adhesion.
The skilled artisan would view that treating an injury by applying a polymerizable composition wherein the composition comprises a first and a second reactive silane adhesion
promoters that synergistically enhance adhesion of the polymerized composition to skin and/or
tissue at the injury is highly unpredictable.
Regarding the presence or absence of working examples: In the instant case, Table 2 provides a working example that uses a two part composition where the first part comprises a vinyl endblocked polydimethyl siloxane polymer, fumed silica, and a platinum catalyst, and the second part comprises vinyl endblocked polydimethyl siloxane polymer, fumed silica, trimethyl endblocked methyl-hydrogen siloxane polymer crosslinker, 1,3,5,7-tetramethylene-1,3,5,7-tetravinyl-cyclotetrasiloxane, and the adhesion promoters tetrapropoxysilane and N-(triethoxysilylpropyl)-O-polyethylene oxide urethane all in specific amounts, and it was shown in Table 1 that the composition of Table 2 with two adhesion promoters shows synergistic adhesion properties, whereas other tested compositions with one adhesion promoter show inferior adhesion properties. See, examples and tables.
Regarding the amount of direction or guidance provided: The application provides no guidance or direction as to the mechanism behind the synergistic effect of the two particular adhesion promoters, nor the structure-activity relationship of the adhesion promoters as to the efficacy for enhanced adhesion, particularly synergistically. Further, note that the specification provides no working examples as factual evidence, i.e., no testing results or data demonstrating that, in general, any two of the adhesion promoters would enhance the adhesion synergistically for any silicone mixture comprising components (a) and (b) on the particular substrate: skin and/or tissue at the injury. Thus, the specification fails to provide clear and convincing evidence in sufficient support of the broad methods herein.
Genentech, 108 F.3d at 1366, states that "a patent is not a hunting license. It is not a
reward for search, but compensation for its successful conclusion" and "[p]atent protection is
granted in return for an enabling disclosure of an invention, not for vague intimations of general
ideas that may or may not be workable".
Therefore, in view of the Wands factors, and In re Fisher (CCPA 1970) discussed above,
to practice the claimed invention herein, a person of skill in the art would have to engage in
undue experimentation to test the instant compounds for treating any possible diseases
encompassed by the claims herein, with no assurance of success.
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, 4, 6, 7, and 9-18 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.
Claims 1 and 6 were amended to require “the first and second reactive silane adhesion promoter are formed by pairing a hydrophobic network-forming silane with a hydrophilic PEG-urethane silane that co-condenses at the interface”. The limitation is indefinite because it is not clear how both the first and the second adhesion promoters are formed by a pairing of the two compounds. The first adhesion promoter is a separate chemical compound from the second adhesion promoter, and it does not make sense that both are formed the same combination of chemical compounds. According to the examples, the combination of adhesion promoters is tetrapropoxysilane and N-(triethoxysilylpropyl)-O-polyethylene oxide urethane, which are two distinct chemical compounds. For the purpose of examining the claims, the newly added limitation is interpreted as requiring the first and second adhesion promoters to be a hydrophobic network-forming silane and a hydrophilic PEG-urethane silane, wherein the two co-condense at the interface.
Claim 1 recites the limitation "the interface" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the interface" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claims 3, 4, 7, and 9-18 are indefinite because the claims depend from an indefinite base claim.
Response To Arguments
In the remarks dated December 30, 2025, applicant traversed the rejections in view of
amendment of the claims that requires the adhesion promoter to be a reactive silane and wherein the first and the second reactive adhesion promoter are formed by pairing a hydrophobic network-forming silane with a hydrophilic PEG-urethane silane.
Applicant's arguments were fully considered but are not found persuasive for the
following reasons.
Amendment of claims 1 and 6 wherein the adhesion promoters are further defined is not sufficient to obviate the enablement rejection because the specification does not provide any guidance on selecting a first and a second reactive silane adhesion promoter that synergistically enhance adhesion of the polymerized composition to skin and/or tissue at the injury. Paragraphs 0048-0051 were considered, and Table 1 shows one example having synergistic properties. Paragraph 0069 was also considered, however it does not provide guidance on how to select the two adhesion promoters that synergistically enhance adhesion to tissue. A hydrophobic network-forming silane is broad and encompasses the whole class of silane compounds, and it would not have been reasonable for the skilled artisan to extrapolate the synergistic results obtained for tetrapropoxysilane to every hydrophobic network-forming silane. A hydrophilic PEG-urethane silane encompasses broad range of compounds, whereas the applicant specifically tested N-(triethoxysilylpropyl)-O-polyethylene oxide urethane. The applicant did not show that the synergistic results would have occurred in every combination of claimed adhesion promoters and components (a) and (b) as claimed. Furthermore, the synergistic results were obtained from a composition having a specific concentration of each component, whereas the claims do not limit amounts of components used and the applicant did not show that any amount of the components would have produced the synergistic effect.
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617