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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 12, 2026 has been entered.
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 7, 23-24, and 27 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 claims recite the API to be a salt of chlorhexidine, a salt of alexidine, a dihydrochloride salt of chlorhexidine or alexidine, octenidine, a octenidine salt, or biguanidine agent. However, the parent claim requires that “the API…is thermally stable up to 280⁰C”. There is no discussion of a particular chlorhexidine salt, alexidine salt, octenidine compound, or biguanide agent that is thermally stable to 280⁰C. for example, chlorhexidine hydrochloride, which is a claimed chlorhexidine compound, degrades due to thermal exposure at 240⁰C (see Elisei et al. Journal of Pharmaceutical Sciences 2018 107:121-126; page 122 second column second full paragraph). The disclosure does not discuss any protocols or procedures that confer added thermal stability to the active pharmaceutical ingredients to the degree instantly claimed such that they qualify for inclusion. Thus the identity of compounds and any associated stabilizing treatments that permit them to fulfill the thermal stability requirement is not known. Therefore the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as instantly claimed at the time of filing.
This is a new matter rejection.
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 7, 23-24, and 27 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.
Due to the lack of adequate written description, the scope of compounds embraced by the rejected claims is unclear because their identities or required structure are not known.
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 6 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. The claim recites that “the API…”is thermally stable at a temperature range of 200⁰C to 280⁰C”, but the parent claim already requires the API to be “thermally stable at a temperature up to 280⁰C” which includes the entire range of claim 6. 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
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6, 8, 20, 28, 31-33, 35, and 37 are rejected under 35 U.S.C. 103 as obvious over Loxley et al. (previously cited) in view of Vachon et al. (US PGPub No. 2017/0304815), Tecophilic™ HP Series TP Specification Sheet (previously cited; henceforth the Tecophilic™ reference), Jones et al., and Greatorex et al. (previously cited).
Loxley et al. teach a medical device made from a pelletized composite (see paragraphs 96-99). A dry blended thermoplastic hydrophilic polyurethane and an active pharmaceutical ingredient (API) are fed into a twin screw extruder, extruded into a compounded (bulk distributed) mixture at 200⁰C, cooled via air knives, and pelletized (see paragraphs 96-99; instant claim 1). Air cooling and pelletization implicitly requires extrusion from an outlet of the extruder (see instant claims 20 and 37). The preferred material is a hydrophilic aliphatic polyurethane with a water uptake that ranges from 5 to 40%, or more preferably from 10 to 25% (see paragraph 34; instant claims 1, 33, and 37). Commercial sources of the hydrophilic polyurethane are detailed under the Tecophilic™ name (see paragraph 33). The API loading level in the polyurethane ranges from 0.2 to 1 wt% (see paragraph 74-75; instant claims 32). Active agents are envisioned to include antibacterial agents (see paragraph 68). A conveyor belt is not detailed nor are particular antibacterial compounds.
Vachon et al. teach biologically active compounds that are modified via complexation with an ion exchange polymer that provides polymer salt forms conferred with added thermal stability (see abstract). They further incorporate the compounds into polymers that are formed into composite materials (see abstract). Specifically, they teach compounds such as silver ions, chlorhexidine salt, benzalkonium salt chloride, and octenidine salt (see paragraphs 65-66). They go on to detail vaginal devices as envisioned medical devices in which the compounds are incorporated (see paragraph 105). Vachon et al. also teach extrusion as a technique to form the taught composite into final form (see paragraph 111 and examples 79-81). They also teach polyurethanes as envisioned polymers into which to incorporate the active compounds (see paragraphs 25-26). Vachon et al. further teach an example comparing benzalkonium chloride with a benzalkonium complexed with polystyrene sulfonate salt and see that the complexed compound has a thermal stability to 300 ⁰C while the unmodified compound is stable to 200 ⁰C (see paragraphs 51 and 316). They note the added thermal stability facilitates thermal processing of the compound (see paragraph 316).
The Tecophilic™ reference teaches details of the polymers and note that they are medical grade aliphatic and hydrophilic polyurethanes (see page 1; instant claim 1). It details that all thermoplastic polyurethane products are adversely affected by water moisture and recommend drying as well as dehumidification prior to heat processing (see page 2). The polymers have various degrees of water uptake where the HP-60D-20 and the HP-60D-35 versions have water uptake levels of 20% and 35% (see page 1 table; instant claims 1 and 33). The reference warns against exceeding the melting temperature of 260⁰C (see page 2 first paragraph). They additionally teach temperatures for extrusion of the polymer and detail a range of 177⁰C to 193⁰C for various parts of the extruder (see page 2 table; instant claim 1).
Jones et al. teach producing a biologically active agent compounded polymer with an extruder, where the product is cooled by passing through an air ring and by being pulled along a cooling track (see abstract and page 3047 second column first paragraph).
Greatorex et al. teach providing a heated or cooled belt/track for controlling the temperature of a thermoplastic material to facilitate desired processing (see column 1 lines 9-24). Here, the inside of a conveyor belt is contacted with a heated or cooled platen to produce a heated or cooled belt upper surface for the conveyed material (see column 6 line 66-column 7 line 11). The belt transfers heat (thermally conductive) between the platen and the conveyed material (see column 3 lines 50-59; instant claim 28). They teach chilling the cooled platens with water (see column 5 lines 44-58; instant claim 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a variety of the Tecophilic™ polymer taught by the Tecophilic™ reference as the hydrophilic polyurethane of Loxley et al. because it is the brand they envisioned and it is a known, extrudable medical grade polyurethane. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific hydrophilic polyurethane vs. generic hydrophilic polyurethane). Selection of either the HP-60D-20 or the HP-60D-35 versions of Tecophilic™ would follow since they meet the preferred water uptake of Loxley et al. This polymer when mixed with an API and fed as a stream into an extruder, as detailed by Loxley et al., provides a stream of thermoplastic polymer, a stream of hydrophilic polymer and a stream of API because the polymer stream qualifies as both the hydrophilic polymer stream and the thermoplastic polymer stream (see instant claim 37). It would then also follow to employ the guidance of the Tecophilic™ reference and exclude water from the cooling process and processing so as to avoid the deleterious effects of the water on the polymer (see instant claims 1 and 37). Choosing an antibacterial compound to incorporate would have been obvious because Loxley et al. suggest to do so. Further, the selection of an antibacterial agent as taught by Vachon et al. that is complexed with an ion exchange polymer, namely benzalkonium complexed with polystyrene sulfonate salt, would have been obvious due to its ability to be stable through extrusion temperatures and as the application of the same technique to a similar product in order to yield the same improvement. The loading level of Loxley et al. for the API overlaps with the instantly claimed range, thereby rendering the claimed range obvious (see instant claim 32). “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). Incorporating a cooling track/belt as detailed by Jones et al. along with the cooling air already present as part of the technique to cool the extrudate of Loxley et al. would have been obvious to because they teach use of air with a cooled surface and the combination also facilitates the cooling process without added water for cooling a biologically active agent compounded polymer (see instant claims 1 and 37). Greatorex et al. then detail water as a particular source of cooling for such a cooling track/belt that would have been obvious to include because it was a known means of cooling a thermoplastic material. These modifications would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Claims 1 and 37 recite “wherein the pellets retain 85-100% of the API". A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed. Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.") (see MPEP 2111.04). The wherein clause of instant claim 1 characterizes the results of the recited steps. Therefore, we determine that the "wherein" clause is not entitled to weight in construing the claim. Therefore claims 1, 6, 8, 20, 28, 31-33, 35, and 37 are obvious over Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al.
Claims 1, 6, 8, 20, 28-30, 32-33, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. as applied to claims 1, 6, 8, 20, 28, 30, 32-33, 35, and 37 above, and further in view of Waan (US PGPub No. 2011/0196125).
Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. render obvious the limitations of instant claims 1 and 32, where a chilled platen cools the conveyor belt that receives the extruded compounded mixture. Stainless steel is not explicitly detailed for the belt composition material.
Waan teaches cooling polymer pastilles (pellets) on a stainless steel belt that is cooled from beneath via chilled water (see paragraph 128).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a known conveyor belt material that is able to be cooled from below with water based upon Waan for the method of Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. This choice would have been obvious because this was a known compositional material in the same type of belt. The modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 6, 8, 20, 28-30, 32-33, 35, and 37 are obvious over Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al., and Waan et al.
Claims 1, 6, 8, 20, 28, 30-33, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. as applied to claims 1, 6, 8, 20, 28, 31-33, 35, and 37 above, and further in view of Beven et al. (previously cited) and Rosenbluth et al. (previously cited).
Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. render obvious the extrusion compounding process of instant claims 1, 6, 8, 20, 28, 31-33, 35, and 37, where the extruded product is cooled on a platen cooled belt surface. A piezoelectric chiller is not detailed.
Beven et al. teach cooling an extruded product that contains a water soluble material (see column lines 52-57). They detail a conveyor belt with air knives (see column 2 lines 39-53). In addition, other cooling techniques are detailed that include several techniques such as a cooled surface, where the surface is cooled by water or Peltier (see column 3 lies 32-36). Rosenbluth et al. describes Peltier coolers as piezoelectric coolers (see paragraph 158).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a piezoelectric Peltier tile and water as the cooling mechanism for the belt cooling platen of Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. This modification would have been obvious in light of Beven et al. and Rosenbluth et al. who teach such coolers and teach them as known for cooling belt surfaces in order to cool an extruded product. The modification is also obvious as the simple substitution of known element for another in order to yield a predictable outcome. (e.g., specific cooling plate/platen vs. generic cooling plate/platen). Therefore claims 1, 6, 8, 20, 28, 30-33, 35, and 37 are obvious over Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., Greatorex et al., Beven et al. and Rosenbluth et al.
Claims 1, 6, 8, 20, 28, 31-35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. as applied to claims 1, 6, 8, 20, 28, 31-33, 35, and 37 above, and further in view of Rodriguez-Gonzalez et al. (previously cited) and Choi et al. (previously cited).
Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. render obvious the extrusion compounding process of instant claims 1, 6, 8, 20, 28, 31-33, 35, and 37. An ionizer is not discussed as a part of the process line.
Rodriguez-Gonzalez et al. teach of the loss of material during extrusion processing of polymers that occurs due to the build-up of electrostatic charge on the polymer and results in the polymer sticking to equipment (see abstract and page 386).
Choi et al. teach an in-line ionizer for placement around a metal feed pipe to reduce the build-up of static charge on powdered/granular polymer material (see abstract, page 255, page 260 first column last partial paragraph-second column first partial paragraph, figures 3 and 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ionizer of Choi et al. into the extruder of Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., and Greatorex et al. This modification would have been obvious in light of Rodriguez-Gonzalez et al. as the application of the same technique to a similar product in order to yield the same improvement (e.g., material loss reduction due to reduced electrostatic charge during extrusion). Therefore claims 1, 6, 8, 20, 28, 31-35, and 37 are obvious over Loxley et al. in view of Vachon et al., the Tecophilic™ reference, Jones et al., Greatorex et al., Rodriguez-Gonzalez et al., and Choi et al.
Claims 1, 6, 8, 20-22, 28, 31-33, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Vachon et al. in view of Santerre et al. (previously cited), Szycher (previously cited), the Tecophilic™ reference, Jones et al., and Greatorex et al.
Vachon et al. teach biologically active compounds that are modified via complexation with an ion exchange polymer that provides polymer salt forms conferred with added thermal stability (see abstract). They further incorporate the compounds into polymers that are formed into composite materials such as catheters/tubing (see abstract and paragraphs 12 and 35). Specifically, they teach compounds such as silver ions, chlorhexidine salt, benzalkonium salt chloride, and octenidine salt (see paragraphs 65-66). Loading levels of 10 to 25 wt% are envisioned (see paragraph 60; instant claim 32). Vachon et al. also teach extrusion as a technique to form the taught composite into final form (see paragraph 111 and examples 79-81). They also teach polyurethanes as envisioned polymers into which to incorporate the active compounds (see paragraphs 25-26). Vachon et al. further teach an example comparing benzalkonium chloride with a benzalkonium complexed with polystyrene sulfonate salt and see that the complexed compound has a thermal stability to 300 ⁰C while the unmodified compound is stable to 200 ⁰C (see paragraphs 51 and 316). They note the added thermal stability facilitates thermal processing of the compound (see paragraph 316). A polyurethane with the instantly claimed properties is not detailed.
Santerre et al. teach aliphatic thermoplastic polyurethanes employed to produce catheters (see abstract; instant claim 25). They name polyurethanes sold under the Tecophilic™ name as envisioned options (see paragraphs 29-32). Santerre et al. additionally teach extrusion to produce the catheters (see paragraph 27).
The Tecophilic™ reference teaches details of the polymers and note that they are medical grade aliphatic and hydrophilic polyurethanes (see page 1; instant claim 1). It details that all thermoplastic polyurethane products are adversely affected by water moisture and recommend drying as well as dehumidification prior to heat processing (see page 2). The polymers have various degrees of water uptake where the HP-60D-20 and the HP-60D-35 versions have water uptake levels of 20% and 35% (see page 1 table; instant claims 1 and 33). They additionally teach temperatures for extrusion of the polymer and detail a range of 177⁰C to 193⁰C for various parts of the extruder (see page 2 table; instant claim 1). The reference warns against exceeding the melting temperature of 260⁰C (see page 2 first paragraph).
Szycher teaches the production of an antimicrobial tubing/catheter composed of polyurethane (see abstract and paragraphs 31-32 and 34; instant claims 20-22). The catheter is made via twin screw extrusion, where the polymer is added in a first feed and then melts as it traverses to the second feed, where the silver components are added (see paragraph 28; instant claim 1). The material is further mixed in the extruder, output from the die head, cooled via blown cooling air and pelletized (chopped) for later formation into a catheter (see paragraph 28 and figure 1; instant claim 1).
Jones et al. teach producing a biologically active agent compounded polymer with an extruder, where the product is cooled by passing through an air ring and by being pulled along a cooling track (see abstract and page 3047 second column first paragraph).
Greatorex et al. teach providing a heated or cooled belt/track for controlling the temperature of a thermoplastic material to facilitate desired processing (see column 1 lines 9-24). Here, the inside of a conveyor belt is contacted with a heated or cooled platen to produce a heated or cooled belt upper surface for the conveyed material (see column 6 line 66-column 7 line 11). The belt transfers heat (thermally conductive) between the platen and the conveyed material (see column 3 lines 50-59; instant claim 28). They teach chilling the cooled platens with water (see column 5 lines 44-58; instant claim 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a variety of the Tecophilic™ polymer taught by the Tecophilic™ reference as the polyurethane of Vachon et al. because it is envisioned by Santerre et al. to produce catheters from polyurethane and this polymer is generically envisioned by Vachon et al. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific hydrophilic polyurethane vs. generic hydrophilic polyurethane). Selection of either the HP-60D-20 or the HP-60D-35 versions of Tecophilic™ would follow as one of a finite number of options from which to choose. Applying the extrusion configuration of Szycher et al. with two feed ports and the extrusion temperature taught by the Tecophilic™ reference would have been obvious as a known technique for producing catheters via extrusion. This provides a stream of thermoplastic polymer, a stream of hydrophilic polymer, and a stream of API, where the polyurethane qualifies as both the thermoplastic polymer stream and hydrophilic polymer stream (see instant claim 37). The extrusion temperature overlaps with that instantly required, thereby rendering the claimed range obvious (see MPEP 2144.05). It would then also follow to employ the guidance of the Tecophilic™ reference and exclude water from the cooling process and processing so as to avoid the deleterious effects of the water on the polymer (see instant claims 1 and 37). Further, the selection of an antibacterial agent and loading level as taught by Vachon et al. that is complexed with an ion exchange polymer, namely benzalkonium complexed with polystyrene sulfonate salt would follow due to its ability to be stable through extrusion temperatures. The range for the API loading would then overlap with that instantly claimed, thereby rendering the instantly claimed range obvious (see MPEP 2144.05). Incorporating a cooling track/belt as detailed by Jones et al. along with the cooling air already present as part of the technique to cool the extrudate would have been obvious because Jones teaches their combined utility and it also facilitates the cooling process without added water for cooling a biologically active agent compounded polymer (see instant claims 1 and 37). Greatorex et al. then detail a particular source of cooling for such a cooling track/belt that would have been obvious to include because it was a known means of cooling a thermoplastic material. These modifications would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Claims 1 and 37 recite “wherein the pellets retain 85-100% of the API". A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed. Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.") (see MPEP 2111.04). The wherein clause of instant claim 1 characterizes the results of the recited steps. Therefore, we determine that the "wherein" clause is not entitled to weight in construing the claim. Therefore claims 1, 6, 8, 20-22, 28, 31-33, and 36-37 are obvious over Vachon et al. in view of Santerre et al. (previously cited), Szycher, the Tecophilic™ reference, Jones et al., and Greatorex et al.
Response to Arguments
Applicant's arguments filed February 12, 2026 have been fully considered. In light of the amendment to the claims, the rejections under 35 USC 112 and those under 35 USC 103 reliant upon Falken et al., Szycher, and Solomon et al. as the primary reference are hereby withdrawn. In light of the amendment to the claims, new grounds of rejection are detailed to address the new claim limitations.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
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