DETAILED ACTION
This Office Action is responsive to the amendment filed on 7/1/2026.
The objections and rejections not addressed below are deemed withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Interpretation
Regarding claims 30-32: Claims 30 to 32 depend from claim 22 and recite limitations regarding a contact lens. Note, however, that the claimed invention is not a contact lens. Rather, the invention recited by the instant claims is a mold for a contact lens. Claims 30 to 32 have therefore been interpreted to require that the claimed mold is used for the production of a contact lens as described by the recited limitations.
Claim Rejections - 35 USC § 103
Claim(s) 22, 23, 26-28, 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Kindt-Larsen et al, US5849209, in view of Zanini et al, EP1818692.
Kindt discloses a mold used for the production of contact lenses (for claim 22), wherein said mold is made from a composition comprising polypropylene, corresponding to the claimed polyolefin (for claim 22) which is a propylene homopolymer (for claim 23), and at least 0.5 wt% of an additive (abstract). Note that Kindt specifically teaches that the additive is used as a mold release agent (Column 6, lines 54-55).
Kindt is silent regarding the use of a polyether-modified polyolefin composition.
Zanini discloses a method of making biomedical devices such as ophthalmic lenses/contact lenses (abstract, ¶0001), wherein a polyether such as polyethylene glycol, corresponding to the claimed polyether (for claim 22), is used as an additive in the plastic material used to make the mold (¶0031). As taught by Zanini, it was known that the addition of said polyether to the mold facilitates the release of the lens from said mold (¶0009).
Regarding claim 28: Zanini further teaches that polyethylene glycol methyl ether (i.e., methoxypolyethylene glycol) can be used as a mold release agent (¶0016). “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…. [T]he idea of combining them flows logically from their having been individually taught in the prior art;” see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Barring a showing of evidence demonstrating unexpected results, it therefore would have been obvious to use a combination of polyethylene glycol and polyethylene glycol methyl ether, corresponding to the claimed hydrophilic additive, as a mold release agent.
As discussed above, Kindt discloses a mold for use in the production of a contact lens, wherein said mold is made from a composition comprising a blend of polypropylene and an additive which is a mold release agent. As taught by Zanini, it was known in the art that polyethers such as polyethylene glycol could be added as a mold release agent to plastic compositions used for the production of contact lens(es).
It has been held that the selection of a known material based on its suitability for its intended use is prima facie obvious; see Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). The use of polyethers as a mold release agent was known in the art, as taught by Zanini. Barring a showing of evidence demonstrating unexpected results, it therefore would have been obvious to one of ordinary skill in the art to modify the mold of Kindt by using a polyether as the additive, with the reasonable expectation of obtaining a final contact lens mold having improved release properties. Note that said modification would result in a composition in which a polyether is used as a modified for polypropylene-i.e., the composition rendered obvious by the prior art is a polyether-modified polyolefin (for claim 22).
Regarding claims 26-27: Alternatively, note that Kindt discloses that the mold release additive may comprise a polypropylene wax (Column 9: lines 43-45).
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…. [T]he idea of combining them flows logically from their having been individually taught in the prior art;” see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As taught by Kindt and Zanini, both polypropylene wax and polyethers were known in the art to be suitable for use as mold release agents in contact lens molds. Barring a showing of evidence demonstrating unexpected results, it therefore would have been obvious to one of ordinary skill in the art to modify the teachings of Kindt by using a combination of a polypropylene wax and a polyether as the additive, with the reasonable expectation of obtaining a final mold having improved release properties. Note that said modification would result in a final mold made from a composition comprising polypropylene, corresponding to the claimed unmodified polyolefin (for claim 26), and at least 0.5 wt%, overlapping the claimed range (for claim 27), of an additive which is a blend of polyether and polypropylene wax, corresponding to the claimed polyether-modified polypropylene (for claim 26).
Regarding claims 30-32: 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. As discussed in the previous paragraphs, the prior art renders obvious a mold comprising the same components (i.e., a polyether and a polyolefin) which is used for the same purpose of manufacturing a contact lens as the claimed invention. As the mold rendered obvious by the prior art appears to be identical to the claimed mold, it is reasonably expected that it could be used for the production of a contact lens having the recited properties. The burden is therefore shifted to applicant to provide evidence demonstrating that the mold rendered obvious by the prior art could not be used for the required use.
Allowable Subject Matter
Claims 25 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The following references are relevant to the patentability of the claimed invention.
Kindt-Larsen et al, US5849209: As discussed earlier in this Action, Kindt discloses the production of a mold for a contact lens, wherein said mold is made from a composition comprising polypropylene and at least 0.5 wt% of an additive which is a mold release agent.
Zanini et al, EP1818692: As discussed earlier in this Action, Zanini teaches that it was known in the art to add a polyether such as polyethylene glycol as an additive to plastics used in the production of contact lens molds. Zanini further teaches that the addition of said polyether results in improved mold release properties.
The prior art of record renders obvious a contact lens mold prepared from a composition made by mixing a polyether with polypropylene to obtain a composition having improved mold release properties. Note that this results in a composition which is a physical blend of the polypropylene and the polyether.
Regarding claim 25: In contrast to the prior art, the claimed invention requires that the composition comprises a polyether reacted with a maleated graft polymer of a polyolefin. This limitation corresponds to the structure of a comb polymer having a polyolefin backbone to which polyether sidechains are attached through grafted maleic anhydride units. Neither Kindt nor Zanini teaches the use of a polymer having the structures recited in the instant claims in a mold for a contact lens, and no reference has been found that would motivate an ordinary artisan to modify the prior art teachings by using a polymer having the required structure.
Regarding claim 29: The claimed invention requires the use of a polyolefin which is either a graft polymer or copolymer containing anhydride or carboxylic acid functionality, and further states that the amount of hydrophilic additive is 0.25 to 1.00 molar equivalents relative to the amount of said anhydride or carboxylic acid functionality. Neither Kindt nor Zanini teaches these limitations. Furthermore, no reference has been found that provides a motivation to modify the prior art composition by both using a polyolefin with anhydride or carboxylic acid groups in combination with one of the required hydrophilic additives, and adjusting the amount of said hydrophilic additive to be in the range of 0.25 to 1.00 molar equivalent relative to the anhydride/carboxylic acid content of the polyolefin.
Response to Arguments
Applicant's arguments filed 7/1/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art does not render the claimed invention obvious, alleging that the claimed invention requires a polyolefin that has been chemically modified with a polyether whereas the prior art only teaches blending a polyether with a polyolefin.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., chemically modification of the polyolefin) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As currently written, the claimed invention only requires a polyolefin that has been modified via addition of a polyether; the claims do not recite any limitations requiring that the polyether has reacted with/become chemically bonded to the polyolefin.
In response to applicant’s argument that the term “modified” is used in chemistry to refer specifically to chemical modification, the examiner disagrees with this position. Stehling et al, published in Journal of Applied Polymer Science vol. 26 (1981), uses the phrase “rubber modified polypropylene impact blends” (Title) to refer to compositions which are made by simply blending a rubber into polypropylene (page 2695: Blending). See also Peacock, US5468808 (title; abstract; Column 6: lines 10-17), and Park et al, US2017/0198140 (title, abstract, ¶0003, 0006-0007, 0014, 0071) which use the word “modified” to describe polymer compositions wherein a base polymer is merely blended with one or more additional polymers as additives. Finally, Iwasaki et al, US2023/0174742 (title, abstract, 0001, 0012, 0045, 0059), and Amos et al, US5929146 (title, abstract, Column 1: lines 4-12, Column 6: lines 34-49) use the term “modifying agent” to refer to an additive which is blended into polyolefins to act as a nucleating agent, thereby improving (i.e., modifying) its properties.
Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time; see MPEP § 2111.01. Contrary to applicant’s arguments, the plain meaning of “modified” in the polymer arts does not require the formation of new chemical bonds. Rather, as evidenced by the references cited in the previous paragraph, it was known in the polymer art to use the term “modified” to refer to compositions wherein a polymer such as a rubber or an additive such as a nucleating agent is blended with a base resin in order to improve (i.e., modify) the properties of said base resin.
As written, the claims do not recite any limitations requiring either that the polyether is chemically bonded to the polyolefin or the formation of a comb-type or graft copolymer in which polyether side chains are covalently bonded to a polyolefin backbone as alleged by applicant. So long as the prior art teaches a composition wherein a polyether is used as an additive to modify the properties of a polyolefin, the claimed limitations are met regardless of whether the two polymers are chemically bonded to one another.
Applicant argues that the specification teaches that the “modified” requires a chemical bond. Note that the passage cited by applicant only definitively states that “[T]hese polyolefins are modified by the introduction of polyethers to produce the polyether modified polyolefin.” Contrary to applicant’s arguments, the word “introduced” does not necessitate a chemical reaction between the polyether and the polyolefin; rather, it reads on any process wherein the two polymers are brought into contact with one another regardless of whether they form a chemically bond. To the extent that the cited passage discusses grafting and/or copolymerization methods, it is noted that the specification employes the phrases “may be accomplished”, “for example”, “may be formed”, and “may be prepared”. The use of the phrases “may be” and “for example” indicate that the disclosed methods are possibilities, not requirements.
The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. To act as their own lexicographer, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366, 62 USPQ2d 1658, 1662 (Fed. Cir. 2002) (MPEP § 2111.01(IV)). Contrary to applicant’s arguments, the disclosure in the specification that the polyether-modified polyolefin may be a polymer made via a method that would chemically bond the two polymers to one another is not sufficient to act as a definition to replace the ordinary and customary meaning in the art. As the specification does not contain any clear definition, the term “modified” therefore is given its ordinary meaning which reads on simply blending the polymers together as discussed above.
In response to applicant's argument that the polyether modified polyolefin is the product of a chemical reaction and is engineered to exhibit properties such as controlled polarity (see remarks page 4:1st and 2nd paragraphs), the examiner notes that these features are not recited in the rejected claim(s). Such arguments therefore are not persuasive; see In re Van Geuns, cited earlier in this Action.
Applicant alleges that the objection to claims 25 and 29 supports the analysis that the term “modified” implicitly requires the formation of a chemical bond between the polyether and the polyolefin. Claims 25 and 29 are reproduced below.
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Claim 25 states that the composition comprises a polyether that is reacted with a maleated polyolefin; the claim therefore requires the inclusion of a compound that is the product of reacting these two polymers. Claim 29 states that the polyether modified polyolefin is a grafted or copolymerized polyolefin containing an anhydride or carboxylic acid group. Dependent claims 25 and 29 therefore explicitly recite limitations that fall outside the scope of the prior art as noted in the Allowable Subject Matter section of this Action. Contrary to applicant’s arguments, however, the fact that two dependent claims explicitly require additional limitations not taught by the art of record does not mean that the independent claim implicitly requires a chemical bond between the polyether and the polyolefin.
Regarding applicant’s arguments that Kindt teaches surface segregation of the polyether: Applicant’s arguments are all directed towards limitations that are not required by the claims as currently written. As such, they are not persuasive; see In re Van Geuns, cited earlier in this Action.
Regarding the combination with Zanini: Applicant argues that Zanini teaches the use of a polyether as an additive that is blended with a polyolefin. Applicant therefore alleges that the combination of Kindt and Zanini therefore would not render the claimed invention obvious as it only teaches a physical blend of the polymers and does not teach forming a bond between the polyolefin and the polyolefin.
These arguments are not persuasive because they are directed towards limitation(s) not required by the rejected claims (i.e., forming a bond between the polyolefin and the polyolefin).
As discussed earlier in this Action, the evidence in the record demonstrates that terms such as “modified” and “modifying agent” were used in the polymer art to refer to compositions wherein an additives are blended into a polymer to modify its properties. Furthermore, the cited references demonstrate that such modifying agents could be polymers, such as the use of “rubber modified” to refer to blends in which a rubber is mixed with a polyolefin as an impact modifier. The term “modified” therefore does not implicitly require a chemical bond between the polyether and the polyolefin as alleged by applicant. Rather, the plain meaning of the term “modified” in the phrase “polyether modified polyolefin” includes physical blends wherein a polyether is added to a polyolefin to modify its properties. Applicant’s arguments are not persuasive, as they are based on the premise that the polyether modified polyolefin has a chemical structure which is not required by the claims as currently written. The rejection is therefore maintained.
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 JEFFREY S LENIHAN whose telephone number is (571)270-5452. The examiner can normally be reached Mon.-Fri. 5:30-2:00PM.
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, Heidi Riviere Kelley can be reached at 571-270-1831. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY S LENIHAN/Primary Examiner, Art Unit 1765
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