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 .
Claims 1-23 are pending as amended on February 16, 2026. Support for amended claim 1 is found in original claim 10 and specification [0013].
The new grounds of rejection set forth below were necessitated by the amendment incorporating claim 10 and limiting the flexural strength of the polymer composition. Therefore, this action is properly made final.
Any objections and/or rejections made in the previous Office action and not repeated below are hereby withdrawn. The text of those sections of Title 35, U.S. Code not included in the action can be found in a prior Office action.
Response to Arguments
Applicant’s arguments filed February 16, 2026 have been fully considered.
Applicant argues (page 7, paragraph 1) that one would not have been motivated to select a polymer containing repeating units derived from 6-hydroxy-2-naphthoic acid (HNA) in an amount of from about 10 mol.% to about 25 mol.% based on the disclosure of Kim (US 8,932,483 B2) because Kim also teaches polymers with lower amounts of naphthenic repeating units. This argument is not persuasive because Kim teaches repeating units derived from HNA in an amount of up to 15 mol.% (Kim, col. 7, lines 41-46 and col. 8, lines 10-12) and selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I. Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See MPEP § 2123 II.
Applicant further argues (page 7, paragraph 1) that even if one did choose a polymer on the higher end of the naphthenic content ranges taught by Kim, the composition would fail to meet the flexural strength requirement of about 150 to about 300 MPa because Kim’s Sample 4 and 5 have 12.5 mol.% repeating units derived from HNA and exhibit flexural strengths of 133 MPa. While Kim does not exemplify a polymer having both the claimed amount of HNA and the claimed flexural strength, this does not negate a finding of obviousness under 35 USC 103 since a preferred embodiment such as an example is not controlling. Rather, all disclosures “including unpreferred embodiments” must be considered. In re Lamberti 192 USPQ 278, 280 (CCPA 1976) citing In re Mills 176 USPQ 196 (CCPA 1972). In this case, Kim teaches HNA in an amount of up to 15 mol.% (Kim, col. 7, lines 41-46) and a flexural strength of 100 to about 350 MPa (Kim, col. 5, lines 63-66). Both of these ranges overlap with the claimed ranges and selection of overlapping portions of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I. Therefore, it would have been obvious to one of ordinary skill in the art to utilize a HNA content and flexural strength in the claimed ranges given that Kim teaches each one. In addition, the examples to which Applicant points differ from the polymer relied upon in the rejection below because Samples 4 and 5 are derived from HNA, 4-hydroxbenzoic acid, 4,4’-biphenol, terephthalic acid, and N-acetyl-p-aminophenol (Kim, col. 22, line 62), but the rejection does not rely on a polymer derived from 4,4’-biphenol and/or N-acetyl-p-aminophenol.
Applicant argues (page 7, paragraph 2) that the flow additive of Kim results in compositions having lower flexural strength whereas the instant application shows a good combination of flow properties and mechanical properties without needing flow modifiers. It is noted that the feature upon which applicant relies (i.e., no flow modifier) is 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). In this case, Kim teaches the claimed flexural strength and flow properties (viscosity) even though the composition of Kim comprises a flow additive. A melt viscosity of from about 0.5 to 50 Pa-s (Kim, col. 24, lines 58-63) falls within the claimed range of about 50 Pa-s or less. A flexural strength of 100 to about 350 MPa overlaps with the claimed range of about 150 to about 350 MPa. Selection of overlapping portions of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Claim Rejections - 35 USC § 103
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Santini (US 2008/0015494 A1, 5th U.S. patent application publication cited on 2/10/2023 IDS) in view of Kim (US 8,932,483 B2).
Regarding claims 1, 5-11, 16, 18, and 20, Santini teaches a medical device for administering a drug compound to a user (Santini, [0002]), wherein the medical device comprises a drug reservoir that includes the drug compound, a pump that is in fluid communication with the drug reservoir, and a housing that encloses the drug reservoir and the pump (Santini, [0012]). Santini further teaches wherein the device further comprises an injection assembly that is configured to receive the drug compound from the pump and deliver the drug compound to the user (Santini, [0016]) (claim 20) and wherein the drug compound includes insulin (Santini, [0101]) (claim 16).
Santini teaches that the substrate can be the structural body in which the reservoirs are formed (Santini, [0079]) and that the body portion of the device comprises a polymer and suggests the use of liquid crystal polymers (Santini, [0082]). Santini therefore teaches that the medical device comprises a polymer composition containing a polymer matrix that includes a liquid crystalline polymer, but is silent as to the specific liquid crystal polymer.
However, Kim teaches liquid crystalline polymer compositions (Kim, col. 2, lines 6-8) that have a combination of high flowability and good mechanical properties and are well suited for parts having a small dimensional tolerance (Kim, col. 16, lines 61-65). The liquid crystal polymer comprised in Kim’s composition contains repeating units derived from 4-hydroxybenzoic acid, terephthalic acid and/or isophthalic acid, and 6-hydroxy-2-napthoic acid (Kim, col. 7, line 55- col. 8, line 13). Kim teaches repeating units derived from 4-hydroxybenzoic acid in an amount of 45-90 mol.% (Kim, col. 7, lines 59-64), repeating units derived from terephthalic acid or isophthalic acid in an amount of 1 mol.% to about 30 mol. % (Kim, col. 7, lines 63-66), and repeating units derived from 6-hydroxy-2-napthoic acid in an amount of up to 15 mol.% (Kim, col. 7, lines 41-46 and col. 8, lines 10-12). A total amount of repeating units derived from naphthenic hydroxycarboxylic and/or dicarboxylic acids is about 15 mol.% or less (Kim, col. 2, lines 8-11). Kim’s composition has a melt viscosity from about 0.5 to 50 Pa-s as determined in accordance with ISO Test No. 11443 at a shear rate of 1,000 seconds-1 and a temperature that is 15°C above the melting temperature (Kim, col. 24, lines 58-63). Kim’s composition also has a flexural strength of about 100 to about 350 MPa (Kim, col. 5, lines 63-66).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have substituted the liquid crystal polymer of Santini with the liquid crystal polymer composition of Kim in order to utilize a liquid crystal polymer composition that is well suited for parts having a small dimensional tolerance and has good mechanical properties. This substitution results in a medical device where the body and drug reservoir comprise the polymer composition of Kim (claim 18). A liquid crystalline polymer derived from 4-hydroxybenzoic acid, 6-hydroxy-2-napthoic acid, and either terephthalic acid or isophthalic acid reads on claims 5-8 because these monomers are all aromatic and terephthalic acid and isophthalic acid are dicarboxylic acids. Kim’s teaching of a total amount of repeating units derived from naphthenic hydroxycarboxylic and/or dicarboxylic acids in an amount of about 15 mol.% or less falls within the claimed range of 25 mol.% or less (claim 1).
A melt viscosity of from about 0.5 to 50 Pa-s falls within the claimed range of about 50 Pa-s or less. While Kim determines the melt viscosity at 15°C above the melting temperature rather than the instantly claimed condition of 30°C above melting temperature, one of ordinary skill would expect the viscosity to decrease with increasing temperature and would therefore expect the melt viscosity measured by Kim to also be within the claimed range when measured under the claimed conditions.
Kim’s polymer does not anticipate repeating units derived from 6-hydroxy-2-naphthoic acid in an amount of about 10 mol.% to about 25 mol.%. However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to have selected up to 15 mol.% of repeat units derived from 6-hydroxy-2-napthoic acid because Kim teaches this range (Kim, col. 7, lines 41-46). A range of up to 15 mol.% overlaps with the claimed ranges of about 10 mol.% to about 25 mol.% (claim 1) and about 12 mol.% to about 24 mol. % (claims 9-10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Kim’s polymer does not anticipate repeating units derived from 4-hydroxybenzoic acid in an amount of about 75 mol.% to about 90 mol.%. However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to have selected 45-90 mol.% of repeat units derived from 4-hydroxybenzoic acid because Kim teaches this range (Kim, col. 7, lines 59-64). A range of 45-90 mol.% overlaps with the claimed range of about 75 mol.% to about 90 mol.% (claim 11). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Kim’s polymer does not anticipate a flexural strength from about 150 to about 350 MPa. However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to have selected any flexural strength in the range of about 100 to about 350 MPa because Kim teaches this range (Kim, col. 5, lines 63-66). A range of about 100 to about 350 MPa overlaps with the claimed range of about 150 to about 350 MPa. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Regarding claim 2, modified Santini teaches the medical device of claim 1 where the liquid crystal polymer of Santini was substituted for the liquid crystalline polymer composition of Kim. Kim further exemplifies a deflection temperature under load of 210-249°C as determined in accordance with ISO Test No. 75-2 at a load of 1.8 MPa (Kim, see examples in Tables 1-4 and col. 20, lines 65-67). Kim’s polymer does not anticipate a deflection temperature under load of 230-300°C.
However, it would have been obvious to one of ordinary skill in the art to have selected a deflection temperature under load of 210-249°C as determined in accordance with ISO Test No. 75-2 at a load of 1.8 MPa because Kim exemplifies this range. A range of 210-249 °C overlaps with the claimed range of from about 230°C to about 300°C. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Regarding claims 3-4, modified Santini teaches the medical device of claim 1 where the liquid crystal polymer of Santini was substituted for the liquid crystalline polymer composition of Kim. Kim further teaches a tensile modulus of 8,000-20,000 MPa (claim 4) and a tensile elongation of about 0.8-3.5% as determined in accordance with ISO Test No. 527 at a temperature of about 23°C (Kim, col. 5, lines 55-63 where tensile break strain reads on tensile elongation).
Kim’s polymer does not anticipate a tensile elongation of 0.5% to about 2.5%.
However, it would have been obvious to one of ordinary skill to have selected a tensile elongation in the range of 0.8-3.5% because Kim teaches this range. A tensile elongation of 0.8-3.5% overlaps with the claimed range of from about 0.5% to about 2.5% (claim 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I.
Regarding claims 12-15, modified Santini teaches the medical device of claim 1 where the liquid crystal polymer of Santini was substituted for the liquid crystalline polymer composition of Kim. Kim further teaches that the composition includes 1.8-3 wt% of an aromatic carboxylic acid to achieve the desired melt viscosity (col. 11, line 64-col. 12, line 6) and 5-16 wt.% of fiber (claim 15) to help achieve the desired mechanical properties (Kim, col. 13, lines 40-43 and 55-57). Kim therefore teaches wherein the polymer matrix constitutes about 81-93 wt.% (100-3-16=81 and 100-1.8-5= 93.2) of the polymer composition (claim 12). The fibrous fillers of Kim include glass fibers (claims 13-14) (Kim, col. 13, lines 3-5).
Regarding claim 17, modified Santini teaches the medical device of claim 1. Santini teaches that the housing may be formed from a polymer (Santini, [0159]), but Santini is silent as to the specific polymer.
However, as discussed above for claim 1, Kim teaches the polymer composition described in claim 1 and teaches that the composition has a combination of high flowability and good mechanical properties and is well suited for parts having a small dimensional tolerance (Kim, col. 16, lines 61-65). Kim further teaches using the composition for housing (Kim, col. 17, lines 64-67).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have substituted the unspecified polymer of Santini with the composition of Kim in order to obtain a housing with good mechanical properties from a composition that is well suited for parts with small dimension tolerance and housing.
Regarding claim 19, modified Santini teaches the medical device of claim 1. Santini teaches that the pump may be essentially any pumping apparatus, including syringe pumps (Santini, [0148]), but is silent as to the material used to make the pump.
However, as discussed above for claim 1, Kim teaches the polymer composition described in claim 1 and teaches that the composition has a combination of high flowability and good mechanical properties and is well suited for parts having a small dimensional tolerance (Kim, col. 16, lines 61-65).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have substituted the unspecified material of Santini with the composition of Kim when making a syringe pump in order to obtain a pump with good mechanical properties and small dimensional tolerance.
Regarding claim 21, modified Santini teaches the medical device of claim 1 and further teaches an injection assembly comprising a needle (Santini, [0016] and [0164]). Santini teaches that the needle has a length of 50-2000 µm, a width of 20-500 µm (Santini, [0166]), and can be constructed of polymers (Santini, [0167]). Santini is silent as to the specific polymer that is used to make the needle.
However, as discussed above for claim 1, Kim teaches the polymer composition described in claim 1 and teaches that the composition has a combination of high flowability and good mechanical properties and is well suited for parts having a small dimensional tolerance (Kim, col. 16, lines 61-65). Kim teaches that the composition is appropriate for compositions with micro-seized dimensions such as from about 50-450 µm (Kim, col. 17, line 1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have substituted the unspecified polymer of Santini with the composition of Kim when forming the needle in order to obtain a needle with good mechanical properties from a composition that is well suited for parts with small dimensions.
Claim 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Santini (US 2008/0015494 A1) in view of Kim (US 8,932,483 B2) as applied to claim 20 above, and further in view of Aeschlimann (US 2015/0148757 A1, second U.S. patent application publication cited on page 4 of 2/10/2023 IDS).
Modified Santini teaches the medical device of claim 20. As a means of delivering the drug to the patient, Santini teaches options such as a hypodermic needle, a microneedle, a catheter in fluid communication with a subcutaneous needle, and/or one or more other components for transdermally delivering the combined carrier fluid/drug into/through a patient’s skin (Santini, [0164] and [0059]). Santini teaches that the needle has a length of 50-2000 µm, a width of 20-500 µm (Santini, [0166]), and can be constructed of polymers (Santini, [0167]). Santini does not teach a cannula that is sheathed by a sleeve.
However, Aeschlimann teaches a cannula comprising a core needle and a sleeve (Aeschlimann, abstract). The sleeve forms a composite needle having one or multiple conduits for fluid transfer the length of the cannula (Aeschlimann, abstract). Both the core needle and the sleeve of Aeschlimann comprise polymeric materials (Aeschlimann, abstract). Aeschlimann teaches that the combination of a core needle within a sleeve provides a composite needle with adequate strength to be able to manufacture composite needles having relatively small gauges, such as about 0.2 mm outside diameter or larger (Aeschlimann, [0026]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have combined the polymeric needle of Santini with the sleeve of Aeschlimann in order to provide a composite needle with adequate strength and one or more conduits for fluid transfer. A cannula comprising a core needle and a sleeve reads on wherein the injection assembly includes a cannula that is sheathed by a sleeve (claim 22).
As discussed above for claim 1, Kim teaches the polymer composition described in claim 1 and teaches that the composition has a combination of high flowability and good mechanical properties and is well suited for parts having a small dimensional tolerance (Kim, col. 16, lines 61-65). In particular, Kim teaches that the composition is appropriate for compositions with micro-seized dimensions such as from about 50-450 µm (Kim, col. 17, line 1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have substituted the unspecified polymer of Santini with the composition of Kim when forming the needle in order to obtain a needle with good mechanical properties from a composition that is well suited for parts with small dimensions. A cannula wherein the needle portion comprises the composition of Kim reads on wherein the cannula includes the polymer composition (claim 23).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AUDRA J DESTEFANO/Examiner, Art Unit 1766
/RANDY P GULAKOWSKI/Supervisory Patent Examiner, Art Unit 1766
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