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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 30, 2026 has been entered.
Claims 1-23 are pending as amended on June 30, 2026. Support for amended claims 1, 9, and 10 is found in claims 1, 9, and 10.
Any objections and/or rejections made in the previous Office action and not repeated below are hereby withdrawn.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, see page 6, filed June 30, 2026, with respect to the rejection(s) of claims 1-23 under 35 U.S.C. 103 have been fully considered and are persuasive. Santini (US 2008/0015494 A1) in view of Kim (US 8,932,483 B2) does not teach or suggest repeating units derived from 6-hydroxy-2-naphthoic acid in the amended amount of 20 mol.% to about 25 mol.%. Therefore, the rejection over Santini in view of Kim has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Santini in view of Yu (US 2016/0152801 A1).
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 11 of claim 1, “an amount 20” should read “an amount of 20.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-8 and 12-23 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.
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 1 recites the broad recitation “repeating units derived from naphthenic hydroxycarboxylic and/or dicarboxylic acids in an amount of about 25 mol.% or less”, and the claim also recites “repeating units derived from 6-hydroxy-2-naphthoic acid in an amount 20 mol.% to about 25 mol.%” which is the narrower statement of the range/limitation. The compound 6-hydroxy-2-naphthoic acid is a naphthenic hydroxycarboxylic acid. It is therefore unclear how the content of repeating units derived from naphthenic hydroxycarboxylic and/or dicarboxylic acids can be less than 20 mol% when a minimum of 20 mol.% of 6-hydroxy-2-naphthoic acid is required. 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. This issue can be corrected by amending “about 25 mol.% or less” to read “20 mol.% to about 25 mol.%.” A range of 20 mol.% to about 25 mol.% is used for the purposes of examination.
Claims 2-8 and 12-23 are rejected by virtue of dependency on claim 1 because they require all of the limitations of claim 1, including those that are indefinite.
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.
Claim 11 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.
Claim 11 contains the limitation “wherein the liquid crystalline polymer contains repeating units derived from 4-hydroxybenzoic acid in an amount of from about 75 mol.% to about 90 mol.%.” Claim 11 depends from claim 10. Claim 10 requires that the polymer contains 20 mol.% to about 24 mol.% of repeating units derived from 6-hydroxy-2-naphthoic acid. Claim 10 therefore requires that repeating units derived from all other monomer types make up about 76 mol.% to 80 mol.% (100-20=80 and 100-24=76). Claim 11 does not require all of the limitations of claim 10 because the range recited in claim 11 (about 75 mol.% to about 90 mol.%) extends above the range permitted by claim 10 (about 76 mol.% to 80 mol.%). This issue can be corrected by amending the upper limit of the claim 11 range to 80 mol.%.
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
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 Yu (US 2016/0152801 A1).
Regarding claims 1, 5-10, 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 (LCPs) (Santini, [0082]). Santini therefore teaches a medical device comprising a polymer composition containing a polymer matrix that includes a LCP.
Santini does not teach the specific LCP composition recited in claim 1.
However, Yu teaches LCP compositions used in molding (Yu, abstract). Yu’s compositions possess high flowability and good mechanical properties and are well suited for parts having a small dimensional tolerance (Yu, [0053]). The LCP comprised in Yu’s composition contains repeating units derived from naphthenic hydroxycarboxylic and/or dicarboxylic acids in an amount of about 15-35 mol.% of the polymer (Yu, [0025]). The naphthenic hydroxycarboxylic acid can be 6-hydroxy-2-naphthoic acid (Yu, [0025]). The LCP further comprises about 5-70 mol.% of units derived from 4-hydroxybenzoic acid and about 0.1-20 mol.% of units derived from terephthalic acid and/or isophthalic acid (Yu, [0025]). Yu’s composition has a melt viscosity of about 0.5-50 Pa-s (Yu, [0014]) and a flexural strength of about 100 to about 350 MPa (Yu, [0015]).
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 LCP of Santini with the LCP composition of Yu in order to utilize a LCP composition that has good mechanical properties and is well suited for parts having a small dimensional tolerance. This substitution results in a medical device where the body and drug reservoir (claim 18) comprise the polymer composition of Yu. It would have been obvious to select a LCP derived from 15-35 mol.% 6-hydroxy-2-naphthoic acid, 5-70 mol.% 4-hydroxybenzoic acid (claim 6), and about 0.1-20 mol.% terephthalic acid and/or isophthalic acid (claim 5 and 7) because Yu teaches using these monomer in these amounts. The LCP is wholly aromatic because these monomers are all aromatic (claim 8).
Santini in view of Yu does not anticipate the claimed content of repeating units derived 6-hydroxy-2-napthoic acid (also reading on naphthenic hydroxycarboxylic acid).
However, it would have been obvious to one of ordinary skill to have selected any amount of 6-hydroxy-2-napthoic acid in the range of about 15-35 mol.% because Yu teaches it. A range of about 15-35 mol.% overlaps with the claimed ranges of 20 mol.% to about 25 mol.% or less (claim 1) and 20 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.
A melt viscosity of 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 (Yu, [0014]) falls within the claimed range of about 50 Pa-s or less. While Yu 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 Yu to also be within the claimed range when measured under the claimed conditions.
Santini in view of Yu does not anticipate the claimed flexural strength.
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 Yu teaches this range. A range of about 100 to about 350 MPa overlaps with the claimed range of about 150 to about 300 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 LCP of Santini was substituted for the LCP composition of Yu. Yu further exemplifies a deflection temperature under load of about 255-286°C as determined in accordance with ISO Test No. 75-2 at a load of 1.8 MPa (Yu, [0071] and Tables 1-4). It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have selected a deflection temperature under load in the range of 255-286°C because Yu exemplifies this range.
Regarding claims 3-4, modified Santini teaches the medical device of claim 1 where the LCP of Santini was substituted for the LCP composition of Yu. Yu 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 (Yu, [0015] where tensile break strain reads on tensile elongation).
Yu does not anticipate a tensile elongation of about 0.5% to about 2.5%.
However, it would have been obvious to one of ordinary skill to have selected any tensile elongation in the range of 0.8-3.5% because Yu 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 claim 11, modified Santini teaches the medical device of claim 1 where the LCP of Santini was substituted for the LCP composition of Yu. Yu’s LCP comprises about 5 to about 70 mol.% of units derived from 4-hydroxybenzoic acid (Yu, [0025]).
Santini in view of Yu does not anticipate the claimed content of repeating units derived from 4-hydroxybenzoic acid.
However, it would have been obvious to one of ordinary skill to have selected any content of repeating units derived from 4-hydroxybenzoic acid in the range of about 5 mol.% to about 70 mol.% because Yu teaches this range. A range of about 5 mol.% to about 70 mol.% (4-77 mol.% taking about mean ±10%) overlaps with the claimed range of about 75 mol.% to about 90 mol.% (67.5-99 mol.% taking about mean ±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.
Regarding claim 12, modified Santini teaches the medical device of claim 1 where the LCP of Santini was substituted for the LCP composition of Yu. Yu further teaches that the LCP composition constitutes about 70 wt.% to about 98 wt.% of the polymer composition LCP (Yu, [0041]).
Regarding claims 13-15, modified Santini teaches the medical device of claim 12 where the LCP of Santini was substituted for the LCP composition of Yu. Yu further teaches that the composition further includes about 1 wt.% to about 20 wt.% of an inorganic filler in order to improve mechanical properties (Yu, [0041]). The inorganic filler can be glass fibers (Yu, [0042]) (claims 13-14).
Santini in view of Yu does not anticipate the claimed glass fiber content.
However, it would have been obvious to one of ordinary skill in the art to have selected any glass fiber content in the range of about 1 wt.% to about 20 wt.% because Yu teaches this range. A range of about 1 wt.% to about 20 wt.% overlaps with the claimed range of about 5 wt.% to about 25 wt.% of the composition (claim 15). 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 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, Yu 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 (Yu, [0053]). Yu further teaches using the composition for housing (Yu, [0057]).
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 Yu in order to obtain a housing with good mechanical properties from a composition that is well suited for parts with small dimension tolerance and parts used as 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, Yu 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 (Yu, [0053]).
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 Yu 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 20 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, Yu 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 (Yu, [0053]). Yu teaches that the composition is appropriate for compositions with micro-seized dimensions such as from about 50-450 µm (Yu, [0053]).
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 Yu 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 Yu (US 2016/0152801 A1) 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, Yu 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. In particular, Yu teaches that the composition is appropriate for compositions with micro-seized dimensions such as from about 50-450 µm (Yu, [0053]).
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 Yu 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 Yu reads on wherein the cannula includes the polymer composition (claim 23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDRA DESTEFANO whose telephone number is (703)756-1404. The examiner can normally be reached Monday-Friday 9-5.
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, Randy Gulakowski can be reached at (571)272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AUDRA J DESTEFANO/Examiner, Art Unit 1766
/RANDY P GULAKOWSKI/Supervisory Patent Examiner, Art Unit 1766
Prosecution Insights