CTNF 18/565,817 CTNF 84188 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions Applicant's election with traverse of Group I in the reply filed on 22 April 2026 is acknowledged. The traversal is on the ground(s) that “the restriction relies on overly broad characterizations of the subject matter of the identified groups” and “Although, Bonk may disclose certain features identified in the Restriction Requirement, the Restriction Requirement does not sufficiently establish that the alleged common features are known from Bonk in the manner claimed, or that such features therefore fail to define a contribution which each of the claimed inventions, considered as a whole, males of the prior art..”. This is not found persuasive. Firstly, Examiner notes that Applicant fails to point to any supposed special technical features shared by the claimed inventions and not found in Bonk, as characterized in the requirement. No analysis has been provided by Applicant and therefore Applicant’s assertions can be considered nothing more than conclusory statements. Secondly, further demonstration of a lack of unity can be clearly established through consideration of the prior art presented below, see e.g. Taha Additionally, with respect to Applicant’s characterization of the method of Claim 6 being “a method of reducing an amount of lubricant used for moving an article within a barrel for use as a medical injection device…” Examiner notes that the body of the claim provides no actual method steps. Any suggestion of a “method” is found in the preamble only. When reading the preamble in the context of the entire claim, the recitation of a “method of reducing” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co. , 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Furthermore, a “method” claim without any actual “method” steps is indefinite on its face, see MPEP 2173.05(q). The invention of Claim 6 is defined solely by the product, wherein the instant claim creates confusion as to what product is even required by the claim, i.e. the “barrel” is only recited in association with its functional recitation in combination with the “article” and the supposed “method” appears to only involve itself with supplying “the article” with “at least a partial coating of a fluoropolymer material on at least a front face thereof”, with additional functional limitations related to the “article” or its intended association with the “barrel”. With respect to the grouping of Claims 10-14, Examiner is in agreement that these claims should have been grouped with Group I, but were mistakenly grouped with Group III because they were presented out of order. It is noted that these claims do depend from Claim 1 and appear to address and modify the overarching method of Claim 1, i.e. a method of storing a medical injection device barrel/article combination through the assertion of additional limitations to the article itself. Claims 10-14 are hereby enjoined as part of Group I and therefore the pending claims for examination comprise Claims 1, 3-5, and 10-14. The requirement is still deemed proper and is therefore made FINAL. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. Claim(s) 3, 4, 11, 14, and dependents thereof is/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. Regarding Claim 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, 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 3 recites the broad recitation “less than approximately 25N”, and the claim also recites “less than 20N”, which is the narrower statement of the range/limitation. 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. Regarding Claim 4, Applicant recites “wherein the maximal gliding force is measured by…” However, the metes and bounds of this limitation create confusion as what extent this gliding force measurement testing protocols limits the claims. Specifically, the method of Claim 1 is directed toward a “method of storing”, whereas the specifics of Claim 4 indicate a standard for testing gliding force without clearly articulating whether or not the described testing methodology is positively required by the claims. Specifically, Claim 4 modifies a functional limitation recited in Claim 3 which quantifies a gliding force which is achievable by the stopper/syringe system stored in Claim 1, but does not positively require a testing step to occur (and wherein such a testing step would generally not be understood as perfecting the actual act of “storing”, but rather only a validation of the efficacy of the “storing” method where it would be presumed that not every barrel that is stored under the claimed conditions of Claim 1 would be subjected to such validation testing). Claim 4 qualifies HOW the gliding force is measured, but again does not appear to actually positively require a testing step to occur, simply qualifying how the article used in the method of Claim 1 should perform when subjected to a particular test. Furthermore, the range of storage temperatures cited in association with the gliding force test are not consistent with the storage temperatures required by Claim 1. Specifically, Claim 1 requires actual storage to occur between -80 and -40 degrees Centigrade, whereas the testing encompasses storage conditions greatly exceeding that range and therefore incompatible with that range. This creates substantial confusion as to what method steps are or are not required in order to infringe upon the instantly claimed invention. Specifically, it is unclear (presuming the method of testing gliding force steps are positively required) exactly HOW the specifics of both claims would be carried out. Specifically, Claim 1 requires specific storage conditions to exist including a particular temperature range. Claim 4 recites testing conditions outside this storage range. For Claims 1 and 4 to be practiced together it would appear that the same barrel would need to be stored for two distinct periods of time under distinct conditions – once for testing and once for actual storage of the medicinal product. Regarding Claim 11, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, 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 11 recites the broad recitation “at least a first rib and a second rib” which indicates a minimum requirement of two ribs without any upward bound, and the claim also recites “the number of perimetrical contact surfaces is preferably three”, which is the narrower statement of the range/limitation requiring a discrete value of three (as value which lies within the range of 2-4 as set forth by the “at least…” limitation. 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. 07-34-08 Regarding Claim 14, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim(s) 1, 3, 10-12, and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Publication No. 2023/0263957 (“Taha”) . Regarding Claim 1, Taha discloses a method for storing an article (e.g. 509) within a pre-filled silicone-free (Par. 128) barrel (e.g. 501) for use as a medical injection device (500), the barrel comprising a tubular member having an inner surface and an outer surface (see Fig. 52), the article comprising an elastomeric material (Par. 161, 619) having at least a partial coating of a fluoropolymer material (Par. 621), the film “coats or resides on substantially all of the outer surfaces of the gasket” (Par. 621) inclusive to the front face (see Fig. 55, 57), wherein the article has between two and four perimetrical contact surfaces with respect to the inner surface of the barrel (see Fig. 52, 56, 57) the perimetrical contact surfaces separately disposed with respect to each other along a longitudinal length of the article and the barrel (see e.g. Fig. 56), wherein the method of storing the article within the pre-filled silicone-free barrel comprises storing the article within the pre-filled silicone-free barrel in cold storage at temperatures within the range of −80° C. to −40° C. (see e.g. Par. 692) and wherein the container closure integrity (CCI) of the article within the pre-filled silicone-free barrel is maintained upon thawing to ambient conditions (Par. 118). Regarding Claim 3, Taha discloses the maximal gliding force of the article within the barrel may be less than 20N (Par. 591, 592). Regarding Claim 10, Taha discloses the fluoropolymer coating covers at least a portion of a first perimetrical contact surface located adjacent to the front face (Par. 621 – see e.g. Fig. 57) Regarding Claim 11, Taha discloses the perimetrical contact surfaces comprise at least a first rib and a second rib (see e.g. Fig. 2). Regarding Claim 12, Taha discloses the fluoropolymer coating comprises at least one an ethylene tetrafluoroethylene (ETFE), a polyvinylidene fluoride (PVDF), a polyvinyl fluoride (PVF), and a polytetrafluoroethylene (PTFE) coating (Par. 621). Regarding Claim 14, Taha discloses the article comprises a rubber material (Par. 597, 613) Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2023/0263957 (“Taha”) . Regarding Claim 4, Taha is silent as to the specific methodology for measuring the gliding force to specify that it may be determined using WFI stored between -80C and 40C for at least seven days to one month. However, in the instant claim limitations are not found to be specifically recited, positively required method steps, but rather functional limitations which are not particularly tied to any specific or particular structural feature, but merely serve to quantify the results of a specific test. The Patent Office is not an experimental testing facility and cannot be expected to produce all of the various variations of the stoppers contemplated in the disclosure of Taha and subject to them to the wide range of experimental testing conditions (temperature range and storage duration range) to determine whether or not any of these produceable configurations result in the disclosed gliding force range (i.e. “less than approximately 25N”) to be achievable. However, to the extent that Taha contemplates that the syringes should be stored at temperatures within this claimed range, for periods within this claimed range (see e.g. Par. 127) and that it is desired to produce syringes which effect a gliding force within the claimed range, it would have been obvious for one having ordinary skill in the art at the time the invention was made to produce a syringe that maintains its low gliding force when subjected to expected storage conditions . 07-21-aia AIA Claim (s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2023/0263957 (“Taha”) as applied above, and further in view of EP 2,750,736 (“Gibler”) Regarding Claim 5, Taha discloses the invention substantially as claimed except that for disclosing the radial contact pressure between the inner surface of the barrel and the outer surface of the article/stopper. However, Gibler discloses that in related syringes sealing can be affected by controlling contact pressure to range between 20 and 400psi (0.13 – 2.76 MPa; see Par. 42), a range which wholly encompasses Applicant’s claimed range with substantial overlap. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Taha to exhibit a contact pressure between 1.5-2.0 MPa, an obvious range limited within the prior art range identified by Gibler, in order to ensure that the contents of the syringe are sufficiently sealed, but ensuring that the break-loose force of the plunger is not too high to be overcome by typical use by a clinician . 07-21-aia AIA Claim (s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2023/0263957 (“Taha”) as applied above, and further in view of U.S. Publication No. 2020/0155760 (“Dix”) Regarding Claim 13, Taha discloses the invention substantially as claimed except that article is “gamma-sterilizable”. However, Dix discloses that gamma radiation sterilization is an obvious, known, and desirable means for terminal sterilization (Par. 71). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the article of Taha to be gamma radiation sterilizable, as disclosed by Dix, in order to ensure that the article is able to withstand a typical, standard, and well-known sterilization method. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT). 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, KEVIN SIRMONS can be reached at (571) 272-4965. 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. /WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/16/2026 Application/Control Number: 18/565,817 Page 2 Art Unit: 3783 Application/Control Number: 18/565,817 Page 3 Art Unit: 3783 Application/Control Number: 18/565,817 Page 4 Art Unit: 3783 Application/Control Number: 18/565,817 Page 5 Art Unit: 3783 Application/Control Number: 18/565,817 Page 6 Art Unit: 3783 Application/Control Number: 18/565,817 Page 7 Art Unit: 3783 Application/Control Number: 18/565,817 Page 8 Art Unit: 3783 Application/Control Number: 18/565,817 Page 9 Art Unit: 3783 Application/Control Number: 18/565,817 Page 10 Art Unit: 3783 Application/Control Number: 18/565,817 Page 11 Art Unit: 3783 Application/Control Number: 18/565,817 Page 12 Art Unit: 3783
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