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 .
Response to Amendment
This office action is responsive to the amendment filed on 10/16/25. As directed by the amendment: claims 1, 3, 4, 11, and 13-16 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-20 are presently pending in this application.
The amendment to claim 3 is sufficient to overcome the objection from the prior action. The amendment to claim 11 is sufficient to overcome prior rejections of claims 11 and 12 under 35 U.S.C. 112(b).
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.
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 9, 10, and 13-16 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 9, it is unclear how reciting the wedge is unitary and “chosen from” a malleable metal is further limiting what is now recited in independent parent claim 1, which requires both unitary and metal construction.
Claim 10 inherits the deficiencies of parent claim 9.
Regarding claims 13-16, the phrase “is subjected to” and its subsequent limitations render the claims indefinite. It is unclear if this limitation is reciting an intended use and/or functional limitation, whether this limitation is reciting a product-by-process, or whether this limitation is reciting a positively recited method step within the body of a product claim, which would itself be indefinite. It is further unclear how the “additional compression” relates to the initially recited compression in independent claim 1, when the additional compression is being recited in the same direction as that of claim 1.
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.
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.
Claim(s) 1-3, 6-8, 11-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capillary Biomedical Inc. (WO 2020097552; hereinafter “Capillary”) in view of Ryan et al. (US 5312363).
Regarding claim 1, Capillary discloses a septum and wedge assembly for fluid delivery (assembly of fig. 15A-B) comprising a septum 151; and a wedge (outer housing of fig 15A-B) comprising a cup portion 1212 and a stem portion (unlabeled stem at the distal end of 1212 in fig. 15A-B; see annotated fig. 15A below) defining a fluid path (fluid path within stem portion visible in fig. 15a-B), the cup portion being a unitary, integral component (see fig. 15A-B) and having a continuous, circumferential side wall (cylindrical side wall of 1212 visible in fig. 15A-B; in particular, the portion of the sidewall positioned between proximal end of 1212 and 1216 is continuous with no interruptions; however, the entire sidewall may also be said to be “continuous” through the entire area it covers) and a proximal opening dimensioned to receive the septum (proximal end of opening within 1212, see fig. 15A-B) and a distal opening to the fluid path defined by the stem portion (distal end of opening within 1212 preceding the stem portion, see fig. 15A-B), the side wall having an inner diameter that is less than an outer diameter of the septum to provide radial compression of the septum (0079), wherein the cup portion has a retaining edge 1218 along the proximal opening of the wall (see fig. 15A-B), the retaining edge being configured to extend over at least a portion of a proximal surface of the septum that is accessible via the proximal opening (see fig. 15A-B) and provide an axial force along an axis parallel to the stem portion to retain the septum in the cup portion (see fig. 15A-B; par. 0079), except for the cup portion being formed from a metal. However, Ryan et al. teaches a similar assembly for insertion and sealing of a surgical instrument therethrough (see fig. 1-2), and teaches that it is known to use metal interchangeably with plastic for forming all of the parts of such a device (col 7, ln. 54 – col. 8, ln. 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Capillary to utilize metal for the cup portion, as taught by Ryan et al., since Ryan et al. teaches that metal is usable interchangeably with plastic to form all parts of such types of medical devices (col. 7, ln. 54 – col. 8, ln. 6). Additionally, such a modification would be obvious to try since it involves selection from a finite number of identified, predictable solutions to achieve a predictable result (using either appropriate metal or appropriate plastic to form elements of the medical assembly).
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Regarding claim 2, Capillary discloses the retaining edge comprises a rolled retaining edge (1218 extends from 1212 in a roll, see fig. 15A-B) formed by rolling the retaining edge inwardly with respect to the cup portion and septum received therein (structure visible in fig. 15A-B is rolled, as claimed, and fully capable of being formed by a process of rolling inwardly as claimed), the rolled retaining edge extending a selected distance over the proximal surface of the septum in order to provide the axial force (see fig. 15A-B, the retaining edge extends a distance over the septum surface as claimed and performs this function).
Regarding claims 3, Capillary discloses the assembly as claimed, including the retaining edge is coined inwardly with respect to the cup portion to form the rolling retaining edge (structure visible in fig. 15A-B is rolled, as claimed, and fully capable of being formed by a process of coining inwardly as claimed).
Regarding claim 6, Capillary discloses the stem portion has an inner diameter that is less than the inner diameter of the cup portion (visible in fig. 15A-B).
Regarding claim 7, Capillary discloses the wedge comprises a flared portion joining the cup portion and the stem portion (flare that exists between the stem portion and the cup portion, see fig. 15A-B; see also annotated fig. 15A above) to define the fluid path (flared portion in fig. 15A-B is hollow and forms a part of the fluid path), the flared portion having a varying inner diameter that decreases distally (see annotated fig. 15A above; the labelled flared portion has an inner diameter that decreases from proximal end to distal end) and varies from less than the inner diameter of the side wall of the cup portion and greater than the inner diameter of the stem portion (see annotated fig. 15A above, the labelled flared portion starts from a diameter, at the proximal end, that is both smaller than the inner diameter of the cup portion and larger than an inner diameter of the stem portion).
Regarding claims 8 and 17, Capillary further discloses a needle 1300 (fig. 15A), wherein the stem portion has a catheter 1206 secured thereto that is dimensioned to slidably receive the needle (see fig. 15A) resulting in alignment of the needle and septum and wedge assembly (see fig. 15A).
Regarding claim 11, Capillary discloses the fluid path of the wedge is fluidically connected to a fluid path from a reservoir of the fluid delivery device (fluid path of 888, fig. 15A-B), and discloses a cup portion and a septum which inherently have relative dimensions, as apparent from fig. 15A-B, utilize radial compression, as discussed in par. 0079, and frictionally engage devices punctured through the septum, as also discussed in par. 0079, which will be fully capable of withstanding a designated filling pressure introduced to the fluid path of the wedge when the reservoir in the fluid delivery device undergoes filling that does not exceed the pressure exerted by the cup and septum disclosed in Capillary.
Regarding claims 12, 13, 15, and 16, as best understood, Capillary discloses the assembly as claimed, except for specifically disclosing the designated filling pressure of 20-55 PSI, the rolled retaining edge comprising an annular ring shape dimensioned with an outer diameter of 2.8 mm and an inner diameter of 2.4 mm, and the cup portion is dimensioned to have between 1.4 mm pre-crimp and 1.0 mm post-crimp, the cup portion has a height prior to axial compression of 1.6 mm with a tolerance of .04 mm, and the cup portion after the axial compression is 1.4 mm with a tolerance of .05 mm, and the outer diameter of the septum is 3 mm, the cup portion has an inner diameter less than the outer diameter of the septum prior to radial compression, and the inner diameter of the cup portion is reduced after the radial compression to a diameter chosen from 2.1-2.5 mm. However, there is no evidence of record that establishes that changing these claimed parameters would result in a difference in function of the Capillary device. Further, a person having ordinary skill in the art, being faced with modifying assembly of Capillary, would have a reasonable expectation of success in making such modifications and it appears the device would function as intended being given the claimed ranges and values. Lastly, applicant has not disclosed that the claimed ranges and values solve any stated problem, indicating that these ranges and values are exemplary (such as in par. 0017, 0043, 0046, 0049) and therefore there appears to be no criticality placed on the ranges and values as claimed such that they produce unexpected results. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the elements cited in Capillary to the values and ranges claimed in claims 12, 13, 15, and 16 as an obvious matter of design choice within the skill of the art.
Regarding claim 14, as best understood, Capillary’s cup inherently possesses a height and an inner diameter (see fig. 15A-B), and is discloses as exerting a compressive force on the septum (par. 0079); this disclosed structure is fully capable of being formed by additional compression in one or both of the axial and radial directions, and is also fully capable of being additionally compressed in one or both directions due to forces applied during use of the device.
Regarding claim 18, Capillary discloses the septum is manufactured from an elastomeric material (par. 0079).
Regarding claim 20, Capillary discloses a catheter hub 700 (fig. 8D, which illustrates the structures from fig. 15A-B interfacing with the hub 700).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capillary in view of Ryan et al., and further in view of DeStefano (US 20080243085).
Regarding claims 4 and 5, Capillary discloses the assembly as claimed, including a retaining edge that comprises at least one finger that extends from a portion of the circumferential side wall of the cup portion and that is folded inwardly with respect to the cup portion and septum received therein to form a flanged retaining edge that extends a distance over the proximal surface of the septum to provide the axial force (retaining edge 1218 forms a single, circumferential inwardly extending finger, extending as claimed, and performs this function; see fig. 15A-B), except for disclosing the at least one finger has a width less than a circumference of the circumferential side wall, or the retaining edge comprising a plurality of such fingers. However, DeStefano teaches forming a flanged retaining edge with a plurality of fingers as opposed to a unitary flange/finger as disclosed by Capillary. The fingers are illustrated, but not labelled, in fig. 8 of DeStefano in the act of retention, and are also visible exposed in both fig. 9 and fig. 10. See also annotated fig. 8 and annotated fig. 10 below. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Capillary to utilize a plurality of fingers oriented as claimed, each having a width less than total relative circumference, as disclosed in fig. 8-10 of DeStefano, for the purpose of providing sufficient structure to allow assembly of the retained element (the septum of Capillary) into the housing through the proximal end, and subsequently retain the septum in the assembled position, similarly to the retention achieved in fig. 8 of DeStefano.
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Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capillary in view of Ryan et al., and further in view of Weeks et al. (US 4802885).
Regarding claim 9 and 10, as best understood, Capillary in view of Ryan et al. teaches the assembly as claimed, except for specifically teaching the metal is malleable and biocompatible with fluid delivered the device, and further is stainless steel. However, Weeks et al. teaches specifically utilizing stainless steel (col. 3, ln. 34-41), which is malleable and biocompatible, for a septum housing element 12 that interfaces with delivered fluid (see fig. 6-8). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize stainless steel as the metal of Capillary as modified by Ryan et al. above, since Weeks et al. teaches that stainless steel is useable in such an environment (see fig. 6-8). Additionally, such a modification is a simple substitution of one known material (stainless steel) for another (general metal of Ryan et al.) to achieve predictable results (utilizing a type of metal appropriate for medical applications).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Capillary in view of Ryan et al. and Weeks et al., and further in view of Medical Applications of Stainless Steel 304.
Regarding claim 19, Capillary discloses the apparatus as claimed, except for disclosing the wedge is manufactured from 304 stainless steel. However, Ryan et al. and Weeks et al. teach utilizing metal, and specifically stainless steel, as set forth in the rejections for claims 9 and 10 above which are hereby incorporated into the rejection of claim 19. Capillary, as modified by Ryan et al. and Weeks et al., fails to teach specifically using 304 stainless steel as the type of stainless steel. However, Medical Applications of Stainless Steel 304 teaches that 304 stainless steel is one of the most suitable materials for medical device manufacture (see body of article). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specifically utilize 304 stainless steel, since the modified assembly of Capillary in view of Ryan et al. and Weeks et al. requires use of stainless steel, and since Medical Applications of Stainless Steel 304 teaches that it is a well-known, suitable, and ubiquitous form of stainless steel for use in medical applications (see body of article). Additionally, such a modification is a simple substitution of one known material (304 stainless steel) for another (stainless steel in general) to achieve predictable results (utilizing a type of metal appropriate for medical applications).
Response to Arguments
Applicant's arguments filed 10/16/25 have been fully considered but they are not persuasive.
Applicant argues on pg. 8 of the Remarks, regarding claim 1, that element 1212 of Capillary, by having a sideport, is not continuous. Examiner respectfully disagrees. First, the claim only requires presence of a continuous sidewall. As noted in the updated rejection above, there is a sidewall that extends between the proximal end of 1212 and the port 1216 that is continuous by applicant’s argued interpretation of lacking a sideport. Furthermore and alternatively, the term “continuous” is interpreted to mean that the material portion of the cup itself is continuous, where the sideport identified by applicant is not a part of such continuous structure, which is also noted in the updated rejection above.
Applicant argues on pg. 8-9 of the Remarks, regarding claim 3, that Capillary fails to disclose that the retaining edge is coined inwardly. Examiner respectfully disagrees, noting that the limitation regarding coining is a product-by-process limitation. Product-by-process limitations are not limited to the manipulations of the recited steps, only the structure implied by the steps. Regarding the structure, examiner points to the rejection provided above.
Applicant argues on pg. 8-9 of the Remarks, regarding claim 3, that the motivation to combine Ryan et al. with Capillary is improper. Examiner respectfully disagrees. Specifically in col. 7, ln. 54-58, Ryan et al. identifies that plastic and metal are interchangeable for elements of the medical device.
Applicant agues, on pg. 9-10 of the Remarks, that DeStefano does not teach the limitations of claims 4 and 5, because the fingers identified by the examiner in DeStefano do not retain/connect to the same elements as claimed. Examiner respectfully disagrees, noting that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). DeStefano is relied upon for modifying the finger first identified in Capillary with the fingers disclosed by DeStefano. DeStefano is not relied upon for the exact interactions argued by applicant, which are disclosed by Capillary.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783