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 Arguments
Applicant’s amendment filed 07/07/2025 is accepted and entered.
Applicant's arguments filed 07/07/2025 have been fully considered but they are not persuasive. Regarding Claim 12, the amended language does not require that the main passageway be sealed along the entire length of the main passageway, and therefore Shubin reads on the claim limitations as set forth below. Regarding Claim 17, the amendments to the claim have resulted in a new interpretation of Shubin as set forth below.
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 12-16, 18, and 22-24 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.
Claim 12 recites the limitation "the main passage" in line 15. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, this limitation is interpreted as “the main passageway”. Claims 13-16 and 22-24 are also rejected based on their dependency on Claim 12.
Claim 18 recites the limitation "the interior volume" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, this limitation is interpreted as “the first interior volume”.
Claim Rejections - 35 USC § 102
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.
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 12-20 and 22-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shubin et al (US 2014/0275758).
Regarding Claim 12, Shubin discloses a method of making a polymeric sleeve (102, Fig. 2) comprising:
placing a lower mold component (510, Figs. 5-6), the lower mold component (510, Figs. 5-6) structurally defines a negative image of an insertion end (106, Fig. 2) of the polymeric sleeve (102, Fig. 2; ¶ [0046]), and the lower mold component (510, Figs. 5-6) defines a negative image of a first portion (116, Fig. 2) of a main passageway (combination of 116 and 208, Fig. 2) of the polymeric sleeve (102, Fig. 2; ¶ [0050]);
assembling into mating relationship (¶ [0062]) a disk assembly (combination of 512 and 516, Figs. 5 and 7-10), the disk assembly (512 and 516, Figs. 5 and 7-10) structurally defines a negative image of an internal volume (122, Fig. 2) of the polymeric sleeve (102, Fig. 2; ¶ [0055]), and the disk assembly (512 and 516, Figs. 5 and 7-10) defines a negative image of at least two stanchions (120A-120C, Fig. 1; ¶ [0055]) and a first flange (114, Fig. 2; ¶ [0055]);
stacking the disk assembly (512 and 516, Figs. 5 and 7-10) into mating relationship with the lower mold component (510, Figs. 5-6; ¶ [0062]);
coupling a rod member (514, Fig. 5) to the disk assembly (512 and 526, Figs. 5 and 7-10; ¶ [0046]), an exterior surface of the rod member (514, Fig. 5) defines a negative image of the main passageway (116 and 208, Fig. 2) from the internal volume (122, Fig. 2) to a vent end (204, Fig. 2) of the polymeric sleeve (102, Fig. 2; ¶ [0046-0048]), wherein the main passageway (116 and 208, Fig. 2) runs from the insertion end (106, Fig. 2) to the vent end (204, Fig. 2) along a longitudinal axis (L, Fig. 2), and wherein the main passage (116 and 208, Fig. 2) is sealed along a length of the main passageway (116 and 208, Fig. 2) between the insertion end (106, Fig. 2) and the vent end (204, Fig. 2; the main passageway is sealed along portion 208, which is a length of the main passageway that is between the insertion end and the vent end; the claim does not require that the main passageway be sealed along the entire length of the main passageway);
closing an outer mold assembly (502, Fig. 5) around the disk assembly (512 and 516, Figs. 5 and 7-10) and rod member (514, Fig. 5; ¶ [0048]), an interior surface (508, Fig. 5) of the outer mold assembly (502, Fig. 5) structurally defines a negative image of an outer surface of the polymeric sleeve (102, Fig. 2; ¶ [0045, 0048]); and
injecting a polymeric compound in a liquid state into the outer mold assembly (502, Fig. 5; ¶ [0048]).
Regarding Claim 13, Shubin discloses assembling further comprises abutting a lower disk member (512, Figs. 5 and 7-8) against an upper disk member (516, Figs. 5 and 9-10; ¶ [0047]).
Regarding Claim 14, Shubin discloses the lower disk member (512, Figs. 5 and 7-8) and the upper disk member (516, Figs. 5 and 9-10), when assembled, define a negative image of a first stanchion (120A, Fig. 1) at a first radial direction, a second stanchion (120B, Fig. 1) at a second radial direction, and a third stanchion (120C, Fig. 1) at third radial direction (¶ [0055, 0060]).
Regarding Claim 15, Shubin discloses assembling further comprises abutting a lower disk member (bottom half of 512, Figs. 5 and 8) against a medial disk member (top half of 512, Figs. 5 and 7), and abutting the medial disk member (top half of 512, Figs. 5 and 7) against an upper disk member (516, Figs. 5 and 9-10; ¶ [0055, 0060]); the lower disk member (bottom half of 512, Figs. 5 and 8) and medial disk member (top half of 512, Figs. 5 and 7) define the negative image of at least two stanchions (120A-120C, Fig. 1) and the first flange (114, Fig. 2; ¶ [0055]); and the medial disk member (top half of 512, Figs. 5 and 8) and the upper disk member (516, Figs. 5 and 9-10) define a negative image of at least two stanchions (320A-320C, Fig. 1) and a second flange (314, Fig. 4; ¶ [0060]).
Regarding Claim 16, Shubin discloses assembling further comprises abutting a lower disk member (bottom half of 512, Figs. 5 and 8) against a medial disk member (top half of 512, Figs. 5 and 7), and abutting the medial disk member (top half of 512, Figs. 5 and 7) against an upper disk member (516, Figs. 5 and 9-10; ¶ [0055, 0060]); the lower disk member (bottom half of 512, Figs. 5 and 8) and medial disk member (top half of 512, Figs. 5 and 7) define the negative image of three stanchions (120A-120C, Fig. 1) and the first flange (114, Fig. 2; ¶ [0055]); and the medial disk member (top half of 512, Figs. 5 and 8) and the upper disk member (516, Figs. 5 and 9-10) define a negative image of three stanchions (320A-320C, Fig. 1) and a second flange (314, Fig. 4; ¶ [0060]).
Regarding Claim 17, Shubin discloses a mold system (500, Fig. 5) for creating a polymeric sleeve (102, Fig. 2), the mold system (500, Fig. 5) comprising:
a lower mold (510, Figs. 5-6) defining a mold surface (602, Fig. 6) and a stem (610, Fig. 6) that protrudes upwardly from the mold surface (602, Fig. 6; ¶ [0049]) at a lower end along a longitudinal axis (612, Fig. 6) and extending to an upper end, wherein the stem (610, Fig. 6) defines a first portion (116, Fig. 2) of a main passageway (116 and 208, Fig. 2) of the polymeric sleeve (102, Fig. 2; ¶ [0050]);
a disk assembly (512 and 516, Figs. 5 and 7-10) configured to stack into mating relationship with the upper end of the stem (610, Fig. 6; ¶ [0046]), the disk assembly (512 and 516, Figs. 5 and 7-10) extending between a lower surface (as seen in Fig. 8) at the upper end of the stem (610, Fig. 6) and an upper surface (as seen in Fig. 9; ¶ [0055]), the disk assembly (512 and 516, Figs. 5 and 7-10) defining at least two channels (700A-700C, 702A-702C, and 900A-900C, Figs. 5 and 7-10) into a first interior volume (122, Fig. 2; ¶ [0046, 0056]) that circumscribes the longitudinal axis (L, Fig. 2); and
a rod member (514, Fig. 5) configured to couple to the upper surface (as seen in Fig. 9) of the disk assembly (512 and 516, Figs. 5 and 7-10) and extend along the longitudinal axis (¶ [0046]), such that the disk assembly (512 and 516, Figs. 5 and 7-10) is positioned axially between the stem (610, Fig. 6) and the rod member (514, Fig. 5), wherein the rod member (514, Fig. 5) defines a second portion (208, Fig. 2) of the main passageway (116 and 208, Fig. 2) and wherein the first (116, Fig. 2) and second portions (208, Fig. 2) are adjacent opposing ends (106, 204, Fig. 2) of the polymeric sleeve (102, Fig. 2; ¶ [0046]).
Regarding Claim 18, Shubin discloses the disk assembly (512 and 516, Figs. 5 and 7-10) further comprises a lower disk member (512, Figs. 5 and 7-8) and an upper disk member (516, Figs. 5 and 9-10), the lower (512, Figs. 5 and 7-8) and upper disk members (516, Figs. 5 and 9-10) defining three channels (700A-700C, 702A-702C, and 900A-900C, Figs. 5 and 9-10) into the interior volume (122, Fig. 2), the three channels extending along three distinct radial directions relative the longitudinal axis (as seen in Figs. 7-10; ¶ [0058]).
Regarding Claim 19, Shubin discloses the disk member (512 and 516, Figs. 5 and 7-10) further comprises: a lower disk member (bottom half of 512, Figs. 5 and 8) abutting a medial disk member (top half of 512, Figs. 5 and 7), and the medial disk member (top half of 512, Figs. 5 and 7) abutting an upper disk member (516, Figs. 5 and 9-10; ¶ [0055, 0060]); the lower disk member (bottom half of 512, Figs. 5 and 8) and medial disk member (top half of 512, Figs. 5 and 7) defining at least two channels (700A-700C, Figs. 5 and 7-8) the first interior volume (400, Fig. 4); and the medial disk member (top half of 512, Figs. 5 and 7) and the upper disk member (516, Figs. 5 and 9-10) defining at least two channels (900A-900C, Figs. 9-10) into a second interior volume (402, Fig. 4), the second interior volume (402, Figs. 9-10) circumscribing the longitudinal axis (L, Fig. 4).
Regarding Claim 20, Shubin discloses the disk member (512 and 516, Figs. 5 and 7-10) further comprises: a lower disk member (bottom half of 512, Figs. 5 and 8) abutting a medial disk member (top half of 512, Figs. 5 and 7), and the medial disk member (top half of 512, Figs. 5 and 7) abutting an upper disk member (516, Figs. 5 and 9-10; ¶ [0055, 0060]); the lower disk member (bottom half of 512, Figs. 5 and 8) and medial disk member (top half of 512, Figs. 5 and 7) defining a first, second, and third channels (700A-700C, Figs. 5 and 7-8) the first interior volume (400, Fig. 4), the first, second, and third channels extending along a first, second, and third radial directions (as seen in Figs. 7-8); and the medial disk member (top half of 512, Figs. 5 and 7) and the upper disk member (516, Figs. 5 and 9-10) defining a fourth, fifth, and sixth channels (900A-900C, Figs. 9-10) into a second interior volume (402, Fig. 4), the second interior volume (402, Fig. 4) circumscribing the longitudinal axis (L, Fig. 4), the fourth, fifth, and sixth channels extending along a fourth, fifth, and sixth radial directions, respectively (as seen in Figs. 9-10).
Regarding Claim 22, Shubin discloses during use of the polymeric sleeve (102, Fig. 2), air in the first portion (116, Fig. 2) is displaced along the main passageway (208, Fig. 2) to the vent end (204, Fig. 2) of the polymeric sleeve (102, Fig. 2; ¶ [0031]).
Regarding Claim 23, Shubin discloses during use of the polymeric sleeve (102, Fig. 2), displaced air moves along the main passageway to the vent end (204, Fig. 2) of the polymeric sleeve (102, Fig. 2; ¶ [0031]).
Regarding Claim 24, Shubin discloses during use of the polymeric sleeve (102, Fig. 2), a plurality of interstitial volumes enable the displaced air to move distally (¶ [0033]; rifling of the sleeve results in a plurality of interstitial volumes).
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.
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.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shubin et al (US 2014/0275738).
Regarding Claim 21, Shubin is silent whether the first radial direction is 60 angular degrees from the fourth radial direction.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Shubin to have the first radial direction be 60 angular degrees from the fourth radial direction since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Shubin would not operate differently with the first radial direction being 60 angular degrees from the fourth radial direction and since these channels would still serve to create stanchions the device would function appropriately with the claimed angular shift between the first radial direction and the fourth radial direction. Further, applicant places no criticality on the range claimed, indicating simply that the distance between the first and fourth radial directions “may” be within the claimed ranges (¶ [0021] of Applicant’s published specification). This is further motivated by Shubin who discloses in ¶ [0038, 0065] that the stanchions can have an angular shift.
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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