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 .
Claim Objections
Claims 1-20 are objected to because of the following informalities: Syntax can be improved for claims 1-20, for instance claim 1 should recite “A cap…” and dependent claims should recite “The cap…” Further, claim 1 lacks a transitional phrase to clearly establish the scope of the claim. 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.
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 2-4, 6, 7, 9-20 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 2 is rejected under 35 U.S.C. 112(b) as indefinite because the limitation “wherein preferably the groove longitudinal extension encloses an angle of 0° to 25° when the cap is arranged on the hollow medical body in the closing position and the axial direction of the hollow medical body” is grammatically incomplete and fails to clearly recite what structure encloses the recited angle with what reference structure. Further, the term “preferably” renders the scope uncertain because it is unclear whether the recited angle is required by the claim. See MPEP §§ 2173.02 and 2173.05(e).
Claim 3 is rejected under 35 U.S.C. 112(b) as indefinite because the clause “preferably the winding axis of the at least one first groove and the axial direction of the hollow medical body are parallel to each other” uses permissive language that makes it unclear whether the parallel relationship is a required limitation of the claim. The use of “preferably” leaves the metes and bounds of the claim uncertain. See MPEP § 2173.05(e).
Claim 4 is rejected under 35 U.S.C. 112(b) as indefinite because it depends from claim 2 and therefore incorporates the indefiniteness of claim 2. Specifically, because claim 2 fails to clearly define the angular relationship of the groove longitudinal extension, the scope of claim 4 cannot be determined with reasonable certainty.
Claim 6 is rejected under 35 U.S.C. 112(b) as indefinite because the term “the sealing element” lacks proper antecedent basis. Claim 1, from which claim 6 depends, does not recite a sealing element, and therefore it is unclear what previously introduced structure is being referenced. See MPEP § 2173.05(e).
Claim 7 is rejected under 35 U.S.C. 112(b) as indefinite because the term “the sealing element” lacks proper antecedent basis. Claim 1 does not recite a sealing element, and therefore the claim fails to distinctly identify the referenced structure. See MPEP § 2173.05(e).
Claim 9 is rejected under 35 U.S.C. 112(b) as indefinite because the phrase “the engaging element and/or the sealing element are arranged at least partially within the base body” is unclear. First, “the sealing element” lacks antecedent basis because claim 1 does not recite a sealing element. Second, the use of “and/or” renders the claim ambiguous as to whether the claim requires the engaging element, the sealing element, or both to be arranged within the base body. See MPEP §§ 2173.05(e) and 2173.05(h).
Claim 10 is rejected under 35 U.S.C. 112(b) as indefinite because “the base body” lacks antecedent basis in claim 1. Additionally, the clause “wherein the thread is preferably a Luer thread” renders the scope uncertain because it is unclear whether a Luer thread is required by the claim. See MPEP § 2173.05(e).
Claim 11 is rejected under 35 U.S.C. 112(b) as indefinite because both “the sealing element” and “the base body” lack antecedent basis. Claim 1 does not recite either structure, and thus the claim fails to clearly identify the elements being further limited. See MPEP § 2173.05(e).
Claim 12 is rejected under 35 U.S.C. 112(b) as indefinite because “the base body” lacks antecedent basis and because the phrase “wherein preferably the lower part comprising the internal thread” is grammatically defective and unclear. It is not reasonably certain whether the lower part must comprise the internal thread or whether this is merely an optional feature. See MPEP §§ 2173.02 and 2173.05(e).
Claim 13 is rejected under 35 U.S.C. 112(b) as indefinite because “the base body” lacks antecedent basis and because the phrase “it preferably engages around the medical hollow body” is indefinite as to whether the recited engagement is required. The use of “preferably” renders the claim scope uncertain. See MPEP § 2173.05(e).
Claim 14 is rejected under 35 U.S.C. 112(b) as indefinite because “the base body” and “the sealing element” lack antecedent basis in claim 1, and because the phrase “and preferably the engaging element” makes it unclear whether production of the engaging element by the recited two-component injection moulding process is required. The claim therefore fails to set forth its scope with reasonable certainty. See MPEP § 2173.05(e).
Claim 15 is rejected under 35 U.S.C. 112(b) as indefinite because “the sealing element” lacks antecedent basis and because the phrase “preferably consists of at least one thermoplastic elastomer” makes it unclear whether the claim is open-ended (comprises) or closed (consists of). The claim thus fails to distinctly define the material limitation. See MPEP § 2173.05(e).
Claim 16 is rejected under 35 U.S.C. 112(b) as indefinite because the phrase “preferably consists of at least one elastomer” renders unclear whether the engaging element merely includes at least one elastomer or is limited exclusively to at least one elastomer. The use of alternative scope with “preferably” results in uncertainty as to the metes and bounds of the claim. See MPEP § 2173.05(e).
Claim 17 is rejected under 35 U.S.C. 112(b) as indefinite because the phrase “wherein the base body comprising a first gripping mould and a second gripping mould” is grammatically defective, and the repeated use of “preferably” renders unclear which positional features are required limitations. The claim therefore does not particularly point out and distinctly claim the invention. See MPEP §§ 2173.02 and 2173.05(e).
Claim 18 is rejected under 35 U.S.C. 112(b) as indefinite because “the base body” and “the sealing element” lack antecedent basis, and because the clause “preferably projects out of the at least one recess in a preferably axial and/or radial direction” is unclear as to the required projection direction. The phrase “axial and/or radial” in combination with repeated “preferably” language leaves the claim scope uncertain. See MPEP §§ 2173.05(e) and 2173.05(h).
Claim 19 is rejected under 35 U.S.C. 112(b) as indefinite because “Medical hollow body with a cap according to claim 1” the scope of the claim is unclear – it’s seemingly a preamble only without a transitional phrase to define the components of the claim. See MPEP §§ 2111.03.
Claim 20 is rejected under 35 U.S.C. 112(b) as indefinite because “the base body” and “the sealing element” lack antecedent basis in the method claim as written, and because the phrase “and preferably the engaging element are produced by means of a two-component injection moulding process” makes it unclear whether producing the engaging element by that process is required. The claim therefore fails to particularly point out the steps of the method. See MPEP § 2173.05(e).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/703,014 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are substantial duplicates, the main difference being the difference in engaging element type specified in the independent claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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)(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.
Claim(s) 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20240131273 A1 to Ricci.
As to claim 1, Ricci discloses a cap 100 for a medical hollow body 2, with an engaging element 20 which is configured such that it engages at least partially in a distal opening of the hollow medical body when the cap is arranged on the hollow medical body in the closing position (fig 3), wherein the engaging element has at least one first groove (24), wherein a groove direction associated with the at least one first groove is aligned along an axial direction of the medical hollow body when the cap is arranged on the medical hollow body in the closing position (figs 2 and 3).
As to claim 2, Ricci discloses the cap according to claim 1, wherein the at least one first groove extends straight and has a groove longitudinal extension as the groove direction (fig 2), wherein preferably the groove longitudinal extension encloses an angle of 0° to 25° when the cap is arranged on the hollow medical body in the closing position and the axial direction of the hollow medical body.
As to claim 3, Ricci discloses the cap according to claim 1, wherein the at least one first groove is configured along a spatial curve (fig 2), in particular a helical line or a conical spiral, wherein the spatial curve extends around a winding axis (fig 2), preferably the winding axis of the at least one first groove and the axial direction of the hollow medical body are parallel to each other when the cap is arranged on the hollow medical body in the closing position.
As to claim 4, Ricci discloses the cap according to claim 2, wherein the engaging element has at least one second groove which extends in a plane, wherein a normal direction of the plane when the cap is arranged on the hollow medical body in the closing position and the axial direction of the hollow medical body enclose an angle of 0° to 18° [0055] (fig 2).
As to claim 5, Ricci discloses the cap according to claim 1, having a sealing element, wherein the sealing element is configured in such a way that it bears in a sealing manner against at least one distal area of the hollow medical body when the cap is arranged on the hollow medical body in a closing position [0060] (figs 5 and 6).
As to claim 6, Ricci discloses the cap according to claim 1, wherein the sealing element and the engaging element are configured single-piece with each other (figs 5 and 6).
As to claim 7, Ricci discloses the cap according to claim 1, wherein the sealing element and the engaging element are configured in two-pieces (figs 5 and 6).
As to claim 8, Ricci discloses the cap according to claim 1, wherein the engaging element has a sealing lip 22 which extends in the circumferential direction and is arranged on the engaging element in such a way that the sealing lip comes to rest on an end face of the distal opening of the hollow medical body when the cap is arranged on the hollow medical body in the closing position.
As to claim 9, Ricci discloses the cap according to claim 1, with a base body 5, wherein the engaging element and/or the sealing element are arranged at least partially within the base body (figs 5-6).
As to claim 10, Ricci discloses the cap according to claim 1, wherein the base body has an internal thread 6 which engages around a distal area of the medical hollow body when the cap is arranged on the medical hollow body in the closing position (fig 5), wherein the thread is preferably a Luer thread.
As to claim 11, Ricci discloses the cap according to claim 1, wherein the sealing element and the engaging element are arranged in the base body such that they are spaced apart from each other in at least one first area along the groove longitudinal extension, wherein they come to rest on each other in at least one second area (figs 5-6).
As to claim 12, Ricci discloses the cap according to claim 1, wherein the base body comprises an upper part and a lower part, wherein the upper part and the lower part are connected by means of a plurality of ribs (figs 5-6), wherein preferably the lower part comprising the internal thread.
As to claim 13, Ricci discloses the cap according to claim 1, having a retaining element which is arranged on the base body in such a way that it preferably engages around the medical hollow body in a form and/or force-fit manner when the cap is arranged on the medical hollow body in the closing position, wherein the retaining element has at least one anti-rotation section which engages in a recess of the base body [0064].
As to claims 14 and 20, Ricci discloses the cap according to claim 1, wherein the base body and the sealing element and preferably the engaging element are produced by means of a two-component injection moulding process (claim is too unclear, based on limited understanding figures 3-6 appear to support a structure capable of being produced by injection molding).
As to claim 15, Ricci discloses the cap according to claim 1, wherein the sealing element comprises at least one thermoplastic elastomer [0070], preferably consists of at least one thermoplastic elastomer.
As to claim 16, Ricci discloses the cap according to claim 1, wherein the engaging element comprises at least one elastomer [0070], preferably consists of at least one elastomer.
As to claim 17, Ricci discloses the cap according to claim 1, wherein the base body comprising a first gripping mould and a second gripping mould, wherein the first gripping mould and the second gripping mould are configured on a lateral surface of the base body (figs 3-6), wherein preferably, the first gripping mould and the second gripping mould are arranged diametrically opposite one another, wherein preferably the first gripping mould and the second gripping mould are configured on the lower part of the base body.
As to claim 18, Ricci discloses the cap according to claim 1, wherein the base body comprises at least one recess, wherein the sealing element comprises at least one anchoring element, wherein the sealing element is arranged in the base body in such a way that the at least one anchoring element engages in the at least one recess (figures 3-6) and preferably projects out of the at least one recess in a preferably axial and/or radial direction.
As to claim 19, Ricci discloses a medical hollow body 2 with a cap 100 according to claim 1.
Conclusion
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/IMANI N HAYMAN/Supervisory Patent Examiner, Art Unit 2841
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