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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 05/06/2026, 05/17/2024, and 04/19/2024, the submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement is being considered by the examiner, with the exception of the references line through by the examiner.
The cited references do not meet the USPTO format. The examiner cited them in a US PTO-892 form.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the winding axis set forth in claim 4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3-5, 7-18, and 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.
Claims 3-4 are indefinite since the scope of the claims is unclear. The terms “preferably” in claims 3-4, and “in particular” in claim 4 establish a broad and narrow language (before and after the terms) making the scope of the claims unclear if applicant is intending to claim either a broader or a narrow statement. It is not clear what applicant is trying to claim in view of these terms. For examination purposes, the examiner will consider the broader limitation.
Claims 7-9, there is no antecedent basis for “the sealing element”.
Claim 10, there is no antecedent basis for “the base body” in line 2. The scope of the claim is further indefinite. The term “preferably” establishes a broad and narrow language (before and after the terms) making the scope of the claim unclear if applicant is intending to claim either a broader or a narrow statement. Therefore, it is not clear what applicant is trying to claim in view of this term. For examination purposes, the examiner will consider the broader limitation.
Claim 11, there is no antecedent basis for “the groove longitudinal extension” and “the base body”.
Claims 12-18, and 20 are indefinite because the term “preferably” establishes a broad and narrow language (before and after the terms) making the scope of the claim unclear if applicant is intending to claim either a broader or a narrow statement. Therefore, it is not clear what applicant is trying to claim in view of this term. For examination purposes, the examiner will consider the broader limitation.
Claim 12, there is no antecedent basis for “the internal thread” and “the base body”.
Claims 13-14, and 17-18, there is no antecedent basis for “the base body”.
Claim 20, there is no antecedent basis for “the base body” and “the sealing element”.
Claims 12, 14, and 20 are further indefinite because it is not clear is applicant intends to invoke 112(f). Claim limitations “by means of a plurality of ribs” in claim 12, and “by means of a two-component injection moulding process” in claims 14 and 20 have been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive.
Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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.
Claims 1, 6-8, 15-16, 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geiger et al (US 20060178627 A1).
Regarding claim 1, Geiger discloses a cap (Figs 1-2,12) for a medical hollow body 103, with
- an engaging element 117, wherein
- the engaging element 117 has a sealing lip (protrusion around 141’; fig 12) which extends in the circumferential direction and is arranged on the engaging element 117 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.
Regarding claim 6, Geiger discloses the cap 101 having a sealing element (fig 12 below), 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 103 when the cap is arranged on the hollow medical body 103 in a closing position.
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Regarding claim 7, Geiger discloses a cap wherein the sealing element and the engaging element 117 are configured single-piece with each other (fig 12 above).
Regarding claim 8, Geiger discloses a cap wherein a sealing element 117 and an engaging element 135 can be configured in two-pieces (figs 1-2 shows these two features).
Regarding claim 15, Geiger discloses a cap wherein the sealing element (fig 12 above) comprises at least one thermoplastic elastomer (TPE); [0050].
Regarding claim 16, Geiger discloses a cap wherein the engaging element 117 comprises at least one elastomer [0050].
Regarding claim 19, Geiger discloses a medical hollow body 103 with a cap 101 according to claim 1.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 6, 7, 9-10, 12-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Glocker (US 20150238703 A1) in view of Geiger et al (US 20060178627 A1).
Regarding claim 1, Glocker discloses a cap 1 (Figs 1-5) for a medical hollow body 5, with an engaging element 23. However, Glocker fails to disclose the engaging element 23 has a sealing lip 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 5 when the cap is arranged on the hollow medical body 5 in the closing position.
Geiger discloses a cap 101 having an engagement element 117 having a sealing lip (protrusion around 141’; fig 12) 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 103 when the cap is arranged on the hollow medical body 103 in the closing position. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Glocker’s engagement element with a sealing lip taught by Geiger to add an additional sealing between the end face of the distal opening of the hollow medical device and the engaging element.
Regarding claim 6, Glocker discloses the cap 1 having a sealing element (fig 1 below), 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 13 when the cap is arranged on the hollow medical body 13 in a closing position (fig 3).
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Regarding claim 7, Glocker discloses a cap 1 wherein the sealing element (fig 1 above) and the engaging element 23 are configured single-piece with each other.
Regarding claim 9, Glocker discloses a cap 1 having a base body (17,19), wherein the engaging element (23) and/or the sealing element (see fig 1 above) are arranged at least partially within the base body.
Regarding claim 10, Glocker discloses a cap 1 wherein the base body (17,19) has an internal thread (at 19 and 25) which engages around a distal area (9) of the medical hollow body (5) when the cap (1) is arranged on the medical hollow body (5) in the closing position.
Regarding claim 12, Glocker discloses a cap 1 wherein the base body (17,19) comprises an upper part (17) and a lower part (19), wherein the upper part (17) and the lower part (19) are connected by means of a plurality of ribs (at 21; [0020]).
Regarding claim 13, Glocker discloses a cap 1 having a retaining element (25; [0021-0022]) which is arranged on the base body (17,19) in such a way that it preferably engages around the medical hollow body (5) in a form and/or force-fit manner when the cap (1) is arranged on the medical hollow body (5) in the closing position (fig 3), wherein the retaining element (25) has at least one anti-rotation section (27, fig 5) which engages in a recess (29) of the base body (17,19).
Regarding claim 14, this claim is a product-by-process claim. Therefore, the end product only is given patentable weight. Glocker discloses a cap base body 17,19 and a sealing element (shown in fig 1 above) that can be made by a two-component injection molding. However, Glocker and Geiger discloses the use of two-component injection molding to manufacture the cap and some other elements. Therefore, this manufacturing process is known in the art.
Regarding claim 15, Glocker discloses the invention substantially as claimed. But does not disclose the sealing element comprises at least one thermoplastic elastomer (TPE).
Geiger teaches a cap wherein the sealing element (fig 12 above) comprises at least one thermoplastic elastomer (TPE); [0050]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Glocker’s sealing element with the material taught by Geiger since such modification or material substitution is within the skill of the ordinary artisan obtained through routine experimentation in determining optimum results.
Regarding claim 16, Glocker discloses the invention substantially as claimed. But does not disclose the engaging element comprises at least one elastomer. Geiger teaches a cap wherein the engaging element (117, fig 12 above) comprises at least one; [0050]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Glocker’s engaging element with the material taught by Geiger since such modification or material substitution is within the skill of the ordinary artisan obtained through routine experimentation in determining optimum results.
Regarding claim 19, Glocker discloses a medical hollow body 5 with a cap 1 according to claim 1.
Regarding claim 20, Glocker and Geiger discloses a method of producing a cap according to claim 1 (and some of its components) via a two-component injection moulding process. But they fail to specifically disclose the base body and the sealing element are produced by means of a two-component injection moulding process. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Glocker/Geiger cap and components by making them in a two-component injection moulding process since this process is old and well known in the art of injection moulding.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Glocker (US 20150238703 A1) in view of Geiger et al (US 20060178627 A1), and further in view of Hund et al (WO 2008077484 A1).
Regarding claim 17, Glocker/Geiger discloses the invention substantially as claimed. However, they fail to disclose the cap 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.
Hund teaches in figure 2 a cap 1 having a first and second gripping mould 27 on a lateral surface of the base body to assist with the grip. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Glocker/Geiger cap by proving it with a first and second gripping mould on a lateral surface of the base body since such modification would have enhance the grip of the cap while handling it.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 3-5, 11, and, 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the art of record does not teach or render obvious a cap including the engaging element has at least one first groove, 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, in combination with the elements set forth in the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm.
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, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights