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 .
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 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.
DETAILED ACTION
This is the first action for application #17/683884, Means of Attaching A Disposable Drainage Bag For Urological, Gynecological, and Other Surgical Procedures, filed 3/1/2022, since the filing of a Request for Continued Examination on 5/5/26. Claims 1, 3, 11-13, and 16-25 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “111” has been used to designate a flap, but is pointing to a threaded tube, and “114” has been used to designate a threaded tube but is pointing to a flap in Figure 2A.
The drawings are objected to under 37 CFR 1.83(a) because Figure 3A fails to show a band acceptance slot 307 as described in the specification. While the numeral is there, the band acceptance slot is not depicted. Only the rail channel is depicted. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 335.
The drawings are objected to because the lower leader line of numeral “335” in Figure 3A is not pointing to the lower prong.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “327” has been used to designate both a flange and a screw head.
The drawings are objected to because there are two occurrences of numeral “411” in Figure 4A.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 515, 517.
The drawings are objected to because there are two occurrences of the numeral “511” in Figure 5A that both appear to be pointing to a rod, which is redundant.
The drawings are objected to under 37 CFR 1.84(h)(5) because it is not clear which portions belong to Figure 6A, 6B, and 6C. The figures should be spaced apart such that each figure clearly stands on its own. There is structure under the numeral “602” that appears to be a different view altogether.
The drawings are objected to because in Figure 10, it is unclear if the threaded portion passes INTO the structure of the mount arm since that is what appears to be depicted but the specification does not state this and none of the mount arms are depicted with recesses or apertures on the lower surface thereof.
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.
Specification
The specification was previously objected to as being replete with errors. An amended specification was filed on 5/5/2026 but it was NOT ENTERED:
The specification amendment filed 9/25/2025 has a marked copy and a clean copy. The first line of the second full paragraph on page 23 of the specification was amended as shown in the marked copy. However, the clean copy did not have the same amendments. In the specification amendment filed 5/5/2026, the amendment of 9/25/2025 of the first line of the second full paragraph on page 23 of the specification was NOT included. Therefore, the amendment of 5/5/2026 was NOT ENTERED. All future specification amendments should be based on the MARKED copy from 9/25/25.
In an effort to further prosecution, the Examiner has listed many of the errors below, many of which were previously listed. The Examiner notes that it is the burden of the Applicant to assure that the application is clear and free of errors. The Examiner suggests that the Applicant review the specification in its entirety and amend accordingly to assure that each element is accounted for. Each element should be defined correctly in the specification and be defined in the drawings. No new matter will be permitted. The Examiner notes that upon initial review of the not-entered specification, all of the objections would not have been overcome.
The specification is objected to because numeral “110” is used to refer to both the drainage bag system and the drainage bag drape.
The specification is objected to because the specification defines numeral “101a” and then states “not shown”. A reference numeral cannot be defined in the specification and not included in the drawings. Therefore, the numeral “101a” should be deleted from the specification.
The specification is objected to because numeral “103” defines both a drain tube and a threaded tube.
The specification is objected to because medial surface 209, lip 210, and lip 211 are all defined as being a “proximal surface”. However, the lips oppose the medial surface and therefore they cannot all be considered ‘proximal’.
The specification is objected to because in the second to last paragraph of page 22, the band acceptance slot is referred to as “208”, but it was previously defined as “207”.
The specification is objected to because the first sentence of the second full paragraph on page 23 is a fragment (marked-copy of 9/25/25).
The specification is objected to because in the second paragraph of page 24, the specification states that the knob 301 engages 318 “via fin 315” but fin 315 is on the opposite side of the accessory mount clamp so the knob would not engage with the fin.
The specification is objected to because the accessory mount clamp in Figure 3A is defined as both “316” and “331” in the specification, and “316” is also used to define an upper arm.
The specification is objected to because the first line of page 25 is referencing numerals 221 and 217 that are from a previous embodiment, and not the embodiment being discussed.
The specification is objected to because the spacer has been referred to as both 323 and 322
The specification is objected to because the disposable clamp is defined as both “401”, “418”, and “410” in the specification. Numeral “418” is also used to define the upper ledge.
The specification is objected to because both numerals “510” and “520” were used to define the hole in the lower arm 518.
The specification is objected to because numeral “604” was used to define both the hole in the spacer and in the lower arm.
The specification is objected to because numeral “630” was used to define both the clamp and the lower ledge.
The specification is objected to because numeral “820” is used to define a prong and also the band. The band is further defined by numerals “807” and “829”.
The specification is objected to because numeral “1013” is used to define both a protuberance and a hole.
The specification is objected to because numeral “1115” has been defined as both an “engagement surface” and a “proximal clamp wall”.
The specification is objected to because on page 29 of the specification it is stated that the distance “Q” is measured between center line “E” of the hole 1111 and center line “E” of the clamp 1110, but the clamp does not have a center line “E”.
The specification is objected to because numeral “1114” has been defined as both a “chase” and a “table rail”.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: In Claim 1, when defining the accessory mount clamp, the phrase “wherein said upper and lower arms are substantially parallel with a top surface of the upper platform and a bottom surface of the lower platform” needs to be added to the specification.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: The phrase “of the band of the band” should be ---of the band---. 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 1, 3, 11-13, and 16-25 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 pre-AIA the applicant regards as the invention.
Regarding Claim 1:
-The phrase “wherein the accessory mount clamp comprises at least one upper arm, at least one lower arm, wherein said upper and lower arms are substantially parallel with a top surface of the upper platform and a bottom surface of the lower platform” is unclear.
First, the accessory mount clamp is not positively defined in combination with the drainage band system (drainage bag, band, and at least one mounting clamp), so claiming the specific structure thereof makes it unclear if the accessory mount clamp is being claimed in combination. The Examiner suggests claiming the accessory mount clamp after claiming the at least one mounting clamp, such that the rest of Claim 1 and the dependent claims can properly claim the structure and relationships, and since the allowable subject matter is based on the interaction between the accessory mount clamp and the rail acceptance channel.
Secondly, from viewing elected Figure 2C, the accessory mount clamp (215) only comprises one upper arm (216) and one lower arm (217). Therefore, it is unclear what the structure would be with additional arms as suggested by the “at least one” phrase. The Examiner suggests removing the “at least one” phrases and replacing them with the terms “a” or “an”.
-There is no antecedent basis for “the upper surface” in the last line of the claim.
Regarding Claims 11-13:
-It is unclear if the chase being claimed in Claim 11 and its dependents is the same chase claimed in claim 1.
Regarding Claim 16:
-The Examiner notes that the accessory mount arm is not positively claimed and therefore the fin cannot be positively claimed. The Examiner suggests positively claiming the accessory mount arm in Claim 1.
Regarding Claims 17, 21, and 22:
-There are several phrases beginning with the term “upper” or “lower” that are not preceded by an article (a, the). The term “the” should be added before each of these phrases for proper antecedent basis.
Regarding Claim 23:
-It is unclear if “a protrusion” is in addition to the protuberance (212) already claimed in Claim 1. In Figure 2C, the Examiner does not see any other ‘protrusion’ formed on the band other than the protuberance 212, which was already claimed.
Allowable Subject Matter
Claims 1, 3, 11-13, and 16-25 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 Examiner notes that claim 1 should be amended to positively claim the accessory mount clamp.
Additionally, the claims currently have several 112 rejections, and the drawings and specifications are replete with errors. Any amendment that changes the scope of the invention may alter the allowability of the claims.
Response to Arguments
Regarding the Drawings:
-The Applicant argues that the band acceptance slot is clearly depicted in Figure 3A. The Examiner has fully considered this but it is not persuasive. While the numeral “307” is there, the band acceptance slot is not depicted. Only the rail channel is depicted. For reference, the Examiner suggests viewing Figure 2C, which does show both a band acceptance slot and a rail channel, while Figure 3A only depicts a rail channel.
-The Applicant argues that the two occurrences of numeral “411” in Figure 4A are both pointing to the bag. While the Examiner understands that both are pointing to the bag, having two occurrences of the same numeral in the same Figure is redundant and one of the numerals should be deleted.
Regarding the Specification:
-As noted above, the specification amendment was NOT ENTERED.
Regarding the Claims:
-Regarding Claim 1, the Examiner had previously rejected the claim under 112(a) since the only ‘arms’ that were defined as being substantially parallel with the platforms belonged to the mounting clamp, not the accessory clamp. The Applicant argues that the “arms” are part of the accessory mount clamp and reproduced a portion of page 23. The Examiner has fully considered this but it is not persuasive. The portion of the specification reproduced by the Applicant merely defined the accessory mount clamp has having upper and lower arms. It did not disclose that these arms were parallel with the platforms. The Examiner’s argument wasn’t that the accessory mount clamp didn’t comprise arms, but rather that the specification didn’t teach those specific arms as being parallel with the platforms. However, the Examiner has reconsidered the rejection, and instead objected to the specification as lacking antecedent basis for the claimed terminology since the figures reasonably depict the claimed limitation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to INGRID M WEINHOLD whose telephone number is (571)272-8822. The examiner can normally be reached on Monday-Tuesday 7:00am-5:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terrell McKinnon can be reached on 571-272-4797. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/INGRID M WEINHOLD/
Primary Examiner, Art Unit 3632
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