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 statement(s) (IDSs) submitted on 9/9/24, listing about 207 documents, is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Claims
Claims 1-27 are pending in the application.
Claim Interpretation
The claims are interpreted in light of the teachings of Applicants’ Specification. MPEP 2173.01. However, since limitations from the specification are not read into the claims MPEP 2111.01(II), the claims are interpreted according to their broadest reasonable interpretation MPEP 2173.01. The claims use the term “plastomer”, as defined by Applicants, as a polymer material having both plastic properties and elastomer properties, including polybutene-1 (PB-1) blended with polyolefins (Spec. [0019]). The claims will be so interpreted.
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 1-27 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.
Independent claims 1 and 14, lines 1-3, are considered indefinite for the use of the term “extending between drainage eyelets at a proximal insertion end of the catheter shaft”, because it is unclear whether the drainage eyelets are part of the claimed urinary catheter, as the language does not specify that the drainage eyelets are part of the urinary catheter. Appropriate correction is required, e.g., amending claim 1 to recite: “a lumen, and drainage eyelets, the lumen extending between the drainage eyelets at a proximal insertion end of the catheter shaft”. For purposed of examination, the claim will be interpreted where the drainage eyelets are considered to be part of the catheter.
Claim 26, line 3, is considered indefinite for the term “preferably”, as it is not clear whether the limitation after “preferably” is included in the claim or not. Appropriate correction is required, e.g., deleting the term “preferably”.
The remaining claims are rejected as dependent upon a rejected base claim.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 1-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hollister (WO 2019/113077 A1) in view of Gustavsson (US 2015/0001107 A1).
As to independent claims 1 and 14, Hollister teaches a urinary catheter (as urinary catheter made of materials having mechanical properties, such as stiffness and flexibility, that are stable over range of temperatures (Abstract), comprising: a catheter shaft comprising a substrate (catheter tube material; ([0012]) and a hydrophilic coating provided on the substrate ([0012],ll.15-16), wherein the substrate is formed of a material comprising 70-99% or at least 80% of a plastomer (5-95%, up to 100% [0019],ll.1-3) and 1-30% of a polyolefin (30% polyolefin [0019],ll.5) as at least one of polyetheylene or polypropylene (where a portion of urinary catheter tube may include a thermoplastic elastomer (TPE) or TPE blended with other polymers, and where the TPE may be compounded or blended with a polyolefin such as polypropylene, polyethylene, [0017], where the TPE may be a poly(1-butene)-based plastomer, such as PB-1 Purell KT MR 07 and copolymers thereof [0018],ll.8-9) (with Purell KT MR 07 the same component as disclosed by Applicants [0095],ll.5-6), and/or copolymers thereof [0018]); where the plastomer, as comprising TPE and polyolefin can be 5-95%, such that plastomer can be up to 100% [0019],ll.1-3, thus including where:) the plastomer can be at least 80%.
Hollister does not teach the specific structural details of the urinary catheter, including a catheter shaft and a discharge element, a lumen extending between drainage eyelets at a proximal insertion end of the catheter shaft and an opposite distal discharge end at the discharge element.
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However, Gustavsson teaches a urinary catheter 1 (Fig.2) comprising a hydrophilic surface coating (Abstract, ll.2; [0046],ll.2) comprising a catheter shaft 12 (Fig.2;[0047],ll.4) and a discharge element 14 (applicator 14; [0048]), a lumen (within 12 Fig.2) extending between drainage eyelets (as openings adjacent proximal insertion end 13 Fig.2; [0047],ll.5-6) at a proximal insertion end 13 (Fig.2; [0047],ll.5-6) of the catheter shaft 12 (Fig.2) and an opposite distal discharge end 11 (catheter insertion end 11; Fig.2; [0047],ll.4-5) at the discharge element 14 (Fig.2, [0046]–[0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of Hollister with the functional and structural elements of Gustoavsson, and one of skill would have been motivated to do so, in order to provide the functional and structural elements of a urinary catheter that are required for the proper use of a urinary catheter.
As to claims 2-4 and 15-16, Hollister teaches wherein the substrate (e.g., the catheter shaft) is formed of a material comprising: at least 90, 99, and 100 wt% of plastomer (where the plastomer as comprising TPE and the polyolefin can each be 5-95%, such that plastomer with both the TPR and polyolefin can be up to 100% [0019],ll.1-3, thus including where the plastomer can be at least 90, 99, or 100%, as claimed); and 10-30 wt% of polyethylene or polypropylene (a polyolefin (30% polyolefin [0019],ll.5) as at least one of polyetheylene or polypropylene [0017].
As to claims 5-7 and 17-19, Hollister teaches wherein the plastomer comprises an ethylene alpha olefin copolymer, where. the alpha olefin comprises at least one of 1-butene or 1-hexene and 1-octene; and wherein the plastomer comprises polybutene-1 (where the TPE may be a poly(1-butene)-based plastomer as an ethylene alpha olefin copolymer, such as PB-1 Purell KT MR 07 and copolymers thereof [0018],ll.8-9) (with Purell KT MR 07 the same component as disclosed by Applicants [0095],ll.5-6), and/or copolymers thereof [0018]).
As to claims 8 and 20, Hollister does not specifically teach wherein the discharge element, in the form of a flared funnel, is formed as an integrated, monolithic unit with the catheter shaft, and formed of the same material as the substrate.
However, Gustovsson teaches wherein the discharge element 14, in the form of a flared funnel (flared cuff as shown in Fig.2; [0048],ll.1-2), is formed as an integrated, monolithic unit with the catheter shaft (as attached including integrated, optionally releasably attached [0048],ll.1-2), and formed of the same material as the substrate (where entire catheter can be made of a hydrophilic material [0037],ll.3,1-3), in order to provide a hydrophilic urinary catheter to provide a smooth and slippery surface when wetted, for safe and comfortable insertion into the urinary canal or urethra [0002],ll.11-14. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of Hollister with the flared funnel integrated with the catheter shaft 12 and formed of the same of Gustavsson, and one of skill would have been motivated to do so, in order to provide a hydrophilic urinary catheter to provide a smooth and slippery surface when wetted, for safe and comfortable insertion into the urinary canal or urethra.
As to claims 9-10 and 21, Hollister does not specifically teach wherein the hydrophilic coating comprises a hydrophilic polymer or polyvinylpyrrolidone.
However, Gustavsson teaches wherein the hydrophilic coating comprises a hydrophilic polymer or polyvinylpyrrolidone (PVP or alternative hydrophilic polymer [0049],ll.9-18), in order to provide a hydrophilic urinary catheter to provide a smooth and slippery surface when wetted, for safe and comfortable insertion into the urinary canal or urethra [0002],ll.11-14.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of Hollister with the hydrophilic coating comprising a hydrophilic polymer or PVP of Gustavsson, and one of skill would have been motivated to do so, in order to provide a hydrophilic urinary catheter to provide a smooth and slippery surface when wetted, for safe and comfortable insertion into the urinary canal or urethra.
As to claims 13 and 26-27, Hollister teaches a urinary catheter assembly comprising the urinary catheter of claim 1 (as presented above). Hollister does not teach a package accommodating the urinary catheter, wherein the package is made of a material comprising a polyolefin as same material as catheter as at least one of polyethylene and polypropylene.
However Gustovsson teaches a package accommodating the urinary catheter ([0010],ll., wherein the package is made of a material comprising a polyolefin (as 1st and 2nd sheet material [0053],ll.1-2 where sheets made of polyolefin as polyethylene and/or polypropylene [0054],ll.1,4-5) (as same polyolefin materials disclosed by Applicants as polyolefin comprising polyethylene and/or polypropylene (Applicants’ Spec: [0060]))
in order to provide easy, clean, and efficient wetting and handling of the hydrophilic catheter and to provide sterile conditions [0016],ll.4-6.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter assembly of Hollister with the olefin package of Gustavsson, and one of skill would have been motivated to do so, in order to provide easy, clean, and efficient wetting and handling of the hydrophilic catheter and to provide sterile conditions.
As to claims 11-12 and 22-23, Hollister and/or Gustavsson do not specifically teach specifically wherein the material of the substrate further comprises a slip agent in the range of 0.01 wt% to 3 or 0.5 wt%.
However, it would have been obvious to one of skill in the art before the effective filing date to provide well known slip agents in the recited range, where Applicants’ specification teaches that slip agents are well known in the art in the recited ranges of wt% (where “slip agents are per se known in the art” Applicants’ specification, [0043],ll.4-5; in the recited ranges Applicants’ specification [0044]), and where Applicants do not teach that the recited ranges provide unexpected results over the prior art teachings, and provide the advantage of preventing sticky surfaces of the catheter, where blended in slip agents alleviate this problem by reducing the coefficient of friction of the material to which they are added (Applicants’ specification, [0043],ll.1-4).
As to claim 24, Hollister teaches wherein the substrate is formed of a material comprising a blend (TPE blended with a polyolefin [0017],2-3) of: 70-90 wt% of polybutene-1 (65-95%, up to 100% [0019],ll.1-2,5; polyolefin as as poly(1-butene) as plastomer, such as PB-1 Purell KT MR 07 and copolymers thereof [0018],ll.8-9) (with Purell KT MR 07 the same component as disclosed by Applicants [0095],ll.5-6)) and 10-30 wt% (5 to 30 wt% [0019],ll.3,5) of polypropylene ([0017],ll.6).
As to claim 25, Hollister teaches wherein the substrate is formed of a material comprising a blend (TPE blended with a polyolefin [0017],ll.2-3) of: 70-90 wt% of ethylene-alpha olefin copolymer (65-95%, up to 100% [0019],ll.1-2,5; plastomer as an ethylene alpha olefin copolymer, such as PB-1 Purell KT MR 07 and copolymers thereof [0018],ll.8-9) (with Purell KT MR 07 the same component as disclosed by Applicants [0095],ll.5-6), and/or copolymers thereof [0018]); and 10-30 wt% 5 to 30 wt% [0019],ll.3,5) of polyethylene (polyethylene [0017],ll.7); and 15-25 wt% (5 to 30 wt% [0019],ll.3,5) of polyethylene (polyethylene [0017],ll.7).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957). Claims 1-3 and 14-27 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-7, 9-10, 12-13, and 15-21 of co-pending Application No.18/828469, as mapped below. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claim
1
2
3
14
15
16
17
18
19
‘469
19
20
21
1
2
3
4
5
6
Claim
20
21
22
23
24
25
26
27
‘469
7
9
10
12
13
15,16
17
18
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Non Statutory Obviousness Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-27 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-21 of US Patent Application No. 18/828469 (‘469). This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
As to Claims 1-27, claims 1-21 of ‘469 disclose or suggest the claimed delivery and fluid storage bridge, as mapped below (wherein claim dependency in the cited claims are indicated where cited claim 3, dependent on claim 2, dependent on claim 1, is designated “3(/2/1)”, etc.):
Claim
1
2
3
4
5
6
7
8
9
10
‘469
19
20 (/19)
21 (/19)
21 (/19)
4 (/1)
5 (/4 /1)
6 (/4 /1)
7
(/1)
8
(/1)
9
(/1
Claim
11
12
13
14
15
16
17
18
19
20
‘469
11
(/10
/1)
12
(10
/1)
17
(/1)
1
2 (/1)
3 (/1)
4 (/1)
5 (/4/1)
6
(/1)
7 (/1)
Claim
21
22
23
24
25
26
27
‘469
9 (/1)
10 (/1)
12
(/10 /1)
13 (/1)
15 (/1), 16 (/1)
17 (/1)
18 (/17 /1)
The differences between present claims and most of the claims of ‘469 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, the ‘469 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘469 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘469 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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