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 Amendment
In light of Applicant’s amendment, claim(s) 1 is/are amended. Claims 1-10 are pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 4/10/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Pattison is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the present invention, Shah and Pattison are directed to medical devices, and specifically to dilators.
In response to applicant's argument that Pattison’s dilators are used for esophageal strictures, thus would not be used for PCNL surgery, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Although Pattison is directed to an esophageal dilator system, the shape of the distal end is similar to the distal end of the claimed dilator, and can easily be used in place of the claimed dilator to achieve the same goal.
Further, Applicant argues Pattison is directed to solving different problems from the claimed invention. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Pattison is solely relied upon for teaching plurality of dilators comprising a cone at a distal end of each respective dilator of the plurality of dilators and all the dilators have the same tip length from a proximal end of the cone to the distal end of each respective dilator. The modification to the dilator mentioned in Shah would be obvious as dilators are known in the art, and changing the shape and/or size of a component would be obvious to one having ordinary skill in the art since it has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). In re Rinehart, 531 F.2d 1048, 189 USPQ 143(CCPA 1976). MPEP 2144 and since it has been held that changing the shape was a matter a choice one of ordinary skill in the art would have found obvious. See MPEP 2144. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, both references disclose a plurality of dilators and providing a plurality of dilators with the same tip lengths is known in the art. Further, since Shah is silent towards the tip length of the dilators, there is no indication or reason the modification would result in a disadvantage to Shah's use of dilators for PCNL surgery.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Furthermore, Applicant argues Pattison does not disclose catheters with tip lengths of the same size. However, Pattison teaches tip lengths tapering for about 4 cm in length for dilators with different diameters (Figure 2-3; Col 2, line 48-58). As shown in Figures 1-3, two ends of the dilator constitute different sized dilators and both have a distal most end tapering at about 4 cm. Further, the tips shown in Figure 4 seemingly show tapered tips of the same length across dilators of different diameters.
As such, the arguments are not persuasive and the rejections to claims 1-10 stand over Shan in view of Pattison.
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.
Claim(s) 1, 6, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US 20180289394 A1) in view of Pattison (US 6010520 A) (noted on IDS).
Regarding Claim 1, Shah discloses a device set (kit) designed for PCNL surgery (Paragraph 0019), comprising a puncture needle (Figure 3a, 3b; Paragraph 101), a guidewire (Figure 3a, 3b; Paragraph 101), a plurality of dilators (serial dilators) having different sizes (Figure 3a, 3b; Paragraph 101), a sheath (10) (Figure 3a, 3b; Paragraph 101), and a drainage catheter (11) (Figure 3a, 3b; Paragraph 52, 101) which are all placed in a single package, but fails to teach wherein each of said plurality of dilators comprising a cone at a distal end of each respective dilator of the plurality of dilators and all the dilators have the same tip length from a proximal end of the cone to the distal end of each respective dilator.
However, Pattison is directed to a surgical device set (35) and teaches a device set wherein each
of said plurality of dilators (1a-1e) comprising a cone (2) at a distal end of each respective dilator of the
plurality of dilators (Figures 1-4) and all the dilators have the same tip length from a proximal end of the
cone to the distal end of each respective dilator (Figure 4).
Shah discloses the claimed invention except for wherein each of said plurality of dilators comprising a cone at a distal end of each respective dilator of the plurality of dilators and all the dilators have the same tip length from a proximal end of the cone to the distal end of each respective dilator. Pattison teaches that it is known to have kits wherein each of a plurality of dilators comprises a cone at a distal end of each respective dilator of the plurality of dilators and all the dilators have the same tip length from a proximal end of the cone to the distal end of each respective dilator. It would have been obvious to one having ordinary skill in the art at the time the invention was made to include dilators that
have the same tip length from a proximal end of the cone to the distal end of each respective dilator as
taught by Pattison, since it has been held change in size/proportion does not distinguish over the prior
art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). In re Rinehart, 531 F.2d 1048, 189 USPQ 143(CCPA 1976). MPEP 2144 and since it has been held that changing the shape was a matter a choice one of ordinary skill in the art would have found obvious. See MPEP 2144. In re Dailey, 357 F.2d 669, 149
USPQ 47 (CCPA 1966).
Regarding Claim 6, Shah further teaches the device set wherein the sheath (10) has a size corresponding to a size of one of the dilators having the largest size (Figure 3a, 3b; Paragraph 101).
Regarding Claim 8, Shah further teaches the device set wherein a size of the drainage catheter
(11) is 2Fr less than the size of one of the dilators (serial dilators) having the largest size (Paragraph
0070, 0094). Shah discloses dilators ranging from 6 to 30 Fr and drainage catheters with a diameter of
10 or 12 Fr, thus disclosing two combinations of drainage catheters 2 Fr less than the dilators. It would
have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed
invention to choose a drainage catheter of 10 or 12 Fr and select one of the largest dilators to be 12 or
14 Fr in order to create an opening in the tissue slightly larger than the catheter, as is the common
method during surgery.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Pattison, and further in view of Hibbs et. al (US 4950257).
Regarding Claim 2-3, Shah and Pattison teach the components of the device set in Claim 11, but
fail to teach wherein the tip length is in a range of 0.8 cm to 3 cm, and wherein the tip length is 2 cm.
However, Hibbs is directed to a catheter device and teaches the tip (26) length is in a range of 1.2 cm to 2.5 cm, which encompasses the claimed range of 0.8 cm to 3 cm, and specifically the claimed length of 2 cm (Col 4, line 69- Col 5 line 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention
would have been motivated to modify Shah and Pattison such that the tip length is in a range of 0.8 cm
to 3 cm, as taught by Hibbs, as the references and the claimed invention are directed to a device set for
surgery. It would be obvious to someone of ordinary skill in the art before the effective filing date of the
claimed invention to have modified Shah and Pattison by including the tip length is in a range of 0.8 cm
to 3 cm, as taught by Hibbs, because such a tip length is well known in the art as noted above, and including a tip length in the claimed range would have no impact on the effectiveness of the device since it has been held change in size/proportion does not distinguish over the prior art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). n re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). MPEP 2144
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Pattison,
and further in view of Zwierstra et al. (US 10265234).
Shah and Pattison teach the device set of Claim 1, but fail to teach a plurality of chambers are
formed in the package.
However, Zwierstra is directed to a disposable container for a disposable kit for medical items
and teaches a plurality of chambers (230) are formed in the package (110) (Figure 2; Col 11, lines 1-7,
15-17).
A person of ordinary skill in the art before the effective filing date of the claimed invention
would have been motivated to modify Shah and Pattison such that a plurality of chambers are formed in
the package, as the references and the present invention are directed to a device set. It would be
obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shah and Pattison with the teachings of Zwierstra by incorporating a plurality of chambers formed in the package in order to form compartments to accommodate different types of
items to be stored within the package (Zwierstra Col 11, lines 13-14).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Pattison,
and further in view of Shen (CN 204485018) (All citations to Shen will be made according to the
provided English translation) (previously of record).
Regarding claim 5, Shah and Pattison teach the device set of Claim 1, but fail to teach wherein one or more of the puncture needle, the guidewire, the dilator, the balloon catheter, the sheath and the drainage catheter are provided with scale markers.
However, Shen is directed to a medical device and teaches wherein a drainage catheter (2) is provided with scale markers (22) (Figure 1; Paragraph 0011).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Shah and Pattison such that the drainage catheter is provided with scale markers, as the references and the present invention are directed to a device set for use on
patients. It would be obvious to someone with ordinary skill in the art before the effective filing date of
the invention to have modified Shah and Pattison with the teachings of Shen by incorporating the
drainage catheter provided with scale markers in order to measure the volume of drained urine.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Pattison, and further in view of Guo (US 20080154206 A1).
Regarding claim 7, Shah and Pattison teach the device set of Claim 11, but fail to teach wherein the sheath of the device set is a tearable sheath.
However, Guo is directed to a surgical catheter device and teaches wherein the sheath (2) of the device set is a tearable sheath (Paragraph 0019, 0047).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Shah and Pattison such that the sheath of the device set is a tearable sheath as taught by Guo, as the references and the present invention are directed to devices
for surgery. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shah and Pattison with the teachings of Guo by including the
sheath of the device set is a tearable sheath to allow the sheath to be removed easily (Guo, Paragraph
0003).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Pattison, and further in view of Ceng (CN206434630 U) (All citations to Shen will be made according to the provided English translation).
Regarding Claim 19, Shah and Pattison teach the device set according to Claim 11, but fail to
teach the set further comprising a drainage bag.
However, Ceng is directed to a surgical device set and teaches a set further comprising a
drainage bag (2) (Figure 2; Paragraph 0007).
A person of ordinary skill in the art before the effective filing date of the claimed invention
would have been motivated to modify Shah and Pattison such that the set further comprises a drainage
bag as taught by Ceng, as the references and the claimed invention are directed to device sets for
surgery. It would be obvious to someone of ordinary skill in the art before the effective filing date of the
claimed invention to have modified Shah and Pattison with the teachings of Ceng by including a set
further comprising a drainage bag to store drained urine from a patient.
Regarding Claim 10, Shah and Pattison teach the device set according to Claim 1, but fail to
teach wherein the device set further comprises a drainage bag having a volume in a range of 500ml to
3000ml.
However, Ceng further teaches wherein the device set further comprises a drainage bag (2)
having a volume in a range of 500ml to 3000ml (Figure 2; Paragraph 0019).
A person of ordinary skill in the art before the effective filing date of the claimed invention
would have been motivated to modify Shah and Pattison such that wherein the device set further
comprises a drainage bag having a volume in a range of 500ml to 3000ml, as taught by Ceng, as the
references and the claimed invention are directed to device sets for surgery. It would be obvious to
someone of ordinary skill in the art before the effective filing date of the claimed invention to have
modified Shah and Pattison with the teachings of Ceng by including wherein the device set further
comprises a drainage bag having a volume in a range of 500ml to 3000ml in order to retain a sufficient
amount of urine (Ceng Paragraph 0004).
Conclusion
THIS ACTION IS MADE FINAL. 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 ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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