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 .
Status of Claims
The amendment filed 07/08/2026 has been entered. Claims 1-4, 7-12 are pending in the application. Applicant’s amendments to the claims have not overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 04/08/2026.
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, 7, and 10 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 3 recites the limitation “the adhesion material” in line 3. It is unclear if this is the same or different than the adhesion material recited in claim 1. For the sake of examination, the limitation will be interpreted as reciting “a second adhesion material”.
Claim 7 recites the limitation, “the sealing tube of silicone rubber” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the sake of examination, claim 7 will be interpreted as depending from claim 3.
Claim 10 recites “the hydraulic system” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the sake of examination, the limitation will be interpreted as “the rear base piece”
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 1-4, 7, 10, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 5,160,319) in view of Yoshime (US 2018/0193123) and further in view of Bacich (US 2020/0023162) and further in view of Oktay (US 2006/0205073) and further in view of Hastings (US 2022/0062563) as evidenced by Axsom (“Teflon (Polytetrafluoroethylene) PTFE and the Coefficient of Friction”).
Regarding Claim 1, Emery discloses an oocyte aspiration needle (10, Fig 2) with double lumen, said aspirator needle comprising a needle (30, Fig 3) connected to a bifurcated chamber (chamber near numeral 22) composed of a front base piece (12, Fig 2) and coupled to a rear base piece (20, Fig 2); wherein said needle has an aspiration hose (36, Fig 2) inserted internally into said needle (See Fig 2);
Emery is silent regarding a rod; said needle being fitted into a duct and joined in the fastening region with adhesion material wrapped in the housing internal to said front base piece; and wherein said aspiration hose consists of a thermoplastic material with low friction coefficient; and wherein said needle has a total length less than 110 mm.
Yoshime teaches an analogous aspiration needle comprising a rod coupled a proximal end of the base (2, Fig 1), wherein the rod is coupled via a threaded connection (8, Fig 1) (Para 0021).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to include a rod and threaded connection as taught by Yoshime in order to have improved fastening of a rod, have fewer components, and aid in leading the device into a guide device (Para 0003, Para 0028-0029).
The modified invention of Emery and Yoshime discloses all of the elements of the invention as discussed above, however is silent regarding said needle being fitted into a duct and joined in the fastening region with adhesion material wrapped in the housing internal to said front base piece; and said aspiration hose consists of a thermoplastic material with low friction coefficient; and wherein said needle has a total length less than 110 mm.
Bacich teaches an analogous aspiration hose (16 and 30, Figs 1A and 1B) consisting of a thermoplastic material with low friction coefficient (“Teflon”, Para 0071) (As detailed in the table on page 5 of Axsom, Teflon has a static coefficient of friction of between 0.02-0.23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration hose to consist of Teflon as taught by Bacich in order to have a hose made of a translucent material to allow the physician to visualize the tissue being pulled into the hose (Para 0071).
The modified invention of Emery, Yoshime, and Bacich discloses all of the elements of the invention as discussed above, however is silent regarding needle has a total length less than 110 mm; and said needle being fitted into a duct and joined in the fastening region with adhesion material wrapped in the housing internal to said front base piece.
Oktay teaches an analogous aspiration needle wherein the regarding needle has a total length less than 110 mm (“3cm-9cm”, Para 0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle to have a total length of less than 110mm as taught by Oktay in order to allow for accurate needle placement and oocyte retrieval (Para 0025).
The modified invention of Emery, Yoshime, Bacich, and Oktay discloses all of the elements of the invention as discussed above, however is silent regarding said needle being fitted into a duct and joined in the fastening region with adhesion material wrapped in the housing internal to said front base piece
Hastings teaches a needle (12, Fig 1) being fitted into a duct (106, Fig 1) and joined in the fastening region with adhesion material (200b, Fig 19E) wrapped in the housing internal to a front base piece (100, Fig 19E) (Para 0143-0144; See Figs 19a-19E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle to be fitted in a duct and joined in the fastening region with adhesion material as taught by Hastings in order to reliably and axially secure the needle to the front base piece (Para 0144-0145).
Regarding Claim 2, the modified invention of Emery, Yoshime, Bacich, Oktay, and Hastings discloses the thermoplastic material (“Teflon”, Para 0071 -Bacich) of the aspiration hose having a static friction coefficient of 0.05 p (As detailed in the table on page 5 of Axsom, Teflon has a static coefficient of friction of between 0.02-0.23).
Regarding Claim 3, the modified invention of Emery, Yoshime, Bacich, Oktay, and Hastings discloses all of the elements of the invention as discussed above, however is silent regarding said aspiration hose being fastened and insulated, by means of a sealing tube of silicone rubber, together with an adhesion material, to an entire internal watertight hydraulic system composed of the bifurcated chamber and said needle.
Hastings teaches a tube or hose (12, Fig 1) being fastened and insulated, by means of a sealing tube of silicone rubber (100, Fig 19E; Para 0093), together with a second adhesion material (200a, Fig 198E), to a chamber (14, Fig 19E) (Para 0134; See Figs 19a-19E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration hose to be fastened and insulated to the front base piece, by means of a sealing tube of silicone rubber, together with an adhesion material as taught by Hastings in order to have a connection that can relieve radial stress imparted on the hose arising from movement of the hose during use (Para 0092).
Regarding Claim 4, the modified invention of Emery, Yoshime, Bacich, Oktay, and Hastings discloses said adhesion material comprising an epoxy glue (Para 0134 -Hastings).
Regarding Claim 7, the modified invention of Emery, Yoshime, Bacich, Oktay, and Hastings discloses said aspiration hose (36, Fig 2 -Emery) being passed through a channel (18, Fig 2 -Emery) and kept pressed by the sealing tube of silicone rubber (100, Fig 1-Hastings) housed in a cavity subsequent and aligned with the channel (Para 0134 -Hastings; See Fig 19E wherein the sealing tube is aligned with the channel 42).
Regarding Claim 10, the modified invention of Emery, Yoshime, Bacich, Oktay, and Hastings discloses the front base piece fits tightly to the cavity in the rear base piece (Col 3, lines 51-57; See Fig 2 -Emery), and said rear base piece has a coupling thread (8, Fig 2 -Yoshime) for connecting the rear base piece to the rod (Para 0021 -Yoshime).
Regarding Claim 11, the modified invention of Emery, Yoshime, Bacich, Oktay, and Hastings discloses a method for using an oocyte aspiration needle with double lumen, as defined in claim 1 (See the rejection of claim 1 above), said method comprises using the needle in the collection of oocytes in ovaries from animals, in assisted reproduction procedures (Col 1, lines 5-10 -Emery).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 5,160,319) in view of Yoshime (US 2018/0193123) and further in view of Bacich (US 2020/0023162) and further in view of Oktay (US 2006/0205073) and further in view of Hastings (US 2022/0062563) and further in view of Williams (US 4,553,957).
Regarding Claim 8, the modified invention of Emery, Yoshime, Bacich, Oktay, and Hastings discloses said aspiration hose (36, Fig 2 -Emery) being in a space of relief and communication (See space in Fig 2 near numeral 22 -Emery), through which it is directed internally to said needle (30, Fig 2 -Emery) until close to the bevel (46, Fig 2 -Emery), leaving a spacing between the internal walls of said needle and the external surface of said aspiration hose (Col 4, lines 21-24 -Emery), however, is silent regarding the aspiration hose being slightly curved.
Williams teaches an analogous aspiration needle having an aspiration hose (30, Fig 2) that is slightly curved in a space of relief and communication, through which it is directed internally to said needle (40, Fig 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration needle to have a handle to have a handle tube and curved aspiration hose arranged as taught by Williams in order to have a device arranged such that the handle tube can serve as a reservoir for supplied pressurized fluid (Col 4, lines 4-17).
Regarding Claim 9, the modified invention of Emery, Yoshime, Bacich, Oktay, Hastings, and Williams discloses said relief and communication space creating a direct communication between said spacing and the communication channel which is directly connected to the irrigation inlet duct, which is connected to the irrigation hose (Col 4, lines 4-17 -Williams).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Emery (US 5,160,319) in view of Yoshime (US 2018/0193123) and further in view of Bacich (US 2020/0023162) and further in view of Oktay (US 2006/0205073) and further in view of Hastings (US 2022/0062563)and further in view of Hagby (US 2010/0179377).
Regarding Claim 12, the modified invention of Emery, Yoshime, Bacich, Oktay, and Hastings discloses all of the elements of the invention as discussed above, however is silent regarding the animals are selected from the group consisting of cattle, horses and/or pigs.
Hagby teaches an analogous method comprises using the needle in the collection of oocytes in ovaries from animals, in assisted reproduction procedures (Para 0001-0002, 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to include collection of oocytes in ovaries from animals including cattle and horses as taught by Hagby as it is well known that assisted reproduction procedures can be done in humans as well as animals such as cattle and horses (Para 0054).
Response to Arguments
Applicant’s arguments filed 07/08/2026, on pages 6-12, regarding Emery’s device is very specialized and thus does not lend itself to simple modifications have been fully considered but is not persuasive. Applicant argues that the Examiner relied on impermissible hindsight reconstruction. 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). As detailed in the rejection of claim 1 above, Examiner has provided motivation for each and every modification. Those motivations are only gleaned from the prior art itself. Further, Applicant has not provided any specific reasoning why the cited reference cannot be combined other than Emery’s device is unique. Even unique devices can be improved with knowledge from the art that may not have been considered at the time they were invented.
Applicant’s arguments filed 07/08/2026, on pages 13, regarding the lack of motivation to combine the prior art have been fully considered but is not persuasive. Applicant argues that Bacich does not recognize the issue of cellular damage due to friction or suggests the use of low-friction materials. This is not necessarily relevant as the basis for one of ordinary skill to modify a piece of prior art to arrive at a claimed invention is not reliant on the motivations being the same as those of the inventor. In the case of modifying the material of the aspiration hose to be Teflon, Bacich makes it clear the translucent or optically clear property makes it desirable to allow the physician to visualize the tissue being pulled into the device (Para 0071). Thus, one of ordinary skill could choose the material for its optical properties even if Applicant chose the material for its friction properties.
Applicant’s arguments filed 07/08/2026, on pages 13-14, regarding the unexpected results have been fully considered but are not persuasive. Applicant is comparing a 500mm metal needle to the instant invention in trying to argue unexpected results. However, as detailed in the rejection of claim 1 above, the combined invention teaches a 3cm – 9cm (30mm-90mm) length needle (Para 0025 of Oktay). Figure 9 has no bearing on comparing the prior art combination and the instant invention. Thus, Applicant has not provided sufficient evidence of unexpected results.
Applicant’s arguments filed 07/08/2026, on pages 14-15, regarding Combining the prior art devices results in an inoperable device have been fully considered but are not persuasive. Applicant argues that Emery is directed to a transvaginal procedure while Oktay is directed to oocyte collection from ovarian tissue implanted subcutaneously. First, Emery teaches a laparoscopic or transvaginal procedure (Col 1, lines 19-26) and does not provide a specific length of the needle. Examiner points out that Emery is directed to “a device…described for retrieving human oocytes form a female ovary “ (Col 2, lines 21-24). Oktay’s needle is also for retrieving human oocytes form a female ovary (Para 0004). Therefore, the combined device would still be able to retrieve human oocytes form a female ovary, thus the device would still be capable of performing the intended function.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
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