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
The amendment filed 03/12/2026 has been entered. Claims 1-20 remain pending in the application . Applicant’s amendments to the claims have overcome each 112(b) rejection and drawing objection, however has not overcome the interpretation of the prior art rejection previously set forth in the Non-Final Office Action mailed 12/12/2025.
Response to Arguments
Applicant's arguments filed 03/12/2026 have been fully considered but they are not persuasive.
With regards to Applicant's arguments on pages 7-9 in that modifying Hariri's device in view of Schaub would render Hariri's device unsatisfactory or inoperable for its intended purpose, by reducing the constriction and grasping function central to Hariri's elongated cylindrical net-like structure, the Office respectfully disagrees. Schaub's hydrogel provides the advantage of reducing friction of the unopened amniotic sac with the birth canal as disclosed in paragraph 17. The effect of the lubricant as disclosed in paragraph 14 is to form "a lubricant layer between preferably the entire surface of the birth canal and the fetus. Vaginal child birthing is considerably facilitated and expedited by a reduction in friction (irrespective of whether it is static friction, sliding friction and/or rolling friction) between fetus and surface of the birth canal." The grasping/tractive force of Hariri would still be able to operate as intended to, as Schaub's hydrogel would only facilitate the process. Hariri's device is NOT being replaced with the hydrogel composition of Schaub, as Schaub's hydrogel membrane is being included with the cylindrical net-like structure of Hariri to further assist in childbirth. This inclusion would not predictably detract from Hariri’s traction/grasping function, as the tractive forces would still be applied in addition to the lubricating hydrogel to help facilitate the process, as taught by Schaub. Therefore, the rejection is maintained.
In response to applicant's argument on page 10 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). Applicant states there is no apparent reason to combine Hariri and Schaub in the manner suggested by the Office. However, the combination of Hariri in view of Schaub applies the structure of the device of Hariri which assists in childbirth, and modifies the structure of Hariri to add the hydrogel membrane as taught by Schaub who provides several compositions which assists in childbirth. Thus, there is no impermissible hindsight since Hariri and Schaub are related to assisting in childbirth, and such modification would have been obvious to one of ordinary skill in the art.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hariri et al. (US Patent 4,875,482), hereinafter known as “Hariri,” in view of Schaub (US PGPub 2005/0053670).
With regards to claim 1, Hariri discloses (Figures 4-5) a device (figure 4) for assisting childbirth (Abstract), the device (figure 4) comprising:
a crown 10/40 for being worn on a baby’s head (figures 4-5; Col 8 lines 51-61); and
a bulbous rim 44 defining an opening in the crown 10/40 (figures 4-5; Col 8 lines 14-61 – rim of the guide ring 44 inflates and protrudes/bulges radially outwards similarly to a bulbous structure);
wherein the opening is for receiving the baby’s head (Col 8 lines 51-61).
Hariri is silent wherein the crown and the bulbous rim are made from a lubricating hydrogel.
However, in a similar field of endeavor of birth delivery devices, Schaub teaches wherein hydrogels are a physiologically acceptable organic substance and can be used by women as a lubricant during vaginal childbirth (Abstract; paragraphs 14-22).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hariri to add wherein the crown and the bulbous rim are made from a lubricating hydrogel as taught by Schaub for the purpose of reducing friction of the unopened amniotic sac with the birth canal (paragraph 17 of Schaub).
The combination of Hariri in view of Schaub results in the device that is made from the synthetic polymer fibers (Hariri: Col 5 line 60 – Col 6 line 11) AND the hydrogel (Schaub: paragraphs 14-22), therefore the synthetic polymer fibers of the crown and the bulbous rim of Hariri are made in addition to the hydrogel of Schaub.
With regards to claim 2, Hariri/Schaub disclose wherein the lubricating hydrogel (of Schaub) is reinforced with synthetic polymer fibers (Hariri: Col 5 line 60 – Col 6 line 11 – Nylon thread is a synthetic polymer fiber).
With regards to claim 3, as rejected above, it would have been obvious to modify the device of Hariri to include the lubricating hydrogel as taught by Schaub. Schaub further discloses wherein the lubricating hydrogel comprises water or a water-based lubricant (paragraphs 19-21). Thus, when incorporating the lubricating hydrogel of Schaub, the claimed limitation is considered obvious.
With regards to claim 4, Hariri further discloses wherein the device (figure 4) is a cap (Col 8 lines 51-61; figure 5 – baby’s head is inserted through the opening, therefore reading on the claim language of being a cap).
With regards to claim 5, Hariri further discloses wherein the device (figure 4) is a sleeve (figures 4-5 – baby’s head is inserted through the opening defined by the bulbous rim 44 and into the sleeve as seen in figure 5), wherein the opening is a first opening 44 at one end and the bulbous rim is a first bulbous rim 44 defining the first opening (figures 4-5; Col 8 lines 14-61 – rim of the guide ring 44 inflates and protrudes similarly to a bulbous structure), the sleeve further comprising a second opening 30 at the other end (figures 4-5; Col 7 lines 15-19 and 32-38), and a second bulbous rim 30 located between the first bulbous rim 44 and the second opening 30 (Col 7 lines 15-19 and 32-38 – second guide ring 30 is an alternative guide ring for insertion of a fetal head; Col 8 lines 14-61 – rim of the guide ring inflates and protrudes similarly to a bulbous structure).
With regards to claim 6, Hariri/Schaub disclose the device as claimed in claim 4. The combination does not explicitly disclose wherein the opening of the cap has a diameter (or largest length) of 8 cm to 14 cm.
There is no evidence of record that establishes that changing the diameter of the opening would result in a difference in function of the Hariri/Schaub device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hariri/Schaub, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter. Lastly, applicant has not disclosed that the claimed diameter solves any stated problem, indicating that the diameter “may” be within the claimed diameter, and offering other acceptable diameters (specification at page 7 lines 7-15) and therefore there appears to be no criticality placed on the diameter as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the opening of the cap of Hariri/Schaub to have a diameter (or largest length) of 8 cm to 14 cm as an obvious matter of design choice within the skill of the art.
With regards to claims 7-8, Hariri/Schaub disclose the device as claimed in claim 5. The combination does not explicitly disclose wherein the first opening of the sleeve has a diameter (or largest length) of 7 cm and 12 cm (claim 7); and wherein the second opening of the sleeve has a diameter (or largest length) of 16 cm (claim 8).
There is no evidence of record that establishes that changing the diameter of the first and second openings would result in a difference in function of the Hariri/Schaub device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hariri/Schaub, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameters. Lastly, applicant has not disclosed that the claimed diameter solves any stated problem, indicating that the diameter “may” be within the claimed diameter, and offering other acceptable diameters (specification at page 7 lines 16-33) and therefore there appears to be no criticality placed on the diameter as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first opening of the sleeve of Hariri/Schaub to have a diameter (or largest length) between 7 cm and 12 cm, and the second opening of the sleeve to have a diameter (or largest length) of 16 cm as an obvious matter of design choice within the skill of the art.
With regards to claim 9, as rejected above, it would have been obvious to modify the device of Hariri to include the lubricating hydrogel as taught by Schaub. Schaub further discloses wherein the lubricating hydrogel is biocompatible (paragraph 20). Thus, when incorporating the lubricating hydrogel of Schaub, the claimed limitation is considered obvious.
With regards to claim 10, as rejected above, it would have been obvious to modify the device of Hariri to include the lubricating hydrogel as taught by Schaub. Schaub further discloses wherein the lubricating hydrogel is made from one or more polymers including PVA (paragraph 27). Thus, when incorporating the lubricating hydrogel of Schaub, the claimed limitation is considered obvious.
With regards to claim 11, as rejected above, it would have been obvious to modify the device of Hariri to include the lubricating hydrogel as taught by Schaub. Schaub further discloses wherein the lubricating hydrogel is made from PVA (paragraph 27). Thus, when incorporating the lubricating hydrogel of Schaub, the claimed limitation is considered obvious.
With regards to claim 12, Hariri further discloses wherein the synthetic polymer fibers are woven (cylindrical net-like structure is formed of braided strands of fibers knitted to define a mesh as disclosed in Col 3 lines 49-57 and Col 5 line 60 – Col 6 line 11).
With regards to claim 13, Hariri further discloses wherein the synthetic polymer fibers form a mesh (Col 3 lines 49-57 and Col 5 line 60 – Col 6 line 11).
With regards to claims 14-15, Hariri further discloses wherein the mesh is a warp knit mesh (Col 3 lines 49-57 and Col 5 line 60 – Col 6 line 20).
With regards to claim 16, Hariri further discloses wherein the synthetic polymer fibers are made from polyamide (Col 5 line 60 – Col 6 line 11 – Nylon is a type of polyamide).
With regards to claim 17, Hariri further discloses wherein the synthetic polymer fibers are made from polyamide (Col 5 line 60 – Col 6 line 11 – Nylon is a type of polyamide).
With regards to claim 18, Hariri further discloses wherein the synthetic polymer fibers are made from nylon (Col 5 line 60 – Col 6 line 11).
With regards to claim 19, Hariri/Schaub disclose the device as claimed in claim 1. The combination does not explicitly disclose wherein the lubricating hydrogel of the crown is between 0.1 mm and 2 mm in thickness or between 0.05 mm and 0.5 mm in thickness.
There is no evidence of record that establishes that changing the thickness of the crown would result in a difference in function of the Hariri/Schaub device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hariri/Schaub, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed thickness solves any stated problem, indicating that the thickness “may” be within the claimed range, and offering other acceptable thicknesses (specification at page 18 lines 8-15) and therefore there appears to be no criticality placed on the thickness as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the lubricating hydrogel of the crown of Hariri/Schaub to be between 0.1 mm and 2 mm in thickness or between 0.05 mm and 0.5 mm in thickness as an obvious matter of design choice within the skill of the art.
With regards to claim 20, Hariri/Schaub disclose the device as claimed in claim 1. Hariri further discloses wherein the bulbous rim can be inflated and expanded (Col 8 lines 14-37). Hariri/Shaub do not explicitly disclose wherein the bulbous rim is 5-fold thicker than the crown.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hariri/Schaub to have the bulbous rim 5-fold thicker than the crown since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hariri/Schaub would not operate differently with the claimed thickness of the bulbous rim. Further, it appears that applicant places no criticality on the thickness of the bulbous rim claimed, indicating simply that the thickness “may” be within the claimed ranges (specification page 18 lines 1-6).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bulbous rim of Hariri/Schaub to be 5-fold thicker than the crown as the device would not operate differently.
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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 04/09/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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