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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/30/2026 has been entered.
Response to Amendment
The amendment filed 03/30/2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome the interpretation of the prior art rejection previously set forth in the Final Office Action mailed 01/30/2026, however a new rejection is made in view of Haadem (see rejection below).
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 9, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haadem (US PGPub 2011/0022056).
With regards to claim 1, Haadem discloses (Figures 2A-2B and 5A-5B) a device 10 for assisting childbirth (paragraph 31), the device 10 comprising:
a hydrogel membrane 21/22 formed from a hydrogel material for at least one of covering at least a part of a baby in a birth canal or lining at least part of the birth canal during childbirth (paragraphs 31-37 – “the hydrophilic layer or coating may be a hydrophilic polymer… To improve the attachment of the hydrophilic polymers to the device, aryl ketones, such as benzophenone, may be used as a linker to covalently bind a hydrogel to a polymeric surface” – the hydrophilic polymer forming a hydrogel membrane from a hydrogel material (any of poly-N-vinylpyrrolidone (PVP), PEO (polyethylene oxide), PEG (polyethylene glycol), or hyaluronan disclosed in paragraph 35)).
With regards to claim 2, Haadem discloses wherein the part of the baby is a head 51 of the baby (paragraph 54; figure 5A).
With regards to claim 9, Haadem discloses wherein the hydrogel membrane comprises a water-based lubricant (paragraph 35 - hyaluronan).
With regards to claim 12, Haadem discloses wherein the hydrogel membrane is biocompatible (paragraph 35 - hyaluronan).
With regards to claim 13, Haadem discloses wherein the hydrogel membrane is made from one or more polymers including PEG (paragraph 35).
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 1-3, 9-10, 12-13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cherkassky (US Patent 4,602,623) in view of Haadem.
With regards to claim 1, Cherkassky discloses (Figures 1-13) a device 20/21 for assisting childbirth (Abstract; Col 6 lines 31-48), the device 20/21 comprising:
a sheet 20/21 for at least one of covering at least a part of a baby in a birth canal or lining at least part of the birth canal during childbirth (Col 9 lines 28-33).
Cherkassky is silent wherein the sheet comprises of a hydrogel membrane formed from a hydrogel material.
However, in a similar field of endeavor of birth delivery devices, Haadem teaches (Figures 2A-2B and 5A-5B) a hydrogel membrane 21/22 formed from a hydrogel material (paragraphs 31-37 – “the hydrophilic layer or coating may be a hydrophilic polymer… To improve the attachment of the hydrophilic polymers to the device, aryl ketones, such as benzophenone, may be used as a linker to covalently bind a hydrogel to a polymeric surface” – the hydrophilic polymer forming a hydrogel membrane from a hydrogel material (any of poly-N-vinylpyrrolidone (PVP), PEO (polyethylene oxide), PEG (polyethylene glycol), or hyaluronan disclosed in paragraph 35)).
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 Cherkassky to include a hydrogel membrane formed from a hydrogel material as taught by Haadem for the purpose of providing for a smooth and slippery surface, facilitating the child during child birth to slide over the upper side of the device (paragraph 34 of Haadem).
With regards to claim 2, Cherkassky further discloses wherein the part of the baby is a head of the baby (Abstract; figures 11-13).
With regards to claim 3, Cherkassky/Haadem disclose wherein the hydrogel membrane (Cherkassky: 20/21 comprising of the hydrogel membrane of Haadem) includes or is in a form of a crown for being worn on a baby’s head (opening in figures 12-13 is in the form of a crown so that the baby’s head is inserted), and
the crown includes an opening for receiving the baby’s head (see opening in figures 12-13 where the baby’s head is inserted).
With regards to claim 9, as rejected above, it would have been obvious to modify the device of Cherkassky to include the hydrogel membrane as taught by Haadem. Haadem further discloses wherein the hydrogel membrane comprises a water-based lubricant (paragraph 35 - hyaluronan). Thus, when incorporating the hydrogel membrane of Haadem, the claimed limitation is considered obvious.
With regards to claim 10, Cherkassky further discloses wherein the device 20/21 is a cap (figures 12-13 – sheets 20/21 are rolled together to form an opening of a cap where the baby’s head can be inserted).
However, Cherkassky/Haadem do not explicitly disclose where a circumference of an opening for receiving a baby’s head is at least 24 cm.
There is no evidence of record that establishes that changing the circumference of an opening of a cap would result in a difference in function of the Cherkassky/Haadem device. Further, a person having ordinary skill in the art, being faced with modifying the device of Cherkassky/Haadem, 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 circumference. Lastly, applicant has not disclosed that the claimed circumference solves any stated problem, indicating that the circumference “may” be within the claimed circumference, and offering other acceptable circumferences (specification at para. [0038]) and therefore there appears to be no criticality placed on the circumference 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 Cherkassky/Haadem to have a circumference of 24 cm as an obvious matter of design choice within the skill of the art.
With regards to claim 12, as rejected above, it would have been obvious to modify the device of Cherkassky to include the hydrogel membrane as taught by Haadem. Haadem further discloses wherein the hydrogel membrane is biocompatible (paragraph 35 - hyaluronan). Thus, when incorporating the hydrogel membrane of Haadem, the claimed limitation is considered obvious.
With regards to claim 13, as rejected above, it would have been obvious to modify the device of Cherkassky to include the hydrogel membrane as taught by Haadem. Haadem further discloses wherein the hydrogel membrane is made from one or more polymers including PEG (paragraph 35). Thus, when incorporating the hydrogel membrane of Haadem, the claimed limitation is considered obvious.
With regards to claim 20, Cherkassky/Haadem disclose the device as claimed in claim 1. Haadem further discloses in paragraphs 31 and 34 that low friction is advantageous during delivery.
However, Cherkassky/Haadem do not explicitly disclose wherein the hydrogel membrane has a coefficient of friction of 0.5 or less according to a 2D bench.
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 Cherkassky/Haadem to have the hydrogel membrane having a coefficient of friction of 0.5 or less according to a 2D bench 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 Cherkassky/Haadem would not operate differently with the claimed coefficient of friction and since Haadem discloses the advantage of having low friction, the device would function appropriately having the claimed coefficient of friction. Further, it appears that applicant places no criticality on the coefficient of friction claimed, indicating simply that the coefficient of friction “may” be within the claimed ranges (specification pp. [0068-0069]).
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 hydrogel membrane of Cherkassky/Haadem to have a coefficient of friction of 0.5 or less according to a 2D bench as the device would not operate differently.
Claims 1, 4-8, 11, and 15-19 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 Haadem.
With regards to claim 1, Hariri discloses (Figures 4-5) a device (figure 4) for assisting childbirth (Abstract), the device (figure 4) comprising:
a cylindrical net-like structure 10/40 for at least one of covering at least a part of a baby in a birth canal or lining at least part of the birth canal during childbirth (figures 4-5; Col 8 lines 51-61).
Hariri is silent wherein the net-like structure comprises of a hydrogel membrane formed from a hydrogel material.
However, in a similar field of endeavor of birth delivery devices, Haadem teaches (Figures 2A-2B and 5A-5B) a hydrogel membrane 21/22 formed from a hydrogel material (paragraphs 31-37 – “the hydrophilic layer or coating may be a hydrophilic polymer… To improve the attachment of the hydrophilic polymers to the device, aryl ketones, such as benzophenone, may be used as a linker to covalently bind a hydrogel to a polymeric surface” – the hydrophilic polymer forming a hydrogel membrane from a hydrogel material (any of poly-N-vinylpyrrolidone (PVP), PEO (polyethylene oxide), PEG (polyethylene glycol), or hyaluronan disclosed in paragraph 35)).
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 include a hydrogel membrane formed from a hydrogel material as taught by Haadem for the purpose of providing for a smooth and slippery surface, facilitating the child during child birth to slide over the upper side of the device (paragraph 34 of Haadem).
The combination of Hariri in view of Haadem results in the device that is made from the synthetic polymer fibers (Hariri: Col 5 line 60 – Col 6 line 11) AND the hydrogel membrane formed from a hydrogel material (Haadem: paragraphs 31-37), therefore the synthetic polymer fiber of the crown and bulbous rim of Hariri are made in addition to the hydrogel of Haadem.
With regards to claim 4, Hariri further discloses further comprising a bulbous rim 44 (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).
With regards to claim 5, Hariri further discloses wherein the bulbous rim 44 defines an opening 44 for receiving a baby’s head (figures 4-5; Col 8 lines 14-61).
With regards to claim 6, Hariri/Haadem disclose wherein at least one of:
the bulbous rim (Hariri: 44) is made from or comprises a hydrogel (Hariri’s device of figure 4 forms the bulbous rim 44 as seen in figures 4-5 and includes the hydrogel membrane of Haadem as rejected in claim 1 above).
With regards to claim 7, Hariri/Haadem disclose wherein the bulbous rim (Hariri: 44) is made from or comprises a same hydrogel as the hydrogel membrane (Hariri’s device of figure 4 forms the bulbous rim 44 as seen in figures 4-5 and includes the hydrogel membrane of Haadem as rejected in claim 1 above).
With regards to claim 8, Hariri/Haadem disclose wherein the hydrogel membrane (of Haadem) is reinforced with synthetic polymer fibers (Hariri: Col 5 line 60 – Col 6 line 11 – Nylon thread is a synthetic polymer fiber, Haadem also teaches in paragraphs 34-37 the hydrophilic polymer reinforced with a polymer).
With regards to claim 11, 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) comprising a first bulbous rim 44 (figures 4-5; Col 8 lines 14-61 – rim of the guide ring 44 inflates and protrudes similarly to a bulbous structure) defining a first opening 44 at one end, and a second opening 30 at another end (figures 4-5; Col 7 lines 15-19 and 32-38).
However, Hariri/Haadem do not explicitly disclose wherein a circumference of the first opening is less than 26 cm and a circumference of the second opening is greater than 28 cm, or the circumference of the first opening and the circumference of the second opening are greater than 28 cm.
There is no evidence of record that establishes that changing the circumference of a first and second opening would result in a difference in function of the Hariri/Haadem device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hariri/Haadem, 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 circumference. Lastly, applicant has not disclosed that the claimed circumference solves any stated problem, indicating that the circumference “may” be within the claimed circumference, and offering other acceptable circumferences (specification at para. [0038]) and therefore there appears to be no criticality placed on the circumference 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 and second opening of the rim of Hariri/Haadem to have a circumference of the first opening less than 26 cm and a circumference of the second opening greater than 28 cm, or wherein the circumference of the first opening and the circumference of the second opening are greater than 28 cm as an obvious matter of design choice within the skill of the art.
With regards to claim 15, 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).
With regards to claim 16, Hariri further discloses wherein the synthetic polymer fibers form a mesh (Col 3 lines 49-57), and 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 17, Hariri further discloses wherein the mesh is the warp knit mesh (Col 3 lines 49-57 and Col 5 line 60 – Col 6 line 20).
With regards to claim 18, Hariri further discloses wherein the synthetic polymer fibers are made from a polyamide (Col 5 line 60 – Col 6 line 11 – Nylon is a type of polyamide).
With regards to claim 19, Hariri further discloses wherein the synthetic polymer fibers are made from a polyamide, or the synthetic polymer fibers are made from nylon (Col 5 line 60 – Col 6 line 11 – Nylon is a type of polyamide).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Haadem in view of Schaub (US PGPub 2005/0053670).
With regards to claim 14, Haadem discloses the device as claimed in claim 1. Haadem is silent wherein the hydrogel membrane is made from PVA, PAAm, or a HEMA copolymer.
However, in a similar field of endeavor of childbirth, Schaub teaches wherein the hydrogel membrane is made from PVA (paragraphs 25-27).
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 Haadem to include wherein the hydrogel membrane is made from PVA as taught by Schaub since the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious); Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988) (Claimed agricultural bagging machine, which differed from a prior art machine only in that the brake means were hydraulically operated rather than mechanically operated, was held to be obvious over the prior art machine in view of references which disclosed hydraulic brakes for performing the same function, albeit in a different environment). PVA is a known material and another example of a hydrophilic polymer, and thus would be suitable for the intended purpose of delivering a baby by providing a low friction surface.
Conclusion
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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/MOHAMMED S ADAM/Examiner, Art Unit 3771 05/06/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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