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
Claims 1-20 are pending, of which claims 1, 12, & 18 are independent. All claims are examined on the merits.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 6, 9-14, 16-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 8-9, 16, 18 of U.S. Patent No. 11,872,115. Although the claims at issue are not identical, they are not patentably distinct from each other because said patented claims 1, 8, & 18 recite the same limitations as the current claims 1, 12, & 18 except that the pouch exhibits a positive Poisson’s ratio such that it radially narrows when the pouch is stretched lengthwise. However, this is a natural behavior of a bag/pouch that when it is pulled in a lengthwise/axial direction that its width/radial direction would narrow, thus one skilled in the art has reason to believe that the invention of the patented claims can also exhibit a positive Poisson’s ratio as claimed. The patented claim 1 also reads on the current claim 6. Patented claim 8 also reads on the current claims 16-17. Patented claims 2, 5-6, 9 & 16 read on the current claims 9-11, 14 & 13, respectively.
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.
Claims 1-3, 5-6, 8-13, 15-16, 18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 2013/0110066).
Re Claim 1, Sharma discloses a method for treating post-partum hemorrhaging (PPH), comprising placing a plurality of sponges disposed within a tubular pouch (implant 200, e.g., Figs. 9 & 14), into a patient's uterus (e.g., see Abstract), wherein:
each of the plurality of sponges (foam disks 270) is configured to expand in volume (e.g., [0006] “expandable foam body”) within the patient's uterus by absorbing blood ([0031] “permit blood to enter the foam” & [0039] “the foam expands”);
the tubular pouch is comprised of a porous, expandable material (tubular or bag-shaped membrane 280, [0056], [0060]) with a length and a flat width (see Fig. 14), wherein the length is greater than the flat width (evident in Fig. 14).
Sharma does not explicitly disclose that the tubular pouch exhibits a positive Poisson's ratio, shortening when the pouch expands as a result of expansion of the sponges and radially narrowing when the tubular pouch is stretched lengthwise. However, since Sharma discloses that the tubular pouch may be made of nylon or PTFE, both of which have a positive Poisson’s ratio, nylon being at 0.39 and PTFE being at 0.46. Additionally, they are not highly elastic materials and therefore one skilled in the art would reasonably expect reduction in one or two dimensions when a third dimension is lengthened (i.e., stretching in the lengthwise direction will necessarily lead to narrowing in the radial direction).
Re Claim 2, Sharma discloses claim 1 and also discloses wherein the porous, expandable material permits expansion of the sponges to their maximum expansion limit ([0056] “may be sized to loosely envelop the fully-expanded implant”).
Re Claim 3, Sharma discloses claim 1 but does not explicitly disclose wherein the tubular pouch has a length of 25-150 cm and a flat width of 1-15 cm. However, the device/implant is designed to fill the uterine space of a woman after giving birth, thus one skilled in the art would have an idea of what dimensions would be suitable for such uses. Therefore the claimed dimensions are likely achievable through routine observations/experimentations by one skilled in the art at the time of filing.
Re Claim 5, Sharma discloses claim 1, but does not teach wherein the plurality of sponges are distributed within the tubular pouch at a density of 0.2 g/cm to 1.0 g/cm. However, the number and size of sponges can be tailored by the caregiver based on the size/shape of the patient’s uterus as well as the degree of bleeding ([0051]). Therefore the density of the sponges inside the pouch, which is dependent on the number of sponges fit inside the pouch, would also be adjustable by the caretaker based on the need. One skilled in the art at the time of filing may be able to arrive at the claimed sponge density by adjusting the number of sponges used to exert pressure on the uterus.
Re Claim 6, Sharma discloses claim 1 and further discloses wherein the tubular pouch is separated into two or more compartments (see Fig. 12A showing that the pouch 280 having a compartment filled with the foam and another compartment that does not).
Re Claim 8, Sharma discloses claim 1 and further discloses removing the tubular pouch from the patient's uterus (implied by the presence of pulling string 220, [0046], [0062]). As explained under claim 1, due to the material characteristics, one skilled in the art would reasonable expect that during removal, the tubular pouch extends in length and narrows radially.
Re Claim 9, Sharma also discloses wherein placing a plurality of sponge disposed within a tubular pouch into a patient's uterus further comprises (see [0062]):
inserting a tubular applicator into a patient's vaginal canal so that a portion of the tubular applicator including its open end is disposed within the patient's uterus;
injecting, using a plunger, the tubular pouch from the tubular applicator into the patient's uterus; and
removing he tubular applicator, leaving the tubular pouch in the patient's uterus.
Re Claim 10, Sharma discloses claim 9 and further disclosing wherein:
the tubular pouch further comprises a removal strand (pulling string 220) disposed upon an end of the tubular pouch; and
removing the tubular applicator comprises leaving at least a portion of the removal strand outside of the patient's uterus ([0062]).
Re Claim 11, Sharma discloses claim 10 and also discloses removing the tubular pouch from the patient's uterus by pulling upon the removal strand ([0053]).
Re Claim 12, Sharma discloses a device (implant 200) for treating post-partum hemorrhaging (PPH), comprising:
a tubular pouch (280, [0060]) having a first end and a second end distal from the first end, the tubular pouch comprised of a porous, expandable material and having a length and a flat width, wherein the length is greater than the flat width (e.g., Figs. 9 & 14); and
a plurality of sponges (270) disposed within the tubular pouch, each of the plurality of sponges configured to expand in volume upon absorption of a fluid ([0031] “permit blood to enter the foam” & [0039] “the foam expands”),
wherein the tubular pouch is configured to expand as at least a subset of the plurality of sponges expand upon absorption of the fluid (implied since the entire device/implant would be delivered through an applicator such as shown in Fig. 10 and then the device/implant expands to fill the entire uterus).
Sharma does not explicitly disclose that the tubular pouch exhibits a positive Poisson's ratio, shortening when the pouch expands as a result of expansion of the sponges and radially narrowing when the tubular pouch is stretched lengthwise. However, since Sharma discloses that the tubular pouch may be made of nylon or PTFE, both of which have a positive Poisson’s ratio, nylon being at 0.39 and PTFE being at 0.46. Additionally, they are not highly elastic materials and therefore one skilled in the art would reasonably expect reduction in one or two dimensions when a third dimension is lengthened (i.e., stretching in the lengthwise direction will necessarily lead to narrowing in the radial direction).
Re Claim 13, Sharma discloses claim 12 but does not explicitly disclose wherein the tubular pouch has a length of 25-150 cm and a flat width of 1-15 cm. However, the device/implant is designed to fill the uterine space of a woman after giving birth, thus one skilled in the art would have an idea of what dimensions would be suitable for such uses. Therefore the claimed dimensions are likely achievable through routine observations/experimentations by one skilled in the art at the time of filing.
Re Claim 15, Sharma discloses claim 12, but does not teach wherein the plurality of sponges are distributed within the tubular pouch at a density of 0.2 g/cm to 1.0 g/cm. However, the number and size of sponges can be tailored by the caregiver based on the size/shape of the patient’s uterus as well as the degree of bleeding ([0051]). Therefore the density of the sponges inside the pouch, which is dependent on the number of sponges fit inside the pouch, would also be adjustable by the caretaker based on the need. One skilled in the art at the time of filing may be able to arrive at the claimed sponge density by adjusting the number of sponges used to exert pressure on the uterus.
Re Claim 16, Sharma discloses claim 12 and further discloses wherein the tubular pouch is separated into two or more compartments (see Fig. 12A showing that the pouch 280 having a compartment filled with the foam and another compartment that does not).
Re Claim 18, Sharma discloses a system for treating post-partum hemorrhaging (PPH) in a patient's uterus, comprising:
a PPH device (implant 200) comprised of:
a tubular pouch (280) having a first end and a second end distal from the first end, the tubular pouch comprised of a porous, expandable material and having a length and a flat width (e.g., Fig. 14), wherein the length is greater than the flat width; and
a plurality of sponges (270) disposed within the tubular pouch, each of the plurality of sponges configured to expand in volume within the patient's uterus by absorbing blood ([0031], [0039]), and
wherein the tubular pouch is configured to expand as at least a subset of the plurality of sponges expand upon absorption of the fluid (implied since the entire device/implant would be delivered through an applicator such as shown in Fig. 10 and then the device/implant expands to fill the entire uterus),
an applicator (300) comprised of a hollow tube (outer cylinder 310, e.g., Fig. 10, [0062]), sized to receive and enclose the PPH device; and
a plunger (inner cylinder 320) configured to eject the PPH device from the applicator and into the patient's uterus.
Sharma does not explicitly disclose that the tubular pouch exhibits a positive Poisson's ratio, shortening when the pouch expands as a result of expansion of the sponges and radially narrowing when the tubular pouch is stretched lengthwise. However, since Sharma discloses that the tubular pouch may be made of nylon or PTFE, both of which have a positive Poisson’s ratio, nylon being at 0.39 and PTFE being at 0.46. Additionally, they are not highly elastic materials and therefore one skilled in the art would reasonably expect reduction in one or two dimensions when a third dimension is lengthened (i.e., stretching in the lengthwise direction will necessarily lead to narrowing in the radial direction).
Re Claim 20, Sharma discloses claim 18 and also discloses wherein the hollow tube comprises a semi-flexible material to permit adjustability of configuration of the hollow tube (the petals shown at the tip of the applicator, see Figs. 10 & 15, necessarily allow adjustability such that the device/implant can be ejected from the applicator).
Claims 4 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Gregory et al. (US 2011/0077682).
Re Claims 4 & 14, Sharma discloses the invention of claim 1 or 12 but does not disclose that there are 250 to 350 sponges. Sharma appears to show just about 4-10 sponges but also discloses that the number and size of the sponges can be tailored by the caregiver based on the size/shaper of the patient's uterus as well as the degree of bleeding ([0051]). Gregory discloses a plurality of small sponge disks ([0039]) for stopping bleeding in wounds, wherein the disks have a diameter of 1-20mm ([0038]). Given the size of each disk, it is likely that large numbers will need to be used for a large bleeding wound, such as a hemorrhaging post-partum uterus, and subsequently hundreds of these disks are likely necessary. It would have been obvious to one skilled in the art at the time of filing to modify Sharma with the hemostatic sponge disks taught by Gregory as the smaller size would make the implant more easily shape to fit the irregular shape of a post-partum uterus and the additional surface area (from having smaller disks) would increase the rate of blood absorption. After the modification with the material, a caretaker will also need to adjust the number of disks used, as taught by Sharma, because every patient's uterus and degree of bleeding would be different. Thus one skilled in the art would be able to arrive at the claimed number of sponges based on the situation.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Jessup et al. (US 5,659,934).
Re Claim 19, Sharma discloses claim 18 but does not teach wherein the applicator includes a curve along the hollow tube to aid in insertion of the applicator into the patient's uterus. Jessup discloses a tampon applicator that is curved (Fig. 9). It would have been obvious to one skilled in the art at the time of filing to modify with Jessup since the simple substitution of a known element for another to obtain predictable results establishes a prima facie case of obviousness (MPEP 2143).
Allowable Subject Matter
Claims 7 & 17 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Re Claim 7, there is no disclosure or suggestion from Sharma to have a separate compartment formed of the pouch where the second compartment also includes a sponge.
Re Claim 17, there is no disclosure or suggestion from Sharma to have a sponge tip enclosed within a compartment of the tubular pouch separate from the plurality of sponges or disposed on an outside of the tubular pouch.
Conclusion
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
24 January 2026