DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims Pending
Applicant's arguments, filed 09/17/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 09/17/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant’s previous cancellation of claims 1-57 and 73 is acknowledged.
Claims 58-72 and 74-82 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112 – Withdrawn
Applicant’s amendment’s, filed 09/17/2025, have been fully considered, and the previous rejection withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The claims are generally directed towards a method for collecting amniotic fluid with an amniotic fluid collector that has a collection chamber, extraction tube, and soft piercing tip. The method comprises penetrating the amniotic membrane with the amniotic fluid collector, inserting the extraction tube through the punctured membrane, and collecting the amniotic fluid.
Claims 58, 60, 63-64, 66-72, 74-75, 78-79, and 82 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Billings (US Pat. No. 5713351 A) hereinafter Billings, and further in view of Young (US Pat. No. 4308875) hereinafter Young, Brunner (US Pub. No. 20170311934) hereinafter Brunner, and Sundberg (US Pat. No. 5494044) hereinafter Sundberg.
Regarding claim 58, Billings discloses a method for collecting amniotic fluid (Col. 12, Lines 38-41), comprising:
wherein the amniotic fluid collector (Fig. 2 (device of Figure 2)) (Abstract) comprises:
a collection chamber (Syringe – 58), the collection chamber coupled to an inlet valve (Col. 7, Lines 11- 20),
the distal fluid extraction tube, wherein the distal fluid extraction tube is in fluid communication with the collection chamber (Col. 7, Lines 40- 53) (Fig. 2, Syringe – 58, distal port – 16) (Col. 6, lines 27-38)(Fig. 2,2b, fluid lumen - 30),
the distal fluid extraction tube comprising a longitudinal axis (Col. 6, lines 27-38)(Fig. 2,2b, fluid lumen - 30), a transfer portion (Col. 6, lines 27-38((the transfer portion is region between the proximal and distal ends)), and an inlet (Col. 7, lines 61- 67 (fluid is entering, thus there must be an inlet)), the inlet comprising a main inlet (Col. 6, lines 31-38 (main inlet at distal port 16 of fluid lumen 30 where amniotic fluid is drawn into the fluid lumen)), and
(e) collecting and retaining in the collection chamber (syringe – 58) a volume amniotic fluid from the amniotic sac of the subject (Col. 7, lines 44-53) (Abstract) (examiners note: amniotic fluid is located in the amniotic sac).
Billings fails to explicitly disclose making an incision in a uterine wall of a subject.
However, Young teaches making an incision in a uterine wall of a subject (Col. 1, lines 10-16)(Claim 1, “said stylet having a sharp-cutting tip at its distal end to penetrate the skin, fascia and uterine muscle of the pregnant woman” (initial incision is the moment when the tip penetrates)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method Billings with that of Young to include making an incision in a uterine wall of a subject through the combination of references as it would have yielded the predictable result of explicitly providing a direct pathway to obtain amniotic fluid (Young (Col. 1, lines 10-16)).
Modified Billings fails to explicitly disclose inserting a distal extraction tube of an amniotic fluid collector through the incision in the uterine wall and into the uterus of the subject.
However, Young further teaches inserting a distal extraction tube of an amniotic fluid collector through the incision in the uterine wall and into the uterus of the subject (Col. 1, lines 10-16 (through the uterine muscle and into the uterine cavity))(Claim 1, “said stylet having a sharp-cutting tip at its distal end to penetrate the skin, fascia and uterine muscle of the pregnant woman” (advancement of the stylet forward through the skin after the tip penetrated the skin and through the uterine wall)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method Billings and Young with that of Young to include inserting a distal extraction tube of an amniotic fluid collector through the incision in the uterine wall and into the uterus of the subject through the combination of references as it would have yielded the predictable result of explicitly providing a direct pathway to obtain amniotic fluid (Young (Col. 1, lines 10-16)).
Modified Billings fails to explicitly disclose the inlet comprising a plurality of lateral inlets.
However, Young further teaches the inlet comprising a plurality of lateral inlets (Col. 2-3, lines 65-24 (side holes)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method Billings and Young with that of Young to include the inlet comprising a plurality of lateral inlets through the combination of references as it would have yielded the predictable result of preventing clogging (Young (Col. 2, lines 45-48)).
Modified Billings fails to explicitly disclose a soft piercing tip, the soft piercing tip comprising a cutting angle of between 25 degrees to 75 degrees from the longitudinal axis so as to puncture an intact amniotic membrane without penetrating or damaging fetal skin.
However, Brunner teaches a soft piercing tip (Par. 20 (the needle is made of a polymer material)) (Fig. 1A, Par. 26, “A cutting angle α that is at least 45 degrees facilitates the needle to be forced into a curved trajectory when a force on the handle 2, respectively the proximal end 4 of the needle 3 is applied.”), the soft piercing tip comprising a cutting angle (Par. 20 (the needle is made of a polymer material)) (Fig. 1A, Par. 26, “A cutting angle α that is at least 45 degrees facilitates the needle to be forced into a curved trajectory when a force on the handle 2, respectively the proximal end 4 of the needle 3 is applied.”) of between 25 degrees to 75 degrees from the longitudinal axis (Fig. 1A, Par. 26, “A cutting angle α that is at least 45 degrees facilitates the needle to be forced into a curved trajectory when a force on the handle 2, respectively the proximal end 4 of the needle 3 is applied.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings and Young with that of Brunner to include a soft piercing tip, the soft piercing tip comprising a cutting angle of between 25 degrees to 75 degrees from the longitudinal axis so as to puncture an intact amniotic membrane without penetrating or damaging fetal skin through the combination of references as differing materials are known in the art (Brunner (Par. 20)) as it would have yielded the predictable result of penetrating the tissue with the proper shape (Brunner (Par. 10)) without damaging the fetus as damage to the fetus is a known problem in the art (Young (Col. 2, lines 20-28)).
Modified Billings fails to explicitly disclose piercing an amniotic membrane of the subject with the soft piercing tip.
However, Young does teach piercing a membrane of the subject (Col. 1, lines 10-16 (through the uterine muscle and into the uterine cavity))(Claim 1, “said stylet having a sharp-cutting tip at its distal end to penetrate the skin, fascia and uterine muscle of the pregnant woman” (advancement of the stylet forward through the skin after the tip penetrated the ski, through the uterine wall, and into the amniotic cavity)) (Col. 2, lines 34-41 (penetrating through the uterine muscle, and into the amniotic cavity)) (Col. 4, lines 27-30, “inserts, at such determined location, such assembled needle through the skin, fascia and uterine muscle and into the amniotic cavity of the uterus”) (Examiner's Note: claimed steps B and C can happen near simultaneously, where Young teaching penetration through uterine muscle and into the amniotic cavity reads on the indicated limitations).
Sundberg teaches piercing an amniotic membrane of the subject with the tip (Col. 5, lines 43-57 (tip of the hollow needle creates a hole through the wall of the amniotic cavity that the needle passes through)).
Brunner further teaches a soft piercing tip (Par. 20 (the needle is made of a polymer material)) (Fig. 1A, Par. 26, “A cutting angle α that is at least 45 degrees facilitates the needle to be forced into a curved trajectory when a force on the handle 2, respectively the proximal end 4 of the needle 3 is applied.”).
Billings, Young, Brunner, and Sundberg are considered to be analogous art to the claimed invention as they are involved with the biological sample collection.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings, Young, and Brunner with that of Sundberg and Brunner to include piercing an amniotic membrane of the subject with the soft piercing tip of Brunner through the combination of references as differing materials are known in the art (Brunner (Par. 20) and it would have yielded the predictable result of directly opening a direct pathway to collect the amniotic fluid and penetrating the tissue with the proper shape (Brunner (Par. 10)) without damaging the fetus as damage to the fetus is a known problem in the art (Young (Col. 2, lines 20-28)).
Modified Billings fails to explicitly disclose inserting the inlet of the distal fluid extraction tube through the pierced amniotic membrane and into the amniotic fluid therein.
However, Sundberg further teaches inserting the inlet of the distal fluid extraction tube (hollow needle - 15) through the pierced amniotic membrane and into the amniotic fluid therein (Col. 5, lines 43-57 (the hollow needle moves through the hole created by the tip of the hollow needle into the amniotic cavity)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings, Young, Brunner, and Sundberg with that of Sundberg to include inserting the inlet of the distal fluid extraction tube through the pierced amniotic membrane and into the amniotic fluid therein through the combination of references as it would have yielded the predictable result of directly providing a pathway to collect the amniotic fluid.
Regarding claim 60, modified Billings fails to explicitly disclose the collection chamber is configured to contain a volume of fluid comprising at least about 10 mL.
However, Sundberg further teaches wherein the collection chamber is configured to contain a volume of fluid comprising at least about 10 mL (Col. 9, lines 5-12).
Therefore, it would have been further obvious to modify the method of Billings, Young, Brunner, and Sundberg with that of Sundberg to explicitly include a collection chamber is configured to contain a volume of fluid comprising at least about 10 mL through substitution of syringe sizes as it would have yielded the predictable result of obtaining sufficient cells for examination (Sundberg (Col. 1, lines 22-30)).
Regarding claim 63, modified Billings fails to explicitly disclose the limitations of the claim.
However, Sundberg further teaches penetrating a chorionic membrane of the subject (Col. 5, lines 43-57 (tip of the hollow needle creates a hole through the wall of the amniotic cavity that the needle passes through)).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Billings, Young, Brunner, and Sundberg with that of Sundberg include penetrating a chorionic membrane of the subject for the reasoning as indicated in claim 68 above.
Regarding claim 64, modified Billings further discloses the inlet valve is configured to allow fluid flow in the direction of the collection chamber (Billings (Fig. 2a, diverter valve – 39)).
Regarding claim 66, modified Billings fails to explicitly disclose the limitations of the claim.
However, Brunner further teaches wherein the cutting angle is about 45 degrees from the longitudinal axis (Par. 20 (the needle is made of a polymer material)) (Fig. 1A, Par. 26, “A cutting angle α that is at least 45 degrees facilitates the needle to be forced into a curved trajectory when a force on the handle 2, respectively the proximal end 4 of the needle 3 is applied.”).
Therefore, it would have been obvious to further modify the method of Billings, Young, Brunner, and Sundberg with that of Brunner to include that the cutting angle is about 45 degrees from the longitudinal axis for the reasoning as indicated in claim 58 above.
Regarding claim 67, modified Billings fails to explicitly disclose the limitations of the claim.
However, Young further teaches the lateral inlets are configured to provide pressure relief when the distal fluid extraction tube inlet is adhered to a surface (Col. 2-3, lines 65-24 (the side holes are capable of the indicated function)).
It would have been further obvious to further modify the method of Billings, Young, Brunner, and Sundberg with that of Young to include the lateral inlets are configured to provide pressure relief when the distal fluid extraction tube inlet is adhered to a surface through the combination of references as it would have yielded the predictable result of preventing clogging (Young (Col. 2, lines 45-48)) and minimize required suction pressure (Young (Claim 3)).
Regarding claim 68, modified Billings further discloses wherein the collection chamber further comprises a proximal fluid extraction tube coupled to the inlet valve (Billings (Col. 6, lines 26 – 42, Fig. 2,2A)).
Regarding claim 69, modified Billings further discloses wherein the inlet valve is configured to switch between a closed position wherein no fluid may pass from the proximal fluid-extraction tube to the collection chamber (Billings (Col. 7, lines 11-20, Fig. 2a, diverter valve - 39, diverter valve – 64)), and an open position wherein fluid may pass from the proximal fluidextraction tube to the collection chamber (Billings (Col. 7, lines 11-20, Fig. 2a, diverter valve - 39, diverter valve – 64)).
Regarding claim 70, modified Billings further discloses an outlet valve coupled to the collection chamber (Billings (Col. 7, lines 11-20, Fig. 2a, diverter valve - 39, diverter valve – 64)).
Regarding claim 71, modified billings further discloses the outlet valve is configured to switch between a closed position wherein no fluid may pass from the collection chamber to a drain (Billings (Col. 7, lines 11-20, Fig. 2a, diverter valve - 39, diverter valve – 64) (“Contents of the syringe to be expelled” corresponds to the drain)), and an open position wherein fluid may pass from the collection chamber to the drain (Billings (Col. 7, lines 11-20, Fig. 2a, diverter valve - 39, diverter valve – 64) (“Contents of the syringe to be expelled” corresponds to the drain)).
Regarding claim 72, modified Billings fails to explicitly disclose the limitations of the claim.
However, Young further teaches the lateral inlets are configured to allow fluid flow through the proximal fluid-extraction tube when the distal fluid extraction tube inlet is blocked (Col. 2-3, lines 65-24 (the side holes are capable of the indicated function)).
It would have been further obvious to further modify the method of Billings, Young, Brunner, and Sundberg with that of Young to include the lateral inlets are configured to allow fluid flow through the proximal fluid-extraction tube when the distal fluid extraction tube inlet is blocked through the combination of references as it would have yielded the predictable result of preventing clogging (Young (Col. 2, lines 45-48)) and minimize required suction pressure (Young (Claim 3)).
Regarding claim 74, modified Billings fails to explicitly disclose the limitations of the claim.
However, Young further teaches the incision is made by the amniotic fluid collector (Col. 1, lines 10-16)(Claim 1, “said stylet having a sharp-cutting tip at its distal end to penetrate the skin, fascia and uterine muscle of the pregnant woman” (initial incision is the moment when the tip penetrates)).
It would have been further obvious to further modify the method of Billings, Young, Brunner, and Sundberg with that of Young to explicitly include the incision is made by the amniotic fluid collector for the reasoning as indicated in claim 1 above.
Regarding claim 75, modified Billings further discloses wherein the fluid collected from the amniotic sac is stored in the collection chamber (Billings (Col. 7, lines 44-53 (syringe)) (Abstract) (examiners note: amniotic fluid is located in the amniotic sac)).
Regarding claim 78, modified Billings further discloses wherein the main inlet is located at the distal end (Billings (Col. 3, lines 1-3)) of the soft piercing tip (As taught above in claim 58).
Regarding claim 79, modified Billings fails to explicitly disclose the limitations of the claim.
However, Sundberg further teaches wherein the step of piercing the amniotic membrane is performed (Claim 1, “penetrating the wall of the amniotic cavity by means of a hollow needle”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings, Young, Brunner, and Sundberg with that of Sundberg to include wherein the step of penetrating the amniotic membrane of a subject with the amniotic fluid collector is performed through the combination of references for the reasoning as indicated in claim 58 above.
However, Billings does teach during cesarean section (Billings (Col. 1, lines 41-53)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings, Young, Brunner, and Sundberg with that of Billings to include during cesarean section through the combination of embodiments as it would have yielded the predictable result of informing doctors of Meconium aspiration syndrome in the infant (Billings (Col. 1, lines 41-53)).
Regarding claim 82, modified Billings fails to explicitly disclose the limitations of the claim.
However, Sundberg further teaches further comprising a preliminary step of identifying a pregnant subject in which the amniotic membrane of a fetus is intact (Col. 2, lines 23-31 (carried out at early stages of pregnancy)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings, Young, Brunner, and Sundberg with that of Sundberg to include further comprising a preliminary step of identifying a pregnant subject in which the amniotic membrane of a fetus is intact through the combination of references as it would have yielded the predictable result of decreasing the abortion risk (Sundberg (Col. 2, lines 23-31)).
Claim 59 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Billings in view of Young, Brunner, and Sundberg as applied to claim 58 above, and further in view of Mor (US Pub. No. 20130165816) hereinafter Mor.
Billings, Young, Brunner, and Sundberg teach the method of claim 58
Regarding claim 59, modified Billings fails to explicitly disclose the limitations of the claim.
However, Mor teaches further comprising removing the amniotic fluid collector (Par. 54).
Billings, Young, Brunner, Sundberg, and Mor are considered to be analogous art to the claimed invention as they are involved with the biological sample collection.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Billings, Young, Brunner, and Sundberg with that of Mor to include remove the amniotic fluid collector through the combination of references as it would have yielded the predictable result of not leaving the device in after the collection is complete.
Claim 61 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Billings in view of Young, Brunner, and Sundberg as applied to claim 60 above, and further in view of Chen (US Pub. No. 20110184315) hereinafter Chen.
Billings, Young, Brunner, and Sundberg teach the method of claim 60 above.
Regarding claim 61, modified Billings fails to explicitly disclose the limitations of the claim.
However, Chen teaches the collection chamber is configured to contain a volume of at least about 50 mL (Par. 7)(50 mL syringe is “about 50 mL”).
Billings, Young, Brunner, Sundberg, and Chen are considered to be analogous art to the claimed invention as they are involved with the biological sample collection.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings, Young, Brunner, and Sundberg with that of Chen to explicitly include a collection chamber is configured to contain a volume of at least about 50 mL through the substitution of syringe types as it would have yielded the predictable result of obtaining a sufficient volume of fluid for cultivation (Par. 6).
Claim 62 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Billings in view of Young, Brunner, and Sundberg as applied to claim 58 above, and further in view of O’Donoghue et al. (“Amniocentesis in the third trimester of pregnancy”, 2007) hereinafter O’Donoghue.
Billings, Young, Brunner, and Sundberg teach the method of claim 58 above.
Regarding claim 62, modified Billings fails to explicitly disclose wherein the subject is a pregnant mother of at least 30 gestational weeks.
However, O’Donoghue teaches wherein the subject is a pregnant mother of at least 30 gestational weeks (Results).
Billings, Young, Brunner, Sundberg, and O’Donoghue are considered to be analogous art to the claimed invention as they are involved with the biological sample collection.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Billings, Young, Brunner, and Sundberg with that of O’Donoghue to include that the subject is at least at 30 gestational weeks as varying the gestational week when amniocentesis is performed is known in the art and would have yielded predictable results (Results).
Claim 65 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Billings in view of Young, Brunner, and Sundberg as applied to claim 58 above, and further in view of Christopher (US Pat. No. 6378523) hereinafter Christopher.
Modified Billings, Young, Brunner, and Sundberg teach the method of claim 58.
Regarding claim 65, modified Billings fails to explicitly disclose the limitations of the claim.
However, Christopher teaches a ring of soft material surrounding the outside of the distal fluid-extraction tube (Col. 4, lines 14-21, Fig. 1, inflatable cuff -16) (the cuff can inflate and deflate, making it a soft material), the ring configured to facilitate the formation of a substantially impervious seal (Col. 1, lines 22-25).
Billings, Young, Brunner, Sundberg, and Christopher are considered to be analogous art to the claimed invention as they are involved devices placed inside the body.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Billings, Young, Brunner, and Sundberg with that of Christopher to include a ring of soft material surrounding the outside of the distal fluid-extraction tube, the ring configured to facilitate the formation of a substantially impervious seal as it would have yielded the predictable result of holding the tube in place (Col. 1, Lines 15-25).
Claim 76 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Billings in view of Young, Brunner, and Sundberg as applied to claim 75 above, and further in view of Schultz (US Pat. No. 7802574) hereinafter Schultz.
Billings, Young, Brunner, and Sundberg teach the method of claim 75 above.
Regarding claim 76, modified Billings fails to explicitly disclose the limitations of the claim.
However, Schultz teaches initiating a siphon to transfer the amniotic fluid to the collection chamber by opening the inlet valve (Col. 7, lines 29- 32) (Col. 35, lines 19- 23).
Billings, Young, Brunner, Sundberg, and Schultz are considered to be analogous art to the claimed invention as they are involved with the biological sample collection.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Billings, Young, Brunner, and Sundberg with that of Schultz to initiate a siphon to transfer the amniotic fluid to the collection chamber by opening the inlet valve as it would have yielded the predictable result of providing automatic irrigation to deliver the liquid quickly (Col. 15, lines 11- 30).
Claim 77 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Billings in view of Young, Brunner, and Sundberg as applied to claim 58 above, and further in view of Allickson (US Pub. No. US 20080064098) hereinafter Allickson.
Billings, Young, Brunner, and Sundberg teach the method of claim 58 above.
Regarding claim 77, Modified Billings fails to explicitly disclose the limitations of the claim.
However, Allickson teaches isolating a cell from the amniotic fluid, the cell comprising surface expression of CD73 and CD90 (Abstract).
Billings, Young, Brunner, Sundberg, and Allickson are considered to be analogous art to the claimed invention as they are involved with the biological sample collection.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Billings, Young, Brunner, and Sundberg with that of Allickson to isolate a cell from the amniotic fluid, the cell comprising surface expression of CD73 and CD90 as these are known maternal placental stem cell markers (Abstract).
Claims 80-81 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable Billings in view of Young, Brunner, Sundberg, and Christopher as applied to claim 65 above, and further in view of Schultz.
Billings, Young, Brunner, Sundberg, and Christopher teach the method of claim 65 above.
Regarding claim 80, modified Billings fails to explicitly disclose the limitations of the claim.
However, Schultz teaches wherein the substantially impervious seal is configured to facilitate a gravity-flow siphon for transferring the amniotic fluid to the collection chamber (Col. 7, lines 29- 32) (Col. 35, lines 19-23).
Billings, Young, Brunner, Sundberg, Christopher, and Schultz are considered to be analogous art to the claimed invention as they are involved devices placed inside the body
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings, Young, Brunner, Sundberg, and Christopher with that of Schultz to include wherein the substantially impervious seal of Christopher is configured to facilitate a gravity-flow siphon for transferring the amniotic fluid to the collection chamber as it would have yielded the predictable result as indicated above in claim 76.
Regarding claim 81, modified Billings fails to explicitly disclose the limitations of the claim.
However, Billings does teach further comprising positioning the collection chamber below the inlet (Billings (Col. 7, lines 11-20 (the syringe is downstream in the fluid flow path))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Billings, Young, Brunner, Sundberg, Christopher, and Schultz with that of Billings to include further comprising positioning the collection chamber below the inlet through the rearrangement of parts as it would have yielded the predictable result of result of providing automatic irrigation to deliver the liquid quickly (Schultz (Col. 15, lines 11- 30)).
Response to Arguments
Applicant's arguments, filed 09/17/2025, regarding the previous 103 rejections, have been fully considered but deemed as not persuasive.
The applicant’s arguments, that the prior art does not disclose making an incision in the uterine wall and that any incisions would interfere with the intended use of the device of Billings, have been fully considered and deemed as not persuasive.
As indicated above, Young teaches making an incision in a uterine wall of a subject (Col. 1, lines 10-16)(Claim 1, “said stylet having a sharp-cutting tip at its distal end to penetrate the skin, fascia and uterine muscle of the pregnant woman” (initial incision is the moment when the tip penetrates)). Further, the applicant’s recitation of Col. 1, lines 16-25 of Young does not teach away from making an incision, as Young directly states in Claim 1 “said stylet having a sharp-cutting tip at its distal end to penetrate the skin, fascia and uterine muscle of the pregnant woman” (Young (Claim 1)).
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, it would have been obvious to a person of ordinary skill in the art to modify the method Billings with that of Young to include making an incision in a uterine wall of a subject through the combination of references as it would have yielded the predictable result of explicitly providing a direct pathway to obtain amniotic fluid (Young (Col. 1, lines 10-16)).
In response to applicant's argument that Young 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, Billings, Young, Brunner, and Sundberg are considered to be analogous art to the claimed invention as they are involved with the biological sample collection.
The applicant’s argument, that Billings is only able to be used during labor, has been fully considered and deemed as not persuasive. As stated previously, Billings discloses the measurement of meconium, which is measured at the stages both before and during birth (Billings (Col. 1, lines 16-21)). Billings further states “the present invention also provides a corresponding method for intrauterine detection of a selected biological substance including the steps of: providing at least a first lumen, the first lumen having a first port located at a distal end of the lumen; inserting the first port into a uterus; drawing fluid from the uterus into the first port into the first lumen; and observing the fluid drawn up the lumen such that a biological substance in the fluid can be detected.” (Billings (Col. 3-4, lines 63-3)). As such, Billings does not require for the amniotic sac to be ruptured and is used prior to birth.
The applicant’s arguments, regarding the soft piercing tip, have been fully considered and deemed as not persuasive. The applicant has specifically pointed to the tip of Brunner, stating that the materials of the tip of Brunner do not make a soft tip. The corresponding materials identified within the applicant’s specification for the tip are identified as “polyvinyl chloride ("PVC"), poly(ethylene terephthalate), polyurethane, or poly(propylene carbonate), or any suitable combination thereof. In some embodiments, softeners may be added as needed for a required stiffness. Without being bound by any theory, any suitable moldable polymer plastics may be used for manufacturing the distal fluid extraction section 150. In other embodiments, nylon, silicone and polypropylene are used. Without being bound by any theory, any suitable material can be used for the piercing end of the distal fluid extraction section 150…” (Par. 66 of applicant’s spec.) and “In some embodiments, the inlet 170 is constructed of polyvinyl chloride ("PVC"), poly(ethylene terephthalate), polyurethane, or poly(propylene carbonate), or any suitable combination thereof. In some embodiments, softeners may be added as needed for a required stiffness. Without being bound by any theory, any suitable moldable polymer plastics may be used for manufacturing the inlet 170. In other embodiments, nylon, silicone and polypropylene are used.” (Par. 69 of applicant’s spec.). As such, Brunner’s soft piercing tip (Brunner (Par. 20 (the needle is made of a polymer material)) (Fig. 1A, Par. 26, “A cutting angle α that is at least 45 degrees facilitates the needle to be forced into a curved trajectory when a force on the handle 2, respectively the proximal end 4 of the needle 3 is applied.”)) reads on the claimed soft piercing tip.
Additionally, Young does not teach away from the use of piercing tip as Young directly involves piercing an amniotic membrane of the subject (Young (Col. 1, lines 10-16 (through the uterine muscle and into the uterine cavity))(Claim 1, “said stylet having a sharp-cutting tip at its distal end to penetrate the skin, fascia and uterine muscle of the pregnant woman” (advancement of the stylet forward through the skin after the tip penetrated the ski, through the uterine wall, and into the amniotic cavity)) (Col. 2, lines 34-41 (penetrating through the uterine muscle, and into the amniotic cavity)) (Col. 4, lines 27-30, “inserts, at such determined location, such assembled needle through the skin, fascia and uterine muscle and into the amniotic cavity of the uterus”)).
In response to applicant's argument that Brunner 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, Billings, Young, Brunner, and Sundberg are considered to be analogous art to the claimed invention as they are involved with the biological sample collection.
The applicant’s arguments, regarding piercing the amniotic membrane, have been fully considered and deemed as not persuasive. As indicated in the 103 rejection above, Sundberg teaches piercing an amniotic membrane of the subject with the tip (Col. 5, lines 43-57 (tip of the hollow needle creates a hole through the wall of the amniotic cavity that the needle passes through)). As the applicant’s claims are given their broadest reasonably interpretation, “pierce” is defined as “to make a hole through”, while “penetrate” is defined as “to pass into or through” with an additional definition of “to enter by overcoming resistance: pierce” (Merriam-Webster dictionary). As such, Sundberg teaches the piercing an amniotic membrane of the subject (as indicated above).
The applicant’s argument, regarding the ring of soft material, has been fully considered and deemed as not persuasive. In response to applicant's argument that Christopher 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, Billings, Young, Brunner, Sundberg, and Christopher are considered to be analogous art to the claimed invention as they are involved devices placed inside the body.
As the applicant’s claims are given their broadest reasonable interpretation, the claim itself recites “a ring of soft material surrounding the outside of the distal fluid-extraction tube, the ring configured to facilitate the formation of a substantially impervious seal”, where the functionality of the ring is based on the material. As indicated above, Christopher teaches a ring of soft material surrounding the outside of the distal fluid-extraction tube (Col. 4, lines 14-21, Fig. 1, inflatable cuff -16) (the cuff can inflate and deflate, making it a soft material), the ring configured to facilitate the formation of a substantially impervious seal (Col. 1, lines 22-25).
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, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Billings, Young, Brunner, and Sundberg with that of Christopher to include a ring of soft material surrounding the outside of the distal fluid-extraction tube, the ring configured to facilitate the formation of a substantially impervious seal as it would have yielded the predictable result of holding the tube in place (Col. 1, Lines 15-25). As such, the applicant’s arguments are deemed as not persuasive.
The applicant' s argument, that the prior art does not teach the added limitations to claim, have been fully considered and deemed as not persuasive. As the limitation was not previously addressed, the limitation has been addressed in the 103 rejection as indicated above.
The applicant’s arguments regarding the dependent claims, rely on the arguments related to the independent claim, and as such are also deemed as not persuasive.
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 ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/ Examiner, Art Unit 3791
/RENE T TOWA/ Primary Examiner, Art Unit 3791