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 .
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 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.
Response to Amendment
In response to the preliminary amendment filed on 6/3/2025, claims 1-19 and newly added claims 20-25 are pending.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
There is no discussion in the specification of the features of claim 16, specifically, the concave portion is on the posterior edge. The specification only describes the concave portion as on the anterior edge 112.
Claim Objections
Claims 17, 20, 23 and 25 are objected to because of the following informalities:
In claim 17, “said first flexibly deformable compression element said second flexibly deformable compression element” should instead recite - - said first flexibly deformable compression element and said second flexibly deformable compression element - -.
In claims 20 and 25, the sentence ends with two periods.
In claim 23, a period is missing after the number “23”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 13 each recites “a central support element comprising a contact surface” in line 3, and then recites “said central support element including a contact surface” in lines 6-7. It is unclear if the second recitation of a contact surface is referring to the same initial contact surface, or an additional contact surface. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the second recitation of a contact surface to be the same as the initially introduced contact surface.
Claim(s) 2-12, 14-19 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 6-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blurton et al (US 2007/0260163).
Blurton et al discloses the following limitations:
Claim 1. A non-invasive intrapartum support device (Figs. 14-20) for use on a patient (10), comprising:
a central support element (300) comprising a contact surface (312) configured and dimensioned to extend across an anal orifice of the patient along a midline axis in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening (11) of the patient to a posterior portion posterior to the anal orifice of the patient, the central support element including the contact surface (312) sized and configured to fit within a gluteal cleft (13) of the patient ([0045], [0046]; Figs. 14-16, 20), the contact surface having a width (defined as from first end 314 to second end 316; see annotated figure of ‘W1’ below; [0045]) that extends along the midline axis from an anterior edge to a posterior edge of the non-invasive intrapartum support device;
a first flexibly deformable compression element (520) extending from the central support element in a first lateral direction to a first distal end (lateral end 529 furthest from the contact surface), the first flexibly deformable compression element comprising a first surface (522) configured to face and flexibly follow at least a part of a first buttock (15) within the gluteal cleft of the patient when applied to the patient (Figs. 19-20; [0048]-[0060], the flexibility and deformability of the compression elements can be seen between the transition from Fig. 18 to Figs. 19 and 20 when they are applied to the buttocks), said first flexibly deformable compression element having a first width that extends from said anterior edge to said posterior edge, said first width being greater than said width of said contact surface (see annotated figure of ‘W2’ below);
and a second flexibly deformable compression element (530) extending from the central support element in a second lateral direction to a second distal end (lateral end 539 furthest from the contact surface), the second flexibly deformable compression element comprising a second surface (532) configured to face and flexibly follow at least a part of a second buttock within the gluteal cleft of the patient when applied to the patient (Figs. 19-20; [0048]-[0060], the flexibility and deformability of the compression elements can be seen between the transition from Fig. 18 to Figs. 19 and 20 when they are applied to the buttocks), said second flexibly deformable compression element having a second width that extends from said anterior edge to said posterior edge, said second width being greater than said width of said contact surface (see annotated figure of ‘W3’ below); and
a first fastening member on the first surface of the first flexibly deformable compression element disposed only between the first distal end and the contact surface, and a second fastening member on the second surface of the second flexibly deformable compression element ([0049]).
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Claim 2. The non-invasive intrapartum support device of claim 1, wherein the non-invasive intrapartum support device has a rigidity, the rigidity being sufficient for the contact surface to apply force to tissue superficial to a pelvic floor of the patient ([0050]).
Claim 3. The non-invasive intrapartum support device of claim 2, wherein the rigidity varies from the central support element laterally outwardly along the first and second flexibly deformable compression elements (Figs. 14-20, the thickness and material of central support element (300) and first and second flexibly deformable compression elements (520, 530) vary and are not the same. Therefore, the rigidity would also vary as the entire device is not one integrally formed device of the same material and same thickness. Materials of the device are discussed in [0048], [0057]-[0059]).
Claim 6. The non-invasive intrapartum support device of claim 1, wherein the first fastening member includes a first releasable fastening system (510), and wherein the second fastening member includes a second releasable fastening system (512) ([0049]; each fastening member includes a hook and loop system or adhesive system which is each the first half of first and second releasable systems (510, 512) to cooperate with the second half (anchors pads 524, 534) of the first and second releasable systems, respectively).
Claim 7. The non-invasive intrapartum support device of claim 6, wherein the first fastening member is disposed only between the first distal end and the contact surface ([0049]; wherein the first fastening member is being interpreted as a hook and loop system or adhesive system disposed on the surface; “The fixation member includes a first half of a releasable fastening system on surface 522, such as a hook and loop system or a releasable adhesive system”; it can be seen in Figs. 18-19 the fastening member extends only between the first distal end and the contact surface as nothing extends past end 529), and wherein the second fastening member is disposed only between the second distal end and the contact surface ([0049]; wherein the first fastening member is being interpreted as a hook and loop system or adhesive system disposed on the surface; “The fixation member includes a first half of a releasable fastening system on surface 532, such as a hook and loop system or a releasable adhesive system”; it can be seen in Figs. 18-19 the fastening member extends only between the first distal end and the contact surface as nothing extends past end 539).
Claim 8. The non-invasive intrapartum support device of claim 7, wherein the first releasable fastening system comprises a first adhesive, and wherein the second releasable fastening system comprises a second adhesive ([0049]).
Claim 9. The non-invasive intrapartum support device of claim 1, wherein the first fastening member is fixed on the first flexibly deformable compression element, and wherein the second fastening member is fixed on the second flexibly deformable compression element ([0049]; the hook and loop system or adhesive system (cited as the fastening members) are disposed on the buttocks facing surface (522, 532) of the first and second flexibly deformable compression elements (520, 530) for securing the support device onto the buttocks and are therefore fixed to the first and second flexibly deformable compression elements to provide such a function.
Claim 10. The non-invasive intrapartum support device of claim 1, wherein the non-invasive intrapartum support device is sterile ([0057]).
Claim 11. The non-invasive intrapartum support device of claim 1, wherein the contact surface comprises a gauze pad (410) (Figs. 17-19; [0047]).
Claim 12. The non-invasive intrapartum support device of claim 11, wherein the gauze pad comprises a material that is configured to frictionally engage perianal tissue of the patient to inhibit movement between the contact surface and the patient ([0047]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13-15, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blurton et al in view of Haadem (US 2011/0022056).
Claim 13. Blurton et al discloses a non-invasive intrapartum support device (Figs. 14-20) for use on a patient (10), comprising:
a central support element (300) comprising a contact surface (312) configured and dimensioned to extend across an anal orifice of the patient along a midline axis in a sagittal plane of the patient from an anterior portion posterior to a vaginal opening (11) of the patient to a posterior portion posterior to the anal orifice of the patient, the central support element including the contact surface (312) sized and configured to fit within a gluteal cleft (13) of the patient ([0045], [0046]; Figs. 14-16, 20);
a first flexibly deformable compression element (520) extending from the central support element in a first lateral direction to a first distal end (lateral end 529 furthest from the contact surface), the first flexibly deformable compression element comprising a first surface (522) configured to face and flexibly follow at least a part of a first buttock (15) within the gluteal cleft of the patient when applied to the patient (Figs. 19-20; [0048]-[0060], the flexibility and deformability of the compression elements can be seen between the transition from Fig. 18 to Figs. 19 and 20 when they are applied to the buttocks);
and a second flexibly deformable compression element (530) extending from the central support element in a second lateral direction to a second distal end (lateral end 539 furthest from the contact surface), the second flexibly deformable compression element comprising a second surface (532) configured to face and flexibly follow at least a part of a second buttock within the gluteal cleft of the patient when applied to the patient (Figs. 19-20; [0048]-[0060], the flexibility and deformability of the compression elements can be seen between the transition from Fig. 18 to Figs. 19 and 20 when they are applied to the buttocks); and
a first fastening member on the first surface of the first flexibly deformable compression element disposed only between the first distal end and the contact surface, and a second fastening member on the second surface of the second flexibly deformable compression element ([0049]).
Blurton et al fails to disclose wherein one of an anterior edge or a posterior edge of said non-invasive intrapartum support device includes a concave portion. However, in the same field of endeavor, Haadem teaches an intrapartum support device, wherein an anterior edge of said device is provided with a concave portion to follow the curvature of the vaginal opening edge (seen along reinforcement beam 73 in Fig. 9 for example) (Figs. 9, 11; [0089]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Blurton et al with the anterior edge having a concave portion as taught by Haadem to maximize the support around the vaginal opening during birth by following the curvature of the vaginal opening, while not obstructing the child labor process ([0090]).
Claim 14. The combination discloses the invention substantially as claimed above, wherein Haadem further discloses the midline axis extends through the concave portion (Figs. 9, 11).
Claim 15. The combination discloses the invention substantially as claimed above, wherein Haadem further discloses wherein the concave portion is on the anterior edge (Figs. 9 and 11, the concave portion is along the reinforcement beam 73 following the curvature of the vaginal opening; [0089]).
Claim 17. The combination discloses the invention substantially as claimed above, wherein Blurton et al further discloses the first (529) and second distal ends (539) of the first flexibly deformable compression element the second flexibly deformable compression element are curved between the anterior edge and the posterior edge (Fig. 18, edges of the distal ends are rounded).
Claim 19. The non-invasive intrapartum pelvic floor support device of claim 13, wherein the first fastening member is disposed only between the first distal end and the contact surface ([0049]; wherein the first fastening member is being interpreted as a hook and loop system or adhesive system disposed on the surface; “The fixation member includes a first half of a releasable fastening system on surface 522, such as a hook and loop system or a releasable adhesive system”; it can be seen in Figs. 18-19 the fastening member extends only between the first distal end and the contact surface as nothing extends past end 529), and wherein the second fastening member is disposed only between the second distal end and the contact surface ([0049]; wherein the first fastening member is being interpreted as a hook and loop system or adhesive system disposed on the surface; “The fixation member includes a first half of a releasable fastening system on surface 532, such as a hook and loop system or a releasable adhesive system”; it can be seen in Figs. 18-19 the fastening member extends only between the first distal end and the contact surface as nothing extends past end 539).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blurton et al in view of Haadem as applied to claim 14 above, and further in view of Trieu (US 2009/0148503).
Claim 16. The combination discloses the invention substantially as claimed above, but fails to disclose the concave portion is on the posterior edge.
However, in a similar field of endeavor, Trieu teaches an intrapartum support device attached during childbirth delivery, wherein the support device comprises a concave portion on the posterior edge (Fig. 14 – heart shaped; [0087], [0088]). Trieu further teaches the shape (and thus curvature and concavity) of the support device can have various geometries ([0088]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the posterior edge of the combination to have a concave portion as taught by Trieu to provide support while following the natural curvature of the buttocks (Fig. 14).
Claim(s) 20-23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blurton et al in view of Toth (US 2001/0003157).
Claim 20. Blurton et al discloses a non-invasive intrapartum support device (Figs. 14-20) for use on a patient (10), comprising:
a central support element (300) comprising a contact surface (312) configured to fit within a gluteal cleft (13) of a patient and dimensioned to extend across an anal orifice of the patient from a posterior edge to an anterior edge of said central support element ([0045], [0046]; Figs. 14-16, 20);
a first flexibly deformable compression element (520) extending from the central support element in a first lateral direction to a first distal end (lateral end 529 furthest from the contact surface), the first flexibly deformable compression element comprising a first surface (522) configured to face and flexibly follow at least a part of a first buttock (15) within the gluteal cleft of the patient when applied to the patient (Figs. 19-20; [0048]-[0060], the flexibility and deformability of the compression elements can be seen between the transition from Fig. 18 to Figs. 19 and 20 when they are applied to the buttocks);
and a second flexibly deformable compression element (530) extending from the central support element in a second lateral direction to a second distal end (lateral end 539 furthest from the contact surface), the second flexibly deformable compression element comprising a second surface (532) configured to face and flexibly follow at least a part of a second buttock within the gluteal cleft of the patient when applied to the patient (Figs. 19-20; [0048]-[0060], the flexibility and deformability of the compression elements can be seen between the transition from Fig. 18 to Figs. 19 and 20 when they are applied to the buttocks); and
a first fastening member on the first surface of the first flexibly deformable compression element disposed only between the first distal end and the contact surface, and a second fastening member on the second surface of the second flexibly deformable compression element ([0049]).
Blurton et al fails to disclose said central support element comprising a focusing pressure element disposed on the contact surface and comprising a raised protrusion extending outwardly from the contact surface and transverse to said midline axis, said focusing pressure element comprising a shape configured to apply a focal area of increased pressure to a perianal region of the patient. Instead, Blurton et al discloses a cotton pad (410) disposed on the contact surface ([0047]).
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely to support the anal tissue and prevent hemorrhoids (see Applicant’s specification paragraph [00216] regarding suppressing hemorrhoid development), Toth teaches a support device (20) for placement against the anus between the buttocks ([0034]), wherein the support device comprises a focusing pressure element (34) disposed on the contact surface (upper surface seen in Fig. 13 defined by sections 28 and 29) and comprising a raised protrusion (protruding crest 34) extending outwardly (upwardly) from the contact surface and transverse to said midline axis, said focusing pressure element comprising a shape configured to apply a focal area of increased pressure to a perianal region of the patient ([0036], [0039]). Similar to the gauze pad (410) of Blurton et al, the focusing pressure element of Toth may be formed of an absorbent material such as cotton ([0037]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to before the effective filing date of the invention to modify the gauze pad (410) of Blurton et al to a focusing pressure element comprising a raised protrusion to apply a focal area of increased pressure as taught by Toth to provide a retaining pressure directly to distressed tissue to restrict the growth and inflammation of hemorrhoids ([0039]).
Claim 21. The combination discloses the invention substantially as claimed above, wherein Toth discloses said focusing pressure element comprises a curved shape (Figs. 3, 5).
Claim 22. The combination discloses the invention substantially as claimed above, but fails to explicitly disclose said focusing pressure element comprises a polygonal shape. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to change the crescent shape of the raised protrusion of Toth to a polygonal shape because Applicant has not disclosed that a polygonal shape provides an advantage, is used for a particular purpose or solves a stated problem (see Applicant’s discussion of the polygonal shape in paragraph [00159]). One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with a polygonal shape since the shape would still be a raised protrusion for applying pressure to the anal region. Therefore, it would have been obvious to one skilled in the art before the effective filing date of the invention to modify the shape of the focusing pressure element in the combination to a polygonal shape since this is a mere obvious design choice that fails to patentably distinguish the invention of claim 22 from the prior art.
Claim 23. The combination discloses the invention substantially as claimed above, wherein said focusing pressure element comprises a textured area (Toth discloses the focusing pressure element is made of cotton in [0037] while Blurton et al discloses pad (410) is a gauze pad in [0047]) having a different texture than a remainder of the contact surface (Blurton et al discloses remainder of device 300 is made of a more rigid material polycarbonate material).
Claim 25. The combination discloses the invention substantially as claimed above, wherein Toth discloses said focusing pressure element (34) includes a length (defined by lengths of ends 32 and 33) along the midline axis that is less than a length of the contact surface along the midline axis (Figs. 3 and 5; length of the contact surface includes length of all of sections 28 and 29).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12213701 in view of Blurton ‘163.
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader in some respects and merely add an obvious feature absent from the claims of the patent claim in other respects.
Claim 1 recites the additional feature of the widths of the first and second flexibly deformable compression element being greater than the width of the contact surface absent from the patent claims. However, in the same field of endeavor, Blurton et al teaches this feature as seen in the annotated figure from the rejection of claim 1 above (W2 and W3 are greater than W1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patent claims to include such a feature to have a larger width on the flexibly deformable compression elements to adhere to the larger structure of the buttocks (as compared to the smaller size of the anal region).
Claims 13-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12213701 in view of Haadem.
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader in some respects and merely add an obvious feature absent from the claims of the patent claim in other respects.
Claim 13 recites the additional feature of the one of an anterior edge or a posterior edge of said non-invasive intrapartum support device includes a concave portion absent from the patent claims. However, in the same field of endeavor, Haadem teaches an intrapartum support device, wherein an anterior edge of said device is provided with a concave portion to follow the curvature of the vaginal opening edge (seen along reinforcement beam 73 in Fig. 9 for example) (Figs. 9, 11; [0089]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patent claims with the anterior edge having a concave portion as taught by Haadem to maximize the support around the vaginal opening during birth by following the curvature of the vaginal opening, while not obstructing the child labor process ([0090]).
Claims 20-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12213701 in view of Toth.
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader in some respects and merely add an obvious feature absent from the claims of the patent claim in other respects.
Claim 20 recites the additional feature of said central support element comprising a focusing pressure element disposed on the contact surface and comprising a raised protrusion extending outwardly from the contact surface and transverse to said midline axis, said focusing pressure element comprising a shape configured to apply a focal area of increased pressure to a perianal region of the patient absent from the patent claims.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely to support the anal tissue and prevent hemorrhoids (see Applicant’s specification paragraph [00216] regarding suppressing hemorrhoid development), Toth teaches a support device (20) for placement against the anus between the buttocks ([0034]), wherein the support device comprises a focusing pressure element (34) disposed on the contact surface (upper surface seen in Fig. 13 defined by sections 28 and 29) and comprising a raised protrusion (protruding crest 34) extending outwardly (upwardly) from the contact surface and transverse to said midline axis, said focusing pressure element comprising a shape configured to apply a focal area of increased pressure to a perianal region of the patient ([0036], [0039]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to before the effective filing date of the invention to modify the patent claims to include a focusing pressure element disposed on the contact surface and comprising a raised protrusion extending outwardly from the contact surface and transverse to said midline axis, said focusing pressure element comprising a shape configured to apply a focal area of increased pressure to a perianal region of the patient as taught by Toth to provide a retaining pressure directly to distressed tissue to restrict the growth and inflammation of hemorrhoids ([0039]).
Allowable Subject Matter
Claims 4, 5, 18 and 24 are 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 and if the double patenting rejections are obviated.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Bluton ‘163 discloses the eventually substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or combination the claimed device comprising, inter alia, the structures of claims 4, 5, 18 and 24. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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