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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 15, 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because the same reference character “32” appears to be used in Fig. 1 to designate both an outer edge of a first flap (consistent with ¶ 59) as well as an upper edge of a pouch and a lower edge of the pouch; the same reference number “16” appears to be used to designate both an upper edge of the pouch attachment area (consistent with ¶ 58) in Fig. 1 and an upper edge of the first flap in Fig. 2; and the same reference number “18” appears to be used to designate both a lower edge of the pouch attachment area (consistent with ¶ 58) and some part of the second flap in Fig. 2.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include reference number “62” mentioned in the description. See ¶¶ 64 and 65.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include reference numbers “86”, “90”, “92”, “94”, and “95” (see Figs. 1 and 7-8) and “821” (see Fig. 8B) which are not mentioned in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In ¶ 58, lines 3-4, “on the same said” should read --on the same side--.
In ¶ 76, line 2, “pouch 20” should read --pouch 70--.
In ¶ 99, it appears that each instance of “loop 851” should read --loop 853--, since reference number “851” is used elsewhere to denote an attachment on the blanket (see Fig. 8C and ¶ 97) and reference number “853” is used in Fig. 8D to denote what appears to be a loop but is not mentioned in the description.
Appropriate correction is required.
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.
Claims 20, 23-26, 30-31, 33-35, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Bruyn-Zuidam (EP 1,190,631 A2, hereinafter Bruyn-Zuidam).
Regarding independent claims 20 and 30, Bruyn-Zuidam discloses an infant swaddling (outer cloth 2 of swaddling assembly 1, Figs. 1-3C; the outer cloth 2 being usable alone, see ¶ 55) comprising:
an upper edge (top edge of outer cloth 2);
a lower edge (bottom edge of outer cloth 2);
a first side edge (left or right side edge of outer cloth 2);
a second side edge (right or left side edge of outer cloth 2);
a first region (leftward region carrying VELCRO strips 22a, 23a, or rightward region carrying VELCRO strips 22b, 23b, Figs. 2B-D) extending laterally inward from the first side edge, the first region comprising a first attachment (22a, 23a; or 22b, 23b, ¶ 32);
a second region (rightward region carrying VELCRO strips 22b, 23b, or leftward region carrying VELCRO strips 22a, 23b, Figs. 2B-D) extending laterally inward from the second side edge, the second region comprising a second attachment (22b, 23b; or 22a, 23a, ¶ 32); and
a retainer (cord 18) spaced apart from the lower edge;
wherein the infant swaddling (2) is configured to be laid flat for positioning of an infant relative to the infant swaddling (see Fig. 3A), the first region is configured to be folded over at least a portion of the infant and the second region is configured to be folded over at least a portion of the infant (Fig. 3C), the first and second attachments (22a, 22b; 22b, 23b) are configured to be secured (¶ 32), and a lower portion of the infant swaddling (2) is configured to be gathered and passed through the retainer (18) to close access to the infant near the feet of the infant (¶ 32).
Bruyn-Zuidam differs from the claimed invention in that the retainer (18) is not necessarily a “single retainer” due to an additional intermediate cord (19), and in that the location at which the retainer is coupled is not “closer to the second side edge than the first side edge.” Each of these limitations will be addressed in turn below.
First, with respect to the retainer being a “single retainer,” Bruyn-Zuidam teaches that use of the additional intermediate attachment (cord 19) may be undesirable in infants under six months of age “for whom it should be made sure that the legs are not wrapped too tightly, in connection with the prevention of hip dysplasia” (¶ 44). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bruyn-Zuidam by eliminating the intermediate attachment (19), such that the retainer/lowermost cord (18) is a single retainer, in order to prevent misuse of the device in younger infants for whom the additional leg restriction would be undesirable.
Second, with respect to the retainer being coupled closer to the second side edge, the examiner notes that relocating the attachment point of the retainer from the rear of the swaddling (as in Bruyn-Zuidam) to closer to the second side edge would not change the function of the retainer to close the lower portion of the swaddling, because in either location, the retainer would be accessible to the user for passing the gathered lower portion through the retainer (since the second side edge is exposed and accessible when the second region is folded over the first region, as shown in Figs. 2D and 3C). Because the particular location of the retainer does not appear to be critical to the operation of the swaddling, the examiner concludes that would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to relocate the attachment point of the retainer to be closer to a second side edge than the first side edge, since the court has held that rearranging parts of an invention is an obvious matter of engineering design choice when the rearrangement of parts would not have modified the operation of the device. In re Japikse, 86 USPQ 70. See MPEP 2144.04.VI.C.
Regarding claim 23, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 20. The examiner notes that dependent claim 23 locates the first attachment on an outward surface, and dependent claim 32 locates the second attachment on an outward surface. In the context of claim 23, the VELCRO strips 22a, 23a of Bruyn-Zuidam read on the first attachment which is located on an outward facing surface of the infant swaddling (2) when the infant swaddling is laid flat. See Figs. 2A-B.
Regarding claim 24, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 20. In the context of claim 24, the VELCRO strips 22b, 23b of Bruyn-Zuidam read on the second attachment which is located on an inward facing surface of the infant swaddling (2) when the infant swaddling is laid flat. See Figs. 2A-B.
Regarding claim 25, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 20. Bruyn-Zuidam further teaches the upper portion comprises an upper section that, when in use, is near the nape of the infant’s neck. See Fig. 3C.
Regarding claim 26, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 20. Bruyn-Zuidam further teaches the infant swaddling (2) is configured to be adjusted to accommodate growth of the infant (“user can easily adjust the tightness of the wrap,” ¶ 33; “the age, build … of the child … can be adjusted to,” ¶ 54). One of ordinary skill in the art would immediately recognize that the swaddling (2) can be adjusted to accommodate growth of the infant by means of the elongated VELCRO attachments (22a, 22b, 23a, 23b) shown in Fig. 2D.
Regarding claim 31, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 30. Bruyn-Zuidam further teaches the infant swaddling (2) is configured to be adjusted to accommodate different sized infants (“user can easily adjust the tightness of the wrap,” ¶ 33; “the age, build … of the child … can be adjusted to,” ¶ 54). One of ordinary skill in the art would immediately recognize that the swaddling (2) can be adjusted to accommodate different sized infants by means of the elongated VELCRO attachments (22a, 22b, 23a, 23b) shown in Fig. 2D.
Regarding claim 33, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 30. Bruyn-Zuidam further teaches the lower portion of the infant swaddling is configured to be passed through the single retainer (18) to open access to the infant near the feet of the infant (see Figs. 3A-C, ¶ 32, the cord 18 being just below the infant’s feet).
Regarding claims 34 and 35, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 30. Bruyn-Zuidam further teaches the first and second attachments (22a, 23a; 22b, 23b) are each selected from the group consisting of a tab of loop fabric, tabs of loop fabric, a tab of hook fabric, and tabs of hook fabric (“VELCRO strips 22a, 22b and 23a, 23b,” ¶ 32).
Regarding claim 38, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 30. Bruyn-Zuidam further teaches the first attachment (22a, 23a; or 22b, 23b) comprises a plurality of tabs of hook or loop fabric (¶ 32), wherein the tabs are vertically aligned (see Figs. 2B-D).
Claims 21, 22, 29, 32, 37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Bruyn-Zuidam in view of Sims (US Patent No. 6,839,924, hereinafter Sims).
Regarding claims 21 and 22, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 20. Bruyn-Zuidam further teaches the first and attachments (22a, 23a; 22b, 23b) each comprise two tabs of hook or loop fabric (¶ 32), rather than three tabs each as claimed. However, Sims teaches a similar infant swaddling (Figs. 2A-D) comprising a first and second attachments (26a-c and 32a-c) each comprising three tabs of complementary hook-and-loop fabric (“a first set of three hook and loop fastener segments 32a, 32b and 32c are inset from the second side edge 30,” col. 4:45-51; “on the back side of the blanket [are] hook and loop fastener sections 26a, 26b and 26c which engage corresponding parts 32a-c,” col. 5:1-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bruyn-Zuidam by adding a third tab of loop fabric to the first attachment (claim 21) and a third tab of hook fabric to the second attachment (claim 22), as taught by Sims, in order to provide a more secure attachment of the swaddling around the infant.
Regarding claim 29, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 20. Bruyn-Zuidam does not teach that the second attachment comprises a larger surface area than the first attachment. However, Sims teaches a similar swaddling (Figs. 2A-D) comprising a second attachment (fastener sections 26a-c) with a larger surface area than a first attachment (fastener sections 32a-c). See comparative sizes as shown in Figs. 2A-C. Sims teaches that the larger surface area of the second attachment (26a-c) contributes to adjustability of the swaddling (col. 5:4-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bruyn-Zuidam by providing the second attachment with a larger surface area than the first attachment, as taught by Sims, in order to facilitate adjustability of the swaddling for infants of different sizes.
Regarding claim 32, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 30. As noted above, dependent claim 23 locates the first attachment on an outward surface, and dependent claim 32 locates the second attachment on an outward surface. In the context of claim 32, the VELCRO strips 22a, 23a of Bruyn-Zuidam read on the second attachment comprising multiple tabs of hook or loop fabric spaced along an outward surface. See Figs. 2B-D. Bruyn-Zuidam does not teach such tabs being laterally spaced (where “laterally” is interpreted in view of Applicant’s specification as referring to a direction “generally perpendicular to the head-to-toe vertical positioning of the infant,” ¶ 60). However, Sims teaches a similar swaddling (Figs. 2A-D) comprising multiple tabs of hook or loop fabric (32a, 33a) spaced laterally along a surface of the swaddling. Sims teaches that this configuration of tabs facilitates adjustment of the swaddling for infants of different sizes (col. 5:4-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the second attachment of Bruyn-Zuidam to include multiple tabs of hook or loop fabric spaced laterally as taught by Sims along the outward surface, in order to facilitate adjustability of the swaddling for infants of different sizes.
Regarding claim 37, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 30. Bruyn-Zuidam does not teach that the second attachment comprises a larger lateral measurement than the first attachment. However, Sims teaches a similar swaddling (Figs. 2A-D) comprising a second attachment (fastener sections 26a-c) with a larger lateral measurement than a first attachment (fastener sections 32a-c). See comparative sizes as shown in Figs. 2A-C. Sims teaches that the larger lateral measurement of the second attachment (26a-c) contributes to adjustability of the swaddling (col. 5:4-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Bruyn-Zuidam by providing the second attachment with a larger lateral measurement than the first attachment, as taught by Sims, in order to facilitate adjustability of the swaddling for infants of different sizes.
Regarding claim 39, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 30. Bruyn-Zuidam further teaches the second attachment (22a, 23a; or 22b, 23b) comprises a plurality of tabs of hook or loop fabric (¶ 32), wherein the tabs are vertically aligned (see Figs. 2B-D). Bruyn-Zuidam does not teach at least one tab that is offset. However, Sims teaches a similar swaddling (Figs. 2A-D) comprising a plurality of tabs of hook or loop fabric (32a-c, 33a-b), wherein at least two tabs are vertically aligned (e.g., tabs 32a-c being vertically aligned, as shown in Fig. 2A) and at least one tab is offset (e.g., tabs 33a and 33b being laterally offset from tabs 32a-c, Fig. 2A). Sims teaches that this configuration of tabs facilitates adjustment of the swaddling for infants of different sizes (col. 5:4-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the first attachment of Bruyn-Zuidam to include at least one tab offset from the vertically aligned tabs, as taught by Sims, in order to facilitate adjustability of the swaddling for infants of different sizes.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Bruyn-Zuidam in view of Barski (US Patent No. 8,607,364, hereinafter Barski).
Regarding claims 27 and 28, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 20. Bruyn-Zuidam does not explicitly teach that the swaddling comprises a spandex blend (claim 27) or a polyester blend (claim 28). However, Barski teaches an infant swaddling comprising spandex, polyester, or blends thereof (“spandex, polyesters … and combinations or blends thereof,” ¶ 19), to provide optimal swaddling with “a normal range of motion in a womb-like environment thereby promoting and enhancing motor development while maintaining an effective swaddle” (¶ 47). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Bruyn-Zuidam by selecting a spandex blend (claim 27) or a polyester blend (claim 28) as taught by Barski for the material of the swaddling, in order to facilitate an effective swaddle while permitting an appropriate range of motion for enhancing motor development.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Bruyn-Zuidam in view of Schneider (US Patent No. 4,083,064, hereinafter Schneider).
Regarding claim 36, Bruyn-Zuidam teaches the claimed invention substantially as claimed, as set forth above for claim 30. Bruyn-Zuidam does not teach that the single retainer comprises elastic. However, Schneider teaches an infant gown comprising an elastic retainer (“fastening device 84 which may be constituted, for example, of a rubber band,” col. 6:55-68; see Fig. 4) through which a gathered lower portion of the gown is passed (see gathered arrangement 82, Fig. 4). Schneider teaches that the elastic retainer is advantageous for closing the bottom of the gown “while permitting nevertheless an opening for the ingress and egress of connections … which lead to and from supervisory or regulatory medical apparatus or the like” (col. 6:63-68). Additionally, the examiner notes that Bruyn-Zuidam recognizes drawbacks to the use of a tied cord, teaching that the cords must be of minimal length “in order to prevent that the cords are used for securing to the bed” (¶ 29). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Bruyn-Zuidam by replacing the tied cord with an elastic retainer as taught by Schneider, since this involves the simple substitution of one known retainer for closing the lower portion of an infant covering with another known retainer for closing the lower portion of an infant covering, to yield predictable results. Moreover, one of ordinary skill in the art would have recognized that the elastic retainer taught by Schneider may be preferable to a tied cord because it reduces the risk of harm from misuse of the cord, while also permitting ingress and egress for medical monitoring.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,188,150 (hereinafter the ‘150 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘150 patent recite the same features described in the instant claims. including a swaddling comprising first and second attachments on first and second side portions and an elastic loop corresponding the instant retainer spaced apart from the lower edge.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,188,151 (hereinafter the ‘151 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘151 patent recite the same features described in the instant claims. including a swaddling comprising first and second attachments on first and second side portions and a loop corresponding the instant retainer spaced apart from the lower edge.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,779,579 (hereinafter the ‘579 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘579 patent recite the same features described in the instant claims. including a swaddling comprising first and second attachments on first and second side regions and a loop corresponding the instant retainer spaced apart from the lower edge.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,779,580 (hereinafter the ‘580 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘580 patent recite the same features described in the instant claims. including a swaddling comprising first and second attachments on first and second side regions and an elastic loop corresponding the instant retainer spaced apart from the lower edge.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,470,888 (hereinafter the ‘888 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘888 patent recite the same features described in the instant claims. including a swaddling comprising first and second attachments on first and second side regions and a closure comprising a loop corresponding the instant retainer.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,910,841 (hereinafter the ‘841 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘841 patent recite the same features described in the instant claims. including a swaddling comprising first and second attachments on first and second side regions and a loop corresponding the instant retainer spaced apart from the lower edge.
Claims 20-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,171,278 (hereinafter the ‘278 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘278 patent recite the same features described in the instant claims. including a swaddling comprising first and second attachments on first and second side regions and a single loop corresponding the instant retainer spaced apart from the lower edge.
Claim 20-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-40 of copending Application No. 17/932,787 (hereinafter the ’787 application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘787 application recite the same features described in the instant claims, including a swaddling comprising first and second attachments on first and second regions and a retainer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/Laura Davison/Primary Examiner, Art Unit 3993