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 .
Priority
The instant application, filed on 03/14/2025, is a continuation of US Application 17/885,665, filed on 08/11/2022, which is a divisional of US Application 17/534,001, filed on 11/23/2023, which is a continuation in part of US Application 16/537,088, filed on 08/09/2019, which is a continuation in part of US Application of 16/151,591, filed on 10/04/2018, which claims priority to Provisional Application 62/586,690, filed on 11/15/2017. Claims 1 – 12 and 17 – 24 of the instant application are directed to subject matter that was introduced for the first time in the US Application 17/534,001, filed on 11/23/2023. The earlier Provisional Application and U.S. Applications fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for an outer needle portion, an inner needle portion, and a needle receiver as recited by independent claims 1, 17, 18, and 21. Accordingly, claims 1 – 12 and 17 – 24 are not entitled to the benefit of the prior applications because the elements listed above as claimed in the instant application are unsupported within the disclosures listed above. The earliest disclosure for the subject matter of claims 1 – 12 and 17 – 24, and thus the effective filing date for the subject matter of claims 1 – 12 and 17 – 24, is 11/23/2021.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “110” has been used to designate both “the bore” of the first needle in Fig. 4 and what appears to be the distal end of second / outer needle in Fig. 3. 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.
Claim Objections
Claims 1, 5, 17, 18, and 21 are objected to because of the following informalities:
Claims 1, 17, 18, and 21 recite at least one of “a outer needle portion”, “a inner needle portion”, and/or “A interlocking”, however, these lines are not grammatically correct; therefore, the Examiner suggests the lines be amended to recite “an outer needle portion”, “an inner needle portion”, and “An interlocking”, respectively;
Claims 1 and 18 recite “each configured to” in two locations in various lines, although the lines are understood by the Examiner to mean “each of the one or more non-resistance sections” AND “each of the one or more resistance sections” as discussed previously, the Examiner suggests the first instance of “each configured to” in each claim be amended to read “each of the one or more non-resistance sections” and suggests the second instance of “each configured to” in each claim be amended to read “each of the one or more resistance sections” for the purpose of maintaining consistent language throughout the claims;
Claim 5 recites “a second space less than the first space” in line 4, although the line does not rise to the level of being indefinite as the line is understood by the Examiner to mean “smaller than” as defined in Applicant’s disclosure, the Examiner suggests the line be amended to read “a second space smaller than the first space” for the purpose of maintaining consistent language throughout the claims;
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.
Claim 10 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.
Regarding claim 10, the phrase "the one resistance section" renders the claim indefinite because it is unclear whether Applicant is intending for the line to read “the one or more resistance sections” as previously defined or if Applicant is intending for claim 10 to further limit the system to have only one resistance section. For the purpose of examination the Examiner will read the claim to mean the former.
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 1 – 12 and 17 – 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 12 and 17 – 20 of U.S. Patent No. 11,439,386.
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 11,439,386.
Regarding claim 1 of the Instant Application, claim 1 of U.S. Patent No. 11,439,386 also claims an interlocking two-part sewing needle comprising:
an outer needle portion having a needle tip (claim 1) (Examiner’s note: claim 1 of U.S. Patent No. 11,439,386 claims a first needle portion; however, the first needle portion is recited as accepting a second needle portion therein; therefore, the first needle portion is an outer needle portion);
an inner needle portion configured to be inserted into the outer needle portion for removably connecting the outer needle portion and the inner needle portion together (claim 1) (Examiner’s note: claim 1 of U.S. Patent No. 11,439,386 claims a second needle portion; however, the second needle portion is recited as being inserted into the first needle portion; therefore, the second needle portion is an inner needle portion); and
a needle receiver formed in the outer needle portion and configured to receive the inner needle portion when the inner needle portion is inserted into the outer needle portion (claim 1), the needle receiver including:
one or more non-resistance sections, each configured to exert only a friction force on the inner needle portion when the inner needle portion is inserted into the needle receiver (claim 1); and
a needle interlock comprising one or more resistance sections, each configured to exert a compressive force on the inner needle portion when the inner needle portion is inserted into the needle receiver (claim 1).
Regarding claim 2 of the Instant Application, claim 2 of U.S. Patent No. 11,439,386 also claims wherein the needle receiver comprises a channel that, when the inner needle portion is inserted into the outer needle portion, partially surrounds the inner needle portion, the channel formed by a bottom located between a pair of shoulders that are separated from one another by a first space (claim 2).
Regarding claim 3 of the Instant Application, claim 3 of U.S. Patent No. 11,439,386 also claims wherein one of the one or more resistance sections is located in the channel (claim 3).
Regarding claim 4 of the Instant Application, claim 4 of U.S. Patent No. 11,439,386 also claims wherein one of the one or more non-resistance sections is located in the channel (claim 4).
Regarding claim 5 of the Instant Application, claim 5 of U.S. Patent No. 11,439,386 also claims wherein one of the one or more resistance sections of the needle interlock comprises a channel crimp formed by a portion of the shoulders of the channel that are separated from one another by a second space that is less than the first space, wherein the second space is sized such that the portion of the shoulders at the channel crimp exert the compressive force on the inner needle portion when the outer needle portion and the inner needle portion are connected together (claim 5).
Regarding claim 6 of the Instant Application, claim 6 of U.S. Patent No. 11,439,386 also claims wherein one of the one or more non-resistance sections comprises a portion of the shoulders located at the channel but not located at the channel crimp that exerts only a friction force on the inner needle portion when the outer needle portion and the inner needle portion are connected together (claim 6).
Regarding claim 7 of the Instant Application, claim 7 of U.S. Patent No. 11,439,386 also claims wherein the needle receiver comprises a bore formed and extending longitudinally within the outer needle portion such that the outer needle portion and the inner needle portion are connected together by sliding the inner needle portion into the bore such that the bore substantially surrounds at least a portion of the inner needle portion (claim 7).
Regarding claim 8 of the Instant Application, claim 8 of U.S. Patent No. 11,439,386 also claims wherein one of the one or more resistance sections is located in the bore (claim 8).
Regarding claim 9 of the Instant Application, claim 9 of U.S. Patent No. 11,439,386 also claims wherein one of the one or more non-resistance sections is located in the bore (claim 9).
Regarding claim 10 of the Instant Application, claim 10 of U.S. Patent No. 11,439,386 also claims wherein the one resistance section is sized and configured to arrest sliding movement of the inner needle portion with respect to the outer needle portion (claim 10).
Regarding claim 11 of the Instant Application, claim 11 of U.S. Patent No. 11,439,386 also claims further comprising a stop crimp formed in the outer needle portion and reducing a widest internal wall-to-wall size of the bore taken at a cross section such that, when the outer needle portion and the inner needle portion are connected together, the inner needle portion contacts the stop crimp within the bore and the stop crimp exerts the compressive force on the inner needle portion (claim 11).
Regarding claim 12 of the Instant Application, claim 12 of U.S. Patent No. 11,439,386 further comprising a stop crimp receiver provided in the inner needle portion, wherein, when the outer needle portion and the inner needle portion are connected together, the stop crimp is configured to snap into the stop crimp receiver for removably connect the outer needle portion and the inner needle portion together (claim 12).
Regarding claim 17 of the Instant Application, claim 17 of U.S. Patent No. 11,439,386 also claims an interlocking two-part sewing needle (claim 17) comprising:
an outer needle portion (Examiner’s note: claim 17 of U.S. Patent No. 11,439,386 claims a first needle portion; however, the first needle portion is recited as accepting a second needle portion therein; therefore, the first needle portion is an outer needle portion) formed from a hollow tube with an internal bore that extends from a leading end of the outer needle portion to a trailing end of the outer needle portion to provide open ends; a channel located at the trailing end of the outer needle portion and including a bottom located between a pair of shoulders that are separated from one another by a first space and a needle tip provided at the leading end of the outer needle portion (claim 17);
an inner needle portion (Examiner’s note: claim 1 of U.S. Patent No. 11,439,386 claims a second needle portion; however, the second needle portion is recited as being inserted into the first needle portion; therefore, the second needle portion is an inner needle portion) configured to be removably connected together with the outer needle portion by inserting a leading end of the inner needle portion into the internal bore via the trailing end of the outer needle portion and then sliding the inner needle portion at least partially through the internal bore (claim 17);
a channel crimp provided in a portion of the channel wherein a portion of the shoulders located at the channel crimp are separated by a second space that is smaller than the first space such that the shoulders contact the inner needle portion at the channel crimp and align the inner needle portion with the internal bore (claim 17); and
a stop crimp that constricts the internal bore and exerts a compressive force on the inner needle portion for resisting movement of the inner needle portion through the internal bore beyond the stop crimp (claim 17).
Regarding claim 18 of the Instant Application, claim 18 of U.S. Patent No. 11,439,386 also claims a method of using a needle comprising the steps of:
providing a two-part sewing needle comprised by an outer needle portion (Examiner’s note: claim 18 of U.S. Patent No. 11,439,386 claims a first needle portion; however, the first needle portion is recited as accepting a second needle portion therein; therefore, the first needle portion is an outer needle portion) having a needle tip (claim 18);
an inner needle portion (Examiner’s note: claim 18 of U.S. Patent No. 11,439,386 claims a second needle portion; however, the second needle portion is recited as being inserted into the first needle portion; therefore, the second needle portion is an inner needle portion) configured to be inserted into the outer needle portion for removably connecting the outer needle portion and the inner needle portion together; and a needle receiver formed in the outer needle portion and configured to receive the inner needle portion when the inner needle portion is inserted into the outer needle portion, the needle receiver including: one or more non-resistance sections, each configured to exert only a friction force on the inner needle portion when the inner needle portion is inserted into the needle receiver (claim 18); and a needle interlock having one or more resistance sections, each configured to exert a compressive force on the inner needle portion when the inner needle portion is inserted into the needle receiver (claim 18);
removably connecting the outer needle portion and the inner needle portion together by inserting the inner needle notion into the needle receiver such that a friction force is exerted onto the inner needle portion by one of the one or more non-resistance sections (claim 18); and
with one of the one or more resistance sections, exerting a first compressive force on the inner needle portion that is greater than the friction force exerted on the inner needle portion (claim 18).
Regarding claim 19 of the Instant Application, claim 19 of U.S. Patent No. 11,439,386 also claims further comprising the step of, with another one of the one or more resistance sections, exerting a second compressive force on a different and longitudinally spaced apart portion of the inner needle portion that is greater than the first compressive force and greater than the friction force (claim 19).
Regarding claim 20 of the Instant Application, claim 20 of U.S. Patent No. 11,439,386 also claims wherein:
the needle receiver comprises:
a channel that, when the inner needle portion is inserted into the needle receiver, partially surrounds the inner needle portion, the channel formed by a bottom located between a pair of shoulders that are separated from one another by a first space (claim 20);
a bore formed and extending longitudinally within the outer needle portion such that the outer needle portion and the inner needle portion are connected together by sliding the inner needle portion into the bore such that the bore substantially surrounds at least a portion of the inner needle portion;
the first compressive force is provided by a channel crimp formed in a portion of the channel, wherein a portion of the shoulders located at the channel crimp is separated by a second space that is smaller than the first space such that the shoulders contact the inner needle portion at the channel crimp and exert the first compressive force on the inner needle portion and aligns the inner needle portion with the bore (claim 20); and
the second compressive force is provided by a stop crimp that constricts the bore and exerts the second compressive force on the inner needle portion and resists movement of the inner needle portion through the bore beyond the stop crimp (claim 20).
Regarding claim 21 of the Instant Application, claim 20 of U.S. Patent No. 11,439,386 also claims a method for removably connecting together elongate structures comprising the steps of: providing an outer needle portion (Examiner’s note: claim 18 of U.S. Patent No. 11,439,386 claims a first needle portion; however, the first needle portion is recited as accepting a second needle portion therein; therefore, the first needle portion is an outer needle portion) having a longitudinal axis, a leading end, a trailing end (Examiner’s note: all needle portions have a longitudinal axis, leading end, and a trailing end), and an elongate receiver (needle receiver) having an opening formed at the trailing end of the outer needle portion (opening in receiver wherein the inner / second needle portion is inserted) and extending along the longitudinal axis (claim 18);
providing an inner needle portion (Examiner’s note: claim 18 of U.S. Patent No. 11,439,386 claims a second needle portion; however, the second needle portion is recited as being inserted into the first needle portion; therefore, the second needle portion is an inner needle portion) having a longitudinal axis, a leading end, and a trailing end (Examiner’s note: all needle portions have a leading end, a trailing end, and a longitudinal axis) (claim 18);
inserting the leading end of the inner needle portion into the opening of the elongate receiver of the outer needle portion such that the longitudinal axes of the inner and outer needle portions are parallel and then sliding the inner needle portion into the elongate receiver (Examiner’s note: as claimed in claim 20, the bore of the inner needle portion is longitudinally extending; and the bore surrounds the second needle, therefore the inner and outer needles have to be parallel);
providing a non-resistance section in the elongate receiver of the outer needle portion (claim 18);
with the non-resistance section, exerting only a friction force on the inner needle portion as the inner needle portion is sliding into the elongate receiver; providing a resistance section in the elongate receiver of the outer needle portion (claim 18); and
with the resistance section, exerting a compression force on the outer needle portion as the inner needle portion is inserted into the elongate receiver (claim 18).
Regarding claim 22 of the Instant Application, claim 20 of U.S. Patent No. 11,439,386 also claims wherein: the outer needle portion comprises a hollow tube having an internal bore (channel – claim 20) formed by an outer wall providing opposing open ends (claim 20), the resistance section comprises a crimp (channel crimp) formed in the outer wall of the hollow tube that reduces a widest internal wall-to-wall spacing of the internal bore located at the crimp and taken at a cross section (Examiner’s note: the definition of a crimp is a reduction in diameter; therefore, the channel crimp has to be formed by a reduction in the widest internal wall-to-wall spacing of the channel), the inner needle portion has a width (width not the stop crimp) that is greater than the widest internal wall-to-wall spacing (claim 20), and
the method further comprising the step of exerting a compressive force onto the inner needle portion by contacting the inner needle portion with an internal wall surface located at the crimp (claim 20).
Regarding claim 23 of the Instant Application, claim 20 of U.S. Patent No. 11,439,386 also claims wherein the inner needle portion comprises an outer wall and a crimp receiver (crimp stop) formed in the outer wall, the method further comprising the step of positively engaging a portion of the outer wall located at the crimp into the crimp receiver (claim 20).
Regarding claim 24 of the Instant Application, claim 20 of U.S. Patent No. 11,439,386 also claims wherein the inner and outer needle portions each comprise a hollow tube, each having an internal bore (channel ; bore) formed by an outer wall providing opposing open ends (claim 20).
Allowable Subject Matter
Claims 1 – 12 and 17 – 24 are allowed over the prior art. However claims 1 – 24 are rejected under Non-Statutory Double Patenting. Therefore, a eTerminal Disclaimer must be submitted or the claims must be amended to overcome the Non-Statutory Double Patenting rejection. Additionally, Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art alone or in combination with fails to disclose or make obvious the interlocking two-part sewing needles of claims 1, 17, 18, and 21. More specifically:
With respect to claims 1, 18, and 22, the prior art alone or in combination with fails to disclose or make obvious the interlocking two-part sewing needle comprising, inter alia, an outer needle portion having a needle tip, an inner needle portion configured to be inserted into the outer needle portion for removably connecting the outer needle portion and the inner needle portion together and a needle receiver formed in the outer needle portion and configured to receive the inner needle portion when the inner needle portion is inserted into the outer needle portion, wherein the needle receiver includes one or more non-resistance sections configured to exert only a friction force on the inner needle portion when the inner needle portion is inserted into the needle receiver and a needle interlock comprising one or more resistance sections configured to exert a compressive force on the inner needle portion when the inner needle portion is inserted into the needle receiver.
With respect to claim 17, the prior art alone or in combination with fails to disclose or make obvious the interlocking two-part sewing needle comprising, inter alia, an outer needle portion having a needle tip at a leading end thereof and an internal bore that extends from the leading end to the trailing end, an inner needle portion configured to be inserted into the outer needle portion for removably connecting the outer needle portion and the inner needle portion together, the outer needle portion including a channel at the trailing end comprising a bottom located between a pair of shoulders that are separated from one another by a first space and a channel crimp, wherein a portion of the shoulders located at the channel crimp are separated by a second space that is smaller than the first space such that the shoulders contact the inner needle portion at the channel crimp and align the inner needle portion with the internal bore; and a stop crimp that constricts the internal bore and exerts a compressive force on the inner needle portion for resisting movement of the inner needle portion through the internal bore beyond the stop crimp.
Regarding the above, the closest prior art, Reddy (US 5,352,219), discloses an interlocking two-part apparatus (two part modular tool 10) (abstract, col. 3 lines 55 – 67, and Figs. 1 – 5) comprising, inter alia, an outer needle portion (instrument 14; and designated in annotated Fig. 4) having a needle tip (tip of hook 42) (col. 3 lines 55 – 67, col. 5 lines 10 – 12, and Figs. 1 – 5), an inner needle portion (elongate shaft 12; and designated in annotated Fig. 4) configured to be inserted into the outer needle portion (instrument 14) for removably connecting the outer needle portion and the inner needle portion together (col. 3 lines 55 – 67 and Figs. 1 – 5), a needle receiver (see annotated Fig. 4) formed in the outer needle portion (instrument 14) and configured to receive the inner needle portion when the inner needle portion is inserted into the outer needle portion (col. 3 lines 55 – 67 and Figs. 1 – 5, annotated Fig. 4), the needle receiver including: one or more non-resistance sections (designated in annotated Fig. 4), a needle interlock (designated in annotated Fig. 4) comprising one or more resistance sections (designated in annotated Fig. 4), each configured to exert a compressive force on the inner needle portion when the inner needle portion is inserted into the needle receiver (Examiner’s note: the threads 34 of the needle interlock / resistance sections exert a compressive force on the inner needle portion). However, Reddy does not disclose or make obvious wherein the “non-resistance” sections only exert a frictional force, as stated in col. 4 lines 50 – 56 of Reddy the “non-resistance” section designated in the annotated Fig. 4 below, which are parts of the shank 18, expands and the resistance to expansion provides a compressive force onto the shaft 12 (i.e., the inner needle portion); therefore, the “non-resistance” sections of Reddy do not only exert a frictional force. Additionally, Reddy does not disclose or make obvious a channel at the trailing end of the outer needle, wherein the channel includes a channel crimp. It would not have been obvious to one of ordinary skill in the art to modify the “non-resistance” sections to only exert a frictional force as this would reduce the level of engagement between the inner and outer members, thereby teaching away from system; moreover, it would not have been obvious to one of ordinary skill in the art to modify the outer needle portion of Reddy to further include a channel with a channel crimp at the trailing end thereof, as Reddy already teaches means of fixing the inner and outer portions together, and there is no motivation, absent hindsight, to add an additional means of do so. Additionally, no other references, or reasonable combination thereof, could be found which discloses or suggests these features in combination with other limitations in the claims.
Annotated Figure 4 of Reddy
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Vanderhoof (US 4,846,811) teaches a means of restricting proximal and distal movement of an inner needle within an outer member.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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