NON-FINAL REJECTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/2/2026 has been entered.
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.
Claims 1, 4, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ridge, US 2023/0139828 A1 (hereinafter “Ridge”) in view of Ajluni, US 7,055,204 B2 (hereinafter “Ajluni”).
Regarding claims 1 and 14: Ridge discloses a device adapted to monitor the follicles (¶ [0011], [0056]) and to assess the thickness of the endometrium (¶ [0104]) of a subject, comprising:
a) an elongated member (“main body section 2” 102, Fig. 1) having a tip that houses an ultrasound probe (“piezo detector”/“piezo crystal array” 107, Fig. 1);
b) a handle (“handle section 2” 104, Fig. 1) adapted to be held in the hand of a subject; and
c) an angular positioning mechanism (“handle joint” 108) positioned between the elongated member and the handle.
Ridge does not disclose that the angular positioning mechanism comprises:
(i) toothed housing portion; and
(ii) a toothed plug comprising teeth and ridges, said toothed plug coupled to the handle, so that teeth of the toothed plug engage teeth of the toothed housing portion to maintain the handle at selected angular positions relative to the elongated member and ridges of the toothed plug engage corresponding slots in the handle.
In this sense, Ridge can be considered a “base” device upon which the claimed invention can be seen as an improvement.
Ajluni teaches a device comprising:
a) an elongated member (handle 48, handle parts 102 and 100);
b) a handle (arm 40) adapted to be held in the hand of a subject; and
c) an angular positioning mechanism (see Figs. 5-6) positioned between the elongated member and the handle, the angular positioning mechanism comprising:
(i) toothed housing portion (hubs 80); and
(ii) a toothed plug (buttons 90) comprising teeth and ridges (locking tabs 92 collectively read on both teeth and ridges; e.g., two of the locking tabs can read on the claimed teeth and the remaining two locking tabs can read on the claimed ridges), said toothed plug coupled to the handle, so that teeth of the toothed plug engage teeth of the toothed housing portion to maintain the handle at selected angular positions relative to the elongated member (hub 80 can be considered to have teeth formed by cutting slots 84 into throughbore 82, Figs. 5 and 8; “When in their extended position (FIG. 10), the button locking tabs 92 are partially positioned within both the arm hub slot 76 and handle hub slots 84. Thus, when in their extended position, the locking tabs 92 prevent pivoting of the arm 40 relative to the handle 48.” col. 3, line 66 – col. 4, line 3) and ridges of the toothed plug engage corresponding slots in the handle (“When in their extended position (FIG. 10), the button locking tabs 92 are partially positioned within both the arm hub slot 76 and handle hub slots 84. Thus, when in their extended position, the locking tabs 92 prevent pivoting of the arm 40 relative to the handle 48.” col. 3, line 66 – col. 4, line 3).
Ajluni is not in the same field of endeavor (i.e., Aljuni is drawn to a cleaning device resembling a broom or similar sweeping device, while Ridge and Applicant’s inventions are drawn to ultrasound probes). In this sense, Ajluni can be considered a “comparable” device (method, or product that is not the same as the base device) that has been improved in the same way as the claimed invention. It is noted that Ajluni is still considered to be analogous art because of the following reason(s):
MPEP 2141.01(a) recites in part:
I. TO RELY ON A REFERENCE UNDER 35 U.S.C. 103, IT MUST BE ANALOGOUS ART TO THE CLAIMED INVENTION
In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103 , the reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. The examiner must determine whether a reference is analogous art to the claimed invention when analyzing the obviousness of the subject matter under examination. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023). If a reference is not analogous art to the claimed invention, it may not be used in an obviousness rejection under 35 U.S.C. 103. However, there is no analogous art requirement for a reference being applied in an anticipation rejection under 35 U.S.C. 102. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997).
When determining whether the "relevant field of endeavor" test is met, the examiner should consider "explanations of the invention’s subject matter in the patent application, including the embodiments, function, and structure of the claimed invention." Airbus S.A.S. v. Firepass Corp., 941 F.3d 1374, 1380, 2019 USPQ2d 430083 (Fed. Cir. 2019) (quoting Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212). When determining whether a prior art reference meets the "same field of endeavor" test for the analogous art, the primary focus is on what the reference discloses. Airbus, 41 F.3d at 1380. The examiner must consider the disclosure of each reference "in view of the ‘the reality of the circumstances.’" Airbus, 41 F.3d at 1380 (quoting Bigio, 381 F.3d at 1326, 72 USPQ2d at 1212). These circumstances are to be weighed "from the vantage point of the common sense likely to be exerted by one of ordinary skill in the art in assessing the scope of the endeavor." Airbus, 41 F.3d at 1380. See also Donner Technology, LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 2020 USPQ2d 11335 (Fed. Cir. 2020); Sanofi-Aventis, 66 F.4th at 1378; and Netflix, Inc. v. DivX, LLC, 80 F.4th 1352, 1358-59, 2023 USPQ2d 1057 (Fed. Cir. 2023) ("The field of endeavor is ‘not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field.’") (quoting Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001, 120 USPQ2d 1593, 1597 (Fed. Cir. 2016)).
As for the "reasonably pertinent" test, the examiner should consider the problem faced by the inventor, as reflected - either explicitly or implicitly - in the specification. In order for a reference to be "reasonably pertinent" to the problem, it must "logically [] have commended itself to an inventor's attention in considering his problem." In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (quoting In re Clay, 966 F.2d 656,658, 23 USPQ2d 1058, 1061 (Fed. Cir. 1992)). See also In re Klein, 647 F.3d 1343, 1348, 98 USPQ2d 1991, 1993 (Fed. Cir. 2011) An inventor is not expected to have been aware of all prior art outside of the field of endeavor. Airbus, 41 F.3d at 1380-82. A reference outside of the field of endeavor is reasonably pertinent if a person of ordinary skill would have consulted it and applied its teachings when faced with the problem that the inventor was trying to solve. Airbus, 41 F.3d at 1380-82. In order to support a determination that a reference is reasonably pertinent, it may be appropriate to include a statement of the examiner's understanding of the problem. The question of whether a reference is reasonably pertinent often turns on how the problem to be solved is perceived. If the problem to be solved is viewed in a narrow or constrained way, and such a view is not consistent with the specification, the scope of available prior art may be inappropriately limited. It may be necessary for the examiner to explain why an inventor seeking to solve the identified problem would have looked to the reference in an attempt to find a solution to the problem, i.e., factual reasons why the prior art is pertinent to the identified problem. See Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 1359, 2020 USPQ2d 11335 (Fed. Cir. 2020) ("Thus, when addressing whether a reference is analogous art with respect to the claimed invention under a reasonable-pertinence theory, the problems to which both relate must be identified and compared.").
The Supreme Court’s decision in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), did not change the test for analogous art as stated in Bigio. Under Bigio, a reference need not be from the same field of endeavor as the claimed invention in order to be analogous art. Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. This is consistent with the Supreme Court's instruction in KSR that "[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one." KSR, 550 U.S. at 417, 82 USPQ2d at 1396. The Federal Circuit reads KSR as "direct[ing] us to construe the scope of analogous art broadly" because "familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle." Wyers v. Master Lock Co., 616 F.3d 1231, 1238, 95 USPQ2d 1525, 1530 (Fed. Cir. 2010) (quoting KSR, 550 U.S. at 402, 127 S. Ct. at 1727).
Any argument by the applicant that the examiner has misconstrued the problem to be solved, and as a result has improperly relied on nonanalogous art, should be fully considered in light of the specification. In evaluating the applicant's argument, the examiner should look to the teachings of the specification and the inferences that would reasonably have been drawn from the specification by a person of ordinary skill in the art as a guide to understanding the problem to be solved. A prior art reference not in the same field of endeavor as the claimed invention must be reasonably pertinent to the problem to be solved in order to qualify as analogous art and be applied in an obviousness rejection.
In this case, Ajluni is reasonably pertinent to one of the problems faced by the inventor (i.e., how to mechanically realize an adjustable angle joint between the handle the elongated member in such a way to provide for a plurality of discrete selectable angular positions but can also maintain the angular position of the handle relative to elongated member at a selected one of the plurality of discrete selectable angular positions) because Ajluni teaches a solution thereof as discussed above. The ordinarily skilled artisan would have recognized that these kinds of joints already exist in the joint art itself, and are common in a variety of handheld tools where an adjustable angle handle is desired including household tools such as cooking and cleaning, personal hygiene, gardening tools, etc. (see Additional Prior Art section below). Thus, the ordinarily skilled artisan would have looked to Ajluni (or similar reference) when confronted with the aforementioned problem regarding the adjustable angle joint as it pertains to the joint in Ridge.
Since these kinds of joints are already in use in a variety of handheld devices, the ordinarily skilled artisan could easily have applied the known “improvement” technique in the same way to the base device (method, or product) and the results would have been predictable to one having ordinarily skilled in the art.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ridge such that angular positioning mechanism comprises: (i) toothed housing portion; and (ii) a toothed plug comprising teeth and ridges, said toothed plug coupled to the handle, so that teeth of the toothed plug engage teeth of the toothed housing portion to maintain the handle at selected angular positions relative to the elongated member and ridges of the toothed plug engage corresponding slots in the handle, as taught by Ajluni, because it would have merely involved use of a known technique to improve similar devices (methods, or products) in the same way. Furthermore, the ordinarily skilled artisan would have been motivated to make this modification in order to realize an adjustable angle joint between the handle the elongated member in such a way to provide for a plurality of discrete selectable angular positions but can also maintain the angular position of the handle relative to elongated member at a selected one of the plurality of discrete selectable angular positions.
Regarding claim 4: Ridge further discloses that the angle between the central axis of the elongated member and that of the handle can be changed between 0° and 180° (e.g., Fig. 5 illustrate approximately 120° which is between 0° and 180°).
Regarding claim 13: Ridge further discloses a protrusion on the elongated member (“main body section 1” 101 appears to include a circumferential protrusion at the proximal end).
Claims 6-8, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ridge in view of Ajluni as applied to claim 1 above, and further in view of Morokawa et al., US 2004/0249286 A1 (hereinafter “Morokawa”).
Regarding claims 6-10, Ridge in view of Krieger does not disclose a ring on the elongate member (claim 6); wherein the ring can slide along the length of the elongated member (claim 7); a fastener in the ring that applies pressure on a surface of the elongated member (claim 8); and a rough surface formed along a length of the elongated member (claim 10).
Morokawa teaches a ring (5, Figs. 4A, 4B, 5A, 5B) on the elongate member adapted to prevent a user from inserting the elongated member at a depth greater than appropriate; wherein the ring can slide along the length of the elongated member (2, Figs. 4A and 4B); a fastener (3, Figs. 5A and 5B) in the ring that applies pressure on the surface of the elongated member; and a rough surface (2b, Figs. 5A and 5B) formed along a length of the elongated member.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Ridge such that the device further comprises a ring on the elongate member, wherein the ring can slide along the length of the elongated member; a fastener in the ring that applies pressure on a surface of the elongated member; and a rough surface formed along a length of the elongated member, as taught by Morokawa; and the ordinarily skilled artisan would have been motivated to make this modification in order to prevent over insertion of the elongated member in the patient with regards to depth of insertion.
Regarding claim 12: the ring of Morokawa as discussed above can be considered to read on a telescopic section of the elongated member because the elongated member extends in a telescopic manner as shown in Figs. 4A and 4B.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Ridge such that the ring comprises a telescopic section of the elongated member, as taught by Morokawa; and the ordinarily skilled artisan would have been motivated to make this modification in order to adjust the length of the insertable portion of the device (i.e., the elongated member) to thereby prevent over insertion of the elongated member in the patient with regards to depth of insertion.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ridge in view of Ajluni and Morokawa as applied to claim 6 above, and further in view of Sverdlik et al., US 2021/0298812 A1 (hereinafter “Sverdlik”).
Regarding claim 11: Ridge does not disclose one or more rulers provided on the elongated member, said rulers comprising indicia indicative of a length.
Sverdlik teaches one or more rulers provided on an elongated member, said rulers comprising indicia indicative of a length (“In some embodiments, markings and/or a ruler on the surface of the applicator body 802, optionally close to the gripping member 806, provide indications regarding the depth and/or the orientation of the applicator body 802 within the vagina 810.” ¶ [0236]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Ridge such that the device further comprises one or more rulers provided on the elongated member, said rulers comprising indicia indicative of a length, as taught by Sverdlik; and the ordinarily skilled artisan would have been motivated to make this modification in order to provide indications regarding the depth and/or the orientation of the device inserted within the body.
Response to Arguments
Applicant's arguments filed 6/2/2026 have been fully considered but they are not entirely persuasive.
The amendments to the claims are sufficient to avoid means-plus-function interpretation under §112(f).
The amendments to the claims are sufficient to overcome the rejections under §112(a) and §112(b).
Applicant argues by way of amendment that the prior art cited in the previous Office Action does not teach the amended limitations; i.e., the toothed housing and the toothed plug as specifically recited in claims 1 and 14 as currently amended.
In view of the amendments, the examiner has performed an updated search which has result in new grounds of rejection presented above based on the modifying Ridge in view of the teachings of Ajluni as discussed in the rejection above. All pending claims remain rejected; therefore, this application is not in condition for allowance.
Additional Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure with regard to the adjustable angular joint.
Chuang, US 5,265,969
Armstrong, US 6,155,620
Harrington et al., US 10,575,703 B2
Jiang, US 2002/0078518 A1
Cheng et al., US 2013/0174364 A1
Moore et al., US 7,600,287 B1
Knopow et al., US 7,802,340 B2
Tsuchiya et al., US 7,293,317 B2
Lin, US 2008/0052856 A1
Heneveld, US 7,032,941 B2
Conclusion
All pending claims are rejected; this application is not in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
11 June 2026
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