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 .
Election/Restrictions
Applicant's election with traverse of claims 8-15 in the reply filed on January 28, 2026 is acknowledged. The traversal is on the ground(s) that NOT “’distinct’ inventions” because:
“opening” and “discontinuity” are structurally the overlapping. This is not found persuasive because opening is not structurally the SAME. What’s the scope of overlapping? It’s clear that opening can still be continuous on the side whereas something is discontinuous, nothing is attached from one side to another side.
Claims 23-26 recites “the first and second surfaces as transparent/opaque or clear/colored such that contrast of the surfaces,” but claims 23-26 is NOT in claim 21 as shown by the Examiner in the restriction.
Applicant also argues that “specifying a color difference and specifying clear/transparent VS. colored/opaque are predictable variants directed to the same function of visualizing the sleeve orientation and reducing twisting during implant positioning. These are the kinds of routine, predictable modifications that do not rise to a separate invention for restriction purposes, particularly where the core sleeve architecture and use are the same,” then why Applicant would claim these if they are not NEW. Even if they are claimed, the Examiner has shown that additional search for different colors is a necessary step in which Applicant has not explained whether the search and/or consideration should not be needed.
The requirement is still deemed proper and is therefore made FINAL.
Furthermore, Applicant cancelled claims 21-32, and added new claims 33-44. It is unclear what Applicant’s purposes of these arguments on the restriction required for these cancelled claims are. Claims 33-44 are not restricted with respect to claims 8-15
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 8-15, 33-44 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.
In re claims 8, 33, 44, it is unclear what the metes and bounds of “a first surface” and “second surface” with respect to “both sides of the opening” are. What is the scope of “both sides of the opening”? What’s the definite of pockets? Under normal understanding, a pocket would have ONE opening but enclosed on all other side. How are the sides of opening is being determined?
Furthermore, does claim 8 or 33 requires a sling implant at all? It does not seem claim 8 requires any sling implant. The Examiner will interpret as capable of.
In re claims 9, 10, 35, 36, 38, 42, the term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
In re claim 11, it’s unclear what the metes and bounds of “clear” are. Clear is a property of transparency. Color is a visual perception of different wavelengths of light.
In re claim 12, if claim 8 does not require a sling implant. What’s the scope of claim 12, what would make the sling implant at least partially exposed through the opening of the sleeve? Is this a capability of the sleeve but based on user’s preference? What’s the further narrowing structure limitation here?
In re claims 36 and 38, sling implant was not positively claim in claim 33. Is now the sling implant a necessary structure element? Or the clam merely allows the second surface to be capable of? So then for claim 38, is now the sling implant a necessary structure element with distinct color than the second surface? For claim 38, what’s the scope of “clear visualization”? How “clear” is clear? Would different color inherently make “clear visualization”?
In re claim 37, it is unclear what the metes and bounds of “a contrast between .. detects twisting” are. What is the structure limitation here? Would any contrast inherently detects twisting? Claim 33 already have CONTRAST due to different color. So what’s new and narrow about this contrast in claim 37 that would detect twisting?
In re claim 40, again, is now the sling implant a necessary structure element? And what further structure limitation would make sling is exposed through the opening? What’s the scope of “exposed”?
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 8, 33, 37, 41, 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmer Harry (US 2,790,316, hereinafter Palmer ‘316).
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[AltContent: textbox (First Surface)][AltContent: textbox (Second Surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Opening)][AltContent: arrow]In re claim 8, Palmer ‘316 teaches a sleeve for a sling implant, comprising: a first surface (fig. 1); and a second surface having an opening therein, the second surface comprising a different color than the first surface (second surface is white, and first surface is black and then white); and, wherein the first surface and the second surface are joined at their respective edges to form pockets on both sides of the opening for receiving the sling implant (fig. 1)
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[AltContent: textbox (First Surface)][AltContent: textbox (Second Surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Opening)][AltContent: arrow]In re claim 33, Palmer ‘316 teaches a protective sleeve for a sling implant, comprising: a first surface; and a second surface comprising a different color than the first surface and having an opening; wherein the first and second surfaces are joined together such that pockets are formed on both sides of the protective sleeve to position the sling implant therein (fig. 1).
In re claim 37, Palmer ‘316 teaches wherein a contrast between the first surface and the second surface (fig. 1), hence, the contrast would work the same way to detect twisting throughout a length of the sleeve.
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[AltContent: textbox (First Surface)][AltContent: textbox (Second Surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Opening)][AltContent: arrow]In re claim 41, Palmer ‘316 teaches a protective sleeve, comprising: a first surface; and a second surface having an opening therein; wherein the first surface and the second surface are joined at their sides and ends to form pockets on both sides of the opening to position a sling inside the pockets (fig. 1).
In re claim 42. Palmer ‘316 teaches wherein the second surface is substantially opaque and colored (white is a color).
Claim(s) 8, 33, 34, 37, 41, 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zimmermann (US D759,349S, hereinafter Zimmermann ‘349).
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[AltContent: textbox (First Surface)][AltContent: textbox (Second Surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Opening)][AltContent: arrow]In re claim 8, Zimmermann ‘349 teaches a sleeve for a sling implant, comprising: a first surface (fig. 1); and a second surface having an opening therein, the second surface comprising a different color than the first surface (second surface is white, and first surface is black and then white); and, wherein the first surface and the second surface are joined at their respective edges to form pockets on both sides of the opening for receiving the sling implant (fig. 1)
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[AltContent: textbox (First Surface)][AltContent: textbox (Second Surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Opening)][AltContent: arrow]In re claim 33, Zimmermann ‘349 teaches a protective sleeve for a sling implant, comprising: a first surface; and a second surface comprising a different color than the first surface and having an opening; wherein the first and second surfaces are joined together such that pockets are formed on both sides of the protective sleeve to position the sling implant therein (fig. 1).
In re claim 34, Zimmermann ‘349 wherein the second surface comprises the opening approximately at a mid-point of a length of the protective sleeve (fig. 1).
In re claim 37, Zimmermann ‘349 teaches wherein a contrast between the first surface and the second surface (fig. 1), hence, the contrast would work the same way to detect twisting throughout a length of the sleeve.
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[AltContent: textbox (First Surface)][AltContent: textbox (Second Surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Opening)][AltContent: arrow]In re claim 41, Zimmermann ‘349 teaches a protective sleeve, comprising: a first surface; and a second surface having an opening therein; wherein the first surface and the second surface are joined at their sides and ends to form pockets on both sides of the opening to position a sling inside the pockets (fig. 1).
In re claim 42. Zimmermann ‘349 teaches wherein the second surface is substantially opaque and colored (white is a color).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 8-15, 33-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu, Michael S.H. (US 2005/0256366, hereinafter Chu ‘366).
In re claim 8, Chu ‘366 teaches a sleeve for a sling implant, comprising: a first surface (fig. 1, any distal potion towards 107b of 104a could be the first surface); and a second surface having an opening therein (fig. 1, any proximal portion towards 110 could be the second surface, 110, 102; 0033), the second surface comprising a different color than the first surface (para 0038 teaches “The sleeve 104 may include both transparent and colored sections.” Hence, it would be matter of design choice to divide first surface section and second surface section into transparent and/or color sections in order to see the sling inside the sleeve and facilitate placement of the sling); and, wherein the first surface and the second surface are joined at their respective edges to form pockets on both sides of the opening for receiving the sling implant (it would have been obvious that when first surface section and second surface section is divided into transparent and/or color sections, two sections are join together as a sleeve for 104).
In re claim 9, Chu ‘366 teaches wherein the first surface of the sleeve is substantially transparent (0038).
In re claim 10, Chu ‘366 teaches wherein the second surface of the sleeve is substantially opaque (0038).
In re claim 11, Chu ‘366 teaches wherein the first surface is clear and wherein the second surface is colored (0038).
In re claim 12, Chu ‘366 teaches wherein the sling implant is at least partially exposed through the opening of the sleeve (fig. 1A/B, 110 and 102c area; 0033).
In re claim 13, Chu ‘366 teaches wherein a first dilator tube is attached to a first end of the sleeve (fig. 1A/B; 107a, 108a; 0030).
In re claim 14, Chu ‘366 teaches wherein a second dilator tube is attached to a second end of the sleeve (fig. 1A/B; 107a, 108a; 0030, 0038; 0054-0055).
In re claim 15, Chu ‘366 teaches wherein the opening is positioned at a mid- section of the second surface (fig. 1A/B, 110 and 102c area; 0033).
In re claim 33, Chu ‘366 teaches a protective sleeve for a sling implant, comprising: a first surface (fig. 1, any distal potion towards 107b of 104a could be the first surface); and a second surface comprising a different color than the first surface and having an opening (any proximal portion towards 110 could be the second surface, 110, 102; 0033; and 0038 teaches “The sleeve 104 may include both transparent and colored sections.” Hence, it would be matter of design choice to divide first surface section and second surface section into transparent and/or color sections in order to see the sling inside the sleeve and facilitate placement of the sling); wherein the first and second surfaces are joined together such that pockets are formed on both sides of the protective sleeve to position the sling implant therein (it would have been obvious that when first surface section and second surface section is divided into transparent and/or color sections, two sections are join together as a sleeve for 104).
In re claim 34 Chu ‘366 teaches wherein the second surface comprises the opening approximately at a mid-point of a length of the protective sleeve (fig. 1A/B, 110 and 102c area; 0033).
In re claim 35, Chu ‘366 teaches wherein the first surface is substantially transparent (0038).
In re claim 36, Chu ‘366 teaches wherein the second surface of the protective sleeve for the sling implant is substantially opaque (0038).
In re claim 37, Chu ‘366 teaches wherein a contrast between the first surface and the second surface (0038 that “both transparent and colored sections” would create contrast) which inherently able to detect twisting throughout a length of the sleeve. Applicant has not narrowed the contrast in anyway that would make any contrast different from detection.
In re claim 38, Chu ‘366 in para 0038 already teaches “the sling 102 and/or sleeve 104 may be colored to facilitate placement of the sling by the operator. The sleeve 104 may include both transparent and colored sections.” Hence, it would have been obvious as a design choice to have wherein one or more portions of the sling implant comprises a color different than a color of the substantially opaque second surface for clear visualization in order to facilitate placement of the sling by the operator.
In re claim 39, Chu ‘366 teaches wherein a length of the protective sleeve is longer than a length of the sling implant (fig. 1A/B, 104 ends at 107b and 108b, which is longer than 102).
In re claim 40, Chu ‘366 teaches wherein at least a portion of the sling implant is exposed through the opening of the second surface of the protective sleeve (fig. 1A/B, 110 and 102c area; 0033).
In re claim 41, Chu ‘366 teaches a protective sleeve, comprising: a first surface (fig. 1, any distal potion towards 107b of 104a could be the first surface); and a second surface having an opening therein (fig. 1, any proximal portion towards 110 could be the second surface, 110, 102; 0033); wherein the first surface and the second surface are joined at their sides and ends to form pockets on both sides of the opening to position a sling inside the pockets (both distal end of 104a and proximal end of 104a are joined as shown in fig. 1; 102 is inside 104).
In re claim 42, Chu ‘366 teaches wherein the second surface is substantially opaque and colored (0038).
In re claims 43 and 44, Chu ‘366 teaches wherein a first dilator tube is attached at a first terminal end of the protective sleeve and a second dilator tube is attached at a second terminal end of the protective sleeve (107a, 108a, fig. 1, 0030, 0038, 0054-0055).
With respect to limitation “the second surface comprising a different color than the first surface” of claim 8, “a second surface comprising a different color than the first surface” of claim 33, and claims 9, 10, 11, 35, 36, 37, 38, 42, “wherein a color of the first and second dilator tubes are different than a color of the second surface of the protective sleeve” of claim 44, these limitations can also be interpreted as non-functional description material (NFDM).
As show above, Chu ‘366 teaches “[t]he sleeve 104 is preferably transparent so that an operator can to see the sling 102 inside the sleeve 104. In some embodiments, the sling 102 and/or sleeve 104 may be colored to facilitate placement of the sling by the operator. The sleeve 104 may include both transparent and colored sections” except breaking down which part is first surface and which part is second surface. As shown above, it would have been obvious to divide into distal end and proximal end of 104.
Furthermore, Under Federal Circuit precedent, because printed matter itself is nonstatutory subject matter, it must have a functional relationship to a substrate in order to have patentable weight. See, e.g., In re Miller, 418 F.2d 1392, 1396 (CCPA 1969) (observing that “printed matter by itself is not patentable subject matter, because [it is] non-statutory,” but finding that because the printed matter at issue – volumetric indicia and a legend – had a “new and unobvious functional relationship” to the claimed measuring receptacle, the printed matter had patentable weight). Consistent with this logic, non-obvious and functional printed matter receives no patentable weight if the difference between the prior art and a claim limitation lies in the printed matter, as opposed to in the functionality. See In re Xiao, 462 Fed. Appx. 947, 950-52 (Fed. Cir. 2011) (Non-precedential) (holding that use of “wildcard position labels,” instead of letters or numbers on combination lock, had no patentable weight, because they performed the same function as a letter or a number on the lock).
While most of the NFDM case law involves printed matter on a product (substrate), our reviewing court has seen no reason for limiting this reasoning to that specific context. In King Pharmaceuticals, the Federal Circuit expressly extended the reasoning to method claims.
The specific question before us is whether an otherwise anticipated method claim becomes patentable because it includes a step of “informing” someone about the existence of an inherent property of that method. We hold it does not. The “informing” limitation adds no novelty to the method, which is otherwise anticipated by the prior art. In other words, in light of our holding that the method of taking metaxalone with food to increase the drug’s bioavailability, as recited in claim 1, is not patentable, it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.
In an analogous context, we have held that “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (alterations added). In such cases, we have recognized that the printed matter is not independently patentable, but have cautioned that the limitation must not be excised from the claim. See id. at 1385 (“[T]he board cannot dissect a claim, excise the printed matter from it, and declare the remaining portion of the mutilated claim to be unpatentable. The claim must be read as a whole.”) (alterations added). Instead, the relevant question is whether “there exists any new and unobvious functional relationship between the printed matter and the substrate.” Id. at 1386 (citing In re Miller, 57 C.C.P.A. 809, 418 F.2d 1392, 1396 (1969)). The rationale behind this line of cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet functionally unrelated limitations. See In re Ngai, 367 F.3d at 1339.
Although these “printed matter” cases involved the addition of printed matter, such as written instructions, to a known product, we see no principled reason for limiting their reasoning to that specific factual context. See In re Ngai, 367 F.3d at 1338-39; In re Gulack, 703 F.2d at 1385-87. Rather, we believe that the rationale underlying these cases extends to the situation presented in this case, wherein an instructional limitation is added to a method, as opposed to a product, known in the art. Thus, the relevant inquiry here is whether the additional instructional limitation of claim 21 has a “new and unobvious functional relationship” with the known method of administering metaxalone with food. See In re Ngai, 367 F.3d at 1338 (quoting In re Gulack, 703 F.2d at 1386).
King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1278-79 (Fed. Cir. 2010) (emphasis added). Additionally, the Federal Circuit did not find error in the Board’s extension of this reasoning to computer-implemented (data processing) claims when it affirmed, without opinion, the Board’s decision in Ex parte Mathias, 84 USPQ2d 1276 (BPAI 2005) (informative), aff’d 191 Fed.Appx. 959 (Fed. Cir. 2006) (Rule 36).
The descriptive material, first surface have different color or transparency than the second surface have not been shown to have functional relationship with the substrate (sleeves with options to be color coded and/or transparent). Even if functional, the descriptive material may not be functionally different from Chu ‘366. The claimed surfaces differs from Chu ‘366 only in which the surface is color code and which is transparent or which is differently color coded, which is not a patentable distinction. The functional relationship is not “new and nonobvious,” the descriptive material has the same functional component as Chu ‘366 because Chu ‘366’s sleeve and its sections and sling are color coded. (0038)
It has been repeatedly held that an applicant cannot create a novel product by attaching printed matter to it, even if that printed matter itself is new. See, e.g., Ngai. Thus, adding instructions to a kit that describe a method of using it does not make the kit patentable over the same kit with a different set of instructions. Also, it has been held that the “on screen icon for viewing the score of a broadcast sporting event” is unpatentable, because the particular event is a sporting event does not change the product. It merely describes a new, non-functional feature for a product that already exists. Ex parte Mathias, 84 USPQ2d 1276 (BPAI 2005) (informative), aff’d 191 Fed.Appx. 959 (Fed. Cir. 2006)
There are cases in which the descriptive material can form a functional relationship with the underlying substrate. For example, in In re Miller, the addition of printed matter to the outside of a cup permitted an otherwise ordinary cup to be used like a measuring cup to half recipes. The printed matter in Miller served as a computing or mathematical recipe conversion device permitting a cook to perform calculations automatically with no further thought.
However, the claim before us is more like the claim in Ngai, Mathias, than Miller. The fact that a first surface and a second surface have different color or transparency characteristics does not change the product. It merely describes a new, non-functional feature for a product that already exists.
Allowing applicant’s particular NFDM to distinguish over Chu ‘366 would lead to repeated patenting, or permit a patent to issue where the only distinction over the prior art can be characterized appropriately as non-functional, lead to repeated patent such as someone else could claim that the display attribute for the ROI frame could be a Mario, or Luiji, or Cross, or letter “U” for ultrasound.
The rationale behind this prior art rejection is preventing the repeated patenting of essentially a known product by the mere inclusion of novel non-functional descriptive material. King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010) (“The rationale behind this line of cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet functionally unrelated limitations.”) Cf. In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004) (“If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.”).
Hence, Chu ‘366 anticipates the claim because Chu ‘366 teaches each and every limitation of the claim. Any argued difference between the prior art and the claimed invention is simply a substitution of one piece of NFDM (one surface of transparency) for another piece of NFDM (another surface of different color), which does not change the functioning of the color coded sleeve and sling.
Furthermore, Applicant admit that “specifying a color difference and specifying clear/transparent VS. colored/opaque are predictable variants directed to the same function of visualizing the sleeve orientation and reducing twisting during implant positioning. These are the kinds of routine, predictable modifications that do not rise to a separate invention for restriction purposes, particularly where the core sleeve architecture and use are the same.” See Elc. Filed on January 28, 2026. Hence, Chu ‘366 teaches color coded sleeves and slings with the same structure as the claimed invention. Any variations of color or transparency are merely “routine, predictable modifications” as admitted by Applicant.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu ‘366 in view of Chu et al. (US 2009/0171143, hereinafter Chu ‘143).
In re claim 44, furthermore, Chu ‘143 teaches a color of the first and second dilator tubes (0281) are different than a color of the second surface of the protective sleeve (0274, specifically “both the sleeves 6026 and the dilators 6028 are color-coded.” Hence, it would have been a design choice of using color-coded (different color) visualization to ensure the correct identification of different parts of the implant device, i.e. sleeve, dilator tubes).
Hence, it would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Chu ‘366 to include the color coded features of Chu ‘143 in order to help with the organization of the delivery process.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/ Primary Examiner, Art Unit 3797
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