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 .
DETAILED ACTION
Claims 1, 3, 6-11, and 13-15 of S. Kikunaga et al., US 18/027,954 (Oct. 6, 2021) are pending. Claim 3 is withdrawn as not reading on the elected species. Claims 1, 6-11, and 13-15 are under examination on the merits and are rejected.
Election/Restrictions
Pursuant to the election of species requirement, Applicant elected, by way of the Reply filed on August 18, 2025, the product of Example 1, which is MD5.2DR13.2DR21.3DR33.5M, with traverse. In the Reply (and in the specification at page 26, lines 28-31), Applicant indicates the following, with respect to MD5.2DR13.2DR21.3DR33.5M:
For the elected reaction product above, R1, R2, and R3 have the structures indicated below:
R1 = -C2H4Si(OSiMe3)3 [the Examiner infers R1 corresponds to claim 1 variable L1]
R2= Hydrophilic group expressed by -C3H6O--X, where X is a diglycerin portion [the Examiner infers R2 corresponds to claim 1 variable Q], where the elected species has the following structure
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R3 = -C16H33 [the Examiner infers R3 corresponds to claim 1 variable R2]
Previous Reply at page 11.
Subject to the § 112(b) rejection below, the provisional election of species requirement is given effect and claim 3 (as amended) is withdrawn from consideration as not encompassing the elected species. See, MPEP § 803.02.
Claim 3 as amended does not read on the elected species for the following reasons. Claim 3 recites:
3. (Currently Amended) The co-modified organopolysiloxane according to claim 1, wherein in structural formula (1), Q comprises hydrophilic units expressed by structural formulae (3-3), (3-4), or (3-5) with the number of repetitions thereof being in a range of on average within 1.5 to 2.4, and
wherein the divalent linking group Z in formula Q is a divalent organic group containing no oxyalkylene structure with an average number of repetitions of oxyalkylene units of 2 or more.
However, neither base claim 1 nor claim 3 (as amended) recite the structural meaning of “formulae (3-3), (3-4), or (3-5)”. As such, claim 3 appears indefinite for lack of antecedent basis respecting “structural formulae (3-3), (3-4), or (3-5)”. MPEP § 2173.05(e).1 Claims should be complete in themselves and not reference embodiments in the specification or preceding claims that are not incorporated by dependency. See MPEP § 2173.05(s). The specification defines “structural formulae (3-3), (3-4), or (3-5)” as follows:
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where W is a hydrogen atom or an alkyl group having 1 to 20 carbon atoms and where the hydrophilic groups are being bonded to silicon atom via a divalent linking group (Z).
Specification at page 12, lines 1-11. The elected species of formula (1), where Q is:
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does not fall within the scope of claim 3 as amended because it does not meet the claim 3 limitation of “Q comprises hydrophilic units expressed by structural formulae (3-3), (3-4), or (3-5) with the number of repetitions thereof being in a range of on average within 1.5 to 2.4”.
Claim Interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See, MPEP § 2111. During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification. MPEP § 2111.
The Claimed Invention
Understanding the claim 1 genus of structural formula (1) is aided by review of specification working Examples 1-4, which are the only working examples purported to be directed to preparing the claim 1 product. Working Example 1 is summarized by the Examiner below.
Specification Example 1 at page 26, [0070]
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Specification at page 26, lines 15-31. Specification working Examples 2-4 employ the procedure and the same starting reagents, but in varying amounts and with different compositional averages of the methylhydrogenpolysiloxane. Specification at pages 27-28. Specification Table 1 summarizes the HLB and viscosity data for working Examples 1-4. Specification at page 30.
With respect to the nomenclature of the working example products (e.g., Example 1 product MD5.2DR13.2DR21.3DR33.5M), the instant specification provides the following guidelines.
Note that in the following compositional formulae, Me3SiO groups (or Me3Si groups) are notated as "M", Me2SiO groups are notated as "D", and MeHSiO groups are notated as "DH". Units in which a methyl group in D is modified by an arbitrary substituent (R) are notated as DR.
Specification at page 26, [0069]. Such shorthand nomenclature is often used to represent silicone polymers based upon polymer units. Dow Corning Corporation, Silicone Chemistry Overview, 1-11 (1997) (“Dow Corning”); J. Grande et al., 46 Chem. Commun., 4988-4990 (2010).
Withdrawal Claim Rejections/Objections
All rejections/objections of the previous Office action not specifically addressed in this Office action, with respect to Examined claims, are withdrawn.
Withdrawal Non-Statutory Double Patenting
Rejection of claims 1 and 5-11 on the ground of non-statutory double patenting as being unpatentable over conflicting claims 1-3 and 16 of A. Hayashi, et al., US 9,994,680 (2018) is withdrawn in view of Applicant’s amendments. The conflicting claims do not teach or suggest formulae 5-1 or 5-2 of instant claim 1. .
Rejections 35 U.S.C. 112(b)
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.
Pursuant to 35 U.S.C. 112, the claim must apprise one of ordinary skill in the art of its scope so as to provide clear warning to others as to what constitutes infringement. MPEP 2173.02(II); Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention. MPEP § 2173.05(a).
Elected Species “MD5.2DR13.2DR21.3DR33.5M” Does Not Appear to Fall Within the Genus of Claim 1 Leading to Unclear Claim Scope
Claim 1 (and its dependent claims 6-11, and 13-15) are rejected under 35 U.S.C. 112(b) as indefinite because the elected species and working example products do not appear to fall within the scope of claim 1, which lends confusion and uncertainty with the respect to the meaning of “structural formula (1)”. The reasons are as follows.
Claim 1 recites “structural formula (1)”:
1. (Previously Presented) A co-modified organopolysiloxane expressed by structural formula (1) below,
wherein the value of HLB, defined as HLB = (total molecular weight of hydrophilic group portions / total molecular weight) x 20, is within a range of 0.5 to 2.0, and
wherein the viscosity at 25°C is within a range of 200 to 1500 mPas;
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In the Reply filed on August 18, 2025, Applicant indicated the following, with respect to the elected species, which is product of specification working Example 1 (i.e., MD5.2DR13.2DR21.3DR33.5M):
R1 = -C2H4Si(OSiMe3)3 [the Examiner infers R1 corresponds to claim 1 variable L1]
R2= Hydrophilic group expressed by -C3H6O--X, where X is a diglycerin portion [the Examiner infers R2 corresponds to claim 1 variable Q]
R3 = -C16H33 [the Examiner infers R3 corresponds to claim 1 variable R2]
See, specification at page 26, lines 28-31; Reply at page 11.
Plugging these specification identities for R1, R2, and R3 into the Example 1 product MD5.2DR13.2DR21.3DR33.5M gives the following structure (where X is diglycerin):
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Product of Specification Example 1 (i.e., MD5.2DR13.2DR21.3DR33.5M)
However, this structure does not fall within the scope of claim 1 because the ordering of the units DR1 (the claim 1, L1 unit); DR2 (the claim 1, Q unit); and DR3 (the claim 1, R2 unit) differs from the following unit order recited in claim 1.
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Working Examples 2-4 are directed to similar reaction products that also do not appear to fall within the scope of claim 1 for the same reasons. The fact that the elected species and working example products do not appear to fall within the scope of claim 1 lends confusion and uncertainty with the respect to the meaning of claim 1, formula (1). Claim 1 is therefore indefinite in view of Applicant’s representation that “[i]t is believed that this election reads on all claims generically”. Reply filed on August 18, 2025. Dependent claims 6-11 and 13-15 do not cure this issue.
Applicant’s Argument
In response Applicant argues that claim 1 “structural formula (1)” does not require the sequential arrangement units along the polymer chain as drawn. Reply at page 10. Rather, Applicant argues that structural formula (1) should be interpreted as permitting any order of structural units. Reply at page 10.
This argument is not persuasive because Applicant’s interpretation is contrary to the plain meaning of “structural formula (1)” and the specification does not clearly set forth a special definition that supports this interpretation. MPEP § 2111.01(IV). To act as their own lexicographer, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess. MPEP § 2111.01(IV).
In the chemical arts, the plain meaning of a single line connecting two atoms is a direct electronic association (in the form of a single bond) between those two atoms. J. Brecher, Graphical Representation Standards for Chemical Structure Diagrams (IUPAC Recommendations 2008), 80 Pure Appl. Chem. 277-410 (2008) (“Brecher”) (see pages 288-291). Thus, the plain meaning of “structural formula (1)” (drawn using standard chemical-bond nomenclature) is that the structural units are arranged in the order drawn. MPEP § 2111.01(I) (“the words of a claim must be given their "plain meaning" unless such meaning is inconsistent with the specification”). MPEP § 2111.01(I). It is duly noted that the art recognizes that shorthand format is often used in silicone nomenclature.2 However, claim 1 is not drawn using shorthand silicon nomenclature. Further, none of the references cited in footnote 2 support Applicant’s position that claim 1 does not require the sequential arrangement units along the polymer chain as drawn in claim 1, nor has Applicant cited any art supporting its position.
Here it is true that that the products of specification working Examples 1-4 do not fall within the scope of claim 1 “structural formula (1)” because the following circled units of the working examples are in a different order than required by claim 1; however, the non-circled units of the working examples are arranged as set forth in claim 1.
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Thus, certain specification embodiments are inconsistent with claim 1 order of only three of five structural units. However, "[t]hough understanding the claim language may be aided by explanations contained in the written description, it is important not to import into claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment”. MPEP § 2111.01 (quoting Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004)). Furthermore, interpretation of claim 1 “structural formula (1)” (per Applicant’s argument) as permitting any order of all five structural units is not even supported by the specification working examples because the examples relate to only three of the five structural units. There is no support in the specification working example permitting all five of the “structural formula (1)” units to be arranged in a different order than drawn.
Applicant argues that:
Here, this intuition is reinforced by the specification. The specification explains that the example products are presented using conventional silicone compositional nomenclature, in which M, D, D', and substituted D units identify polymer units present in the organopolysiloxane. See Paragraph [0077] and [0085] and Table 1. In this context, the example expression for the elected species is reasonably understood as identifying the types and average amounts of the different substituted D units present in the comodified organopolysiloxane, rather than requiring a single exact sequential arrangement of those units along the polymer chain.
Reply at page 10. In response, claim 1 is not drawn using conventional or shorthand silicone compositional nomenclature; rather claim 1, structure formula (1) is drawn using standard chemical-bond nomenclature.
Applicant further argues that:
That reading is reinforced by the decimal subscripts in the elected-species formula, such as 3.2, 1.3, and 3.5. See Table 1. Those values are compositional averages and therefore are not consistent with a literal depiction of one exact ordered sequence of distinct blocks. Instead, they indicate the relative molar content of the respective functionalized D units in the organopolysiloxane composition. On that understanding, the different placement of the unit labels in the shorthand formula versus claim 1 does not create uncertainty as to claim scope and does not mean the elected species falls outside the claim.
Reply at page 11. In response, the fact that the specification using shorthand silicone nomenclature (versus the claim 1 standard chemical-bond nomenclature) encompasses compositional averages as expressed by decimal subscripts, does support Applicant’s interpretation. The decimal subscripts relate to the number repeating units of that particular unit, not to its order of placement within the particular polymer.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under AIA 35 U.S.C. 103(a) 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.
Claims 1, 6-11, and 13-15 are rejected under AIA 35 U.S.C. 103 as being unpatentable over A. Hayashi et al., US 2014/0371330 (2014) (“Hayashi”).
A. Hayashi et al., US 2014/0371330 (2014) (“Hayashi”)
Hayashi teaches a co-modified organopolysiloxane having a viscosity at 25° C of not more than 1,500 mPas, a group that has a siloxane dendron structure, a hydrophilic group, and expressed by the following general formula (1).
R1aR2bL1cQdSi(O4-a-b-c-d)/2 (1)
Hayashi at page 2, [0016].
With respect to HLB, Hayashi teaches that
The co-modified organopolysiloxane described in 1, wherein an HLB value calculated by formula (A) below is not more than 2.0.
HLB = (total molecular weight of hydrophilic group moiety/total molecular weight) x 20 (A)
Hayashi at page 2, [0016]. Hayashi teaches the following formula (1) subgenus of formula (1-1-1):
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Hayashi at page 2, [0016].
In Practical Example 6, Hayashi discloses the following synthesis of a glycerin co-modified organopolysiloxane:
Synthesis of Co-Modified Organopolysiloxane (Compound P6)
First, 67.91 g of methylhydrogen polysiloxane represented by the average composition formula MD30DH6M, 16.03 g of tris-trimethylsiloxy vinyl silane, 7.7 g of diglycerine monoallyl ether, 8.36 g of 1-octene, and 20 g of toluene were added into a reaction vessel and heated to 70° C while stirring under a stream of nitrogen.
Next, 0.100 g of a platinum catalyst was added, and the mixture was reacted for 16 hours. The completion of the reaction was confirmed by an alkali decomposition gas generation method. After the reaction solution was heated at 120° C under reduced pressure to distill out the low-boiling components, the product was subjected to filtration to obtain a glycerin co-modified organopolysiloxane A having a siloxane dendron structure represented by the average composition formula MD30DR12DR41 DR63M.
Hayashi at page 19, [0132].
The Examiner summarizes Hayashi Practical Example 6 as follows:
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In the Hayashi’s above product P6 (i.e., MD30DR12DR41 DR63M), variables R1, R4 and R6 have the following identities.3
R1 = -C2H4Si(OSiMe3)3
R4 = hydrophilic group represented by -C3H6O-X, wherein X is a diglycerin portion, which is:
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and
R6 = -C8H17.
See footnote 3.
Thus, Hayashi’s MD30DR12DR41 DR63M (P6) has the following structure, where correspondence to claim 1 structural formula (1) is indicated below:
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In Practical Example 7, Hayashi teaches similar syntheses of co-modified organopolysiloxane P7, only replacing 1-octene with 1-dodecene to produce MD30DR12DR41 DR73M (P7), where R1 and R4 are the same as the above product P6 and R7 is -C12H25). Hayashi at page 19, [0133]. Hayashi summarizes the HLB and viscosity data for P6 and P7 in Table 1.
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Hayashi at page 20, col. 2.
The P6 and P7 viscosity values fall within the viscosity ranges of claims 1 and 13. The P6 and P7 HLB values fall within the HLB range of claim 1.
Significantly, the co-modified organopolysiloxanes of instant specification working Examples 1-4 are prepared in essentially the same manner as Hayashi organopolysiloxanes P6 and P7, using essentially the same reactants. The specification working examples differ from Hayashi’s synthesis merely in the repeating group number of starting material methylhydrogenpolysiloxane (D30 is Hayashi versus D5.2 in the specification) and in that the specification examples employ hexadecene as a reactant whereas Hayashi employs 1-octene or 1-dodecene. Specification at pages 26-28.
Differences between Hayashi and Claim 1
It is first noted that this § 103 rejection assumes Applicant’s interpretation that that structural formula (1) should be interpreted as permitting any order of structural units. Reply at page 10.4
Under Applicant’s interpretation, Hayashi co-modified organopolysiloxanes MD30DR12DR41 DR63M (P6) and MD30DR12DR41 DR73M (P7) differ from formula (1), claim 1 in that they do not meet the following bolded claim 1 limitation respecting n1:
Claim 1 . . . (n1 + n2 + n3 + n4) is a number with a range of 2 to 50,
n1 is a number within a range of 0 to 20,
n2 is a number within a range of 1 to 10,
n3 is a number within a range of 0.1 to 10, and
n4 is a number within a range of 0.3 to 2.5.
because n1 in Hayashi’s P6 and P7 corresponding claim 1 variable n1 is 30, which falls outside the claimed range.
Obviousness Rationale
One of ordinary skill is motivated to develop workable or optimum ranges for result-effective parameters, where Applicant can rebut a prima facie case of obviousness by showing the criticality (unexpected result) of the range. MPEP § 2144.05; see also, In re Boesch, 617 F.2d 272,276 (CCPA 1980); In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Claim 1 is obvious because one of ordinary skill is motivated to structurally modify either of Hayashi co-modified organopolysiloxanes MD30DR12DR41DR63M (P6) or MD30DR12DR41DR73M (P7) by lowering the number of D units to within the claimed range of “n1 is a number within a range of 0 to 20” (i.e., substitute Hayashi’s MD30 in P6 and/or P7 with MD0-20).; where a D unit has the following structure. See footnote 2.
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One of ordinary skill is so motivated because Hayashi teaches that variable n1 in formula (1-1-1):
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is “a number in a range from 0 to 70”. Hayashi at page 11, [0062]. This overlaps with the claim 1 range of 0 to 20. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05(I) (citing In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)).
Here, Hayashi motivates one of ordinary skill to explore the full range of n1 = 0 to 70 so as to arrive at co-modified organopolysiloxanes having HLB values “preferably in a range from 0.1 to 2.0” (Hayashi at page 11, [0058]) and viscosity “more preferably in a range from 200 to 1,300 mPa s (Hayashi a page 6, [0023]).
Hayashi specifically teaches that viscosity is a result-effective variable suitable for optimization and a low viscosity is desired. Hayashi at page 2, [0014]. Hayashi discusses the viscosity problems in prior art powder dispersion using a hydrophilic group-modified organopolysiloxane that has good compatibility with the powder surface. Hayashi at page 1, [0004]. Hayashi teaches that
However, the co-modified organopolysiloxane copolymers described in Patent Documents 4 to 6 have a large content of hydrophilic groups and many hydroxyl groups, and the viscosity of the copolymer itself tend to increase due to cohesive force resulting from hydrogen bonding.
Hayashi at page 1, [0006] (emphasis added). Hayashi teaches viscosity ranges as follows:
[0023] The viscosity of the co-modified organopolysiloxane according to the present invention is not more than 1,500 mPas, and is preferably in a range from 50 to 1,400 mPais, more preferably in a range from 150 to 1,350 mPa's, and even more preferably in a range from 200 to 1,300 mPas.
If the viscosity of the co-modified organopolysiloxane exceeds the upper limit described above, handling workability when used as a powder treatment agent will be negatively affected.
Hayashi at page 6, [0023]. One of ordinary skill is particularly motivated to explore lowering the number of D units in Hayashi’s MD30DR12DR41 DR63M (P6) or MD30DR12DR41 DR73M (P7) because Hayashi teaches one of ordinary skill that the number of D units is an optimizable result-effective variable/parameter. MPEP § 2144.05.
For example, Hayashi Table 1 shows a trend that lower D repeating units (i.e., products P1, P2, and P4, where D is 15) gives desired lower viscosities than products P3 or P5 where D is 33 mPas or 470 mPas. .
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Hayashi at page 20, Table 1 (emphasis added). One of ordinary skill can readily accomplish the above-proposed optimization by lowering the D units in the starting methylhydrogen polysiloxane of formula MD30DH6M from 30 to within the claimed range of 0 to 20. For example, by using the methylhydrogenpolysiloxane of formulae MD15DH3M (per Hayashi practical Examples 1, 2, and 4) as a replacement for the MD30DH6M employed in the cited Hayashi Examples 6 and 7. Hayashi at pages 18-19.
The above-proposed modification of either of Hayashi co-modified organopolysiloxanes MD30DR12DR41DR63M (P6) or MD30DR12DR41DR73M (P7) meets the claim 1 limitations of:
1 . . . wherein the value of HLB, defined as HLB = (total molecular weight of hydrophilic group portions / total molecular weight) x 20, is within a range of 0.5 to 2.0, and
wherein the viscosity at 25°C is within a range of 200 to 1500 mPa·s . . .
because Hayashi teaches that low viscosity and HLB value is a general property extending through the full range of disclosed co-modified organopolysiloxanes. Hayashi at page 11, [0058] (HLB); Hayashi at page 6, [0020]; see also, Id. at [0023] (viscosity). Furthermore, lowering the D units in MD30DR12DR41DR63M (P6) or MD30DR12DR41DR73M (P7), as proposed, is expected to give HLB and viscosity in the claimed range based on Hayashi Table 1. As discussed above, Hayashi Table 1 shows a trend that lower D repeating units (i.e., products P1, P2, and P4) gives desired lower viscosities. MPEP § 2112(V) (citing In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).5
Claims 6-11 are obvious because Hayashi teaches that the disclosed co-modified organopolysiloxane are useful as cosmetic raw material components, more particularly is extremely useful as a powder treatment agent or powder dispersing agent for use in surface treating a powder or dispersing a powder. Hayashi at page 14, [0075]. Respecting claims 9 and 11, Hayashi teaches the following powder in oil dispersion:
A powder in oil dispersion comprising:
(A) the co-modified organopolysiloxane described in any one of 1 to 9,
(B) a powder or coloring agent, and
(C) one or more oil agent selected from a silicone oil, a nonpolar organic compound, and a low polarity organic com pound that is liquid from 5° C. to 100° C.
Hayashi at page 5, col. 2.
Respecting claim 10, the cosmetic powder formulations taught by Hayashi are clearly topical agent compositions.
The limitations of claim 13 are met for the following reasons.
13. The co-modified organopolysiloxane according to claim 1, wherein
the HLB value is within a range of 1.5 to 2.0,
R2 in structural formula (1) is an alkyl group having 8 to 20 carbon atoms,
and the viscosity at 25°C is within a range of 700 to 1450 mPa-s.
The limitations of claim 13 are met because in proposed modified compounds MD0-20DR12DR41DR63M (modified P6) and MD0-20DR12DR41DR73M (modified P7) the corresponding R2 variable are the respective alkyl groups -C8H17 and -C12H25. Further, the HLB values and viscosities of the proposed compounds would fall within the claim 5 range for the same reasons discussed above. MPEP § 2112(V) (citing In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977). The proposed modification gives a co-modified organopolysiloxane expressed by structural formula (1) that is very close in structure to the elected species differing only in R2 is -C16H33 (elected species) versus proposed product R2 is -C12H17.
The limitations of claim 14 are met because in proposed modified compounds MD0-20DR12DR41DR63M (modified P6) and MD0-20DR12DR41DR73M (modified P7) the corresponding R1 variable is methyl.
The limitations of claim 15 are met because in proposed modified compounds MD0-20DR12DR41DR63M (modified P6) and MD0-20DR12DR41DR73M (modified P7) R1 in general formula (2-1) is methyl.
Applicant’s Argument
Applicant argues that Hayashi does not direct a skilled artisan to the presently claimed combination of the specifically recited L1 and Q groups together with the claimed siloxane-unit distribution and property limitations. Reply at page 13. Rather, the rejection relies on selecting L1 from one portion of Hayashi, selecting a particular diglycerin-type Q from another portion, and then further modifying Hayashi' s example compounds to change the siloxane composition in a way that aligns with Applicant's claim. Applicant argues that this is not a straightforward teaching of the presently claimed compound from Hayashi itself, but a reconstruction of Applicant's invention using Applicant's disclosure as a roadmap. Reply at page 13.
This argument is not persuasive for the following reasons. Any judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper. MPEP § 2145(X)(A). Here the § 103 rationale takes into account only subject matter disclosed in the cited art.
The § 103 rational sets forth specific motivation to select the product of Hayashi Practical Examples 6 or 7, because these are working examples demonstrated as effective by Hayashi; for instance P6 below:
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and thereafter structurally modify this product by lowering the number of D units to within the claimed range of “n1 is a number within a range of 0 to 20” (i.e., substitute Hayashi’s MD30 in P6 and/or P7 with MD0-20) to lower the viscosity as suggested by Hayashi. The § 103 rational does not select L1 from one portion of Hayashi and select a particular diglycerin-type Q from another portion; rather Hayashi products P6 and P7 already have the same Q and L1 variables as claimed. Although it is noted that Hayashi does teach using the methylhydrogenpolysiloxane of formulae MD15DH3M (per Hayashi practical Examples 1, 2, and 4) as a replacement for the MD30DH6M employed in the cited Hayashi Examples 6 and 7. Hayashi at pages 18-19. This provides one of ordinary skill further motivation to make the proposed modification.
Applicant argues that a general appreciation that viscosity may be influenced by structural changes does not, by itself, provide a reason to select Hayashi' s compounds and then alter them in the precise way required by the claims. Reply at page 13. Applicant argues that moreover, to modify Hayashi in such a manner is directly opposite Hayashi' s express teachings and it could be argued that the proposed modification would render Hayashi unsuitable for its intended purpose.
This argument is not persuasive because Hayashi teaches that variable n1 in formula (1-1-1):
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is “a number in a range from 0 to 70”. Hayashi at page 11, [0062]. This overlaps with the claim 1 range of 0 to 20. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05(I) (citing In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)). Hayashi effectively teaches that the prosed modification of Hayashi’s co-modified organopolysiloxanes MD30DR12DR41DR63M (P6) or MD30DR12DR41DR73M (P7), by lowering the number of D units to within the claimed range of “n1 is a number within a range of 0 to 20” (i.e., substitute Hayashi’s MD30 in P6 and/or P7 with MD0-20) give effective compounds.
Claim Rejections 35 U.S.C. 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
For an originally filed claim, 35 U.S.C. 112(a) requires that the specification shall contain a written description of the invention demonstrate that the inventor was in possession of the invention that is claimed.6 MPEP § 2163(I); MPEP § 2163(II)(A)(3)(a). Possession may be shown by disclosure of drawings or structural chemical formulas that show that the invention was complete. MPEP § 2163(I).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. MPEP § 2163(II)(A)(3)(a)(ii). A "representative number of species" means that the species which are adequately described are representative of the entire genus. MPEP § 2163(II)(A)(3)(a)(ii). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. MPEP § 2163(II)(A)(3)(a)(ii) (citing AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
The § 112(a) rejection
Claims 1, 6-11, and 13-15 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement because the application as filed does not disclose either sufficient species of structural formula (1) that, per claims 1 or 13, function such that:
Claim 1 . . . wherein the viscosity at 25°C is within a range of 200 to 1500 mPa·s . . .
Claim 13 . . . wherein . . . the viscosity at 25°C is within a range of 700 to 1450 mPa·s . . .
or a structure-function correlation between formula (1) and viscosity, such that one of skill can recognize which species of structural formula (1) will function so as to exhibit the claimed viscosity.
Claims 13-15 are added to this rejection view of Applicant’s amendments. Applicant cancelled claim 12 and made claim 13 dependent upon claim 1, which increases the scope of claim 13 and its dependents. Still further, the amendment to claim 13 now renders variable Z structurally undefined (per amended claim 1) as any “divalent organic group”, thereby greatly increasing the scope of claim 13 as well as its dependent claims 14 and 15. Amended claims 13-15 are further added to this rejection in view of Applicant’s argument that claim 1 “structural formula (1)” should be interpreted as not requiring the sequential arrangement units along the polymer chain as drawn; rather structural formula (1) should be interpreted as permitting any order of structural units. Reply at page 10; see also, § 112(b) rejection above. Such interpretation greatly increases the complexity of claim 1 “structural formula (1)”.
Guidance and Predictability
It is first noted that what is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. MPEP § (II)(A)(3)(a). Thus, the state of and predictability in the art is a relevant consideration in determining compliance with § 112(a), written description. MPEP § (II)(A)(3)(a) (citing Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1085 (Fed. Cir. 2005) ("The ‘written description’ requirement must be applied in the context of the particular invention and the state of the knowledge…. As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution”).
Specification Body up to the Working Examples
The most relevant specification guidance, before the working examples, is that in order to achieve the claimed viscosity, one of ordinary skill must balance the hydrophilicity as well as the number of repeating units (i.e., variables n1 to n4). For example, the specification teaches that the HLB value is related to viscosity and that as the number of hydrophilic groups increases within formula (1), the viscosity of the co-modified organopolysiloxane itself tends to increase due to the cohesive force caused by hydrogen bonding, which may result in insufficient handling workability when used as a powder treatment agent. Specification at page 5, [0011]. The specification further teaches that:
[0013] Note that the viscosity of the co-modified organopolysiloxane is greatly affected by the type and amount of the hydrophilic group (Q) as well as the degree of polymerization n1 to n4 of each diorganosiloxy unit in general formula (1) and the sum (n1 +n2+n3+n4). Therefore, the values of n1 to n4 in structural formula (1) must be within the viscosity range described above, and it is particularly preferable that the range of (n1 + n2 + n3 + n4) is 8 to 25, n1 is 3 to 10, n2 is 1 to 10, n3 is 0.1 to 10, and n4 is 0.5 to 2.0.
Specification at page 6, [0013] (emphasis added). In sum, the specification, up to the working examples, merely teaches that there is general relationship between formula (1)’s hydrophilicity (particularly the hydrophilicity of groups Q) and viscosity, but does not teach any specific structure function relationship; that is how one of skill mixes and matches variables R1, L1, and Q, as well as the number of repeating units to achieve the claimed viscosity.
Specification Working Examples
Specification Examples 1-4 are the only working examples purported to be directed to preparing the claim 1 product. Working Example 1 directed to preparation of MD5.2DR13.2DR21.3DR33.5M is summarized by the Examiner below.
Specification Example 1 at page 26, [0070]
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Specification at page 26, lines 15-31. The specification does not identify the platinum catalyst. Specification working Examples 2-4 employ the same procedure and starting reagents, but in varying amounts and with different compositional averages of the methylhydrogenpolysiloxane to achieve the addition three co-modified organopolysiloxane polymers MD5.2DR13.0DR21.5DR33.5M (Example 2); MD18DR10.2DR20.7DR32.6M (Example 3); and MD29DR11.6DR20.7DR35.0M (Example 4). Specification at pages 27-28. Specification Table 1 summarizes the HLB and viscosity data for working Examples 1-4. Specification at page 30.
In sum, the products of working Examples 1 to 4 all have the same R1, R2, L1 and Q groups and differ only in the number of repeating units.
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Neither the art cited by Applicant (by way of Information Disclosure Statements) nor art identified in searches supplements the specification by disclosing structure function relationship guiding one of skill to the mixing and matching of claim 1, formula (1) variables R1, R2, L1, and Q, as well as the number of repeating units, to achieve the claimed viscosities.
Further, the specification gives no guidance regarding the case where the claim 1 “structural formula (1)” is interpreted (as proposed by Applicant) as permitting any order of structural units. Reply at page 10; see also, § 112(b) rejection above. Such interpretation greatly increases the complexity of claim 1 “structural formula (1)”. The specification working Examples give products all having the same structural-unit-arrangement order.
Predictability of Viscosity in Organopolysiloxanes
The art teaches that viscosity of organopolysiloxanes is dependent upon a number of interrelated structural factors. For example, Zolper teaches that polymer viscosity increases with macromolecule length, branch content, and branch length, effectively the molecular mass and for polymers of the same branch type and content, viscosity increases linearly with the weight average molecular mass Mw, up to the critical mass Mc but molecular entanglement becomes significant above the critical molecular mass. T. Zolper et al., 136 Journal of Tribology, 1-12 (2014) (Zolper at page 2, col. 1). Zolper further teaches that molecular entanglement becomes significant above the critical molecular mass, which varies from 2000 to 60,000 g/mol for different polymers. Id.
In another example, A. Hayashi et al., US 9,994,680 (2018) teaches that that with organopolysiloxanes, if the content of the hydrophilic groups is high, the polyglycerol and the sugar alcohol residue will have many hydroxyl groups and the viscosity of the co-modified organopolysiloxane itself will tend to increase due to cohesive force resulting from hydrogen bonding and as a result, handling workability may be negatively affected in cases when used as a powder treatment agent. At col. 22, lines 1-10.
Clearly, there is a complicated balance between organopolysiloxane structure and the resulting viscosity, including molecular weight, repeating unit length, and the degree of hydrophilicity of claim 1 variable Q.
Claim Breadth
Claim breath is relevant to the instant § 112(a) written description rejection. The written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. MPEP § 2163(II)(A)(3)(a)(ii) (citing Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021)).
Here the genus of formula (1) is vast and complex respecting mixing and matching variables R1, R2, Q and L1, their respective order of arrangement, and particularly respecting hydrophobic and hydrophilic portions, which the specification teaches is the key to arriving at the claimed viscosity. Specification at page 6, [0013].
For example, in structural formula (1), the choices are made from amongst a vast number of potentials because:
R1 is a substituted or unsubstituted monovalent hydrocarbon group having 1 to 30 carbon atoms, or a hydrogen atom;
R2 represents a substituted or unsubstituted straight-chain or branched monovalent hydrocarbon group having 6 to 30 carbon atoms; and
Z [in formula Q and L1] is any divalent organic group,
Claims 1, 6-11, and 13-15 Lack an Adequate Written Description
Claims 1, 6-11, and 13-15 lack adequate written description support because the application as filed does not disclose either sufficient species of formula (1) that, per claim 1 or 13, function such that:
Claim 1 . . . wherein the viscosity at 25°C is within a range of 200 to 1500 mPa·s . . .
Claim 13 . . . wherein . . . the viscosity at 25°C is within a range of 700 to 1450 mPa·s . . .
or a strong structure-function correlation between formula (1) and viscosity, such that one of skill can recognize which species of formula (1) will exhibit the claimed viscosity. Dependent claims 6-11, and 14-15 do not sufficiently narrow in this respect.
Here, Applicant is not in possession of the full claim scope because neither the specification nor the art of record provides sufficient guidance allowing one of skill to correctly choose claim 1, formula (1) variables R1, L1, and Q as well as the correct number of repeating units (i.e., correctly choose variables n1, n2, n3, and n4, where their sum is within 2 to 50) such that one of skill would recognize Applicant’s possession of the full scope of those members encompassed by claim 1 formula 1 that exhibit the claimed viscosity.
In sum, the claims recite numerous possible structural combinations but neither the art nor the specification shows a well-established correlation between the claimed viscosity and mixing and matching the claim 1 variables such that one of skill can recognize which variable combinations perform the claimed function. As stated above, the written description requirement may also be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. MPEP § 2163(II)(A)(3)(a)(i). In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. MPEP § 2163(II)(A)(3)(a)(i) (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406).
As discussed above, the specification discloses a general relationship between the number of hydrophilic groups and viscosity. But this does not amount to a strong correlation between specific structure and obtaining a co-modified organopolysiloxane expressed by structural formula (1) with the particular viscosity at 25°C in the range of 200 to 1500 mPa·s.
Here, it is true that claim 1 recites some structure, but it also leaves a large number of the formula (1) structural aspects undefined. Disclosure of function and minimal structure may be sufficient when there is a well-established correlation between structure and function. MPEP § 2163(II)(A)(3)(a)(i). In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. MPEP § 2163(II)(A)(3)(a)(i) (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406). Accordingly, a “sufficient description . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010).
Here, the specification does not disclose a representative number of species because, as discussed above, only four co-modified organopolysiloxane polymers: MD5.2DR13.2DR21.3DR33.5M (Example 1)’ MD5.2DR13.0DR21.5DR33.5M (Example 2); MD18DR10.2DR20.7DR32.6M (Example 3); and MD29DR11.6DR20.7DR35.0M (Example 4) are disclosed.
And these all have the same basic structure and all have the same R1, R2, L1 and Q groups, and essentially differ only in the number of repeating units.
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A "representative number of species" means that the species which are adequately described are representative of the entire genus. MPEP § 2163(II)(A)(3)(a)(ii); see also, Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1164 (Fed. Cir. 2019) (“[a]s a result, a POSA is deprived of any meaningful guidance into what compounds beyond the examples and formulas, if any, would provide the same result”). Here the very structurally similar disclosed species are clearly not representative of the claimed genus.
Applicant’s Argument
Applicant argues that the specification expressly teaches that viscosity is affected by the type and amount of hydrophilic group Q, the degrees of polymerization n1 to n4, and the sum of n1+n2+n3+n4, and it further provides preferred ranges for those values. In particular, the specification states that viscosity is "greatly affected" by those parameters and identifies preferred ranges for n1 to n4 and their sum in relation to the desired viscosity.
This argument is not persuasive because the values of n1, n2, n3, and n4 is only one parameter encompassed by the claims. To achieve the claimed viscosities, one of ordinary skill must balance many additional structural relationships and variable.
Applicant argues that the § 103 rationale relies on the proposition that a skilled artisan would understand how viscosity changes as the number of siloxane repeating units is adjusted, characterizing the number of D units as an optimizable result-effective variable and asserting that lowering the number of D units would predictably lower viscosity. Reply at page 14. Applicant reasons that if that is so for purposes of the Examiner's obviousness rationale, then it likewise confirms that a skilled artisan would understand from the present specification how the claimed viscosity is tied to polymer structure, including adjustment of the repeating units. Reply at page 14.
This argument is not persuasive because the § 103 rationale is based on specific selection of Hayashi’s prior art co-modified organopolysiloxanes MD30DR12DR41DR63M (P6) or MD30DR12DR41DR73M (P7), and further lowering the number of D units to within the claimed range of “n1 is a number within a range of 0 to 20” (i.e., substitute Hayashi’s MD30 in P6 and/or P7 with MD0-20) give effective compounds. And Hayashi specifically teaches that variable n1 in formula (1-1-1) is “a number in a range from 0 to 70”. Hayashi at page 11, [0062]. Thus, the § 103 rationale is based on specific teachings to arrive at specific specie falling within the claims. Further, § 103 and § 112(a) are analyzed on under different statutes.
Applicant further argues that the working examples reinforce possession rather than undermine it. The Office Action recognizes that Examples 1-4 use the same core R1, R2, L1, and Q groups and differ principally in the number of repeating units, and specification Table 1 reports the resulting HLB and viscosity values for those examples. Reply at page 14. Applicant argues that is exactly the sort of disclosure a skilled artisan would use to understand how viscosity is controlled within this family of organopolysiloxanes. Reply at page 14.
This argument is not persuasive for the following reasons. The point of the § 112(a) rejection is not whether viscosity can be controlled by structural modification, but whether one of skill can recognize which species fall within the functionally claimed genus. The specification working examples disclose only four co-modified organopolysiloxane polymers: MD5.2DR13.2DR21.3DR33.5M (Example 1)’ MD5.2DR13.0DR21.5DR33.5M (Example 2); MD18DR10.2DR20.7DR32.6M (Example 3); and MD29DR11.6DR20.7DR35.0M (Example 4), all with the same core R1, R2, L1, and Q groups. Thus, a claim to limited to these particular species would be supported under § 112(a). Here, however, the neither the specification nor the art of record provides sufficient guidance (e.g., representative species or structure-function relationships) allowing one of ordinary skill to recognize, outside of those species disclosed, which polymers otherwise falling within the board genus of structural formula (1) will exhibit the claimed viscosity.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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ALEXANDER R. PAGANO
Examiner
Art Unit 1692
/ALEXANDER R PAGANO/Primary Examiner, Art Unit 1692
1 As discussed in the MPEP a lack of clarity could arise where a claim refers to "said lever" or "the lever," where the claim contains no earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation was making reference. MPEP § 2173.05(e). Similarly, if two different levers are recited earlier in the claim, the recitation of "said lever" in the same or subsequent claim would be unclear where it is uncertain which of the two levers was intended. MPEP § 2173.05(e). A claim which refers to "said aluminum lever," but recites only "a lever" earlier in the claim, is indefinite because it is uncertain as to the lever to which reference is made. MPEP § 2173.05(e).
2 Chemical shorthand nomenclature is often used to represent silicone polymers based upon polymer units. Dow Corning Corporation, Silicone Chemistry Overview, 1-11 (1997) (“Dow Corning”); A. Colas et al., Handbook of Polymer Applications in Medicine and Medical Devices, 131-143 (2013); A. O’Lenick, 3 Journal of Surfactants, 229-236 (2000) (page 231, col. 2, Table 1). Dow Corning provides a description of the short hand nomenclature for siloxane units as follows.
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In these silicone building blocks, the numerator in the subscript "fraction" following the "O" represents the number of oxygen atoms connected to the particular silicon, and the denominator "2" indicates that each of these oxygen atoms are shared between two silicon atoms. Id.; see also, J. Grande et al., 46 Chem. Commun., 4988-4990 (2010) (see page 4990 under “Notes and references”). For example with SiO4/2, that there are four single bonds to oxygen from silicon, and that each oxygen bonds to another silicon through a single bond, i.e., Si(OSi)4 rather than SiO2, which might imply SiO2 double bonds. Id.
3 See, Hayashi at page 19, [0132] (stating that “In this formula, R1 and R4 are synonymous with those described above and R6 has the structure described below: R6 = -C8H17”). These asserted identities of R1, R4,and R6 in Hayashi’s MD30DR12DR41 DR63M are also confirmed by S. Hori et al., US 10,172,779 (Jan. 8, 2019) (“Hori”) at col. 43, lines 1-8. Hori teaches the same preparation of MD30DR12DR41 DR63M and states these specific identities of R1, R4 and R6.
4 If a claim is subject to more than one interpretation, at least one of which would render the claim unpatentable over the prior art, the examiner should reject the claim as indefinite and should reject the claim over the prior art based on the interpretation of the claim that renders the prior art applicable. MPEP § 2143.03(I).
5 When the examiner "has reason to believe" that the prior art reference inherently teaches the functional limitation, the burden shifts to the patent applicant to show that the functional limitation cannot be met by the prior art reference. MPEP 2112(V), see also, In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997); In re Chudik, 674 F. App'x 1011, 1012 (Fed. Cir. 2017)
6 While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, a question as to whether a specification provides an adequate written description may arise in the context of an original claim. MPEP § 2163.03 (V) (citing In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976)). An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. MPEP § 2163.03 (V) (citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) ("[e]ven if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed”).
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